Medical Design & Outsourcing – SEPTEMBER 2023

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Medical Design

EDITORIAL

EDITORIAL STAFF

TUESDAYS

DIGITAL MARKETING

WEB DEV/DIGITAL OPERATIONS

DeviceTalks Tuesdays is a weekly virtual event that brings the insights and energy of our in-person events to your desktop.

Each DeviceTalks Tuesday will kick off with a quick briefing from the editors of MassDevice and Medical Design and Outsourcing. These presentations will give attendees insights on what trends will be moving medtech in the days to come.

Be sure to check back frequently as new live events continue to be added.

Executive Editor Chris Newmarker cnewmarker@wtwhmedia.com @newmarker

Managing Editor Jim Hammerand jhammerand@wtwhmedia.com

Senior Editor Danielle Kirsh dkirsh@wtwhmedia.com

Pharma Editor Brian Buntz bbuntz@wtwhmedia.com

Associate Editor Sean Whooley swhooley@wtwhmedia.com @SeanWhooleyWTWH

Editorial DirectorDeviceTalks Tom Salemi tsalemi@wtwhmedia.com

Managing EditorDeviceTalks Kayleen Brown kbrown@wtwhmedia.com

Senior Vice President Courtney Nagle cseel@wtwhmedia.com 440.523.1685

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AUDIENCE DEVELOPMENT Director, Audience Development Bruce Sprague bsprague@wtwhmedia.com

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A mixed year for the Medtech Big 100 — and an opportunity to show we care

The results are in from our annual Medtech Big 100 ranking of the largest medical device companies, and while total sales and R&D spending are up, it doesn’t feel right to celebrate.

That’s because our analysis shows a 5% decline in employment across the industry. This is no surprise to anyone who is active on LinkedIn, given this year’s headlines about layoffs and posts from friends and co-workers seeking new opportunities.

It’s not the first time that’s happened. Last year’s analysis captured job cuts due to the COVID-19 pandemic that delayed procedures, snapped supply chains and sickened or killed millions of patients, healthcare providers and medical device employees globally.

But our latest tally shows aggregate employment for the 100 largest medical device companies is at its lowest level since our prepandemic analysis in 2019, which included employment counts from late 2018 and early 2019.

Some of this is likely due to the number of spinoffs in recent years as business units go independent and take up their own spot on the Big 100 for the first time, leaving their parent company with a smaller workforce. There could also be some job loss due to role redundancy from mergers, and other factors like automation and outsourcing allow device developers and manufacturers to do the same work with fewer employees on their payroll.

Jim Hammerand | Managing Editor | Medical Design & Outsourcing | jhammerand@wtwhmedia.com

Whatever the reason, let’s keep the champagne on ice for another occasion. Maybe you’ll celebrate a former colleague’s new job after you’ve provided them with a referral or reference. Or perhaps we’ll raise a glass the next time we meet and pledge to be there for friends in need. Our industry is built on relationships, and this is an opportunity to get in touch and show each other how much we care.

Go deeper into our Big 100 analysis with reporting from Senior Editor Danielle Kirsh not only on the list’s big movers and shakers, but an analysis of medtech compensation for CEOs and median workers as disclosed under relatively new securities regulations.

On top of that, Executive Editor Chris Newmarker has ranked the world’s largest orthopedic companies and offers a preview of the growth they expect in the months ahead, while Pharma Editor Brian Buntz offers a taste of his Pharma 50 ranking.

Two of our articles this month focus on Medtronic, the longtime No. 1 company on the Medtech Big 100. In Product Development, we explore the design defect that’s likely to blame for the company’s massive defibrillator recall. Later, in our Regulatory department, we dive deep into the Medtronic conflict minerals program that investigates red-flag suppliers.

Other coverage this month includes a conversation with Vicarious Surgical’s new operations chief about its robotics technology, along with a roundup of digital health startups that might just one day join the Medtech Big 100 whether through organic growth or acquisition.

And on the cover is Mike Mahoney — CEO of Medtech Big 100 No. 12 Boston Scientific — who offers perspective from the helm of a device manufacturer that’s growing and innovating. We interviewed him at DeviceTalks Boston in May, and if you missed out, make sure you get to DeviceTalks West in Santa Clara, California this Oct. 18–19. It’s a unique opportunity to build relationships that you can count on when the going gets tough — and a great chance to toast the innovators, risktakers and reliable partners that help us advance medtech’s mission.

As always, I hope you enjoy this edition of Medical Design & Outsourcing — and thanks for reading.

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DEPARTMENTS

HERE’S WHAT WE SEE: A mixed year for the Medtech Big 100 — and an opportunity to show we care

ORTHOPEDICS: The 10 largest orthopedic device companies in the world

PHARMA:

2023 Pharma 50: The largest pharma companies in the world

PRODUCT DESIGN: Too risky to replace: The design flaw that likely caused Medtronic’s massive ICD and CRT-D recall

PRODUCT DEVELOPMENT: How LivaNova developed a next-generation perfusion system

REGULATORY:

How Medtronic’s conflict minerals program investigates red flag suppliers

ROBOTICS: These surgical robotics arms are destined for the trash — by design

TUBING: Four gastroenterology device innovations doctors need now

MEDTECH BIG 100: THE LARGEST MEDICAL DEVICE COMPANIES IN THE WORLD

Our latest list ranks the giants of medtech manufacturing by annual revenue, R&D spending and employee headcount.

BIG 100 BREAKDOWN RANKED BY REVENUE

JUST MISSED THE LIST BIG 100 ANALYSIS R&D SPENDING RANKINGS RANKED BY EMPLOYMENT HEADQUARTERS LOCATIONS

HOW DOES MEDTECH CEO COMPENSATION STACK UP TO THE RANK AND FILE?

Major medical device companies are now disclosing how much their median employees make — and comparing it to CEO pay.

5 KEYS TO MIKE MAHONEY AND BOSTON SCIENTIFIC’S SUCCESS

Boston Scientific’s market capitalization has grown nearly 10 times larger since Mike Mahoney joined as CEO in 2011. He shared key insights about corporate strategy at DeviceTalks Boston in May.

DIGITAL HEALTH STARTUPS YOU NEED TO WATCH

Keep an eye on these startups as Big 100 medtech firms race to build — or buy — digital technology.

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Medtech Big 100: The world's largest medical device companies

Each year, Medical Design and Outsourcing collects thousands of data points to rank and analyze the largest medical device companies in the world, including publicly traded companies and privately held firms.

The Medtech Big 100 includes annual revenue, R&D spending, headcount, CEOs and key leaders, headquarters locations and descriptions of each company.

Typically, we gather the data from regulatory disclosures filed with the U.S. Securities and Exchange Commission. Some companies, such as privately held firms, share data directly with us.

A majority of these companies operate on a standard calendar year, but some have fiscal years for which we’ve collected data as recently as April 2023.

We used fiscal 2022 data for companies with fiscal years that end in June or September such as Accuray, Asahi Intecc, BD, Cardinal Health, Carl

Zeiss Meditec, Cochlear, Electromed, Embecta, Hologic, ResMed and Siemens Healthineers because their annual reports don’t come out before production time. Also note that companies that report their financial results in foreign currency have been converted to U.S. dollars using standardized Federal Reserve rates for the revenue ranking.

Medtech Big 100 movers and shakers

While the industry awaits the upcoming spinoffs of 3M Health Care and Baxter’s Vantive kidney care unit, completed spinoffs like Embecta , GE HealthCare and ZimVie have made their way into the 2023 Medtech Big 100. Last year, Zimmer Biomet’s dental and spine spinoff ZimVie was among the largest companies at No. 69. Some medtech applications perform better than others each year, and oftentimes that can be apparent in how companies rank among the 100 year-over-

year (see our Medtech Big 100 analysis for more). Notable changes this year include ICU Medical, which moved 10 spots up the list versus last year after its merger with Smiths Medical. Haemonetics also rose nine spots, having grown revenue by 17%. Most notably, Shockwave Medical, which is highlighted in our annual analysis, jumped 11 spots up the list. Inspire Medical, which didn’t make the list last year, is now at No. 94 as sales grow for its implantable sleep apnea devices. However, as the effects of the COVID-19 pandemic on medtech settle, some companies have fallen to lower spots in the Medtech Big 100. Dräger’s medical division, which makes ventilators and other medical supplies, dropped nine spots. Fisher & Paykel Healthcare, which also develops respiratory care devices, dropped 10 spots down the list.

– Senior Editor Danielle Kirsh

COMPANIES RANKED BY REVENUE

(continued from page 12)

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COMPANIES RANKED BY REVENUE

Medtronic

Dublin, Ireland (operational HQ in Fridley, Minnesota) United States

$31,227,000,000*

*Fiscal year ended 4/29/2023

2022 rank: 1

R&D spend: $2,696,000,000

Employees: 95,000

Company CEO: Geoff Martha

MEDTRONIC has had its share of setbacks over the past year, but the world’s largest medical device company has also made moves that could set it up to make a difference in the treatment of chronic health conditions such as atrial fibrillation. Fiscal 2023 revenue was down 1.4% compared to the previous year. Analysts are taking a wait-and-see approach to Medtronic’s performance in fiscal 2024. Even as it spins off some businesses and engages in significant cost reductions, including layoffs, Medtronic is now spending more annually than before the pandemic on R&D. It’s also engaging in tuck-in acquisitions to gain new, innovative tech. For example, it doubled down on its commitment to boost its diabetes business by announcing plans in May to spend $738 million to buy EOFlow and its tubeless, wearable and fully disposable insulin delivery

device. Medtronic officials also predict they’ll be one of the first companies to the U.S. market with a pulsed-field ablation catheter — a technology that has generated excitement in the cardiology space when it comes to treating atrial fibrillation (AFib). In addition, the company has reported positive momentum in rolling out its Hugo robotic surgery system internationally. Medtronic’s next big opportunity seemed to be its renal denervation (RDN) technology for treating hypertension. RDN could be a billiondollar business for Medtronic after two failed trials in the past decade, but an unfavorable FDA review panel vote in August left Medtronic less likely to win FDA approval. Meanwhile, Medtronic is facing yet another challenge: a major recall of ICDs and CRT-Ds. –CN

www.medtronic.com

Johnson & Johnson MedTech

New Brunswick, New Jersey United States

$27,400,000,000*

*Fiscal year ended 1/3/2023

2022 rank: 2

R&D spend: $2,488,000,000

Employees: Not available

Company CEO: Joaquin Duato, CEO; Ashley McEvoy, EVP and J&J MedTech worldwide chair

JOHNSON & JOHNSON will have a new focus on medtech and pharmaceuticals now that it’s spinning off its consumer business as a new public company called Kenvue. In December, J&J boosted the profile of J&J MedTech inside the company through its $16.6 billion acquisition of Abiomed and its Impella heart pump portfolio for treating coronary artery disease and heart failure. Meanwhile, EVP and MedTech worldwide chair Ashley McEvoy joined the ranks of J&J’s top-paid executives and started a two-year term as chair of the trade group AdvaMed. Another bright spot is Biosense Webster, which has a new president, Jasmina Brooks. Biosense Webster launched an atrial fibrillation (AFib) mapping catheter called Optrell with TrueRef technology, and

is also moving forward with its investigational Thermocool SmartTouch SF dual energy catheter for treating AFib. The system enables doctors performing an ablation to toggle between two types of energy: pulsed-field and radiofrequency. It appears to be Johnson & Johnson MedTech’s answer to Affera, which competitor Medtronic acquired for $1 billion last year. As for the DePuy Synthes ortho device business, it has a new major partnership with GE HealthCare in the spine surgery space. On the flip side, the company remains mostly quiet about its Ottava surgical robotics system, with surgical robotics among the areas where J&J MedTech cut jobs earlier this year. –CN

www.jnjmedtech.com

Siemens Healthineers Erlangen

$22,799,700,000*

*Fiscal year ended 9/30/2022

(€ 21,714,000,000)

2022 rank: 3 R&D spend: $1,874,250,000

Employees: 69,500

Company CEO: Bernd Montag

SIEMENS HEALTHINEERS management has pared back some businesses as they seek to continue revenue growth in the present economic environment. The German medtech giant scaled back its robotic surgery ambitions, announcing in May that it plans to discontinue the use of its Corindus surgical robotics for cardiology procedures. Siemens Healthineers spent $1.1 billion on Corindus in 2019. In addition, Siemens Healthineers is streamlining its diagnostics business. In November 2022, it announced plans to halve the number of diagnostic platforms it offers in coming years as it seeks to overcome supply chain and other external challenges. CEO Bernd Montag said

during a recent earnings call that he was excited about diagnostics after FDA clearance of the Atellica CI Analyzer, which he called a missing puzzle piece to complete what he described as the youngest platform on the market. He said savings from diagnostics portfolio simplification are kicking in. Meanwhile, Siemens Healthineers is working through some temporary logistics challenges at Varian Medical Systems. Spun out of Siemens to become its own publicly traded company in 2018, Siemens Healthineers became even larger after closing its $16.4 billion acquisition of Varian in 2021. –CN

www.siemens-healthineers.com

Medline Industries Northfield, Illinois United States

$21,200,000,000*

*Fiscal year ended 12/31/2022

2022 rank: 5 R&D spend: Not available Employees: 35,000

Company CEO: Charlie Mills (until Oct. 1, 2023); Jim Boyle, incoming CEO

MEDLINE sales were up roughly 5% year-overyear to $21.2 billion in 2022, enabling the privately held medtech giant to move up one spot in the MedTech Big 100 rankings. Medline announced in June that it is promoting from within to fill CEO and president positions. Jim Boyle is taking over the corner office at Medline, effective Oct. 1. Boyle has been at Medline since 1996 and served as EVP since 2018, managing the company’s customer base of over 5,000 healthcare providers. Meanwhile, Jim Pigott will become president and chief operating officer. After more than 26 years of leadership, CEO Charlie Mills, President

Andy Mills and COO Jim Abrams will retire from their current positions. They’ll continue to play important roles in the company, however, with Charlie Mills as board chair and Andy Mills and Abrams as vice chairs. Blackstone, Carlyle and Hellman & Friedman made a multibillion-dollar investment in Medline in 2021, with the Mills family remaining the largest single shareholder. The company used the investment to fund new distribution centers, manufacturing capabilities and IT upgrades. –CN

www.medline.com

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Royal Philips Amsterdam Netherlands

$18,718,350,000*

*Fiscal year ended 12/31/2022 (€ 17,827,000,000)

2022 rank: 4 R&D spend: $2,208,150,000

Employees: 77,233

Company CEO: Roy Jakobs

The all-consuming story for PHILIPS over the past year remains its massive recall involving millions of CPAPs, ventilators and other respiratory devices. The recall has removed the Dutch medtech giant from the respiratory devices market for the past two years. Reports of problems continue. The devices — used for sleep apnea therapy and more — had sound abatement foam that could potentially degrade and get into the airways. FDA presently has more than 100,000 reports of problems — including 384 mentioning deaths. Philips CEO Roy Jakobs has said the Dutch medtech giant is deeply sorry about the recall. Philips remains in the midst of

consent decree talks with the U.S. Department of Justice and the FDA. Meanwhile, Philips continues to engage in major belt-tightening. It cut at least 6,600 jobs in 2023 and planned a total of 10,000 cuts by 2025. The company announced in July that it is raising its full-year 2023 outlook to mid-single-digit comparable sales growth. Said Jakobs: “I’m very confident that our innovation portfolio is well-positioned to help hospitals worldwide address their staffing shortages, enhance productivity and improve patient and staff experience.” –CN

www.philips.com

Stryker

Kalamazoo, Michigan

United States

$18,449,000,000*

*Fiscal year ended 12/31/2022

2022 rank: 7

R&D spend: $1,454,000,000

Employees: 51,000

Company CEO: Kevin Lobo

STRYKER is proving itself to be a leader in medtech’s transition to digital healthcare. It’s little wonder, then, that the ortho device giant moved up a spot to No. 6 in this year’s Medtech Big 100. Stryker’s popular Mako robotic surgery systems are more than just a robot when it comes to knee and hip surgeries. They also offer preoperative data modeling and planning, plus software and displays that assist the surgeon with navigation during the surgery. On top of that, Stryker is tapping health data and artificial intelligence (AI) to improve surgical robotics outcomes. The idea is that data collection and analysis can help surgeons personalize procedures for individual patients to

improve outcomes. Stryker plans to expand the reach of Mako even more next year with new spine and shoulder applications. “There are no robots in total shoulders right now. When that gets released, that runway is so large. There are so many different things we could do in shoulders with the existing Mako platform,” Robert Cohen, president of Digital, Robotics and Enabling Technologies at Stryker, told MDO in January. In light of Street-beating Q2 results, Stryker has raised its full-year 2023 outlook, predicting net sales growth within the 9.5% to 10.5% range. –CN

www.stryker.com

GE HealthCare Chicago, Illinois United States

$18,341,000,000*

*Fiscal year ended 12/31/2022

2022 rank: 6 R&D spend: $1,026,000,000

Employees: 50,000

Company CEO: Peter Arduini

During its first six months as a stand-alone company, GE HEALTHCARE’S revenue grew nearly 8% year-over-year. The Chicago-based medtech giant’s second quarter was strong enough that it upped its full-year guidance to 6-8% revenue growth. Imaging, patient care solutions and pharmaceutical diagnostics served as significant growth drivers in Q2. GE HealthCare has been has been on a tear when it comes to forging partnerships to boost its business. In June, it announced that it would work with Johnson & Johnson’s DePuy Synthes in the spine space, pairing its OEC 3D Imaging

System with the J&J unit’s extensive product portfolio. In March, GE HealthCare announced a long-term joint venture with Sinopharm as it seeks to make additional inroads in China’s medical device market. It’s also inked a 10-year medical device maintenance deal with Advantus Health Partners worth $760 million. Other top news this year included the acquisition of Caption Health and its AI-powered image guidance tech. The FDA also cleared its Carescape Canvas patient monitoring platform. –CN

www.gehealthcare.com

Cardinal Health

Dublin, Ohio United States

$15,887,000,000*

*Fiscal year ended 6/30/2022

2022 rank: 8

(Note: We’ve used the same figures as our 2022 Big 100 ranking because more recent figures were not available in time for our analysis.)

R&D spend: Not available

Employees: Not available

Company CEO: Jason Hollar, CEO; Steve Mason, medical segment CEO

One of the most significant medical device stories out of CARDINAL HEALTH over the past 12 months involved the launch of a pilot supply chain network to enable hospital-level healthcare in people’s homes. The Dublin, Ohio–based medical device and pharmaceuticals supplier announced in November 2022 that it was kicking off the Velocare supply chain network and lastmile fulfillment service through a strategic partnership with Boston-based Medically Home. (Cardinal Health is an investor in Medically Home.) Since the launch, Cardinal Health at-Home Solutions has grown the offering to support several hospital-at-home programs around the country. Velocare is creating critical infrastructure and scalability to make hospital-at-home programs work

and grow. It offers a wide range of needed medical products and supplies, oxygen or medical gas, technology, and medically approved meals. It also goes into patients’ homes to perform services, such as providing and installing technology and collecting and disposing medical waste. The goal is to enable safe and consistent hospital-level care in the home. Overall, Cardinal Health continues to work on turning around its medical segment, which as of early August had seen declining revenue and profits this year. CEO Jason Hollar said in May: “In medical, we continue to see improvement in underlying performance and remain confident in our Medical Improvement Plan initiatives.” –CN

www.cardinalhealth.com

Baxter Deerfield, Illinois United States

$15,113,000,000*

*Fiscal year ended 12/31/2022

2022 rank: 10 R&D spend: $605,000,000 Employees: 60,000

Company CEO: José Almeida

Count BAXTER among the major medical device companies seeking to refocus through divestitures. In January, Baxter announced plans to spin its renal care and acute therapies units into an independent, publicly traded company. Baxter expects the new, independent, publicly-traded company — called Vantive — to launch by July 2024. Meanwhile, there is uncertain timing around the sale of Baxter’s biopharma solutions (BPS)

business. Baxter recently said it plans for the BPS sale to complete toward the end of the third quarter. Said Baxter CEO José (Joe) Almeida: “These initiatives are focused on enhancing strategic clarity, increasing market responsiveness and accelerating innovation, in an effort to drive greater value for our stakeholders.” –CN

www.baxter.com

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Abbott

(medical device segment)

Abbott Park, Illinois

United States

$14,687,000,000*

*Fiscal year ended 12/31/2022

2022 rank: 9

R&D spend: Not available

Employees: Not available

Company CEO: Robert Ford, chair and CEO; Lisa Earnhardt, medical devices EVP

ABBOTT has now had two straight quarters of double-digit organic sales growth in its underlying business. Even as COVID-19 test sales continue to decline and hammer overall revenue, Abbott officials are betting on a productive, innovative pipeline to build momentum — especially in its medical device business. Its FreeStyle Libre continuous glucose monitors (CGMs) are one of the most important growth drivers. The addressable market for the sensor keeps increasing, with massive coverage expansions all around the globe. Medicare’s coverage update kicked in this past spring. The FDA cleared Abbott’s next-generation FreeStyle Libre 3 last year. Abbott plans for a 15-day sensor launch in the U.S. in the second half of this year, as well as integration into Tandem Diabetes Care’s insulin pumps. Abbott’s other recent

medical device wins include receiving FDA approval of its TactiFlex Ablation Catheter, Sensor Enabled. The company describes it as the world’s first ablation catheter with a unique flexible electrode tip and contact force sensing technology to treat patients with atrial fibrillation. Abbott aims to increase the safety and efficacy of radiofrequency ablation tech to treat atrial fibrillation (AFib). In July, Abbott announced FDA approval of its Aveir dual-chamber leadless pacemaker system. The company says it’s another first — a dual-chamber leadless pacing system that treats people with abnormal heart rhythms. Earlier this year, Abbott completed its $890 million acquisition of atherectomy technology developer Cardiovascular Systems. –CN

www.abbott.com

BD

(medical and interventional segments)

Franklin Lakes, New Jersey United States

$13,305,000,000*

*Fiscal year ended 9/30/2022

2022 rank: 14

(Note: This year’s analysis added BD’s interventional sales.)

R&D spend: Not available

Employees: Not available

Company CEO: Tom Polen, chair, CEO and president; Mike Garrison, EVP and medical segment president; Richard Byrd, EVP and interventional segment president

Boston Scientific

Marlborough, Massachusetts United States

$12,682,000,000*

*Fiscal year ended 12/31/2022

2022 rank: 12

R&D spend: $1,323,000,000

Employees: 45,000

Company CEO: Michael Mahoney

Henry Schein

Melville, New York United States

$12,647,000,000*

*Fiscal year ended 12/31/2022

2022 rank: 11

R&D spend: Not available

Employees: 22,000

Company CEO: Stanley Bergman

BECTON, DICKINSON & Co.’s medical and interventional segments played an important role in BD’s Street-beating results for its quarter ended June 30, 2023. Medical sales grew by 11.1% year-over-year in the quarter, and interventional increased 6.7%. The growth in the medical segment largely stemmed from robust performance in areas such as medication management and pharmaceutical solutions. Meanwhile, advances in the interventional segment were due to improvements in surgery and peripheral intervention, as well as urology and critical care. BD also recently achieved what CEO Tom Polen said was its No. 1 priority: FDA clearance of updated BD Alaris infusion systems. The clearance ended a hold on shipments of new Alaris systems that had been in place since a Class I recall in 2020. Other recent BD news included the sale of its surgical instrumentation assets to Steris for $540 million and expanded availability of its PosiFlush SafeScrub syringe with an integrated disinfection unit. (Note that we've added BD’s interventional segment to this year's ranking. The medical segment alone was No. 14 last year with nearly $9.5 billion in revenue.) –CN

www.bd.com

Amid unpredictable economic times, BOSTON SCIENTIFIC has stood out as one of the positive stories in the medical device industry. Its sales grew 6.7% to $12.7 billion in 2022, and CEO Mike Mahoney and other top company officials expect it to grow another 10.5–11.5% this year. He said at our DeviceTaks Boston event in May that he sees the company continuing to expand into more interventional procedures where patients receive sameday treatments and go home. “What we try to do is disrupt general surgery,” he said. To get there, Boston Scientific is hiring, and it plans a $170 million expansion in Minnesota. It also continues to make acquisitions to pick up innovative technologies. One of the latest was its $615 million purchase of Apollo Endosurgery and its devices, used during endoluminal surgery (ELS) procedures to close gastrointestinal defects, manage gastrointestinal complications and aid in weight loss. Boston Scientific also continues to benefit from its nearly $300 million acquisition in 2021 of Farapulse and its pulsed-field ablation technology for treating atrial fibrillation (AFib). The system is already available in Europe, where demand is strong, and positive data continues to roll in as Boston Scientific plans to seek FDA approval. –CN www.bostonscientific.com

HENRY SCHEIN is a major distributor of healthcare products and services, with a presence in 32 countries and 3.8 million square feet of distribution and manufacturing space globally. It boasts a selection of more than 300,000 branded products and Henry Schein corporate brand products sold to more than 1 million dental practices, laboratories, physician practices, ambulatory surgery centers, and more, according to its most recent annual report. Recently, it announced it would acquire a majority stake in homecare medical products supplier Shield Healthcare. Henry Schein officials see the move as bolstering the company’s commitment to facilitating a continuum-of-care delivery model. The company is also seeking to support more telehealth, collaborating with Medpod to develop Medpac — a lightweight, portable telediagnostic offering. The companies say Medpac bridges the gap between remote telemedicine consultations and in-person office visits. –CN

www.henryschein.com

Owens & Minor

Mechanicsville, Virginia United States

$9,955,475,000*

*Fiscal year ended 12/31/2022

2022 rank: 13

R&D spend: Not available

Employees: 20,000

Company CEO: Edward Pesicka

OWENS & MINOR accompanied mixed Q4 results in February with an announcement that it would engage in a corporate realignment. At the time, Owens & Minor said the realignment would include sourcing and demand management, organization structure redesign, network rationalization and operational excellence, and commercial excellence and product profitability enhancement. There was no mention of potential job cuts associated with the restructuring, but a mass layoff notice filed with the Massachusetts state government showed 61 employees let go at a distribution center in Franklin. While recently detailing Q2 results, CEO Edward Pesicka said the company has already started to see financial benefits from the restructuring. Founded in 1882, Owens & Minor provides product manufacturing, distribution support and technology services in roughly 70 countries, according to its most recent annual report. –CN www.owens-minor.com

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B. Braun Melsungen

Melsungen, Germany

(U.S. HQ in Bethlehem, Pennsylvania) United States

$8,924,895,000*

*Fiscal year ended 12/31/2022

(€ 8,499,900,000)

2022 rank: 15

R&D spend: $568,260,000

Employees: 65,000

Company CEO: Anna Maria Braun, CEO; Jean-Claude Dubacher, U.S. CEO

Alcon $8,717,000,000*

*Fiscal year ended 12/31/2022

2022 rank: 17

R&D spend: $702,000,000

Employees: 25,178

Company CEO: David Endicott

No. 17

With employees in 64 countries, B. BRAUN MELSUNGEN manufactures over 5,000 medical devices and pharmaceutical products, which it supplements with an extensive range of services. According to the German company’s most recent annual report, the offerings include digital components that improve customers’ processes, increase safety and ease the burden on medical professionals. B. Braun products and services cover 15 therapeutic areas and applications grouped into three divisions: Hospital Care, Aesculap (surgical and interventional), and Avitum (chronic disease treatments). Multiple generations of the Braun family have owned the company since its founding in the 19th century, with Anna Maria Braun presently serving as CEO. In the company’s most recent annual report, she described the company’s Spaceplus infusion pump system, which can be connected to hospital data management systems. There’s also the Aesculap Aeos robot-assisted surgical microscope for the operating room. Said Braun: “New technologies offer possibilities for treating people around the world using the highest medical standards, while also ensuring the affordability of health care through greater efficiency.” –CN

www.bbraun.com

Formerly a subsidiary of pharmaceutical giant Novartis, ALCON spun out as a separate eye care business in 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 remain in Fort Worth, with global operations run out of its Geneva, Switzerland headquarters. As of the writing of this description in early August, the company said it expects revenue to grow 7–9% on a constant currency basis this year. In January, Alcon introduced its Total30 reusable contact lens for people with astigmatism. Total30 is made of a proprietary water gradient material that enables a gradual increase to nearly 100% water on the outermost surface. –CN and SW

www.alcon.com

3M Co. $8,421,000,000*

(healthcare segment)

Maplewood, Minnesota United States

*Fiscal year ended 12/31/2022

2022 rank: 16

R&D spend: Not available

Employees: Not available

Company CEO: Bryan Hanson (effective Sept. 1, 2023)

3M officials say they remain on track to spin off the company’s healthcare business by late 2023 or early 2024. “We’ve made good progress … including regulatory filings and system updates in preparation for a soft spin [in November],” 3M CEO Mike Roman told analysts during the manufacturing giant’s Q2 earnings call in July. In August, 3M hired Zimmer Biomet CEO Bryan Hanson to lead the healthcare spinoff as CEO. The healthcare business will stay headquartered in Minnesota during the transition period, but 3M told the Star Tribune of Minneapolis in April that the new company’s management will decide on a headquarters location in the future. –CN

www.3m.com/healthcare

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No. 18

Fujifilm Holdings

Tokyo Japan

$6,982,410,472*

*Fiscal year ended 3/31/2023

(JP¥917,900,000,000)

2022 rank: 18

R&D spend: $371,218,685

Employees: Not available

Company CEO: Teiichi Goto

No. 19

Zimmer Biomet

Warsaw, Indiana United States

$6,939,900,000*

*Fiscal year ended 12/31/2022

2022 rank: 19

R&D spend: $406,000,000

Employees: 18,000

Company CEO: Ivan Tornos

No.

Olympus $6,618,266,241*

(healthcare only)

(medical business)

*Fiscal year ended 3/31/2023

(JP¥870,030,000,000)

2022 rank: 20

R&D spend: $509,649,784

Employees: 22,756

Company CEO: Stefan Kaufmann, president and CEO; Gabriela Kaynor, therapeutic solutions global division head; Frank Drewalowski, endoscopic solutions global division head; Richard Reynolds, president, Medical Systems Group, Olympus Corporation of the Americas

www.fujifilm.com/us/en/healthcare

ZIMMER BIOMET is pushing innovation and better execution as elective procedures at health providers recover from the pandemic and younger people opt for orthopedic procedures. During ZB’s Q2 2023 earnings call, former CEO Bryan Hanson (who’s joining 3M’s healthcare spinoff as CEO) noted that Zimmer Biomet has 40 planned product launches between this year and the end of 2025, the majority in 4%-plus growth markets. For example, ZB officials said they plan a full market release of their Persona IQ smart knee implant by Q1 2024, and they still expect to be first-to-market with a robotic shoulder surgery application with their Rosa platform. Zimmer Biomet continues to enhance its ZBEdge Dynamic Intelligence platform for hip and knee surgeries. In March, it announced a definitive agreement to acquire Ossis, a maker of personalized 3D-printed implants. –CN

www.zimmerbiomet.com

OLYMPUS faced a challenge in March 2023 after the FDA sent it a warning letter over its endoscope and endoscope accessories plant in Tokyo. The company also received two separate letters at the end of 2022. On the positive side, includes Olympus planned to establish a series of digital excellence centers following its acquisition of Londonbased Odin Vision and its cloud AI-enabled applications for endoscopy. Olympus also recently launched its next-gen EasySuite ES-IP system for procedure room visualization and integration in the U.S. Olympus medical devices primarily serve gastroenterology, general surgery, pulmonology, bronchoscopy, urology, gynecology, otolaryngology, bariatrics, orthopedics and anesthesiology. –CN

www.medical.olympusamerica.com

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Terumo

Tokyo,

$6,239,280,870*

*Fiscal year ended 3/31/2023

(JP¥820,209,000,000)

2022 rank: 21

R&D spend: $468,458,203

Employees: 30,207

Company CEO: Shinjiro Sato

www.terumo.com

Intuitive Surgical

Sunnyvale, California, United States

$6,222,200,000*

*Fiscal year ended 12/31/2022

2022 rank: 22

R&D spend: $879,000,000

Employees: 12,120

Company CEO: Gary Guthart

Medtech companies large and small appear to be learning what INTUITIVE figured out a long time ago: Innovating in surgical robotics is hard. It’s probably why Intuitive remains the dominant company in the soft-tissue robotics space with its da Vinci and Ion systems — and why Intuitive’s top executives are staying quiet about potential timelines for next-generation robotic platforms. During the company’s Q2 earnings call in July, CEO Gary Guthart noted that it’s possible to build features quickly but longterm validation is arduous. For example, the company has initiated a phase 1 launch of Case Insights, a tool that works with the da Vinci system and hospital data to build AI models that find correlations between surgical technique, patient populations, and surgical outcomes. But Guthart noted that it will take several quarters before Intuitive sees material revenue from Case Insights. Intuitive officials also see opportunities for Ion, which has a fully articulating catheter making its way through the lungs for cancer biopsy. In May, Intuitive promoted Dave Rosa to the role of president. –CN

www.intuitive.com

No.

Edwards Lifesciences

$5,382,400,000*

*Fiscal year ended 12/31/2022

2022 rank: 24

R&D spend: $945,200,000

Employees: 18,300

Company CEO: Bernard Zovighian

Strong transcatheter aortic valve replacement (TAVR) sales backed 10% yearover-year revenue growth for EDWARDS LIFESCIENCES during the first half of 2023. In the U.S., improved hospital staffing levels aided TAVR sales, as did the launch of the Sapien 3 Ultra Resilia. The company has upped its full-year sales guidance to between $5.9 billion and $6.1 billion. “Looking beyond 2023, we remain confident that our foundation of innovative therapies along with a differentiated technology pipeline positions us well for continued longer-term success,” said Bernard Zovighian, who took over as CEO for Michael Mussallem in May 2023. –CN

www.edwards.com

*Fiscal year ended 12/31/2022

2022 rank: 25

R&D spend: $345,000,000

Employees: 19,012

Company CEO: Deepak Nath

SMITH+NEPHEW expects 6–7% revenue growth in 2023. “The continued outperformance in Sports Medicine and Advanced Wound Management — representing 60% of our business — has continued,” CEO Deepak Nath recently said. “In Orthopaedics, our actions to improve product supply and execution have increased our ability to benefit from strong elective procedure volumes.” –CN

www.smith-nephew.com

Steris

Dublin, Ireland (Operational HQ in Mentor, Ohio) United States

$4,957,839,000*

*Fiscal year ended 3/31/2023

2022 rank: 26

R&D spend: $101,581,000

Employees: 17,100

Company CEO: Daniel Carestio

Expect STERIS — with its emphasis on infection prevention — to continue to rise in the Medtech Big 100 rankings. The company recently closed on its $540 million acquisition of surgical instrumentation assets from BD. Steris previously bought Cantel Medical for $4.6 billion in 2021. –CN

www.steris.com

Hologic

Marlborough, Massachusetts, United States

$4,862,800,000*

*Fiscal year ended 09/24/2022

2022 rank: 23

R&D spend: $283,400,000

Employees: 6,944

Company CEO: Stephen MacMillan

HOLOGIC revenue declined in fiscal 2022 but was still above prepandemic levels. The decline of COVID-19 testing slashed the women’s health and diagnostics company’s sales by 21% year-over-year during the first three quarters of fiscal 2023, which wraps up at the end of September 2023. However, Hologic’s breast health business grew revenues 27.4% year-over-year in Q3, aided by higher capital equipment revenue and an improving semiconductor chip supply environment. Said CEO Steve MacMillan: “Our results once again highlight that Hologic’s transformation and post-pandemic performance is durable.” –CN

www.hologic.com

Mindray

Shenzhen, China

$4,513,300,639*

*Fiscal year ended 12/31/2022

2022 rank: 32

R&D spend: $474,067,469

Employees: 16,099

Company CEO: Li Xiting, chair

MINDRAY announced earlier this year that it launched the TE Air, its first wireless, handheld ultrasound system. Shenzen, China–based Mindray said it designed the TE Air system to meet the global demand for a high-quality, portable ultrasound device. Other launches in recent months include the mWear system for wireless, wearable patient monitoring of a range of vital signs. –CN and SW

www.mindray.com

No. 29

Fresenius Medical Care

Bad Homburg, Germany

$4,179,000,000*

*Fiscal year ended 12/31/2022

2022 rank: 27

R&D spend: Not available

Employees: Not available

Company CEO: Helen Giza

There have been a lot of changes in top management at FRESENIUS MEDICAL CARE. When Carla Kriwet left after being the division’s CEO for only two months, the renal disease treatment products and services provider promoted then-Deputy CEO and CFO Helen Giza to the corner office. In July, Fresenius Medical Care converted from a legal form of a partnership limited by shares into a German stock corporation. Martin Fischer, head of finance for Siemens Healthineers’ diagnostics division, becomes CFO on Oct. 1. –CN

www.freseniusmedicalcare.com

Dentsply Sirona Sonova

Charlotte, North Carolina, United States

$3,922,000,000*

*Fiscal year ended 12/31/2022

2022 rank: 29

R&D spend: $174,000,000

Employees: 15,000

Company CEO: Simon Campion

DENTSPLY SIRONA recently reported Street-beating Q2 results and upped its full-year guidance, citing solid performance across its business segments. It was welcome news for the dental tech company, which saw a top management shakeup last year amid questions over use of incentives to sell products to distributors. Eventually, a board audit committee found no evidence of intentional wrongdoing or fraud on the part of its former CEO or CFO — but said their actions still violated the company’s ethics code. Former BD executive Simon Campion became the new CEO. –CN

www.dentsplysirona.com

No. 30

Stäfa, Switzerland

$3,914,136,126*

*Fiscal year ended 3/31/2023

2022 rank: 34

R&D spend: $254,450,262

Employees: 17,608

Company CEO: Arnd Kaldowski

Founded in 1947, SONOVA is a developer of hearing instruments and cochlear implants and other products. Its product brands include Phonak, Unitron, Hansaton, and Advanced Bionics. –CN

www.sonova.com

(RMB¥30,370,000,000)

(€ 3,980,000,000)

(CHF3,738,000,000)

(healthcare products)

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No.

Canon Medical

Otawara, Japan

$3,904,878,255*

*Fiscal year ended 12/31/2022

(JP¥513,331,000,000)

2022 rank: 28

R&D spend: Not available

Employees: Not available

Company CEO: Yuji Hamada

CANON announced the establishment of its Canon Healthcare USA subsidiary in late 2022 to strengthen its presence in the American medical market. In April, it said it had kicked off clinical research in Japan with its next-generation X-ray computed tomography (CT) system. Canon’s business strategy includes boosting its competitiveness in diagnostics such as CT, magnetic resonance imaging (MRI), and diagnostic ultrasound systems — as well as medical component businesses such as X-ray tubes, X-ray detectors and key MRI components. –CN

global.medical.canon

No. 33

No.

Align Technology

Tempe, Arizona, United States

$3,734,635,000*

*Fiscal year ended 12/31/2022

2022 rank: 31

R&D spend: $305,258,000

Employees: 23,165

Company CEO: Joseph Hogan

ALIGN TECHNOLOGY is the maker of the Invisalign clear aligner orthodontics system, an alternative to traditional braces. Founded in 1997, Align Technology pioneered the invisible orthodontics market with Invisalign. The system combines digital treatment planning and mass customization. The company also makes Vivera retainers, iTero intraoral scanners, and Exocad computer-aided design and computeraided manufacturing. Align Technology says it has treated more than 14 million people. –JH

www.aligntech.com

Hoya ResMed

Tokyo, Japan

$3,610,466,846*

2022 rank: 33

R&D spend: Not available

Employees: Not available

Company CEO: Eiichiro Ikeda, group president and CEO

HOYA’S offerings in the life sciences include eyeglasses, contact lenses, intraocular lenses and technology that provides minimally invasive treatments using endoscopes. –CN www.hoya.com/en/business/lifecare

No. 34

San Diego, California, United States

$3,578,127,000*

2022 rank: 35

(Note: We’ve used the same figures as our 2022 Big 100 ranking because more recent figures were not available in time for our analysis.)

R&D spend: $253,575,000

Employees: 8,160

Company CEO: Michael Farrell

Founded in Australia in 1989 by Peter Farrell, RESMED is now led by his son, Mick Farrell, as CEO since 2013. Specializing in cloud-connected respiratory devices, the company offers CPAP machines for sleep apnea and ventilators for conditions like COPD. With competitor Philips facing a major recall that effectively pulled it out of the respiratory devices market, ResMed has rapidly expanded sales within its supply chain’s capacity. In November 2022, it opened a 270,000 ft² plant in Singapore to meet skyrocketing demand better. The same month, it completed its nearly $1 billion acquisition of German healthcare software company Medifox Dan. –CN

www.resmed.com

Cooper Cos.

San Ramon, California, United States

$3,308,400,000*

*Fiscal year ended 10/31/2022

2022 rank: 41

R&D spend: $110,300,000

Employees: 14,000

Company CEO: Albert White

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 significant manufacturer of contact lenses, while CooperSurgical’s portfolio focuses on women’s health, fertility and diagnostics. In 2022, Cooper announced an $875 million deal to buy Cook Medical’s Reproductive Health business but terminated the acquisition in August 2023 after the Federal Trade Commission launched an anticompetitive practices investigation. –JH and CN

www.coopercos.com

$3,189,755,036*

2022 rank: 38

R&D spend: $122,340,576

Employees: 13,650

Company CEO: Kristian Villumsen

COLOPLAST develops ostomy, continence, interventional urology, wound and skin care products and services. Coloplast announced in June 2023 that it entered into an agreement to acquire Kerecis, a developer of biologics for the wound care market. Coloplast sees Kerecis as an “attractive opportunity” to strengthen its presence in the advanced wound care market. –CN and SW

www.coloplast.us

(medical segment)

$3,194,587,814*

*Fiscal year ended 03/31/2023

(JP¥419,957,000,000)

2022 rank: 36

R&D spend: $70,250,093

Employees: 27,220

Company CEO: Yoshihiko Sano

NIPRO offers medical devices in five product areas: renal products, interventional catheter-delivered products, hospital products, cardiopulmonary products and enzymes. The Japanese company’s medical device business has been especially focused on dialysis and artificial organs. Nipro says it is one of the leading manufacturers of dialyzers in the world. –CN

www.nipro.com

$2,909,800,000*

2022 rank: 45

R&D spend: $484,200,000

Employees: 7,600

Company CEO: Kevin Sayer

DEXCOM, a developer of continuous glucose monitoring (CGM) technology, continued its rapid growth in 2023 with the launch of its next-generation G7. Soon after, a new Medicare guideline implemented in April increased the addressable market for the company’s CGM. The San Diego-based company is now shifting its focus toward using its technology beyond diabetes management, with eyes on bringing its sensors to even more users. –SW

www.dexcom.com

(DKK kr22,579,000,000)

Bio-Rad Getinge

Hercules, California, United States

$2,802,249,000*

*Fiscal year ended 12/31/2022

2022 rank: 40

R&D spend: $256,889,000

Employees: 8,200

Company CEO: Norman Schwartz

This Hercules, California–based clinical diagnostics company has been in business for more than 70 years, catering to a customer base that includes universities, research institutions, hospitals, biotech firms, pharmaceutical companies and public health and commercial laboratories. BIO-RAD will be an interesting company to watch as the demand for the COVID19-related diagnostics that boosted business over the past few years continues to fall. The company this year initiated a $500 million share repurchase program. –SW

www.bio-rad.com

No. 41

Gothenburg, Sweden

$2,796,287,694*

*Fiscal year ended 12/31/2022

(28,292,000,000 SEK kr)

2022 rank: 37

R&D spend: $117,121,480

Employees: 11,000

Company CEO: Mattias Perjos

GETINGE’S ventilators and extracorporeal life support technologies were in high demand due to COVID-19 in recent years, but the Swedish medtech company has continued to innovate. Getinge launched a new mechanical ventilator system in January, then picked up FDA clearance for a noninvasive mechanical ventilator in July. However, the company has faced regulatory issues, with two recalls within a month for its Datascope subsidiary earlier this year. –SW

www.getinge.com

Teleflex Demant

Wayne, Pennsylvania, United States

$2,791,041,000*

*Fiscal year ended 12/31/2022

2022 rank: 42

R&D spend: $153,819,000

Employees: 15,500

Company CEO: Liam Kelly

TELEFLEX specializes in critical care and surgical technologies. Its portfolio spans vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. It picked up where it left off last year in terms of M&A with a urology play in the form of its $650 million deal to acquire Palette Life Sciences in July. –SW

www.teleflex.com

No. 42

Smørum, Denmark

$2,633,995,423*

*Fiscal year ended 12/31/2022

(DKK kr18,645,000,000)

2022 rank: 39

R&D spend: Not available

Employees: Not available

Company CEO: Søren Nielsen

Healthcare and audio technology company DEMANT’S history stretches back to 1904. Demant provides hearing aids, hearing implants and diagnostic equipment and services to hearing care professionals and users in more than 130 countries. The majority of Demant A/S shares are held by the William Demant Foundation and are listed on Nasdaq Copenhagen as a blue-chip stock. –CN

www.demant.com

(hearing healthcare segment)

Envista

Brea, California, United States

$2,569,100,000*

*Fiscal year ended 12/31/2022

2022 rank: Not applicable

R&D spend: $100,100,000

Employees: 12,700

Company CEO: Amir Aghdaei

ENVISTA has a global family of more than 30 dental brands, including Nobel Biocare, Ormco, Dexis, and Kerr. Its dental implants and treatment options, orthodontics, and digital imaging technologies cover a wide range of dentists’ clinical needs for diagnosing, treating, and preventing dental conditions and improving the aesthetics of the human smile. –CN

www.envistaco.com

Bruker WS Audiology

Billerica, Massachusetts, United States

$2,530,700,000*

*Fiscal year ended 12/31/2022

2022 rank: 47

R&D spend: $235,900,000

Employees: 8,525

Company CEO: Frank Laukien

BRUKER says its high-performance scientific instruments and high-value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular and microscopic levels. Its employees work at over 90 locations globally. German experimental physics professor Günther Laukien helped start the company in 1960, providing what the company says were the first high-resolution systems for analytical chemistry in the U.S. –CN

www.bruker.com

Singapore and Lynge, Denmark

$2,468,550,000*

*Fiscal year ended 09/30/2022

(DKK kr2,351,000,000)

2022 rank: Not applicable

R&D spend: $170,100,000

Employees: 12,000

Company CEO: Eric Bernard

WS AUDIOLOGY is a leader in the hearing aid space. It has a global customer network of thousands of hearing care providers, and also reaches the hearing impaired through consumer-facing businesses. –CN

www.wsa.com

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Paul Hartmann ICU Medical

Heidenheim an der Brenz, Germany

$2,427,180,000*

*Fiscal year ended 12/31/2022

(€ 2,311,600,000)

2022 rank: 43

R&D spend: Not available

Employees: 10,290

Company CEO: Britta Fünfstück

THE HARTMANN GROUP’S history goes back to the early 19th century, with a legacy of medical advances in wound care and skin health. Its focus includes wound care, incontinence management, infection management and more. The company has offices in 36 countries around the world, but its products are available in over 130 countries through a network of distributors. –CN

www.hartmann.info

San Clemente, California, United States

$2,279,997,000*

*Fiscal year ended 12/31/2022

2022 rank: 57

R&D spend: $92,984,000

Employees: 14,500

Syringe and infusion technology company ICU MEDICAL is climbing up the Big 100 ranks following its $2.35 billion acquisition of Smiths Medical last year. With Smiths Medical’s offerings including syringe and ambulatory infusion devices, vascular access, and vital care products, the merger created an infusion therapy company with estimated annual revenues of roughly $2.5 billion. The company could grow even more with rumors swirling earlier this year that it was one of the contenders for some of the business units that Medtronic wants to divest. –SW

www.icumed.com

Amplifon Straumann

Milan, Italy Basel, Switzerland

$2,225,055,000*

*Fiscal year ended 12/31/2022

(€ 2,119,100,000)

2022 rank: 49

R&D spend: Not available

Employees: 19,400

Company CEO: Enrico Vita

AMPLIFON is a major hearing aid provider, offering products and services such as Ampli-easy, Ampli-mini, Ampli-connect, Ampli-energy, the Amplifon App, and Companion smart support. –CN

www.amplifon.com

No. 50

$2,216,555,000*

*Fiscal year ended 12/31/2022

(CHF2,321,000,000)

2022 rank: 50

R&D spend: Not available

Employees: 10,400

Company CEO: Guillaume Daniellot

STRAUMANN is a global provider of tooth replacement and orthodontic products and services. Its brands include Anthogyr, ClearCorrect, Dental Wings, Medentika, Neodent, NUVO and Straumann, and it has other fully/partly owned companies and partners. In May, Straumann announced the full acquisition of GalvoSurge, a Swiss medical device manufacturer in the dental field with a specialization in implant care and maintenance solutions. –CN

www.straumann.com

Cook Medical Convatec

Bloomington, Indiana, United States

$2,200,000,000*

*Fiscal year ended 12/31/2022

2022 rank: 48

R&D spend: Not available

Employees: 10,270

Company CEO: Carl Cook

Privately held COOK MEDICAL has faced some setbacks in 2023. Cooper Cos. abandoned its planned $875 million acquisition of Cook Medical’s reproductive health business after scrutiny from the Federal Trade Commission. Cook Medical in May announced it would lay off 500 workers — about 4% of its global workforce — amid a strategic realignment. –CN

www.cookmedical.com

No. 51

Reading, England, United Kingdom

$2,073,500,000*

*Fiscal year ended 12/31/2022

2022 rank: 51

R&D spend: $92,000,000

Employees: 10,000

Company CEO: Karim Bitar

CONVATEC provides technology for advanced wound care, ostomy care, continence and critical care and infusion care. It offers design and manufacturing services for infusion set technologies and insertion devices for insulin pump treatment. Convatec announced in May that it partnered with Beta Bionics on the launch of the FDA-cleared iLet Bionic Pancreas for automated insulin delivery. The Beta Bionics iLet uses its inset and contact detach infusion sets for subcutaneous insulin administration. –SW and CN

www.convatecgroup.com

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Masimo Carl Zeiss Meditec

Irvine, California, United States

$2,035,800,000*

*Fiscal year ended 12/31/2022

2022 rank: 58

R&D spend: $191,400,000

Employees: 4,000

Company CEO: Joe Kiani

MASIMO shareholders ousted two members of the device developer’s board after a heated battle by activist investor Politan Capital Management. Politan called for more board oversight and was critical of Masimo’s $1 billion acquisition of Sound United and its high-end music and entertainment system brands. Masimo founder, Chair and CEO Joe Kiani and his team argue that the deal will enable Masimo to turn millions of home entertainment systems into health hubs. Analysts wonder whether there could be a strengthened case to separate Sound United. Other top Masimo news includes the unveiling of its Freedom smartwatch for continuous health tracking earlier this year. –CN

www.masimo.com

Jena, Germany

$1,997,977,800*

*Fiscal year ended 09/30/2022

(€ 1,902,836,000)

2022 rank: 52

R&D spend: $305,970,000

Employees: 4,224

Company CEO: Markus Weber

CARL ZEISS MEDITEC products and workflow solutions support the diagnosis and treatment of eye diseases. It also provides technology for visualizing minimally invasive surgical treatments in neurosurgery, ENT, spine, pathology, oncology and dentistry. –CN

www.zeiss.com/meditec-ag

HU Group Dräger

Tokyo, Japan

$1,984,650,716*

*Fiscal year ended 03/31/2023

(JP¥260,900,000,000)

2022 rank: 44

R&D spend: $73,026,627

Employees: Not available

Company CEO: Shigekazu Takeuchi

HU GROUP focuses on lab testing, related services and in vitro diagnostics. It also has a part of the business that provides support services related to hospital administration work. –CN

www.hugp.com

No. 55

Lübeck, Germany

$1,912,575,000*

*Fiscal year ended 12/31/2022

(medical division) (€ 1,821,500,000)

2022 rank: 46

R&D spend: Not available

Employees: Not available

Company CEO: Stefan Dräger, chair

DRÄGER’S medical division has fi ve business units: therapy (anesthesia devices and ventilators, as well as thermoregulation equipment), hospital consumables and accessories, workplace infrastructure (supply units, lights, gas management systems), monitoring (patient mon itoring), and data business (software applications, system products, and new services). Its focus in 2022 was on expanding its product portfolio in the intensive care customer area and in the operating room, with activities centered on developing system solutions, according to the company’s most recent annual report. –CN

www.draeger.com/en-us_us/Hospital

Elekta Nihon Kohden

Stockholm, Sweden

$1,667,276,160*

*Fiscal year ended 04/30/2023

(16,869,000,000 SEK kr)

2022 rank: 54

R&D spend: $140,150,429

Employees: 4,587

Company CEO: Gustaf Salford

ELEKTA in February said an FDA 510(k) clearance marked a new era in precision radiation cancer therapy in the U.S. The new Comprehensive Motion Management (CMM) with True Tracking and automatic gating is part of Elekta’s Unity MR-Linac radiotherapy system. The new features enable Elekta Unity to continuously calculate the movement of a tumor anywhere in the body and account for it automatically. Also this year, Elekta entered into a joint venture with Sinopharm to increase the adoption of radiation therapy in China. –CN

www.elekta.com

Tokyo, Japan

$1,571,616,680*

*Fiscal year ended 03/31/2023

(JP¥206,603,000,000)

2022 rank: 53

R&D spend: $47,163,030

Employees: 5,751

Company CEO: Hirokazu Ogino

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 pulse oximetry, cerebral artery pressure meters, ECGs, heart monitors and fetal monitors. It operates subsidiaries in Santa Ana, California; Irvine, California; Guilford, Connecticut; Alachua, Florida; Charlottesville, Virginia; and Cambridge, Massachusetts. –CN

www.nihonkohden.com

Enovis

Wilmington, Delaware, United States

$1,563,101,000*

*Fiscal year ended 12/31/2022

2022 rank: 56

R&D spend: $60,800,000

Employees: 6,800

Company CEO: Matthew Trerotola

ENOVIS recently upped its 2023 revenue growth projection to 7–7.5% from the prior year. CEO Matt Trerotola says the orthopedic device company is focused on innovationdriven share gain, operational improvement, and compounding impact from M&A. Recent acquisitions include Novastep and its foot and ankle minimally invasive surgical (MIS) platform. In May, Enovis signed a definitive agreement to acquire the Seal external fixation product line from DNE. –CN www.enovis.com

Integra Lifesciences Integer

$1,557,666,000*

*Fiscal year ended 12/31/2022

2022 rank: 55

R&D spend: $101,193,000

Employees: 3,722

Company CEO: Jan De Witte

INTEGRA LIFESCIENCES was founded in 1989 after the acquisition of an engineered collagen technology platform that was designed to repair and regenerate tissue. The company has since expanded its regenerative technology product portfolio to include surgical instruments, neurosurgical devices and advanced wound products. Its brands include AmnioExcel, Aurora, Bactiseal, BioD, CerebroFlo, CereLink Certas Plus, Codman, CUSA, Cytal, DuraGen, DuraSeal, DuraSorb, Gentrix, ICP Express, Integra, Licox, Mayfield, MediHoney, MicroFrance, MicroMatrix, NeuraGen, NeuraWrap, PriMatrix, SurgiMend, TCC-EZ, and VersaTru. –JH, DK and CN

www.integralife.com

$1,376,096,000*

*Fiscal year ended 12/31/2022

2022 rank: 60

R&D spend: $60,918,000

Employees: 10,000

Company CEO: Joseph Dziedzic

INTEGER sales rose nearly 18% year-over-year to nearly $779 million during the first half of 2023. The medtech contract manufacturing giant’s strong results caused Integer to boost its full-year sales outlook to 12% growth at the midpoint. In Integer’s Q2 earnings news release, CEO Joseph Dziedzic said: “Integer delivered another strong quarter of sales and profit growth supported by an improving supply chain and labor environment.” –CN

www.integer.net

Insulet NuVasive

$1,201,942,000* Acton,

$1,305,300,000*

*Fiscal year ended 12/31/2022

2022 rank: 65

R&D spend: $180,200,000

Employees: 2,600

Company CEO: Jim Hollingshead

INSULET develops wearable automated insulin delivery devices, such as its flagship Omnipod patch pump, which is one of the market leaders in the space. Insulet became a member of the S&P 500 this year, replacing Silicon Valley Bank in March. The company also received FDA clearance for a basal-only insulin delivery system this year, expanding the company’s reach within the diabetes patient population. –SW

www.insulet.com

*Fiscal year ended 12/31/2022

2022 rank: 64

R&D spend: $98,524,000

Employees: 3,000

Company CEO: Chris Barry

NUVASIVE recently reported mixed Q2 results ahead of its planned merger with Globus Medical. As of the writing of this description in early August, officials at both companies were sticking by plans to complete the deal — even as the Federal Trade Commission continues to scrutinize the merger. Combining NuVasive and Globus Medical would create the second-largest spine tech company in the world behind Medtronic. –CN

www.nuvasive.com

Haemonetics

Boston, Massachusetts, United States

$1,168,660,000*

*Fiscal year ended 04/01/2023

2022 rank: 72

R&D spend: $50,131,000

Employees: 3,034

Company CEO: Christopher Simon

HAEMONETICS technologies serve medical markets including blood and plasma component collection, the surgical suite and hospital transfusion. News this year included FDA clearance of advancements to its NexSys PCS plasma collection system. Haemonetics also invested €30 million in Galway, Ireland-based Vivasure and its portfolio of fully absorbable, patch-based, large-bore percutaneous vessel closure devices. The agreement includes an option for Haemonetics to acquire Vivasure. –CN and SW

www.haemonetics.com

Merit Medical Systems

South Jordan, Utah, United States

$1,150,981,000*

*Fiscal year ended 12/31/2022

2022 rank: 66

R&D spend: $75,510,000

Employees: 6,846

Company CEO: Fred Lampropoulos

MERIT MEDICAL SYSTEMS in June announced $132.5 million worth of acquisitions to expand its offerings. Merit Medical spent $100 million on Angiodynamics dialysis portfolio products, including DuraFlow, DuraMax, Evenmore, Schon XL, Trio-CT and Vaxel Plus hemodialysis catheter brands. The deal with Angiodynamics also included the BioSentry tract sealant system biopsy brand. In addition, Merit spent $32.5 million on the Surfacer inside-out access catheter system from BlueGrass Vascular Technologies. –CN

www.merit.com

Cochlear Embecta

Sydney, Australia Wilmington, Delaware

$1,140,728,610*

*Fiscal year ended 06/30/2023

(AU$1,641,100,000)

2022 rank: 59

(Note: We’ve used the same figures as our 2022 Big 100 ranking because more recent figures were not available in time for our analysis.)

R&D spend: $146,457,570

Employees: 4,500

Company CEO: Dig Howitt

Founded in Sydney in 1981, COCHLEAR develops ear implants to help people with hearing loss. The company says it has provided more than 600,000 implantable devices. –CN

www.cochlear.com

(operational HQ in Parsippany, New Jersey) United States

$1,129,500,000*

*Fiscal year ended 09/30/2022

2022 rank: Not applicable

R&D spend: $66,900,000

Employees: 2,000

Company CEO: Dev Kurdikar

Since its spinoff from Becton, Dickinson & Co. (BD) last year, EMBECTA says it continues to make progress on the development of a closedloop insulin delivery system for type 2 diabetes. The system utilizes its proprietary patch pump system, which holds FDA breakthrough device designation. Additionally, Embecta has an ongoing collaboration with Tidepool on automated insulin delivery. –SW

www.embecta.com

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Omron Healthcare

Konica Minolta

Kyoto, Japan Tokyo, Japan

$1,080,946,212*

*Fiscal year ended 03/31/2023

2022 rank: 61

R&D spend: Not available

Employees: Not available

Company CEO: Junta Tsujinaga

OMRON is a major manufacturer of home blood pressure monitors. In 2023, it is celebrating the 50th anniversary of the introduction of the HEM-1, its first manual and manometer-type blood pressure monitor. The company says it has continuously worked to improve the technology to make it more accurate and user-friendly. Omron has sold over 350 million units in more than 110 countries. –CN

www.omronhealthcare.com

$1,048,236,369*

*Fiscal year ended 03/31/2023

2022 rank: 71

R&D spend: Not available

Employees: Not available

Company CEO: Toshimitsu Taiko

KONICA MINOLTA Healthcare Americas recently reported that it has significantly expanded the U.S. customer base for its Dynamic Digital Radiography (DDR) X-ray systems, with healthcare institutions in Minnesota, New Hampshire, New York and Oklahoma picking them up. The company describes DDR as the next evolution of X-ray technology because it enables clinicians to view the dynamic interaction of anatomical structures such as tissue and bone with physiological changes over time. –CN

healthcare.konicaminolta.us

(JP¥142,100,000,000)

(healthcare segment) ( JP¥137,800,000,000)

Conmed Fukuda Denshi

Largo, Florida, United States

$1,045,472,000*

*Fiscal year ended 12/31/2022

2022 rank: 70

R&D spend: $47,152,000

Employees: 4,100

Company CEO: Curt Hartman

CONMED offers surgical devices and equipment across a variety of specialties. Surgeons and healthcare professionals use Conmed devices in orthopedics, general surgery, gynecology, thoracic surgery and gastroenterology. –CN

www.conmed.com

No. 71

Tokyo, Japan

$1,024,259,293*

*Fiscal year ended 03/31/2023

(JP¥134,648,000,000)

2022 rank: 62

R&D spend: Not available

Employees: Not available

Company CEO: Kotaro Fukuda

FUKUDA DENSHI is a global producer of electrocardiographs, patient monitors, and other engineered medical devices. Founded in 1939, the company pioneered Japan’s first ECG device in its early history. Fukuda Denshi’s U.S. operations are based in Redmond, Washington. –BB and CN

www.fukuda.com

Globus Medical LivaNova

Audubon, Pennsylvania, United States

$1,022,843,000*

*Fiscal year ended 12/31/2022

2022 rank: 73

R&D spend: $73,015,000

Employees: 2,600

Company CEO: Daniel Scavilla

GLOBUS MEDICAL reported Street-beating Q2 results as it prepares for its merger with fellow spine tech company NuVasive. Globus shareholders would own about three-fourths of the company resulting from the merger, which would create the second-largest spine tech company in the world behind Medtronic. As of the writing of this description in early August, officials at both companies were sticking by plans to complete the deal in the present quarter — even as the Federal Trade Commission continues to scrutinize the merger. –CN www.globusmedical.com

No. 72

London, United Kingdom

$1,021,805,000*

*Fiscal year ended 12/31/2022

2022 rank: 67

R&D spend: $155,805,000

Employees: 2,900

Company CEO: William Kozy (interim CEO)

Cardiac surgery and neuromodulation device company LIVANOVA’S former CEO Damien McDonald resigned in April, with board chair William Kozy still handling interim CEO responsibilities as of the writing of this description in early August. Mike Matson, senior research analyst at Needham & Co., noted that McDonald’s departure came after several pipeline disappointments. –CN www.livanova.com

Fisher & Paykel Healthcare

Auckland, New Zealand

$1,005,737,710*

*Fiscal year ended 03/31/2023

( NZ$1,581,100,000)

2022 rank: 63

R&D spend: $110,872,230

Employees: 6,564

Company CEO: Lewis Gradon

FISHER & PAYKEL HEALTHCARE

manufactures systems for use in acute and chronic respiratory care, surgery and the treatment of obstructive sleep apnea. With central operations in Australia and New Zealand, the company markets its products in more than 120 countries globally. A 6% decline in revenue year-over-year in 2022 caused the company to drop in the rankings in this year’s report. “We were again lapping a year which saw a significant COVID-19-related impact on sales,” CEO Lewis Gradon said in Fisher & Paykel Healthcare’s most recent annual report. Gradon added that results were more encouraging in the second half of the year. –CN and BB

www.fphcare.com/us

ZimVie GN Hearing

Westminster, Colorado, United States

$913,862,000*

*Fiscal year ended 12/31/2022

2022 rank: 69

R&D spend: $62,691,000

Employees: 2,700

Company CEO: Vafa Jamali

In its first full year as an independent dental and spine tech company, ZIMVIE continues to focus on improving its operating profile as it seeks to set itself up for future growth. The company’s refocusing efforts included pulling its spine business out of China and laying off 5% of the total workforce. One of the bright spots in the company’s spine portfolio is the ZimVie Tether, described as a groundbreaking system for treating adolescent idiopathic scoliosis. CEO Vafa Jamali noted in ZimVie’s recent Q2 earnings call that the company has now completed all transitional service agreements related to the separation from its former parent, Zimmer Biomet. –CN

www.zimvie.com

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Ballerup, Denmark

$879,693,725*

*Fiscal year ended 12/31/2022

( DKK kr6,227,000,000)

2022 rank: 75

R&D spend: $87,969,372

Employees: 4,900

Company CEO: Gitte Pugholm Aabo

GN HEARING develops and manufactures intelligent hearing technology, along with audio, video and gaming products. It was founded in 1869, operates in more than 100 countries and employs a total of 7,500 people. –SW

www.gn.com

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Penumbra MicroPort

Alameda, California, United States

$847,133,000*

*Fiscal year ended 12/31/2022

2022 rank: Not applicable

R&D spend: $79,407,000

Employees: 3,900

Company CEO: Adam Elsesser

PENUMBRA was founded in 2004 by President, Chair and CEO Adam Elsesser and Dr. Arani Bose, who formerly served as chair, chief medical officer and chief innovator. Penumbra develops interventional devices for vascular and neuro therapies, including catheters, coils and clot retrievers. Recent FDA clearances include the Lightning Flash mechanical thrombectomy system in 2022 and the Lightning Bolt 7 arterial thrombectomy system in 2023. However, the launch of the Thunderbolt mechanical thrombectomy system will likely be delayed until 2024. –JH

www.penumbrainc.com

Avanos Medical

Alpharetta, Georgia, United States

$820,000,000*

*Fiscal year ended 12/31/2022

2022 rank: 78

R&D spend: $30,600,000

Employees: 4,044

Company CEO: Joseph Woody

AVANOS MEDICAL develops medtech focused on two areas: nonopioid pain management and chronic care, the latter of which includes digestive health, respiratory health, NICU and pharmacy products. In June, it announced plans to acquire Toronto-based Diros Technology and its radiofrequency products to treat chronic pain conditions. The same month, it agreed to sell its respiratory health business to SunMed Group Holdings. Both deals were expected to close by 2024. –CN and DK

www.avanos.com

Shanghai, China

$840,831,000*

*Fiscal year ended 12/31/2022

2022 rank: 77

R&D spend: $419,800,000.00

Employees: 9,435

Company CEO: Zhaohua Chang

MICROPORT’S cardiac rhythm management subsidiary — MicroPort CRM — announced in May that it received FDA approval for its Alizea and Celea implantable pacemakers. Microport said its newly approved devices are the longest-lasting pacemakers for their size on the market today. They offer a volume of just 11 cc and a projected longevity of 13 years. –CN

www.microport.com

Applied Medical Resources

Rancho Santa Margarita, California, United States

$800,000,000*

*Fiscal year ended 12/31/2022

2022 rank: Not applicable

R&D spend: $160,000,000.00

Employees: 5,400

Company CEO: Said Hilal

Founded in 1987, privately held APPLIED MEDICAL RESOURCES provides technologies for minimally invasive and general surgery, as well as cardiac, vascular, urologic, colorectal, bariatric, obstetric and gynecologic specialties. This year, it made headlines when it filed an antitrust lawsuit against Medtronic in U.S. District Court in Central California. In July, the Federal Trade Commission sought court permission to file an amicus brief that would “correct some of Medtronic’s erroneous assertions and mistaken legal points” that it made in its argument for dismissal. –CN

www.appliedmedical.com

No. 80

Invacare

Elyria, Ohio, United States

$741,733,000*

*Fiscal year ended 12/31/2022

2022 rank: 74

R&D spend: $3,492,000

Employees: 2,800

Company CEO: Geoffrey Purtill

INVACARE makes wheelchairs, medical beds, wound care products and more. Invacare earlier this year engaged in a restructuring that saw two U.S.-based subsidiaries go through a voluntary Chapter 11 bankruptcy process. A restructuring support agreement reduced Invacare’s funded debt by approximately $240 million and freed the company to engage in financial transactions to recapitalize. –CN

www.invacare.com

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Össur Orthofix

Reykjavík, Iceland

$718,650,000*

*Fiscal year ended 12/31/2022

2022 rank: 79

R&D spend: $34,024,000

Employees: 4,000

Company CEO: Sveinn Sölvason

ÖSSUR was founded in 1971 by inventor Össur Kristinsson. Össur specializes in developing orthopedics such as bracing and support products, compression therapy and prosthetics. –BB

www.ossur.com

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Lewisville, Texas, United States

$698,244,000*

*Fiscal year ended 12/31/2022

2022 rank: 88

R&D spend: $73,785,000

Employees: 1,600

Company CEO: Keith Valentine

ORTHOFIX’S Jan. 5, 2023 completion of its merger with SeaSpine moved it up six spots in the MedTech Big 100. The company has achieved doubledigit growth in its bone growth therapies franchise so far this year. –CN

www.orthofix.com

No.

Ambu Nikkiso

Ballerup, Denmark Tokyo, Japan

$627,807,759*

*Fiscal year ended 09/30/2022

(DKK kr4,444,000,000)

2022 rank: 82

R&D spend: Not available

Employees: 4,388

Company CEO: Britt Meelby Jensen

AMBU is a developer of single-use scopes for a range of applications. CEO Britt Meelby Jensen recently appeared on our DeviceTalks Weekly podcast to discuss how the company plans to retain its position in the single-use scope industry. She highlighted how single-use endoscopes improve workflow and reduce waiting times. –CN

www.ambu.com

No. 85

Novocure

Root, Switzerland

$537,840,000*

*Fiscal year ended 12/31/2022

2022 rank: 84

R&D spend: $206,085,000

Employees: 1,320

Company CEO: Asaf Danziger

NOVOCURE specializes in developing therapies for difficult-to-treat tumors. The oncology company’s tumor treating fields technology (“TTFields”) is FDA-approved for recurrent and newly diagnosed glioblastoma and mesothelioma. In June 2023, the company said a phase 3 clinical trial found TTFields with standard therapies improved survival for non-small cell lung cancer patients. The company is also studying ovarian, brain and pancreatic cancer. Novocure has its U.S. headquarters in Portsmouth, New Hampshire and R&D operations in Haifa, Israel. –JH

www.novocure.com

$572,041,908*

*Fiscal year ended 12/31/2022

2022 rank: 81

R&D spend: Not available

Employees: Not available

Company CEO: Toshihiko Kai, president and CEO; Masaru Yamamura, medical division GM

NIKKISO holds over half the dialysis machine market in Japan and has a significant global presence. The company has diversified into blood purification devices, equipment for surgery, perioperative, and emergency care, and offers artificial pancreas technology for clinical use. –CN

www.nikkiso.com/products/medical

No. 86

$519,896,333*

*Fiscal year ended 06/30/2022

Nagoya, Japan (JP¥68,345,000,000)

2022 rank: 80

(Note: We’ve used the same figures as our 2022 Big 100 ranking because more recent figures were not available in time for our analysis.)

R&D spend: Not available

Employees: Not available

Company CEO: Masahiko Miyata

ASAHI INTECC creates and markets medical devices for catheter-based treatments involving the cardiovascular, peripheral vascular, abdominal vascular and cerebrovascular systems. The company says its interventional guide wires and microcatheters are based on over 40 years of wire innovation, and that its proprietary wire drawing, wire forming, torque and coating technologies enable it to create products that provide physicians with precise control –CN

www.asahi-inteccusa-medical.com

No. 87 No.

Topcon Shockwave Medical

88

Tokyo, Japan Santa Clara, California, United States

$506,629,829*

*Fiscal year ended 03/31/2023

2022 rank: 86

R&D spend: Not available

Employees: Not available

Company CEO: Takashi Eto

TOPCON Healthcare offers a range of products and services to treat eye conditions. They include multimodal imaging, vendor-neutral data management and remote diagnostic technology. –CN

www.topconhealthcare.com

$489,733,000*

*Fiscal year ended 12/31/2022

2022 rank: 99

R&D spend: $81,679,000

Employees: 1,001

Company CEO: Doug Godshall

SHOCKWAVE MEDICAL’S proprietary intravascular lithotripsy (IVL) tech delivers local sonic pressure waves to treat calcified plaque. The company says the technology safely modifies calcium while significantly reducing the risk of complications. The company announced a $500 million private offering to continue its growth. Major medical device companies reportedly saw Shockwave as an acquisition target this year, but Shockwave Medical is a buyer, too. In April, it paid $147 million for Neovasc and its Reducer system for addressing refractory angina. –CN and SW

www.shockwavemedical.com

No.

89

(radiology solutions segment)

Mortsel, Belgium

$485,100,000*

*Fiscal year ended 12/31/2022

(€ 462,000,000)

2022 rank: 83

R&D spend: Not available

Employees: Not available

Company CEO: Pascal Juéry

AGFA-GEVAERT’S Radiology Solutions division specializes in diagnostic imaging, offering both analogue and digital technologies for clinicians in hospitals and imaging centers globally. Agfa’s imaging equipment, combined with its Musica image processing software, focuses on productivity, safety, and cost-effectiveness. –CN

medimg.agfa.com

(JP¥66,601,000,000)

JMS Co.

Hiroshima, Japan

$484,866,373*

*Fiscal year ended 12/31/2022

2022 rank: 85

R&D spend: $10,025,947

Employees: 5,650

Company CEO: Ryuji Katsura, president and representative director

Dr. Taro Tsuchiya founded JMS in the 1960s after recognizing the need for disposable medical devices to minimize complications from blood transfusions. Today, JMS offers products and services in areas including infusion/transfusion, nutrition, dialysis, surgery, and blood/cells. The company emphasizes its development approach, centering on real-world clinical needs and collaborating closely with healthcare professionals. –CN

www.jms.cc

No.

92

Castel San Pietro, Switzerland

Medacta $458,955,000*

*Fiscal year ended 12/31/2022 (JP¥63,740,000,000) (CHF437,100,000)

2022 rank: 90

R&D spend: $16,380,000

Employees: 1,537

Company CEO: Francesco Siccardi

Established in 1999 in Switzerland, MEDACTA specializes in joint replacement, spine surgery, and sports medicine. Beginning with minimally invasive procedures, the company has transitioned to offerings that are personalized for each patient. Medacta operates in over 40 countries. –CN

www.medacta.com

Accuray iRhythm

Sunnyvale, California, United States

$429,909,000*

*Fiscal year ended 06/30/2022

2022 rank: 89

(Note: We’ve used the same figures as our 2022 Big 100 ranking because more recent figures were not available in time for our analysis.)

R&D spend: $57,752,000

Employees: 1,044

Company CEO: Suzanne Winter

ACCURAY specializes in radiation therapy systems to deliver treatments including stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT). In 2023, the company said it would join the Russell 2000 and Russell 3000 stock indices. In August, Accuray won FDA 510(k) clearance for its VitalHold breast package to minimize radiation dose when used with its image-guided, intensity-modulated radiation therapy Radixact system. –BB and JH

www.accuray.com

No. 93

San Francisco, California, United States

$410,921,000*

*Fiscal year ended 12/31/2022

2022 rank: 92

R&D spend: $46,610,000

Employees: 1,793

Company CEO: Quentin Blackford

Wearable cardiac monitor maker IRHYTHM’S sales jumped more than 21% in the first half of 2023. The company reported its second-highest quarter for its Zio XT monitors, plus growth for its Zio AT device. CEO Quentin Blackford said iRhythm will “continue to redefine the standard of cardiac care and demonstrate our unique value proposition to customers, patients, and payers.” iRhythm has also faced challenges. In May, it received an FDA warning letter involving the Zio AT. The same month, it disclosed its third subpoena from federal investigators; company officials say they’re cooperating. –CN

www.irhythmtech.com

Inspire Medical Systems Nevro

Golden Valley, Minnesota, United States Redwood City, California, United States

$407,856,000*

*Fiscal year ended 12/31/2022

2022 rank: Not applicable

R&D spend: $68,645,000

Employees: 755

Company CEO: Tim Herbert

INSPIRE MEDICAL SYSTEMS revenue grew nearly 74% year-over-year during the first half of 2023, with the implantable sleep apnea device company expecting full-year growth in the 47% to 50% range. Inspire’s pacemaker-like device that provides an alternative therapy to CPAPs has benefited from the Philips recall. Most recently, Inspire hired former Medtronic VP and Spine & Biologics GM Carlton Weatherby as its chief strategy officer and former Applied VR executive Dr. Charisse Sparks as chief medical officer. –CN

www.inspiresleep.com

$406,365,000*

*Fiscal year ended 12/31/2022

2022 rank: 91

R&D spend: $53,065,000

Employees: 1,087

Company CEO: Kevin Thornal

NEVRO provides pacemaker-like spinal cord stimulation systems for pain relief, and new CEO Kevin Thornal is seeking a path back to strong growth. His efforts included bringing on former Stryker VP Greg Siller as chief commercial officer in June. Analysts, for now, appear to be taking a wait-and-see approach. –CN

www.nevro.com

No. 96

Inari Medical Barco

Irvine, California, United States

$383,471,000*

*Fiscal year ended 12/31/2022

2022 rank: 96

R&D spend: $74,221,000

Employees: 1,100

Company CEO: Drew Hykes

INARI MEDICAL focuses on the treatment of venous diseases such as venous thromboembolism, crafting devices to extract blood clots safely and effectively. Its FlowTriever device employs both mechanical and aspiration methods in a single session. The company invests aggressively in R&D. In the first half of 2023, Inari grew significantly through new product launches, expansion into global markets and increased adoption of its equipment in medical procedures. Inari this year launched RevCore and T16 Curve, both designed to treat venous thromboembolism, clots in the leg that are often undiagnosed. –BB

www.inarimedical.com

No. 97

Kortrijk, Belgium

$358,785,000*

*Fiscal year ended 12/31/2022

(healthcare division) (€ 341,700,000)

2022 rank: 93

R&D spend: Not available

Employees: Not available

Company CEO: Co-CEOs Charles Beauduin and An Steegen

BARCO develops networked visualization technologies, including an array of medical displays and imaging systems. The company’s diagnostic displays for radiology, breast imaging, digital pathology and dentistry are certified as Class IIa products, while its surgical and clinical displays are Class I medical devices. In 2023, the company received its Medical Device Regulation (MDR) certificate, certifying that its full medical product line complies with new European legislation for medical devices. –BB

www.barco.com/en/healthcare

Alphatec

Carlsbad, California, United States

$350,852,000*

*Fiscal year ended 12/31/2022

2022 rank: 98

R&D spend: $44,033,000

Employees: 705

Company CEO: Patrick Miles

ALPHATEC Holdings specializes in the manufacturing of spinal implant and tissue technologies for spine surgery procedures. Alphatec CEO Patrick Miles says its 100% spine focus provides a competitive edge in developing procedural-based medical devices optimized for surgeon adoption and procedural volume. Strong revenue drivers include its proprietary prone transpsoas surgery (PTP) and lateral transpsoas (LTP) access systems. In 2023, Alphatec acquired a navigation-enabled robotics platform and debuted an anterior lumbar interbody fusion (ALIF) access system. –BB

www.atecspine.com

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AtriCure Artivion

Mason, Ohio, United States

$330,379,000*

*Fiscal year ended 12/31/2022

2022 rank: 97

R&D spend: $57,337,000

Employees: 1,050

Company CEO: Michael Carrel

ATRICURE develops devices for atrial fibrillation (AFib) and related conditions. AtriCure has carved out a strong niche for itself in the surgical space. Its Isolator Synergy ablation clamp is the only device — catheter-delivered or surgical — that is FDA-approved for the treatment of persistent and longstanding persistent AFib. In addition, AtriCure’s AtriClip left atrial appendage (LAA) exclusion products provide an option for surgeons to reduce stroke risk after heart operations. AtriCure’s Hybrid AF therapy is a minimally invasive procedure for persistent AFib patients, while its cryoablation technology blocks pain in cardiac and thoracic procedures. –CN and BB

www.atricure.com

Kennesaw, Georgia, United States

$313,789,000*

*Fiscal year ended 12/31/2022

2022 rank: 94

R&D spend: $38,879,000

Employees: 1,300

Company CEO: Patrick Mackin

ARTIVION (formerly known as CryoLife) develops devices for cardiac and vascular surgeons who specialize in treating patients with aortic diseases. The company’s devices and implantable tissues are used in aortic repair procedures. In May, the company won FDA approval for its PerClot absorbable hemostatic system, which is used to control bleeding in open and laparoscopic surgical procedures. Baxter paid the company a $14.3 million milestone payment following the regulatory win. –BB

www.artivion.com

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No. 101

Medtech Big 100:

These companies just missed the list

Each year, it takes more and more revenue to make our Medtech Big 100 ranking of the world’s largest medical device companies.

This year’s No. 100 — Artivion (formerly CryoLife) — secured the final spot in our ranking with revenue of $313.8 million.

Last year, $236.2 million was enough to get Cardiovascular Systems (now part of Abbott) onto the Medtech Big100 company ranking at No. 100.

Companies on the bubble in recent years have made their way onto the Medtech Big 100. For example, Inspire Medical Systems missed the list by a single spot last year, but made No. 95 in our new ranking.

With that in mind, here are the companies that would have ranked Nos. 101 to 105 on this year’s list. Watch out for them in future versions of the Medtech Big 100.

— Senior Editor Danielle Kirsh

Glaukos

Aliso Viejo, California, United States

$282,862,000

R&D spend: $123,271,000

Employees: 783

CEO: Thomas Burns

GLAUKOS ranked No. 95 in our 2022 Medtech Big 100 with $294 million in sales. Its drop from the 2023 ranking can be attributed to newcomers to the list and a decrease in its own sales. Glaukos develops ophthalmic medical devices for treating glaucoma, corneal disorders and retinal disease. –DK

No. 102

Axonics

Irvine, California, United States

$273,702,000

R&D spend: $34,410,000

Employees: 610

CEO: Raymond Cohen

AXONICS makes a sacral neuromodulation (SNM) system that is designed to treat overactive bladder and fecal incontinence. Axonics Therapy offers a choice between two long-lasting implant device options: Axonics F15 and Axonics R20. The F15 system is a recharge-free SNM therapy option, providing therapy for 10 to 20 years. Its small and thin design is made for patient comfort and allows patients to safely undergo a full-body MRI. The R20 system is a miniaturized, rechargeable device that provides therapy for 20 or more years. It can be used for six to 10 months between charges and allows patients to safely undergo a full-body MRI. –DK

No. 103

Silk Road Medical

Sunnyvale, California, United States

$138,638,000

R&D spend: $36,449,000

Employees: 414

CEO: Erica Rogers

SILK ROAD MEDICAL is focused on reducing the risk of stroke. It has pioneered an approach to treating carotid artery disease called TransCarotid Artery Revascularization (TCAR). TCAR combines surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing stroke. –DK

Outset Medical

San Jose, California, United States

$115,375,000

R&D spend: $48,855,000

Employees: 728

CEO: Leslie Trigg

OUTSET MEDICAL develops a hemodialysis system to reduce the cost and complexity of dialysis. The company’s Tablo hemodialysis system is FDA-cleared for use in the hospital and the home. It can be used across the continuum of care to allow for dialysis to be delivered at anytime, anywhere and by anyone. It has remote patient monitoring and two-way communication with the cloud via the company’s TabloHub to transmit treatment data to the provider and to a unique remote diagnostics platform that powers service and support. –DK

Si-Bone

Santa Clara, California, United States

$106,409,000

R&D spend: $13,627,000

Employees: 357

CEO: Laura Francis

SI-BONE is an orthopedic company that develops an implant to fuse the sacroiliac joint. The company was originally founded as a spinout from Wright Medical (now a part of Stryker) in 2008 when it bought InBone Technologies. –DK

GROW, JOBS DECREASE, R&D SPENDING CLIMBS

Total sales are up but employment is down in our latest Medtech Big 100 ranking of the world‘s largest medical device companies.

Aggregate revenue for the 2023 Medtech Big 100 grew 2.8% to a recordhigh $453.2 billion, the second straight year of growth after a rare dip in the first year of the COVID-19 pandemic.

More than three-quarters of the companies reported positive sales growth year-over-year, but the industry is still working to return to the type of growth rates it saw before the pandemic.

It‘s worth noting that the aggregate revenue comparison year over year with the Big 100 is not perfect. The companies included on the list can vary a bit each year. However, the results were also positive when we compared the performance of the Medtech Big 100 companies in 2022 and early 2023 with their prior-year results, excluding companies that were not previously ranked. Revenue growth averaged 4.4% at the 94 companies that made the list this year and last year.

Most of our Medtech Big 100 companies disclose R&D spending and employment counts as well. Total headcount for the list is down nearly 5% to 1.18 million — catching the beginning of layoffs the industry has experienced as it grapples not only with a higher cost of doing business but from operational challenges at health provider customers. By May 2023, MDO’s sister site MassDevice had reported on roughly 18,000 job cuts across the industry since mid-2022.

However, even as they engaged in layoffs, it appears that medtech companies made a bet on innovation to boost future growth: R&D spending increased nearly 13% to $26.4 billion.

Medtech sales:

COVID-19 challenges remain

Of the 94 companies that made the list this year and last, 73 reported year-over-year sales gains. Four companies experienced 50% or greater growth.

Shockwave Medical grew revenue 106.5% year-over-year to $489.7 million. ICU Medical followed with 73.2% growth, while Masimo sales grew 64.3%.

Eighteen companies in the analysis reported year-over-year revenue decreases. Invacare had the largest sales decline on the Medtech Big 100 list, decreasing 15% to $741.7 million in 2022.

(continued on page 83)

OUR RANKING OF THE WORLD’S LARGEST MEDICAL DEVICE COMPANIES SHOWS RECORD-HIGH REVENUE AND A DOUBLE-DIGIT BOOST IN R&D ACTIVITIES.

DANIELLE KIRSH SENIOR EDITOR

FOR THIS ANALYSIS, WE COLLECTED THE MOST RECENTLY AVAILABLE ANNUAL REVENUE FIGURES FROM BOTH PUBLIC AND PRIVATELY HELD MEDICAL DEVICE MANUFACTURERS AROUND THE GLOBE. NOTE THAT FISCAL YEARS FROM COMPANIES CAN VARY.

DUE TO THE VARYING STRENGTH OF THE U.S.

RANKING BY TOTAL SPEND

(continued from page 81)

The wheelchair and mobility scooter manufacturer earlier this year engaged in a restructuring that saw two U.S.based subsidiaries go through a voluntary Chapter 11 bankruptcy protection process.

Hologic and Dräger’s medical division had the next largest sales declines, with 13.6% and 11.8% decreases, respectively. Hologic has been providing COVID-19 testing technology, and Dräger makes ventilators — both high-demand technology during the height of the pandemic.

A drop-off in COVID-19-related revenues affected other companies. For example, Abbott’s overall revenue boomed in recent years as it sold hundreds of millions of dollars worth of COVID tests. And 3M CEO Mike Roman attributed its revenue drop to lower sales of its disposable respirators on the company’s most recent earnings call.

Though sales of COVID-related products are waning, staffing shortages continue at hospitals, leading to decreased procedure volumes.

“The staffing issue has been a factor that has been holding back procedure volumes, particularly deferrable procedures,” Andrew Jay, general partner at medtech-focused hedge fund Borna Health Fund, told Medical Design & Outsourcing. “Procedures such as artificial hips and knees, that’s something that could be postponed. There were a lot of procedures that people needed but didn’t have to have right away. You could see this happening in the heart valve market and some other places, as well, where healthcare facilities were not able to maximize their throughput through their [operating rooms].”

While in previous years diagnostics and imaging companies topped the list of increased sales, this year’s analysis saw more of a mix of companies.

(continued on page 85)

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“The staffing issue has been a factor that has been holding back procedure volumes, particularly deferrable procedures. Procedures such as artificial hips and knees, that’s something that could be postponed. There were a lot of procedures that people needed but didn’t have to have right away.”

THIS RANKING EXCLUDES COMPANIES WITH NONMEDICAL DEVICE OPERATIONS THAT DO NOT BREAK OUT R&D SPENDING BY DIVISION AND COMPANIES THAT DO NOT DISCLOSE R&D SPENDING. A HANDFUL OF COMPANIES THAT END THEIR FISCAL YEARS IN LATE JUNE AND SEPTEMBER ARE MARKED WITH AN ASTERISK; THEIR FISCAL 2022 FIGURES ARE LISTED INSTEAD. ACCURAY AND RESMED’S FIGURES ARE THE SAME AS PUBLISHED IN OUR 2022 MEDTECH BIG 100 DUE TO PRODUCTION TIMING.

R&D RANKING BY PERCENTAGE OF REVENUE

(continued from page 83)

The companies that grew the most are developers of devices like heart catheters, intravascular lithotripsy (IVL) therapy, noninvasive patient monitoring and orthopedics.

Shockwave Medical more than doubles revenue, grows R&D more than 60% Shockwave Medical stood out with the highest year-over-year growth, reporting a 106.5% increase in revenue to $489.7 million in fiscal 2022.

Shockwave Medical develops IVL therapy devices that treat various cardiovascular disorders, including peripheral artery disease (PAD) and coronary artery disease (CAD). Using various catheters, the company’s technology uses local delivery of sonic pressure waves. The technology safely modifies calcium

while significantly reducing the risk of complications, according to the company. The company has enjoyed enough success that there was speculation earlier this year that it was an acquisition target.

The company’s R&D spend grew 61.6% over 2021, increasing to roughly 16.7% of its revenue

“To highlight just a few of our key accomplishments in 2022, we had two new products approved in the U.S., demonstrated superiority in one-year follow-up in the PAD III randomized trial, added regulatory shipping approvals in 12 new countries, including Japan and China, launched over 500 coronary accounts in the U.S., had several wins in reimbursement across the globe, and broke ground on a new manufacturing facility in Costa Rica,” Shockwave CEO Doug Godshall said in an earnings call wrapping up the year.

R&D RANKING BY PERCENTAGE OF REVENUE (CONTINUED)

Medtech Big 100 employment drops

There were approximately 1.18 million employees at the 80 companies in the Medtech Big 100 that disclose human capital on their annual report. Total employment at those companies dropped by about 61,000, or 5%.

Some companies give approximate counts rather than exact fi gures; Medtronic, for example, says it has more than 95,000 employees.

This Medtech Big 100 headcount drop came before the layoffs of the first half of 2023 as major manufacturers consolidated facilities and business units or automated manufacturing operations.

“There’s always some amount of restructuring and movement of people and trying to eliminate jobs to maximize profitability,” Jay said.

Despite the overall employment losses, Masimo, ICU Medical and Shockwave Medical grew their headcounts by more than 50%.

The biggest increase in headcount came from Masimo, which increased its workers 81.8% to 4,000 employees after purchasing Sound United parent company Viper Holdings for $1 billion.

The next highest headcount increase was at ICU Medical, which bought Smiths Medical for $2.35 billion last year. It grew its workforce 70.6% to 14,500 in 2022.

Shockwave Medical added 52.4% employees in 2022, bringing its headcount to 1,001.

Eleven companies reported lower headcounts year-over-year: Elekta, Royal Philips, B. Braun Melsungen, Integra Lifesciences, Ambu, Paul Hartmann, LivaNova, Invacare, Fisher & Paykel Healthcare, Avanos Medical and Cook Medical.

For example, Cook Medical reported a nearly 6% decrease in headcount year-over-year. The privately held company reported 10,270 employees for our current report, down from 10,898 a year before.

In May 2023, the company announced it was laying off 500 workers in what Cook Medical President Pete Yonkman described as the “most diffi cult decision we have had to make in support of our strategy.”

(continued on page 88)

HERE’S HOW MANY PEOPLE EACH COMPANY REPORTED AS EMPLOYEES, EITHER IN THEIR MOST RECENT ANNUAL REPORTS (AS OF JULY 21, 2023) OR PROVIDED DIRECTLY TO MEDICAL DESIGN & OUTSOURCING

BIG100 ANALYSIS

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(continued from page 85) Medtech Big 100 R&D rises nearly 20% Medical device companies on the Medtech Big 100 are investing more in R&D than years prior. The 62 companies that disclose R&D spending collectively ramped up those activities by more than $4.4 billion — or 19.8% — to $26.4 billion year-over-year.

“New products are the life and blood of the medical technology industry. … New products can create new markets, new products can shift market share, new products can drive market growth by allowing physicians to treat patients that were previously untreatable,” Jay said.

Twelve companies reduced their R&D expenditures year-over-year: Getinge (-1%), Medtronic (-1.8%), Convatec (-2.6%), Smith+Nephew (-3.1%), Avanos Medical (-5.3%), Bio-Rad (-5.4%), Dexcom (-6.4%), Zimmer Biomet (-6.9%), LivaNova (-15.1%), Alcon (-16.6%), Globus Medical (-25%) and Invacare (-59.7%).

A dozen companies grew their R&D spending by more than 25%: ICU Medical (95.8%, though the Smiths Medical acquisition could have played a role), Shockwave Medical (61.6%), Orthofix (48.7%), Inari Medical (45.5%), MicroPort (41%), Masimo (39.5%), Medacta (38%), Alphatec (37.5%), HU Group (31.5%), Intuitive Surgical (31%), B. Braun Melsungen (29.8%) and Carl Zeiss Meditec (25.5%).

Three companies spent more than 20% of their revenue on R&D: MicroPort (49.9%), Novocure (38.3%), and Applied Medical Resources (20.0%).

“R&D is very important for these companies,” Jay said. “One factor that may be driving it is that traditionally, most of the new products or a good portion of the exciting new products in the larger companies came through acquisitions of smaller companies. Typically, larger companies, the way they grow is by acquiring smaller companies.

What’s interesting is that for the smaller companies, the M&A activity has been significantly less over the past year or so.”

Rather than making big acquisitions (with the exception of J&J’s Abiomed acquisition), large medtech companies are allocating resources to more development within their own firms because the technology at the smaller companies is becoming more expensive to buy, Jay suggested.

“What may be driving it is that the smaller companies with the attractive fast-growing technology, fast-growing products for creating new markets — those companies may be too expensive to acquire,” he said.

— Managing Editor Jim Hammerand contributed to this report.

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CEO COMPENSATION

Major medical device companies are now disclosing how much their median employees make — and comparing it to CEO pay.

DANIELLE KIRSH SENIOR EDITOR

For the fi rst time, we’re ranking medical device CEO pay and comparisons to the wages earned by their employees as part of our Medtech Big 100 report.

The relatively new disclosure of these CEO pay ratios — which show how many times higher a CEO’s total pay is than their median worker’s pay — has shed new light on the medical device industry's compensation practices.

These fi gures are rare public data points on pay in an industry where recruiting and retaining top talent is crucial. At the same time, medtech investors are increasingly scrutinizing executive pay. In recent years, companies like Masimo, Henry Schein and Zimmer Biomet faced pushback from shareholders in advisory “say-on-pay” votes on their executive pay packages.

(continued on page 92)

CEO COMPENSATION

(continued from page 90)

Due to the wiggle room the SEC gives companies in calculating their median worker’s wage (excluding certain foreign workers, for example), you shouldn’t consider median wages or pay ratios to be equally comparable across different companies. But if you’re a medtech engineer weighing your options in the field, they offer information about prospective employers that’s hard to come by anywhere else.

Methodology

We used total CEO compensation and pay ratios as reported by publicly traded companies in filings with the U.S. Securities and Exchange Commission. Total compensation includes salary and/or bonuses, stock awards, options and all other compensation. Our analysis focused on 51 companies in our Medtech Big 100 list that filed proxies with relevant discloures.

We included the CEOs of Abbott, 3M and Johnson & Johnson because they have prominent medical device businesses. However, we also included the leaders of the healthcare businesses within those companies if their pay was disclosed: Ashley McEvoy (Johnson & Johnson MedTech worldwide chair), Jeffrey Lavers (3M Health Care interim group president) and Steve Mason (Cardinal Health’s medical segment CEO) run some of the largest medical device divisions in the Big 100.

The SEC gives new companies extra time to file proxies and pay ratio disclosures. As such, new spinoff companies Embecta, GE HealthCare and ZimVie do not yet disclose CEO pay ratios, but they do disclose CEO total compensation.

How do medtech executives stack up? Average annual compensation among all the CEOs and executives in our analysis

was $10.2 million. The average median employee’s salary was $76,068 and the average pay ratio among the companies that filed proxies was 220:1.

The highest-paid CEO in the medical device industry is not at the largest company. Abbott CEO Robert Ford topped the list, earning $21.7 million in compensation in 2022. However, Abbott makes more than medical devices — it has nutritional, diagnostic, medical device and pharmaceutical divisions.

With $18.7 million in total compensation, Align Technology CEO and President Joseph Hogan is the highest-paid medtech executive among publicly traded Big 100 companies that focus on devices.

Align Technology, which makes the Invisalign clear dental aligners, stood out for its pay ratio of 1,026:1, the widest gap in our analysis.

The company did not respond to an offer to provide more context, but said in its proxy filing with the SEC: "The objective of our executive management compensation program is to encourage our corporate leaders to achieve our financial and strategic objectives, thereby creating long-term value for our stockholders.”

At the other end of the range, Penumbra CEO Adam Elsesser had the lowest pay of our analysis at $601,620, almost all of it from salary, while the median employee pay amounted to $77,926, resulting in a pay ratio of 8:1. Elsesser is also the lowest-paid CEO of the U.S.-based Big 100 companies that filed proxies within the last year.

Penumbra characterized Elsesser’s pay package as “below market,” saying that the CEO has “expressed a preference to the Compensation Committee that his cash compensation be modest so we could invest in other areas of the business.”

At the world’s largest medical device company by revenue, Medtronic Chair and CEO Geoff Martha made $15.4 million in fiscal 2023. That’s a 14% decrease from 2022, primarily due to Martha receiving nothing this year under the Medtronic Incentive Plan. Medtronic’s median employee pay was $67,073, resulting in a CEO pay ratio of 230:1.

Medtronic’s 2023 revenue decreased 1% year-over-year to $31.2 billion, while profits decreased 25% to approximately $3.8 billion.

(continued on page 94)

CEO COMPENSATION

(continued from page 92)

The highest and lowest median wages in medtech

Inspire Medical Systems reported the highest median wage of $266,163, followed by Shockwave Medical ($167,938), Inari Medical ($163,160) and Nevro ($153,039). These companies all spend a relatively high percentage of their revenue on R&D.

Owens & Minor had the lowest median wage at $6,216, followed by

Avanos Medical ($6,786) and Align Technology ($18,215). These companies have a large share of their workforces in foreign countries.

For example, Align Technology said 9% of its employees work in the U.S. and that its median employee is a CAD designer at its treat facility in Costa Rica.

“Compensation rates are benchmarked and set to be marketcompetitive in the country in which the jobs are performed,” the company said

in its proxy, adding that the company doesn’t use the CEO pay ratio for making compensation decisions and only calculated the pay ratio to comply with the law.

Below is a list of the top-paid CEOs, ranked by total compensation. The median employee salary and pay ratios are also listed.

— Managing Editor Jim Hammerand contributed to this report.

CEO COMPENSATION VERSUS MEDIAN EMPLOYEE SALARY

* Former CEOs ** Former CEO, pre-merger

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“The objective of our executive management compensation program is to encourage our corporate leaders to achieve our financial and strategic objectives, thereby creating long-term value for our stockholders.”

CEO COMPENSATION VERSUS MEDIAN EMPLOYEE SALARY (CONTINUED)

Chris Newmarker Executive Editor

The 10 largest orthopedic device companies in the world

tryker and Zimmer Biomet both upped their 2023 guidance during recent earnings calls, a sign that orthopedic procedures are bouncing back from the COVID-19 pandemic.

GlobalData predicted earlier this year that the recovery will lift the ortho devices market to nearly $50 billion this year. The question is whether companies can continue the momentum. Stryker and ZB are betting on innovation, building arrays of products and services around their surgical robotics systems and surgical planning and digital health tools.

During ZB’s second-quarter earnings call, CEO Bryan Hanson (who has since then left to lead 3M’s healthcare spinoff) noted ZB has 40 planned product launches by 2026, the majority in 4%-plus growth markets.

Stryker meanwhile seeks to harness data collection and analysis to help surgeons personalize procedures for individual patients to improve outcomes, according to Robert Cohen, president of Stryker’s Digital, Robotics and Enabling Technologies organization.

Listening to Cohen, one can sense urgency to innovate at the world’s largest ortho device company.

“It doesn’t matter how big Stryker is. It doesn’t matter how long Stryker has been around. A slow company will fail,” Cohen said earlier this year.

Below are the world’s 10 largest orthopedic device companies, ranked by ortho business revenue pulled from their most recent annual reports.

Two of the world’s largest orthopedic device companies expect accelerated revenue growth this year.

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Welcome to our third-annual ranking of the largest pharma companies in the world, compiled according to 2023 revenue data taken from the companies’ respective annual reports.

Pfizer, which tops our list, led for the second consecutive year. In 2022, the drugmaker’s revenue broke the $100 billion mark. That was a first in the industry, largely as a result of robust sales of COVID-19 products. However, the company anticipates a dip in COVID-19 related sales in 2023. Recent financial data supports this assertion. In the second quarter of the year, Pfizer’s Comirnaty COVID-19 vaccine sales dropped 83% compared to the same period last year, while sales of COVID-19 antiviral Paxlovid fell by 98%.

Claiming the second position on our list, Merck & Co. maintained a

2023 Pharma 50:

sturdy footing in the pharma market. In 2022, sales of its juggernaut Keytruda jumped 20%, driving $5.8 billion in revenue. Keytruda sales in 2023 continue to be strong, increasing 19% in the second quarter of 2023. While the company faces challenges such as an upcoming patent expiration for Keytruda in 2028, it remains focused on expanding its portfolio, leveraging innovative treatments to ensure sustained growth.

AbbVie also stood its ground in 2022, maintaining impressive sales even as it grappled with stiffening competition from biosimilars for its flagship rheumatoid arthritis drug, Humira. AbbVie continues to show strength in the pharmaceutical landscape in 2023, demonstrating a sustained growth trajectory in the first half of the year.

2023 TOP PHARMA COMPANIES

Pharmaceutical developers and manufacturers have shown remarkable resilience and innovation in the face of the COVID-19 pandemic.

The largest pharma companies in the world

THE 2023 PHARMA 50 REPORT

See all 50 companies and a comprehensive analysis — including the top-selling pharmaceuticals, company profi les and top employers — in the complete 2023 Pharma 50 report at wtwh.me/pharma50

2023 TOP PHARMA COMPANIES (CONTINUED)

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Medtronic has recalled implantable cardioverter defi brillators and cardiac resynchronization therapy defi brillators that may fail to deliver life-saving shocks for cardiac patients.

An insulation defect appears to be to blame for Medtronic’s massive Class I recall of implantable cardioverter defibrillators (ICDs), including cardiac resynchronization therapy defibrillators (CRT-Ds).

The FDA said it has not yet determined a cause and that Medtronic is investigating. But Medtronic — the world’s largest medical device manufacturer — identified the likely problem in an urgent medical device correction notice sent to

Medtronic identified 348,616 devices in the U.S. for the recall, distributed from Oct. 13, 2017 to June 9, 2023. The recall covers 120 Medtronic ICD products, including devices sold under the product lines of Amplia, Brava, Claria, Cobalt, Compia, Crome, Evera, Mirro, Primo, Visia and Viva.

These devices are designed to deliver high-voltage shocks — sometimes up to 40 joules — to correct rapid and/or irregular heartbeats known as arrhythmias, which can be fatal.

The company reported 22 injuries across 28 incidents as of July, and the FDA classified the recall as a Class I, the most serious kind.

However, Medtronic is not recommending patients undergo surgery to have their devices removed and replaced. The company said the procedure’s risks — including potentially fatal infections and other complications — outweigh the “rare potential” of harm from the defect.

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Too risky to replace: The design

flaw that likely caused Medtronic’s massive ICD and CRT-D recall

Implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators are failing to deliver life-saving shocks for cardiac patients.

Photo courtesy of Medtronic

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What’s causing Medtronic ICD and CRT-D malfunctions?

The recall covers ICDs and CRT-Ds manufactured after 2017 with a glassed feedthrough. The feedthrough is the interconnection between the inside of the hermetically sealed pulse generator and the sockets on top of the device that connect to the heart leads.

In its notice to healthcare providers in May, Medtronic laid out the conditions under which the devices malfunctioned while attempting to deliver high voltage (HV) therapy. The company warned that “significant separation of the layers of insulation materials in the feedthrough components of the device header” can cause an “unintended current pathway [to form] within the void created by the insulation separation, capable of conducting high levels of current during HV therapy.”

When that happens, it can trigger the Short Circuit Protection (SCP) safety feature, designed to truncate energy delivery during HV therapy to protect the device when an unintended current pathway is detected in the device or the lead during a shock.

If the SCP feature detects a short while the device is attempting to deliver HV therapy, the device won’t deliver the appropriate shock, if any at all. Without that shock, a patient experiencing a life-threatening cardiac event could die.

Medtronic said the problem has been observed in a particular configuration. These devices can be programmed to deliver HV therapy in biphasic electric shocks of two polarities: “B>AX” and “AX>B”, where B is the right ventricular coil and AX is the device’s active canister and superior vena cava coil. Medtronic said the malfunction has been observed in the AX>B shock configuration, where the right ventricular coil acts as the cathode for the first phase and the anode for the second phase.

What’s the fix — and why not replace the Medtronic ICDs? Similar Medtronic ICD recalls last year were determined to be due to device design and fixed with a software update.

For the latest recall, Medtronic has not yet said whether it will make design changes to the devices. Right now, the company is recommending patients have their implants configured with the AX>B high voltage therapies reprogrammed to B>AX.

Medtronic said the risk of mortality after reprogramming is 0.001% at 9 years, compared to a mortality risk between 0.032% and 0.043% for replacement due to the risk of complications.

Without reprogramming, Medtronic estimated a malfunction rate of 0.02% over 5 years for the more than 816,000 devices with glassed feedthroughs. That equals a mortality risk of 0.004% over 5 years, Medtronic said.

However, the malfunction rate increases to 0.48% over 5 years for patients with a history of HV therapy, equal to a mortality risk of 0.08% over 5 years.

Medtronic is asking healthcare providers to prioritize reprogramming of patients with a history of HV therapy who have devices programmed to deliver an AX>B shock as the first shock (Rx1) in a series of up to six shocks.

“Rx1 provides the greatest statistical likelihood to resolve an arrhythmia, and therefore it is important to minimize risk of a reduced- or no-energy HV therapy in the first sequence,” Medtronic said in the notice.

For any other patients whose devices are configured to deliver an AX>B shock, doctors should schedule their next follow-ups as in-person visits for reprogramming all HV shocks to B>AX.

Perfusionists are essential players on a cardiac surgery team, ensuring patients receive critical clinical support to maintain vital functions during a procedure. In short, the breath and heartbeat of patients’ lives rest in the hands of perfusionists operating a perfusion system, while the surgical team intervenes on the heart.

Today’s perfusionists need connected and real-time data in addition to effective technical and hardware functionality. Their clinical roles are evolving in the operating room (OR), and a new era is emerging in which access to technology, integrated systems, data analytics and actionable information will drive quality, effi ciency and continuously improved patient care across all phases of a procedure, including recovery.

As a provider of perfusion systems, including heart-lung machines (HLMs) and cardiopulmonary equipment, LivaNova is ushering in this new era in response to what the worldwide perfusionist community requires.

How LivaNova next-generation perfusion system

developed a

Access

Giving voice to the global perfusionist community

When the time came to transform our existing cardiopulmonary platform, we asked an important question: How do we advance perfusion performance in the OR? To address this, we launched a comprehensive, user-centric design process. More than 300 customers worldwide weighed in and worked alongside us during every step of development.

Perfusionists participated in one-on-one interviews, focus groups and surveys, offering open and candid conversation with our product development team. This uncovered some of their critical needs to be addressed with a nextgeneration perfusion system, including:

• Unobstructed visibility of the OR and patient area

• Centralized monitor displaying patient vitals and procedure parameters with an intuitive user interface

• Customized settings that can be saved and serve as a baseline for future procedures

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to technology, integrated systems and data reign supreme in the new era of perfusion.

Marco Dolci LivaNova

LivaNova’s Essenz Perfusion System Image courtesy of LivaNova

Marco Dolci is president of the Cardiopulmonary Business Unit for LivaNova. He joined the company in 2017. Dolci has more than 30 years of experience working in the healthcare and medical device industries.

Your Strategic Partner

(continued from page 104)

One piece of feedback collected during the discovery phase reigned supreme: Access to integrated and comprehensive data, especially intra-operatively, was a requirement.

Perfusionists ensure blood remains adequately oxygenated throughout the procedure to support organ function when the patient’s heart is placed in cardiac arrest. To do this, perfusionists use continuous monitoring of Oxygen Delivery index (DO2i) during cardiac perfusion, which perfusionists maintain above a set threshold to keep the patient in a specific aerobic zone.

This monitoring is possible through paper charting or electronic data monitoring. Paper charting can lead to transcription errors and issues with data interpretation. Perfusionists using electronic data monitoring systems instead want intuitive and centralized data visualization to facilitate more informed decision-making.

Designing for an improved user experience

Our main goal in designing our nextgeneration perfusion system was to build on existing features while adding advanced technology and intelligence to improve the user experience.

We asked perfusionists to get creative and build the new system using cardboard boxes, sticky notes and virtual reality. For example, perfusionists used a mock-up screen, indicating how and where key parameters should appear on the screen to improve data visualization.

As we finished the prototypes, perfusionists challenged the creations. From this process, we derived hundreds of ideas on how to improve the existing cardiopulmonary platform and worked jointly to test each one.

A holistic perfusion system

The entire process resulted in the Essenz Perfusion System, which consists of a next-generation HLM and a new patient monitoring system that directly address the feedback and challenges raised during the discovery phase.

The HLM features an ergonomic design and advanced cable management, which minimizes distractions during the procedure. The pumps are mastmounted to optimize the position of the disposables (i.e., oxygenator

and perfusion tubing set), which minimizes priming volumes and reduces hemodilution. It also helps improve visibility of the surgical area and keeps the perfusion space clean and hygienic. Each pump is controlled individually for simple, straightforward operations. Plus, HLM sensor checks confirm readiness before the cardiopulmonary bypass procedure begins.

The new patient monitor features a high-resolution, graphical user interface that is intuitive, easy to use and designed around the perfusionist’s workflow for quick deployment. A Quality Indicators Dashboard allows perfusionists to implement an individualized patient care strategy during the case. Data is automatically and seamlessly transferred to the patient monitor, minimizing manual data entry and freeing up valuable time for the perfusionist. Official formulas help perfusionists implement goal-directed perfusion, a therapy effective in reducing the risk of acute kidney injury.

Integration within the OR environment and beyond

Data can dramatically enhance patient care outside of the OR. The patient monitor sends procedure data to external devices (e.g., electronic medical records, hospital information systems, middleware) during surgery. Perfusionists and anaesthetists can view the procedural parameters parallel to the surgery, thereby supporting the on-bypass perfusionist in intra-op decision-making. Plus, parameter data can be exported for input into statistical tool packages and patient data registries for research and publications.

All parties working toward the same shared goal

The digitization of hospitals is redefining the delivery of care. Hospitals no longer look at companies such as ours simply as suppliers, but as partners contributing to the delivery of care.

By advocating the perfusionists’ point of view, addressing requirements in the OR and ensuring seamless integration of systems and data, it resulted in a new platform designed for all parties (manufacturers, clinicians and hospitals) to attain their most important, shared goal — offering patients favorable outcomes during and after life-saving cardiac surgery procedures.

LivaNova’s Essenz Perfusion System patient monitor Image courtesy of LivaNova

How Medtronic’s conflict minerals program investigates red flag suppliers

Materials like gold, tin and tungsten can save lives when used in medical devices, but global manufacturers like Medtronic must take steps to avoid inadvertently funding violence and human rights abuses with these “conflict minerals.”

Medtronic is once again No. 1 in our Medtech Big 100 ranking of the largest medical device companies in the world, so its conflict minerals program is a good example of how device manufacturers look deep into their supply chain to comply with federal disclosure requirements.

“At Medtronic, we’re committed to maintaining good citizenship as a company, which includes obtaining the minerals necessary to manufacture our products only from socially responsible sources,” the company said in a statement to Medical Design & Outsourcing.

What are conflict minerals?

Conflict minerals include cassiterite, columbite-tantalite (coltan), gold, wolframite and their derivatives, which are commonly extracted to fund violent conflicts. Some of the most commonly used conflict minerals are referred to as 3TG: tantalum, tin and tungsten and gold.

The Dodd-Frank Act of 2010 requires publicly traded companies to disclose their use of conflict minerals and exercise

due diligence on sourcing, specifically to identify whether the materials came from facilities in or near the Democratic Republic of Congo, where illicit gold exports

financed armed groups as they engaged in the deadliest conflict since WWII.

The DRC and adjoining countries — the Republic of the Congo, the Central African Republic, South Sudan, Uganda, Rwanda, Burundi, Tanzania, Zambia, and Angola — are collectively defined by the law as the “covered countries,” a term you’ll see often in conflict minerals sourcing.

Medtronic’s conflict

minerals program design

Medtronic based its conflict minerals program design on five steps from the Organization for Economic Cooperation and Development (OECD) Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas:

1. Establish and maintain strong company management systems (including Medtronic’s conflict minerals policy)

2. Identify and assess risks in the supply chain

3. Design and implement a strategy to respond to identified risks

(continued on page 110)

Medtronic’s conflict minerals program looks deep into its supply chain to avoid inadvertently funding violence and human rights abuses.

Image courtesy of Adobe Stock

(continued from page 108)

4. Carry out an independent thirdparty audit of smelter or refiner due diligence practices

5. Report annually on supply chain due diligence

Medtronic’s conflict minerals program has three teams of management: a steering committee that includes the chief procurement officer, a central team — made up of the Responsible Supply Management Program director, a supply chain program manager, a data analyst, and a legal representative — and a third team of global supply management representatives who support the central team and act as liaisons.

“Due to the depth of the company’s supply chain, the company is far removed from the sources of ore from which conflict minerals are produced and the smelters and refiners that process those ores, and the company has limited influence over the behavior of these smelters and refiners,” Medtronic said in its latest

conflict minerals report. “Moreover, because of the geographic diversity and ongoing changes in the company’s supply chain, the company often has significant difficulty identifying those suppliers who are further upstream from the company’s direct suppliers. As a result, the company’s program was specifically designed to relate to our position in the minerals supply chain as a ‘downstream’ purchaser.”

How Medtronic investigates suppliers for conflict mineral compliance

After Medtronic determines it needs particular conflict minerals to make its products, it conducts a reasonable country of origin inquiry (RCOI) to check whether those materials come from the covered countries.

The company uses the Responsible Minerals Initiative (RMI) Conflict Minerals Reporting Template to survey direct suppliers that provide products or components that might contain conflict minerals. Medtronic has been an RMI

member since 2015, and uses a thirdparty software and services provider for its conflict materials program.

Medtronic surveyed 234 direct suppliers last year and received 214 responses. For non-responders, Medtronic sent up to three reminders and had commodity managers personally follow up with high-spend suppliers.

Of the responsive suppliers, 63 confirmed or gave reason to believe that they sourced conflict minerals from the covered countries. Medtronic follows up with those suppliers to compile lists of smelters and refiners for comparison against the RMI’s Responsible Minerals Assurance Process (RMAP) list of facilities.

RMI assesses facilities for conformance to RMAP standards and makes its lists publicly available for manufacturers to verify whether facilities are conformant or active (active means they’re in the pre-assessment, assessment, or corrective-action phases). Medtronic’s 2022 list included 468 potential unique smelters or refiners, of which 221

were on the RMAP conformant list. Nine smelters were on the active list.

For the 112 suppliers who listed facilities that aren’t listed as RMAP conformant or active, Medtronic asked them to encourage their smelters and refiners to become RMAP conformant.

of these facilities on a survey, Medtronic’s program immediately emails the supplier with instructions to take their own risk mitigation actions and escalate the issue within the supplier to remove the red flag facilities from their supply chain.

Medtronic warns that its program “can provide only reasonable, not absolute, assurance regarding the source and chain of custody of the necessary conflict minerals.”

Red

flag review of conflict mineral

suppliers Medtronic said it performed an automated red flag review of all supplier responses. Using the RMI definition of a 3TG smelter or refiner, Medtronic assesses each facility according to the OECD’s due diligence guidance. Three factors determine a facility’s level of risk: geographic proximity to the covered countries, RMAP audit status, and credible evidence of unethical or conflict sourcing.

In 2022, this review identified 24 smelting or refining facilities with red-flag risks in their supply chain, including one facility each in Belgium, Sudan, Zimbabwe, UAE, Uganda, and the remaining 19 in Russia. If a Medtronic supplier reports any

The number of Medtronic suppliers reporting high-risk smelters or refiners grew from 56 in 2021 to 63 in 2022 due to the addition of those 19 non-conformant Russian smelters. RMI suspended new RMAP assessments in Russia last year following the invasion of Ukraine. Despite that, Medtronic reported “a significant decrease in the number of smelters reported and the number of non-legitimate smelter entities” from 2021 to 2022.

Medtronic’s annual conflict minerals disclosure includes lists of all identified conflict minerals smelters and refiners in its supply chain, along with the mineral supplier, the facility location and RMAP audit status. The report also lists all known countries of origin, from Afghanistan to Zimbabwe.

“The company’s due diligence processes are based on the necessity of seeking data from direct suppliers and those suppliers seeking similar information within their supply chains to identify the original sources of the necessary conflict minerals,” Medtronic said in the report. “The company also relies, to a large extent, on information collected and provided by independent third-party audit programs. Such sources of information may yield inaccurate or incomplete information due to, among other reasons, gaps in supplier or smelter data, errors or omissions in information provided by suppliers or smelters, or misunderstandings by suppliers or smelters regarding the SEC requirements.”

For links to conflict minerals reporting resources, go to wtwh.me/conflictminerals

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Disposable components will be a key advantage for Vicarious Surgical, its new operations chief said in an interview that also covered upcoming milestones, manufacturing plans and recent layoffs.

system’s robotic arms and camera are disposable, as are the system’s trocar and drape.

apping off a medtech career spanning more than three decades, John Mazzola had only been retired from Becton, Dickinson & Co. (BD) for about a week when Vicarious Surgical cofounder and CEO Adam Sachs hired him to lead strategic manufacturing planning.

One year later, the surgical robotics developer has promoted Mazzola to the newly created position of chief operating officer, covering product development, manufacturing, supply chain, quality, clinical, regulatory, IT, people and culture.

Mazzola spoke with Medical Design about the latest from Waltham, Massachusetts-based Vicarous Surgical, its plans for manufacturing and outsourcing, the company’s recent layoffs and lessons learned about developing and launching products.

Where is Vicarious Surgical on development and what milestones are next?

Mazzola: “We’re going through sort of the final stages, if you will, of our development process and preparing for the next phase, which is V&V (verification and validation). And our plan is to be exiting Phase II, entering Phase III V&V toward the end of this year, first quarter of next year. Then we’ll proceed through V&V and then through a human clinical

trial for de novo authorization that we’ll be seeking through the FDA. … There are different elements of the system that are a different maturity through their development stage, but we’re probably at 80% of the design complete.”

How much of the manufacturing is Vicarious Surgical doing in-house, how much is off-the-shelf, and what’s your philosophy on that?

Mazzola: “One of the things that I did when I first came in is I said, ‘What do we want to do for manufacturing strategy both to get us through V&V, as well as our initial scale, our initial launch?’ And I think what we’re going to do is take an approach where we do more of the pilot manufacturing and more of the assembly here initially, and then eventually transfer and partner with one of the three big [contract manufacturers] to move more of it as we scale to them. We have a clean room that we’ve set up where we can do human clinical builds, and we plan to use that for both our V&V builds as well as our clinical builds. But then as we submit for approval, and as we prepare for scale, we’ll probably start shifting some of that to contract manufacturers that are better positioned and have better infrastructure to meet the requirements and the scale that we’re going to need.”

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These surgical robotics arms are destined for the trash — by design

The Vicarious Surgical

Photo courtesy of Vicarious Surgical

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(continued from page 112)

Who are those big three contract manufacturers?

Mazzola: “Jabil, Celestica and Sanmina are three that I’m familiar with just based on my work at BD that we used quite a bit in the diagnostic area. But there are other mid-size contract manufacturers that do both disposable as well as capitaltype builds. … Working with contract manufacturers that have huge buying power and great leverage, we’re able to secure better responsiveness and better supply [than dealing with suppliers directly] as a small company on our own.”

What are some of the other outsourcing partners that you’ll use?

Mazzola: “Our system has a disposable drape that will be used to drape our patient cart. There are companies where that’s all they do, development and manufacturing of custom drapes. We partner with them not only for the manufacturing, but also the development work. … Same with things like the trocar, where we partnered with an outside design firm that will also do our initial manufacturing for our trocar. We’re going to focus on the things that we do best: some of the capital, the surgeon console and the patient cart, as well as the instrument arms and cameras. The instrument arms and cameras — which are the two other disposable elements to our system — are probably at the center of what we’re doing. It truly differentiates our technology from what’s out there right now.”

Those arms and the camera are entirely disposable?

Mazzola: “Yes, that is our goal. That’s one of the differences that we have versus some of the competitors out there. The four elements of our disposable model will be the arm, the camera, the trocar, and the drape. And the only thing that will be multi-use is the hardware, the capital, the patient cart and the surgeon console. One of the other benefits is because we’ve simplified the hardware, the capital up-front expense to a hospital is significantly less than that of our competitors right now. They built a lot of the complexity into their capital equipment.”

Is there any potential for those disposables to be reprocessed, recycled or scrapped in any way?

Mazzola: “We’re probably going to go out at a cost that is higher than what we want to get them to. But with the work

that we have going on to drive cost out of those — looking at more economic material selection, as well as looking at where we manufacture these and the scale at which we manufacture — I think that will drive the cost out. We’re designing it as single-use disposable, and I’ve worked on a lot of single-use disposables that were attempted to be reprocessed and reused. We will control what we can control.”

Vicarious Surgical had layoffs earlier this year like a lot of other medtech companies. Are we getting to the point where you think there will be rebuilding this year or next?

Mazzola: “We’re constantly being opportunistic in our hiring. And we currently have probably close to about 20 positions that we’re looking to fill, some just based on progress that we’re making and now the time has come to start filling some of those positions, and others for replacement of folks that have left for one reason or another. But we’re constantly looking at that and we’re being a little bit selective and making sure that we don’t get ahead of ourselves. I think that was part of the challenge we had with the last

[reduction in force] is that maybe we got a little bit too ahead of ourselves and were hiring for positions that were a little bit in advance of where we were as a company.”

What have you learned in your career about developing and launching products that you could share with MDO readers?

Mazzola: “What we need to do more of — rather than wait until an issue occurs and then react to it — is to be a little bit more proactive with our thinking. Understand where some risks could occur and put in plans now before they occur. That helps with driving a timeline. Throughout my whole career in medical devices, the most important thing that any product manager or project manager is faced with is time to market, a schedule. Everything has a window of opportunity, and you want to seize on that window of opportunity. Timeline management, managing to milestone is critical. And you don’t want to have surprises. So as much as you can, be proactive and contemplative in terms of what could go wrong and putting in plans now will help you manage a more aggressive timeline.”

“That’s one of the differences that we have versus some of the competitors out there. The four elements of our disposable model will be the arm, the camera, the trocar, and the drape. And the only thing that will be multi-use Is the hardware, the capital, the patient cart and the surgeon console.”

camera are small enough cavity through a single

Photo courtesy of Vicarious Surgical

Surgical Chief Operating Officer John Mazzola

Drs. Aasma Shaukat and Bara El Kurdi said tools to prevent serious complications topped their gastroenterology device innovations wishlist.

Gastroenterology is a field ripe for medical device innovation, and medtech developers know that some of the best ideas come from practicing doctors.

With that in mind, Medical Design & Outsourcing spoke with two gastroenterologists about what device innovations would help them better diagnose and treat gastrointestinal diseases.

Dr. Aasma Shaukat is the director of outcomes research at NYU Langone Health’s Division of Gastroenterology and Hepatology. She’s also the NYU Grossman School of Medicine’s Robert M. and Mary H. Glickman professor of medicine and a professor of population health.

Dr. Bara El Kurdi is a gastroenterology fellow at the University of Texas Health Science Center in San Antonio. He also serves on the American

College of Gastroenterology’s Innovation and Technology Committee. Here are the four device innovations that are on their wishlist.

1. Better devices to repair iatrogenic colonic perforation (ICP)

ICP is a rare but serious complication of endoscopic procedures. The risk increases as the complexity of procedures increases, and ICP is not uncommon with large polyp resection procedures. This limits the safety, availability and access to endoscopic procedures, which can be life-saving in cases of precancerous polyps.

Currently, rudimentary devices such as endoclips, over-the-scope clips and endoscopic suturing are used for perforation closure.

(continued on page 118)

Photo courtesy of Adobe Stock

Four gastroenterology device innovations doctors need now

Dr. Bara El Kurdi University of Texas Health Science Center in San Antonio

Dr. Aasma Shaukat NYU Langone Health’s Division of Gastroenterology and Hepatology

(continued from page 116) However, clips are often small and only work for a limited subset of simple perforations. Endoscopic suturing can work for large perforations, but is technically challenging and timeconsuming, thereby limiting its use to a few highly experienced providers. We need improved, easy-to-use devices which can be utilized for complex perforations and be accessible to endoscopists without extensive training.

2. Sustainable endoscopy devices Endoscopy is resource-intensive and generates a surprising amount of greenhouse gas (GHG) emissions and waste. The average colonoscopy produces 18 kg of CO2 equivalent (CO2e), which is equivalent to driving 70 km in a car. Based on recent studies, endoscopy units in England produce about 5,000 tonnes of waste per year, which is equivalent to filling 500 double-decker buses.

Additionally, most endoscopic tools are single-use plastic devices and accessories such as endoscopes, biopsy forceps, snares, polyp traps, mouthguards, oxygen tubing, etc. These devices are often made from non-recyclable materials and require energy-intensive manufacturing and disposal processes. And recently, there has been a push for the adoption of single-use endoscopes to reduce risk of infection. Therefore, we need green endoscopy products to reduce the environmental impact of endoscopy procedures. Green endoscopy products are products that use less energy, water and materials, or use renewable, recyclable, or biodegradable resources.

3. Automated defecation training using a pressure-sensing kegel weight for patients with dissynergic defecation Dyssynergic defecation is a condition where the pelvic floor muscles do not coordinate properly during bowel

movements, resulting in incomplete evacuation of feces. This can cause chronic constipation, abdominal pain, bloating, and other symptoms.

We often treat dyssynergic defecation with biofeedback therapy, which involves teaching patients how to relax and contract their pelvic floor muscles in response to sensory feedback from their rectum. This usually requires multiple sessions with a trained therapist who monitors the patient’s muscle activity using special sensors. However, biofeedback therapy can be costly, timeconsuming, and inconvenient.

Therefore, there is a need for alternative methods that can provide similar benefi ts without requiring professional supervision. One possible solution is automated defecation training using a pressure-sensing kegel weight. A kegel weight is a device that can be inserted into the vagina or anus to strengthen the pelvic fl oor muscles by providing resistance. A pressure-

sensing kegel weight can also measure the pressure inside the rectum and provide feedback to the patient through vibrations or sounds. The patient can use this feedback to learn how to relax and contract their pelvic fl oor muscles during defecation.

4. Polyp screening test that does not require a bowel preparation

Currently, colonoscopy remains the gold standard in colon cancer and colon polyp screening. However, it is limited by cost and need for bowel preparation prior to procedures.

Bowel preparation entails drinking large amounts of laxatives to clean out the colon prior to visual inspection by the endoscopist. This is often very difficult and is poorly tolerated by patients. Failure to clean the colon results in poor visualization during the test and missed lesions, which could be cancerous or precancerous.

Alternatives to colonoscopy, such as stool-based tests, perform well in detecting cancer but not in detecting precancerous lesions such as polyps. Therefore, there is a need for polyp screening tests that can detect precancerous lesions without requiring bowel preparation.

Expanding production capacity To meet your medical device needs

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The latest addition to our global footprint is a newly facilitated 32,000 sq. ft. location in Costa Rica featuring clean room assembly and light manufacturing. This facility, located in the Zona Franca Metro Business Park, achieved ISO 13485:2016 certification for its Medical Device Quality Management System in October of 2022.

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Boston Scientific’s market capitalization has grown nearly 10 times larger since Mike Mahoney joined as CEO in 2011. He shared key insights about corporate strategy at DeviceTalks Boston in May.

CHRIS NEWMARKER EXECUTIVE EDITOR

Boston Scientific is one of the bright spots as the medical device industry goes through a rough patch.

It’s more expensive to run a business, and health provider customers face operational challenges. But while other medtech companies are laying off workers, Boston Scientific is hiring. The interventional medical device giant’s workforce grew 10% over the past year to 45,000 employees.

Boston Scientific sales grew 6.7% to $12.7 billion in 2022, and CEO Mike Mahoney and other top company officials expect it to grow another 10.5–11.5% this year.

“Thankfully, we have a very strong innovation cadence right now. In Europe, we grew 20% [operationally] in the first quarter. So why I’m so bullish about the future is many of the products that are driving that growth in Europe are going to be launching in the U.S. from now over the next two years,” Mahoney said during a keynote interview at our annual DeviceTalks Boston show in early May.

(continued on page 122)

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(continued from page 120)

Mahoney went on: “It’s always about the innovation that we’ve created that’s driving the growth, and we’ve got an excellent operations/supply chain team with great depth globally that have helped us manage the supply chain issues better than most.”

BSX shares were selling for under $6 apiece when Mahoney joined the company as CEO in October 2011. They’re now regularly trading at more than $50 apiece.

So how did Mahoney lead Boston Scientific to this point? Here are five leadership themes that came out of his DeviceTalks Boston talk:

1. Find the courage to take on new challenges.

Back in 2011, Mahoney was running Johnson & Johnson’s medical device business, one of the largest in the world. Meanwhile, Boston Scientific faced slack demand for its ICDs and stents while grappling with debt and legal issues, and CEO Ray Elliott unexpectedly announced he was leaving.

At the time, Mahoney was in his mid40s, so he thought he had time for the

challenge. “I felt like I was ready to take on a company that was in trouble and have a chance to turn it around.”

“I think they ultimately hired me because they couldn't find an experienced CEO who wanted it,” he joked.

He was motivated but had doubts. He personally recruited a consultant to help him decide. The day before he interviewed with Boston Scientific, the consultant gave him a binder with an analysis that basically told him to stay at J&J.

“I called him on my way home from the interview. He goes, ‘You must be so relieved to not take this job and go to New Jersey on Monday morning.’ I said, ‘I took the job.’ He was like, ‘What the F-bomb,’” Mahoney said.

So what happened?

“I'm at the interview, not sure if I want the job. And they actually said to me, ‘We're not sure you want the job.’ I'm thinking to myself, ‘How do they know? How do they know that?’” Mahoney recalled to laughter.

He asked to be excused from the interview and went to the men’s room. “I finally looked at myself in the mirror … and said, ‘Mike, it’s Monday morning. You didn’t take the job. How do you feel?’

And my whole body went, ‘Ugh.’ And I came back, and I said, ‘I want this job.’ And they ended up hiring me.”

Mahoney summed it up: “I did it because it was a massive challenge, and with a little bit of time, we could do it. It’s a special place.”

2. Help your company find its inner startup mentality.

Mahoney honed his leadership style during his stint in the early 2000s as the founding CEO of healthcare supply chain management company GHX. GHX now serves more than 19,000 healthcare facilities.

Of being a startup CEO, Mahoney said, “You’re worried about the balance sheet and cash flow and starting a company and culture literally from the ground up.”

A few months into the Boston Scientific job, he had a business dinner where an executive congratulated him. “He goes, ‘Your company is like an aging elephant.’ I’m like, ‘Holy cow.’”

Mahoney used that moment as a motivator to go into startup mode at Boston Scientific and remove management layers.

(continued on page 124)

“I felt like I was ready to take on a company that was in trouble and have a chance to turn it around.”

DeviceTalks Editorial Director Tom Salemi (left) interviews Boston Scientific CEO Mike Mahoney at DeviceTalks Boston.

Photo by Jeff Pinette for Medical Design & Outsourcing

Full Product Lifecycle

(continued from page 122)

He wanted less corporate bureaucracy between him and the people leading operations on the front lines.

“We actually thought of it as a startup: ‘Let’s create Boston Scientific,’” Mahoney said. “We created ‘Advancing Science for Life.’ We changed the colors of the company. We created new values as a company. Like, you don’t do that with established companies. We started over: ‘This is the company we want to be 10 years from now.’ We really excited our leaders around that.”

demand is strong, and positive data continues to roll in as Boston Scientific seeks FDA approval in 2024.

“That easily could have not worked out, but it worked out fantastic,” Mahoney said of Farapulse. “And so that one deal will make up for four early-stage investments that completely flopped or maybe 10 investments that completely flopped.”

4. But don’t venture too outside your wheelhouse. One area where Boston Scientific never really considered expanding into was surgical robotics, Mahoney said. These days, the move appears wise considering the challenges large medtech companies such as Medtronic, Johnson & Johnson and Siemens Healthineers have experienced when competing against Intuitive in soft-tissue surgical robotics.

“We’re in interventional medicine — so catheters get stuff anywhere in your body, and hopefully, you're out in the same day,” Mahoney said.

5. Company culture is key — and it must be local.

“We want leaders to run our companies, not managers,” Mahoney said of Boston Scientific’s culture.

One of the important changes that Mahoney ushered into the company involved completely changing the operating model so there were business unit leaders with global responsibility.

As an example, he mentioned Meghan Scanlon, Boston Scientific SVP and president of urology, who also spoke at DeviceTalks Boston. “As a leader, she's able to align resources where she wants around the world. … It gives her the flexibility to do that and to prioritize R&D projects without having to go through me or a bunch of other people to do that, because we empower her as a leader.”

3. Be willing to take risks to innovate and grow.

Mahoney also steered Boston Scientific toward more innovative, fast-growing areas. When he joined, drug-eluting stents and cardiac rhythm management made up more than half of the company’s portfolio mix. Today, it’s 15%.

“We really modifi ed the portfolio quarter after quarter through M&A, through alliances, through organic R&D consistently over 10 years to put ourselves in faster growth markets along the way,” Mahoney said.

The push to innovate means there are going to be failures. Mahoney acknowledged that many companies in Boston Scientific’s venture portfolio haven’t worked out. “You’re better off … taking a swing than constantly waiting.”

“If you're going to get that large, the size of some of our bigger competitors, you need big things to work, to grow faster. And oftentimes, you can't play it safe all the time with innovation M&A and win that way.”

Mahoney recalled how Boston Scientific first invested in Farapulse and its pulsed-field ablation technology for treating atrial fibrillation (AFib) nine years ago, eventually acquiring the company for nearly $300 million in 2021. The system is already available in Europe, where

He sees the company continuing to expand into more interventional procedures where patients receive sameday treatments and go home. “What we try to do is disrupt general surgery.”

Meanwhile, “Intuitive is an amazing company, and what they do is best-in-class.”

“We haven't had the clinical need to have a robot, nor will we be very good at it. … I don’t think an Intuitive would ever be as good at med devices as we are. And we’ll never be as good at robots as they are.” Mahoney said, later continuing: “I think sometimes you have to know what you’re really good at to avoid wasting a lot of money.”

wasting

Mahoney doesn’t just want leaders at the top of businesses, either, because a person often defines their employer based their immediate boss. “A culture is local. … It's often what your supervisor or manager is,” he said.

“We really try to go deeper in the organization with our great HR teams and our leaders to really push that culture.”

Mahoney also said that company culture and the search for innovation is not a box a business leader can check off before moving on.

“As soon as you get settled on people and on innovation, then your growth slows, then you lay off people. So you have to be really restless on making sure you have great talent and culture and innovation.”

“If you’re going to get that large, the size of some of our bigger competitors, you need big things to work, to grow faster.”

The Farapulse pulsed-field ablation system's Farawave catheter (pictured) uses an energy field to treat atrial fibrillation. Image courtesy of Boston Scientific

Keep an eye on these startups as Big 100 medtech firms race to build — or buy — digital technology.

JIM HAMMERAND MANAGING EDITOR

Digital health startups are breaking ground with new medtech innovations in wearable devices, software, robotics and patient personalization.

A wide range of digital technologies promise to increase the safety and effectiveness of patient care while lowering costs for healthcare providers still struggling with financial challenges from the COVID-19 pandemic.

The world’s largest medical device developers and manufacturers are racing to add and improve digital technology in their portfolios. They can fast-track those initiatives by purchasing digital health startups, strategic acquisitions with the additional benefit of bringing potential future competitors onto their team.

With so many impressive and intriguing digital health startups in medtech, it’s hard to know which to keep tabs on. So we’ve identified some of the most exciting digital health startups to watch this year.

Hinge Health

Hinge Health might be the most valuable digital health startup based on its $400 million Series E in 2021 that valued the company at $6.2 billion.

The Digital Musculoskeletal Clinic developer aims to reduce surgeries and opioid use for joint and muscle pain by offering a combination of motion technology, wearable pain relief devices and physical therapists, physicians, and board-certified health coaches.

(continued on page 128)

Hinge Health provides at-home musculoskeletal therapy with wearable devices and motion technology.

Photo courtesy of Hinge Health

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With a strategic focus on quality and personal service, we help our clients ensure the safety and efficacy of their products by delivering unparalleled testing services with complete, compliant and accurate data.

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(continued from page 126)

Hinge Health has raised more than $1 billion from investors. The company said it landed more customers in 2022 than the previous seven years combined and now serves 25 million members through more than 1,250 customers such as Boeing, Google and Verizon.

This year, Hinge Health hired James Budge as CFO and Deborah Conrad as the company’s first chief marketing officer.

Cognixion

Cognixion won FDA breakthrough designation this year for its noninvasive Cognixion One Axon brain-computer interface augmented reality device.

The wireless device is designed to facilitate communication and interaction for severe motor impairment patients who can’t use eye-tracking technology due to ocular motor decline.

Breakthrough device designation means the FDA sees big potential in the system and will allow Cognixion to accelerate its next regulatory submission. The breakthrough designation “validates the potential of our technology to make a real difference in the lives of individuals with severe motor impairments and underscores the importance of how AI can be used to assist people in everyday situations,” Cognixion founder and CEO Andreas Forsland said.

Proprio

Proprio won FDA clearance this year for its AI-powered Paradigm platform, which uses light field technology in spine surgery navigation for the first time. The radiation-free system’s sensors are designed to help surgeons better visualize procedures and complete them faster Proprio CEO Gabriel Jones founded the startup in 2016 with Seattle Children’s Hospital neurosurgeon Dr. Samuel Browd, University of Washington professor Joshua Smith and computer vision specialist James Youngquist.

Ceribell

Ceribell makes a portable electroencephalogram (EEG) device to help quickly diagnose seizures in acute care situations. Cleared by the FDA in 2017, the system uses a headband and handheld recorder to continuously monitor

brain activity. The FDA gave the system breakthrough device designation last year for detecting acute brain failure, an indicator of an ongoing brain injury.

Ceribell raised $105.2 million last year. This year, Fast Company named Ceribell as one of the most innovative companies in the world.

“With an unparalleled combination of machine learning and ease of use, Ceribell empowers healthcare providers to quickly and confidently make decisions, setting a new standard of care for critically ill patients,” Ceribell co-founder and CEO Jane Chao said when announcing the recognition.

Endiatx

What more can we say about Endiatx, the developer of a swallowable, swimming robot to help gastroenterologists diagnose stomach problems?

After we introduced the wirelessly controlled PillBot to the world last year, Endiatx inked a partnership with Mayo Clinic and closed an oversubscribed $1.5 million seed round. Most recently, they won the 2023 American Gastroenterological Association Tech Summit Shark Tank competition and took top honors for gamechanging innovation at the Edison Awards.

“Our biggest technical goal is that we must improve our video quality substantially and we are on the verge of a breakthrough,” Endiatx co-founder and CEO Torrey Smith said.

Somatus

Somatus’ $325 million Series E funding round was one of the largest healthcare venture capital deals last year. The company’s proprietary RenalIQ kidney care platform tracks patient health and identifies at-risk patients using predictive analytics and machine learning algorithms.

In November 2022, the company said it became the first and only kidney care company to win Validation Institute certification for its claim that kidney disease (continued on page 130)

“We are on the verge of a breakthrough.”

1) The Cognixion One Axon Image courtesy of Cognixion

2) Proprio’s Paradigm system monitors procedures in real time with four cameras, using sensors and AI to stitch the images together. Photo courtesy of Proprio

3) Ceribell’s EEG system

Photo courtesy of Ceribell

4) Endiatx co-founder and CEO Torrey Smith holds a prototype of the swallowable PillBot.

Photo by Hardy Wilson for Medical Design & Outsourcing

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(continued from page 128) patients who receive Somatus Transition of Care Assessment (TCA) services have fewer hospital readmissions than similar patients who don’t receive TCA services.

This year, company has launched and expanded partnerships with nephrology providers.

“Together, we will deliver the best care and services to our patients to slow disease progression, achieve more healthy days, and improve quality of life,” Somatus cofounder and CEO Dr. Ikenna Okezie said.

Biofourmis

Biofourmis raised more venture capital funding than any other medical device developer last year with its $320 million Series D round. Last February, the company launched Biofourmis Care, offering remote care for patients with heart failure, hypertension, diabetes, lipid management or atrial fibrillation.

The software-as-a-medical-device (SaMD) developer has FDA 510(k) clearances for its Biovitals Analytics Engine and RhythmAnalytics devices, which use proprietary algorithms to measure and analyze health data.

Biofourmis CEO Kuldeep Singh Rajput said at this year’s J.P. Morgan Healthcare Conference that the company is “building a specialty network of physicians” as its second go-to-market strategy. “We see ourselves in the future as a provider,” he told Axios.

The company recently entered into a partnership with Chugai Pharmaceutical Co. to objectively measure pain in endometriosis patients.

Cera

Cera was another leading medtech fundraiser last year with its $312.35 million Series C round.

The elder care platform uses artificial intelligence algorithms to predict patient deterioration, and users of its app can schedule appointments and track symptoms, vital signs, medications, nutrition and activity in real-time.

With the need for elder care increasing as global populations age and demand climbing for elder care providers, watch Cera as it deploys cash from its latest funding round to expand.

Avail Medsystems

Avail Medsystems is building a network of operating room consoles that can show

remote experts what’s going on and let them communicate with the surgeon in real-time. It’s pitched as a way to let surgical experts and medical device representatives be in more places than if they were traveling in person.

Avail recently partnered with Medtronic Neurovascular to let neurosurgeons use Avail’s operating room consoles during stroke procedures — and connect virtually with other surgeons or Medtronic for assistance, training or other real-time communication.

“It’s a beautiful platform and a beautiful technology ... to engage with the physician who’s working through the procedure,” Medtronic Neurovascular President Dan Volz said in an interview.

Avail is also opening its hardware up for third-party software developers this year, making it easier for software-as-amedical-device (SaMD) makers to get into operating rooms.

Cleerly Health

Cleerly Health, the developer of FDAcleared diagnostic solutions driven by machine intelligence, raised $223 million last year for its AI-based software designed to spot atherosclerosis based on coronary computed tomography (CT) angiograms.

Last year’s Series C round followed a $43 million Series B fundraise in 2021, announced when the company launched its digital care software for heart attack prevention.

This year, the company brought on two new leaders: CFO Krissy Wright and Regulatory Affairs EVP Sandra Statz. Wright was previously VP and GM of Brain Modulation at Medtronic and CFO of the Neuromodulation operating unit before that, while Statz was SVP of Clinical and Regulatory Affairs at Exact Sciences Corp.

Casana

Once you get past the jokes about a toilet seat that checks your vitals, it’s easy to see how Casana’s Heart Seat could save lives from hypertension.

The FDA recently cleared Heart Seat for home heart monitoring. The seat collects data when in use and uploads it to the cloud for review by a healthcare provider. The company plans to expand to systolic and diastolic blood pressure monitoring sometime this year.

“The healthcare system has been searching for this actionable intelligence for decades, and it turns out, we were sitting on a great idea all along,” the company said in announcing the FDA clearance.

1) Somatus co-founder and CEO Dr. Ikenna Okezie

2) Cleerly Health CFO Krissy Wright

3) The Casana Heart Seat Photo courtesy of Casana

Specializing in Class III and II medical devices and components, our staff of engineers and manufacturing experts stands ready to help you succeed at any or every stage of your product development cycle, including design/development, manufacturing and finished device assembly.

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demanding medtech problems at DeviceTalks West

In the medical device industry, stubborn problems can cost millions in development expenses and delay the introduction of new life-saving tools and technologies.

That’s why we build our DeviceTalks meetings as a forum where successful medical device engineers, manufacturers and market-builders can share their best practices, providing solutions that help clear hurdles, speed product development and potentially save lives.

DeviceTalks attendees leave our meeting with notebooks full of critical advice and pockets full of business cards. We’ll help fill both at DeviceTalks West, which takes place Oct. 18-19 at the Santa Clara Convention Center in California. You can view the full agenda on our website, west.devicetalks.com.

In building the agenda, we identified diseases and conditions that have inspired significant leaps in innovation, including cardiovascular, diabetes, heart disease, neurological, mental health, stroke, and structural heart. Then we layered upon those needs the technologies that have emerged to

help patients better overcome those conditions, such as catheters, digital surgery, heart valves, interventional tools, pulse generators, robotics, sensors, wearables and other technologies.

PROBLEM: Battling cardiovascular disease

SOLUTION: We’ll draw insights and inspirations from sector leaders and startups. In an opening keynote interview with Abbott SVP and Vascular President Julie Tyler, we’ll talk about Abbott’s growing vascular portfolio and its recent acquisition of Cardiovascular Systems. We’ll also hear from startups in the space.

PROBLEM: Treating stroke patients sooner

SOLUTION: The message “Time is Brain” drives innovation from neurovascular companies, as we’ll hear from two of the field’s leaders. Imperative Care will share how the company is adding digital health and robotics to its innovative catheter delivery designs. Attendees will hear from senior executives as well as co-founder, Chair and CEO Fred Khosravi, who will sit down for a keynote interview.

(continued on page 134)

ABBOTT JOHNSON & JOHNSON MEDTECH

DAVE

ROSA FRED KHOSRAVI JULIE TYLER HANI ABOUHALKA

to your most

Add some essentials to your toolbox with engineering expertise from our upcoming show in California.

(continued from page 132) Stryker is also sending a team of design experts from its neurovascular business led by R&D VP John Daniel.

PROBLEM: Developing devices to treat drug-resistant neurological disorders and mental health

SOLUTION: Neuromodulation companies employing different approaches to directing energy to critical parts of the nervous system are reporting encouraging data from clinical trials and commercial launches. Boston Scientific will report on its partnership with software company Brainlab AG to provide improved deep brain stimulation. Attendees can also connect with emerging entrants and more established startups such as Cala Health, SetPoint Medical and Synchron.

PROBLEM: Building better diabetes devices

SOLUTION: Over the past few years, people managing their diabetes are getting powerful tools to keep their conditions under control. DeviceTalks West attendees will have the opportunity to connect with senior executives involved with two of the more successful devices in the market. Marc Taub, divisional VP of technical operations for Abbott’s diabetes business, will speak to the success of the Freestyle Libre system. In a separate session, Mark Field, SVP and chief technology officer of Insulet, will sit down for an interview about the design and build efforts that went into the Omnipod 5 insulin pump.

PROBLEM: Mending or repairing a failing heart SOLUTION: In multiple presentations we’ll hear from companies developing the most successful — and most promising — devices used to treat heart failure. Santosh

Prabhu, divisional VP of global product development for Abbott’s Structural Heart business, will sit down with interventional cardiologist Dr. Frederick St. Goar to talk about the lessons learned from two decades of the MitraClip, the world’s first transcatheter mitral valve repair (TMVR) therapy used to stop a leaky heart. In a separate talk, Dr. Lars Søndergaard, Abbott Structural Heart chief medical officer, will lead a discussion about pumps and valves aimed at providing life-saving support for children suffering from heart failure.

PROBLEM: Collecting, managing and interpreting medical device data SOLUTION: In multiple sessions, experts will share the tools, technologies and systems that enable medical devices to better utilize data. Canary Medical co-founder and CEO Dr. Bill Hunter will present his company’s work on developing a new line of sensors for smart medical devices. Canary already has a partnership with Zimmer Biomet for data-collecting knee implants. Ha Hong, chief AI officer at Medtronic Gastrointestinal, will examine how the company is using AI technology and discuss strategy, best practices and recent AI innovations.

PROBLEM: Streamlining surgery with robotics, data and telecommunications SOLUTION: We’ll explore the design, economics and broader opportunities for surgical robotics. Keynote interview guests include Intuitive President Dave Rosa and Hani Abouhalka, company group chairman, robotics and digital surgery at Johnson & Johnson MedTech, which is developing its own soft-tissue robotic surgery system. Kathryn Rieger, senior director, human factors and user research at Intuitive, will also explore the company’s approach to human-

centered design. In multiple discussions, attendees will hear from Moon Surgical, Avail Medsystems and other leaders in the space. People and process matter too, so we included discussions around building better product management systems, humancentered design, scaling up manufacturing lines, licensing out university technologies and building stronger startups.

PROBLEM: Limits in engineering careers

SOLUTION: The conference will open with a panel providing engineers with advice to help them further their careers. (And networking breaks throughout our show are great opportunities to build relationships.)

PROBLEM: Startup costs

SOLUTION: In multiple panels attendees will hear from investors, executives and others who can give practical advice for starting a company. We’ll also hear from the leader of the new FDA Total Product Life Cycle Advisory Program (TAP) to help startups pass through regulatory review and win approval more easily.

PROBLEM: Sterilization of medical devices

SOLUTION: The search continues for sterilization alternatives to ethylene oxide. Hear from executives at entities developing new technologies that can help medical device companies ensure their products are safe and ready for clinical use. These are just some highlights. Track the progress of our agenda and speaker rolls at devicetalks.com.

But we hope you see the event as more than just an opportunity to network and connect. We’re building these conferences — as well as our podcasts and digital meetings — as essential tools to helping medtech professionals do a better job.

We built this network for you.

We built this network for you.

expertise you

count on end-to-end.

expertise you can count on end-to-end.

With 25 sites around the globe, 100’s of design and manufacturing experts, and world-class supply chain capabilities, our expansive network is here to help you deliver your medical device projects at the speed, cost, and quality level you expect. Together, we’re in it for life.

With 25 sites around the globe, 100’s of design and manufacturing experts, and world-class supply chain capabilities, our expansive network is here to help you deliver your medical device projects at the speed, cost, and quality level you expect. Together, we’re in it for life.

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Why do medical professionals have so much confidence in our devices, sets and kits? It starts with five decades of contract manufacturing. The pharmaceutical industry relies on us to build custom kits with all the devices necessary to dispense and administer your drug. Our product portfolio contains hundreds of standard components plus capabilities including design, regulatory, manufacturing, packaging and sterilization. Think of us as your best, most direct route to market. After all, our devices and capabilities do more than simply meet expectations. They deliver confidence. Always have. Always will.