Medical Design & Outsourcing – NOVEMBER 2021 by WTWH Media LLC

A N E V E N L A R G E R M E D T E C H S U P P LY C H A I N S H O C K L O O M S B E Y O N D T H E PA N D E M I C

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www.medicaldesignandoutsourcing.com NOVEMBER 2021

THE TOP MEDICAL DEVICE EMPLOYERS

RESEARCH & DEVELOPMENT: WHO’S SPENDING THE MOST?

WHERE ARE THE GLOBAL MEDTECH HEADQUARTERS?

A N E V E N L A R G E R M E D T E C H S U P P LY C H A I N S H O C K L O O M S B E Y O N D T H E PA N D E M I C

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www.medicaldesignandoutsourcing.com NOVEMBER 2021

THE TOP MEDICAL DEVICE EMPLOYERS

RESEARCH & DEVELOPMENT: WHO’S SPENDING THE MOST?

WHERE ARE THE GLOBAL MEDTECH HEADQUARTERS?

Innovative Sensor Manufacturing If you can dream it, we can design it, develop it, and produce it.

Partner with leading industry experts to bring breakthrough medical devices and diagnostics to market. Take your products further with comprehensive sensor design, advanced engineering, micro-manufacturing, and assembly solutions. Visit Resonetics.com.

2 Conceptual rendering of the multi-jointed robotic arm of a surgical system.

3 1 4

Giving robots a sense of touch FUTEK's miniaturized sensor technology allows surgeons to perform as if they had virtual fingertips. The sensors’ precise measurement and feedback allow the machine to emulate the dexterity and haptics of human hands.

QTA143

Micro Reaction Torque Sensor

Dimensions: 14 mm × 10 mm × 26 mm Provides closed-loop feedback on torque measurement.

LSB205

Miniature S-Beam Jr. Load Cell

Dimensions: 19 mm × 18 mm × 6.6 mm Provides critical force feedback.

QLA401

Load Cell Built for Autoclave

Dimensions: Ø 14 mm × 3.28 mm Designed to withstand the autoclave sterilization process.

go.futek.com/medtech

QLA414

ANSI

ISO

Z540-1

17025

9001

13485

U.S. Manufacturer

Nano Force Sensor

Dimensions: 4mm × 5mm Enables direct measurement that eliminates any drift in the output.

Solutions First Medical Device Solutions YKK solves complex fastening and attaching challenges for the medical device market. Our portfolio spans from off the shelf to tailored product and machinery options allowing us to customize the ultimate solution for your needs.

Extruded Hook Fasteners

Injection Molded Buckles

Production Process Improvements

ECG Studs

Water Resistant Mattress Zipper

MEDICAL DEVICE SOLUTIONS

Medical Design & OUTSOURCING EDITORIAL S TA F F

EDITORIAL

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EVENTS

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Senior Editor Danielle Kirsh dkirsh@wtwhmedia.com

2011 - 2020

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2014 Winner

Editorial Director DeviceTalks Tom Salemi tsalemi@wtwhmedia.com

VP Lifesciences Mary Ann Cooke mcooke@wtwhmedia.com 781.710.4659

2014 - 2016

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2013 - 2017

medicaldesignandoutsourcing.com November 2021 ∞ Vol7 No7

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Medical Design & Outsourcing

11 • 2021

PRECISION METAL COMPONENTS & ASSEMBLIES

Trusted supplier of Endo-Mechanical Electro-Surgical Pharmaceutical Ophthalmic Blade Blanks Custom Electrical Contacts

Partners in Innovation

The relationship between design, material, and manufacturing is symbiotic. Each element is continually pushed to its limit by the other. It is the foundation of innovation.

Look Beyond Possibility

Innovation happens when we look beyond what we know to be possible. Disruptive thinking, advanced technology, and challenging our own experience makes the breakthroughs of tomorrow a reality.

Pioneering Mindset

As a pioneer in manufacturing precision components for medical and surgical devices, Hobson & Motzer has the tools, technology, and mindset to drive robotic innovation.

PRECISION METAL STAMPING • COINING • CNC MACHINING • PROJECT MANAGEMENT PROJECT BASED RAPID PROTOTYPING • TOOL DESIGN & ENGINEERING • PRECISION ASSEMBLY & SECONDARY OPERATIONS • R&D—MECHATRONICS • PRECISION ELECTRO-CHEMICAL MACHINING

www.hobsonmotzer.com 1-800-476-5111

Improving Lives, Advancing Technology, Transforming Metal

Ask about our rapid precision prototype program, First Step.

NEW!

HERE’S WHAT WE SEE

4 AXIS SERVO from

People move the medtech industry forward

2.25”

he term “supply chain” brings to mind cold, hard steel, rather than the living, breathing people who keep medical device manufacturing moving from start to finish. The global scramble for semiconductors and raw materials like resin has confounded manufacturers across all industries, and we’re all feeling the pain of shipping delays, whether by sea, rail or road. Companies that are successfully keeping up or ramping up are quick to credit the people who make it happen, from engineering teams to procurement groups, warehouse workers and suppliers. When automakers canceled their chip orders in anticipation of a long, deep pandemic recession, buyers in the medical device industry got even closer with their suppliers — and kept cash flowing to the people who make and move the goods. Everyone’s paying in minutes, hours, days and dollars for the shipping industry’s short-sighted layoffs, but the medtech industry’s largest companies — as featured in this edition’s annual Big 100 rankings — did what they could to retain or add workers. The big companies’ efforts to preserve and grow jobs matter even more considering that their aggregate revenue dropped 1.2% in 2020 compared to 2019, according to our analysis of Big 100 data. Of the nearly 90 companies in the Big 100 that provided employment data, about half added workers amid the pandemic, and more than a handful of others kept their headcounts the same. The medical device industries’ largest companies certainly weren’t recession-proof this time around. Still, they held their own as they played a vital role in the fight against COVID-19. These same companies are prioritizing their people when planning for climate change — the next big Jim Hammerand disruption that’s already upon us —as you’ll read Managing Editor in one of the feature stories in this edition. The Medical Design & extreme weather events causing power outages Outsourcing and damaging medical device facilities are also j i m h a m m e ra n d@ wtwh m e di a .c o m hammering the same neighborhoods, cities and regions where our industry’s most valuable assets live. When a factory returns to service faster than anticipated after a natural disaster, local teams are often to thank for the heavy lifting even as they help their own families and neighbors. We’re not out of this pandemic yet, but the enduring resilience of medtech should encourage us as we push forward and remind us that when we take care of our people, they take care of us.

- brushed or bldc motors - 5 amps per axis - 16 analog inputs - 16 on/off drivers - home and limit in - live tech support - made in the USA See the

EZQUAD SERVO in action!

"The medical device industries' largest companies certainly weren't recession-proof this time around. "

WWW.ALLMOTION.COM

(510) 471-4000 30097 Ahern Avenue Union City, CA 94587 Te c h n i c a l S u p p o r t

(408) 460-1345

Medical Design & Outsourcing

11 • 2021

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SHI

P IN M ED T

WINNERS CONGRATULATIONS PRESENTED BY

Medical Design & OUTSOURCING

LEA

DERSHIP

WIN

A D VA N CED MATERI A L S CA B L ES

CO N TRA CT MA N U FA CTU RI N G CO U PL I N G S D ESI G N SERVI CES D IG I TA L MA N U FA CTU RI N G

Medical Design & Outsourcing is excited to release the winners of our annual Leadership in Medical Technology

EL ECTRICA L FA STEN IN G & JO I N IN G F L U ID PO W ER

program. Since we announced the nominees

I N JECTI O N MO L D I N G

in our January 2021 issue and online, our user community has voted on what companies they feel best exemplify medical technology leadership in 15 categories. We are happy to celebrate the winners here.

MA CH IN IN G MO TIO N CO N TRO L PRO D U CT D EVEL O PMEN T SO F TWA RE TESTIN G / CO MPL IA N CE 11 • 2021

Medical Design & Outsourcing

Congratulations Master Bond

HIP IN ME DT

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A D VA N C E D M AT E R I A L S PRESENTED BY

Medical Design & OUTSOURCING

LEA

DERSHIP

N WIN

Master Bond is celebrating 40 years of formulating cutting edge adhesives, sealants, coatings and potting/encapsulation systems for challenging medical device applications. Our epoxies, silicones, UV curable and LED curable compounds can be customized to meet requirements including high/low temperature resistance, electrical conductivity/insulation, thermal conductivity, sterilization resistance, high/low viscosity, ﬂexibility and toughness, and optical clarity. Developed to withstand harsh environmental conditions, our products feature superior long-term durability. Used in a variety of industries and designed to meet stringent industry standards, they are certiﬁed for USP Class VI, ISO 10993-5, NASA low outgassing, FDA CFR 175.300 & FDA CFR 175.105, UL 94V-0 and UL 94V-1.

See how Master Bond began in a video that celebrates our 40 year history as an adhesives formulator.

Master Bond makes customer support a fundamental priority. Our technical specialists have decades of experience and will work with you throughout design, prototyping and manufacturing. MasterSil 912Med is a single component silicone with a paste viscosity offering a non-corrosive, neutral cure. Complying with USP Class VI and ISO 10993-5 speciﬁcations, it resists many kinds of sterilization and withstands rigorous thermal cycling as well as thermal and mechanical shock. Master Bond UV15DC80Med is a special dual cure epoxy based system that offers a primary cure using UV light along with a secondary heat curing mechanism. This enables the adhesive to cure areas on parts that do not allow UV light curing because of “shadowing” issues. It also meets USP Class VI speciﬁcations and passes ISO 10993-5 cytotoxicity testing.

Medical Design & Outsourcing

11 • 2021

www.medicaldesignandoutsourcing.com

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C ABLES

Congratulations New England Wire Technologies

PRESENTED BY

Medical Design & OUTSOURCING

LEA

DERSHIP

N WIN

Founded in 1898 in response to the birth of the communication age, today New England Wire is advancing innovation in several industries including medical device and electronics, aerospace, defense, robotics/automation, power generation, and alternative energy. Our capabilities include custom Litz wire, miniature, micro-miniature, single and multiconductor cables, low-noise, high temperature, coaxial and hybrid cables. Since the 1960’s, we have provided cabling and insulating services to the superconductor industry where our products are integrated into most of the major accelerator projects, ore separator magnets, NMR magnets, and superconducting magnetic energy storage (SMES) magnets. Through our creative design and development expertise, our engineering staff specializes in product development, concurrent engineering, design for manufacturability, and quick-turn prototyping. Our onsite manufacturing processes include wire drawing, plating, braiding, insulating, and extrusion services. And, since all of our proprietary equipment and tooling is designed and built in-house, we have complete control while also offering quick modiﬁcations when needed. Through true vertical integration of the manufacturing processes, our customers’ design-to-market curve is the shortest in the industry! New England Wire Technologies is committed to being the premier custom cable manufacturer of choice for customers in existing and emerging worldwide specialty cable markets. We help our customers dream beyond today’s technology and achieve the impossible!

NEW ENGLAND WIRE T E C H N O LO G I E S

www.medicaldesignandoutsourcing.com

11 • 2021

Medical Design & Outsourcing

Congratulations Freudenberg Medical

HIP IN ME DT

S ER

CO N T R AC T M A N U FA C T U R I N G PRESENTED BY

Medical Design & OUTSOURCING

LEA

DERSHIP

N WIN

Freudenberg Medical is a global CMO / CDMO with 11 manufacturing operations and more than 1,500 associates worldwide. Manufacturing capabilities range from high precision molded components and medical tubing to drug coatings, finished devices, catheter shafts and hypotubes for minimally invasive, handheld, and catheter-based devices. Freudenberg Medical has recently introduced a number of pioneering process and product innovations, including: Helix iMC™, a groundbreaking extrusion technology that continuously measures the inner geometry of silicone tubes, increasing product quality for critical applications and dramatically reducing material waste and process time. HelixTwist™ multi-lumen tubing, designed to provide an equal balance of stress across the inner and outer lumens as the tube bends. Ideal for pacemakers, breathing tubes, and other applications for tortuous bodily navigation. Freudenberg Medical has developed a proprietary conductive silicone compound used for smart therapeutic devices that deliver electrical currents also to shield sensitive electronics. Freudenberg Medical holds 5 patents for minimally invasive technologies, including the Composer® Catheter Handle Platform, hemostasis valves with variable diameter seals, and expandable introducer sheaths. Three next generation Product Solutions were added to the portfolio: Composer® EPIC and Composer® Toccata Catheter Handle Platforms, and the HyperSeal® Mini hemostasis valve. And from Cambus Medical, Velona Custom & Specialty Needles for fine needle aspiration, fine needle biopsy, minimally invasive delivery systems, and structural heart applications.

Medical Design & Outsourcing

11 • 2021

www.medicaldesignandoutsourcing.com

Congratulations Rotor Clip

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COUPLINGS PRESENTED BY

Medical Design & OUTSOURCING

LEA

DERSHIP

N WIN

Rotor Clip is a globally recognized manufacturer of high-quality retaining rings, spiral rings, wave springs and hose clamps. Companies across a broad range of industries rely on Rotor Clip products, value-added services and expertise to build reliable and safe equipment for virtually any application. Rotor Clip operates in the US, UK, Germany, China, and the Czech Republic, providing worldwide service to its customers. Rotor Clip has received quality awards from major OEMs, automotive manufacturers, and distributors. Rotor Clip produces its products under IATF 16949, ISO 9001, AS 9100C, and ISO 14001 standards. Wave Springs - Rotor Clip manufactures the largest range of Wave Springs in the market, from .188” to 25” O.D. Spiral Rings - Spiral Rings are axially installed into machined grooves in housings/bores or on shafts to retain assemblies. Tapered Section Retaining Rings –We make over 50 different styles, and well over 1000 part numbers. Hose Clamps - Perfect ﬁt every time, uniform hose pressure, and a lower cost and weight leaving more budget room. Custom Material and Finish Options - We can produce these parts in Carbon Steel, Stainless Steels Alloys, Beryllium Copper, Phosphor Bronze, and Specialty Steel Alloys. We also have several ﬁnishing options to withstand almost any condition: including many RoHS and REACH compliant options.

www.medicaldesignandoutsourcing.com

11 • 2021

Medical Design & Outsourcing

Congratulations Stock Drive Products/ Sterling Instrument

HIP IN ME DT

S ER

DESIGN SERVICES PRESENTED BY

Medical Design & OUTSOURCING

LEA

DERSHIP

N WIN

Established 1950, SDP/SI provides engineering development and manufacturing for many of the most recognized companies in medical, aerospace and robotics today. The state-of-the-art Hicksville, NY facility houses the latest manufacturing, industrial automation, and inspection equipment available. Employing skilled machinists, CNC programmers, inspectors, engineers, and customer service personnel, we meet and surpass expectations. Standard catalog components can be found and purchased online where free 3D CAD models and part speciﬁcations can be easily downloaded. Manufacturing capabilities include precision gear cutting, 5-axis milling, 9-axis Swiss turning, and world class quality. Facing a design challenge? SDP/SI partners with many Fortune 500 companies in new and exciting projects. Applying years of experience, product knowledge, and design acumen our engineering and manufacturing teams provide innovative solutions through part selection, modiﬁcations, or custom design. Sometimes the best solution is the simplest. Standard components are a costeffective option and with 87,000 machined and molded components offered, SDP/SI is the engineer’s preferred source. Celebrating our 70th anniversary this year, we continue to grow. Our ability to fully support projects from the development and prototype stage through the entire life cycle of a product has built a strong and loyal customer base. Our precision gears, machined parts, molded components, and drive assemblies can be found in high-tech operating rooms, movie sets, military operations, space exploration, and even on Mars. Partnering with OEMs around the world we manufacture and manage supply chain of precision components required for medical, surgical robotics, aviation, satellites, defense, automation, and commercial industries.

Medical Design & Outsourcing

11 • 2021

www.medicaldesignandoutsourcing.com

HIP IN ME DT

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D I G I TA L M A N U FA C T U R I N G

Congratulations Accumold

PRESENTED BY

Medical Design & OUTSOURCING

LEA

DERSHIP

N WIN

Accumold’s focus is on very small micro-sized plastic parts and components that other companies can’t produce. The original MicroMolder® was designed to help manufacture parts with minimal waste and short cycle times for electronic component manufacturing. The company focuses on industries that require fast turn around and complex parts for high tech industries such as Micro Electronics, Micro Optics and Medical, as well as emerging markets and technologies. Micro-Mold® parts are often measured in microns and are no bigger than 0.5 cubic inches, typically weighing less than a gram. These parts have very tight tolerances and must be molded efﬁciently and precisely — time and time again. Accumold builds specialized molding machines for this, engineered to handle volumes from prototypes to millions per year while maintaining consistent, precise tolerances. The specialized tooling and molding for micro-sized components are only available at Accumold. Not every micro-molded application requires microscopic parts, but many require demanding geometry and tight tolerances on a slightly larger scale. Micro-features incorporate very small features on a part up to about 3 inches in diameter. Lead Frame / Insert Molding Insert micro-molding involves molding in or around a variety of materials such as plastic, ceramic, glass, fabrics, ﬁlm or foil. This type of overmolding can be can be operator loaded or our Automation Team can build a custom loading system for high-volume applications.

www.medicaldesignandoutsourcing.com

11 • 2021

Medical Design & Outsourcing

Congratulations OKW Enclosures, Inc.

HIP IN ME DT

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ELEC TRIC AL PRESENTED BY

Medical Design & OUTSOURCING

LEA

DERSHIP

N WIN

OKW manufactures advanced enclosures for today’s electronics equipment. The enclosures can be supplied fully customized to customer speciﬁcations. The range includes the following popular versions: Handheld Enclosures Modern and ergonomically designed enclosures for mobile electronics used both indoors and outside. Standard features include recessed tops for locating membrane keypads, battery compartments for AAA, AA and 9V cells, integrated cable glands, infra-red versions, sealing kits up to IP 65, desk stations for charging and wall holders for storing. Many of these enclosures can also be used as wearable devices with the optional wrist/ hand straps, belt/pocket clips and lanyards. Instrument Enclosures Stylish high quality enclosures for table-top and portable electronic instruments. Large range of designs in plastic or aluminum with removable front panels or sloping front sections. Options include aluminum or plastic front panels recessed for membrane keypads, ventilation slots, battery compartments, bail arms or integrated handles and non-slip feet. Wall Mount Enclosures Advanced wall mount enclosures for indoor and outdoor electronics equipment. Stylish and modern design sets these enclosures apart from the norm. Standard features include hidden ﬁxing screws for a clean and tamperproof assembly, recessed top for a membrane keypad, standard ingress protection up to IP 67 ( NEMA 4X) and hinged solid or transparent lids.

Medical Design & Outsourcing

11 • 2021

www.medicaldesignandoutsourcing.com

Congratulations Lee Spring Company

HIP IN ME DT

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FA S T E N I N G & JOINING PRESENTED BY

Medical Design & OUTSOURCING

LEA

DERSHIP

N WIN

Founded in 1918, Lee Spring is headquartered in New York, with multiple locations in the United States, Mexico, Europe, India and China. The Lee Spring brand sets the standard for excellence through bold product innovations, quality manufacturing and responsive customer care. Lee Spring takes pride in creating solution-driven responses. The Lee Spring Sales Team, Engineering Team and Manufacturing Team collaborate to develop application specific resolutions. Lee Spring understands the value of our customers for well qualified engineering support. Lee Spring engineers can offer assistance from design conception through project completion. Extensive expertise in spring design and mechanical engineering complement our customers’ design teams. Lee Spring’s expanding global presence and in-depth knowledge of the worldwide marketplace puts Lee Spring at the leading edge of creating market specific solutions for customers’ needs. Lee Spring manufactures and distributes mechanical springs, wire forms, stampings and fourslide parts worldwide. Our extensive print and online catalog offers over 25,000 inventoried products in a variety of materials. From 10 springs to 10 million springs, Lee Spring is a premier global source for stock catalog and custom designed mechanical springs and related products. Lee Spring continues to respond to the voice of the customer with advanced Custom capabilities and unique Stock products such as LeeP™ Plastic Springs, Bantam™ Mini Springs, Lite™ Pressure Springs and our latest expansion of Stainless Steel 316 springs.

www.medicaldesignandoutsourcing.com

11 • 2021

Medical Design & Outsourcing

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F LU I D P O W E R

Congratulations Nitto Kohki USA, Inc.

PRESENTED BY

Medical Design & OUTSOURCING

LEA

DERSHIP

N WIN

Nitto Kohki USA, Inc. designs, develops, engineers, and continuously improves high quality air compressors and vacuum pumps for applications like medical devices, laboratory equipment, applied robotics and environmental sensing equipment. Nitto Kohki’s unique linear free piston design has one moving part per pump— the piston. The result is a pump with exceptionally reliable performance in tough medical applications. The linear free piston concept enables Nitto Kohki pumps to be smaller and lighter than conventional aerators, allowing designers greater ﬂexibility in system design. Nitto Kohki leads through exceptional product design and execution, with pumps that meet the rigorous demands of today’s medical device industry. Nitto Kohki pumps feature a unique, patent-awarded linear-motor-driven free piston system that is globally proven in the medical device, instrumentation, and other critical industries. This unique design theory eliminates the wear components typically found in conventional air compressors and vacuum pumps, such as crank shafts, connecting rods and ball bearings. The only moving part is the piston! Also eliminated is the need for any lubrication. Fewer parts translate into fewer problems. WHY DESIGNERS CHOOSE NITTO KOHKI • Exceptionally reliable performance for critical applications • World class manufacturing expertise ensures consistent product quality • Clean, simple design maximizes performance, minimizes maintenance — adding value over the integrated product lifecycle.

Medical Design & Outsourcing

11 • 2021

www.medicaldesignandoutsourcing.com

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INJEC TION MOLDING

Congratulations PTI Engineered Plastics

PRESENTED BY

Medical Design & OUTSOURCING

LEA

DERSHIP

PTI Engineered Plastics is a custom injection molder and manufacturer of plastic components and assemblies for the medical, automotive, defense/ aerospace, consumer products, and electronics industries. Design PTI Design can optimize your design or take your idea through a ﬁve-phase process to ensure your product has a competitive edge in the market. Tooling The PTI Tool Room is comprised of 40 highly skilled mold makers and utilizes a fully integrated network of 25 CNC machining centers. Production Manufacturing capabilities include low and high volume production, insert/overmolding, high-temperature molding, contract manufacturing, assembly and packaging.

www.medicaldesignandoutsourcing.com

N WIN

Smart Factory Technology PTI has 12 Arburg presses that are all equipped with a host computer system. These “smart machines” provide numerous beneﬁts from improved efﬁciency, safety, security, cost reduction and performance. Cleanroom Manufacturing Services within ISO Class 8 Cleanroom include injection molding, assembly, secondary operations and packaging. Secondary Services PTI offers an array of secondary services such as plastic joining, laser marking, and assembly. Color Lab PTI has added a color management lab to reduce lead time, allow for onsite adjustments, and reduce cost with its demand-based system. Validation PTI is fully versed and staffed in the IQ/OQ/PQ validation processes.

11 • 2021

Medical Design & Outsourcing

Congratulations Hobson & Motzer

HIP IN ME DT

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M AC H I N I N G PRESENTED BY

Medical Design & OUTSOURCING

LEA

DERSHIP

N WIN

As a trusted supplier to OEMs, we drive the latest thinking in manufacturing through innovation and technology. We are often relied upon to make the impossible possible—or pick up where others have failed. Our company is vertically integrated with key competencies in metal stamping, and 3-, 4-, and 5-axis high-speed CNC machining, PECM, laser cutting, welding, and assembly services. We also perform a wide range of secondary operations, all in house: pad printing, PTFE coating, metal ﬁnishing, electro polishing, and more. We have an extensive team of toolmakers and a highly equipped tool room—all supported by industryleading design engineers and skilled project managers. Our plants are highly automated, featuring robotic automation technology that is engineered, designed, built, and supported in house. Vertical integration is a solid strategy—but listening to the needs of our customers has truly been the driving force behind our manufacturing depth. We invest in the right equipment, resources, and people to successfully develop in-house expertise. This ensures the highest quality end-to-end, so medical device OEMs can have conﬁdence in our precision, our consistent quality, and a robust supply chain.

Medical Design & Outsourcing

11 • 2021

www.medicaldesignandoutsourcing.com

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MOTION CO N T R O L

Congratulations maxon

PRESENTED BY

Medical Design & OUTSOURCING

LEA

DERSHIP

N WIN

maxon combines electric motors, gears and DC motor controls into high-precision, intelligent drive systems that can be custom-made to fit the specific needs of customer applications. maxon helps provide innovative solutions at competitive prices for numerous applications in various markets, such as industrial automation, medical, robotics and aerospace. We focus on comprehensive solutions optimized through a diversified product range and client consultation. maxon manufactures small, high-quality brush and brushless DC motors ranging in size from 4 mm to 90 mm. maxon’s rhombic wound ironless rotor motors provide exceptionally high efficiency, low EMI emissions, fast acceleration, no preferred rotor position, torque constants and long service life. The drive components are assembled and designed according to your individual needs. Our modular system includes planetary, spur and special gearheads as well as encoders and control electronics. maxon X drives are extremely powerful and easily configured online. Customers can fit the drives with mechanical and electrical components specific to their needs. It is possible to customize the shaft lengths, winding types, ball bearings and much more. With over 50 years of experience, high-tech innovations and superior product quality, maxon is the reliable partner in drive technology. Individual, customized drive solutions are our greatest strength.

www.medicaldesignandoutsourcing.com

11 • 2021

Medical Design & Outsourcing

Congratulations Nelipak Healthcare Packaging

HIP IN ME DT

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PRODUC T D E V E LO P M E N T PRESENTED BY

Medical Design & OUTSOURCING

LEA

DERSHIP

N WIN

Nelipak Healthcare Packaging has cultivated a global team of first-rate, 100% healthcare-focused engineers and designers that apply extensive expertise to develop custom packaging solutions to meet customers’ unique and specific needs for pack performance, functionality and product protection – all while adhering to the stringent considerations of surgical environments. Nelipak is a true partner that adds value to customers’ packaging products from the earliest design phase through to manufacturing and validation. Nelipak’s development process starts with an experienced team providing sketches or digital images followed up with detailed CAD drawings and prototypes. As the project progresses, preproduction items will be made and then tooling is created, tested and put into production once approved. Throughout this process, Nelipak has an ongoing dialogue with customers about the design, progress and potential modifications to ensure satisfaction. Design Expertise and Technology Nelipak understands that modern software and technology is critical to successful outcomes and keeps abreast of the latest developments to maintain our leadership position through regular investments in new and upgraded systems. Waste and Cost Reduction through Design Nelipak engineers and designers always keep in mind that the package should fit all your requirements and provide the most costeffective solution while minimizing waste.

Medical Design & Outsourcing

11 • 2021

www.medicaldesignandoutsourcing.com

Congratulations PTC

HIP IN ME DT

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S O F T WA R E PRESENTED BY

Medical Design & OUTSOURCING

LEA

DERSHIP

N WIN

The COVID-19 pandemic has impacted the entire medical sector. For medical device manufacturers, it has become even more critical to service equipment while offsite; whether due to a hospital lock-down or an internal concern over technician safety. And now, more than ever, medical equipment downtime is beyond an inconvenience—it can directly compromise medical outcomes during a time of extreme stress on healthcare systems. PTC’s Internet of Medical Things (IoMT) solutions are providing essential support for medical device makers as they shift to remoteenhanced service models that were nice-to-have before the pandemic— and have since become business critical. With remote condition monitoring providing real-time insights, technicians are able to reduce medical equipment downtime, improve ﬁrst-time-ﬁx rates, and support medical leaders who are under unprecedented pressure. Service parts planning made possible through off-site data connectivity helps ensure the right parts are available at the right location, for the right problem, at the right time. And augmented remote assistance provides the justin-time instructions and coaching needed to keep equipment running seamlessly, even if service teams can’t get to it for hands-on repairs. PTC’s IoMT service solutions provide crucial protection for both technicians and patients—ensuring that medical device service teams can support medical practitioners by safeguarding the equipment that saves lives.

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11 • 2021

Medical Design & Outsourcing

Congratulations Euroﬁns Medical Device Testing

HIP IN ME DT

S ER

TESTING / CO M P L I A N C E PRESENTED BY

Medical Design & OUTSOURCING

LEA

DERSHIP

N WIN

From implants and instruments, to single-use and combination products, as well as active electronic devices, Eurofins Medical Device Testing provides the optimal strategy for all types of medical devices and delivers rapid turnarounds, the highest level of service and the most advanced technologies. With extensive knowledge of the commercialization process, regulatory requirements and scientific trends in the Medical Device Industry, our scientists and engineers have been assisting companies, large and small, with developmental testing and regulatory submissions for more than 40 years. Our state-of-the-art facilities throughout North America, Europe and Asia Pacific offer extensive capacity and the highest level of instrument technology, enabling us to provide the full scope of testing services required by the Medical Device Industry, including analytical chemistry, microbiology, biocompatibility, electrical and mechanical, and package testing. Eurofins Medical Device Testing can help develop and execute your test plans and navigate the regulatory pathway to market anywhere in the world. Our laboratories maintain quality systems compliant with cGMP, GLP, and ISO 17025, and conducts testing in accordance with ISO, ASTM, ANSI, AAMI standards, as well as custom test methodologies to meet the unique needs of our customers.

Medical Design & Outsourcing

11 • 2021

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CONTRIBUTORS

ANTLER

CHIUCHIOLO

GLASER

COOMBS

KOU

JUDITH ANTLER is the EVP of quality assurance and regulatory affairs at Eitan Medical. She has over a decade of experience in regulatory affairs and quality assurance within the medical device industry and holds a bachelor of technology chemistry and biotechnology engineering from Ariel University. CONNOR CHIUCHIOLO spearheads strength and quality testing as associate design engineer at Carl Stahl Sava Industries and develops manufacturing automation equipment to help production be more predictive by reducing variability during high-quantity line runs. CRAIG COOMBS is president of Coombs Medical Device Consulting, an instructor in medical device submissions at the University of California, Santa Cruz, and on the board of advisors for Nyquist Data.

DAILEY

LOH

KEITH GLASER has more than two decades of experience working for YKK, currently as director of the medical and hygiene units for the Americas Group. He also oversees the Industrial Fastening Material Division, which includes textile and plastic fastening products. QIANG KOU is the tech co-founder of Nyquist Data. He holds a PhD in bioinformatics from Indiana University. KAI LOH, an applications engineer at Times Microwave Systems, has worked in the RF/microwave industry for two decades and held various roles in engineering, marketing, and product management. His product experience ranges from microelectronic components to interconnects for technically demanding applications.

SCOTT DAILEY has been producing sustainable, actionoriented and results-minded marketing campaigns that drive revenue for more than 20 years. He leads branding and marketing as VP of Marketing at Carl Stahl Sava Industries, a manufacturer of ultraﬁne mechanical cable for medical devices and surgical robotics.

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11 • 2021

Medical Design & Outsourcing

CONTENTS

medicaldesignandoutsourcing.com ∞ November 2021 ∞ Vol7 No7

FEATURES

COLUMNS 6

• • • • • THE BIG100 ISSUE

HERE’S WHAT WE SEE

People move the medtech industry forward

23 CONTRIBUTORS 122 CABLES & CONNECTORS

3 RF interconnect considerations to save time and money powering MRI systems

126 CATHETERS

BD seeks to establish a new standard of care in blood collection

128 CLINICAL TRIALS

Introducing ‘BYOP’ clinical trials

130 COMPONENTS

Pitfalls to avoid when choosing fasteners for wearables

ON THE COVER BIG 100: THE LARGEST MEDICAL DEVICE COMPANIES IN THE WORLD

These are the heavy hitters of medtech, the 100 biggest companies in the medical device industry ranked by annual revenue, R&D spending and number of employees.

134 MATERIALS

Tungsten cable for surgical robotics

28 BIG 100 BREAKDOWN

138 ORTHOPEDICS

Zimmer Biomet’s plan to be the ‘boldest’ company in medtech

144 QUALITY ASSURANCE

Extra steps to ensure medical device quality assurance

R&D SPENDING RANKING WHERE ARE THE HEADQUARTERS?

RANKED BY EMPLOYMENT THIS YEAR’S BIGGEST M&A DEALS

156 AN EVEN LARGER MEDTECH SUPPLY CHAIN SHOCK LOOMS BEYOND THE PANDEMIC

Superstorms, fires, droughts and other extreme events driven by climate change are already straining the industry’s supply chain — and it could get a lot worse.

146 REGULATORY

161 HOW MEDTECH FARED IN THE FIRST WAVES OF THE PANDEMIC

150 TUBING TALKS

164 MEDTRONIC MOVES FORWARD WITH ITS HUGO SURGICAL ROBOT

The advantages of an AI/MLenabled search engine for FDA records

Medtech industry revenue, research spending and employment declined in the first year of the COVID-19 pandemic, according to an MDO analysis of financial data. There’s excitement at Medtronic after the Hugo robotic surgery platform hit a major regulatory milestone.

What is renal denervation?

166 DEVICETALKS

Expect more from your medtech meetings

AWA R D W I N N E R S ( P G . 7 )

168 AD INDEX 24

Medical Design & Outsourcing

11 • 2021

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S S S

COMPANIES RANKED BY REVENUE

The Big 100 Ranked by Revenues RANK COMPANY

REVENUES ($USD)

REVENUES (INTERNATIONAL)

2020 RANK/CHANGE

Medtronic

$30,117,000,000

2020 rank: 1 (no change)

Johnson & Johnson (medical device segment)

$22,959,000,000

2020 rank: 2 (no change)

Siemens Healthineers

$20,516,580,000

€17,997,000,000

2020 rank: 6 (+3)

€17,313,000,000

2020 rank: 3 (-1)

Royal Philips

$19,736,820,000

Danaher (life sciences & diagnostics segments)

$17,979,000,000

2020 rank: 10 (+5)

Medline Industries

$17,500,000,000

2020 rank: 9 (+3)

GE Healthcare (General Electric)

$17,000,000,000

2020 rank: 4 (-3)

Cardinal Health (medical segment)

$16,687,000,000

EssilorLuxottica

$16,449,060,000

Stryker

$14,351,000,000

2020 rank: 8 (-2)

Abbott (medical device segment)

$11,787,000,000

2020 rank: 11 (no change)

2020 rank: 7 (-1) €14,429,000,000

2020 rank: 5 (-4)

Baxter

$11,673,000,000

2020 rank: 12 (no change)

Henry Schein

$10,119,141,000

2020 rank: 14 (+1)

Boston Scientific

$9,913,000,000

2020 rank: 13 (-1)

Becton, Dickinson (medical segment)

$9,479,000,000

2020 rank: 16 (+1)

Owens & Minor

$8,480,177,000

B. Braun Melsungen

$8,465,982,000

3M Co. (Health Care segment)

$8,345,000,000

2020 rank: 20 (+2)

Zimmer Biomet

$7,024,500,000

2020 rank: 18 (-1)

2020 rank: 15 (-1) €7,426,300,000

2020 rank: 17 (no change)

Alcon

$6,763,000,000

Olympus (medical business)

$5,857,894,737

¥625,506,000,000

2020 rank: 21 (no change)

Terumo

$5,748,660,798

¥613,842,000,000

2020 rank: 22 (no change)

Hologic

$5,632,300,000

Fujiﬁlm Holdings (healthcare only)

$5,400,000,000

2020 rank: 24 (no change)

Smith+Nephew

$4,560,000,000

2020 rank: 23 (-2)

Edwards Lifesciences

$4,386,300,000

2020 rank: 26 (no change)

Intuitive Surgical

$4,358,400,000

2020 rank: 25 (-2)

Fresenius Medical Care (health care products)

$4,269,300,000

€3,745,000,000

2020 rank: 27 (-1)

BioMerieux

$3,554,748,000

€3,118,200,000

2020 rank: 34 (+5)

Dentsply Sirona

$3,342,000,000

Nipro (medical segment)

$3,255,740,775

¥347,648,000,000

2020 rank: 32 (+1)

2020 rank: 19 (-1)

2020 rank: 29 (+6)

2020 rank: 28 (-2)

Getinge

$3,237,676,439

29,819,000,000 SEK kr

2020 rank: 38 (+6)

Hoya (life care segment)

$3,200,983,330

¥341,801,000,000

2020 rank: 30 (-3)

ResMed

$3,196,825,000

2020 rank: 35 (+1)

Steris

$3,107,519,000

2020 rank: 33 (-2)

Hillrom

$3,018,700,000

2020 rank: 37 (+1)

Medical Design & Outsourcing

11 • 2021

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S S S

COMPANIES RANKED BY REVENUE

RANK COMPANY

REVENUES (INTERNATIONAL)

2020 RANK/CHANGE

Coloplast

$2,970,336,391

DKK kr19,426,000,000

2020 rank: 39 (+2)

Paul Hartmann

$2,773,620,000

€2,433,000,000

2020 rank: 42 (+4)

Sonova

$2,771,221,642

CHF2,601,900,000

2020 rank: 36 (-3)

Dräger (medical division)

$2,624,508,000

€2,302,200,000

Bio-Rad

$2,545,626,000

2020 rank: 44 (+3)

Teleﬂex

$2,537,156,000

2020 rank: 41 (-1)

Align Technology

$2,471,900,000

2020 rank: 43 (no change)

Cooper Cos.

$2,430,900,000

Demant

$2,212,385,321

DKK kr14,469,000,000

HU Group (previously Miraca)

$2,088,406,069

¥223,000,000,000

Cook Medical

$2,035,000,000

2020 rank: 48 (+8)

2020 rank: 40 (-4) 2020 rank: 45 (no change) 2020 rank: 51 (+5) 2020 rank: 46 (-1)

Bruker

$1,987,500,000

2020 rank: 47 (-1)

Dexcom

$1,926,700,000

2020 rank: 57 (+8)

ConvaTec

$1,894,000,000

2020 rank: 50 (no change)

Nihon Kohden

$1,870,453,268

¥199,727,000,000

2020 rank: 52 (+1)

Amplifon

$1,773,270,000

€1,555,500,000

2020 rank: 49 (-3)

Carl Zeiss Meditec

$1,545,270,000

€1,355,500,000

2020 rank: 53 (no change)

Straumann

$1,518,798,594

CHF1,426,000,000

2020 rank: 54 (no change)

Elekta

$1,494,353,963

SEK kr13,763,000,000

2020 rank: 55 (no change)

¥146,756,000,000

Fukuda Denshi

$1,374,377,224

Integra Lifesciences

$1,371,868,000

Fisher & Paykel Healthcare

$1,280,885,760

ICU Medical

$1,271,004,000

2020 rank: 60 (+4) 2020 rank: 56 (-1)

NZ$1,971,200,000

2020 rank: 75 (+17) 2020 rank: 58 (-1)

Omron Healthcare

$1,152,715,864

Masimo

$1,143,744,000

2020 rank: 71 (+10)

Colfax (Medical Technology segment, including DJO)

$1,120,700,000

2020 rank: 98 (+36)

REVENUES ($USD)

Smiths Medical (Smiths Group)

$1,084,003,200

¥123,087,000,000

£849,000,000

2020 rank: 64 (+4)

2020 rank: 61 (-2)

Integer

$1,073,442,000

2020 rank: 59 (-5)

NuVasive

$1,050,582,000

2020 rank: 62 (-3)

Cochlear

$1,030,227,670

Konica Minolta (healthcare segment)

AU$1,493,300,000.00

2020 rank: 70 (+4) 2020 rank: 76 (+9)

$990,434,000

Merit Medical Systems

$963,875,000

2020 rank: 66 (-2)

LivaNova

$934,241,000

2020 rank: 63 (-6)

Insulet

$904,400,000

2020 rank: 77 (+7)

Haemonetics

$870,463,000

2020 rank: 67 (-4)

Conmed

$862,459,000

2020 rank: 68 (-4)

Invacare

$850,689,000

2020 rank: 72 (-1)

Abiomed

$847,522,000

2020 rank: 74 (no change)

GN Hearing

$722,477,064

Avanos Medical

$714,800,000

Medical Design & Outsourcing

11 • 2021

DKK kr4,725,000,000

www.medicaldesignandoutsourcing.com

2020 rank: 69 (-6) 2020 rank: 78 (+2)

S S S

COMPANIES RANKED BY REVENUE

RANK COMPANY

REVENUES ($USD)

REVENUES (INTERNATIONAL)

2020 RANK/CHANGE

Össur

$629,503,000

Nikkiso (medical segment)

$626,521,821

¥66,900,000,000

2020 rank: 81 (+3)

Ambu

$613,761,468

DKK kr4,014,000,000.00

2020 rank: 86 (+7)

Agfa-Gevaert (radiology solutions segment)

$552,900,000

€485,000,000

JMS Co.

$539,220,828

¥57,578,000,000

2020 rank: 82 (+1)

Asahi Intecc (medical ﬁeld segment)

$531,232,441

¥56,725,000,000

2020 rank: 84 (+2)

Novocure

$494,366,000

2020 rank: 79 (+2)

2020 rank: 80 (no change)

2020 rank: 90 (+7)

Natus Medical

$415,684,000

Topcon (eye care segment)

$414,412,811

Orthoﬁx

$406,562,000

2020 rank: 85 (-1)

Accuray

$396,289,000

2020 rank: 89 (+2)

2020 rank: 83 (-1) 2020 rank: 87 (+2)

¥44,251,000,000

Nevro

$362,048,000

Medacta

$344,840,880

€302,492,000

2020 rank: 91 (+2)

Barco (healthcare division)

$298,566,000

€261,900,000

2020 rank: 93 (+3)

iRhythm

$265,166,000

2020 rank: 88 (no change)

n/a

Cardiovascular Systems

$258,973,000

2020 rank: 96 (+4)

Glaukos

$224,959,000

2020 rank: 95 (+2)

AtriCure

$206,531,000

2020 rank: 97 (+3)

SeaSpine

$154,345,000

2020 rank: 99 (+4)

Sectra (Imaging IT division)

$151,758,958

Alphatec

$144,861,000

n/a

Inari Medical

$139,670,000

n/a

Vapotherm

$125,733,000

n/a

100

Inspire Medical Systems

$115,381,000

n/a

1,397,700,000 SEK kr

2020 rank: 100 (+4)

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11 • 2021

Medical Design & Outsourcing

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No.

Medtronic

Dublin, Ireland (operational HQ in Fridley, Minnesota)

$30,117,000,000* *Fiscal year ended 4/30/2021

2020 rank: 1 R&D spend: $2,493,000,000 Employees: 90,000 Key personnel: GEOFF MARTHA, chair and CEO; NOEL COLÓN, SVP, chief quality officer; ALEX GU, SVP and president, greater China; RICHARD KUNTZ, SVP, chief medical and scientific officer; CHRIS LEE, SVP and president, Asia Pacific; BRAD LERMAN, SVP, general counsel and corporate secretary (retiring Dec. 31, 2021); JOHN LIDDICOAT, EVP and president, Americas region; Laura Mauri, SVP, chief clinical and regulatory officer; TOROD NEPTUNE, SVP and chief communications officer; KAREN PARKHILL, EVP and CFO; SEAN SALMON, EVP, president of the cardiovascular portfolio and diabetes operating unit; GREG SMITH, EVP, global operations and supply chain; CAROL SURFACE, EVP and chief human resources officer; ROB TEN HOEDT, EVP and president, Europe, Middle East, and Africa region; BRETT WALL, EVP and president, neuroscience portfolio; BOB WHITE, EVP and president, medical surgical portfolio.

Founded in 1949 by legendary medtech figure Earl Bakken, MEDTRONIC began as a repair shop for medical equipment before a foray into pacemakers. Among the company’s big splashes in the space was the 2015 acquisition of Covidien, which became the largest medtech acquisition ever at $42.9 billion and placed Medtronic’s official base in Dublin, Ireland, even as it continues to be run operationally out of Minnesota. Other major acquisitions by Medtronic include Mazor Robotics and its robotic surgical platform, Titan Spine and its orthopedic implants, MiniMed and its insulin pumps, and more. Today, Medtronic’s offerings range from neurostimulation devices to replacement heart valves, along with insulin pumps and robotic surgery platforms, plus

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more across 20 operating units that a massive reorganization effort created at the end of 2020. This year, the company has continued to move forward in surgical robotics, winning European approval for the Hugo robot-assisted surgery platform and initiating the Canadian launch of its Mazor X system for robotic-guided spine surgery. It bought intellectual property regarding insulin pumps from the Alfred E. Mann Foundation and is reportedly set to buy insulin pump maker Triple Jump out of Israel. Medtronic also received FDA approval for its next-generation Evolut transcatheter aortic valve replacement (TAVR) platform while it will continue the clinical trial for its Symplicity Spyral renal denervation (RDN) system as it looks toward an eventual FDA nod. –SW

11 • 2021

Medical Design & Outsourcing 33

2021-09-14 Ad Medical_03_print.indd 1

14.09.2021 14:02:03

No.

2 Johnson & Johnson

New Brunswick, New Jersey

(medical device segment)

$22,959,000,000* *Fiscal year ended 1/3/2021

2020 rank: R&D spend: Employees:

2 $2,174,000,000 not available

Key personnel: ALEX GORSKY, chairperson, board of directors and CEO; JOAQUIN DUATO, vice chairperson, executive committee; PETER FASOLO, EVP, chief human resources officer; ASHLEY MCEVOY, EVP, worldwide chairperson, medical devices; THIBAUT MONGON, EVP, worldwide chairperson, consumer health; MICHAEL SNEED, EVP, global corporate affairs and chief communication officer; PAUL STOFFELS, vice chairperson, executive committee and chief scientific officer; JENNIFER TAUBERT, EVP, worldwide chairperson, pharmaceuticals; MICHAEL ULLMANN, EVP, general counsel; KATHY WENGEL, EVP and chief global supply chain officer; JOSEPH J. WOLK, EVP, CFO

The New Jersey–based conglomerate has a host of subsidiaries serving various medical device segments: DePuy Synthes for orthopedic devices; Ethicon for surgical technologies; Acclarent for ear, nose and throat (ENT) treatments; Biosense Webster for electrophysiology tools; Cerenovus for stroke treatment technologies; Mentor for breast implants; Sterilmed for reprocessed single-use devices; and JOHNSON & JOHNSON Vision for eye protection and treatment products. Overall, 2021 appears to have been a year

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of ongoing recovery for J&J’s medical device business. It’s also a time of transition as CEO Alex Gorsky prepares to end a decade of leadership at the company, turning over the reins to J&J veteran Joaquin Duato in the new year. Big wins this year included the FDA clearance and U.S. launch of the Velys robotassisted knee replacement system. Meanwhile, the company reported a two-year delay in the development timeline for its Ottava general surgery robot, the company’s answer to Intuitive and its da Vinci robots. –CN

11 • 2021

Medical Design & Outsourcing

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No.

3 Siemens Healthineers Erlangen, Germany

$20,516,580,000* *Fiscal year ended 9/30/2021

(€ 17,997,000,000)

2020 rank: 6 R&D spend: $1,762,440,000 Employees: 66,100 Key personnel: BERND MONTAG, CEO; JOCHEN SCHMITZ, CFO; CHRISTOPH ZINDEL, managing board member; DARLEEN CARON, chief human resources officer and labor director

SIEMENS HEALTHINEERS is a global provider of healthcare solutions and services, with its main production sites in the U.S., China and Germany and a presence in nearly 70 other countries. The Erlangen, Germany-based company moved up to No. 3 from No. 6 in the Big 100 after closing its $16.4 billion acquisition of Varian Medical Systems in April 2021, creating what it described as the most comprehensive cancer care portfolio in the industry. Overall, Siemens Healthineers develops, manufactures and sells a diverse range of imaging, diagnostic and advanced therapies products and services to healthcare providers, plus clinical consulting

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services. This comprehensive portfolio supports customers all along the care continuum, from prevention and early detection to diagnosis, treatment and follow-up care. Business operations are divided into three segments: Imaging, Diagnostics, and Advanced Therapies. Corindus Vascular Robotics and its roboticassisted platform for endo-vascular coronary and peripheral vascular interventions is now part of Advanced Therapies. The Varian Medical Systems acquisition added an additional business segment providing products and services in cancer care, in particular within radiation oncology and related software. –JH

11 • 2021

Medical Design & Outsourcing 37

No.

4 Royal Philips Amsterdam

$19,736,820,000* *Fiscal year ended 12/31/2020

2020 rank: R&D spend: Employees:

(€ 17,313,000,000)

3 $2,077,080,000 77,000

Key personnel: FRANS VAN HOUTEN, CEO; SOPHIE BECHU, EVP, chief operations officer; ABHIJIT BHATTACHARYA, EVP, CFO; MARNIX VAN GINNEKEN, EVP, chief legal officer; ANDY HO, EVP, chief market leader, Philips Greater China; ROY JAKOBS, EVP, chief business leader, connected care; DEEPTHA KHANNA, EVP, chief business leader, personal health; BERT VAN MEURS, EVP, chief business leader, image guided therapy; EDWIN PAALVAST, EVP, chief, international markets; SHEZ PARTOVI, EVP, chief innovation and strategy officer; VITOR ROCHA, EVP, chief market leader, Philips North America; DANIELA SEABROOK, EVP, chief human resources officer; KEES WESDORP, EVP, chief business leader, precision diagnostics

ROYAL PHILIPS began as a light bulb maker when it was ﬁrst founded in the Netherlands in 1891, but it shifted its focus to healthcare over the past decade, spinning off its lighting business in 2016. Philips’ offerings include a wide array of imaging systems and diagnostic products. The company produces respiratory products for diseases such as sleep apnea, although recent recalls have knocked it out of that market for the foreseeable future as the

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company also faces lawsuits and congressional scrutiny over issues with its sleep devices. Philips bookended this year with two major acquisitions to make a big play in the cardiac monitoring space. The company paid $2.8 billion for BioTelemetry and its diagnostics and monitors for heart rhythm disorders, then bought Cardiologs and its artiﬁcial intelligence (AI)-based technology for cardiac diagnostics for an undisclosed amount. –SW

11 • 2021

Medical Design & Outsourcing

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No.

5 Danaher

(life sciences & diagnostics segments)

Washington, D.C.

$17,979,000,000* *Fiscal year ended 12/31/2021

2020 rank: 10 R&D spend: not available Employees: not available Key personnel: RAINER BLAIR, president and CEO; JENNIFER HONEYCUTT, EVP; MATT MCGREW, EVP and CFO; JOAKIM WEIDEMANIS, EVP; BRIAN ELLIS, SVP and general counsel; JOSE-CARLOS GUTIERREZ-RAMOS, SVP and chief scientific officer; WILLIAM KING, SVP, strategic development; ANGELA LALOR, SVP, human resources; ROBERT LUTZ, SVP and chief accounting officer; DANIEL RASKAS, SVP, corporate development

Washington, D.C.-based DANAHER is a global science and technology innovator with nearly 70,000 employees and research and development, manufacturing, sales, distribution, service and administrative facilities in more than 60 countries. Founded in 1984, Danaher is comprised of more than 20 operating companies organized as three segments: Life Sciences, Diagnostics, and Environmental and Applied Solutions. Its Big 100 ranking jumped to No. 5 from a previous No. 10 thanks to the company’s $20 billion purchase of GE’s BioPharma business in early 2020. Life Sciences was established in 2005 with Danaher’s acquisition of Leica

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Microsystems, and now offers instruments and consumables used to study genes, proteins, metabolites and cells to understand the causes of disease, identify new therapies, and test and manufacture new drugs and vaccines. Established in 2004 with the acquisition of Radiometer, the Diagnostics segment offers analytical instruments, reagents, consumables, software and services that hospitals, physicians’ offices, reference laboratories and other critical care settings use to diagnose disease and make treatment decisions. Then-EVP Rainer Blair was promoted into the corner office after Tom Joyce’s retirement in September 2020. –JH

11 • 2021

Medical Design & Outsourcing 41

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No.

6 Medline Industries Northﬁeld, Illinois

$17,500,000,000* *Fiscal year ended 12/31/2020

2020 rank: R&D spend: Employees:

9 not available 28,000

Key personnel: CHARLIE MILLS, CEO; ANDY MILLS, president; JIM ABRAMS, chief operating ofﬁcer

Northﬁeld, Illinois–based MEDLINE INDUSTRIES is the largest privately held manufacturer and distributor of healthcare supplies in the U.S., with sales of $17.5 billion in 2020. The company is led by the Mills family, which remained the largest single shareholder after selling a majority stake in 2021 to a partnership of funds managed by Blackstone, Carlyle and Hellman & Friedman. Medline does business in more than 100 countries, offering more than 550,000 medical products and clinical solutions ranging from surgical gloves to wheelchairs to face masks to thermometers. Its customers include the largest healthcare systems in the U.S. and independent facilities. Business boomed during the COVID-19 pandemic, as Medline expanded its manufacturing and distribution capabilities

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to ramp up production of face masks, hand sanitizer and other essential medical supplies. Since 2018, Medline has spent $1.5 billion on new distribution centers, manufacturing capabilities and information technology, an effort that Medline said created 8,500 jobs at eight new distribution centers and around 150 manufacturing expansion projects. The latest project is a $77.5 million distribution center in Bonner Springs, Kansas. The company has also grown through acquisitions, paying $167.5 million to buy the Namic ﬂuid management business from AngioDynamics in 2019, spending $29 million in 2020 to buy the SensiCare and Aloe Vesta collection of skincare product lines from ConvaTec, and paying $286 million to buy the Hudson RCI respiratory business from Teleﬂex in 2021. –JH

11 • 2021

Medical Design & Outsourcing

No.

7 GE Healthcare (General Electric) Chicago

$17,000,000,000* *Fiscal year ended 12/31/2020

2020 rank: 4 R&D spend: $872,000,000 Employees: 47,000

Key personnel: KIERAN MURPHY, president and CEO; HELMUT ZODL, VP and CFO; KATYA KRUGLOVA, VP, human resources; MICHAEL MCALEVEY, VP, general counsel and business development; JAN MAKELA, president and CEO, imaging; ROLAND ROTT, president and CEO, ultrasound; THOMAS WESTRICK, president and CEO, life care solutions; KEVIN O’NEILL, president and CEO, pharmaceutical diagnostics; AMIT PHADNIS, VP and chief digital officer; LUIZ VERZEGNASSI, president and CEO, services and GE Healthcare chief diversity officer; EVERETT CUNNINGHAM, president and CEO, U.S. and Canada; CATHERINE ESTRAMPES, president and CEO, EMEA; YIHAO ZHANG, president and CEO, China; ROB WALTON, president and CEO, ASEAN, Korea and ANZ; SOICHIRO TADA, president and CEO, Japan; RAFAEL PALOMBINI, president and CEO, Latin America; SHRAVAN SUBRAMANYAM, president and CEO, India and South Asia; IAN DALE, chief supply chain officer; LAILA GURNEY, chief quality and regulatory officer; STEVE LAURENT, chief information officer; GREG GIBBONS, chief communications officer; BRIAN MONTGOMERY, strategy leader; DAVID BRIGGS, senior lean leader

Incorporated in 1994, GE HEALTHCARE remains one of the largest medical device manufacturers. In November 2021, the parent company announced its plans to split the conglomerate into three publicly traded companies focused on healthcare, aviation and energy, respectively. The company anticipates that it will complete the healthcare spinoff in 2023. Currently, GE Healthcare specializes in the development of imaging, mobile, diagnostic and monitoring devices. In 2021, the company announced its plan to acquire ultrasound technology company BK Medical for $1.45 billion. Subject to customary closing conditions, it would expand the company’s ultrasound platform to include several new applications. Like its parent company, GE Healthcare has a significant history. The foundation for the organization came in 1896 when Victor Electric Co. began producing components for X-ray tubes and electrotherapeutic devices. By 1920, General Electric decided to purchase Victor Electric to bolster its X-ray

tube manufacturing capabilities. In the 1950s, GE created a dedicated medical systems division. The healthcare unit continued to diversify in the decades that followed. It began making CT machines in the 1970s. MRI machines and patient-monitoring systems would become a focus in the 1980s. Its emphasis on medical imaging and diagnostics continued to sharpen toward the end of the twentieth century, leading to the christening of the division as GE Healthcare in 1994. In the early 2000s, the organization continued to grow thanks to a string of acquisitions. In 2018, the parent company had proposed making GE Healthcare a standalone company, but GE ultimately decided to sell a biopharma division to Danaher for $21.4 billion instead. That same year, GE Healthcare unloaded a number of healthcare information technology assets to Veritas Capital for $1.05 billion. Peter Arduini is in the process of leaving the top spot at Integra Lifesciences to become GE Healthcare’s CEO effective Jan. 1, 2022. –BB

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11 • 2021

Medical Design & Outsourcing 45

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No.

8 Cardinal Health Dublin, Ohio

(medical segment)

$16,687,000,000* *Fiscal year ended 6/30/2021

2020 rank: 7 R&D spend: not available Employees: not available Key personnel: SCOTT BARNHART, president, global manufacturing and supply chain; BEN BRINKER, president, international, medical segment; STEVE C DE BACA, EVP, quality and regulatory affairs; CRAIG COWMAN, EVP, global sourcing; VICTOR CRAWFORD, CEO, pharmaceutical segment; SUZANNE FOSTER, president, Cardinal Health at-Home solutions; MICHELE HOLCOMB, EVP, chief strategy and business development officer; JASON HOLLAR, CFO; HEIDI HUNTER, president, specialty solutions; MIKE KAUFMANN, CEO; STEVE MASON, CEO, medical segment; JESSICA MAYER, chief legal and compliance officer; MIKE PINTEK, president, nuclear and precision health solutions; ROBERT RAJALINGAM, president, U.S. medical products and distribution; BRIAN RICE, EVP, chief information officer and global business services; OLA SNOW, chief human resources officer; DEBBIE WEITZMAN, president, pharmaceutical distribution and The Medical Shoppe International; SARAH WILLS, EVP, chief corporate affairs officer

Headquartered in Dublin, Ohio and founded in 1979, CARDINAL HEALTH provides pharmaceuticals, medical products and supply chain efficiency solutions for the healthcare system. The goal is to connect patients, providers, payers, pharmacists and manufacturers for integrated care coordination and patient management. Cardinal Health has two segments: Pharmaceutical and Medical. Pharmaceutical distributes branded and generic pharmaceutical, specialty pharmaceutical and over-the-counter healthcare and consumer products in the U.S. The Medical segment manufactures, sources and distributes Cardinal Health branded medical,

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surgical and laboratory products worldwide. It also distributes a broad range of medical, surgical and laboratory products known as national brand products and provides supply chain services and solutions to health providers in the U.S. and Canada — and distributes medical products to patients’ homes in the U.S. through the Cardinal Health at-Home Solutions division. Major news in 2021 included the company completing the $1 billion sale of its Cordis business to private equity firm Hellman & Friedman. The deal took place six years after Cardinal Health bought Cordis and its minimally-invasive cardiovascular technology from J&J for nearly $2 billion. –JH

11 • 2021

Medical Design & Outsourcing 47

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9 EssilorLuxottica

Charenton-le-Pont, France

$16,449,060,000* *Fiscal year ended 12/31/2020

(€ 14,429,000,000)

2020 rank: 5 R&D spend: $327,180,000 Employees: 180,000 Key personnel: LEONARDO DEL VECCHIO, chairperson; FRANCESCO MILLERI, CEO; PAUL DU SAILLANT, deputy CEO

The Franco-Italian eyeglasses giant in July announced the creation of a dedicated innovation center within the company’s industrial facility in Dijon, France. The goal is to accelerate initiatives to address consumers’ evolving needs and fully capture the potential of the fast-growing wearables segment. The Smart Eyewear Technologies Center will coordinate with R&D and industrialization

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sites in Toulouse and Créteil, France and collaborate with R&D teams in Agordo, Italy. “On the back of a decade of research and development around smart eyewear, we are accelerating our investments and reinforcing our capacity to bring digital technology into eyewear, in the service of good vision,” CEO Francesco Milleri and Deputy CEO Paul du Saillant said at the time. –CN

11 • 2021

Medical Design & Outsourcing 49

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No.

10 Stryker

Kalamazoo, Michigan

$14,351,000,000* *Fiscal year ended 12/31/2020

2020 rank: 8 R&D spend: $984,000,000 Employees: 43,000 Key personnel: KEVIN LOBO, chair and CEO; ROBERT FLETCHER, VP, chief legal officer; YIN BECKER, VP, chief corporate affairs officer; PRESTON WELLS, VP, investor relations; VIJU MENON, group president, global quality and operations; M. KATHRYN FINK, VP, chief human resources officer; SPENCER STILES, group president, orthopaedics and spine; TIMOTHY SCANNELL, advisor to the CEO; ANDY PIERCE, group president, MedSurg and neurotechnology; GLENN BOEHNLEIN, VP and CFO

STRYKER is the world’s largest orthopedic device company, employing more than 43,000 people. The Kalamazoo, Michiganbased company was started in 1941 and was originally known as The Orthopedic Frame Co. Its first device was the Wedge Turning Frame that allowed caregivers to turn patients with serious back injuries while keeping the spine immobilized. Stryker took its current name in the 1960s and went public in 1979, entering the orthopedic implant space the same year. Stryker has recently made a number of notable acquisitions, including the $4.7 billion purchase of Wright Medical in November 2020. Stryker

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acquired Mako Surgical in 2013 to enter the robotic-assisted surgery space. The following year, it acquired four other companies and hasn’t slowed down since. Stryker first reached $10 billion in sales in 2016. Today, the company brings in more than $14 billion annually. Stryker’s devices focus on numerous specialties, including craniomaxillofacial, emergency care, endoscopy, foot and ankle, interventional spine, joint replacement, neurosurgical, neurovascular, orthopedic instruments, spine, spine enabling technologies, sports medicine, surgical technologies and trauma and extremities. –DK

11 • 2021

Medical Design & Outsourcing 51

No.

11 Abbott

(medical device segment)

Abbott Park, Illinois

$11,787,000,000* *Fiscal year ended 12/31/2020

2020 rank: R&D spend: Employees:

11 $1,300,000,000 not available

Key personnel: MILES WHITE, executive chair; ROBERT FORD, president and CEO; HUBERT ALLEN, EVP, general counsel and secretary; JOHN CAPEK, EVP, ventures; LISA EARNHARDT, EVP, medical devices; ROBERT FUNCK JR., EVP, ﬁnance and CFO; JOHN GINASCOL, EVP, core diagnostics; ANDREW LANE, EVP, established pharmaceuticals; MARY MORELAND, EVP, human resources; DANIEL SALVADORI, EVP, nutritional products; ANDREA WAINER, EVP, rapid and molecular diagnostics; GREG AHLBERG, SVP, core laboratory diagnostics, commercial operations; CHRISTOPHER CALAMARI, SVP, U.S. nutrition; MICHAEL DALE, SVP, structural heart; SCOTT HOUSE, SVP, quality assurance regulatory and engineering services; SAMMY KARAM, SVP, emerging markets established pharmaceuticals; JOSEPH MANNING, SVP, international nutrition; LOUIS MORRONE, SVP, rapid diagnostics; MICHAEL PEDERSON, SVP, electrophysiology and heart failure; JULIE TYLER, SVP, vascular; JARED WATKIN, SVP, diabetes care; ALEJANDRO WELLISCH, SVP, established pharmaceuticals, Latin America; RANDEL WOODGRIFT, SVP, cardiac rhythm management

Abbott Park, Illinois-based ABBOTT was founded in 1894 and was originally incorporated as the Abbott Alkaloidal Company. It made “alkaloidal” medicine granules and later produced its ﬁrst synthetic medicine, the antiseptic Chlorazene. By 1972, Abbott was beginning its modern diagnostics business with its ABA-100 blood chemistry analyzer that detected serum hepatitis. Abbott was also an early player in continuous glucose monitors with the launch of its FreeStyle Libre in 2014. The device eliminated the need for routine ﬁngersticks when testing for glucose in people living with diabetes. The company made a big leap into the medical device space with its largest acquisition to date — its $25 billion purchase of St. Jude Medical in 2017. The purchase added innovations in cardiovascular

Medical Design & Outsourcing

11 • 2021

and neuromodulation devices to Abbott’s portfolio of technology. The company has continued to innovate on its investments and entered the TAVR market in September this year, competing against Edwards Lifesciences and Medtronic with its FDA-approved Portico with FlexNav. Some of the cardiac conditions Abbott designs its devices to treat include cardiac arrhythmias, coronary artery disease, heart failure and heart valve disease. The company is also making specialized devices for spinal cord stimulation to treat chronic pain. Abbott has been an integral part of efforts against the COVID-19 pandemic, as it provided numerous diagnostic tests for the virus. It was one of the ﬁrst companies to launch a commercial at-home rapid COVID-19 test kit, the BinaxNow. –DK

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No.

12 Baxter

Deerfield, Illinois

$11,673,000,000* *Fiscal year ended 12/31/2020

2020 rank: 12 R&D spend: $521,000,000 Employees: 50,000

Key personnel: JOSÉ ALMEIDA, chairperson, president and CEO; GIUSEPPE ACCOGLI, SVP and president, Americas and global business units; PAULO BOLGAR, VP, human resources, Americas, global business units and R&D; DAVID BONDI, chief procurement officer; WIL BOREN, president, advanced surgery; JAMES BORZI, SVP, chief supply chain officer; ELLEN BRADFORD, SVP and corporate secretary; GAVIN CAMPBELL, GM, U.S. renal; DENNIS CROWLEY, SVP, business development and licensing; STACEY EISEN, SVP, global communications and president, Baxter International Foundation; ROBERT FELICELLI, head, global technical services; CRISTIANO FRANZI, SVP and president, EMEA; ANDREW FRYE, SVP and president, APAC; ANDY GOLDNEY, VP, medication delivery and pharmaceuticals - Europe; JESSICA HAMELINE, VP, global digital transformation office; TOBI KARCHMER, VP, worldwide medical; HEATHER KNIGHT, GM, U.S. hospital products; JACQUELINE KUNZLER, SVP, chief quality officer; KAREN LEETS, SVP and treasurer; TALVIS LOVE, SVP and chief information officer; SEAN MARTIN, SVP and general counsel; JEANNE MASON, SVP, human resources; PIERO NOVELLO, GM, Baxter Mexico, Central and South America; LYNN PAWELSKI, VP, global regulatory affairs; JOHN QUICK, VP, finance, Americas and global business units; SUMANT RAMACHANDRA, president, pharmaceuticals and SVP, chief science and technology officer; REAZ RASUL, GM, acute therapies; JON RUSHFORD, VP, integrated supply chain - Americas; JAMES SACCARO, EVP and CFO; JOSEPH SCHWAN, deputy general counsel, global government policy and reimbursement; BRIAN STEVENS, SVP, chief accounting officer and controller; CLARE TRACHTMAN, VP, investor relations; JORGE VASSEUR, GM, clinical nutrition; HEATHER WECHET, VP, human resources, global functions, talent management and employee relations; SHIRLEY XU, GM, Greater China

Founded in 1931 as the Don Baxter Intravenous Products Corp. by two doctors — Ralph Falk and Don Baxter — BAXTER was the first commercial manufacturer of prepared IV solutions and developed the Transfuso-Vac container for blood collection and storage, allowing for blood bank storage of up to three weeks. Baxter Laboratories, as it later called itself, opened its first manufacturing facility in a former auto showroom in Glenview, Illinois. Baxter now provides a broad portfolio of essential healthcare products, including acute and chronic dialysis therapies, sterile intravenous solutions,

Medical Design & Outsourcing

11 • 2021

infusion systems and devices, parenteral nutrition therapies, inhaled anesthetics, generic injectable pharmaceuticals, and surgical hemostat and sealant products. Baxter’s customers are hospitals, kidney dialysis centers, nursing homes, rehabilitation centers, doctors’ offices and patients at home under physician supervision. The Deerfield, Illinois-based company manufactures products in more than 20 countries and sells them in more than 100 countries. Baxter remains on track to complete its $12.4 billion acquisition of Hillrom, which is expected to close in 2022. –JH

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No.

13 Henry Schein Melville, New York

$10,119,141,000* *Fiscal year ended 12/26/2020

2020 rank: 14 R&D spend: not available Employees: 21,000 Key personnel: STANLEY BERGMAN, chairperson and CEO; ANDREA ALBERTINI, president, international distribution group; GERALD BENJAMIN, EVP, chief administrative officer; JAMES BRESLAWSKI, vice chairperson and president; DAVID BROUS, CEO, strategic business group; BRAD CONNETT, CEO, North America distribution group; MICHAEL ETTINGER, SVP, corporate and legal affairs and chief of staff, secretary; LORELEI MCGLYNN, SVP, chief human resources officer; MARK MLOTEK, EVP, chief strategic officer; JAMES MULLINS, SVP, global supply chain; KELLY MURPHY, SVP and general counsel; STEVEN PALADINO, EVP, CFO; CHRISTOPHER PENDERGAST, SVP and chief technology officer; MICHAEL RACIOPPI, SVP, chief merchandising officer; WALTER SIEGEL, SVP and chief legal officer; RENÉ WILLI, CEO, global oral reconstruction group

HENRY SCHEIN says it is the world’s largest provider of health care products and services primarily to office-based dental and medical practitioners, as well as alternate sites of care, with operations or affiliates in 31 countries and territories.The Melville, New York-based company offers more than 120,000 branded products and private brand products in stock and more than 180,000 products available as special orders. Henry Schein serves its customers through two segments: Health Care Distribution, and Technology and Value-Added Services. Health Care Distribution distributes consumable products, equipment, laboratory products, equipment repair services, branded and generic pharmaceuticals, vaccines, surgical products, diagnostic tests, infection-control

Medical Design & Outsourcing

11 • 2021

products and vitamins. Technology and ValueAdded Services provides software, technology and other value-added services to health care practitioners and includes a small medical software business known as MicroMD. Henry Schein One is the largest sales contributor in this category, offering software systems for dental practitioners. Technology and ValueAdded Services also offers physicians a broad suite of services for electronic health records, integrated revenue cycle management, and patient communication. Henry Schein’s financial services include practice finance solutions such as credit card billing and facilitation of loans to acquire equipment and technology, as well as solutions to broker dental practice transitions. –JH

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No.

14 Boston Scientific

Marlborough, Massachusetts

$9,913,000,000* *Fiscal year ended 12/31/2020

2020 rank: 13 R&D spend: $1,143,000,000 Employees: 38,000

Key personnel: MICHAEL MAHONEY, chairperson and CEO; DANIEL BRENNAN, EVP and CFO; VANCE BROWN, SVP, general counsel and corporate secretary; ART BUTCHER, EVP and president, Asia Pacific; WENDY CARRUTHERS, SVP, human resources; JODI EDDY, SVP and chief information and digital officer; JOSEPH FITZGERALD, EVP and president, interventional cardiology; EDWARD MACKEY, EVP, global operations; IAN MEREDITH, EVP and global chief medical officer; JEFF MIRVISS, EVP and president, peripheral interventions; MAULIK NANAVATY, SVP and president, neuromodulation; SCOTT OLSON, SVP and president, rhythm management; DAVID PIERCE, EVP and president, MedSurg and president, endoscopy; MEGHAN SCANLON, SVP and president, urology and pelvic health; BRAD SORENSON, SVP, manufacturing and supply chain; ERIC THÉPAUT, EVP and president, EMEA

Marlborough, Massachusetts–based BOSTON SCIENTIFIC is developing numerous devices across its six businesses: endoscopy, interventional cardiology, neuromodulation, peripheral interventions, rhythm management and urology and pelvic health. The company was the first to receive FDA clearance for a single-use duodenoscope, securing a 510(k) for the Exalt Model D in 2019. It was designed for endoscopic retrograde cholangiopancreatography procedures as an alternative to reusable duodenoscopes to eliminate the use of reprocessing and repairs. Boston Scientific has since received FDA clearance for its Exalt Model B single-use bronchoscope. The company also makes well-known devices for structural heart and coronary therapies, such as the Watchman for left atrial appendage closure. It makes drug-eluting stents, catheters, balloons, guidewires, TAVR devices

Medical Design & Outsourcing

11 • 2021

and specializes in cerebral embolic protection. Deep brain stimulation for chronic pain treatment and other minimally invasive therapies for arterial disease, venous disease and cancer are also in its product portfolio. Boston Scientific’s Emblem MRI S-ICD system is one of the industry’s first MR-conditional subcutaneous implantable defibrillators (S-ICD) to provide protection for patients at risk for sudden cardiac death. Throughout 2021, the company has continued on an acquisition spree. Early in the year, Boston Scientific acquired Preventice Solutions and its remote patient monitoring technology for up to $1.2 billion. Lumenis and its surgical portfolio of laser systems, fibers and urology and otolaryngology procedures was acquired by the company for $1.1 billion earlier this year as well. It also purchased Farapulse for $450 million and Baylis Medical for $1.75 billion this year. –DK

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No.

15 Becton, Dickinson

(medical segment)

Franklin Lakes, New Jersey

$9,479,000,000* *Fiscal year ended 9/30/2021

2020 rank: 16 R&D spend: not available Employees: 30,000

Key personnel: TOM POLEN, chair, CEO and president; CHRISTOPHER DELOREFICE, EVP and CFO; ALBERTO MAS, EVP and president, Medical segment; SIMON D. CAMPION, EVP and president, Interventional segment; ALEXANDRE CONROY, EVP, Integrated Supply Chain; TONY EZELL, president North America and chief marketing officer; JERRY FLASZ, EVP, Global Services and chief information officer; ROLAND GOETTE, EVP and president, Europe, Middle East and Africa (EMEA); DAVE HICKEY, EVP and president, Life Sciences segment; SAM KHICHI, EVP, corporate development and public affairs, regulatory affairs and general counsel; BETTY LARSON, EVP and chief human resources officer; JAMES LIM, EVP and president, Greater Asia; ELIZABETH MCCOMBS, EVP and CTO; CHRISTOPHER R. REIDY, EVP and chief administrative officer; DAVID SHAN, EVP and chief quality officer; WILLIAM R. SIGMUND II, EVP and chief medical officer; AMI SIMUNOVICH, EVP and chief regulatory officer

Founded in 1897 by Maxwell Becton and Fairleigh Dickinson, BECTON, DICKINSON AND CO. (BD) is comprised of three segments: medical, interventional and life sciences. The company’s first sale was a glass syringe — a product the company continues to sell today. BD employs nearly 70,000 people across 50 countries, led by CEO Thomas Polen, who took up the leadership position in early 2020. The Franklin Lakes, New Jersey-based company’s medical segment includes diabetes care, medication delivery solutions, medication management solutions and pharmaceutical systems, although BD announced earlier this year that it intends to spin off its diabetes arm as an independent, publicly-traded company. The medical segment includes syringes and

Medical Design & Outsourcing

11 • 2021

hypodermic needles, both of which have come to the fore amid the COVID-19 pandemic as the company has provided several hundred million injection devices for the United States’ federal vaccination campaign, having amassed more than 2 billion orders and expanded its manufacturing capacity. The segment also includes BD’s infusion systems, many of which including the Alaris platform were brought into the company through its $12.2 billion acquisition of CareFusion in 2015. Earlier this year, BD acquired Velano Vascular as part of an effort to change the standard of care in blood collection through its “one-stick stay” initiative. The company also develops diagnostics and surgical products, among several other offerings across its interventional and life sciences arms. –SW

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16 Owens & Minor

Mechanicsville, Virginia

$8,480,177,000* *Fiscal year ended 12/31/2020

2020 rank: 15 R&D spend: not available Employees: 18,800

Key personnel: ED PESICKA, president and CEO; PERRY BERNOCCHI, CEO, Byram Healthcare; JEFF JOCHIMS, EVP, COO and president, medical distribution; ANDY LONG, EVP, CFO; CHRIS LOWERY, president, global products; SHANA NEAL, EVP, chief human resources officer; NICK PACE, EVP, general counsel, corporate secretary

OWENS & MINOR first opened in 1882 under the name Owens & Minor Drug Co. Now based in Mechanicsville, Virginia, the company started to grow beyond its pharmaceutical wholesaling background in 1981 and became a publicly-traded company in 1988. Owens & Minor, through its subsidiary Halyard, was a big player in personal protective equipment during the COVID-19 pandemic. It distributed masks and N95 respirators for frontline workers and

Medical Design & Outsourcing

11 • 2021

continued to make surgical gowns, drapes and packs, sterilization wraps, surgical accessories and equipment covers, exam gloves and other PPE. Its other two global product divisions, MediChoice and Medical Action Industries, make patient monitoring, respiratory, skin care, urology, wound care, IV start kits, procedure trays, mobility aids and more. Owens & Minor consistently ranks among the top 20 revenue earners in the medical device industry. –DK

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No.

17 B. Braun Melsungen

Melsungen, Germany (U.S. HQ in Bethlehem, Pennsylvania)

$8,465,982,000* *Fiscal year ended 12/31/2020

(€ 7,426,300,000)

2020 rank: 17 R&D spend: $421,572,000 Employees: 64,317 Key personnel: ANNA MARIA BRAUN, CEO; JEAN-CLAUDE DUBACHER, CEO at B. Braun of America; ANNETTE BELLER, board member, finance, taxes and controlling, central service departments; MEINRAD LUGAN, board member, hospital care division; STEFAN RUPPERT, board member, chief human resources officer and director, labor relations; JOACHIM SCHULZ, board member, B. Braun Aesculap division; MARKUS STROTMANN, board member, B. Braun Avitum division

B. BRAUN began as a pharmacy selling medical herbs through the mail in Melsungen, Germany, in 1839. Still based in Melsungen, the company now offers more than 5,000 different healthcare products thanks to its more than 60,000 employees across more than 60 countries throughout Asia, Europe, North America, the Pacific Rim and South America. Among its offerings are products for infusion therapy and pain management as the company seeks to tackle challenges including opioid abuse issues, hospital-acquired malnutrition and hazardous drug exposure while eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. The company is a full line supplier of IV therapy products, including IV solutions, and drug delivery systems. Other offerings include products in the area of anesthesia, renal therapies, wound management

Medical Design & Outsourcing

11 • 2021

and vascular access. Aesculap, B. Braun’s American unit, was initially founded in Germany in 1867 before Aesculap Inc. — the American division — was founded in 1977 in Center Valley, Pennsylvania. Aesculap AG was incorporated into the B. Braun Group in 1998 and manufactures surgical equipment, including sutures, handheld surgical instruments, implants, and electrosurgical devices and powers systems. B. Braun’s current U.S. operations are headquartered in Bethlehem, Pennsylvania, with primary U.S. manufacturing facilities located in Allentown, Pennsylvania, Irvine, California, Carrollton, Texas, and the Dominican Republic. The company’s U.S. operations are currently headed up by CEO Jean-Claude Dubacher, who took over for longtime company leader Carroll Neubauer at the start of 2020 after he had held the role of CEO of B. Braun Medical since 1997. –SW

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No.

18 3M Co.

(healthcare segment)

Maplewood, Minnesota

$8,345,000,000* *Fiscal year ended 12/31/2020

2020 rank: 20 R&D spend: not available Employees: 13,000 Key personnel: MICHAEL ROMAN, chair and CEO; MOJDEH POUL, group president, Health Care; JOHN BANOVETZ, EVP, chief technology officer and environmental responsibility; ZOE DICKSON, EVP and chief human resources officer; IVAN FONG, EVP, chief legal and policy officer and secretary; VEENA LAKKUNDI, SVP and chief strategy officer; MONISH PATOLAWALA, EVP and CFO; DENISE RUTHERFORD, SVP and chief corporate affairs officer; ASRAF BHUGALOO, SVP and general auditor, corporate auditing, finance; MICHAEL DAI, assistant secretary; SARAH GRAUZE, SVP and treasurer; MICHAEL DURAN, SVP and chief ethics and compliance officer; THERESA REINSETH, SVP, corporate controller and chief accounting officer; MICHAEL GEISE, assistant secretary; RODOLFO ESPINOSA, assistant treasurer

Over the first nine months of 2021, 3M’s Health Care segment saw its revenue jump more than 30% year-over-year. CEO Mike Roman credited the growth to 3M Science supporting the “unprecedented pace of advancement over the past 18 months to develop therapeutics and vaccines and scale

Medical Design & Outsourcing

11 • 2021

manufacturing to help address the pandemic.” 3M Health Care’s offerings include food safety indicators; healthcare procedure coding and reimbursement software; skin, wound care and infection prevention products and services; dentistry and orthodontia solutions; and filtration and purification systems. –CN

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No.

19 Zimmer Biomet Warsaw, Indiana

$7,024,500,000* *Fiscal year ended 12/31/2020

2020 rank: 18 R&D spend: $372,000,000 Employees: 20,000 Key personnel: BRYAN HANSON, chair, president and CEO; RACHEL ELLINGSON, SVP and chief strategy officer; ELLIE HUMPHREY, SVP and chief transformation officer; VAFA JAMALI, CEO, ZimVie; DAVID KUNZ, SVP, global quality and regulatory affairs; ANGELA MAIN, SVP, global chief compliance officer and associate general counsel, Asia Pacific; KERI MATTOX, SVP, investor relations and chief communications officer; CARRIE NICHOL, VP, controller and chief accounting officer (outgoing); CHAD PHIPPS, SVP, general counsel and secretary; ZEESHAN TARIQ, SVP and chief information officer; IVAN TORNOS, chief operating officer; KENNETH TRIPP, SVP, global operations and logistics; SUKETU UPADHYAY, EVP & CFO; LORI WINKLER, SVP and chief human resources officer; SANG YI, group president, Asia Pacific; WILFRED VAN ZUILEN, president, EMEA

ZIMMER BIOMET designs, manufactures and sells orthopedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic (CMFT) products; dental implants; and related surgical products. Founded in Warsaw, Indiana as Zimmer Manufacturing Co. in 1927, the company spun off from Bristol-Myers Squibb in 2001 and acquired Biomet parent company LVB Acquisition in 2015. Its knee replacement brands include Persona, NexGen, Vanguard and Oxford, while its hip brands include Taperloc, Zimmer M/L Taper Hip Prosthesis, Avenir Complete Hip, Arcos Modular Hip, Continuum Acetabular

Medical Design & Outsourcing

11 • 2021

System and the G7 Acetabular System. Zimmer Biomet has four robotically-assisted surgery systems under the Rosa name for hip, knee, spine and brain procedures. In 2021, Zimmer Biomet launched its ZBEdge platform for collecting and sharing data between sensorenabled implants, surgical systems and apps for physicians and patients. ZB has been making bold, aggressive moves this year. Its launch of a smart knee implant — the Persona IQ — in partnership with Canary Medical was an industry first. The company plans to become leaner and more focused next year through the spinoff of its spine and dental businesses into a new company called ZimVie. –JH

www.medicaldesignandoutsourcing.com

No.

20 Alcon

Geneva, Switzerland

$6,763,000,000* *Fiscal year ended 12/31/2020

2020 rank: R&D spend: Employees:

19 $673,000,000 23,655

Key personnel: DAVID ENDICOTT, CEO; LAURENT ATTIAS, head corporate development, strategy, business development and licensing and mergers and acquisitions; HEATHER ATTRA, SVP, head global quality; JEANNETTE BANKES, president and GM, global surgical franchise; ROYCE BEDWARD, SVP, general counsel and corporate secretary; IAN BELL, president, global business and innovation; SERGIO DUPLAN, president, North America; KAREN KING, SVP, investor relations and communications; FRANCK LEVEILLER, SVP, head global R&D; SUE-JEAN LIN, SVP, chief information and transformation ofﬁcer; KIM MARTIN, SVP, chief human resources ofﬁcer; ED MCGOUGH, SVP, head global manufacturing and technical operations; RAJKUMAR NARAYANAN, president, international; ANDY PAWSON, president and GM, global vision care franchise; TIM STONESIFER, SVP, CFO

Formerly a subsidiary of pharmaceutical giant Novartis since 2011, ALCON ofﬁcially spun out as a separate eye care business in April 2019. The company was founded in 1945 by Robert Alexander and William Conner as a small pharmacy in Fort Worth, Texas. Its U.S. headquarters remains in Fort Worth today, with global operations run out of its Geneva, Switzerland headquarters. The company’s offerings exist in the surgical and vision care spaces. Alcon develops ophthalmic surgical products, with a portfolio including technologies and devices for cataract, retinal, refractive surgery and advanced technology intraocular lenses to treat conditions like

Medical Design & Outsourcing

11 • 2021

presbyopia and astigmatism. The surgical portfolio also includes advanced viscoelastics, surgical solutions, surgical packs, and other disposable products for cataract and vitreoretinal surgery, while the vision care business offers a wide range of daily disposable, reusable and color-enhancing contact lenses and a comprehensive portfolio of ocular health products. These include products for dry eye, contact lens care and ocular allergies, as well as ocular vitamins and redness relievers. Alcon made a massive ophthalmic play this year when it announced its intention to acquire glaucoma surgery device maker Ivantis for $475 million upfront. –SW

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No.

(medical business)

Olympus Tokyo

$5,857,894,737*

Key personnel: YASUO TAKEUCHI, president and CEO; NACHO ABIA, COO; AKIHIRO TAGUCHI, chief technology officer; CHIKASHI TAKEDA, CFO; STEFAN KAUFMANN, chief administrative officer

2020 rank: 21 R&D spend: $509,833,302 Employees: 21,512

Tokyo-based OLYMPUS makes precision machines and instruments. Its medical devices primarily serve gastroenterology, general surgery, pulmonology, bronchoscopy, urology, gynecology, otolaryngology, bariatrics, orthopedics and anesthesiology. Founded in 1919, the company developed the world’s first gastrocamera in 1950 and now offers endoscopes, endoscope reprocessors, laparoscopes, video imaging systems, system integration solutions and medical services through its Endoscopy unit. Its Therapeutic portfolio includes surgical energy devices and instruments to help prevent, detect and treat disease, such as devices for endotherapy, urology/gynecology, respiratory heath and ear/nose/throat applications. Scientific Solutions, a third business unit outside of Medical Solutions, makes microsocope systems for the life science industry, as well as videoscopes, nondestructive testing technology and X-ray analyzers. –JH

Terumo

Key personnel:

*Fiscal year ended 3/31/2021

(¥625,506,000,000)

No.

Tokyo

SHINJIRO SATO, president and CEO; TAKAYOSHI MIMURA, chair

$5,748,660,798* *Fiscal year ended 3/31/2021

(¥613,842,000,000) 2020 rank: 22 R&D spend: $459,786,477 Employees: 26,000

Medical Design & Outsourcing

11 • 2021

TERUMO is one of the few medical device companies with roots stretching back one century. Beginning life as a thermometer manufacturer, Terumo has a diversified range of products spanning interventional cardiology, blood transfusion and cell therapy. In addition to its presence in Asia, the Tokyobased company has subsidiaries in the EMEA region, South America and North America. Since the mid-1990s, the company has developed devices for transradial intervention, a technique involving the insertion of a catheter in the wrist to grant blood vessel access. It also makes devices for diabetes care and peritoneal dialysis treatments. In total, the company offers 50,000 products and services. –BB

www.medicaldesignandoutsourcing.com

No.

Hologic

Key personnel:

Marlborough, Massachusetts

$5,632,300,000* *Fiscal year ended 9/25/2021

No.

2020 rank: 29 R&D spend: $276,300,000 Employees: 6,350

(healthcare only)

Fujifilm Holdings Tokyo

Founded in 1985, Marlborough, Massachusetts–based HOLOGIC develops and manufactures diagnostics products, imaging systems, and surgical products focused on women's health and well-being through early detection and treatment. The company successfully pivoted toward more general diagnostics during the COVID-19 pandemic, becoming a major provider of tests and testing machines for the novel coronavirus. The resulting influx of cash enabled Hologic to reactivate full-time R&D operations and send business development teams shopping for M&A opportunities. Deals completed or in the works include $64 million for Somatex Medical Technologies, which develops minimally invasive devices for tumor diagnostics, biopsy and interventional specialties; $159 million for Diagenode, a PCR assay manufacturer; $808 million for Mobidiag, a FinnishFrench developer of molecular low-plex and high-plex testing; and $160 million for Bolder Surgical, a developer and manufacturer of advanced energy vessel-sealing surgical devices. –JH

Key personnel: KENJI SUKENO, board chair and representative director; TEIICHI GOTO, president and CEO, representative director

$5,400,000,000* *Fiscal year ended 3/31/2021

STEPHEN MACMILLAN, chair, president and CEO; ERIK ANDERSON, president, global services; MONICA AGUIRRE BERTHELOT, chief of staff; PATRICK BRADY, SVP, global supply chain, quality and regulatory; SEAN DAUGHERTY, president, breast/skeletal health and GYN surgical solutions; JOHN GRIFFIN, general counsel; LISA HELLMANN, SVP, human resources; JENNIFER MEADE, division president, breast and skeletal health solutions; ESSEX MITCHELL, division president, GYN surgical solutions; KARLEEN OBERTON, CFO; KEVIN THORNAL, division president, diagnostic solutions; JAY STEIN, cofounder, chairperson emeritus, SVP & chief technology officer; JAN VERSTREKEN, group president, international; MICHAEL WATTS, VP, investor relations and corporate communications (outgoing).

2020 rank: 24 R&D spend: $649,900,000 Employees: 73,275

FUJIFILM Healthcare Americas is headquartered in Lexington, Massachusetts, offering diagnostic and enterprise imaging solutions across prevention, diagnosis and treatment. The medical imaging portfolio includes solutions for digital radiography, mammography, computed tomography, magnetic resonance imaging, ultrasound, endoscopy, and endosurgery. Fujifilm’s Synapse Enterprise Imaging portfolio provides healthcare professionals with imaging and data access to deliver a complete patient record. Fujifilm’s artificial intelligence initiative, REiLI, combines the Tokyo-based parent company’s image-processing expertise with cutting-edge AI innovations. The In-Vitro Diagnostic portfolio provides molecular based immunoassay technology for liver surveillance, clinical diagnostic chemicals for leading laboratories across the country and diagnostic chemicals for OEM white labeling products. –JH

www.medicaldesignandoutsourcing.com

11 • 2021

Medical Design & Outsourcing 73

No.

Smith+Nephew

Key personnel:

$4,560,000,000*

ROLAND DIGGELMANN, CEO; ANNE-FRANÇOISE NESMES, CFO; BRAD CANNON, president, sports medicine and ear, nose and throat; PETER COENEN, president, EMEA; CATHERYN O’ROURKE, chief legal and compliance officer; ELGA LOHLER, chief human resources officer; MYRA ESKES, president, Asia Pacific; PHIL COWDY, chief business development and corporate affairs officer; SIMON FRASER, president, advanced wound management; SKIP KIIL, president, orthopedics; SUSAN SWABEY, company secretary; VASANT PADMANABHAN, president, R&D

London

*Fiscal year ended 12/31/2020

2020 rank: R&D spend: Employees:

23 $307,000,000 18,000

SMITH+NEPHEW is a medical technology company that specializes in advanced wound management, orthopedics and trauma and sports medicine. The Londonbased company makes orthopedic implants such as the Legion Genesis Total Knee System and its numerous hip systems. The company recently announced its intent to seek FDA clearance for the RI.Hip Navigation software that would enable use of its Cori surgical robotic system for total hip arthroplasty. –DK

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No.

Edwards Lifesciences Irvine, California

$4,386,300,000* *Fiscal year ended 12/31/2020

2020 rank: R&D spend: Employees:

26 $760,700,000 15,878

Key personnel: MICHAEL MUSSALLEM, chair and CEO; DONALD BOBO, CVP, strategy and corporate development; TODD BRINTON, CVP, advanced technology, chief scientific officer; DAVEEN CHOPRA, CVP, surgical structural heart; DIRKSEN LEHMAN, CVP, public affairs; JEAN-LUC LEMERCIER, CVP, EMEA, Canada and Latin America; CHRISTINE MCCAULEY, CVP, human resources; GARY SORSHER, VP, quality and regulatory compliance; JOSEPH NUZZOLESE, CVP, global supply chain and quality; KATIE SYZMAN, CVP, critical care; SCOTT ULLEM, CVP, CFO; HUIMIN WANG, CVP, Japan, Asia and Pacific; ARNOLD PINKSTON, CVP, general counsel; LARRY WOOD, CVP, transcatheter aortic valve replacement; BERNARD ZOVIGHIAN, CVP, transcatheter mitral and tricuspid therapies

EDWARDS LIFESCIENCES is one of medtech's biggest heart valve makers. The Irvine, California-based company treats advanced cardiovascular disease with its numerous heart valve therapies and critical care and vascular technologies. One of Edwards' most known specialties is its transcatheter aortic valve replacement (TAVR) devices. The medtech giant also specializes in blood conservation, enhanced surgical recovery, clot management, hypotension management, infection control and sepsis shock management. –DK

No.

Intuitive Surgical Sunnyvale, California

$4,358,400,000* *Fiscal year ended 12/31/2020

2020 rank: R&D spend: Employees:

25 $595,100,000 8,081

Key personnel: GARY GUTHART, CEO; MYRIAM CURET, EVP and chief medical officer; MARSHALL MOHR, EVP and CFO; DAVE ROSA, EVP and chief business officer; BOB DESANTIS, EVP and chief product officer; BRIAN MILLER, chief digital officer; KARA ANDERSEN REITER, SVP, general counsel and chief compliance officer; CHRIS CARLSON, SVP and general manager, Multiport; HENRY CHARLTON, SVP and GM, U.S. and Europe; CRAIG CHILD, SVP, human resources; GILLIAN DUNCAN, SVP, professional education and program services worldwide; MARK JOHNSON, SVP, regulatory, quality and program management office; LESLY MARBAN, SVP, corporate marketing; JULIAN NIKOLCHEV, SVP, corporate development and strategy; GLENN VAVOSO, SVP and GM, Asia and worldwide indirect. (Note: Top leadership changes expected to take effect Jan. 1, 2022, with Rosa becoming EVP and chief strategy and growth officer, Charlton becoming chief commercial officer, Mohr becoming EVP for Global Business Services, and Jamie Samath becoming CFO.)

INTUITIVE SURGICAL is at the forefront of surgical robotics. Founded by Frederic Moll in 1995 and based in Sunnyvale, California, Intuitive developed the da Vinci robot-assisted surgery system, which received FDA approval for general laparoscopic surgery in 2000 before subsequent approvals for prostate surgery, thoracoscopic surgery, cardiac procedures performed with adjunctive incisions, and gynecologic procedures. As of 2020, a total of 67 countries house da Vinci systems, and 8.5 million procedures have been performed with the platform. Led by CEO Gary Guthart, the company also develops the Ion endoluminal system for minimally invasive peripheral lung biopsies. –SW

www.medicaldesignandoutsourcing.com

11 • 2021

Medical Design & Outsourcing

No.

(healthcare products)

Fresenius Medical Care

Key personnel: RICE POWELL, CEO and chair of the Management Board; HELEN GIZA, CFO; FRANKLIN W. MADDUX, global CMO; DR. KATARZYNA MAZUR-HOFSÄSS, CEO for Europe, Middle East and Africa; OLAF SCHERMEIER, CEO for global R&D; WILLIAM VALLE, CEO for North America; KENT WANZEK, CEO for global manufacturing, quality and supply; HARRY DE WIT, CEO for Asia-Pacific

Bad Homburg, Germany

$4,269,300,000* *Fiscal year ended 12/31/2020

(€ 3,745,000,000) 2020 rank: 27 R&D spend: $221,160,000 Employees: 30,000

FRESENIUS MEDICAL CARE is one of the world’s top providers of products and services for people with renal diseases. Severe COVID-19 cases can cause acute kidney failure, so Fresenius Medical Care expanded production of acute dialysis products at short notice at the start of the pandemic. Around the same time, FDA cleared the company’s Novalung system — which reduces or eliminates the need for mechanical ventilation by pumping a person’s blood through an oxygenator for gas exchange. –CN

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No.

29 BioMérieux

Marcy-l’Étoile, France

$3,554,748,000*

*Fiscal year ended 12/31/2020

(€ 3,118,200,000) 2020 rank: 34 R&D spend: $454,632,000 Employees: 13,000

Key personnel: ALEXANDRE MÉRIEUX, chairperson and CEO; PIERRE BOULUD, chief operating officer, clinical operations; GUILLAUME BOUHOURS, EVP, CFO, purchasing, information systems; PIERRE CHARBONNIER, EVP, global quality, manufacturing and supply chain; FRANÇOIS LACOSTE, EVP, R&D; VALÉRIE LEYLDÉ, EVP, human resources and communications; MARK MILLER, EVP, chief medical officer; YASHA MITROTTI, EVP, industrial microbiology; ESTHER WICK, EVP, legal, IP and compliance

An important player in the in vitro diagnostics space for more than 55 years, BIOMÉRIEUX has a presence in 44 countries and serves more than 160 countries with the support of large distributors. The company provides a wide range of diagnostic systems, reagents, software and services to detect diseases and contamination, improve people’s health, and bolster consumer safety. An upturn in U.S. respiratory panels demand amid the COVID-19 Delta variant wave pushed sales up 12% through the first nine months of 2021. In October, BioMérieux and Baxter announced CE mark approval for their Nephroclear CCL14 test to predict persistent severe acute kidney injury. –CN

11 • 2021

Medical Design & Outsourcing 77

No.

Dentsply Sirona Charlotte, North Carolina

$3,342,000,000* *Fiscal year ended 12/31/2020

2020 rank: 28 R&D spend: $115,000,000 Employees: 15,000

No.

Nipro

(medical segment)

Key personnel: DONALD CASEY, CEO; CHIDAM CHIDAMBARAM, SVP, chief digital officer; MATTHEW COGGIN, SVP, chief strategy and business development officer; KEITH EBLING, EVP, general counsel and secretary; JORGE GOMEZ, EVP and CFO; DAN KEY, chief supply chain officer; WALTER PETERSOHN, chief commercial officer; CORD STAEHLER, SVP digital platforms and solutions, chief technology officer; LISA YANKIE, SVP, chief human resources officer; ERANIA BRACKETT, SVP, chief marketing officer

Charlotte, N.C.–based DENTSPLY SIRONA is a dental equipment manufacturer for endodontics and implant dentistry procedures. The company was founded in 1899 as Dentists' Supply Co. and as Sirona Dental Systems in 1877. The two companies merged in 2016 to become Dentsply Sirona — one of the main manufacturers of dental products and technologies. Early in 2021, Dentsply acquired clear dental aligner maker Byte in an all-cash deal for $1.04 billion. –DK

Key personnel:

Osaka, Japan

YOSHIHIKO SANO, president

$3,255,740,775*

This Japanese company’s medical device business is especially focused on dialysis and artificial organs. The company boasts that it is one of the leading manufacturers of dialyzers in the world. –CN

*Fiscal year ended 3/31/2021

(¥347,648,000,000) 2020 rank: 32 R&D spend: $92,273,834 Employees: 26,315

No.

Key personnel:

Getinge

Gothenburg, Sweden

$3,237,676,439* *Fiscal year ended 12/31/2020

(SEK 29,819,000,000) 2020 rank: 38 R&D spend: $158,740,499 Employees: 10,800

Medical Design & Outsourcing

11 • 2021

MATTIAS PERJOS, president and CEO; LARS SANDSTRÖM, CFO; STÉPHANE LE ROY, president, surgical workflows; JENS VIEBKE, president, acute care therapies; CARSTEN BLECKER, chief commercial officer; LENA HAGMAN, EVP, quality regulatory compliance; JEANETTE HEDÉN CARLSSON, EVP, communications and brand management; HERALD CASTLER, president, life science; MAGNUS LUNDBÄCK, EVP, human resources and sustainability; ANNA ROMBERG, EVP, legal, compliance and governance

The COVID-19 pandemic had a major impact on this Swedish medtech company, especially when it came to the steep rise in demand for ventilators and extracorporeal life support. In fact, the company nearly tripled its production of ventilators in 2020. GETINGE in April 2021 announced that it had received FDA clearance for three products to expand its Servo platform of ventilators. In June, it announced the U.S. launch of its Torin AI-based operation room management system. –CN www.medicaldesignandoutsourcing.com

No.

Hoya

(life care segment)

Tokyo

Key personnel: HIROSHI SUZUKI, president and CEO; RYO HIROOKA, CFO; EIICHIRO IKEDA, CTO; AUGUSTINE YEE, chief legal officer and head of corporate development and affairs

$3,200,983,330* *Fiscal year ended 3/31/2021

(¥341,801,000,000)

HOYA’s healthcare and information technology offerings include eyeglasses, medical endoscopes, intraocular lenses, optical lenses and key components for semiconductor devices. –CN

2020 rank: 30 R&D spend: $133,976,400 Employees: 20,676

No.

ResMed

Key personnel:

San Diego, California

$3,196,825,000* *Fiscal year ended 6/30/2021

2020 rank: 35 R&D spend: $225,284,000 Employees: 7,970

MICHAEL FARRELL, CEO; ROB DOUGLAS, president and chief operating officer; DAVID PENDARVIS, chief administrative officer, global general counsel; BRETT SANDERCOCK, CFO; JIM HOLLINGSHEAD, president, sleep and respiratory care business; BOBBY GHOSHAL, president, SaaS and chief technology officer; KATRIN PUCKNAT, president, ResMed Germany; JUSTIN LEONG, president, Asia and Latin America; VERED KEISAR, chief people officer; HEMANTH REDDY, chief strategy officer; CARLOS NUNEZ, chief medical officer; ANDREW PRICE, president, global operations

Founded by Peter Farrell in Australia in 1989, RESMED remains a family affair today, with his son Mick Farrell now CEO. It’s a position Mick Farrell has held since his father transitioned into a non-executive role in 2013. Now headquartered in San Diego, ResMed develops cloud-connected medical devices for respiratory diseases. Among its offerings are continuous positive airway pressure (CPAP) machines for sleep apnea, as well as ventilators for treating chronic obstructive pulmonary disease (COPD) and other respiratory conditions. The company’s devices have also been used as alternative options to invasive ventilators during the COVID-19 pandemic. –SW

No.

Steris

Key personnel:

Dublin, Ireland

DAN CARESTIO, president and CEO

(Operational HQ in Mentor, Ohio)

$3,107,519,000* *Fiscal year ended 3/31/2021

2020 rank: 33 R&D spend: $66,326,000 Employees: 13,000

Expect STERIS to rise higher in its Big 100 ranking in 2022. The sterilization and surgical products company in June 2021 completed its acquisition of Cantel Medical, provider of infection prevention products and services to endoscopy, dental, dialysis and life sciences customers. Walt Rosebrough left the corner office at Steris over the summer of 2021, with then-COO Dan Carestio promoted into the top spot. –CN

www.medicaldesignandoutsourcing.com

11 • 2021

Medical Design & Outsourcing 79

No.

36 Hillrom

Chicago

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2020 rank: R&D spend: Employees:

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Flexible pricing models Contract coating services Superior service to support your development project

37 $144,900,000 10,000

Key personnel: JOHN GROETELAARS, president and CEO; BARBARA BODEM, CFO; Francisco Canal, president, EMEA; AMY DODRILL, president, global surgical solutions; ANDREAS FRANK, president, front line care; CHERYL JAMES, chief human resources officer; PAUL JOHNSON, president, patient support systems; MARY KAY LADONE, SVP, corporate development, strategy and investor relations; TIM LAWRENCE, SVP, operations; ANGELA LEE, chief talent and diversity officer; RICHARD MARRITT, chief marketing officer; DEBORAH RASIN, chief legal officer and secretary; JASON RICHARDSON, VP, financial planning and analysis; ILANA SHULMAN, chief compliance officer; JESSICA SMITH, VP, regulatory affairs; JANET STEVENS, VP, quality assurance; MARK WALLWORK, president, Asia Pacific

The Chicago-based connected care technology developer remains on track to complete its $12.4 billion merger with Baxter in 2022. HILLROM President and CEO John Groetelaars said in an early November 2021 news release that he and the company “remain enthusiastic” about the pending combination as the companies continue to make progress with integration planning and regulatory approvals. –CN

To learn more about Biocoat visit our website www.biocoat.com 80

Medical Design & Outsourcing

11 • 2021

No.

Coloplast

Key personnel:

Humlebæk, Denmark

$2,970,336,391* *Fiscal year ended 9/30/2021

(DKK 19,426,000,000)

2020 rank: 39 R&D spend: $115,443,425 Employees: 12,578

KRISTIAN VILLUMSEN, president and CEO; ANDERS LONNING-SKOVGAARD, EVP, CFO; NICOLAI BUHL ANDERSEN, EVP, innovation; PAUL MARCUN, EVP, growth; CAMILLA MØHL, SVP, people and culture; ALLAN RASMUSSEN, EVP, global operations

COLOPLAST develops ostomy, continence, interventional urology, wound and skincare products and services. The goal, according to the Danish medtech company, is to make life easier for people with intimate healthcare needs. The company in November 2021 announced that it will spend DKK 16 billion (roughly $2.4 billion) to acquire Swedish laryngectomy care device company Atos Medical. –CN

No.

Paul Hartmann

Heidenheim an der Brenz, Germany

$2,773,620,000*

*Fiscal year ended 12/31/2020

(€ 2,433,000,000)

Key personnel: BRITTA FÜNFSTÜCK, chair and CEO; JONATHAN PROCOPIO, managing director; AARON BOWER, CFO; JOHN BROUGHTON, VP, marketing; TODD DEVEE, VP, sales

The Hartmann Group boasts a 200-year legacy of medical advancements in wound care and skin health. The company sells wound dressings, absorbent incontinence products, compression and fixation bandages, and wicking fabric and pre-moistened wipes. –CN

2020 rank: 42 R&D spend: not available Employees: 10,625

No.

Sonova

Key personnel:

Stäfa, Switzerland

ARND KALDOWSKI, CEO; BIRGIT CONIX, CFO; CLAUDE DIVERSI, GVP, hearing instruments wholesale; VICTORIA CARR-BRENDEL, GVP, cochlear implants; CHRISTOPHE FOND, GVP, audiological care; MARTIN GRIEDER, GVP, hearing instruments marketing; CLAUDIO BARTESAGHI, GVP, corporate HRM and communications; LUDGER ALTHOFF, GVP, operations; ANDI VONLANTHEN, GVP, research and development

$2,771,221,642* *Fiscal year ended 3/31/2021

(CHF 2,601,900,000)

2020 rank: 36 R&D spend: $125,572,478 Employees: 14,508

SONOVA is a major provider of hearing care products and services. The Switzerland-based group operates through its core business brands Phonak, Unitron, Hansaton, Advanced Bionics and AudioNova. Its offerings include hearing aids, cochlear implants, wireless communication products, eSolutions and professional audiological care. –CN

www.medicaldesignandoutsourcing.com

11 • 2021

Medical Design & Outsourcing 81

No.

(medical devision)

Dräger

Lübeck, Germany

$2,624,508,000* *Fiscal year ended 12/31/2020

(€ 2,302,200,000) 2020 rank: 48 R&D spend: not available Employees: not available

Key personnel: STEFAN DRÄGER, chair; GERT-HARTWIG LESCOW, CFO, board member, IT and vice chair; RAINER KLUG, executive board member, safety division; REINER PISKE, board member, sales and human resources; ANTON SCHROFNER, board member, medical division

Founded in Lübeck in 1889, DRÄGER has grown into a global, publiclytraded enterprise over five generations as a family-run business. During the COVID-19 pandemic, the company experienced an unprecedented rise in demand for ventilators, patient monitors and associated consumables — all the way through to FFP masks and carbon dioxide sensors. Dräger announced in April 2021 that it bought a majority stake in Swiss medtech startup Stimit and its noninvasive tech to stimulate intensive care patients’ respiratory muscles. –CN

No.

Bio-Rad

Key personnel:

Hercules, California

$2,545,626,000* *Fiscal year ended 12/31/2020

2020 rank: 44 R&D spend: $226,598,000 Employees: 8,000

NORMAN SCHWARTZ, chair, president and CEO; ANDREW LAST, EVP, chief operating officer; ILAN DASKAL, EVP, CFO; TIMOTHY ERNST, EVP, general counsel and secretary; MIKE CROWLEY, EVP, global commercial operations; ANNETTE TUMOLO, EVP, president, life sciences; DARA WRIGHT, EVP, president, clinical diagnostics; AJIT RAMALINGAM, SVP, chief accounting officer

BIO-RAD develops and makes products for the life science research and clinical diagnostic markets. Customers include universities, research institutions, hospitals, public health and commercial laboratories, biotechnology firms, pharmaceutical companies, as well as applied laboratories that include food safety and environmental quality. During the third quarter of 2021, the company reported continued demand for products associated with COVID-19 testing and research, though at a more moderate level. –CN

No.

Teleflex

Key personnel:

Wayne, Pennsylvania

$2,537,156,000* *Fiscal year ended 12/31/2020

2020 rank: 41 R&D spend: $119,747,000 Employees: 14,000

LIAM KELLY, chair, president and CEO; THOMAS POWELL, EVP and CFO; PETRO BARCHUK, VP, financial planning and analysis; KAREN BOYLAN, CVP, strategic projects; JOHN DEREN, CVP and chief accounting officer; MICHAEL DIGIUSEPPE, president, Latin America and Americas commercial operations group; TIMOTHY DUFFY, VP and chief information officer; JAMES FERGUSON, president and GM, surgical; MICHELLE FOX, SVP and chief medical officer; SUNNY GOH, president, APAC; KEVIN HARDAGE, president and GM, interventional urology; MARIE HENDRIXSON, VP, internal audit; CAMERON HICKS, CVP and chief human resources officer; MATTHEW JAMES, president, EMEA and global urology; LAWRENCE KEUSCH, VP, investor relations and strategy development; MICHAEL KRYUKOV, VP, global tax; LISA KUDLACZ, president and GM, vascular; BERT LANE, VP, global logistics and distribution; DANIEL LOGUE, CVP, general counsel and secretary; JUSTIN MCMURRAY, VP, global strategic R&D; JAKE NEWMAN, group president; DANIEL PRICE, VP, commercial finance; KEVIN ROBINSON, VP and GM, anesthesia and emergency medicine; GREG STOTTS, VP and GM, OEM; ED WEIDNER, VP, customer experience and commercial operations; JAY WHITE, CVP and president, global commercial; JAMES WINTERS, CVP, manufacturing and supply chain

The Wayne, Pennsylvania–based critical care and surgical tech company boasts a diverse portfolio serving the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. Its notable brands include Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck. –CN

www.medicaldesignandoutsourcing.com

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Medical Design & Outsourcing 83

No.

Align Technology Tempe, Arizona

$2,471,900,000* *Fiscal year ended 12/31/2020

Key personnel: JOSEPH HOGAN, president and CEO; JOHN MORICI, CFO and SVP, global finance; RAJ PUDIPEDDI, chief product and marketing officer, SVP and managing director, Asia Pacific; SIMON BEARD, SVP and managing director, Americas; JULIE COLETTI, SVP, chief legal and regulatory officer; STUART HOCKRIDGE, SVP, global human resources; SRINI KAZA, SVP, product R&D; SREELAKSHMI KOLLI, SVP, chief digital officer; JENNIFER OLSON, SVP and managing director; customer success; ZELKO RELIC, SVP, chief technology officer; MARKUS SEBASTIAN, SVP and managing director, EMEA; YUVAL SHAKED, SVP and managing director, iTero Scanner and services business; JULIE TAY, SVP, commercial strategy; EMORY WRIGHT, SVP, global operations

2020 rank: 43 R&D spend: $175,300,000 Employees: 18,070

San Jose, California–based ALIGN TECHNOLOGY is the maker of the Invisalign clear aligner orthodontics system. Started in 1997, Align Technology pioneered the invisible orthodontics market with Invisalign. The system combines digital treatment planning and mass customization. In 2011, Align acquired the iTero intraoral scanner to extend its digital treatment process of the Invisalign system. Align Technology has treated more than 10.9 million people to date. –DK

Cooper Cos.

Key personnel:

No.

San Ramon, California

$2,430,900,000* *Fiscal year ended 10/31/2020

2020 rank: 40 R&D spend: $93,300,000 Employees: 12,000

ALBERT WHITE, president and CEO; DANIEL MCBRIDE, EVP, chief operating officer and president, CooperVision; HOLLY SHEFFIELD, president, CooperSurgical; BRIAN ANDREWS, EVP, CFO and treasurer; AGOSTINO RICUPATI, chief accounting officer and SVP, finance and tax

COOPER COS. has two business units — CooperVision and CooperSurgical — that provide products and services to advance vision care and women's health. CooperVision is a major manufacturer of contact lenses, while CooperSurgical’s portfolio is focused on women’s health, fertility and diagnostics. –CN

No.

Demant

Key personnel:

Smørum, Denmark

SØREN NIELSEN, CEO and president, and president, Oticon; RENÉ SCHNEIDER, CFO

$2,212,385,321*

The Danish hearing healthcare and technology company has roots going back to the early 20th century. Its offerings range from hearing care, hearing aids and hearing implants to diagnostic equipment and services and audio solutions. The William Demant Foundation holds the majority of shares in Demant A/S, which is listed as a blue-chip stock on Nasdaq Copenhagen. –CN

*Fiscal year ended 12/31/2020

(DKK 14,469,000,000) 84

2020 rank: 45 R&D spend: not available Employees: 16,155

Medical Design & Outsourcing

11 • 2021

www.medicaldesignandoutsourcing.com

No.

HU Group

Key personnel:

(previously Miraca) Tokyo

$2,088,406,069* *Fiscal year ended 3/31/2021

(¥223,000,000,000)

SHIGEKAZU TAKEUCHI, president and CEO; NAOKI KITAMURA, managing executive officer; SHUNICHI HIGASHI, executive officer, LTS; GOKI ISHIKAWA, executive officer, IVD; TOSHIHIKO SHIMIZU, chief information officer; ATSUKO MURAKAMI, CFO; Kazuya Omi, R&D; TADASHI HASEGAWA, corporate planning and management; HIROAKI KIMURA, general affairs

The Japan-based company has a focus on lab testing, related services and in vitro diagnostics. The company has been seeking to promote the digitization of testing information and using data to create a medical/health information platform. –CN

2020 rank: 51 R&D spend: not available Employees: not available

No.

Cook Medical Bloomington, Indiana

$2,035,000,000* *Fiscal year ended 12/31/2020

Key personnel: PETE YONKMAN, president Cook Group and Cook Medical; CARL COOK, CEO

Founded in 1963 in Bloomington, Indiana, COOK MEDICAL’s first products were wire guides, needles and catheters. These days, the company sells a wide range of minimally invasive medical devices covering 41 medical specialties, with sales in 135 countries. –CN

2020 rank: 46 R&D spend: not available Employees: 11,131

No.

Bruker

Key personnel:

Billerica, Massachusetts

$1,987,500,000*

FRANK LAUKIEN, president and CEO; GERALD HERMAN, CFO; MARK MUNCH, EVP, president, Bruker Nano group and Bruker Nano surfaces division; JUERGEN SREGA, president, Bruker CALID and Bruker Daltonics division; FALKO BUSSE, president, Bruker BioSpin; BURKHARD PRAUSE, president and CEO, Bruker Energy and Supercon Technologies

BRUKER provides scientific instruments and analytical and diagnostic products and services to enable scientists to explore life and materials at molecular, cellular and microscopic levels. German experimental physics professor Günther Laukien helped start the company in 1960, providing what the company says were the first high-resolution systems for use in analytical chemistry in the U.S. –CN

*Fiscal year ended 12/31/2020

2020 rank: 47 R&D spend: $198,000,000 Employees: 7,400

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Medical Design & Outsourcing 85

No.

Dexcom

Key personnel:

San Diego

KEVIN SAYER, chair, president andCEO; DONALD ABBEY, EVP, quality and regulatory affairs; ANDREW BALO, EVP, regulatory strategy, clinical affairs and strategic partnership development; PAULU FLYNN, EVP, global revenue; JAKE LEACH, EVP, chief technology officer; PATRICK MURPHY, EVP, chief legal officer; STEVEN PACELLI, EVP and managing director, Dexcom Ventures; CHAD PATTERSON, EVP, global marketing; BARRY REGAN, EVP, global operations; SHELLY SELVARAJ, SVP, information technology; SUMI SHRISHRIMAL, SVP, chief risk officer; SADIE STERN, EVP, chief human resources officer; JEREME SYLVAIN, EVP, CFO

$1,926,700,000* *Fiscal year ended 12/31/2020

2020 rank: R&D spend: Employees:

57 $359,900,000 5,500

One of the industry leaders in continuous glucose monitoring for diabetes management, San Diego-based DEXCOM was founded in 1999. Its ﬁrst approved CGM, a three-day sensor, received an FDA nod in 2006 and the company has continued to develop since. Its ﬁrst G-series CGM, the G4, was approved in 2014. The latest version to hit the market — the wearable G6 sensor — offers a one-touch applicator for the sleek sensor, which is compatible with smart devices that display real-time glucose data. CEO Kevin Sayer announced in late October that the next-generation G7 system is expected to launch in Europe in the fall while the company is on track to submit for FDA clearance soon. –SW

At OKAY Industries, we’ve built a culture of quality and continuous improvement that reigns over everything we do. Just ask Jim DeVecchis, Director of Manufacturing Engineering. Jim and his team make sure every component that leaves our facilities meets your exact design and performance specifications. Across our organization, quality means paying attention to the details – even details that are as thin as 0.006mm – like in this heart valve stent. Internally, we call our commitment to quality The OKAY Way. As our customer, you’ll call it peace of mind. What we manufacture is Part of Something Greater. Learn more about this project at okayind.com/king.

“QUALITY IS KING”

Jim DeVecchis Director of Manufacturing Engineering

M E TA L S TA M P I N G • C N C M A C H I N I N G • L A S E R P R O C E S S I N G • A U T O M AT E D A S S E M B LY 200 Ellis Street New Britain, CT 06051 Tel (860) 225-8707

245 New Park Drive Berlin, CT 06037 Tel (860) 225-8707

Medical Design & Outsourcing

11 • 2021

32B Building | Z Industrial Park Alajuela, Costa Rica Tel + (506) 2442-1011

860-225-8707 okayind.com

www.medicaldesignandoutsourcing.com

No.

50 ConvaTec

Reading, U.K.

$1,894,000,000* *Fiscal year ended 12/31/2020

2020 rank: R&D spend: Employees:

50 $53,800,000 9,900

Key personnel: KARIM BITAR, CEO; JOHN MCADAM, chair; FRANK SCHULKES, CFO; DAVID SHEPHERD, president and COO, global advanced wound care; MANI GOPAL, president and COO, global ostomy care; KJERSTI GRIMSRUD, president and COO, global continence care; JOHN LINDSKOG, president and COO, global infusion care; BRUNO PINHEIRO, president and interim COO, global emerging markets; SETH SEGEL, president, home services group; DIVAKAR RAMAKRISHNAN, EVP, CTO; NATALIA KOZMINA, EVP, chief human resources ofﬁcer; EVELYN DOUGLAS, EVP, chief, corporate strategy and business development, general counsel and company secretary; DONAL BALFE, EVP, chief of quality and operations

CONVATEC is an advanced wound care, ostomy care, continence and critical care and infusion care company. Founded in 1978, the company's products and devices include DuoDerm dressings, Aquacel and Hydroﬁber technology, the Flexi-Seal fecal management system, and the Avelle negative pressure wound therapy system. ConvaTec has shipped more than 1 billion products and operates out of more than 80 countries. –DK

11 • 2021

Medical Design & Outsourcing

No.

Nihon Kohden Tokyo

$1,870,453,268* *Fiscal year ended 3/31/2021

(¥199,727,000,000) 2020 rank: 52 R&D spend: $59,533,621 Employees: 5,531

Key personnel: HIROKAZU OGINO, president and CEO; TAKASHI TAMURA, executive operating officer, domestic operations; TADASHI HASEGAWA, senior operating officer, GM, global corporate administration operations, chief compliance officer; KAZUTERU YANAGIHARA, senior operating officer, GM, strategic technology operations; FUMIO HIROSE, senior operating officer, GM, business strategy operations; EIICHI TANAKA, operating officer, GM, U.S. operations; YASUHIRO YOSHITAKE, operating officer, GM, international operations

Yoshio Ogino founded NIHON KOHDEN in 1950 with a vision of bringing the power of electrical engineering to medicine. Over the decades, this Japanese company has been a pioneer in fields including pulse oximetry, cerebral artery pressure meters, ECGs, heart monitors and fetal monitors. –CN

No.

Amplifon Milan, Italy

$1,773,270,000*

*Fiscal year ended 12/31/2020

(€ 1,555,500,000) 2020 rank: 49 R&D spend: not available Employees: 17,500

Key personnel: ENRICO VITA, CEO; FEDERICO BARDELLI, chief retail excellence officer; ALESSANDRO BONACINA, EVP, Americas; RICCARDO CATTANEO, chief regulatory officer; ANDREA CICCOLINI, chief information officer; FEDERICO DAL POZ, chief legal officer; CRISTIAN FINOTTI, chief procurement and supply chain officer; GABRIELE GALLI, CFO; FRANCESCA MORICHINI, chief HR officer; ANTHEA MUIR, EVP, APAC; IACOPO LORENZO PAZZI, EVP, EMEA; GIULIO PIZZINI, chief strategy and business development officer; GIUSEPPE VIRONDA, chief marketing officer

AMPLIFON is a major hearing aid retailer, curating a family of products and services including Ampli-easy, Ampli-mini, Ampli-connect, Ampli-energy, the Amplifon App, and Companion smart support. –CN

No.

Carl Zeiss Meditec Jena, Germany

$1,545,270,000* *Fiscal year ended 9/30/2021

(€ 1,355,500,000)

2020 rank: 53 R&D spend: $249,432,000 Employees: 3,290

Medical Design & Outsourcing

11 • 2021

Key personnel: LUDWIN MONZ, president and CEO; JUSTUS FELIX WEHMER, CFO; JAN WILLEM DE CLER, manager, human resources and employee development, cultural development, global service and customer care and operations.

Zeiss creates and supplies technologies and application-oriented products and services for ophthalmology and microsurgery. CEO Ludwin Monz is expected to step down at the end of the year. Markus Weber, presently responsible for Carl Zeiss AG’s Semiconductor Manufacturing Technology segment, will take over the corner office at CARL ZEISS MEDITEC. –CN

www.medicaldesignandoutsourcing.com

No.

Straumann

Key personnel:

$1,518,798,594*

GUILLAUME DANIELLOT, CEO; PETER HACKEL, CFO; WOLFGANG BECKER, head distributor and emerging markets, EMEA; CAMILA FINZI, head orthodontics business unit; HOLGER HADERER, head marketing and education; MARK JOHNSON, head R&D and operations; PATRICK LOH, head sales Asia/Pacific; DIRK REZNIK, head digital business unit; ALASTAIR ROBERTSON, global people management and development; AURELIO SAHAGUN, head sales North America; RAHMA SAMOW, head dental service organizations; MATTHIAS SCHUPP, head sales Latin America, CEO, Neodent; ROBERT WOOLLEY, head sales Western Europe

Basel, Switzerland

*Fiscal year ended 12/31/2020

(CHF 1,426,000,00) 2020 rank: 54 R&D spend: not available Employees: 7,340

The Swiss company is a global provider of tooth replacement and orthodontic products and services. Its brands include Anthogyr, ClearCorrect, Dental Wings, Medentika, Neodent, NUVO and STRAUMANN. –CN

No.

Elekta

Key personnel:

Stockholm

$1,494,353,963* *Fiscal year ended 4/30/2021

(SEK 13,763,000,000) 2020 rank: 55 R&D spend: $161,346,363 Employees: 4,194

GUSTAF SALFORD, president and CEO; JOHAN ADEBÄCK, CFO; KARIN SVENSKE NYBERG, EVP, human resources; MAURITS WOLLESWINKEL, president, Linac solutions and chief product officer; VERENA SCHILLER, president, neuro solutions; JOHN LAPRÉ, president, brachy solutions; ANDREW WILSON, president, oncology informatics solutions; PAUL BERGSTRÖM, EVP, global services; LARRY BISCOTTI, EVP, region Americas; ANMING GONG, EVP, region China; JONAS BOLANDER, general counsel and EVP; HABIB NEHME. EVP, Turkey, India, Middle East, Africa, APAC and Japan; LIONEL HADJADJEBA, president, MR-Linac solutions and acting EVP, region Europe

The Swedish company has been a pioneer in precision radiation medicine since its founding in 1972. The company has offices in 120 countries and a listing on Nasdaq Stockholm. –CN

No.

Fukuda Denshi

Key personnel:

Tokyo

KOTARO FUKUDA, chair and CEO; DAIJIRO SHIRAI, president and COO

$1,374,377,224*

The Japanese company is a global provider of electrocardiographs, patient monitoring system, and other engineered medical devices. The company boasts that its story — dating back to its founding in 1939 — represents the history of the electrocardiograph. –CN

*Fiscal year ended 3/31/2021

(¥146,756,000,000)

2020 rank: 60 R&D spend: not available Employees: 3,976

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Medical Design & Outsourcing 89

No.

Integra Lifesciences

Princeton, New Jersey

$1,371,868,000* *Fiscal year ended 12/31/2020

2020 rank: 56 R&D spend: $77,381,000 Employees: 3,700

Key personnel: PETER ARDUINI, president and CEO (outgoing); JAN DE WITTE, president and CEO (incoming); CARRIE ANDERSON, EVP and CFO; ANDREA CARUSO, CVP, business development; GLENN COLEMAN, EVP and chief operating officer; WILLIAM COMPTON, CVP and chief information officer; ROBERT DAVIS, EVP and president, tissue technologies; SRAVAN EMANY, CVP, commercial excellence and chief strategy officer; LISA EVOLI, EVP and chief human resources officer; SUSAN KRAUSE, CVP, chief quality officer; STEVE LEONARD, CVP, global operations and supply chain; MICHAEL MCBREEN, EVP and president, Codman specialty surgical; JUDITH O’GRADY, CVP, global regulatory affairs; ERIC SCHWARTZ, EVP, chief legal officer and secretary

INTEGRA LIFESCIENCES was founded in 1989 after the acquisition of an engineered collagen technology platform that was designed to repair and regenerate tissue. The Billerica, Massachusetts-based company has since expanded its regenerative technology product portfolio to include numerous surgical instruments, neurosurgical devices and advanced wound products. Some of its better-known brands include: AmnioExcel, Bactiseal, CerebroFlo, Certas Plus, Codman, CUSA, DuraGen, DuraSeal, MediHoney, SurgiMend and more. –DK

Your needs. Our solutions. True partnership. From ideas to ﬁnal products, our partnership spans the full spectrum of your project. With applications expertise and medical device experience that not only enables, but enhances, each step in the process.

Visit us at spectrumplastics.com

No.

Fisher & Paykel Healthcare Auckland, New Zealand

$1,280,885,760* *Fiscal year ended 3/31/2021

(NZ$1,971,200,000)

Key personnel: LEWIS GRADON, CEO; PAUL SHEARER, SVP, sales and marketing; LYNDAL YORK, CFO; ANDREW SOMERVELL, VP, products and technology; WINSTON FONG, VP, surgical technologies; BRIAN SCHULTZ, VP, quality and regulatory affairs; NICOLA TALBOT, VP, human resources; JONTI RHODES, GM, supply chain; NICHOLAS FOURIE, VP, information and communication technology; MARCUS DRILLER, VP, corporate

Based in New Zealand and founded in 1971, FISHER & PAYKEL HEALTHCARE is a designer, manufacturer and marketer of products and systems for use in acute and chronic respiratory care, surgery and the treatment of obstructive sleep apnea. –CN

2020 rank: 75 R&D spend: $88,827,660 Employees: 5,788

No.

ICU Medical

Key personnel:

San Clemente, California

$1,271,004,000* *Fiscal year ended 12/31/2020

2020 rank: 58 R&D spend: $42,948,000 Employees: 7,900

VIVEK JAIN, chair and CEO; CHRISTIAN VOIGTLANDER, COO; DAN WOOLSON, CVP and GM, infusion systems; VIRGINIA SANZONE, CVP, general counsel; BRIAN BONNELL, CFO

San Clemente, California–based ICU MEDICAL develops and manufactures IV therapy devices for vascular therapy, oncology and critical care applications. Its devices include IV systems, closed system transfer devices, hemodynamic monitoring systems, cardiac output monitoring sensors and catheters, oximetry catheters, thermodilution and monitoring catheters, renal systems and more. ICU Medical acquired Hospira Infusion Systems from Pfizer in 2017 to exclusively focus on IV therapy. It’s set to grow even larger during the first half of 2022, when it expects to complete its $2.35 billion acquisition of Smiths Medical. –DK

No.

Omron Healthcare

Key personnel:

Kyoto, Japan

ISAO OGINO, president and CEO, Omron Healthcare

$1,152,715,864*

The Japanese conglomerate boasts that it is the No. 1 maker of home blood pressure monitors, with more than 300 million units sold in more than 110 countries. Its products also include nebulizers and transcutaneous electrical nerve stimulation (TENS) devices. –CN

*Fiscal year ended 3/31/2021

(¥123,087,000,000) 2020 rank: 64 R&D spend: $63,682,338 Employees: 3,758

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Medical Design & Outsourcing 91

No.

Masimo

Key personnel:

Irvine, California

JOE KIANI, chair and CEO; BILAL MUHSIN, COO; MICAH YOUNG, EVP and CFO; TOM MCCLENAHAN, EVP, general counsel; TAO LEVY, EVP, business development

$1,143,744,000*

Founded in 1989, MASIMO has a product mix that ranges from noninvasive patient monitoring to consumer products. Headquartered in Irvine, California, the company estimates that its Masimo Signal Extraction Technology (SET) is used to monitor some 200 million patients internationally. The company also reports that nine out of the top 10 hospitals in the 2019–2020 U.S. News & World Report Best Hospitals Honor Roll use its primary pulse oximetry technology. In 2005, the company expanded the number of parameters its technology could monitor with the introduction of Masimo Rainbow, which uses advanced signal processing algorithms and adaptive filters to analyze hemoglobin. –BB

*Fiscal year ended 12/31/2020

No.

2020 rank: 71 R&D spend: $118,659,000 Employees: 2,000

(Medical Technology segment, including DJO)

Colfax

Key personnel:

DJO HQ in Lewisville, Texas; Colfax HQ in Wilmington, Delaware

$1,120,700,000* *Fiscal year ended 12/31/2020

2020 rank: 98 R&D spend: not available Employees: 5,000

No.

COLFAX plans to split into two publicly traded companies early next year — with businesses including DJO forming a new stand-alone orthopedic device company called Enovis that will be headquartered in Wilmington, Delaware, with a significant presence in the Dallas area. Current Colfax CEO Matt Trerotol will lead the medtech business, with Colfax EVP Brady Shirley serving as COO. The company over the summer announced the acquisition of Mathys AG Bettlach and its products for artificial joint replacement, synthetic bone graft solutions and sports medicine. Stryker in 2020 sold its total ankle replacements and finger joint implants businesses to Colfax/DJO to appease antitrust regulators as part of Stryker’s merger with Wright Medical. –CN

(Smiths Group)

Smiths Medical Minneapolis

$1,084,003,200* *Fiscal year ended 7/31/2021

(£849,000,000) 2020 rank: 61 R&D spend: not available Employees: 7,770 92

MATTHEW TREROTOLA, president and CEO; CHRISTOPHER HIX, EVP and CFO; SHYAM KAMBEYANDA, CEO, ESAB and Colfax EVP; BRADY SHIRLEY, CEO, DJO and Colfax EVP; LARRY COBLE, SVP, Colfax business system and supply chain; DANIEL PRYOR, EVP, strategy and business development; PATRICIA LANG, SVP, chief human resources officer; BRADLEY TANDY, SVP, general counsel and corporate secretary

Medical Design & Outsourcing

11 • 2021

Key personnel: JEHANZEB NOOR, CEO; MEGAN HANSEN, general counsel; WILSON CONSTANTINE, president, Americas region; NIGEL BARK, VP and GM, EMEA; LARS BONEFELD, VP, global marketing and strategy; DANIEL KHALILI, SVP, global quality, regulatory and R&D; GREG HUTCHISON, SVP, global operations, supply chain and procurement; CRAIG SHIRLEY, VP, human resources

Part of the British multinational Smiths Group and run out of the Minneapolis area, SMITHS MEDICAL’s business includes syringe and ambulatory infusion devices, vascular access and vital care products. It’s set to become part of ICU Medical as part of a $2.35 billion acquisition that’s expected to close during the first half of 2022. – CN www.medicaldesignandoutsourcing.com

No.

Integer

Key personnel:

$1,073,442,000*

JOSEPH DZIEDZIC, president and CEO; JASON GARLAND, EVP, CFO; JOSEPH FLANAGAN, EVP, quality and regulatory affairs; KIRK THOR, EVP, chief human resources ofﬁcer; JOEL BECKER, president, cardiac rhythm management and neuromodulation; PAYMAN KHALES, president, cardio and vascular; JENNIFER BOLT, SVP, global operations and ESG; MCALISTER MARSHALL, interim general counsel; TONY BOROWICZ, SVP, strategy, business development and investor relations; CARTER HOUGHTON, president, portable medical and electrochem

Plano, Texas

*Fiscal year ended 12/31/2020

2020 rank: R&D spend: Employees:

59 $48,500,000 7,500

One of the largest medtech contract manufacturers in the world, INTEGER came out of the 2015 merger of Greatbatch and Lake Region Medical. Integer’s manufacturing expertise is vast, including micro machining, laser processing, injection molding, metal stamping, small diameter and multi-lumen plastic tubing, metal stamping and grinding, precious metal manufacturing, tube fabrication, wire coiling and more. Technical capabilities include metallurgy, catheters, guidewires, implantable pulse generators, batteries, software, battery packs, wireless charging, leads and robotics. Its Electrochem subsidiary develops custom batteries for high-end niche applications in a host of industries. In October 2021, it announced plans to spend $220 million to acquire Oscor. – CN

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11 • 2021

Medical Design & Outsourcing

No.

NuVasive San Diego

$1,050,582,000* *Fiscal year ended 12/31/2020

Key personnel: CHRIS BARRY, CEO; AVIVA MCPHERRON, VP, information technology; DALE WOLF, SVP, global operations; KYLE MALONE, VP, clinical, medical and regulatory affairs; MASSIMO CALAFIORE, chief commercial officer; MATT HARBAUGH, EVP and CFO; MICHAEL FARRINGTON, VP, corporate marketing, brand and communication; NATHANIEL SISITSKY, SVP, general counsel and corporate secretary; RYAN DONAHOE, chief technology officer; SEAN FREEMAN, SVP, strategy and corporate development

2020 rank: 62 R&D spend: $79,838,000 Employees: 2,800

NUVASIVE over the summer announced the commercial launch of the Pulse spinal surgical automation platform after it received its latest 510(k) clearance and CE mark approval. Pulse integrates radiation reduction, imaging enhancement, rod bending, navigation, intraoperative neuromonitoring, spinal alignment tools and more into a single platform. The spine technology company’s portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. –CN

Cochlear

Key personnel:

No.

Sydney

$1,030,227,670* *Fiscal year ended 6/30/2021

(AU$1,493,300,000)

2020 rank: 70 R&D spend: $134,530,500 Employees: 4,000

No.

(healthcare segment))

Konica Minolta

COCHLEAR is a Sydney, Australia-based company that designs and manufactures the Nucleus cochlear implant, the Hybrid electro-acoustic implant and the Baha bone conduction implant. The implantable hearing devices were designed by the company to understand and treat hearing loss better. Cochlear has provided more than 600,000 implantable devices for a broad range of patient populations. –DK

Key personnel:

*Fiscal year ended 3/31/2021

PATRICK BANNO, president and CEO; SAM ERRIGO, chief operating officer; HOLLY DESANTIS, EVP CFO; TODD CROTEAU, president, all covered IT services; ALLAN SCHWEDOCK, SVP, operations & supply chain; WILLIAM TROXIL, corporate SVP, industrial print and production print; DINO PAGLIARELLO, SVP, product management and planning; KAY DU FERNANDEZ, SVP, marketing; KEVIN KERN, SVP, digital transformation and emerging technologies; VICKY RINGWOOD, SVP, human resources; STEVE HERBES, VP and general counsel

KONICA MINOLTA Healthcare Americas is a major medical diagnostic imaging products and services company, with a focus on digital radiography, ultrasound, precision medicine and healthcare IT. The company seeks to serve the entire continuum of care, from prevention to diagnosis to treatment. –CN

Tokyo

$990,434,000*

DIG HOWITT, CEO and president; STUART SAYERS, CFO; JAN JANSSEN, chief technology officer; TONY MANNA, president, Americas; RICHARD BROOK, president, EMEA; ANTHONY BISHOP, president, Asia Pacific and Latin American Regions; DEAN PHIZACKLEA, SVP, global marketing; DAVID HACKSHALL, chief information officer; GREG BODKIN, SVP, supply chain and operational excellence; JENNIFER HORNERY, SVP, people and culture; BRIAN KAPLAN, SVP, clinical strategy and innovation

2020 rank: 76 R&D spend: not available Employees: not available

Medical Design & Outsourcing

11 • 2021

www.medicaldesignandoutsourcing.com

No.

Merit Medical Systems South Jordan, Utah

$963,875,000*

*Fiscal year ended 12/31/2020

2020 rank: 66 R&D spend: $57,537,000 Employees: 5,989

Key personnel: FRED LAMPROPOULOS, chair and CEO; RAUL PARRA, CFO; RONALD FROST, COO; BRIAN LLOYD, chief legal officer and corporate secretary; ROB FREDERICKS, chief strategy and innovation officer; MIKE VOIGT, chief human resources officer; JOE WRIGHT, president, international; JUSTIN LAMPROPOULOS, president, EMEA; NICOLE PRIEST, chief wellness officer; JOHN KNORPP, chief regulatory affairs officer; JOSEPH PIERCE, CIO; Jason Treft, CTO

Founded in 1987, MERIT MEDICAL SYSTEMS develops, makes and distributes proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures. The company is particularly focused on cardiology, radiology, oncology, critical care and endoscopy. –CN

No.

LivaNova

Key personnel:

London

DAMIEN MCDONALD, CEO; STEPHANIE BOLTON, president, International; PAUL BUCKMAN, president, North America; MATTHEW DODDS, SVP, corporate development; MARCO DOLCI, SVP, global operations and R&D; TRUI HEBBELINCK, chief human resources officer; RYAN MILLER, VP, strategy; BRYAN OLIN, SVP, clinical, quality assurance and regulatory affairs; ALEX SHVARTSBURG, CFO; KEYNA SKEFFINGTON, SVP, general counsel

$934,241,000*

*Fiscal year ended 12/31/2020

2020 rank: 63 R&D spend: $152,902,000 Employees: 3,000

LIVANOVA is a U.K.-based company that develops devices for cardiac surgery and neuromodulation. The company was formed in 2015 after a $2.7 billion merger between Cyberonics and Sorin. Although the company sold its heart valve business earlier this year, the company today makes devices for the therapeutic areas of advanced circulatory support, cardiopulmonary, drug-resistant epilepsy, heart failure, difficult-to-treat depression and obstructive sleep apnea. –DK

www.medicaldesignandoutsourcing.com

11 • 2021

Medical Design & Outsourcing 95

No.

Insulet

Key personnel:

Acton, Massachusetts

SHACEY PETROVIC, president and CEO; CHARLES ALPUCHE, EVP and COO; ERIC BENJAMIN, SVP, innovation and strategy; BRET CHRISTENSEN, EVP and chief commercial ofﬁcer; DEBORAH GORDON, VP, investor relations; JOHN KAPPLES, SVP, secretary and general counsel; TRANG LY, SVP and medical director; DAN MANEA, SVP, chief human resources ofﬁcer; WAYDE MCMILLAN, EVP, CFO and treasurer; MICHAEL SPEARS, SVP, regulatory affairs and compliance

$904,400,000* *Fiscal year ended 12/31/2020

2020 rank: R&D spend: Employees:

77 $146,800,000 2,287

Founded in 2000 by a Boston-based entrepreneur and venture capitalist seeking an easier way to treat his young son’s newly diagnosed type 1 diabetes, INSULET develops the Omnipod wearable, automated insulin delivery patch system. As an alternative to traditional insulin delivery methods, the disposable Omnipod provides up to three days of non-stop insulin delivery without the need for needles. Insulet is also developing its Omnipod technology platform for the delivery of non-insulin, subcutaneous drugs across other therapeutic areas. The company’s current Omnipod on the market is the Omnipod Dash, but CEO Shacey Petrovic, who joined Insulet in 2015 and has been CEO since 2019, expects to launch the next-generation Omnipod 5 this year. –SW

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No.

Haemonetics Boston

$870,463,000* *Fiscal year ended 3/28/2021

2020 rank: 67 R&D spend: $32,857,000 Employees: 2,708

Key personnel: CHRISTOPHER SIMON, president and CEO; MICHELLE BASIL, EVP, general counsel; WILLIAM BURKE, EVP, CFO; ANILA LINGAMNENI, EVP, CTO; KERRI DIPIETRO, SVP, global quality assurance; JOSEP LLUIS LLORENS, EVP, global manufacturing and supply chain; LAURIE MILLER, SVP, CHRO; CHAD NIKEL, president, global plasma and blood center; KEVIN O’KELLY-LYNCH, SVP, global business services; STEWART STRONG, president, global hospital

In 1953, Allen “Jack” Latham recognized the need for improved blood processing systems at Harvard Medical School. Eighteen years later, HAEMONETICS was born in Natick, Massachusetts, with its sights set on improving the safety and quality of blood supply. Today, the company employs nearly 2,000 people with offices located in 16 countries, led by President and CEO Christopher Simon. Haemonetics markets its products, which include blood collection devices, plasma collection devices, venous vascular closure systems and more, across more than 50 countries around the globe. –SW

No.

Conmed

Utica, New York

$862,459,000* *Fiscal year ended 12/31/2020

2020 rank: 68 R&D spend: $40,473,000 Employees: 3,400 Key personnel: CURT HARTMAN, chair, president and CEO; PATRICK BEYER, president, international and global orthopedics; TERENCE BERGÉ, VP, corporate controller; HEATHER COHEN, EVP, human resources; SHANNA COTTI-OSMANSKI, EVP, information technology and CIO; TODD GARNER, EVP and CFO; DANIEL JONAS, EVP, legal affairs, general counsel and secretary; JOHN KENNEDY, group EVP, advanced endoscopic technologies; SARAH OLIKER, assistant, general counsel, assistant secretary; JOHONNA PELLETIER, treasurer and VP, tax; STANLEY PETERS, VP and GM, advanced surgical; JACLYN PETERSON, VP, manufacturing and advanced engineering; PETER SHAGORY, EVP, strategy and corporate development; VICTORIA WOMACK STYLES, VP and GM, advanced endoscopic technologies

CONMED focuses on developing and selling surgical and patient monitoring products. It serves healthcare professionals within the orthopedic, laparoscopic, robotic and open surgery, gastroenterology, pulmonology, cardiology, and critical care specialties. –CN www.medicaldesignandoutsourcing.com

11 • 2021

Medical Design & Outsourcing 97

No.

Invacare

Key personnel:

Elyria, Ohio

MATTHEW MONAGHAN, chair, president and CEO; JOOST BELTMAN, SVP and GM, North America; RICK CASSIDAY, SVP and chief human resources officer; ANGELA GOODWIN, SVP and chief information technology officer; ANTHONY LAPLACA, SVP, general counsel, chief administrative officer and secretary; RALF LEDDA, SVP and GM, Europe; KATHLEEN LENEGHAN, SVP and CFO

$850,689,000* *Fiscal year ended 12/31/2020

2020 rank: 72 R&D spend: $12,275,000 Employees: 3,400

Founded to produce wheelchairs in 1885, INVACARE has since established itself as a global leader in the manufacture and distribution of innovative home and long-term care medical products that promote recovery and active lifestyles. The Elyria, Ohio– based company employs around 3,400 people and markets its products in more than 100 countries, led by CEO Matthew Monaghan. In addition to wheelchairs, scooters and walkers — both powered and manual — the company’s product portfolio includes beds, mattresses and accessories, patient care products like posture and pressure cushions and more. It also sells respiratory therapy products related to oxygen, aerosol, sleep therapy, nebulizers and asthma management. –SW

No.

Abiomed

Key personnel:

Danvers, Massachusetts

$847,522,000* *Fiscal year ended 3/31/2021

2020 rank: 74 R&D spend: $121,875,000 Employees: 1,725

MICHAEL MINOGUE, chair, president and CEO; MARC BEGAN, VP and general counsel; ANDREW GREENFIELD, VP and chief commercial officer; KAREN MAHONEY, head, global human resources; LAXMI PERI, VP, engineering; MATT PLANO, VP, operations; THORSTEN SIESS, VP and CTO; CHARLES SIMONTON, VP and chief medical officer; TODD TRAPP, VP and CFO; DAVID WEBER, SVP and COO

Based in Danvers, Massachusetts, ABIOMED develops medical technology that provides circulatory and oxygenation support. Founded in 1981 to develop an artificial heart, the company acquired Impella CardioSystems in 2005 and shifted focus from heart replacement to heart recovery with the Impella heart pump for improving blood flow and/or temporarily assisting with the pumping function of the heart. The company also develops the Breethe OXY-1 compact cardiopulmonary bypass system with extracorporeal membrane oxygenation (ECMO) technology designed to provide oxygenation while supporting patient mobility. Abiomed is led by President and CEO Michael Minogue, who has held the position since 2004. –SW

No.

GN Hearing

Key personnel:

Ballerup, Denmark

$722,477,064*

*Fiscal year ended 12/31/2020

GITTE PUGHOLM AABO, CEO; MORTEN TOFT, CFO

(DKK 4,725,000,000)

2020 rank: 69 R&D spend: $85,321,101 Employees: 4,500 98

Medical Design & Outsourcing

11 • 2021

Denmark-based GN Group sells hearing aids under brands that include ReSound, Beltone and Interton. –CN

www.medicaldesignandoutsourcing.com

No.

Avanos Medical Alpharetta, Georgia

$714,800,000*

*Fiscal year ended 12/31/2020

Key personnel: JOSEPH WOODY, CEO; MICHAEL GREINER, SVP and CFO; MOJI JAMES, SVP and general counsel; DAVID BALL, SVP, global supply chain and procurement; LEE BURNES, SVP, global R&D; BILL HAYDON, SVP and GM, pain; KERR HOLBROOK, SVP and GM, chronic care; MIZANU KEBEDE, SVP, global quality assurance and regulatory; ARJUN SARKER, SVP, international; MICHELLE SCHARFENBERG, SVP, chief ethics and compliance officer

2020 rank: 78 R&D spend: $34,900,000 Employees: 5,380

Formerly known as Halyard Health, AVANOS MEDICAL was founded in 2014. The Alpharetta, Georgia–based company is led by CEO Joseph Woody, who joined in 2017. Avanos Medical, with its more than 5,000 employees, develops products across digestive and respiratory health, acute and chronic pain management and IV therapy, manufacturing and marketing brands in more than 90 countries. Among Avanos’ offerings is the Coolief radiofrequency system for treating osteoarthritis knee pain and the On-Q pain pump system for surgical site and regional anesthesia. The company also makes feeding tubes and devices for protecting against ventilator-associated events. –SW

Össur

Key personnel:

No.

Reykjavík, Iceland

JON SIGURDSSON, president and CEO; MARGRÉT LÁRA FRIÐRIKSDÓTTIR, EVP, human resources and corporate strategy; EGILL JÓNSSON, EVP, manufacturing and operations; GUDJON KARASON, EVP, clinics; SVEINN SÖLVASON, CFO; KRISTLEIFUR KRISTJÁNSSON, EVP, R&D; ÓLAFUR GYLFASON, EVP, prosthetics and Europe/emerging; CHRISTIAN ROBINSON, EVP, bracing and supports and Americas

$629,503,000* *Fiscal year ended 12/31/2020

2020 rank: 79 R&D spend: $31,018,000 Employees: 3,505

No.

ÖSSUR is a global company focused on non-invasive orthopedics, selling prosthetics, braces, supports and compression therapy products. –CN

(medical segment)

Nikkiso

Key personnel:

Tokyo

TOSHIHIKO KAI, president and CEO; YOSHIHIKO KINOSHITA, director, executive officer, GM, medical business unit and division; SHOICHI NAGATO, director, executive officer, GM, aerospace business and division; MASARU YAMAMURA, director, executive officer, GM, industrial business unit and division; SUSUMU KOITO, director, executive officer, GM corporate unit, administration and corporate planning divisions

$626,521,821*

*Fiscal year ended 12/31/2020

(¥66,900,000,000)

NIKKISO is a major provider of dialysis machines in Japan and around the world. The company has also expanded into devices related to blood purification, perioperative and emergency settings, and surgery. –CN

2020 rank: 81 R&D spend: not available Employees: not available www.medicaldesignandoutsourcing.com

11 • 2021

Medical Design & Outsourcing 99

No.

Ambu

Ballerup, Denmark

$613,761,468*

*Fiscal year ended 9/30/2021

(DKK 4,014,000,000) 2020 rank: R&D spend: Employees:

86 not available 4,500

Key personnel: JUAN JOSE GONZALEZ, CEO; MICHAEL HØJGAARD, EVP, CFO

Ballerup, Denmark-based AMBU was founded in 1937 as Testa Laboratory and originally developed the Sicca Haemometer that allowed private doctors to measure the amount of hemoglobin in the blood without sending samples to a lab. However, the company later went on to make the breakthrough device, the Ambu ventilation bag, in 1956. At the time, it was the world’s ﬁrst self-inﬂating resuscitator and a major piece of emergency medical equipment. Today the company makes single-use endoscopes, videoscopes, duodenoscopes and cytoscopes. –DK

No.

(radiology solutions segment)

Agfa-Gevaert Mortsel, Belgium

$552,900,000*

*Fiscal year ended 12/31/2020

(€ 485,000,000) 2020 rank: R&D spend: Employees:

80 $18,240,000 2,328

Key personnel: PASCAL JUÉRY, president and CEO, Agfa-Gevaert and president, radiology; LUC DELAGAYE, president, offset solutions; DIRK DE MAN, CFO; VINCENT WILLE, president, digital print and chemicals; GUNTHER KOCH, chief human resources ofﬁcer

AGFA is a global provider of traditional X-ray film, hardcopy film and printers, digital radiography equipment and image processing software to hospital radiology departments worldwide. The company’s digital radiography systems come with its Musica image processing software and its Musica workstation for image identification, acquisition and quality control. –CN 100 Medical Design & Outsourcing

11 • 2021

No.

JMS Co.

Key personnel:

Hiroshima, Japan

HIROAKI OKUKUBO, president and representative director; YASUHIRO AWANE,senior executive director, Surgical and Therapeutical Business Unit and Sales and Marketing Division; RYUJI KATSURA, executive director. Corporate Affairs Division and Global Marketing Division; MASAFUMI SATO, director, Hospital Products Business Unit and Research and Development Division; SHOGO YANAGIDA, director. Blood Management and Cell Therapy Business Unit and Production Division

$539,220,828* *Fiscal year ended 3/31/2021

(¥57,578,000,000) 2020 rank: 82 R&D spend: $14,984,079 Employees: not available

No.

(medical field segment)

Dr. Taro Tsuchiya established JMS in the 1960s because he saw the need for disposable medical devices to reduce adverse events related to blood transfusion. Fast forward to today, and the company provides products and services related to infusion/transfusion, infusion/nutrition, dialysis, surgical treatment, and blood/cells. –CN

Asahi Intecc

Key personnel:

$531,232,441*

ASAHI INTECC develops, produces and sells medical devices needed for catheter-based treatments involving the cardiovascular, peripheral vascular, abdominal vascular and cerebrovascular systems. –CN

Nagoya, Japan

*Fiscal year ended 6/30/2021

(¥56,725,000,000)

MASAHIKO MIYATA, president and CEO; KENJI MIYATA, EVP and chief information officer

2020 rank: 84 R&D spend: not available Employees: not available

No.

Novocure

Key personnel:

St. Helier, Jersey

$494,366,000* *Fiscal year ended 12/31/2020

2020 rank: 90 R&D spend: $132,010,000 Employees: 1,023

ASAF DANZIGER, CEO; YORAM PALTI, founder; WILLIAM F. DOYLE, executive chair; ELY BENAIM, chief medical officer; ASHLEY CORDOVA, CFO; WILCO GROENHUYSEN, COO; FRANK LEONARD, chief development officer; TODD LONGSWORTH, general counsel; PRITESH SHAH, chief commercial officer; URI WEINBERG, chief science officer; WILLIAM BURKE, chief human resources officer

Headquartered off the French coast in Jersey, Novocure was founded in 2000 by Yoram Palti, a biophysics expert seeking to develop a new way to treat solid tumor cancers that would destroy tumor cells while sparing healthy tissue and avoiding many of the life-altering side effects of existing cancer therapies. Now an international oncology company with more than 1,000 employees and operations in the U.S., Europe and Asia, NOVOCURE offers its tumor treating fields (TTFields) platform of electric fields designed to disrupt cancer cell division. TTFields are intended principally for use with other standard-of-care cancer treatments. –SW

www.medicaldesignandoutsourcing.com

11 • 2021

Medical Design & Outsourcing 101

No.

Natus Medical Pleasanton, California

$415,684,000*

*Fiscal year ended 12/31/2020

Key personnel: JONATHAN KENNEDY, president and CEO; DREW DAVIES, EVP and CFO; AUSTIN NOLL, EVP and chief commercial officer; CHRISTOPHER CHUNG, VP, quality, regulatory affairs and chief medical officer; SEÁN LANGAN, VP, global operations; IVAN PANDIYAN, VP, global research and development; LISA PAUL, VP and chief people officer

NATUS MEDICAL is a provider of medical equipment, software, supplies and services for the diagnosis, monitoring and treatment of health problems affecting newborns, the brain, nerves, muscles, balance, mobility and hearing. –CN

2020 rank: 83 R&D spend: $61,296,000 Employees: 1,420

No.

(eye care segment)

Topcon Tokyo

Key personnel: SATOSHI HIRANO, representative director, president and CEO

$414,412,811*

*Fiscal year ended 3/31/2021

(¥44,251,000,000) 2020 rank: 87 R&D spend: not available Employees: not available

TOPCON was founded in Tokyo, Japan, in 1932 as a manufacturer of surveying equipment. In 1970, Topcon established Topcon Instrument Corporation of America, which is currently Topcon Medical Systems. It develops and supplies diagnostic equipment for the ophthalmic community. The company in 2018 established a medical software division to develop eye care software and provide related healthcare services. Topcon’s offerings cover retina, glaucoma, cataract and refractive eye care treatments with integrated solutions including advanced multimodal imaging, vendor-neutral data management and groundbreaking remote diagnostic technology. –SW

No.

Orthofix

Key personnel:

Lewisville, Texas

$406,562,000*

JON SERBOUSEK, president and CEO; DOUG RICE, CFO; KIMBERLEY ELTING, chief legal and development officer; KEVIN KENNY, president, global Orthofix Spine; PAUL GONSALVES, president, global Orthofix Orthopedics; JILL MASON, chief ethics and compliance officer; EHAB ESMAIL, SVP, quality, regulatory and clinical affairs; ROBERTO DONADELLO, SVP, global operations; SUZANNE ARMSTRONG, VP, human resources

2020 rank: 85 R&D spend: $39,056,000 Employees: 1,036

Founded in 1980, Lewisville, Texas-based ORTHOFIX makes orthopedic devices. It is one of the top orthopedic companies in the world and operates out of more than 60 countries. For the spine, it makes motion preservation, spine fixation, biologics and bone growth therapy devices. It makes pediatric and limb reconstruction devices, fracture management and foot and ankle devices for other orthopedic applications. –DK

*Fiscal year ended 12/31/2020

102

Medical Design & Outsourcing

11 • 2021

www.medicaldesignandoutsourcing.com

No.

Accuray

Key personnel:

Sunnyvale, California

$396,289,000*

JOSHUA LEVINE, CEO; SUZANNE WINTER, president; BRANDON “BRANDY” GREEN, interim CFO; JEAN-PHILIPPE PIGNOL, SVP, chief medical and technology officer; SCOTT CHAPMAN, SVP, global service; JESSE CHEW, SVP, general counsel and corporate secretary; MICHAEL HOGE, SVP, global operations; PATRICK SPINE, SVP, chief administrative officer; JIM DENNISON, SVP, global quality and regulatory affairs

2020 rank: 89 R&D spend: $52,729,000 Employees: 995

ACCURAY develops, manufactures and sells radiotherapy systems as an alternative treatment for cancer. The Sunnyvale, California–based company touts its therapy as a shorter, safer, personalized and more effective way to treat cancer and allow patients to live longer. It is currently developing therapies for breast, intracranial, prostate, lung and head and neck cancers. It has manufacturing facilities throughout the U.S. and China, with regional offices in Hong Kong and Tokyo. –DK

*Fiscal year ended 6/30/2021

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No.

Nevro

Redwood City, California

$362,048,000* *Fiscal year ended 12/31/2020

2020 rank: 88 R&D spend: $45,600,000 Employees: 843

Key personnel: KEITH GROSSMAN, chair, CEO and president; ROD MACLEOD, CFO; DAVID CARAWAY, chief medical officer; KASHIF RASHID, general counsel; NIAMH PELLEGRINI, chief commercial officer; LORI CIANO, chief human resources officer; MICHAEL CARTER, VP, global sales; RICHARD CARTER, VP, finance, corporate controller; CHRISTOFER CHRISTOFOROU, VP, technical operations; JULIE DEWEY, VP, investor relations and corporate communications; DONALD MIDDLEBROOK, VP, clinical regulatory and quality; CLAIRE SMITH, VP, customer excellence; JON SHEAR, VP, corporate development

NEVRO aims to disrupt the space of traditional spinal cord stimulation (SCS) that has been around for more than 30 years. Founded in 2006, the Redwood City, California–based company introduced its next-generation approach for treating patients with chronic pain — 10kHz therapy — which it designed to offer patients significant pain relief and no paresthesia. Nevro’s Senza SCS system for 10 kHz therapy received the CE mark in 2010 and FDA approval in 2015. Today, the company’s SCS systems hold approval in the U.S. to deliver all available SCS frequencies and the most waveform types in a single product as it seeks to help patients achieve long-term pain relief. –SW

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No.

Medacta

Key personnel:

Castel San Pietro, Switzerland

FRANCESCO SICCARDI, CEO; CORRADO FARSETTA, CFO; ALESSANDRO SICCARDI, supply chain director

$344,840,880*

Founded in 1999, Switzerland-based MEDACTA is active in joint replacement, spine surgery and sports medicine. It operates in more than 40 countries. –CN

*Fiscal year ended 12/31/2020

(€ 302,492,000) 2020 rank: 91 R&D spend: $7,785,060 Employees: 1,142

No.

(healthcare division)

Barco

Kortrijk, Belgium

$298,566,000* *Fiscal year ended 12/31/2020

(€ 261,900,000) 2020 rank: 93 R&D spend: not available Employees: not available

Key personnel: CHARLES BEAUDUIN, CEO; WIM BUYENS, CEO, Cinionic; OLIVIER CROLY, APAC; GERWIN DAMBERG, chief technology officer; ANN DESENDER, CFO; ANTHONY HUYGHEBAERT, chief human resources officer; STIJN HENDERICKX, EMEA; ROB JONCKHEERE, global operations; FILIP PINTELON, GM, healthcare; MARC SPENLÉ, chief digital and information officer; GEORGE STROMEYER, GM, enterprise; IAIN URQUHART, Americas; NICOLAS VANDEN ABEELE, GM, entertainment; KURT VERHEGGEN, general counsel; KENNETH WANG, managing director, Barco China

The imaging and visualization technology company provides medical displays, a “digital operating room” portfolio, and skin imaging systems. –CN

No.

iRhythm

Key personnel:

San Francisco

$265,166,000*

*Fiscal year ended 12/31/2020

2020 rank: not applicable R&D spend: $41,329,000 Employees: 1,517

QUENTIN BLACKFORD, CEO; DOUGLAS DEVINE, CFO; MARK DAY, EVP, R&D; JUDITH LENANE, EVP, products and chief clinical officer; DANIEL WILSON, EVP of strategy, corporate development and investor relations; DIETRA JONES, EVP, clinical operations; KAJA ODEGARD, chief people officer; DAVID VORT, EVP of sales; ALLAN WILSKER, EVP of information technology and customer service; MAZI KIANI, VP of quality and regulatory

Seeking to usurp the old-school Holter monitor as the standard of care in electrocardiograph monitoring and AFib detection, IRHYTHM develops the Zio XT platform with cloud-based data analytics and machine-learning capabilities for cardiac monitoring. Founded in 2008, the San Francisco-based company’s Zio service aims to offer quality clinical accuracy, positive patient experience and compliance. It also holds the promise of lower cost of care through the miniature, wearable patch that includes a breathable, waterproof outer layer and a strong adhesive with a flexible design for secure attachment on the left side of the chest. The company is led by CEO Quentin Blackford, who took up the position earlier this year after previously serving as COO of Dexcom. –SW

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11 • 2021

Medical Design & Outsourcing 105

No.

Cardiovascular Systems St. Paul, Minnesota

$258,973,000* *Fiscal year ended 6/30/2021

2020 rank: R&D spend: Employees:

96 $41,061,000 780

Key personnel: SCOTT WARD, chair, president and CEO; ROBERT BEVERLY, VP and GM, peripheral sales; HARRISON BOYD, VP and GM, coronary sales; RYAN EGELAND, chief medical officer; JOHN HASTINGS, VP, manufacturing and operations; JACK NIELSEN, VP, investor relations and corporate communications; JEFFREY POINTS, CFO; STEPHEN REMPE, chief human resources officer; RHONDA ROBB, chief operating officer; ALEXANDER ROSENSTEIN, general counsel and corporate secretary; SANDRA SEDO, chief compliance officer; CHRISTOPHER VOLKER, VP and GM, international; DAVID WHITESCARVER, VP, corporate development and intellectual property

CARDIOVASCULAR SYSTEMS is developing treatment devices for peripheral and coronary artery disease. The St. Paul, Minnesotabased company has six devices in its peripheral portfolio, including the Diamondback 360 peripheral orbital atherectomy system exchangeable series, Diamondback 360 peripheral orbital atherectomy system, Zilient peripheral guidewires, Teleport microcatheter, ViperCath XC peripheral exchange catheter, Wirion peripheral embolic protection system, Jade PTA balloon catheter and the Sapphire II Pro dilation catheter. Cardiovascular Systems has three coronary artery devices: Diamondback 360 coronary orbital atherectomy system, Teleport microcatheter and Sapphire balloons. –DK

No.

Glaukos

Key personnel:

San Clemente, California

$224,959,000*

*Fiscal year ended 12/31/2020

2020 rank: R&D spend: Employees:

95 $85,392,000 653

THOMAS BURNS, president and CEO; CHRIS CALCATERRA, chief operating ofﬁcer; JOSEPH GILLIAM, CFO, SVP, corporate development; MICHELE ALLEGRETTO, SVP, human resources; DIANE BIAGIANTI, SVP, general counsel; DAVID HAFFNER, SVP, new technologies; JAY KATZ, chief medical ofﬁcer; TOMAS NAVRATIL, SVP, R&D; JANE RADY, SVP, corporate strategy and business development; GABRIELLA SZEKELY, VP, R&D, combination pharmaceutical products

GLAUKOS, founded in 1998, is an ophthalmic medical technology and pharmaceutical company that develops novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. The San Clemente, California–based company brought micro-invasive glaucoma surgery (MIGS) to the market, launching the iStent MIGS device in the U.S. in 2012, followed by the next-generation iStent Inect and iStent Inject W in 2018 and 2020, respectively. The company made a play to treat other ophthalmic diseases with its 2019 acquisition of Avedro and its single-use drug formulations for strengthening corneal tissues and stopping the progression of degenerative corneal ectatic disease keratoconus. –SW

No.

AtriCure Mason, Ohio

EPOXY SYSTEM UV15DC80Med

$206,531,000*

*Fiscal year ended 12/31/2020

Meets USP Class VI specifications 2020 rank: R&D spend: Employees:

97 $43,070,000 750

Cures in 5-30 seconds under UV light

Key personnel: MICHAEL CARREL, president and CEO; ANGELA WIRICK, CFO; DOUGLAS SEITH, COO; JUSTIN NOZNESKY, chief marketing and strategy officer; KARL DAHLQUIST, chief legal officer; SALVATORE PRIVITERA, CTO; VINAYAK DORAISWAMY, chief scientific officer; TONYA AUSTIN, chief human resources officer

ATRICURE is developing technologies to treat atrial ﬁbrillation and other related conditions. Founded in 1994 as Enable Medical, the Cincinnati-area company has numerous ablation systems on the market, as well as its AtriClip left atrial appendage exclusion system. AtriCure has served over 375,000 ablation patients since its founding and has sold more than 300,000 AtriClip devices. –DK

Cures in “shadowed out” areas at temperatures as low as 80°C Optically clear: refractive index of 1.52

154 Hobart St. Hackensack, NJ 07601, USA ∙ +1.201.343.8983 ∙ main@masterbond.com www.masterbond.com

www.medicaldesignandoutsourcing.com

11 • 2021

Medical Design & Outsourcing

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No.

SeaSpine

Key personnel:

Carlsbad, California

$154,345,000*

*Fiscal year ended 12/31/2020

2020 rank: 99 R&D spend: $16,258,000 Employees: 421

No.

(Imaging IT division)

Sectra

Linköping, Sweden

$151,758,958*

*Fiscal year ended 4/30/2021

(SEK 1,397,700,000) 2020 rank: 100 R&D spend: not available Employees: not available

KEITH VALENTINE, president and CEO; JOHN BOSTJANCIC, SVP, CFO; BEAU STANDISH, president, enabling technologies; DENNIS CIRINO, SVP, global spinal systems; PATRICK KERAN, SVP, general counsel and corporate secretary; TYLER LIPSCHULTZ, SVP, orthobiologics and business development; LAETITIA COUSIN, VP, regulatory and quality assurance; BILL RHODA, GM, process innovation and development; FRANK VIZESI, VP, orthobiologics R&D, clinical affairs; JOHN WINGE, VP, sales; TROY WOOLLEY, VP, marketing

SEASPINE is developing devices to treat spinal disorders. Founded in 2002, the Carlsbad, California–based company specializes in orthobiologics, interbody devices and modular spinal instrumentation systems. SeaSpine was integrated into Integra Lifesciences’ spine business, which was spun-out in 2015 as an independent company under the name SeaSpine. The company currently markets cervical and thoracolumbar fixation and interbody devices, as well as other orthobiologic allografts, graft deliveries and more. –DK

Key personnel: TORBJÖRN KRONANDER, CEO and president; MATS FRANZÉN, CFO; MARIE ESTRÖM TRÄGÅRDH, president, imaging IT and EVP; SIMO PYKÄLISTÖ, president, secure communications and EVP; JOHAN CARLEGRIM, GM, medical education; GUSTAF SCHWANG, GM, orthopedics; LISA EVERHILL, chief people and brand officer; CLAES LUNDSTRÖM, research director, medical systems; PER ANDERSNÄS, chief information officer; STAFFAN BERGSTRÖM, senior executive VP, imaging IT solutions

SECTRA develops information technology for storing, viewing and working with medical images. Its offerings support diagnosis, planning and patient monitoring in fields as diverse as cancer, osteoarthritis and orthopedic surgery. The company also provides IT for sharing and interacting with medical images in order to boost the quality of medical education. –CN

No.

Alphatec

Key personnel:

Carlsbad, California

$144,861,000*

*Fiscal year ended 12/31/2020

2020 rank: not applicable R&D spend: $18,745,000 Employees: 296 108

Medical Design & Outsourcing

11 • 2021

PAT MILES, chair and CEO; CRAIG HUNSACKER, EVP, people and culture and general counsel; TODD-KONING, CFO; BRIAN SNIDER, EVP, marketing; MARK OJEDA, EVP, cervical and biologics; ERIC DASSO, EVP, adjunctive technologies; KELLI HOWELL, EVP, clinical strategies; DAVID SPONSEL, EVP, sales; SCOTT LISH, SVP, R&D

Carlsbad, California–based ALPHATEC is developing devices for spinal surgeries. It has numerous spinal fixation devices on the market through its wholly-owned subsidiaries, Alphatec Spine, EOS imaging and SafeOp Surgical. The company most recently launched its InVictus OsseoScrew expandable spinal fixation platform, which it designed to be an alternative to cemented fenestrated screws in patients with compromised bone who need a restoration of spinal column integrity. –DK www.medicaldesignandoutsourcing.com

No.

Inari Medical Irvine, California

$139,670,000*

*Fiscal year ended 12/31/2020

Key personnel: BILL HOFFMAN, CEO; DREW HYKES, COO; MITCH HILL, CFO; TOM TU, chief medical officer; PAUL KOEHN, VP, operations; TARA DUNN, VP, clinical affairs and market development; JOHN BORRELL, VP, sales; BRIAN STRAUSS, VP, engineering; ERIC KHAIRY, VP, marketing; VITAS SIPELIS, VP, international; ERIC LOUW, VP, manufacturing; JANET BYK, VP, financing and accounting; ANGELA AHMAD, general counsel; KEVIN STRANGE, VP, strategy and business development

2020 rank: not applicable R&D spend: $18,399,000 Employees: 456

INARI MEDICAL raised roughly $179.2 million from its IPO in May 2020. The company has developed two minimally-invasive, catheter-based mechanical thrombectomy devices to remove large clots from large vessels and eliminate the need for thrombolytic drugs. Both the company’s FlowTriever and ClotTriever are FDA-cleared for the removal of emboli and thrombi from the peripheral vasculature. The FlowTriever also has an FDA indication for the treatment of pulmonary embolism. –CN

Vapotherm

Key personnel:

No.

Exeter, New Hampshire

$125,733,000*

*Fiscal year ended 12/31/2020

2020 rank: not applicable R&D spend: $16,956,000 Employees: 404

JOSEPH ARMY, president and CEO; JOHN LANDRY, SVP and CFO; LINDSAY BECKER, VP, human resources; DAVID BLOUIN, VP, U.S. sales; JOHN COOLIDGE, VP, operations; MARC DAVIDSON, VP, strategic initiatives; JILL DOOLING, VP, strategic accounts; GEORGE DUNGAN, VP, science and innovation; RICHELLE HELMAN, VP, quality, regulatory, R&D; JAMES LIGHTMAN, SVP and general counsel; MICHAEL MCQUEEN, VP, medical education; GREGOIRE RAMADE, SVP and chief commercial officer

VAPOTHERM was founded in Stevensville, Maryland, in 1999 as a medical device manufacturer after creating the first heated and humidified highflow therapy nasal cannula system. Now headquartered in Exeter, New Hampshire, with hundreds of employees headed by President and CEO Joe Army, Vapotherm develops high-velocity “Mask-Free NIV” therapy for those who are on ventilatory support and are mask-intolerant, risking failed treatment with rising costs of care and care escalation. Vapotherm designed its technology to allow patients to eat, drink, talk and take oral medications while receiving ventilatory and oxygenation support. –SW

www.medicaldesignandoutsourcing.com

11 • 2021

Medical Design & Outsourcing 109

No.

100 Inspire Medical Systems Golden Valley, Minnesota

$115,381,000*

*Fiscal year ended 12/31/2020

2020 rank: not applicable R&D spend: $26,092,000 Employees: 317

Key personnel: TIM HERBERT, president and CEO; RICK BUCHHOLZ, CFO; RANDY BAN, chief commercial officer; PHIL EBELING, COO; BRYAN PHILLIPS, SVP, general counsel, chief compliance officer and corporate secretary; STEVE JANDRICH, VP, human resources; ANDREAS HENKE, SVP, European operations; IVAN LUBOGO, SVP, U.S. sales; JOHN RONDONI, SVP, R&D and ventures; KATHY SHERWOOD, SVP, global market access; MARTIN ABRAMS, VP, marketing and customer experience

SMOOTH. LINEAR. FLOW.

With more than 400 employees, INSPIRE MEDICAL SYSTEMS was founded in 2007 when it spun out of medtech giant Medtronic along with a significant intellectual property portfolio. The company is led by President and CEO Tim Herbert, who has held the positions since the company was founded. The Minneapolis-area company develops treatments for obstructive sleep apnea, offering what it says is the first and only FDA-approved obstructive sleep apnea device that treats the root cause of the condition by working inside the body with the patient’s natural breathing process. The device is placed during a same-day, outpatient procedure and opens the patient’s airway while they sleep to allow for normal breathing. –SW

Introducing KNF FP 70, delivering 120 – 850 ml/min while producing up to 29.4 psig (2 barg) pressure under continuous operation. Integrated dampers provide a smooth, gentle flow and innovative 4-point valves ensure reliable self-priming even at very low motor speed. FP 70 is well-suited for a range of applications including medical technology, inkjet and 3D printing, and analytical instruments. With its introduction, the KNF smooth flow pump series now boasts a flow rate range of 120 ml/min to 12.4 l/min. Learn more at knf.com/en/us/solutions/pumps/innovations/ fp70-smooth-flow

110

Medical Design & Outsourcing

11 • 2021

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TOP R&D SPENDERS R&D ranking by total spend:*

RANK COMPANY 1

R&D SPEND

Medtronic device Johnson (medical segment)

R&D ranking by percentage of revenues:*

RANK COMPANY

REVENUES ($USD)

R&D SPEND

% OF REVENUES

$2,493,000,000

Glaukos

$224,959,000

$85,392,000

37.96%

$2,174,000,000

Novocure

$494,366,000

$132,010,000

26.70%

Johnson &

Royal Philips

$2,077,080,000

Inspire Medical Systems

$115,381,000

$26,092,000

22.61%

Siemens Healthineers

$1,762,440,000

AtriCure

$206,531,000

$43,070,000

20.85%

Abbott (medical device segment)

$1,300,000,000

Dexcom

$1,926,700,000

$359,900,000

18.68%

Boston Scientiﬁc

$1,143,000,000

Edwards Lifesciences

$4,386,300,000

$760,700,000

17.34%

Stryker

$984,000,000

LivaNova

$934,241,000

$152,902,000

16.37%

GE Healthcare (General Electric)

$872,000,000

Insulet

$904,400,000

$146,800,000

16.23%

Edwards Lifesciences

$760,700,000

Carl Zeiss Meditec

$1,545,270,000

$249,432,000

16.14%

Alcon

$673,000,000

Cardiovascular Systems

$258,973,000

$41,061,000

15.86%

Fujiﬁlm Holdings (healthcare only) $649,900,000

iRhythm

$265,166,000

$41,329,000

15.59%

Intuitive Surgical

$595,100,000

Natus Medical

$415,684,000

$61,296,000

14.75%

Baxter

$521,000,000

Abiomed

Olympus (medical business)

$509,833,302

Intuitive Surgical

Terumo

$459,786,477

BioMerieux

$454,632,000

B. Braun Melsungen

$421,572,000

Zimmer Biomet

19 20

$847,522,000

$121,875,000

14.38%

$4,358,400,000

$595,100,000

13.65%

Vapotherm

$125,733,000

$16,956,000

13.49%

Accuray

$396,289,000

$52,729,000

13.31%

Inari Medical

$139,670,000

$18,399,000

13.17%

$372,000,000

Cochlear

$1,030,227,670

$134,530,500

13.06%

Dexcom

$359,900,000

Alphatec

EssilorLuxottica

$327,180,000

BioMerieux

Smith+Nephew

$307,000,000

Nevro

Hologic

$276,300,000

Fujiﬁlm Holdings (healthcare only) $5,400,000,000

Carl Zeiss Meditec

$249,432,000

GN Hearing

$722,477,064

$85,321,101

11.81%

Bio-Rad

$226,598,000

Boston Scientiﬁc

$9,913,000,000

$1,143,000,000

11.53%

ResMed

$225,284,000

Abbott (medical device segment)

$11,787,000,000 $1,300,000,000

11.03%

Fresenius Medical Care

$221,160,000

Elekta

$1,494,353,963

$161,346,363

10.80%

Bruker

$198,000,000

SeaSpine

$154,345,000

$16,258,000

10.53%

Align Technology

$175,300,000

Royal Philips

$19,736,820,000 $2,077,080,000

10.52%

Elekta

$161,346,363

Masimo

$1,143,744,000

$118,659,000

10.37%

Getinge

$158,740,499

Bruker

$1,987,500,000

$198,000,000

9.96%

LivaNova

$152,902,000

Alcon

$6,763,000,000

$673,000,000

9.95%

Insulet

$146,800,000

Orthoﬁx

$406,562,000

$39,056,000

9.61%

Hillrom

$144,900,000

device Johnson & Johnson (medical $22,959,000,000 $2,174,000,000 segment)

9.47%

Cochlear

$134,530,500

Bio-Rad

$2,545,626,000

$226,598,000

8.90%

Hoya (life care segment)

$133,976,400

Olympus (medical business)

$5,857,894,737

$509,833,302

8.70%

Novocure

$132,010,000

Siemens Healthineers

$20,516,580,000 $1,762,440,000

8.59%

Sonova

$125,572,478

Medtronic

$30,117,000,000 $2,493,000,000

8.28%

Abiomed

$121,875,000

Terumo

$5,748,660,798

$459,786,477

8.00%

Teleﬂex

$119,747,000

NuVasive

$1,050,582,000

$79,838,000

7.60%

(health care products)

The color codes correspond to the top 10 R&D spenders.

112

Medical Design & Outsourcing

11 • 2021

$144,861,000

$18,745,000

12.94%

$3,554,748,000

$454,632,000

12.79%

$362,048,000

$45,600,000

12.60%

$649,900,000

12.04%

* Excluding companies with non-medical device operations that do not break out R&D spending by division.

www.medicaldesignandoutsourcing.com

TOP R&D SPENDERS R&D ranking by total spend:*

RANK COMPANY

R&D ranking by percentage of revenues:*

R&D SPEND

RANK COMPANY

REVENUES ($USD)

R&D SPEND

% OF REVENUES

$2,471,900,000

$175,300,000

7.09%

Masimo

$118,659,000

Coloplast

Align Technology

$115,443,425

$3,196,825,000

$225,284,000

7.05%

Dentsply Sirona

ResMed

$115,000,000

$1,280,885,760

$88,827,660

6.93%

Cooper Cos.

Fisher & Paykel Healthcare

$93,300,000

Stryker

$14,351,000,000

$984,000,000

6.86%

Nipro (medical segment)

$92,273,834

$4,560,000,000

$307,000,000

6.73%

Fisher & Paykel Healthcare

Smith+Nephew

$88,827,660

$963,875,000

$57,537,000

5.97%

Glaukos

Merit Medical Systems

$85,392,000

$1,371,868,000

$77,381,000

5.64%

GN Hearing

Integra Lifesciences

$85,321,101

$1,152,715,864

$63,682,338

5.52%

NuVasive

Omron Healthcare

$79,838,000

$7,024,500,000

$372,000,000

5.30%

Integra Lifesciences

Zimmer Biomet

$77,381,000

$221,160,000

5.18%

Steris

care products) $4,269,300,000 Fresenius Medical Care (health

$66,326,000

GE Healthcare (General Electric) $17,000,000,000

$872,000,000

5.13%

Omron Healthcare

$63,682,338

$8,465,982,000

$421,572,000

4.98%

Natus Medical

B. Braun Melsungen

$61,296,000

$629,503,000

$31,018,000

4.93%

Nihon Kohden

Össur

$59,533,621

$5,632,300,000

$276,300,000

4.91%

Merit Medical Systems

Hologic

$57,537,000

$3,237,676,439

$158,740,499

4.90%

ConvaTec

Getinge

$53,800,000

$714,800,000

$34,900,000

4.88%

Accuray

Avanos Medical

$52,729,000

$3,018,700,000

$144,900,000

4.80%

Integer

Hillrom

$48,500,000

$2,537,156,000

$119,747,000

4.72%

Nevro

Teleﬂex

$45,600,000

$862,459,000

$40,473,000

4.69%

AtriCure

Conmed

$43,070,000

$2,771,221,642

$125,572,478

4.53%

ICU Medical

Sonova

$42,948,000

$1,073,442,000

$48,500,000

4.52%

iRhythm

Integer

$41,329,000

$11,673,000,000

$521,000,000

4.46%

Cardiovascular Systems

Baxter

$41,061,000

$3,200,983,330

$133,976,400

4.19%

Conmed

Hoya (life care segment)

$40,473,000

$2,970,336,391

$115,443,425

3.89%

Orthoﬁx

Coloplast

$39,056,000

$2,430,900,000

$93,300,000

3.84%

Avanos Medical

Cooper Cos.

$34,900,000

$870,463,000

$32,857,000

3.77%

Haemonetics

$32,857,000

$3,342,000,000

$115,000,000

3.44%

Össur

Dentsply Sirona

$31,018,000

$1,271,004,000

$42,948,000

3.38%

Inspire Medical Systems

ICU Medical

$26,092,000

$552,900,000

$18,240,000

3.30%

Alphatec

Agfa-Gevaert

$18,745,000

$1,870,453,268

$59,533,621

3.18%

Inari Medical

Nihon Kohden

$18,399,000

ConvaTec

$1,894,000,000

$53,800,000

2.84%

(radiology solutions segment)

Agfa-Gevaert

$18,240,000

$3,255,740,775

$92,273,834

2.83%

Vapotherm

Nipro (medical segment)

$16,956,000

$539,220,828

$14,984,079

2.78%

SeaSpine

JMS Co.

$16,258,000

$344,840,880

$7,785,060

2.26%

JMS Co.

Medacta

$14,984,079

$3,107,519,000

$66,326,000

2.13%

Invacare

Steris

$12,275,000

$16,449,060,000

$327,180,000

1.99%

Medacta

EssilorLuxottica

$7,785,060

Invacare

$850,689,000

$12,275,000

1.44%

(radiology solutions segment)

The color codes correspond to the top 10 R&D spenders.

* Excluding companies with non-medical device operations that do not break out R&D spending by division.

www.medicaldesignandoutsourcing.com

11 • 2021

Medical Design & Outsourcing

113

COMPANIES RANKED BY EMPLOYMENT RANK COMPANY RANK COMPANY 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43

114

EMPLOYEE % CHANGE FROM HEADCOUNT PREVIOUS BIG 100

EssilorLuxottica

180,000

20%

90,000

Unchanged

Royal Philips

77,000

-4%

73,275

-1%

Siemens Healthineers

66,100

22%

64,317

Baxter

50,000

47,000

-6%

Stryker

43,000

38,000

Becton, Dickinson (medical segment)

30,000

-12%

30,000

-1%

Medline Industries

28,000

26,315

Terumo

26,000

-2%

23,655

18%

21,512

Medtronic

Fujiﬁlm Holdings (healthcare only) B. Braun Melsungen

GE Healthcare (General Electric) Boston Scientiﬁc

care Fresenius Medical Care (health products)

Nipro (medical segment) Alcon

Olympus (medical business) Henry Schein

21,000

11%

Hoya (life care segment)

20,676

n/a

20,000

Owens & Minor

18,800

22%

Zimmer Biomet

Align Technology

18,070

24%

Smith+Nephew

18,000

17,500

Demant

16,155

15,878

13%

Dentsply Sirona

15,000

-1%

14,508

-4%

Teleﬂex

14,000

-3%

Amplifon

Edwards Lifesciences Sonova

3M Co.

13,000

Unchanged

BioMerieux

13,000

Unchanged

Coloplast

12,578

12,000

Unchanged

Cook Medical

11,131

10%

10,800

Paul Hartmann

10,625

-4%

(Health Care segment)

Steris

Cooper Cos.

Getinge

Hillrom

10,000

Unchanged

ConvaTec

9,900

8,081

10%

Bio-Rad

8,000

Unchanged

7,970

ICU Medical

7,900

-1%

Intuitive Surgical ResMed

Medical Design & Outsourcing

11 • 2021

Smiths Medical (Smiths Group)

EMPLOYEE % CHANGE FROM HEADCOUNT PREVIOUS BIG 100 7,770

-3%

Integer

7,500

-9%

7,400

Straumann

7,340

6,350

Merit Medical Systems

5,989

-6%

Bruker

Hologic

Fisher & Paykel Healthcare

5,788

14%

Nihon Kohden

5,531

5,500

44%

Avanos Medical

5,380

14%

Dexcom

Colfax

(Medical Technology segment, including DJO)

5,000

n/a

GN Hearing

4,500

n/a

4,500

45%

Elekta

4,194

4,000

Unchanged

Fukuda Denshi

3,976

n/a

Ambu

Cochlear

Omron Healthcare

3,758

-11%

Integra Lifesciences

3,700

-8%

3,505

0.1%

Conmed

3,400

-13%

Carl Zeiss Meditec

3,290

3,000

-25%

NuVasive

2,800

Unchanged

2,708

-10%

solutions segment) Agfa-Gevaert (radiology

2,328

n/a

2,287

69%

Masimo

2,000

25%

1,725

12%

iRhythm

1,517

n/a

1,420

-4%

Medacta

1,142

1,036

-2%

Novocure

1,023

31%

Össur

Invacare

LivaNova

Haemonetics

Insulet

Abiomed

Natus Medical Orthoﬁx

Accuray

Nevro

Cardiovascular Systems

995

843

-1%

780

0.1%

AtriCure

750

653

Inari Medical

456

n/a

421

Vapotherm

404

n/a

317

n/a

296

n/a

Glaukos

SeaSpine

Inspire Medical Systems Alphatec

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ISO 13485:2016

•

FDA 21CFR820

•

MedAccred

•

LPA & cGMP

GEOGRAPHIC HEATMAPS

Where are the headquarters?

he headquarters of the world's largest medical device companies are concentrated in speciﬁc countries and regions: Germany, Japan, Northern California, Southern California, MinneapolisSt. Paul, Massachusetts and more.

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11 • 2021

Medical Design & Outsourcing

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MERGERS & ACQUISITIONS

Medtech M&A: The industry's biggest mergers and acquisitions of 2021 The wide range of medtech mergers and acquisitions in 2021 covers medical devices, pharmaceuticals and more. Sean Whooley | Associate Editor |

cross 2021, medtech has seen a wide range of mergers and acquisitions covering several areas of devices, pharmaceuticals and more. Some have gone off without a hitch, while others came under serious scrutiny as mouthwatering financial figures were revealed and major technologies were acquired. Here are the 10 biggest mergers and acquisitions in medtech in 2021: 1. Thermo Fisher — PPD — $17.4B The two companies entered into a definitive agreement for Thermo Fisher to buy PPD at a price of $47.50 per share, totaling $17.4 billion, plus the assumption of approximately $3.5 billion of net debt. That represented a premium of approximately 24% to the unaffected closing price of PPD’s common stock as of Tuesday, April 13, 2021, the last day of trading before the announced merger. Wilmington, North Carolina-based PPD provides clinical research and laboratory services to enable customers to accelerate innovation and increase drug development productivity. The company has more than 26,000 employees operating across 50 countries. It reported revenue of $4.7 billion in 2020 and in 2021 became a part of Thermo Fisher’s laboratory products and services business segment. Waltham, Massachusetts-based Thermo Fisher said at the time of the merger that it expected the transaction to be immediately and significantly accretive to its adjusted EPS, adding $1.40 in the first 12 months after close. “The acquisition of PPD is a natural extension for Thermo Fisher and will enable us to provide these customers with important clinical research services and partner with them in new and exciting ways as they move a scientific idea to an approved medicine quickly, reliably and cost-effectively,” Thermo Fisher President and CEO Marc Casper said at the time of the announcement. “Longer term, we plan to continue to invest in and connect the capabilities across the combined company to further help

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our customers accelerate innovation and drive productivity while driving further value for our shareholders.” 2. Siemens Healthineers — Varian Medical Systems — $16.4B In August, the companies announced that Siemens would acquire Varian in a $16.4 billion deal as the companies sought to create “the most comprehensive” portfolio of cancer care offerings in the industry. Varian shareholders approved the deal in October and a number of high-level personnel moves followed, including the planned retirement of Varian CEO Dow Wilson and the resignation of Varian CFO J. Michael Bruff. Siemens’ acquisition of Varian seeks to build upon a strategic partnership called EnVision, which aims to create a digital, diagnostic and therapeutic ecosystem that includes treatment management. The companies plan to utilize AI-assisted analytics to advance their data-driven precision care while redefining cancer diagnosis, care delivery and post-treatment survivorship. “With the completion of this transaction, we are now best-positioned to take two leaps together: a leap in cancer care and a leap in our impact on healthcare overall,” Siemens Helathineers CEO Dr. Bernd Montag said. “Together, we are establishing a strong and trusted partner capable of supporting customers and patients along the entire cancer care continuum as well as through all major clinical pathways.” 3. Baxter — Hillrom — $12.4 B Baxter agreed to acquire Hillrom at a price of $156 per share in cash for a total equity value of approximately $10.5 billion, with the purchase reaching a total enterprise value of approximately $12.4 billion, including the assumption of debt. That purchase price reflects a 26% premium to Hillrom’s closing stock price on July 27, 2021, the last trading day prior to media reports speculating on the potential transaction.

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The acquisition was expected to add to Baxter’s product portfolio and innovation pipeline in a way that allows it to offer a wider range of medical products and services to patients and clinicians across the care continuum, the company said. A major part of the deal involves accelerating the companies’ expansion into digital and connected care solutions to enable patients to access hospital-level care at home or in other care settings. “Baxter and Hillrom share a common vision for transforming healthcare to better serve all patients and providers,” Baxter Chairman, President and CEO José (Joe) E. Almeida said. “Patients increasingly want to receive their care at home or nearby, while hospitals and other care providers are increasingly using digital health technologies to expand access, improve quality and lower costs.” 4. Danaher — Aldevron — $9.6B Danaher agreed to acquire Aldevron, a manufacturer of high-quality plasmid DNA, mRNA and proteins, for approximately $9.6 billion. Fargo, North Dakota-based Aldevron, which employs approximately 600 people, develops the DNA, mRNA and proteins to serve biotechnology and pharmaceutical customers across research, clinical and commercial applications. It will continue to operate as a standalone company and brand within Danaher’s life sciences business segment. “We are thrilled to have Aldevron join Danaher’s life sciences segment. For nearly 25 years, Aldevron has made tremendous contributions to the advancement of cell, gene and other novel therapies and vaccines,” Danaher President and CEO Rainer Blair said. This acquisition will expand our capabilities into the important field of genomic medicine and help us support our customers and their critical mission to bring more life-saving therapies and vaccines to market faster.” 5. Illumina — Grail — $8B In August, Illumina announced that it completed its long-awaited and muchscrutinized acquisition of cancer detection company Grail, but, due to that scrutiny, it will hold Grail as a separate company as the European Commission conducts an ongoing regulatory review. More than one year ago, the San Diego-based company agreed to acquire Grail, a startup that spun out from Illumina

nearly five years ago, for cash and stock consideration of $8 billion. In the spring, the companies had agreed to postpone the merger while the U.S. Federal Trade Commission (FTC) challenged the deal. A U.S. judge ruled in favor of an FTC petition to drop its case against the merger without prejudice, a move that allowed the EU to continue investigating the merger. Illumina will present a jurisdictional challenge in the General Court of the European Union later this year. The company said that while it holds Grail separate while proceedings are ongoing, it can abide by whatever final decision is reached. Should the deal go through, the combined company aims to provide top-of-the-line multi-cancer early detection offerings. “Just as we are now able to screen for early-stage diabetes and high cholesterol, we will soon be able to conduct multi-cancer early detection with a simple blood test in your doctor’s office,” Illumina CEO Francis deSouza said. “Since early detection of cancer saves lives, this new genomic test will be nothing short of transformational for human health and the economics of healthcare.” 6. PerkinElmer — BioLegend — $5.25B With the largest acquisition in the company’s history, PerkinElmer paid $5.25 billion to expand its life science franchise into high-growth areas including cytometry, proteogenomics, multiplex assays, recombinant proteins, magnetic cell separation and bioprocessing. San Diego-based BioLegend has more than 700 employees based primarily in the U.S. and estimated 2022 revenues of $380 million. Once a part of PerkinElmer, BioLegend will expand the company’s life science franchise into new segments, with its San Diego campus set to become PerkinElmer’s global center of excellence for research reagent content development for the combined company. PerkinElmer expects BioLegend to contribute an incremental $380 million in revenue and adjusted EPS of 30¢ per share in fiscal 2022. “BioLegend’s stellar leaders, teams and technologies will play a critical role in our combined companies’ ability to provide new, innovative solutions to scientists — helping drive novel therapeutic discovery and development,” PerkinElmer President and CEO Prahlad Singh said in a news release. “We also look forward www.medicaldesignandoutsourcing.com

to BioLegend significantly enhancing our leading reagents portfolio as we partner together to innovate and advance science for our customers.” 7. Steris — Cantel Medical — $4.6B In one of the first major medtech acquisitions of 2021, Steris announced in January that it was set to buy Cantel Medical. The acquisition combines Steris’ offerings of sterilizers and washers with Cantel’s devices that center around endoscope disinfection, water purification and filtration for dialysis along with healthcare disposables. The companies said the deal adds a full suite of highlevel disinfection disposables, capital equipment and services and additional single-use accessories to Steris’s endoscopy offerings. Cantel’s dental business will also extend Steris into a new segment of potential customers. “We have long appreciated Cantel, which is a natural complement and extension to Steris’s product and service offerings, global reach and customers,” Steris CEO Walt Rosebrough said. “Our companies share a similar focus on infection prevention across a range of healthcare customers. Combined, we will offer a broader set of customers a more diversified selection of infection prevention and procedural products and services.” 8. Philips — BioTelemetry — $2.8B In another early M&A move in 2021, Royal Philips in February successfully completed its acquisition of all outstanding shares of BioTelemetry, sealing a deal that was initially agreed upon in December 2020. BioTelemetry, a company with approximately 1,900 employees, develops diagnostics and monitors for heart rhythm disorders, including wearable heart monitors that detect and transmit abnormal heart rhythms wirelessly, along with AI-based data analytics and services. The company joined Philips’ connected care business segment as a wholly-owned subsidiary of the Amsterdam-based medtech company. Philips expects to supplement its in-hospital patient monitoring business with BioTelemetry’s cardiac diagnostics and monitoring technologies for outside the hospital. “The acquisition of BioTelemetry fits perfectly with our strategy to be a leading provider of patient care management solutions for the hospital and the home,” Philips CEO Frans van Houten said in the 11 • 2021

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MERGERS & ACQUISITIONS

initial announcement. “BioTelemetry’s leadership in the large and fast-growing ambulatory cardiac diagnostics and monitoring market complements our leading position in the hospital. Leveraging our collective expertise, we will be in an optimal position to improve patient care across care settings for multiple diseases and medical conditions.” 9. Sanofi — Kadmon — $1.9B In a big move in the pharmaceutical space, Sanofi in September entered into a definitive merger with therapeutic developer Kadmon. Shareholders of Kadmon common stock were set to receive $9.50 per share in cash to total $1.9 billion on a fully diluted basis. The boards of directors for both companies unanimously approved the transaction and the companies expect it to be modestly dilutive to Sanofi’s earnings per share in 2022. The acquisition bolsters Sanofi’s transplant portfolio with Rezurock (belumosudil), an FDA-approved, first-in-class treatment for chronic graft-versus-host disease (cGVHD) for patients over 12 years old who have failed at least two prior lines of systemic therapy. Rezurock launched in the U.S. in August as the first and only approved small molecule therapy that inhibits the Rho-associated coiled-coil kinase 2 (ROCK2) signaling pathway. “We are transforming and simplifying our general medicines business and have shifted our focus on differentiated core assets in key markets,” Sanofi EVP of General Medicines Olivier Charmeil said. “We are thrilled to add Kadmon’s Rezurock to our well-established transplant portfolio. Our existing scale, expertise, and relationships in transplant create an ideal platform to achieve the full potential of Rezurock, which will address the significant unmet medical needs of patients with chronic graft-versus-host disease around the world.” 10. Amgen — Five Prime Therapeutics — $1.9B With the largest drug delivery-related acquisition, Amgen bought Five Prime Therapeutics to support its strategy for international expansion and accelerate pipeline programs to complement Amgen’s numerous injectable and oral oncology therapeutics. 120

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The $1.9 billion deal between the two California-based companies adds Five Prime’s pipeline to Amgen’s oncology portfolio, including Five Prime’s lead asset, bemarituzumab. Bemarituzumab is a first-in-class, Phase 3-ready anti-FGFR2b antibody for advanced gastric or gastroesophageal junction cancer. Trial results for the therapeutic suggest that FGFR2b could be used in treating other epithelial cancers, including lung, breast, ovarian and more. “Five Prime fits squarely within Amgen’s leading oncology portfolio and includes bemarituzumab, a Phase 3 trialready, first-in-class program for gastric cancer, the third leading cause of cancer mortality worldwide,” Amgen Chair and CEO Robert Bradway said. “Working with the dedicated professionals joining us from Five Prime, we plan to quickly move bemarituzumab into a Phase 3 study, bringing it one step closer to helping patients suffering from gastric cancer.” Here are 10 more major mergers and acquisitions that just missed out on the top 10:

intraoperative imaging and surgical navigation technology for guiding clinicians during minimally invasive and robotic surgeries. The platform also aids in visualizing deep tissue during procedures in neuro and abdominal surgery and in ultrasound urology.

11. DiaSorin — Luminex — $1.8B Luminex develops diagnostic testing products, including platforms based on multiplexing technology. The Austin, Texas-based company’s diagnostics include COVID-19 tests, which received FDA emergency use authorization last year.

17. Medtronic — Intersect ENT — $1.1B By acquiring Intersect ENT, medtech giant Medtronic) expanded its portfolio of ear, nose and throat medical devices. Intersect ENT makes the Propel and Sinuva sinus implants that open sinus passageways to deliver an anti-inflammatory steroid to aid in healing.

12. Roche — GenMark Diagnostics — $1.8B Roche looks to bolster its molecular diagnostics portfolio with GenMark Diagnostics’ syndromic panel testing portfolio. The ePlex system made by GenMark drives efficiency in the laboratory through a streamlined order-to-reporting workflow, enabling rapid diagnoses. 13. Boston Scientific — Baylis Medical — $1.75B Boston Scientific expanded its electrophysiology and structural heart product portfolios to include the radiofrequency (RF) NRG and VersaCross transseptal platforms from Baylis Medical, as well as a family of guidewires, sheaths and dilators used to support left heart access. 14. GE Healthcare — BK Medical — $1.45B GE Healthcare made a major imaging play by acquiring BK Medical and its www.medicaldesignandoutsourcing.com

15. Boston Scientific — Preventice Solutions — $1.225B Another of several big-time M&A plays by Boston Scientific, the company bought Preventice and its mobile health solutions and remote monitoring offerings for patients with cardiac arrhythmias. Among its products are wearables, including the PatientCare platform and BodyGuardian family of monitors. 16. Philip Morris — Vectura — $1.2B In one of the more controversial moves of 2021, Philip Morris, a cigarette maker, bought Vectura to gain access to the company’s inhaled drug delivery technologies that can help it reach its goal of generating more than 50% of its total net revenue from smoke-free products by 2025.

18. Boston Scientific — Lumenis — $1.1B In the third and final appearance of Boston Scientific on this list, the company picked up Lumenis and its surgical business, which includes premier energy-based laser systems, fibers and accessories for urology and otolaryngology procedures. 19. Adapt Health — AeroCare — $1.1B AeroCare develops technology-enabled respiratory and home medical equipment distribution platforms in the U.S., including direct-to-patient equipment and services like CPAP and BiPAP machines, oxygen concentrators, home ventilators and other durable medical equipment products. 20. Dentsply Sirona — Byte — $1.04B The earliest major acquisition of 2021, Dentsply Sirona’s Jan. 5 announcement confirmed that the buy will utilize Byte’s leadership position in the direct-toconsumer clear aligner market.

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CABLES & CONNECTORS

Image courtesy of Times Microwave Systems

RF interconnects, including coaxial cables and connectors, are an integral part of MRI systems. Early awareness of challenges such as transmission loss, ease of installation and infrastructure requirements can help with performance and cost optimization in the design of new MRI systems.

Kai Loh | Times Microwave Systems |

agnetic resonance imaging (MRI) technology has advanced rapidly in the last decade. Spurred by aging populations and increased cases of certain diseases, demand for more timely and accurate diagnostics has driven adoption of MRI and advancements. In addition to the conventional setup typically found in most healthcare facilities, mobile and portable systems development has gained momentum to broaden access and reduce wait time for MRI diagnostics. The increased emphasis on minimally invasive surgical procedures is another driver 122

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Powering MRIs: 3 RF interconnect considerations to save time and money

11 • 2021

for high-resolution medical imaging. With hardware and software enhancements, leading equipment manufacturers and research institutes have taken MRI technology to new heights. After a period of incremental development and adoption in the decades prior, the approval of 7T MRI (an ultra-high-ﬁeld scanner that more than double the strength of current state-of-the-art MRI scanners) for clinical use and successful operation of an 11.7T MRI system (among the strongest MRI machines ever built) for research applications in the last ﬁve years is a giant leap forward. >>

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CABLES & CONNECTORS

Always an integral part of MRI systems, radio frequency (RF) interconnects, including coaxial cables and connectors, are keeping pace with the technology’s rapid development. It is common for system developers to allocate more resources to areas of high technical complexity. RF interconnects often take a back seat in the early stage of development projects. Missed opportunities for performance and cost optimization can stem from inadequate planning. In most cases, early awareness of challenges such as transmission loss, ease of installation, and infrastructure requirements can help avoid additional costs and future system redesign. Transmission loss One of the critical implications of increased magnetic field strength is the higher operating frequency from the RF interconnect perspective. The widely adopted 1.5T and 3T MRI systems operate at 63.9 MHz and 127.7 MHz, Westfall_LifeSciences Mag Ad_10_20.pdf

10/19/21

respectively. 7T systems operate at 298 MHz, and future equipment will scale even higher on the frequency spectrum. In the age of developing millimeter-wave communication, these figures may appear relatively insignificant. However, insertion loss, a key performance parameter in high power coaxial interconnects, is predominantly a square root function of frequency. Therefore, transmission at 298 MHz over the same cable length would incur about 50% more loss than 127.7 MHz. In addition to lower efficiency, cable loss is dissipated as heat and can add complexity to thermal management within the equipment or system component room. As high operating or ambient temperature accelerates aging and other breakdown modes, robust lowloss RF interconnects with lower thermal dissipation will ultimately contribute to overall system reliability. Instead of carrying a proven design at a lower frequency over to the new systems, a holistic view of the overall interconnect

requirement can lead to performance and reliability improvement opportunities. With the many recent breakthroughs in RF cable and connector products, a wide array of options support the next generation of MRI systems. Ease of installation and cable flexibility An MRI system installation or upgrade is a significant undertaking for any healthcare facility. A typical MRI site is a multi-room setup to ensure personnel and patient safety and meet various equipment shielding requirements. RF interconnects are an integral part of this setup, linking critical system components in different locations, often through constrained space. Given the high-power handling requirement of MRIs, cables and connectors in the transmit path are typically larger. Additional planning to consider specific mechanical properties may improve the ease of initial installation and subsequent maintenance.

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One of the critical mechanical properties for flexible coaxial cables is minimum bend radius, defined as the smallest radius a cable can be bent around without immediate damage or latent defect. The minimum bend radius for a typical flexible cable is 6 to 10 times the overall cable diameter. However, cables with specific construction and material combinations, including the stranded center conductor, foil shield, and optimized dielectric density, can offer a much-reduced bend radius while balancing the power handling need. Understanding minimum bend radius aids the cabling plan for an MRI site and prevents damage from a cable making an excessively tight turn. A more flexible cable can improve handling and directly impact ergonomics, resulting in shorter installation time and other tangible benefits. Cable flexibility in a dynamic environment such as the patient table poses a different challenge. Repeated flexure can lead to material fatigue and displacement, with a damaged center conductor or shield being the typical failure mode. Cables with a stranded center conductor, especially those with high strand count, are optimal solutions in a high flexure environment. Although the stranded configuration is inherently higher loss, the improvement in flex life and overall connection reliability in most cases outweighs the marginal increase in insertion loss. Infrastructure requirements As MRI systems often need to fit into infrastructure with pre-existing constraints and limitations, the layout of RF and other interconnects is seldom straightforward. Depending on the installed location, plenum or riser-rated cables are required to meet building code and general fire safety requirements. To attain the CMP (plenum) or CMR (riser) rating, the coaxial cable must pass rigorous tests and demonstrate its capability to resist flame and minimize smoke, requiring the use of specialty insulator materials. With the many variations in building code and product flame resistance rating, it can be challenging to identify a cable that meets the right electrical and mechanical requirements. Fortunately, most high-performance cables are now available in flame-resistant versions with CMP or CMR rating, making optimal interconnect solutions for MRI at the system and infrastructure level a reality. Although RF interconnects design is typically less complex when compared to active components in an MRI system, the optimal solution requires an end-to-end approach and accounts for key technical aspects. Whether upgrading existing systems or pushing the envelope of next-generation technology, a general understanding of cable and connector properties, operating conditions, and infrastructural constraints can help overall performance. 11 • 2021

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The Original Push-Pull Connector

CATHETERS

PIVO gets its name from the peripheral intravenous (PIV) line to which the device attaches.

Photo courtesy of BD

"Velano is very much focused on this idea of delivering painless, compassionate care for inpatient hospitalization and providing a safer practice as well."

BD seeks to establish a new standard of care in blood collection Sean Whooley | Associate Editor |

Here’s how BD’s purchase of Velano Vascular could minimize needlesticks for hospital patients.

earlier this year announced a move that it believes can change the standard of care in blood collection. With the acquisition of Velano Vascular and its needle-free technology for high-quality blood draws, the company aims to transform the patient experience, according to Rick Byrd, BD’s worldwide president of medication delivery solutions. “Needlesticks can be one of the most traumatic aspects of a hospital stay,” Byrd said in an interview. “For the patient, obviously, but they’re also anxiety-ridden for the phlebotomist and the nurse who has to perform the needlesticks. … The acquisition of Velano Vascular adds an innovative, needle-free blood draw technology to our portfolio that will reduce the pain and discomfort of multiple needle sticks.

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“We believe it will create a whole new standard of care for blood collection.” Financial terms of the deal were not disclosed. The acquisition provides a platform for BD’s “One-Stick Hospital Stay” blood collection strategy. The initiative, according to Byrd, aims to reduce the usual 10–20 needlesticks per hospital stay to just one stick for those who require blood draws. Velano’s FDA-cleared PIVO device attaches to existing peripheral intravenous catheter (PIVC) lines, paving the way for the One-Stick blood collection and vascular access initiative by avoiding blood draws performed through a puncture separate from the IV catheter. “Velano is very much focused on this idea of delivering painless, compassionate care for inpatient hospitalization and providing a safer practice as well,” Byrd said.

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"With BD, we're committed to transforming vascular care and driving innovation to improve clinical outcomes and better serve our patients." “With BD, we’re committed to transforming vascular care and driving innovation to improve clinical outcomes and better serve our patients,” Byrd said. “We were really excited to announce this big step forward that we took in our mission to transform the patient experience through this vision.” Medical Design & Outsourcing

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“Their ambitions were very much aligned to BD,” he continued. “We’re super excited to join forces with them.” San Francisco–based Velano Vascular was named the fastest-growing medical device company in 2020 by Deloitte and, according to Byrd, already has a strong customer base with primary healthcare facilities using its technology. Its system holds FDA clearance, and BD plans to go beyond making it the standard of care in the U.S., including registering the platform worldwide to globalize Velano’s offerings. “They have a very good base of customers, and this is very synergistic to our BD products, to our commercial models and our sales teams,” Byrd said. “We’ve immediately hit the ground running with this.” Byrd said BD will take the necessary steps to ensure that it continues to innovate upon Velano’s technology, making the high-quality specimen management platform compatible with all BD catheters, then compatible with all IV catheters. The aim is to leverage its expertise to try and draw as much utility out of the already-placed IV catheter as possible, demonstrating the catheter’s capabilities beyond delivering medication.

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CLINICAL TRIALS

Introducing 'BYOP' clinical trials Software company Curebase is promoting the concept of ‘bring-your-own-physician’ clinical trials.

BYOD Photo courtesy of Adobe Stock

Brian Buntz | Pharma Editor |

"We have multiple clinical trials right now where patients can participate with their own doctor."

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— “bring your own device” — became a common term in tech circles a decade ago. Now with primary care doctors playing a growing role in clinical trials, the provider of decentralized clinical research software Curebase (San Francisco) aims to popularize the concept of “BYOP” — “bring your own physician.” That is, the company is working to connect patients with local physicians to collect real-world data and execute trials. In any event, decentralized and hybrid clinical trials continue to gain ground as the pandemic persists. The trend is elevating the role of community-based clinical trials in areas such as oncology. Additionally, physicians are playing a growing role in spurring clinical trial recruitment, according to a recent survey from Informa Pharma Intelligence and Rare Patient Voice. Almost half (48%) of patients taking part in a clinical trial had ﬁrst learned of the opportunity from their physician. Among those who had not participated in a clinical trial, 81% said they would be more likely to participate if their physicians informed them of a possibility of enrolling. “We have multiple clinical trials right now where patients can participate with their own doctor,” said Tom Lemberg, CEO of Curebase. One of those trials enables expectant mothers across the country to join a clinical trial. Whereas similar studies in the past would have required patients to visit a local academic medical center to participate, the trial enables women to go to their local doctor. “They can go to their own OB-GYN physician for their normal second- and third-trimester visits, and we can collect data at the point of care,” Lemberg said. Decentralized studies don’t necessarily mean “clinical trials from your couch,” Lemberg said.

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Enabling doctors outside of academic medical centers to play an integral role in clinical trials is “the next big step to realize the full potential,” he added. The clinical trials market was worth $44.3 billion in 2020, according to Grand View Research. Decentralized clinical trials make up a growing slice of the market, thanks in large part to the pandemic. “COVID really forced pharmaceutical companies and regulators to invest in this method,” Lemberg said. One of CureBase’s customers, InBios International Inc., won emergency use authorization for its SCoV-2 Ag Detect rapid SARS-CoV-2 test. The clinical data InBios filed with FDA was based on a decentralized clinical trial. That study drew data from COVID-19 drive-through testing and clinic-based sites. “We turned ordinary healthcare providers into researchers,” Lemberg said. “These were not traditional research sites. They were just COVID testing clinics that we activated to form our research network.”

Although fully decentralized clinical trials are not always feasible, they offer several advantages. In addition to reducing COVID-19 transmission risks, they can also help “achieve greater diversity, access to more patients in different demographic groups, socioeconomic groups, racial groups, etc.,” Lemberg said.

"We turned ordinary healthcare providers into researchers. These were not traditional research sites. They were just COVID testing clinics that we activated to form our research network."

Curebase CEO Timothy Weber

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COMPONENTS

3 pitfalls to avoid when choosing fasteners for wearables Though they’re a small component, fasteners play a critical role in device performance.

M Keith Glaser | YKK (U.S.A.) |

edical wearables technology — devices worn on the body or clothing that diagnose, treat or alleviate disease, or help mitigate injuries — has advanced significantly in recent years. While many people think of fitness trackers and health watches, this booming market also includes items like orthopedic braces, wearable injectors and compression garments. Fasteners play a critical role in product performance, even though they are a small component of the overall device. They are probably the most frequently touched part of the product, used to attach it to the body or make it tighter or looser based on user need. Let’s explore three key pitfalls to avoid when choosing fasteners that can result in underperforming wearables, wasted time and money and missed opportunities for innovation. Pitfall No. 1: Selecting the wrong material Fastener material choice directly impacts product performance and fitness for use. When selecting materials, there are several important considerations to make early in the design process.

YKK’s hook-and-loop Powerhook fastener Photo courtesy of YKK

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For example, how strong or weak does the grip of the fastener need to be based on what you are trying to hold together? Imagine a common wearable such as an armband used to hold a cell phone while running. If the grip isn’t tight enough, the armband will fall off every 11 • 2021

time, rendering the product useless and frustrating the user. Many manufacturers do not realize that the grip of the hook and loop fastener, which is often the fastener of choice for this type of device, can be made very strong or very weak based on its configuration and directionality. The wrong directionality or configuration can also influence the lifecycle of a product. If the loop material degrades too quickly, manufacturers run the risk of receiving a significant volume of complaints about the product and even returns. >>

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Another critical consideration for materials is tied to how the device will be used. If it will have prolonged skin contact, different levels of biocompatibility testing will be required and will need to be planned for in advance. It is also critical to plan for other important properties for the device, such as if it needs to be waterproof or ﬁre retardant, as those requirements may impact whether the desired material is in fact a suitable choice. To protect the effectiveness and safety of medical wearables when selecting fastener materials, manufacturers must also consider what kind of care the device will require over its lifetime. Will it need to be sterilized? Cleaned? Some materials will degrade very quickly when exposed to bleach, for example, so the device maintenance process must be factored into its design. Pitfall No. 2: Overlooking ergonomics and usability Deprioritizing the human aspects of

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Orthopedic devices are just one example of wearables with fasteners.

Photo courtesy of YKK

designing wearable medical devices can decrease their use and acceptance levels. The top priorities here should be comfort and ease of use. User comfort can translate to many things. For some people, it’s the ability to

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no longer sense the device after wearing it for some time. For others, comfort means an acceptable material texture or the ability to move normally when wearing the device. When designing the device, the placement of fasteners and even material

choice can improve comfort. For example, making sure fasteners are not located on pressure points will enhance wearability. Making devices easy to use is also essential. Key factors include a simple and intuitive user interface with easy to reach fasteners that can be operated with one or two hands at the appropriate pull strength. The good news is that there are a wide range of fastener options, from buckles and zippers to snaps and buttons in different shapes, that make ergonomic design feasible. However, forethought and planning are required to maximize the potential of these offerings. Pitfall No. 3: Not seeking support early enough It’s clear that the right material and proper fastener will have a positive impact on the performance of wearable medical devices. However, these elements lose their power if product performance characteristics aren’t factored in from the very beginning of the process. Manufacturers can increase the likelihood of identifying the best solutions for their needs by taking a collaborative approach with their suppliers, versus simply asking them to deliver a product chosen out of a catalog. For example, with snap and button solutions, there are several nuances that can impact product performance, including tension and release and whether the product the fastener will be used on is intended for single or multiple use. The fastener supplier will know these nuances intimately, and working with them early in the product development process can help set the manufacturer up for success. Timely engagement with partners early also maximizes opportunities for innovation and problem-solving by enabling discussions around machinery and services like sub-assembly that can result in efficiencies and cost-savings.

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Medical Design & Outsourcing 133

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MATERIALS

Connor Chiuchiolo | Carl Stahl Sava Industries |

These 0.001 in. tungsten wire filaments are used to manufacture tungsten mechanical cable.

Scott Dailey | Carl Stahl Sava Industries |

Photo courtesy Carl Stahl Sava Industries

Tungsten cable for surgical robotics: A complex material serving a complex application Tungsten mechanical cables are the most popular for surgical robot makers.

he mechanical cables that reside within the motion control systems of the most modern surgical robots can be so small that the individual filaments themselves are nearly impossible to see with the naked eye. So tiny are the wires comprising tungsten cables for surgical robotics that they contain individual strand diameters as small as one-fourth the thickness of a single piece of paper. When a surgical robotics designer comes to a cable manufacturer with a tungsten cable application, there is a specific set of criteria that the cable must satisfy. The cable must tolerate a precise load, for example, while maintaining a miniature diameter, as well as a critical factor of safety. After all, a tungsten cable must shoulder its 134

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load requirements without getting too large to fit within the tight form factors of today’s surgical robots. Therefore, manufacturing tungsten cable for surgical robotics involves the delicate process of understanding how tungsten wire behaves at incredibly small diameters once it’s been stranded into helical cable constructions. While engineers must design manufacturing processes that prevent mating components from damaging the ultrafine tungsten cable, they must also ensure that mating components and the live environment coalesce to deliver world-class motion actuation when a human life is on the line. Plainly said, miniature tungsten cable behaviors get more complex as the engineer introduces additional parts, stresses and other external conditions to the design process.

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MATERIALS

19x19 0.5 mm tungsten cable with 304 stainless steel sleeve swaged at the ends.

19x19 0.5 mm tungsten cable with 304 stainless steel sleeve swaged at the center.

Photo courtesy Carl Stahl Sava Industries

19×19 0.5 mm tungsten cable with plasma-welded ends Photo courtesy Carl Stahl Sava Industries

Like the evolving miniaturization of surgical products in general, making tungsten cable for surgical robotics is an incredibly sophisticated engineering process, made more challenging by its increasingly small footprint and sophisticated behavioral characteristics. Why tungsten mechanical cable? Surgical robotics designers use tungsten cables in more and more of their products because of the material’s unique ability to both bear high load and traverse tight radii. The pulleys inside these surgical marvels may be as small as the tip of a crayon. Mechanical cable that needs to round such sharp turns must therefore possess qualities that permit the product to withstand the beating the cable will take over thousands of cycles, without fear of premature degradation. Tungsten (also known as wolfram) is ideal for these applications, as it is has the highest tensile strength of any natural metal on Earth. But in addition to its inherent might, tungsten cable also possesses a “deadness” to it. As a matter of fact, when stranded, tungsten miniature cable 136

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behaves similarly to a shoelace: held in the center of its length, tungsten cable falls limp. For contrast, stainless steel of the same size and strength would possess a spring-like quality that forces it to return to its original form. And although stainless steel is used to support motion in surgical robots, its natural rigidity causes the material to want to defy the tight turns in tomorrow’s surgical robots. Introducing mating components When an engineer combines a sleeve, ball fitting or other cable fitting to the tungsten cable, the natural behavior of the tungsten strand will change in and around these fittings. The changes these mating parts produce often range from merely unwanted in nature to entirely unacceptable. In a nutshell, this is the engineer’s challenge when designing miniature tungsten cable for surgical robotics. For example, take a tungsten mechanical cable assembly that includes a 3-in. length of 19x19 cable (comprising 361 wires) with a ball fitting attached to the center of the assembly. In this case, it is not uncommon for the tungsten filaments to slightly separate or “bird www.medicaldesignandoutsourcing.com

Tungsten cable is behaviorally limp, as shown in this 7×37 0.021in. tungsten cable. Photo courtesy Carl Stahl Sava Industries

cage” immediately to the left and right of the ball fitting, when an industrial press places pressure on the fitting itself. Cable design engineers are prepared for this and make adjustments to the fitting and/ or the press applying pressure to the mating components. The designers of tomorrow’s surgical robots are concerned with the ball’s diameter, placement and performance, along with the tungsten cable assembly itself. However, cable design experts must concern themselves with the aforementioned requirements as well as tooling, machining and manufacturing processes that create the perfect product every time. And remember that the cable design engineer needs to not only solve temporaneous and predictable complications that emerge from handling tungsten cable, but to do so at a mass scale so robotics makers can compete within fiercely aggressive and rapidly moving global markets.

This article was written by Carl Stahl Sava Industries Associate Design Engineer Connor Chiuchiolo and VP of Marketing Scott Dailey. For more information about Riverdale, New Jersey-based Carl Stahl Sava Industries, visit www.savacable.com.

An 8×19 0.5 mm tungsten cable with a flat ball or “hockey puck” fitting swaged in the center. Photo courtesy Carl Stahl Sava Industries

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ORTHOPEDICS

Zimmer Biomet's plan to be the 'boldest' company in medtech Chief Operating Oﬃcer Ivan Tornos wants to transform Zimmer Biomet into a fast-moving ﬁrm that better leverages tech in orthopedics.

D Danielle Kirsh | Senior Editor |

eviceTalks Editorial Director Tom Salemi spoke with Ivan Tornos, chief operating officer of Zimmer Biomet, about the company’s broad technology offerings including its ZBEdge, Persona IQ smart knee implant and other digital data collectors. Tornos joined the Warsaw, Indianabased company in November 2018 as president of the orthopedics group, became group president of global business and the Americas in 2019 and was promoted to serve as chief operating officer — a new position at Zimmer Biomet — in March 2021. Go to DeviceTalks.com to hear the entire conversation. (We’ve edited the following excerpt for brevity and clarity.) DeviceTalks: As chief operating officer, what are your responsibilities? Tornos: There’s pretty much four key areas: Strategy, operations, culture and innovation. On the strategy front, which is 90 percent of my time, I am tasked to transform the company with a group of people from being historically a metal and plastic company to what we call a customer-centric solutions leader. We want to move from selling implants to solving problems. We know this space very well. We have all kinds of

programs in orthopedics, whether it is the outcomes not being what patients deserve, whether it is the inefﬁciency in the surgical episode of care, whether it is just the overall high cost that still you see in the episode of care. We want to be a solutions leader in solving the problems through our technology, through our implants, through our data and all the elements of our ecosystem. When it comes to operations, I pretty much think of myself as the person responsible to make sure that we drive a very efﬁcient operation here at Zimmer Biomet. We’ve got 23,000 employees across 125 different countries. I want to make sure that we run Zimmer Biomet globally like a startup. I want us to move with speed in the way we operate. I’ve seen that happen in other large companies. And I think of myself as a person that is going to induce that speed in the way that we operate. The third one, which is probably the most important one, is culture and talent. I like to think of myself as a global cheerleader of the company, someone who’s daily inspiring this notion of winning every day in the marketplace for patients, primarily. >>

IS ZIMMER BIOMET MORPHING INTO A TECH COMPANY? In this episode we speak with Ivan Tornos, COO of Zimmer Biomet, about the company’s broad technology offerings, including ZBEdge, PersonaIQ knee implant, and other digital data collectors. Tornos says Zimmer Biomet intends to be the boldest company in the medtech industry. www.devicetalks.com/podcast/

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I spend a large amount of time meeting people that joined the company, developing people as well as hiring people, really driving the message of why we do what we do, talking about our mission. And then the fourth and final area of responsibility is innovation, which is very exciting. We’ve gone through some challenges in the past. The last three years, innovationwise, have been phenomenal. We’re going to be launching close to 50 new products over the short- to mid-term. We have moved our R&D investments from implants to technology, so 70% of all the money that we invest today, you’ve seen in robotics technology and applications beyond the implant. DeviceTalks: Between the robotics, ZBEdge and Persona, it’s sounding less like an orthopedic company and more like a hybrid of tech and orthopedics. I’m guessing that’s how you see things as well? Tornos: 100%.

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DeviceTalks: Let’s get into those different areas. Let’s start with Persona. What does it bring to the orthopedics channel? Tornos: At Hospital for Special Surgery, we inserted the very first smart implant in the world of orthopedics – and I say that with a lot of pride. It’s the very first smart implant, the only FDA-approved smart implant in orthopedics is Persona IQ. The simple way to describe this is a sensor from Canary Medical goes into the tibial extension of the actual implant and post-surgery, it starts to measure things. And what you measure is going to be highly scalable. We measure things like range of motion, step down, walking speed, the quality of your walk, what we call gait metrics. Beyond that, it’s going to start measuring many other things. We strongly believe at some point, we can measure things such as movement of the implant, potential risk of friction, temperature and many other things. It’s also going to also feed data, not only to the patient, but to the actual physician. DeviceTalks: Why is this data important? How do you ensure that the data is accessed, monitored and used by the physicians? Are they accustomed to tracking data and checking the data that come from the sensors? How do they come to use data in their everyday lives? Tornos: The patient and the physician will have access to that data. With the data, I can understand range of motion after the surgery, level of physical therapy, potential risk of readmission and complications. Years from now, you can get alarm bells — is that, is that implant moving, causing infection and other problems? How you feel is very subjective [versus] very quantitative data points in terms of how biomechanically your implant is moving. What do you do with the data later on? 140

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Medical Design & Outsourcing

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You kind of start to really see what is the best time and the best implant for a given patient. You start getting into all kinds of predictive analytics, intentionally redesigning implants, what are things that work or don’t work. DeviceTalks: Let’s move on to the ZBEdge platform. Tornos: ZBEdge is our ecosystem of solutions. It encompasses all kinds of solutions: hips, knees, shoulders, robotics, smart implants. What makes ZBEdge unique is that every single component of this ecosystem either gathers data or feeds data. DeviceTalks: How does ZBEdge present to the world? What does it look like? Tornos: ZBEdge has amazing implants. Those get augmented by the data capabilities around the implant. Those get augmented by the fact that we’re able to feed — through robotics — data intracase to that surgeon to see what is the best implant, how is it going to perform, the anatomy of that patient, the biomechanics, and all of that. So you’re getting data combined with implants to get a dashboard that has all kinds of dynamics. DeviceTalks: Where does Rosa robotics fit into the infrastructure? Tornos: We’re not a robotics company. I see ourselves as a technology company. One of those ingredients in that ecosystem that I keep talking about is robotics. What I like about Rosa is that it interconnects with other parts of the ecosystem. Very excited about it, but no, it’s not the one core component – it’s one of a few. We have four robotic applications today: We’ve got the brain application, spine, knees and hips. DeviceTalks: Let’s look ahead. What’s gone into changing the culture of the company from orthopedics to technology? And where do you see things going forward? What does Zimmer Biomet look like in four or five years? Tornos: Zimmer Biomet is going to be the boldest medtech company in the world. And that’s not a hyperbolic statement. We’ve made a very strong bet in making sure that is the vision. How do you define boldest? We’re going to be No. 1 in solving the problems in orthopedics. We want to drive the most efficient surgery with the best outcome, the safest 11 • 2021

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outcome for the patient. I want to make sure that we do our job when it comes to lowering the cost of care. That’s how we define being the boldest. In 2026, people will look back and say, “These guys really did become the problem solvers and the customer-centric solutions leaders in orthopedics.” We’re going to continue to look for all kinds of opportunities within technology. We’ve seen data. We’ve seen process excellence while we continue to innovate best-in-class devices. How do we align the culture of the organization to that? One of the things that is so striking about orthopedics is that things change slowly. How do we make sure that we move our culture in that direction of being the boldest medtech company in the world? It’s a combination of really expanding the “why” every day to our organization and to educate our

sales team on the fact that an implant is no longer going to be the way to solve a problem. It is part of the solution, but it’s not the only solution. It’s really training. We are certifying every single one of our thousands of reps in terms of why robotics, technology and data need to be part of the solution. I think people by seeing the results, they’ll jump on the journey. The team, the organization from a cultural standpoint, is fully on board with the journey that we have embarked upon. And I’ll tell you that already from a cultural standpoint today, we have a totally different culture at Zimmer Biomet than we did just three years ago.

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QUALITY ASSURANCE

Taking the extra steps to ensure medical device quality assurance Here’s how medical device manufacturers can go the extra mile to address regulatory challenges and user needs with comprehensive and purposeful quality assurance systems.

Q Judith Antler | Eitan Medical |

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uality assurance (QA) control is a central component of any manufacturing process, ensuring the end product is reliable, safe and of the highest quality. This process is critical in the medical device industry, as faulty devices can have severe patient health implications. When we consider the current COVID-19 pandemic and the abundance of critical care administered via medical devices, today more than ever, we must aim to ensure our products meet all safety standards and beyond. Unfortunately, even with the current regulatory policies and systems, there are still recalls and ﬁeld actions in the medical device industry. Both humans and machines are subject to error, but we must do our utmost to avoid these errors. As medical device manufacturers, how can we ensure our products not only adhere to all industry standards and regulations — but also ensure patient safety as the ultimate goal?

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Back to the beginning: Employee onboarding To best ensure device quality, manufacturers must understand that the QA process starts at the beginning: employee onboarding. It’s crucial that new hire training regimens highlight the global health impact of the devices manufactured, mainly that patients in need will use these devices—and those people might be the employee themselves or their loved ones. When employees fully understand the onus of the task at hand, they feel compelled to go above and beyond to ensure they keep regulations to the strictest standards. This sense of urgency, responsibility and genuine care are the fundamental ingredients for better and safer medical devices. With the proper mindset, employees can purposefully tackle the rest of the manufacturing process, starting with device design. The ins and outs of device design Device design starts with and revolves around understanding and addressing user needs.

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Manufacturers must create their own multiphased design QA control process with users at the focal point, with verification and validation stages. The importance of these control stages is crucial, as they act as a checks and balances system to ensure that the initial device design input and resulting output do not have significant differences, removing the need to conduct major design overhauls down the line. Without these self-checking measures, manufacturers may indeed develop a product that “works” but may not deliver care in a way that also answers patient needs. Furthermore, the design process should entail cross-team collaboration to ensure the product assessment through multiple lenses. The collaboration helps keep the overall product design on-target and encourages out-of-the-box thinking to resolve relevant issues or concerns. Crucially, manufacturers must also keep in mind regulatory authority requirements throughout the design and manufacturing process. The FDA, EU MDR and similar organizations provide regulatory processes to ensure devices are kept to the highest safety standards. Acting as a guide, the FDA’s Waterfall Design Process illustrates these steps for device manufacturers, providing simple yet comprehensive instructions for developers to bear in mind. As the QA process becomes more elaborate and intensive, manufacturers must conduct their own risk analysis to better understand where, if at all, mistakes and errors within the manufacturing and medical device design process may happen. As quality control is always performed on a sample basis, this allows developers to tighten controls where necessary, putting manufacturers in the best position to identify and rectify any issues. Assuring quality with care and process The medical device manufacturing process is lengthy and arduous. Manufacturers that have a deep understanding, alignment and care for the end-user, along with comprehensive processes that comply with regulations, will be in the best position for device quality success. As the world increasingly relies on medical devices, the quality and lasting power of our devices will be more vital for improving patient outcomes than ever before. 11 • 2021

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REGULATORY

The advantages of an AI/ML-enabled search engine for FDA records

The FDA’s new list of artiﬁcial intelligence and machine learning-enabled devices highlights opportunity for improvement. Qiang Kou | Nyquist Data |

Craig Coombs | For Nyquist Data |

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he FDA released a list of cleared or approved artiﬁcial intelligence and machine learningenabled devices in September, documenting much of the agency’s work in the innovative area of AI/ML. Extracting this information from the FDA’s decades-old database is labor intensive at best — and often impossible. Despite the time spent by the FDA to make this new list, a lack of even text-based searching capability makes the list itself cumbersome and time-consuming to review. Wouldn’t it be better if there was an AI resource that could quickly compile a list of FDA’s AI/ML clearances and approvals, allowing searches in seconds rather than hours? Like many databases, the FDA database uses text-matching to ﬁnd relevant entries. The weakness of textmatching is that it doesn’t match the search term as a whole. For example, if you search

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for “pain,” all records containing “pain” will be reported — along with records containing “Spain” and “painting.” And text-matching often misses relevant results. When users search “pediatric,” the FDA database won’t search for other spellings such as “paediatric” or related terms such such as “neonate,” “newborn,” “infant,” “children” and so forth. The strength of modern AI-powered searching algorithms is that they can understand the content and help users find what they are looking for. A JAMA paper published in July used a type of AI searching algorithm known as natural language processing (NLP) to identify an additional 23% of FDA database reports with patient deaths that were not classified as deaths using the text-match searching. Many of those misclassified reports never mentioned “death,” but instead “patient expired” or “could not >>

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be resuscitated.” This demonstrates the limitation of text-matching and why the medical device industry should switch to modern AI-powered methods, not just for database searching, but also to interrogate adverse event reporting, recalls, and application review details. The authors used Nyquist Data’s commercially available AI-powered searching engine to evaluate FDA’s database with keywords “machine learning”, “artificial intelligence”, “deep learning” or “neural network.” We only used the publicly available FDA database, which includes the summary files disclosed by the FDA. We quickly generated a list of 222 devices and compared it to the FDA’s list, finding three key differences: 1. Text-searching typically omits relevant citations. NLP methods discovered more than 20 AI/ML devices that were not in

the FDA’s list but were approved earlier than June 2021. For example, the RapidScreen RS-2000 system approved in 2001 clearly stated it used an artificial neural network for classification, and the Pathwork Diagnostics Tissue Of Origin Test approved in 2008 also clearly stated it used a machine learning approach based on marker selection to build a predictive model. 2. A text-matching search will always be out-of-date compared to an AI-enabled search because of the speed of AI. The latest device in FDA’s list is the Precise Position from Philips, approved on June 17, 2021. According to our research, FDA approved at least 24 AI/ ML devices after the list’s cutoff date. FDA says it will periodically update the list, but an AI/ML enabled search engine using NLP algorithms can automatically update in milliseconds.

3. AI/ML search engines are more flexible, yet have clear search and exclusion criteria. The FDA said it created its list “by searching FDA’s publicly-facing information, as well as by reviewing information in the publicly available resources cited below and in other publicly available materials published by the specific manufacturers.” How they searched the information and with which keywords is unclear. Gili Pro BioSensor is on the list, but the publicly available Reclassification Order mentioned nothing about “machine learning” or “artificial intelligence,” only that it uses an optical sensor system and software algorithms to obtain and analyze video signals and estimate vital signs. The RX-1 Rhythm Express Remote Cardiac Monitoring System is also included but didn’t explicitly say “machine learning” or “artificial

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s 7.

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intelligence.” It did mention that an embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology. There are at least 10 other ECG analysis devices included in FDA’s list, but none explicitly mentioned “machine learning” or “artiﬁcial intelligence” in their public information. Assuming these examples belong on the list means the FDA may have employed personal knowledge of the devices in a time-consuming search, underscoring the deﬁciencies of textmatching searches.

Nonetheless, as regulatory professionals, we should be using AI/ ML to unlock the FDA databases for improved regulatory intelligence. The higher quality regulatory intelligence that comes from the use of AI algorithms can result in better business practices in regulatory and clinical affairs, quality management, and business strategy development. View the FDA’s list at https://bit.ly/3EzH9mZ.

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Besides those differences between text-matching and AI algorithms, the AI results could be further interrogated to find interesting results. What if you wanted to know which AI/ML devices required a clinical trial for market clearance? The FDA’s list requires that you individually call up each device, one by one, to review the content of the submission. Using Nyquist Data’s commercially available AI search engine, the authors immediately developed a list of AI/ML devices and simultaneously filtered for descriptions of clinical trials. Most AI/ML devices are radiological FDA clearances that did not require clinical trials to establish substantial equivalence to predicate devices. However, there are five AI/ ML devices that submitted clinical trial data to support their claims of substantial equivalence or claims of safety and effectiveness: one in ophthalmology (K200667), one in microbiology (K142677) and three in radiology (P200003, DEN170073 and K183019). This information is critical to determining potential test criteria of innovations in the same fields. This additional searching takes milliseconds using a commercial AI search engine, but could take many hours using the FDA database search engine. In addition to the amount of work to use non-AI search algorithms, one cannot discount the loss of valuable information that is easily missed. We are excited by the FDA’s innovation, flexibility and intelligence demonstrated in approving/clearing medical devices associated with AI and ML. Their list improves regulatory intelligence for all. www.medicaldesignandoutsourcing.com

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TUBING TALKS

What is renal denervation? Jason Weidman, president of Medtronic’s coronary and renal denervation business, explains the hypertension treatment and the Spyral Symplicity device design that makes it possible.

The Symplicity Spyral device delivers energy to the nerves in the wall of the artery leading to the kidney. Image courtesy of Medtronic

M Jim Hammerand | Managing Editor |

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edtronic continues clinical trials of its Symplicity Spyral renal denervation (RDN) system for treating hypertension. The hope now is to win FDA approval in 2023. To better understand the technology behind what Medtronic leaders expect to become a multibillion-dollar business, Medical Design & Outsourcing spoke with Jason Weidman, Medtronic SVP and president of the coronary and renal denervation business, which is part of Medtronic’s cardiovascular portfolio. (We’ve edited this conversation for brevity and clarity.)

Renal denervation is a minimally invasive outpatient procedure, and in many respects, it’s quite similar to a coronary stenting procedure, except there’s no permanent implant. It’s that level of invasiveness, that level of ease of procedure. Through a tiny incision in your leg, a small device is inserted up through the vessels to that artery that leads to the kidney. Then our device, the Medtronic Symplicity Spyral device, delivers energy to the wall of that artery where those nerves are running through, with the purpose of basically calming that overactivity. This is, in essence, what can help to lower blood pressure.

MDO: What’s the simplest way to explain renal denervation? Weidman: The basic idea is that your kidneys are part of the body’s blood pressure control mechanism and communication happens to and from the brain and the kidney on how to regulate that kidney’s activity. That communication travels through nerves that are inside the walls of the artery that leads to the kidney. Patients with high blood pressure, though, often have overactivity in these nerves, so that communication isn’t working right. If we can interrupt that overactivity, we can bring down blood pressure.

MDO: What’s special about Medtronic’s Symplicity Spyral device design? Weidman: When it was ﬁrst dreamt up a decade ago ... there was a design of a device that was just a single point that you would have to rotate around and try to touch it and apply this energy several different times in the vessel. But what’s unique about our Symplicity Spyral device is that it is multi-electrode. It’s four electrodes in basically four different spots — almost like midnight, three o’clock, six o’clock and nine o’clock — but in a spiral pattern. And so that single catheter allows you to get the optimal energy delivery all in one catheter, >>

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versus a physician manually trying to ﬁnd all of those locations by his or herself. You would have to touch the side of the wall and apply energy, then you’d have to rotate the catheter 90 degrees and then try to push it up against the wall in another part, and then do that again in successive turns. Whereas with Symplicity Spyral, when you put the catheter in, it selfexpands to go up against the vessel and have those four simultaneous points. MDO: How did that design come to be? Weidman: It was just our engineers trying to come up with a better way to do the procedure and to take variation out of it. MDO: What kind of energy are you using? Weidman: There are other people that are trying to do renal denervation, and there are different modes of energy that can be used. We’re using RF energy, or radiofrequency energy. That’s the other Fluoropolymer tubing unique aspect. Some competition is using Image from NewAge Industries ultrasound. Other people are trying to use

"One of the reasons why we like RF is, as we viewed this from the beginning, we've done a lot of clinical work, and we're very comfortable with how that energy then disperses into the vessel and impacts the nerves." direct injection of chemical agents that could interrupt those nerves. MDO: What’s the advantage of RF? Weidman: One of the reasons why we like RF is, as we viewed this from the beginning, we’ve done a lot of clinical work, and we’re very comfortable with how that energy then disperses into the vessel and impacts the

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nerves. And through all not of the that’s the design, PVC may bework the best done, weFor areindustries able to selectively interrupt option. where high purity that activity of the to nerves likeapplications, we intend tubing is critical typical without really doing anyasother damage to other materials such silicones or TPEs the you wouldn’t are vessel more that typically seen. want to have. The other advantage of our RF system is that when you put that all into a catheter, it Silicone makes forisan design thatmaterial is incredibly Silicone anoverall extremely pure easy for the physician to maneuver and that processes into very flexible, soft to get tomaking where ititneeds to goto forkinking this tubing, less prone procedure, for instance, how than other regardless materials. of, It handles a wide tortuous anatomy is.–It’s a system range ofthe temperatures from as lowthat’s as very they would usesilicone in a -100similar °F up to what 500 °F – and many coronary so it’scompliances familiar to the productsstent meetsystem, regulatory physician do NSF this type procedure. related tothat thewill FDA, and of USP. Silicone is non-toxic, naturally translucent and MDO: the components made free ofAre substances of concern suchentirely as by Medtronic, are thereThe signifi cant BPA, latex and or phthalates. tubing pieces that come from contract is also odorless and tasteless and can manufacturers or other suppliers? withstand repeated sterilization. Certain Weidman: The final assembly and the formulations of silicone also perform very fiwell nal when manufacturing the devices is used in a of peristaltic pump. doneSilicone by Medtronic. almost every tubing isLike typically broken other Medtronic product, peroxide-cured we have into two main categories, countless suppliers and sub-suppliers silicone and platinum-cured silicone. of

Both are widely used in medical device applications and offer a high level of purity compared to other material types. However, peroxide-cured silicone does have low levels of benzylic acid as a Medtronic's Symplicity byproduct of its processing. If the highest Spyral device is a fourlevel of purity is required, platinum-cured electrode catheter for silicone is typically the best option. renal denervation.

Image courtesy of Medtronic

TPE Thermoplastic elastomer (TPE) tubing products are another good option if a high-purity, flexible tube is required. A unique advantage to TPE tubing is that it can be welded or sealed to itself using a heat sealer for use in sterile applications. Many versions of this material also meet USP Class VI standards as well as FDA and NSF requirements. Combining properties of plastic and rubber, phthalate-free polyurethane tubing offers more resistance to pressure and vacuum than corresponding sizes of PVC or rubber. It provides abrasion and tear resistance, high tensile and

different We’re not elongation valuescomponents. and virtually unlimited 100% Polyurethane vertically integrated. flexural abilities. offers good chemical resistance, and like silicone, its MDO: Why would a raw materials conform to FDA standards. patient choose RDN for Fluoropolymers hypertension? Weidman: Another set of tubing products Hypertension an historically used in the medicalisdevice enormousincluding problem industry is fluoropolymers, globally. a FEP, PFA and PTFE. These Over products billion live have a very high level ofpeople purity but hypertension, are not as flexiblewith or kink-resistant theother largest contributor compared with the materials to death. Yet despite discussed in this article. Fluoropolymer you’ve gotofless tubing products this, do have a set very thanincluding 20% of the global unique properties, extremely hypertension community high tensile strength and burst pressure, actually has their blood a wide rangethat of chemical resistance, under control. What and a highpressure spectrum of continuous we have today isn’t °F). operating temperatures (upjust to 500 enough, Choosing good the right tubingobviously, for an we’ve got such a low application can ifbe a daunting task, percentage people that as there are almost limitlessof options have their blood pressure available, but very few candidates will under control, tools meet all the requirements. Inthe order to

we have today aren’tsuitable cutting tubing it. We really determine the most believe RDN will provide solutionthat for an application, theanother best option and help fiyour ll thatneeds void. with a idea is to discuss The that two most ways of to treat supplier has a common wide breadth hypertension todayan areunderstanding lifestyle changes product offerings, of and drugs. and Andcompliance particularly when we look regulatory requirements, at pharmaceuticals, westaff know that they and a knowledgeable that can generally work in most patients, but the help recommend the most suitable issue people just don’tyour take individual them. A lot tubingis product to meet of studies out there look at compliance, application needs. or more specifically, noncompliance with the blood Alex Kakadpressure-lowering until recently wasmedication. a product And at a year, what you’ll see is only about manager at NewAge Industries 50% of patients Pa.). are partially compliant to (Southampton, their meds. So only half the people are fully taking their meds. Then you’ve got one-fifth of people that aren’t taking them at all. Even though the drugs work, people aren’t really taking them like they should be, and that’s why you have so few people at their target blood pressure. RDN provides this other option, and essentially you don’t have to worry about compliance. It’s a one-time procedure, there’s no implant, you go in, you do it

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TUBING TALKS

once, and it’s always on ... not something that is dependent on you constantly remembering to take the pill. Patients are really interested in having an option of a procedure to lower blood pressure. MDO: Why would someone not want to undergo renal denervation? Weidman: If someone is uncomfortable having a procedure, that’s why they wouldn’t want to go down the route. But I would say even though the trials are ongoing, we do have several trials completed and thousands of patient experiences in our clinical trials that are completed. The complications are less than 1%.

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MDO: Do you have updated timing on when you hope to secure approval? Weidman: We have four randomized, sham-controlled studies, three of which are complete and successful, showing safety and efﬁcacy. The last one of those studies is called the HTN-ON MED study, and we expect to have the data for that study available in the second half of next year. And then, we would submit for approval in the U.S. and China shortly thereafter. At that point, you’re kind of in the hands of the regulatory bodies, but for a brandnew-to-world therapy, FDA approval comes somewhere around a year after. I would hope it would be by the end of 2023.

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Superstorms, fires, droughts and other extreme events driven by climate change are already straining the industry’s supply chain — and it could get a lot worse.

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rifting wildﬁre smoke made for blazing sunrises and sunsets this summer in Minnesota, where electronics manufacturer Nortech has been replacing air handling equipment to ensure particle ﬁltration and the ability to operate in more extreme temperatures. “I had days where I jumped in the car, and I drove up to Bemidji and [the smoke] got steadily worse,” CEO Jay Miller said. “I'm thinking about not only small particles of particulate matter in very sensitive boards

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that we're manufacturing, I'm also thinking about my employees that have asthma. … I can put them in a good environment for eight hours a day, but how are they going to be the rest of the time? That’s worrisome.” Medical device companies are increasingly focusing on the risk climate change poses to their businesses, supply chains and the health and safety of their employees and patients. “All the major companies are building climate contingency plans and thinking about business

interruption,” said Brian Johnson, president of the Massachusetts Medical Device Industry Council (MassMEDIC). “The last five years have been an extraordinary wake-up call. … I have yet to see a region that is immune to impacts from climate.” For years before COVID-19, we’ve known that a global pandemic was a matter of when, not if. We face the same certainty on climate change. In fact, climate changerelated events on two separate continents are already partly to blame for the global semiconductor shortage.

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When frigid arctic air escaped the polar vortex in February and knocked the Texas state electric grid offline, chip fabrication plants in Austin operated by Samsung and NXP Semiconductors stopped production for weeks after the record cold snap. It’s not only extremely cold weather pressuring reliable electricity, but also heat waves, droughts, wildfires and increasingly powerful superstorms. As ocean temperatures rise, typhoons, hurricanes and cyclones are gaining strength and shifting their global patterns, meaning more precipitation for some regions and less for others. Droughts in Asia threaten to throttle the water-intensive process of semiconductor manufacturing. In Taiwan — the global leader, with the foundries at Taiwan Semiconductor Manufacturing Co. churning out more chips than anyone else in the world — the average number of typhoons making landfall has decreased in recent years, including a typhoon-free 2020. The drought not only depleted freshwater reservoirs that foundries rely upon, but also reduced hydropower generation as electricity demand spiked during a heat wave. On the other side of the Pacific, record-breaking heat killed hundreds of people across Western North America.

Healthcare Ready Executive Director Nicolette Louissaint Photo courtesy of Healthcare Ready

It was the hottest summer on record for the mainland U.S., according to the National Oceanic and Atmospheric Administration, eclipsing the 1936 Dust Bowl summer by 0.01ºF. ‘Grave implications’ Based in the Netherlands, a country with about one-third of its surface area below the rising global sea level, Philips recently offered incentives such as preferential payment terms for suppliers that set goals to reduce greenhouse gas emissions. In addition, the health technology company said it wants half of its supply purchasing by 2025 to come from firms that set science-based targets to help limit the catastrophic effects of global warming. “We are at a critical point of urgency where we need to accelerate the global transition to climate neutral, circular and resource-efficient economies and societies,” Philips CEO Frans van Houten said in an October announcement of its latest climate initiative. Medtronic didn’t use the word “climate” once in its 2020 annual report, though in previous years it warned investors that new climate regulations could increase energy costs and prices of raw materials. But in 2021, Medtronic’s annual report specifically flagged climate change as a real danger to its business.

Olympus Chief Strategy Officer and Head of Environmental, Social, and Governance Tetsuo Kobayashi Photo courtesy of Olympus

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”Climate change resulting from increased concentrations of carbon dioxide and other greenhouse gases in the atmosphere could present risks to our future operations from natural disasters and extreme weather conditions, such as hurricanes, tornadoes, earthquakes, wildfires or flooding,” Medtronic said in the filing. “Such extreme weather conditions could pose physical risks to our facilities and disrupt operation of our supply chain and may impact operational costs.” Medtronic soon followed up with plans to reward suppliers that help reduce greenhouse gas emissions throughout its supply chain, citing "the risks that climate change poses to human health and longterm global financial stability." It’s not just a hypothetical. In September 2017, Hurricane Maria killed thousands of people in Puerto Rice and took Medtronic's four manufacturing plants there offline for nearly two weeks at a cost of approximately $60 million. The following month, California wildfires forced Medtronic to evacuate buildings in Santa Rosa, where several of its cardiovascular operating units are headquartered. Johnson & Johnson’s climate change risk disclosures in its annual reports have shifted over the years. For example, it warned in 2010 of the “potential impact of climate change concerns on the

Nortech Systems CEO Jay Miller Photo courtesy of Nortech

SUPPLY CHAIN SHOCK

design, manufacturing, marketing and sale of health care products” and more recently highlighted extreme weather, natural disasters and water availability. Olympus identiﬁes climate change not only as a serious issue that threatens the global environment, but one that carries “grave implications for the group's business activities.” “The company is acutely aware of the damaging effects of climate change on natural ecosystems,” said Chief Strategy Ofﬁcer Tetsuo Kobayashi, who also leads environmental, social and governance initiatives.

One of her panelists, Mark Thorburn, BD’s North America supply chain VP, said the medtech company lost a North Carolina distribution center to a hurricane a few years ago and diverted orders to the Midwest and West Coast to keep product moving. “Be careful where you’re sole-sourced,” he said. “… Puerto Rico taught us a lot. If you get all your eggs in one basket, you can be in a bad situation, and when your product is the product they need to save

“I'm a biomedical engineer. I get it,” he said. “Designing the product is the fun part. Creating a redundant supply chain or ﬁxing bugs or problems like that, that's not fun. … [But] we've got everybody's attention now. We are getting a lot more engineers that are focused on supply chain, supply chain redundancies, design for manufacturability, design for supply chain. Everybody's got quite a bit of religion around that.”

"We are at a critical point of urgency where we need to accelerate the global transition to climate neutral, circular and resourceefficient economies and societies." The Japan-based company has analyzed physical risk to its factories from natural disasters such as typhoons and floods, created business continuation plans for each site, and forecast supply chain risks and operational disruptions based on different scenarios of global temperature increases. Preparing for climate change disruptions “We just went through Hurricane Ida and saw this storm make landfall in two regions, and we’re seeing significant devastation from natural disasters,” said Nicolette Louissaint, executive director of Healthcare Ready. “On the West Coast, we’ve got wildfires ... whether it’s a snowstorm in Texas or a Category 4 hurricane, there may be these disruptions [to not only supply] but also demand. We’re seeing more patients in greater need of healthcare with more acute needs with these extreme events.” She made the remarks while moderating a supply chain panel hosted by AdvaMed, discussing the kind of work Healthcare Ready does to promote resiliency and preparedness in the industry. “One of the biggest concerns we have is how do we keep our foot on the gas on preparedness even after the pandemic is over,” Louissaint said.

lives and advance healthcare, you’ve got to think about things differently.” These conversations start with supply chain managers, but the best results come from involving all parts of an organization as a normal part of business, said Jim Bourne, VP of global planning, sourcing and logistics at Edwards Lifesciences. “We in supply chain are usually best positioned to bring these scenarios forward to our leadership,” he said. “Sometimes, if we put it in the position of can we afford not to, it does allow us to paint the scenarios in a different light.” “And other times I’ve found if we challenge our regions — for example, we’ve done a look at all of our distribution sites around the world and if one were to go down, where would we service the other one from, so that we literally have a dashboard and go after it — sometimes by doing that and challenging our teams around the world to find different options … you find you can be more creative with those continuity plans than you might have otherwise thought,” Bourne said. Engineers at Nortech are on board, said Miller, whose company has five manufacturing facilities in Minnesota, one in Mexico and one in China, plus thousands of suppliers, each with their own suppliers. www.medicaldesignandoutsourcing.com

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How medtech fared in the first waves of the pandemic Medtech industry revenue, research spending and employment declined in the first year of the COVID-19 pandemic, according to a Medical Design & Outsourcing analysis of financial data.

DA N I E L LE K IR S H S E N I O R ED ITO R

otal sales, R&D spending and employment for the world’s largest medical device companies declined in 2020 and early 2021, according to a Medical Design & Outsourcing analysis tallying the ongoing pandemic’s initial toll on the industry. To compare performance before and during the pandemic, MDO used the financial data that we’ve historically gathered to rank our Big 100 companies in the last three years. The majority of these companies reported full-year results for 2020; others operate on a fiscal year and reported annual results in the first half of 2021. Some companies are not in this year’s Big 100 but were included in the analysis because they were ranked in pre-pandemic years. The handful of companies that joined this year’s Big 100 list are excluded from this analysis because they were not previously ranked. Aggregate revenue for approximately 100 of the largest companies in medtech

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dropped 1.2% in 2020 compared to 2019. Revenues for this group totaled nearly $415.3 billion in 2020. Medtech’s biggest companies made $420.3 billion and $374.4 billion in 2019 and 2018, respectively. Some soared, others survived Companies that increased their sales the most mainly were in diagnostics and imaging, but not exclusively. Two diabetes technology companies in the top 20 companies made signiﬁcant gains, with Dexcom reporting a 30.5% sales increase compared to 2019 and Insulet posting 22.5% sales growth in that same time. Companies that thrived and reported signiﬁcant sales increases during the pandemic include: Fisher & Paykel Healthcare, Dräger (medical division), Danaher (life sciences and diagnostics segments), Ambu, Masimo, Konica Minolta (healthcare segment), BioMerieux, Getinge, Cardiovascular Systems and ResMed.

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Orthopedic companies and other elective procedure device makers were at the middle to the end of the list. The Centers for Medicare and Medicaid Services (CMS) recommended postponing elective procedures to preserve personal protective equipment in March 2020. Analysts expected the move to affect companies specializing in devices for higher-acuity procedures, like cardiovascular devices. CMS relaxed the guidelines in June, stating that hospitals could resume procedures on a case-by-case basis while observing federal and state orders for keeping adequate facilities, workforce and PPE available for COVID patients. However, the Delta variant wave would

“Our recovery improved throughout the quarter, with most of our markets returning to near normal, pre-COVID growth rates,” he said, as he and other industry leaders detailed relief from the pandemic that would soon prove to be short-lived. Highs and lows Fisher & Paykel Healthcare had the most growth from 2019 to 2020 with 53.8% sales growth during the COVID-19 pandemic. The Auckland, New Zealand-based company had a sales growth of 12.3% from 2018 to 2019 before the pandemic. Fisher & Paykel

"In March 2020, when the impacts of the COVID-19 pandemic had gradually become apparent, we raised additional funding, having decided that securing funds would be our top priority, so we could ensure business continuity and continue to supply products to all our patients and healthcare professionals." soon dash hopes of a return to normal, as critical care for patients further delayed more routine procedures. Medtronic — the industry's top revenue earner — reported more than $30 billion in sales during its ﬁrst pandemic year and ranked at 31 for its revenue growth during the pandemic. The Fridley, Minnesota-based medtech giant had a 4.2% sales increase from 2019 to 2020 after sales shrank 5.4% between 2018 and 2019. Delivering prepared remarks in late May, Medtronic CEO Geoff Martha announced fourth-quarter results that showed “continued momentum” at the end of ﬁscal 2021.

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Healthcare makes devices for acute and chronic respiratory care, surgery and sleep apnea, including breathing circuits, chambers, masks, nasal cannula and more. "The unprecedented result was largely driven by the hospital product group. This includes products for invasive ventilation, noninvasive ventilation and surgery, as well as the hardware and consumables used to deliver Optiflow nasal high flow therapy," Fisher & Paykel Chair Scott St. John and CEO Lewis Gradon said in the company’s annual report for the year ended March 31, 2021. The largest sales decrease was at RTI Surgical, which reported a 67% drop after selling its OEM business to Montagu Private Equity and rebranding itself as Surgalign. At the end of 2020, the spine tech company said COVID-19 caused significant disruptions, and warned that patients may continue to avoid surgeries even after the pandemic subsides. www.medicaldesignandoutsourcing.com

Opportunity at Olympus Olympus Group’s medical business reported a drop in revenue of less than half a percentage point year-to-year for the two divisions of the medical business — endoscopic and therapeutic — that together accounted for 86% of total revenue for Tokyo-based Olympus. "In March 2020, when the impacts of the COVID-19 pandemic had gradually become apparent, we raised additional funding, having decided that securing funds would be our top priority, so we could ensure business continuity and continue to supply products to all our patients and healthcare professionals," Olympus Chief Financial Officer Chikashi Takeda said in the annual report. "At the same time, we conducted a review of the internal budget on a zero basis, and first worked to curb expenditures. When the market environment showed signs of recovery, we shifted to taking positive steps toward sustainable growth." The endoscopic and therapeutic divisions both posted double-digit gains in the fourth quarter, and Takeda said he expected that positive momentum to continue in fiscal 2022. "Looking back, I can see now that fiscal year 2021 was an opportunity to reaffirm our strengths and weaknesses," he said. R&D spend slides, payrolls shrink R&D spending also dipped in the early months of the COVID-19 pandemic. The companies in our analysis spent a little under 1% less on research efforts in 2020 than 2019, or $23.7 billion versus $23.9 million. Both figures are still far higher than the $17.2 million of R&D spending by the group in 2018. NovoCure claimed the biggest uptick in R&D spending, at 67.1% more in 2020 than 2019. It logged $132 million in R&D efforts in 2020, $79 million in 2019 and $50.6 million in 2018. Three companies — Nevro, Bio-Rad and Invacare — reported R&D reductions of approximately 23% year-over year, the sharpest decrease on the list. The companies in this analysis also employed 49,291 fewer people compared to 2019. The loss represents a 3.7% decrease in employment compared to 2019, when the top 100

MEDTECH IN THE PANDEMIC

companies that disclose headcounts together employed a combined 1,331,122 people. Dexcom and Insulet increased their workforces by 443.8% and 40.7% in 2020. Dexcom, which employed 3,826 people in 2019, hired more than 1,600 people in 2020 to bring its headcount to 5,500. Insulet grew its headcount from 1,350 people in 2019 to 1,900 in 2020.

With COVID-19 vaccinations approved for most Americans and the Delta variant wave on the decline, there is renewed optimism that business conditions will continue to normalize in the months ahead. MDO will continue to track these companies for further analysis in 2022 and beyond. Managing Editor Jim Hammerand contributed to this report.

"Looking back, I can see now that fiscal year 2021 was an opportunity to reaffirm our strengths and weaknesses."

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go Medtronic moves forward with its surgical robot

There's excitement at

Medtronic after the Hugo

SEAN WHOOLEY ASSOCI AT E EDI TOR

robotic surgery platform hit a major regulatory milestone.

Medtronic's Hugo robotassisted surgery system Photo courtesy of Medtronic

n 2012, Covidien formed an incubator called "Project Einstein," focusing on combining robotic technology, data and analytics. What could they create? Now, about nine years later, the product that emerged from Project Einstein made a significant step forward when the Hugo roboticassisted surgical system received CE mark approval in Europe.

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Plenty happened in between, with Medtronic buying Covidien in one of medtech's largest acquisitions and Project Einstein's work carrying on through as Hugo hit its biggest milestone in the regulatory process so far. Megan Rosengarten, who was part of Project Einstein and now serves as president of Medtronic's surgical robotics business, said the excitement brought on by European approval harkens back to the

early days of Hugo's development. "It goes back to that origin story of how we started this with Project Einstein," Rosengarten said in an interview in mid-October. "It's the idea and belief that robotic technology could bring quality minimally invasive care to more patients." Despite Europe being a highly developed continent, Rosengarten said only approximately 2% of surgical

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MEDTRONIC’S HUGO

procedures are performed robotically there as adoption of robot-assisted surgery remains in its early stages. Medtronic already has hospitals, surgeons, and customers partnering up with the company, helping Rosengarten and the team better understand the barriers to adoption in Europe and create solutions to overcome them. Rosengarten said there are "a lot of those important partnerships" lined up as there is a real hunger to be the first to use the system in Europe. "We look for places where there is an appetite and an ability to access technology with a pent-up need to improve patient care by driving more procedures to a minimally invasive approach," Rosengarten said. (Note: Medtronic officials reported some supply chain and manufacturing problems in late November but predicted that their 2022-23 fiscal year will be a strong year for Hugo.) Hugo itself is comprised of several components, starting with the surgeon console, from where the robot is driven. The system then has independent robotic arms individually mounted on carts, mainly used to hold the surgical instruments inserted into the patient's body. The robotic system's creators designed the wristed instruments to mimic the movement of the surgeon's hands at the console, holding the same degree of freedom that an actual human hand inside the body would as they perform surgical tasks while guided by the surgeon. Hugo's final component is the surgical tower, which Rosengarten likened to the brain or nervous system of the robot. It includes the visualization system and computing systems to analyze and provide data. Within the tower is Medtronic's Touch Surgery Enterprise technology, which is applicable for Hugo and for any laparoscopic or robot-assisted surgery from another vendor. A video management solution in its simplest form, Touch Surgery Enterprise automatically records surgical video. Then, it delivers it to the cloud, offering a way for surgeons to review specific steps while also being useful for training purposes. Current indications for Hugo include procedures in urology and gynecology, while the company will be looking at expanding those to at least general surgery,

thoracic surgery and bariatric surgery. "This system was designed for very broad use," Rosengarten said. Now that Hugo holds European approval, the next steps include entering what Rosengarten said is the most penetrated market for robotics — the U.S. Medtronic received FDA investigational device exemption (IDE) approval for Hugo earlier this year. The IDE clears the way for a U.S. clinical trial, with an initial focus on urological procedures. Medtronic has the tools to build upon European approval as it seeks to gain on Intuitive Surgical at the top of surgical robotics, BTIG analyst Ryan Zimmerman said in late October. "Intuitive is still the leader in the space," Zimmerman said. "It'll take time and effort for Medtronic to displace them, but given the size and scale of Medtronic as a global organization, we think that they're going to have the ability to make inroads in the robotics market, ﬁrst internationally and over time potentially in the U.S." While nobody can predict how long the U.S. regulatory process will take, Rosengarten said everyone can expect to continue seeing data for Hugo as Medtronic collects it from around the world through its global registry. By collecting patient data from around the world, Rosengarten said Medtronic can learn more about Hugo's performance. The company can also use the compiled

President of Medtronic’s surgical robotics business Megan Rosengarten data for subsequent regulatory submissions beyond urology and gynecology. "We'll continue with other indications between the neck, chest, abdomen and pelvis," Rosengarten said. "You'll hear more news in the U.S. and elsewhere as that progresses." While Intuitive remains the biggest player in surgical robotics, Medtronic also faces competition from Johnson & Johnson, Vicarious Surgical and more. Despite the fact that Medtronic may not take over at the top of surgical robotics if Hugo garners FDA clearance, there will deﬁnitely be a demand for it in the states, according to Zimmerman. "I wouldn't say the market will turn when Medtronic comes to the U.S.," Zimmerman said. "But, if and when Hugo gets to the U.S. market, it's something that hospitals, we think, will embrace."

Photo courtesy of Medtronic

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DEVICETALKS

Expect more from your medtech meetings The pandemic has changed how we live, how we work, and how the medical technology industry meets.

To m S a l e m i | D e v i c e Ta l k s E d i t o r i a l Director |

listen to Scott Gottlieb. I track his Tweets. I’m tearing through his book, “Uncontrolled Spread.” As a venture capitalist and former FDA commissioner, he checks all my boxes. He’s been a great guide on where we’ve been and where we’re going, so his recent projection that the pandemic could be over in the U.S. by the start of the new year has me rearing to go. Personally, I look forward to more movies and restaurant meals. Professionally, our DeviceTalks conferences in Boston, Minneapolis, and Santa Clara get a full green light. Let’s go! But meeting organizers need to acknowledge that post-pandemic meetings will be different. Why wouldn’t they be? You can read about the changes to our healthcare system in the pages of Medical Design & Outsourcing magazine, at MassDevice, and our other news sites. The pandemic has changed everything: •

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Connectivity is king. A recent survey by the Medtech Innovator and Deloitte estimates that nearly three quarters of new devices have a connectivity component.

11 • 2021

•

Remote care is essential. Companies like Proximie, Explorer Surgical and Avail Medsystems rose to connect surgeons with each other as well as their industry reps. Medical device companies are taking previously unimaginable steps to secure their supply chains.

The way we meet, network and inform will have to change too. And I’m beyond excited because events need a reboot. Long overdue For too long, conference organizers have relied upon a potent cocktail of FOMO and habit. Sure, organizers try to amp up content, introduce cool partnering apps, and a few gimmicks. (One recent healthcare meeting had puppies, actual puppies … gimmicky, but intriguing.) The pandemic-induced lockdown should force every thoughtful meeting organizer to look inward and ask, “What exactly makes our meeting indispensable?” We know our audience is asking themselves the same question. Larger medical device makers are wondering if they need to spend millions

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Images courtesy of Adobe Stock

to support clinical society meetings, especially if clinicians stay away in great numbers. It’s a legitimate question. These sponsoring companies still reported growth — even when allowing for the slowdown on elective surgery — and they did it without sending legions of salespeople to staff booths on exhibit ﬂoors. The game has changed. Going forward, conference organizers who ignore the world we built over the past two years failed to learn a valuable lesson: We can’t and shouldn’t go back. Meeting planners can’t count on habit, FOMO, or anything that kept people coming to their meetings in the past. Yes, people are weary of seeing each other only through Zoom screens, but they’re also much more careful about how they commit their time. Many medtech workers still want to work from home, at least part-time, because they’ve learned working inside an ofﬁce isn’t worth the time invested in a commute.

Company executives are struggling to find the right model, the mixture of in-office and remote contributions that keep the best employees happy, motivated and productive. Conference organizers must embrace the same struggle. We can’t just wheel out conferences that fit into a pre-pandemic world. If Scott Gottlieb is right (and I’m betting on him), conference organizers must build the advances of the past two years into their future programs. At DeviceTalks, that means: •

•

Even with our in-person meetings in play, we’re going to continue to provide our partners with opportunities to tell their stories through our DeviceTalks Tuesdays virtual meeting series. If we’re unable to hold our in-person meetings, we’ll ramp up DeviceTalks Tuesdays to ensure our sponsors have a stage.

•

We’ll continue to offer platforms to Medtronic, Intuitive Surgical, and medical device companies that see the value in creating podcasts that serve as a digital stage for their most innovative leaders. When crafting programs for our in-person meetings we’ll use our entire portfolio — podcasts, virtual meetings and professional development collaborations — to create on-point content that will ignite the innovative spirit in engineers, manufacturing professionals, regulatory/ reimbursement leaders and other essential players in our medical device industry.

So, I’m looking forward to watching our parts of the world continue to reopen, but we all know this world will never be the same. Our conferences can never be the same either.

For updates on speakers, agendas and more, go to DeviceTalks.com. If you have programming ideas, reach out to tsalemi@wtwhmedia.com.

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3,883

4,165

289

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11,247

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60.6%

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November 2021

Pat Curran, Senior Digital Media Manager

Interpower....................................................155 Isometric Micro Molding...............................32 John Evans’ Sons, Inc....................................82 KNF Neuberger...........................................110 LEMO USA, Inc............................................125 Master Bond.................................................107 maxon........................................cover/corner, 3 mdi Consultants, Inc......................................87 MedAcuity....................................................141 Medbio.........................................................129 Medi-Vantage..............................................148 MICRO..........................................................145 MicroLumen.........................................152, 153 Misumi............................................................42 MTD Micromolding.....................................121 Nelipak Healthcare Packaging...................133 New England Wire & Tubing......................151 Nordson MEDICAL........................................59 Okay Industries..............................................86 Orchid Orthopedics....................................139 Packworld.......................................................36 Parvalux..........................................................55 Penn United Technologies............................44 ProMed Molded Products............................65 PTI.................................................................160 Resonetics.................................................... IFC Smalley Steel Ring.........................................29 Solar Atmospheres Inc................................127 Solenoid Solutions.......................................149 Spectrum Plastics Group...............................90 Stock Drive Products/Sterling Instrument......63 Tegra Medical..............................................IBC Triangle Manufacturing Company, Inc.......163 Viant Medical.................................................48 VitalPath.........................................................50 Westfall-Technik...........................................124 Wuxi AppTec................................................106 YKK ...................................................................2

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Able Electropolishing....................................74 Accumold.......................................................38 AllMotion..........................................................6 Altech Corporation..................................26, 27 Argon Medical Devices...............................147 Asahi Intecc..................................................137 Avail Medsystems Inc....................................57 B. Braun.........................................................BC Bay Associates Wire Technology, Inc.........103 Biocoat...........................................................80 Bird Precision.................................................97 BMP Medical................................................115 Bodine Electric Company.............................40 Cadence.........................................................93 Carclo Technical Plastics...............................61 Catalyst UX...................................................142 Celanese.........................................................34 Celestica.......................................................143 CHEMRES.......................................................76 Cirtec Medical................................................46 Clippard..........................................................25 Components Corporation............................96 CPC Worldwide.............................................71 Cretex Medical...............................................53 Eagle Stainless Tube......................................77 ElectroCraft..................................................100 Emerson.......................................................140 Eurofins Medical Device Testing..................67 FAULHABER MICROMO...............................69 Freudenberg Medical..................................135 FUTEK Advanced Sensor Technology, Inc........1 Galt-Needletech..........................................131 Hobson & Motzer............................................5 ICON.............................................................123 ICS.................................................................132 Instron...........................................................104 Integer..........................................................111 International Polymer Engineering............154

10,189

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