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EDWARDS INNOVATION Resilia’s co-inventor discusses the tissue, how it was developed and how it’s made.
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J&J’S
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EDWARDS INNOVATION Resilia’s co-inventor discusses the tissue, how it was developed and how it’s made.
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2026
September 2026 • Vol.12 No.5 • medicaldesignandoutsourcing.com
LEADERSHIP IN MEDTECH PRESENTED BY
HELP US HONOR THE COMPANIES THAT HAVE PROVIDED THE MOST LEADERSHIP IN THE MEDICAL TECHNOLOGY INDUSTRY.
EDITORIAL
CREATIVE SERVICES
PRODUCTION SERVICES
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VP, Creative Director Matthew Claney mclaney@arrowfly.com
Customer Service Manager Stephanie Hulett shulett@arrowfly.com
Managing Editor Jim Hammerand jhammerand@arrowfly.com
DIGITAL MARKETING
Customer Service Rep Tracy Powers tpowers@arrowfly.com
Senior Editor Sean Whooley swhooley@arrowfly.com Associate Editor Skyler Rivera srivera@arrowfly.com
The medical device industry wrapped up another year with more blockbuster mergers grabbing headlines around the world and new, innovative technologies emerging seemingly every day.
Editorial Director DeviceTalks Tom Salemi tsalemi@arrowfly.com
Portfolio Marketing Manager McKenzie Burns mburns@arrowfly.com
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Customer Service Rep JoAnn Martin jmartin@arrowfly.com
2014 - 2016
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This level of success wouldn’t be possible without the innovation, ingenuity and determination of the people who drive it: leaders. These individuals and companies are working for the growth of the entire medical device industry.
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Medical Design & Outsourcing
9 • 2026
9/3/26 2:52 PM
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HERE’S WHAT WE SEE
The MDO Medtech Big 100 is bigger than ever
M
edical Design & Outsourcing’s Medtech Big 100 is the authoritative ranking of the world’s largest medical device companies, and after many months of work we proudly present you with our 2026 edition. Total revenue has broken the halftrillion-dollar mark for the first time as R&D spending and total employment grew from last year. But before you dive into our Medtech Big 100 rankings and industry analysis, I want to explain why this project is so special and worth the time and energy our team spends every year compiling and crunching data. For more than a decade, the Medtech Big 100 list has definitively ranked the top medical device developers and manufacturers. Our team procures data from public filings and our sources within the industry, and then reaches out to every single company to confirm our facts and figures. Beyond the revenue rankings, we rank companies by R&D spend and employment in this issue and last year started publishing a supplemental R&Dfocused special report with more details, which you’ll soon be able to download at wtwh.me/2026big100 for free. Other rankings include a fraction of the 100 device businesses we include, or include revenue from pharmaceutical sales and other business segments beyond medical devices. But we invest the extra effort to make sure our
Medtech Big 100 ranking meets the needs of our readers. For medical device professionals at OEMs, the Medtech Big 100 grants bragging rights and helps identify competitive trends and opportunities for innovation and career-building. For device pros at contract manufacturers, suppliers and other external vendors, the Medtech Big 100 can identify new partners and offer a window into the OEM world to better understand their needs and trajectories. The Medtech Big 100 also recognizes leaders in R&D, which is the lifeblood of our industry. For many medtech pros, R&D is the most challenging, exciting and rewarding stage of the medical device lifecycle before actually seeing commercialized products making a difference for patients in the real world. This project would not be possible without the help of the companies on this list (and those who missed the cut this time around), our sponsors and the entire MDO team. That includes Senior Editor Sean Whooley, whose invaluable work on this year’s project will be his last as he pursues a new opportunity abroad. To learn more about the Medtech Big 100, please join our team for a live webinar on Sept. 24 or watch the replay when it’s available on-demand. As always, I hope you enjoy this edition of Medical Design & Outsourcing. Thank you for reading.
Jim Hammerand | Managing Editor | Medical Design & Outsourcing | jham me r a n d @ a r ro w fl y. c o m |
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Medical Design & Outsourcing
9 • 2026
www.medicaldesignandoutsourcing.com
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CONTENTS
• • • • • THE BIG 100 ISSUE
medicaldesignandoutsourcing.com • September 2026 • Vol. 12 No. 5
DEPARTMENTS
FEATURES
06 HERE’S WHAT WE SEE:
The MDO Medtech Big 100 is bigger than ever
52
55
57
CARDIOVASCULAR:
St. Jude Medical founder Manny Villafaña says his newest device will be bigger than anything he’s ever done
IMPLANTS:
Medtronic R&D VP James Coles offers a defib pipeline preview
MATERIALS:
SPECIAL ISSUE 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.
Why Boston Scientific is betting $1.5 billion on this superalloy
60 NITINOL:
First Look: Boston Scientific’s next-gen Farawave Ultra PFA catheter
63 ORTHOPEDICS:
How ZB’s Paragon 28 created a novel curved foot nail system
66 PEDIATRICS:
How Philips and Disney are improving children’s MRI experience
69 DEVICETALKS:
Advice from the pros for building a medtech career
8
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9 • 2026
44 10
49
MEDTECH BIG 100 BREAKDOWN 10 RANKED BY REVENUE 36 MEDTECH BIG 100 ANALYSIS 38 R&D RANKINGS 42 HEADCOUNT RANKINGS
44 THIS EDWARDS INNOVATION MAY HAVE SOLVED
THE LEADING CAUSE OF TISSUE VALVE FAILURE
Resila’s co-inventor discusses the tissue, how it was developed and how it’s made.
47
Edwards Lifesciences makes a simple change for a first-of-its-kind tricuspid valve
49 J&J’S ROBOTICS R&D HEAD DISCUSSES OTTAVA’S
FOLDING ARMS, SOOTHING SOUNDS AND HAPTICS CAPABILITY
J&J MedTech Global Head of Robotics & Digital R&D Neda Cvijetic shares what it took to win FDA de novo authorization for the surgical robot. www.medicaldesignandoutsourcing.com
9/3/26 3:02 PM
You Dream It
We Build It
They Live It
Innovation does more than simply advance technology — in healthcare, it changes lives for the better. Jabil brings deep experience in material selection, miniaturization, sensor integration, advanced prototyping, and precision micro-assembly to the production of your minimally invasive devices and complex catheters.
Manufacturing Healthy Outcomes jabil.com/healthcare M E D T E C H | D I A G N O S T I C S | O RT H O P E D I C S | P H A R M A S O L U T I O N S
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E
THE 2026 MEDTECH BIG 100: THE WORLD’S LARGEST MEDICAL DEVICE COMPANIES
2026 RANK
2025 RANK
COMPANY
REVENUE ($USD)
1
1
Medtronic
$36,364,000,000
2
2
Johnson & Johnson MedTech
$33,792,000,000
3
3
Medline Industries
$28,432,000,000
4
4
Siemens Healthineers
$26,427,775,000
5
5
Stryker
$25,116,000,000
6
8
Abbott (medical device segment)
$21,387,000,000
7
6
GE HealthCare
$20,625,000,000
8
7
Royal Philips
$20,163,120,400
9
9
Boston Scientific
$20,074,000,000
10
10
BD (medical and interventional segments)
$18,544,000,000
11
11
Henry Schein
$13,184,000,000
12
12
Cardinal Health
13
14
Baxter
$11,244,000,000
14
15
B. Braun
$10,623,569,840
15
16
Alcon
$10,401,000,000
16
17
Intuitive Surgical
$10,064,700,000
17
18
Zimmer Biomet
$8,231,500,000
18
19
Terumo
$7,567,611,116
19
20
Fujifilm Holdings (healthcare segment)
$7,347,130,347
20
21
Olympus
$6,757,273,920
21
22
Smith+Nephew
$6,164,000,000
22
24
Edwards Lifesciences
$6,067,600,000
23
23
Steris
$5,935,900,000
24
26
Resmed
$5,146,327,000
(global medical products and distribution segment)
$12,636,000,000
(continued on page 12) 10
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9 • 2026
ven after its diabetes tech business went public as MiniMed, Medtronic remained at the top of our Medtech Big 100 ranking of medtech companies based on revenue. With Johnson & Johnson MedTech planning to split off its DePuy Synthes orthopedic device business by mid-2027, Medtronic appears set to continue its reign as the largest medtech business in the world. That’s but one of many insights we've gleaned from this year’s Medtech Big 100, an annual report that we’ve produced for over a decade. We’re seeing major companies such as Abbott, Intuitive, Edwards Lifesciences, and Dexcom advancing up the list through a focus on innovation. Private equity, already heavily involved in the medtech industry contract manufacturing space, is increasingly getting active making deals in the OEM space, taking companies private. Managing Editor Jim Hammerand and Associate Editor Skyler Rivera have more about these trends and additional developments in their Big 100 analysis. It’s a real honor to be so heavily involved in this essential reference work for our industry. If there’s only one issue of MDO that I can bring to a networking meeting, it’s the Medtech Big 100. I hope you find it useful! Keep on innovating,
Chris Newmarker Chris Newmarker Editor-in-chief Medical Design & Outsourcing
www.medicaldesignandoutsourcing.com
9/3/26 1:32 AM
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2026 MEDTECH COMPANIES RANKED BY REVENUE (continued)
Methodology The Medtech Big 100 includes information on the 100 largest medtech businesses in the world, ranked by annual revenue, with nonU.S. currency amounts converted to dollars using the Federal Reserve’s exchange rates table. We’re providing a thoroughly researched, curated report on the industry — an annual reference work on the lay of the land of medtech. For the purposes of this report, we define a medtech as a company that manufactures and supplies physical devices and equipment for the cure, mitigation, treatment, or prevention of medical conditions. To give our audience insights into the diverse medtech landscape, we cast a wide net, including makers of visionand hearing-treating technology, dental devices, and diagnostic scanners and equipment. We gather the data from regulatory disclosures filed with the U.S. Securities and Exchange Commission and annual reports from foreign and privately held firms, as well as other sources of publicly available data. In the case of conglomerates such as Johnson & Johnson and Abbott, we separate out the medtech businesses. For many companies, we include data they share directly with us. The report includes annual revenue, annual R&D spending, employee headcounts, top leadership, headquarters location, website, and descriptions based on the latest news from MassDevice and MDO. We have made efforts to double-check facts with all of the companies on the list. A majority of the companies on the list have fiscal years based on calendar years, but some have fiscal years for which we’ve collected data as recently as April 2026. For companies with fiscal years ending in June or September (for example, Siemens Healthineers, BD, Cardinal Health, and Resmed), we used 2025 data because their annual reports do not come out in time to align with our production cycle. (continued on page 14) 12
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9 • 2026
2026 RANK
2025 RANK
COMPANY
REVENUE ($USD)
25
28
Fresenius Medical Care (healthcare products)
$4,990,044,425
26
27
Solventum (MedSurg segment)
$4,817,000,000
27
30
Dexcom
$4,662,000,000
28
25
Mindray
$4,630,561,308
29
29
Sonova
$4,341,842,264
30
33
Coloplast
$4,214,584,877
31
31
Hologic
$4,100,500,000
32
34
CooperCompanies
$4,092,400,000
33
32
Align Technology
$4,034,964,000
34
37
Hoya (life care segment)
$3,949,244,694
35
36
Canon Medical
$3,881,977,902
36
35
Dentsply Sirona
$3,680,000,000
37
40
Getinge
$3,566,081,991
38
39
Nipro (medical segment)
$3,500,801,639
39
43
Straumann
$3,137,137,869
40
n/a
MiniMed
$3,102,000,000
41
44
Carl Zeiss (medical technology segment)
$3,057,142,400
42
47
Globus Medical
$2,938,931,000
43
42
WS Audiology
$2,915,817,400
44
46
Paul Hartmann
$2,769,539,241
45
48
Envista
$2,719,500,000
46
45
Amplifon
$2,708,578,420
47
54
Insulet
$2,708,100,000
48
n/a
Zoll Medical (part of Asahi Kasei)
$2,700,000,000
49
n/a
Karl Storz (medical segment)
$2,600,380,000
50
51
Convatec
$2,439,000,000
51
49
Cook Medical
$2,400,000,000
52
55
Dräger (medical division)
$2,256,225,360
53
52
Enovis
$2,248,049,000
54
50
ICU Medical
$2,231,262,000
55
41
Teleflex
$1,992,713,000
56
56
Integer
$1,853,637,000
57
57
Elekta
$1,704,874,567
58
58
Integra LifeSciences
$1,635,245,000
59
n/a
Plexus (healthcare/life sciences segment)
$1,629,300,000
60
60
Nihon Kohden
$1,571,847,300
61
53
Masimo (now part of Danaher)
$1,526,900,000
62
59
Cochlear
$1,519,491,000
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9/3/26 3:05 PM
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9/3/26 12:45 AM
2026 MEDTECH COMPANIES RANKED BY REVENUE (continued)
(continued from page 12)
We're counting revenue differently this year than last year for one company. This year we included a portion of Asahi Intecc’s device segment. Last year, we only included its medical segment. As medical component sales have increased for two consecutive years and make up a majority of the company’s device segment, this year we’ve included the company's device segment medical component revenue in addition to the medical segment revenue. We also have several new additions to the list as we reached out to more companies, most of them privately held. There have also been a few significant spinoffs, such as Medtronic’s ongoing separation of its diabetes treatment tech business into a new publicly traded company called MiniMed.
Learn more in our free special report coming soon at wtwh.me/big100
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9 • 2026
2026 RANK
2025 RANK
COMPANY
REVENUE ($USD)
63
63
Merit Medical Systems
$1,515,906,000
64
61
Demant (hearing aids business)
$1,487,971,937
65
67
Penumbra
$1,403,665,000
66
65
LivaNova
$1,388,053,000
67
64
Conmed
$1,374,724,000
68
66
Fisher & Paykel Healthcare
$1,343,950,480
69
62
Haemonetics
$1,334,027,000
70
69
Arjo
$1,121,762,186
71
70
MicroPort
$1,105,381,000
72
71
GN (hearing division)
$1,090,766,137
73
68
Embecta
$1,080,400,000
74
73
Tandem Diabetes Care
$1,014,736,000
75
72
Omron Healthcare
$971,460,587
76
76
Applied Medical Resources
$954,000,000
77
74
Fukuda Denshi
$933,999,516
78
77
Embla Medical
$928,689,000
79
80
Ambu
$912,802,214
80
78
Inspire Medical Systems
$911,981,000
81
79
Orthofix
$822,312,000
82
83
Asahi Intecc
83
82
Medacta
$773,134,806
84
84
Alphatec Holdings (ATEC Spine)
$764,155,000
85
86
iRhythm
$747,138,000
86
81
Avanos Medical
$701,200,000
87
n/a
Ascensia Diabetes Care (PHC Holdings)
$679,159,931
88
85
Novocure
$655,353,000
89
93
TransMedics
$605,494,000
90
89
AtriCure
$534,528,000
91
n/a
Konica Minolta (healthcare segment)
$531,528,676
92
88
Nikkiso (medical unit)
$527,456,966
93
96
Glaukos
$507,442,000
94
92
Accuray
$458,505,000
95
95
Artivion
$441,330,000
96
90
JMS Co.
$440,232,776
97
n/a
Agfa-Gevaert (radiology solutions segment)
$358,400,200
98
98
Barco (healthcare division)
$296,171,976
99
99
OrthoPediatrics
$236,348,000
100
100
Si-Bone
$200,925,000
(medical and device segments without industrial component sales)
$774,213,304
www.medicaldesignandoutsourcing.com
9/3/26 3:04 PM
We’ll make the perfect switch, but first you’ll have to
More medical device manufacturers are switching to Steute because no one else meets their specific needs with better products One of the world’s largest medical device manufacturers was concerned about wireless connectivity issues that can commonly occur in shielded MRI suites, so we developed a customized hybrid foot switch solution that featured cabled backup where wireless signals could not be transmitted.
Other Steute advantages: Leadership in robotic applications – larger selection (1 to 4 pedal designs), variation of contact configurations and actuator types and applicable global certification. Large selection of standard options – Optional auxiliary pushbuttons, fixed or collapsible braces, housing colors, cable and connector types, and contact type and configurations. Our renowned product sample program – We can get you a sample, for the most part, in a week or less.
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9/3/26 12:49 AM
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1
2
Johnson & Medline Johnson MedTech Industries
Medtronic
Galway, Ireland (Operational headquarters in Fridley, Minnesota, United States)
$36,364,000,000
New Brunswick, New Jersey United States
Northfield, Illinois United States
$33,792,000,000
$28,432,000,000
Fiscal year ended 12/28/2025
Fiscal year ended 4/24/2026 2025 rank: R&D spend: Employees: CEO:
2025 rank: 2 R&D spend: $2,838,000,000 Employees: not available CEO: Joaquin Duato EVP and worldwide chair, MedTech: Tim Schmid
1 $2,873,000,000 101,369 Geoff Martha
medtronic.com The world’s largest medical device company has gotten its mojo back. MEDTRONIC reported year-over-year revenue growth of 9.9% in the fourth quarter of its most recent fiscal year — its best quarterly revenue growth in 10 years — with sales for the full year up 8.4%. Needham & Co. analysts said at the time that they see Medtronic in the early stages of a strong product cycle that will drive faster organic revenue growth. AFibtreating cardiac ablation has been a standout performer, with strong commercial demand for the Affera Sphere-9 pulsed-field ablation (PFA) catheter. PFA could become even more of a success for Medtronic as the nitinol-enabled Affera Sphere-360, an all-in-one mapping and single-shot PFA catheter, launches in the EU, with a U.S. pivotal trial enrolling swiftly. On top of PFA, Medtronic officials are also excited about the growth potential of the company’s Symplicity Spyral renal denervation system for uncontrolled hypertension. The company is seeking expanded U.S. indications for its Hugo robotic surgery system as it takes on Intuitive in the soft-tissue surgical robotics space, and there’s excitement around the Altaviva implantable tibial neuromodulation for urge urinary incontinence and the Stealth AXiS robotic spine surgery system. Medtronic has also resumed mergers and acquisitions this year, announcing a string of purchases including $650 million for SPR Therapeutics and its percutaneous peripheral nerve stimulation therapies for chronic pain management, $550 million for Scientia Vascular and its products for treating complex neurovascular conditions, and $585 million for CathWorks and its FFRangio system meant to obtain quick and reliable fractional flow reserve. Said CEO Geoff Martha: “We executed our focused portfolio strategy. In early March, we completed the MiniMed [diabetes business] IPO, establishing it as a standalone, publicly traded [diabetes tech] company. We also advanced our M&A and venture initiatives, targeting higher growth segments to accelerate innovation in markets where we have a right to win.” – CN
jnjmedtech.com JOHNSON & JOHNSON is working toward splitting off its DePuy Synthes orthopedics business by mid-2027. The planned separation has J&J MedTech increasingly focused on its other businesses, especially Cardiovascular, which led the way with 8.3% revenue growth during the first six months of 2026. Cardiovascular business growth has been driven by major acquisitions in recent years, including the $13.1 billion purchase in 2024 of Shockwave Medical and its intravascular lithotripsy (IVL) technology and the $16.6 billion purchase in 2022 of Abiomed and its catheter-delivered Impella heart pumps to treat heart failure. Over the summer, J&J upped its game in AFib-treating ablation procedures with FDA approval of its dual-energy ThermoCool SmartTouch SF platform that enables doctors to switch between pulsed-field and radiofrequency ablation. There was also the launch earlier this year of Shockwave C2 Aero, the latest catheter system for the Shockwave IVL platform. Tim Schmid, the company’s worldwide chair of MedTech, said during our DeviceTalks West event in October 2025: “We made a distinctive decision to say we’re going to play a bigger role in the cardiovascular space. These are the sickest patients. … They’re also patients that create the greatest burden on health systems around the world.” (DeviceTalks West returns Nov. 30–Dec. 1, 2026 in San Jose, California.) Johnson & Johnson MedTech’s Surgery business got a boost in July with the long-awaited FDA de novo authorization of Ottava, the first table-integrated soft-tissue robotics system -tto receive an FDA nod. Ottava represents J&J’s bid to compete against Intuitive, Medtronic and other companies in the dynamic softissue surgical robotics space. Meanwhile, J&J is investing $1 billion in its Florida-based U.S. Vision operations. – CN
www.medicaldesignandoutsourcing.com
BIG100 list_9-26_Vs2JHSRfinal.indd 17
3
Fiscal year ended 12/31/2025 2025 rank: R&D spend: Employees: CEO:
3 $80,000,000 45,000 Jim Boyle
medline.com MEDLINE completed an upsized initial public offering (IPO) worth more than $8 billion in December. The Financial Times labeled it the largest private-equity-backed IPO of all time, providing a meaningful return for Blackstone, Carlyle and Hellman & Friedman after they made a multibilliondollar investment in Medline in 2021. The company is a major provider of medicalsurgical products and supply chain services, operating in more than 100 countries. It continues to enjoy strong growth, too, with full-year sales up 11.5% to $28.4 billion in 2025. For the first half of 2026, sales were up 11.1% year-over-year to $15 billion. Medline delivered the results even as it grappled with tariff-related costs and a fire at its Tracy, California distribution center. CEO Jim Boyle said, “We are effectively managing a dynamic external environment while investing in strategic initiatives to strengthen our market position and support long-term shareholder value creation.” – CN and SW
9 • 2026
Medical Design & Outsourcing
17
9/3/26 2:59 PM
4 Siemens Healthineers Erlangen Germany
$26,427,775,000 Fiscal year ended 9/30/2025
(€23,375,000,000) 2025 rank: R&D spend: Employees: CEO:
4 $2,213,714,800 74,000 Bernd Montag
siemens-healthineers.com More than two years after SIEMENS HEALTHINEERS cut back on the Corindus surgical robotics business that it had acquired for $1.1 billion, the German medtech giant decided to give the space another shot. In September 2025, it announced a strategic partnership with Stryker in the field of neurovascular robotics. Siemens Healthineers brings its expertise in robotics and image-guided therapy, while Stryker adds leadership in neurovascular technologies. By May of this year, AiM Medical Robotics was announcing a collaboration with Siemens Healthineers to combine robotic and MRI technologies. The surgical robotics play comes as Siemens Healthineers faces headwinds from changes in the Chinese diagnostics market and higher than expected inflation. “While the environment remains tough, our synergetic core of Imaging and Precision Therapy is on track with good momentum,” CEO Bernd Montag said during the company’s Q2 earnings announcement in May. Early next year, Siemens Healthineers is set to become even more independent. European tech giant Siemens, which owns a majority stake in the medtech company, is scheduled to have shareholders vote in February 2027 to deconsolidate its remaining stake in Siemens Healthineers through a direct spin-off. – CN
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BIG100 list_9-26_Vs2JHSRfinal.indd 18
Medical Design & Outsourcing
9 • 2026
9/3/26 1:42 AM
5
6
Stryker
Abbott
Portage, Michigan United States
(medical device segment)
Abbott Park, Illinois United States POWERED BY
$25,116,000,000
$21,387,000,000
2025 rank: R&D spend: Employees: CEO:
2025 rank: 8 R&D spend: $1,753,000,000 Employees: not available CEO: Robert Ford EVP and group president of medical devices: Lisa Earnhardt
Fiscal year ended 12/31/2025 5 $1,623,000,000 56,000 Kevin Lobo
stryker.com Orthopedic and surgical devices giant STRYKER has made a play in the fastgrowing intravascular lithotripsy (IVL) space, announcing in May that it had closed on its purchase of Amplitude Vascular and its IVL system to treat calcified peripheral arterial disease. Stryker CEO Kevin Lobo described the deal as a “significant milestone in expanding our peripheral vascular portfolio and enhancing our ability to address challenging arterial disease.” Stryker is also seeking more business in ambulatory surgery centers (ASCs). Its Mako RPS (robotic power system), now fully launched in the U.S., is a handheld version of its Mako surgical robotics technology that Stryker officials think will prove attractive in ASCs. Overall, Mako remains a major growth driver for Stryker on the heels of the launch of the next-gen Mako 4 platform in early 2025, with indications continuing to expand for the system. Stryker, though, has also not been immune from challenges. An Iranbacked hacktivist group hit it with a major cyberattack earlier this year. – CN
Fiscal year ended 12/31/2025
abbott.com ABBOTT has built a $21-billion-a-year medtech business fueled by innovation in continuous glucose monitors, pulsed-field ablation (PFA), LVADs, heart valves, pacemakers, drug-eluting stents, and more. Its innovation pipeline continues to deliver results, too. During our DeviceTalks Minnesota event in May, Abbott’s Lisa Earnhardt said two key factors have driven growth in the medical device segment she leads: listening to what patients need (including what is not being said) and a strong focus on innovation. “Developing breakthrough innovation is richly rewarded in our field,” she said, calling now an exciting time for the industry because we’re “moving from sick care to healthcare,” enabling people to own their own healthcare and prevent disease. During Abbott’s second quarter earnings call in July, CEO Robert Ford pointed to recent milestones, including completed enrollment in a study of intravascular lithotripsy (IVL) technology, the submission of the next generation Amulet 360 left atrial appendage occlusion (LAAO) device (which now has a CE mark), and a CE mark for the Libre Duo dual glucose-ketone sensor, which now also has FDA authorization. Ford said the company anticipates major product launches for these three technologies alongside its TactiFlex Duo PFA catheter in the U.S. over the next 12 months. Abbott also remains on track to complete enrollment in a number of clinical trials to support future products. Those include a balloon-expandable transcatheter aortic valve replacement (TAVR) system, a leadless conduction pacing device for the Aveir pacemaker, a mitral replacement valve developed after acquiring Cephea Valve in 2019, a peripheral IVL device following the 2023 acquisition of CSI, and a wearable continuous lactate monitoring sensor. – CN and SW
9 • 2026
BIG100 list_9-26_Vs2JHSRfinal.indd 19
Medical Design & Outsourcing
19
9/3/26 1:42 AM
7
8
GE HealthCare
Royal Philips
Boston Scientific
$20,625,000,000
$20,163,120,400
$20,074,000,000
(€17,834,000,000)
2025 rank: R&D spend: Employees: CEO:
Chicago, Illinois United States
Amsterdam Netherlands
Fiscal year ended 12/31/2025
Fiscal year ended 12/31/2025 2025 rank: R&D spend: Employees: CEO:
6 $1,260,000,000 54,000 Peter Arduini
2025 rank: R&D spend: Employees: CEO:
gehealthcare.com GE HEALTHCARE recently announced that it is looking at a potential sale and other strategic options for its $3-billion-a-year Patient Care Solutions business. Patient Care Solutions is involved with medtech for patient monitoring, diagnostic cardiology, maternal infant care and anesthesia. Its revenue has been slowly declining in recent years, bringing in $3.14 billion, $3.13 billion, and $3.09 billion in 2023, 2024, and 2025, respectively. During the July second-quarter earnings call, CEO Peter Arduini acknowledged that Patient Care Solutions performance remains challenging but called it “a business with depth and breadth that touches many areas within health systems.” Patient Care Solutions should also get a boost from an expanded partnership with Medtronic. Meanwhile, GE HealthCare’s other two major businesses — Pharmaceutical Diagnostics and Advanced Imaging Solutions — enjoyed strong growth in the company’s second quarter. – CN
20
9
Medical Design & Outsourcing
BIG100 list_9-26_Vs2JHSRfinal.indd 20
9 • 2026
7 $1,922,020,000 65,340 Roy Jakobs
philips.com/global Dutch medtech giant PHILIPS has seen a great deal of software innovation, including artificial-intelligence-based features, as part of its strategy to navigate what CEO Roy Jakobs describes as an uncertain macro environment. In May 2026, it introduced SmartIQ, its coronary imaging technology for the Azurion image-guided therapy platform. According to Philips, the goal behind the new software is to address the trade-off between image quality and radiation exposure for patients and clinical staff. Other recent Philips regulatory approvals and launches have included its Alturion ultrasound system with AI-powered workflow for high-volume settings, AI-powered SmartHeart cardiac planning tech, EchoNavigator R5.0 with DeviceGuide for AI-powered heart valve repair guidance, and AI-enabled Elevate Plus ultrasound workflow tech. – CN
Marlborough, Massachusetts United States
Fiscal year ended 12/31/2025
9 $2,052,000,000 59,000 Michael Mahoney
bostonscientific.com BOSTON SCIENTIFIC broke into the top 10 of the Medtech Big 100 in the 2025 edition of our report. This year, it remains No. 9, but the company — a maker of medtech in cardiology, neurology, urology, and more — is facing challenges. Competitors including Medtronic, J&J, Abbott and others have gained ground in pulsed-field ablation (PFA). There has also been a sharp and unexpected slowdown in the U.S. market for the Watchman left atrial appendage closure (LAAC) device, which complements AFib-treating PFA procedures because LAAC reduces the risk of AFib causing strokes. The result has been a series of guidance cuts this year, with Boston Scientific expecting 5.5%–6.5% revenue growth as of its second quarter earnings announcement on July 29. “This update today is not the outcome we planned or what you have come to expect from us,” CEO Mike Mahoney said at the time. Just days before, the company announced a restructuring plan that is expected to include headcount reductions. Boston Scientific has also faced questions about its handling of pacemaker battery problems. The company, however, has also made significant moves to boost its product offerings, including plans to acquire Penumbra and its stroke- and bloodclot-treating devices for $14.5 billion, a $1.5 billion investment in TAVR developer MiRus, and a $600 million payment to buy Nalu and its spinal cord stimulation and peripheral nerve stimulation tech. – CN
www.medicaldesignandoutsourcing.com
9/3/26 1:43 AM
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9/3/26 12:46 AM
10
11
BD
(medical and interventional segments)
Franklin Lakes, New Jersey United States
Henry Schein Cardinal Melville, New York Health United States
(global medical products and distribution segment)
13 Baxter
Deerfield, Illinois United States
Dublin, Ohio United States
$18,544,000,000
$13,184,000,000
$12,636,000,000
$11,244,000,000
2025 rank: R&D spend: Employees: CEO:
2025 rank: R&D spend: Employees: CEO:
2025 rank: 12 R&D spend: not available Employees: not available CEO: Jason Hollar CEO of Global Medical Products and Distribution: Steve Mason
2025 rank: R&D spend: Employees: CEO:
Fiscal year ended 9/30/2025
22
12
10 not available not available Tom Polen
Fiscal year ended 12/27/2025 11 not available 25,000 Frederick Lowery
bd.com
henryschein.com
BD is now a “new BD” and a “more focused medtech company,” according to CEO Tom Polen, who cited recent Streetbeating third-quarter results as early benefits of this change. BD sold its Biosciences & Diagnostics business to Waters Corp. in a multibillion-dollar deal in February. Said Polen of the three months ended June 30, 2026: “We delivered a strong third quarter, with revenue, adjusted operating margin and adjusted EPS all ahead of our expectations.” BD has also seen some changes among its executive ranks this year, including promoting Vitor Roque as its new CFO, bringing in J&J veteran Peter Menziuso as its new president of Interventional, tapping Edwards Lifesciences’ Gary Sorsher to become chief quality officer, and promoting Manish Sinha to chief people officer. – CN and JRT
HENRY SCHEIN CEO Stanley Bergman retired in March after more than 35 years at the helm. Former Thermo Fisher Scientific executive Frederick Lowery filled the role and also joined Henry Schein’s board of directors. Lowery initiated major organizational restructuring this July, replacing its executive management committee with the Henry Schein Leadership Team (HSLT) as three executives stepped down. The company is also integrating its global supply chain organization with its global distribution group. Last year, the board authorized repurchasing up to $750 million in shares of its common stock, adding $500 million to its January 2025 repurchase program. At the same time, the company received a $250 million investment from private equity firm KKR. Henry Schein offers 300,000 branded and Henry Schein corporate brand products and has been distributing healthcare products for nearly a century. – SR and CN
Medical Design & Outsourcing
BIG100 list_9-26_Vs2JHSRfinal.indd 22
9 • 2026
Fiscal year ended 6/30/2025
cardinalhealth.com CARDINAL HEALTH Global Medical Products and Distribution revenue continues to tick up annually. However, the segment’s profits nearly doubled over the past year, an increase that Cardinal Health CEO Jason Hollar says remained double-digit even excluding refunds from Trump administration tariffs overturned by the U.S. Supreme Court. Cardinal Health has been engaged in tuck-in acquisitions to boost the medtech business. It announced in July that it is paying $360 million for AdaptHealth’s Diabetes Health business and Strive Medical, a multi-specialty supply provider with a focus on urology. – CN
Fiscal year ended 12/31/2025 14 $518,000,000 37,500 Andrew Hider
baxter.com After struggling for years to return to the $80-plus-per-share values that its stock saw early in the decade, BAXTER‘s share price this year has climbed about 30% to more than $25 apiece as of September. Baxter results beat The Street in its second quarter, and it upped its guidance. Said CEO Andrew Hider: “Our second-quarter results exceeded expectations on both the top and bottom lines, driven by both operating performance and an additional benefit from a tariff refund that was not previously contemplated in our guidance.” Baxter’s portfolio includes connected solutions, medical devices, and advanced injectable technologies. – CN
www.medicaldesignandoutsourcing.com
9/3/26 3:06 PM
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9/3/26 12:47 AM
14
15
16
17
B. Braun
Alcon
Intuitive Surgical
Zimmer Biomet
Melsungen Germany
Sunnyvale, California United States
Warsaw, Indiana United States
$10,623,569,840
$10,401,000,000
$10,064,700,000
$8,231,500,000
(€9,396,400,000)
2025 rank: R&D spend: Employees: CEO:
2025 rank: R&D spend: Employees: CEO:
2025 rank: R&D spend: Employees: CEO:
Fiscal year ended 12/31/2025
2025 rank: 15 R&D spend: $660,270,400 Employees: 66,821 CEO: Anna Maria Braun CEO of B. Braun of America Inc.: Michael Parden bbraun.com B. BRAUN manufactures more than 5,000 medical devices and pharmaceutical products, which it supplements with an extensive range of services. B. Braun has locations in 64 countries and three divisions: Hospital Care, Aesculap (surgical and interventional), and Avitum (chronic disease treatments). The company acquired True Digital Surgery in September 2025, expanding B. Braun’s digital microsurgery offerings. In the same month, the company invested $20 million to expand and modernize one of its manufacturing facilities in Pennsylvania. B. Braun’s subsidiary Aesculap agreed to pay $38.5 million to resolve allegations under the False Claims Act after allegations that the company sold knee replacement devices that would prematurely fail at a higher-thanacceptable rate, resulting in false Medicare and Medicaid claims. In May, B. Braun of America CEO Rob Albert retired after 42 years with the company and managing director of B. Braun U.K., Michael Paren, assumed the role. – CN and SR
24
Fribourg Switzerland
Medical Design & Outsourcing
BIG100 list_9-26_Vs2JHSRfinal.indd 24
Fiscal year ended 12/31/2025 16 $990,000,000 25,942 David Endicott
Fiscal year ended 12/31/2025
17 $1,311,800,000 17,021 Dave Rosa
Fiscal year ended 12/31/2025 18 $458,500,000 17,000 Ivan Tornos
alcon.com
intuitive.com
zimmerbiomet.com
ALCON faced numerous woes recently, from failed mergers, patent infringement losses and the recent termination of its PowerVision intraocular lens (IOL) technology program, which resulted in a $402 million writeoff during the second quarter of 2026. The company’s planned $1.5 billion merger with Staar Surgical could’ve been one of medtech’s biggest deals, but the deal dissolved after Staar failed to earn stockholder approval. Alcon’s planned $356 million acquisition of robotic cataract laser treatment developer Lensar was also terminated in March after the U.S. FTC intended to block the planned acquisition. On the upside, Alcon launched a new IOL technology and entered a collaboration with RxSight to develop adjustable presbyopiacorrecting IOLs. – SR
INTUITIVE surpassed $10 billion in annual revenue for the first time in company history. In fiscal 2025, worldwide procedures performed on da Vinci grew 18% and 51% on Ion, the company’s bronchoscopy platform, and exceeded expectations. Intuitive expects 13.5% to 15.5% procedure growth for da Vinci in 2026, even with pressures from new competitors. As more players enter the soft tissue surgical robotics market with Medtronic’s Hugo and Johnson & Johnson’s Ottava, analysts agree that Intuitive’s U.S. competition is not a factor in its continued growth. Intuitive continues to expand indications for da Vinci, and received FDA clearances for “several cardiac procedures” on its da Vinci 5 platform in January 2026. Intuitive CEO Dave Rosa said at the beginning of the year that the company is also developing advancements for Ion to “improve survivability of lung cancer” by shortening the timeline from detection to treatment. – SR
ZIMMER BIOMET moved up one spot on our list with 7% revenue growth despite tariff headwinds. In February 2026, the orthopedics giant transitioned to a “predominantly direct and specialized sales organization in the U.S.,” said CEO Ivan Tornos. Since then, the company has delivered strong first- and secondquarter results this year, reporting a 9% sales increase in Q1 and 5% revenue increase in Q2. In May, Zimmer Biomet increased its planned share repurchase by $250 million. The company now anticipates repurchasing up to $1 billion of its common stock during fiscal 2026. In the first half of Zimmer Biomet’s fiscal 2026, the company continues to expand its surgical robotics offerings, earning FDA 510(k) clearance for an advanced version of its Rosa Shoulder System earlier this year. In June, Zimmer Biomet said it will pay Pacira BioSciences $70 million to acquire its Lovera nerve therapy device; potential revenue-based milestone payments could total an additional $70 million, bringing the deal’s total value to up to $140 million. Zimmer Biomet subsidiary Paragon 28 also launched a series of new products with a new foot and ankle system and a curved nail TTC system. – SR
9 • 2026
www.medicaldesignandoutsourcing.com
9/3/26 1:43 AM
Cretex 9-24.indd 56
9/3/26 12:14 AM
18 Terumo Tokyo Japan
$7,567,611,116
Fiscal year ended 3/31/2026
(JP¥1,131,877,000,000) 2025 rank: R&D spend: Employees: CEO:
19 $514,145,349 31,185 Hikaru Samejima
terumo.com
TERUMO completed one of the medtech’s biggest acquisitions of 2025, purchasing OrganOx for $1.5 billion in October. OrganOx specializes in normothermic machine perfusion to preserve organs longer by circulating oxygen and nutrient-rich perfusate through the organ at near-body temperature. Terumo already operates within the vital organ space with existing lines of heart-lung machines. In addition to the acquisition, the company earned FDA 510(k) clearance for its OpusWave dual-sensor imaging system in October. The first procedure utilizing the system to evaluate coronary artery disease was completed in the U.S. in June 2026. – SR
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19
20
Fujifilm Holdings
Olympus
(healthcare segment)
Tokyo Japan
Tokyo Japan
$7,347,130,347
$6,757,273,920
(JP¥1,098,900,000,000)
(JP¥1,010,676,000,000)
2025 rank: R&D spend: Employees: CEO:
2025 rank: R&D spend: Employees: CEO:
Fiscal year ended 3/31/2026
20 $356,358,220 not available Teiichi Goto
Fiscal year ended 3/31/2026
21 $735,100,817 29,297 Bob White
fujifilm.com/us/en/healthcare
olympus-global.com
FUJIFILM’S healthcare segment revenue accounted for 33% of the Japanese conglomerate’s total revenue. The segment’s products include diagnostic equipment such as X-ray systems, endoscopes, ultrasound systems and medical IT systems. Fujifilm Healthcare Americas is headquartered in Lexington, Massachusetts. In February 2025, the company earned a second, four-year U.S. Defense Logistics Agency contract for its surgical C-arm systems valued at more than $10 million. Fujifilm launched various new products over the fiscal year, such as AIpowered ultrasound technology, a new portable ultrasound system, a next-generation endoscopic imaging system, a portable digital radiography system and more. – SR
June marked former Medtronic EVP Bob White’s first full year as OLYMPUS CEO. One month after he joined Olympus, the company entered a joint investment with a private equity firm Revival Healthcare Capital to co-found Swan EndoSurgical. The two companies each invested $458 million to drive endoluminal robotics innovation, aiming to expand minimally invasive treatment options. In November, Olympus cut 7% of its global workforce (2,000 jobs) in a new corporate strategy. In addition to launching a new next-generation surgical imaging platform and endoscopic ultrasound system, among other products, Olympus announced plans to acquire urologic medical device manufacturer BioProtect for $270 million in May 2026. – SR
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9 • 2026
www.medicaldesignandoutsourcing.com
9/3/26 3:07 PM
Vantedge 9-26.indd 56
9/3/26 12:51 AM
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9/3/26 12:15 AM
21 Smith+
Fresenius
22 Edwards
23 Steris
24 ResMed
25 Medical Care
Watford England
Irvine, California United States
Dublin Ireland
San Diego, California United States
Bad Homburg Germany
$6,164,000,000
$6,067,600,000
$5,146,327,000
$4,990,044,425
2025 rank: 23 R&D spend: $112,900,000 Employees: 18,000 CEO: Daniel Carestio steris.com
2025 rank: 26 R&D spend: $331,284,000 Employees: 10,600 CEO: Michael “Mick” Farrell resmed.com
(€4,413,625,000)
Nephew
Fiscal year ended 12/31/2025 2025 rank: 22 R&D spend: $296,000,000 Employees: 16,988 CEO: Deepak Nath smith-nephew.com
Lifesciences
Fiscal year ended 12/31/2025 2025 rank: 24 R&D spend: $1,079,200,000 Employees: 16,000 CEO: Bernard Zovighian edwards.com
(Operational headquarters in Mentor, Ohio, United States)
$5,935,900,000 Fiscal year ended 3/31/2026
(healthcare products)
Fiscal year ended 12/31/2025
Fiscal year ended 6/30/2025
2025 rank: 28 R&D spend: not available Employees: 29,125 CEO: Helen Giza freseniusmedicalcare.com
26 Solventum
27 Dexcom
28 Mindray
29 Sonova
30 Coloplast
Eagan, Minnesota United States
San Diego, California United States
Shenzhen China
Stäfa, Kanton Zürich Switzerland
Humlebæk Denmark
$4,817,000,000
$4,662,000,000
$4,630,561,308
$4,341,842,264
$4,214,584,877
2025 rank: 27 R&D spend: not available Employees: not available CEO: Bryan Hanson solventum.com
2025 rank: 30 R&D spend: $599,100,000 Employees: 11,000 CEO: Jacob Leach dexcom.com
(RMB¥33,282,159,404)
(CHF3,605,900,000)
(DKK 27,874,000,000)
2025 rank: 25 R&D spend: $497,905,003 Employees: 21,288 Executive director and GM: Wu Hao mindray.com
2025 rank: 29 R&D spend: $262,131,246 Employees: 18,447 CEO: Eric Bernard sonova.com
2025 rank: 33 R&D spend: $143,036,424 Employees: 17,000 CEO: Gavin Wood coloplast.com
32 Cooper Cos.
33 Align
34 Hoya
35 Canon Medical
United States
San Ramon, California United States
Tempe, Arizona United States
Tokyo Japan
$3,881,977,902
$4,100,500,000
$4,092,400,000
$4,034,964,000
$3,949,244,694
(JP¥580,622,000,000)
2025 rank: 31 R&D spend: $248,200,000 Employees: 7,000 CEO: José (Joe) Almeida hologic.com
2025 rank: 34 R&D spend: $172,200,000 Employees: 15,000 CEO: Albert G. White III coopercos.com
2025 rank: 32 R&D spend: $369,911,000 Employees: 20,383 CEO: Joseph Hogan aligntech.com
(JP¥590,683,000,000)
(MedSurg segment)
Fiscal year ended 12/31/2025
31 Hologic Marlborough, Massachusetts
Fiscal year ended 9/27/2025
Fiscal year ended 12/31/2025
Fiscal year ended 10/31/2025
Fiscal year ended 12/31/2025
Technology
Fiscal year ended 12/31/2025
Fiscal year ended 9/30/2025
Fiscal year ended 3/31/2026
(life care segment)
Ōtawara, Japan Fiscal year ended 12/31/2025
Fiscal year ended 3/31/2026
2025 rank: 37 R&D spend: not available Employees: not available CEO: Eiichiro Ikeda hoya.com/en/business/lifecare
2025 rank: 36 R&D spend: $314,043,188 Employees: not available Head of medical group, chair of Canon Medical Systems Corp.: Toshio Takiguchi Canon Medical Systems USA CEO: Tsuneo “Neo” Imai global.medical.canon
36 Dentsply
37 Getinge
38 Nipro
39 Straumann
40 MiniMed
Charlotte, North Carolina United States
Gothenburg Sweden
Osaka Japan
Basel Switzerland
Northridge, California
$3,680,000,000
$3,566,081,991
$3,500,801,639
$3,137,137,869
$3,102,000,000
2025 rank: 35 R&D spend: $150,000,000 Employees: 14,000 CEO: Daniel Scavilla dentsplysirona.com
(SEK 34,969,000,000)
(JP¥523,610,000,000)
(CHF2,605,393,000)
2025 rank: 40 R&D spend: $148,072,609 Employees: 11,670 CEO: Mattias Perjos getinge.com
2025 rank: 39 R&D spend: $115,665,989 Employees: 27,089 CEO: Yamazaki Tsuyoshi nipro.com
2025 rank: 43 R&D spend: not available Employees: 11,824 CEO: Guillaume Daniellot straumann.com
2025 rank: not ranked R&D spend: $448,000,000 Employees: 8,000 CEO: Que Dallara minimed.com
Sirona
Fiscal year ended 12/31/2025
Fiscal year ended 12/31/2025
(medical segment)
Fiscal year ended 3/31/2026
www.medicaldesignandoutsourcing.com
BIG100 list_9-26_Vs2JHSRfinal.indd 29
United States
Fiscal year ended 4/24/2026
Fiscal year ended 12/31/2025
9 • 2026
Medical Design & Outsourcing
29
9/3/26 3:07 PM
Full Page_Med Dsgn Outsourceing_2025.pdf 1 7/1/2025 10:00:48 AM
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Carl Zeiss
(medical technology segment)
Globus Medical
WS Audiology
Paul Hartmann
Envista
Jena Germany
Audubon, Pennsylvania United States
Lynge Denmark
Heidenheim Germany
Brea, California United States
$3,057,142,400
$2,938,931,000
$2,915,817,400
$2,769,539,241
$2,719,500,000
2025 rank: 47 R&D spend: $147,246,000 Employees: 6,000 CEO: Keith Pfeil globusmedical.com
(€2,579,000,000)
(€2,449,619,000)
2025 rank: 42 R&D spend: $200,116,200 Employees: 12,000 CEO: Jan Makela wsa.com
2025 rank: 46 R&D spend: $110,120,440 Employees: 10,066 CEO: Britta Fünfstück hartmann.info
2025 rank: 48 R&D spend: $114,000,000 Employees: 12,000 CEO: Paul Keel envistaco.com
Fiscal year ended 9/30/2025
(€2,704,000,000) 2025 rank: 44 R&D spend: $339,180,000 Employees: 9,349 CEO: Andreas Pecher zeiss.com/meditec-ag
Amplifon
Fiscal year ended 12/31/2025
Insulet
Fiscal year ended 9/30/2025
Zoll Medical (part of Asahi Kasei)
Fiscal year ended 12/31/2025
Fiscal year ended 12/31/2025
Convatec
Karl Storz
(medical segment)
Milan Italy
Acton, Massachusetts United States
Chelmsford, Massachusetts
Tuttlingen
Germany
London England
$2,708,578,420
$2,708,100,000
$2,700,000,000 Fiscal year ended 3/31/2026
$2,600,380,000
Fiscal year ended 12/31/2025
$2,439,000,000
(€2,395,700,000)
2025 rank: 54 R&D spend: $301,100,000 Employees: 5,400 CEO: Ashley McEvoy insulet.com
2025 rank: not available R&D spend: not available Employees: 7,000 CEO: Eric Knudsen zoll.com
Fiscal year ended 12/31/2025
2025 rank: 45 R&D spend: not available Employees: 15,080 CEO: Enrico Vita amplifon.com
Cook Medical
Dräger
(medical division)
United States
Fiscal year ended 12/31/2025
Fiscal year ended 12/31/2025
(€2,300,000,000) 2025 rank: not available R&D spend: not available Employees: 9,000 CEO: Karl-Christian Storz karlstorz.com
Enovis
ICU Medical
2025 rank: 51 R&D spend: $111,000,000 Employees: 10,910 CEO: Jonny Mason convatecgroup.com
Teleflex
Bloomington, Indiana United States
Lübeck Germany
Wilmington, Delaware United States
San Clemente, California United States
Wayne, Pennsylvania United States
$2,400,000,000
$2,256,225,360
$2,248,049,000
$2,231,262,000
$1,992,713,000
2025 rank: 49 R&D spend: not available Employees: 9,518 CEO: Carl Cook cookmedical.com
(€1,995,600,000)
2025 rank: 52 R&D spend: $120,332,000 Employees: 8,217 CEO: Damien McDonald enovis.com
2025 rank: 50 R&D spend: $87,495,000 Employees: 13,000 CEO: Vivek Jain icumed.com
2025 rank: 41 R&D spend: $144,781,000 Employees: 15,500 CEO: Jason Weidman teleflex.com
Fiscal year ended 12/31/2025
Integer
Fiscal year ended 12/31/2025
2025 rank: 55 R&D spend: not available Employees: 9,540 Chair: Stefan Dräger draeger.com/en-us_us/hospital
Elekta
Fiscal year ended 12/31/2025
Integra LifeSciences
Fiscal year ended 12/31/2025
Fiscal year ended 12/31/2025
Plexus
(healthcare/life sciences segment)
Nihon Kohden
Plano, Texas United States
Stockholm Sweden
Princeton, New Jersey United States
Neenah, Wisconsin United States
Tokyo Japan
$1,853,637,000
$1,704,874,567
$1,635,245,000
$1,629,300,000
$1,571,847,300
2025 rank: 56 R&D spend: $49,499,000 Employees: 11,000 CEO: Payman Khales integer.net
(SEK 16,718,000,000)
2025 rank: 58 R&D spend: $98,971,000 Employees: 4,427 CEO: Stuart Essig integralife.com
2025 rank: not ranked R&D spend: not available Employees: not available CEO: Todd Kelsey plexus.com
(JP¥235,099,000,000)
Fiscal year ended 12/31/2025
Fiscal year ended 4/30/2026
2025 rank: 57 R&D spend: $268,509,076 Employees: 4,353 CEO: Jakob Just-Bomholt elekta.com
Fiscal year ended 12/31/2025
www.medicaldesignandoutsourcing.com
BIG100 list_9-26_Vs2JHSRfinal.indd 31
Fiscal year ended 9/27/2025
9 • 2026
Fiscal year ended 3/31/2026
2025 rank: 60 R&D spend: $49,829,978 Employees: 6,116 CEO: Hirokazu Ogino nihonkohden.com
Medical Design & Outsourcing
31
9/3/26 1:44 AM
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9/3/26 12:50 AM
Masimo
Cochlear
(now part of Danaher)
Merit Medical Systems
(hearing aids business)
Smørum Denmark
Irvine, California United States
Sydney Australia
South Jordan, Utah United States
$1,526,900,000
$1,519,491,000
$1,515,906,000
Fiscal year ended 12/31/2025
(DKK 9,841,000,000)
2025 rank: 53 R&D spend: $126,400,000 Employees: 2,200 President: Tim Benner masimo.com
(AU$2,355,800,000)
2025 rank: 63 R&D spend: $97,352,000 Employees: 7,500 CEO: Martha Aronson merit.com
2025 rank: 61 R&D spend: not available Employees: not available CEO: Søren Nielsen President of the hearing aids business: Bassel Rifai demant.com
LivaNova
Conmed
Fiscal year ended 1/3/2026
Fiscal year ended 6/30/2025
2025 rank: 59 R&D spend: $188,017,500 Employees: 5,500 CEO: Dig Howitt cochlear.com
Fisher & Paykel Healthcare
Penumbra
Demant
Alameda, California United States
$1,487,971,937
$1,403,665,000
Fiscal year ended 12/31/2025
Fiscal year ended 12/31/2025 2025 rank: 67 R&D spend: $89,766,000 Employees: 4,700 CEO: Adam Elsesser penumbrainc.com
Arjo
Haemonetics
London England
Largo, Florida United States
Auckland New Zealand
Boston, Massachusetts United States
Malmö Sweden
$1,388,053,000
$1,374,724,000
$1,343,950,480
$1,334,027,000
$1,121,762,186
2025 rank: 65 R&D spend: $185,764,000 Employees: 3,300 CEO: Vladimir Makatsaria livanova.com
2025 rank: 64 R&D spend: $55,884,000 Employees: 3,900 CEO: Patrick Beyer conmed.com
(NZ$2,308,400,000)
2025 rank: 62 R&D spend: $59,766,000 Employees: 3,009 CEO: Christopher Simon haemonetics.com
(SEK 11,000,000,000)
Fiscal year ended 12/31/2025
Fiscal year ended 12/31/2025
GN
MicroPort Shanghai China
$1,105,381,000
Fiscal year ended 12/31/2025 2025 rank: 70 R&D spend: $146,504,000 Employees: 6,547 CEO: Jonathan Chen microport.com
Applied Medical Resources
(hearing division)
Ballerup Denmark
$1,090,766,137
Fiscal year ended 12/31/2025
(DKK 7,214,000,000) 2025 rank: 71 R&D spend: not available Employees: not available CEO: Peter Karlstromer GN hearing division president: Peter Justesen gn.com
Fukuda Denshi
Fiscal year ended 3/31/2026
2025 rank: 66 R&D spend: $137,108,100 Employees: 7,629 CEO: Lewis Gradon fphcare.com
Embecta
Fiscal year ended 12/31/2025
Fiscal year ended 3/28/2026
Tandem Diabetes Care
2025 rank: 69 R&D spend: $14,276,973 Employees: 7,000 CEO: Andréas Elgaard arjo.com
Omron Healthcare
Parsippany, New Jersey United States
San Diego, California United States
Kyoto Japan
$1,080,400,000
$1,014,736,000
$971,460,587
2025 rank: 68 R&D spend: $37,300,000 Employees: 1,850 CEO: Devdatt (Dev) Kurdikar embecta.com
2025 rank: 73 R&D spend: $193,114,000 Employees: 2,500 CEO: John Sheridan tandemdiabetes.com
Embla Medical
Ambu
Fiscal year ended 9/30/2025
Fiscal year ended 3/31/2026
Fiscal year ended 12/31/2025
(JP¥145,300,000,000) 2025 rank: 72 R&D spend: not available Employees: not available CEO of Omron: Junta Tsujinaga Healthcare CEO: Ayumu Okada omronhealthcare.com
Inspire Medical Systems
Tokyo Japan
Reykjavík Iceland
Ballerup Denmark
Golden Valley, Minnesota United States
$933,999,516
$928,689,000
$912,802,214
$911,981,000
Fiscal year ended 12/31/2025
(JP¥139,697,000,000)
(DKK 6,037,000,000)
2025 rank: 76 R&D spend: $184,000,000 Employees: 5,700 CEO: Said Hilal appliedmedical.com
2025 rank: 74 R&D spend: not available Employees: not available President: Daijiro Shirai fukuda.com
2025 rank: 77 R&D spend: $45,856,000 Employees: 4,328 CEO: Sveinn Sölvason emblamedical.com
2025 rank: 78 R&D spend: $103,165,000 Employees: 1,333 CEO: Timothy Herbert inspiresleep.com
Rancho Santa Margarita, California United States
$954,000,000
Fiscal year ended 3/31/2026
Fiscal year ended 12/31/2025
www.medicaldesignandoutsourcing.com
BIG100 list_9-26_Vs2JHSRfinal.indd 33
Fiscal year ended 12/31/2025
Fiscal year ended 9/30/2025
2025 rank: 80 R&D spend: $57,607,693 Employees: 5,200 CEO: Britt Meelby Jensen ambu.com
9 • 2026
Medical Design & Outsourcing
33
9/3/26 3:09 PM
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Orthofix Lewisville, Texas United States
$822,312,000
Fiscal year ended 12/31/2025 2025 rank: 79 R&D spend: $65,847,000 Employees: 1,605 CEO: Massimo Calafiore orthofix.com
Avanos Medical Alpharetta, Georgia United States
$701,200,000
Fiscal year ended 12/31/2025 2025 rank: 81 R&D spend: $23,300,000 Employees: 2,287 CEO: David Pacitti avanos.com
Konica Minolta
(healthcare segment)
Tokyo Japan
$531,528,676
Fiscal year ended 3/31/2026
(JP¥79,500,000,000) 2025 rank: not ranked R&D spend: not available Employees: not available CEO: Toshimitsu Taiko healthcare.konicaminolta.us
JMS Co.
Asahi Intecc
(medical and device without industrial component sales)
Seto-shi, Aichi Japan
Medacta Castel San Pietro Switzerland
$773,134,806
Fiscal year ended 12/31/2025
$774,213,304
Fiscal year ended 6/30/2025
(JP¥115,798,000,000) 2025 rank: 83 R&D spend: not available Employees: not available CEO: Kenji Miyata asahi-inteccusa-medical.com
Ascensia Diabetes Care
(Operates under PHC Holdings)
Basel Switzerland
$679,159,931
Fiscal year ended 3/31/2026
(JP¥101,581,000,000) 2025 rank: not ranked R&D spend: not available Employees: not available CEO: Peter Bodlund ascensia.com
Nikkiso
(€683,827,000)
2025 rank: 82 R&D spend: $26,596,234* Employees: 2,165 CEO: Francesco Siccardi *R&D spending adjusted to include capitalized expenses was $43,754,220 (€38,700,000)
medacta.com
Novocure
San Francisco, California United States
(ATEC Spine)
Carlsbad, California United States
$747,138,000
Fiscal year ended 12/31/2025
$764,155,000
2025 rank: 86 R&D spend: $84,610,000 Employees: 2,400 CEO: Quentin Blackford irhythmtech.com
Fiscal year ended 12/31/2025 2025 rank: 84 R&D spend: $76,268,000 Employees: 913 CEO: Patrick Miles atecspine.com
TransMedics
AtriCure
Andover, Massachusetts United States
Mason, Ohio United States
$655,353,000
$605,494,000
$534,528,000
2025 rank: 85 R&D spend: $224,544,000 Employees: 1,605 CEO: Frank Leonard novocure.com
2025 rank: 93 R&D spend: $69,055,000 Employees: 898 CEO: Waleed Hassanein Transmedics.com
2025 rank: 89 R&D spend: $99,209,000 Employees: 1,350 CEO: Michael Carrel atricure.com
Fiscal year ended 12/31/2025
Fiscal year ended 12/31/2025
Fiscal year ended 12/31/2025
Glaukos
Accuray
Artivion
Tokyo Japan
Aliso Viejo, California United States
Madison, Wisconsin United States
Kennesaw, Georgia United States
$527,456,966
$507,442,000
$458,505,000
$441,330,000
(JP¥78,891,000,000)
2025 rank: 96 R&D spend: $150,614,000 Employees: 1,094 CEO: Thomas Burns glaukos.com
2025 rank: 92 R&D spend: $47,942,000 Employees: 990 CEO: Steve La Neve accuray.com
2025 rank: 95 R&D spend: $30,991,000 Employees: 1,800 CEO: J. Patrick Mackin artivion.com
(medical unit)
Fiscal year ended 12/31/2025
2025 rank: 88 R&D spend: not available Employees: not available CEO: Koichi Kato nikkiso.com/products/medical
AgfaGevaert
Fiscal year ended 12/31/2025
(healthcare division)
Mortsel, Belgium
Kortrijk Belgium
$440,232,776
$358,400,200
$296,171,976
Fiscal year ended 12/31/2025
Fiscal year ended 6/30/2025
Fiscal year ended 12/31/2025
Si-Bone
Barco
(radiology solutions segment)
Fiscal year ended 12/31/2025
(JP¥65,845,000,000)
(€317,000,000)
(€261,960,000)
2025 rank: 90 R&D spend: not available Employees: 5,469 President and Representative Director: Ryuji Katsura jms.cc
2025 rank: not ranked R&D spend: not available Employees: not available CEO: Pascal Juéry agfaradiologysolutions.com
2025 rank: 98 R&D spend: not available Employees: not available CEO: An Steegen barco.com/en/healthcare
www.medicaldesignandoutsourcing.com
BIG100 list_9-26_Vs2JHSRfinal.indd 35
iRhythm
Baar Switzerland
Hiroshima Japan
Fiscal year ended 3/31/2026
Alphatec Holdings
OrthoPediatrics Warsaw, Indiana United States
$236,348,000
Fiscal year ended 12/31/2025 2025 rank: 99 R&D spend: $9,102,000 Employees: 602 CEO: David Bailey orthopediatrics.com
9 • 2026
Santa Clara, California United States
$200,925,000
Fiscal year ended 12/31/2025 2025 rank: 100 R&D spend: $17,448,000 Employees: 376 CEO: Laura Francis si-bone.com
Medical Design & Outsourcing
35
9/3/26 3:23 PM
MEDTECH BIG 100 ANALYSIS
The 2026 Medtech Big 100 breaks $500 billion OUR AUTHORITATIVE RANKING AND ANALYSIS OF THE WORLD’S LARGEST MEDICAL DEVICE COMPANIES FINDS SALES, R&D SPENDING AND EMPLOYMENT ON THE UPSWING. BY JIM HAMMERAND MANAGING EDITOR
& SKYLER RIVERA ASSOCIATE EDITOR
T
he Medical Design & Outsourcing Medtech Big 100 ranking of the world’s largest medical device companies by revenue is bigger than ever, breaking the half-trillion-dollar mark for the first time. Research and development (R&D) spending growth is also up after last year’s big slowdown, and total employment grew nearly 3% year over year. The Medtech Big 100 is an annual index that measures and tracks the medical device industry through its 100 largest businesses, including OEMs, medtech segments of larger, diversified companies like Johnson & Johnson and Abbott, and one pure-play medical device contract manufacturing and development organization. 36
Medical Design & Outsourcing
BIG100-Analysis_9-26_Vs5.indd 36
9 • 2026
The 2026 Big 100 covers financial results as recent as April 2026, but most companies reported results for calendar year 2025. This year’s list includes three new companies in the top 50, including Medtronic’s diabetes business, MiniMed, which landed at No. 40 after its IPO with $3.1 billion in revenue. Medtronic is still reporting that revenue in its total, keeping it atop our ranking as the world's largest medical device company with revenue of $36.4 billion. With 8% revenue growth, Medtronic grew faster than No. 2 Johnson & Johnson MedTech (up 6% to $33.8 billion) and expanded its sales lead by nearly a billion dollars to $2.6 billion. (continued on page 38)
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9/3/26 1:55 AM
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MEDTECH BIG 100 ANALYSIS R&D RANKING BY TOTAL SPEND
FOR THIS ANALYSIS, WE COLLECTED THE MOST RECENTLY AVAILABLE ANNUAL REVENUE FIGURES FROM BOTH PUBLIC AND PRIVATELY HELD MEDICAL DEVICE MANUFACTURERS AROUND THE GLOBE. NOTE THAT FISCAL YEARS FROM COMPANIES CAN VARY. DUE TO THE VARYING STRENGTH OF THE U.S. DOLLAR, THE ANALYSIS USED FOREIGN CURRENCIES IN THE YEAR-OVERYEAR ANALYSES FOR COMPANIES THAT DON’T REPORT THEIR SALES AND R&D SPENDING IN U.S. DOLLARS.
R&D SPEND RANK
COMPANY
BIG 100 RANK
R&D SPEND ($USD)
1
Medtronic
1
$2,873,000,000
2
Johnson & Johnson MedTech
2
$2,838,000,000
3
Siemens Healthineers
4
$2,213,714,800
4
Boston Scientific
9
$2,052,000,000
5
Royal Philips
8
$1,922,020,000
6
Abbott (medical device segment)
6
$1,753,000,000
7
Stryker
5
$1,623,000,000
8
Intuitive Surgical
16
$1,311,800,000
9
GE HealthCare
7
$1,260,000,000
10
Edwards Lifesciences
22
$1,079,200,000
11
Alcon
15
$990,000,000
12
Olympus
20
$735,100,817
13
B. Braun
14
$660,270,400
14
Dexcom
27
$599,100,000
15
Baxter
13
$518,000,000
16
Terumo
18
$514,145,349
17
Mindray
28
$497,905,003
18
Zimmer Biomet
17
$458,500,000
19
MiniMed
40
$448,000,000
20
Align Technology
33
$369,911,000
Fujifilm Holdings (healthcare
19
$356,358,220
Carl Zeiss (medical technology
41
$339,180,000
23
Resmed
24
$331,284,000
24
Canon Medical
35
$314,043,188
25
Insulet
47
$301,100,000
26
Smith+Nephew
21
$296,000,000
27
Elekta
57
$268,509,076
28
Sonova
29
$262,131,246
29
Hologic
31
$248,200,000
30
Novocure
88
$224,544,000
31
WS Audiology
43
$200,116,200
32
Tandem Diabetes Care
74
$193,114,000
33
Cochlear
62
$188,017,500
34
LivaNova
66
$185,764,000
35
Applied Medical Resources
76
$184,000,000
36
CooperCompanies
32
$172,200,000
37
Glaukos
93
$150,614,000
38
Dentsply Sirona
36
$150,000,000
21 22
38
Medical Design & Outsourcing
BIG100-Analysis_9-26_Vs5.indd 38
segment) segment)
9 • 2026
(continued from page 36)
Who’s in and who’s out Several companies that were purchased by private equity in recent years dropped off this year’s Medtech Big 100 because they did not share their latest financial results. They are: Owens & Minor (formerly No. 13, bought by Platinum Equity at the end of 2025), Cordis (formerly No. 75, purchased by Hellman & Friedman in 2021), Topcon’s eye care business (formerly No. 87, went private in deal partially funded by KKR and JIC Capital in 2025), ZimVie (formerly No. 91, purchased by Archimed in 2025), and Highridge Medical (formerly No. 97, purchased by H.I.G. Capital in 2024). The same might happen to Integer, the CDMO at No. 56 that plans to sell to KKR for $5.7 billion in a deal that could close by the end of 2026. Bruker is also off this year’s ranking because their medical device revenue was not available. New names on the list beyond MiniMed include Zoll Medical, Karl Storz’s medical segment, Plexus’ healthcare and life sciences segment, Ascensia Diabetes Care, Konica Minolta’s healthcare segment and AgfaGevaert's radiology solutions segment. Big 100 revenue is up Total revenue for the 2026 Medtech Big 100 was nearly $519.1 billion, up 6% from $486.7 billion last year. Eighty-six companies reported year-over-year sales increases, 12 reported decreases and two did not provide prior-year revenue for comparison: Zoll and Cook Medical, the latter of which previously only shared revenue for its parent company. Organ transplantation device developer and transportation company TransMedics reported the largest yearover-year revenue increase at 37%. The Organ Care System (OCS) developer got into another highly regulated industry — aviation — with its purchase of a charter flight operator in 2023. Since then, TransMedics has purchased at least 22 fixed-wing aircraft to offer end-to-end donor organ retrieval and delivery. The company is expanding to Europe in a move that "could nearly double our transplant addressable market,” said founder, CEO and President Waleed Hassanein. (continued on page 40)
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9/3/26 1:55 AM
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MEDTECH BIG 100 ANALYSIS R&D RANKING BY TOTAL SPEND (continued)
40
R&D SPEND RANK
COMPANY
BIG 100 RANK
R&D SPEND ($USD)
39
Getinge
37
$148,072,609
40
Globus Medical
42
$147,246,000
41
MicroPort
71
$146,504,000
42
Teleflex
55
$144,781,000
43
Coloplast
30
$143,036,424
44
Fisher & Paykel Healthcare
68
$137,108,100
45
Masimo (now part of Danaher)
61
$126,400,000
46
Enovis
53
$120,332,000
(continued from page 38)
47
Nipro (medical segment)
38
$115,665,989
48
Envista
45
$114,000,000
49
Steris
23
$112,900,000
50
Convatec
50
$111,000,000
51
Paul Hartmann
44
$110,120,440
52
Inspire Medical Systems
80
$103,165,000
53
AtriCure
90
$99,209,000
54
Integra LifeSciences
58
$98,971,000
55
Merit Medical Systems
63
$97,352,000
56
Penumbra
65
$89,766,000
57
ICU Medical
54
$87,495,000
58
iRhythm
85
$84,610,000
59
Medline Industries
3
$80,000,000
60
Alphatec Holdings (ATEC Spine)
84
$76,268,000
61
TransMedics
89
$69,055,000
62
Orthofix
81
$65,847,000
63
Haemonetics
69
$59,766,000
64
Ambu
79
$57,607,693
65
Conmed
67
$55,884,000
66
Nihon Kohden
60
$49,829,978
67
Integer
56
$49,499,000
“The impact of our work is measurable in lives saved and transplants performed, but we remain driven by the opportunities in front of us,” he told investors ahead of their May 2026 annual meeting. “Tens of thousands of patients remain on transplant waiting lists in the U.S. alone, and we believe TransMedics is uniquely positioned to close that gap.” Other companies leading revenue growth were Glaukos (32%), Insulet (31%), iRhythm (26%), Alphatec Holdings (25%), BD’s medical and interventional segments (23%), Asahi Intecc’s medical device business (23%), Medacta (21%), Intuitive Surgical (21%), Si-Bone (20%) and Boston Scientific (20%). Teleflex reported the biggest revenue decrease at 35% as it sold its Acute Care, Interventional Urology and OEM businesses for $2 billion. PE firms Montagu and Kohlberg bought the OEM contract development and manufacturing business. Masimo followed with a 27% decrease in revenue. The home health monitoring company, which sold its Sound United consumer audio business in 2025, was purchased by Danaher in June 2026 and might not make our 2027 ranking if financial results aren’t available. Rounding out the rest of the largest sales decreases are Agfa-Gevaert's radiology solutions segment (down 13%), Mindray (down 9%), Konica Minolta’s healthcare segment (down 7%), ICU Medical (down 6%) JMS Co. (down 4%), Nikkio’s medical unit (down 4%), Embecta (down 4%) and Dentsply Sirona (down 3%).
68
Accuray
94
$47,942,000
69
Embla Medical
78
$45,856,000
70
Embecta
73
$37,300,000
71
Artivion
95
$30,991,000
72
Medacta*
83
$26,596,234
73
Avanos Medical
86
$23,300,000
74
Si-Bone
100
$17,448,000
75
Arjo
70
$14,276,973
76
OrthoPediatrics
99
$9,102,000
Medical Design & Outsourcing
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9 • 2026
TransMedics founder, CEO and President Waleed Hassanein
“THE IMPACT OF OUR WORK IS MEASURABLE IN LIVES SAVED AND TRANSPLANTS PERFORMED, BUT WE REMAIN DRIVEN BY THE OPPORTUNITIES IN FRONT OF US.”
R&D spending climbs Seventy-six Medtech Big 100 companies disclosed their annual R&D spending for a total of $32.2 billion. That’s up 9% from last year, when 74 companies disclosed total R&D spending of $29.2 billion. R&D spending as share of revenue has remained steady over the past three years at 6%. Ten companies in the Medtech Big 100 spent more than $1 billion on R&D: (continued on page 42) * R&D spending adjusted to include capitalized expenses was $43,754,220 (€38,700,000).
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AVNA 9-26.indd 56
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9/3/26 12:11 AM
MEDTECH BIG 100 ANALYSIS HEADCOUNT RANKINGS
HERE’S HOW MANY PEOPLE EACH COMPANY REPORTED AS EMPLOYEES IN PUBLIC FILINGS, AT THEIR WEBSITES OR PROVIDED DIRECTLY TO MEDICAL DESIGN & OUTSOURCING. IN CASES OF TIES, COMPANIES SHARE THE SAME RANKING.
HEADCOUNT RANK
COMPANY
BIG 100 RANK
EMPLOYEES AND YEAROVER-YEAR CHANGE
(continued from page 40)
1
Medtronic
1
101,369 (up 1%)
2
Siemens Healthineers
4
74,000 (up 3%)
1. 2.
3
B. Braun
14
66,821 (up 4%)
4
Royal Philips
8
65,340 (down 4%)
5
Boston Scientific
9
59,000 (up 11%)
6
Stryker
5
56,000 (up 6%)
7
GE HealthCare
7
54,000 (up 2%)
8
Medline Industries
3
45,000 (up 5%)
9
Baxter
13
37,500 (down 1%)
10
Terumo
18
31,185 (up 2%)
11
Olympus
20
29,297 (no change)
Fresenius Medical Care
25
29,125 (change not available)
13
Nipro (medical segment)
38
27,089 (change not available)
14
Alcon
15
25,942 (up 4%)
15
Henry Schein
11
25,000 (no change)
16
Mindray
28
21,288 (down 2%)
17
Align Technology
33
20,383 (down 3%)
18
Sonova
29
18,447 (up 3%)
19
Steris
23
18,000 (up 1%)
20
Intuitive Surgical
16
17,021 (up 9%)
21
Zimmer Biomet
17
17,000 (no change)
21
Coloplast
30
17,000 (up 5%)
23
Smith+Nephew
21
16,988 (down 2%)
24
Edwards Lifesciences
22
16,000 (up 1%)
25
Teleflex
55
15,500 (up 10%)
26
Amplifon
46
15,080 (up .1%)
27
CooperCompanies
32
15,000 (down 6%)
28
Dentsply Sirona
36
14,000 (no change)
29
ICU Medical
54
13,000 (down 13%)
30
WS Audiology
43
12,000 (down 5%)
30
Envista
45
12,000 (down 2%)
32
Straumann
39
11,824 (down 2%)
33
Getinge
37
11,670 (down 3%)
34
Dexcom
27
11,000 (up 8%)
34
Integer
56
11,000 (no change)
36
Convatec
50
10,910 (up 9%)
37
Resmed
24
10,600 (up 6%)
12
42
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(healthcare products)
9 • 2026
Medtronic ($2.9 billion, up 5%) J&J MedTech ($2.8 billion, down 23%) 3. Siemens Healthineers ($2.2 billion, up 7%) 4. Boston Scientific ($2.1 billion, up 27%) 5. Royal Philips ($1.9 billion, up 2%) 6. Abbott medical device segment ($1.8 billion, up 13%) 7. Stryker ($1.6 billion, up 11%) 8. Intuitive Surgical ($1.3 billion, up 15%) 9. GE HealthCare ($1.3 billion, down 4%) 10. Edwards Lifesciences ($1.1 billion, up 3%) J&J MedTech was the top R&D spender last year at $3.7 billion, but its year-overyear decrease of 23% was one of the largest among all Big 100 companies. Explaining that decrease in its most recent annual report, J&J pointed to two expenses from 2024: a $500 million in-process R&D expense from the V-Wave acquisition and a $300 million Laminar milestone. J&J MedTech’s R&D spending equaled 8% of revenue in 2025, 12% in 2024, 10% in 2023 and 9% in 2022. J&J “remains committed to investing in research and development with the aim of delivering high quality and innovative products,” the company said in the filing. Employment grows The 2026 Medtech Big 100 list has a total employment of 1.3 million, up 3% from the year before. But only 81 companies offered headcounts (compared to 83 the year before), and some companies rounded to the nearest thousand rather than offering precise numbers. Insulet led the way on workforce growth, expanding its workforce by 39% to about 5,400. Close behind were TransMedics (up 23% to 898), iRhythm (up 20% to 2,400) and LivaNova (up 14% to 3,300). Masimo reported the greatest headcount decrease (down 39% to 2,200 employees), followed by ICU Medical (down 13% to 13,000) and Embecta (down 12% to 1,850). The Medtech Big 100 companies with the most employees are Medtronic
www.medicaldesignandoutsourcing.com
9/3/26 1:56 AM
MEDTECH BIG 100 ANALYSIS HEADCOUNT RANKINGS
HEADCOUNT RANKINGS HEADCOUNT RANK
COMPANY
BIG 100 RANK
EMPLOYEES AND YEAROVER-YEAR CHANGE
HEADCOUNT RANK
38
Paul Hartmann
44
10,066 (up 1%)
39
Dräger (medical division)
52
9,540 (change not available)
40
Cook Medical
51
9,518 (change not available)
41
Karl Storz (medical segment)
49
9,000 (change not available)
Carl Zeiss (medical technology
41
8,748 (up 1%)
43
Enovis
53
8,217 (up 8%)
44
MiniMed
40
8,000 (change not available)
42
segment)
Boston Scientific CEO Mike Mahoney
(101,369, up 1%), Siemens Healthineers (74,000, up 3%), B. Braun (66,821, up 4%) and Royal Philips (65,340, down 4%). Boston Scientific led headcount growth among the top 30 Big 100 companies, increasing 11% to about 59,000 employees, though that count came ahead of a planned global restructuring that will create new jobs in growth areas and cut jobs elsewhere. Boston Scientific was followed by Intuitive (up 9% to 17,021) and Dexcom (up 8% to 11,000). “We have an insatiable desire to be a large company, but not a large slow company,” CEO Mike Mahoney said about Boston Scientific’s culture earlier this year. “We really put a premium on appropriate speed and agility — trying to constantly root out bureaucracy — and appropriate risk-taking. [We] don’t want to just be a good company. We want to be the best company. ... We want to win.”
“WE HAVE AN INSATIABLE DESIRE TO BE A LARGE COMPANY, BUT NOT A LARGE SLOW COMPANY.”
For more analysis of the 2026 Medtech Big 100, go to wtwh.me/2026big100 for a special report coming soon.
COMPANY
BIG 100 RANK
EMPLOYEES AND YEAROVER-YEAR CHANGE
45
Fisher & Paykel Healthcare
68
7,629 (up 3%)
46
Merit Medical Systems
63
7,500 (up 1%)
47
Zoll Medical (part of Asahi Kasei)
48
7,000 (change not available)
47
Hologic
31
7,000 (down 1%)
47
Arjo
70
7,000 (up 3%)
50
MicroPort
71
6,547 (up 3%)
51
Nihon Kohden
60
6,116 (no change)
52
Globus Medical
42
6,000 (up 13%)
53
Applied Medical Resources
76
5,700 (up 6%)
54
Cochlear
62
5,500 (up 10%)
55
JMS Co.
96
5,469 (no change)
56
Insulet
47
5,400 (up 39%)
57
Ambu
79
5,200 (up 4%)
58
Penumbra
65
4,700 (up 4%)
59
Integra LifeSciences
58
4,427 (up 1%)
60
Elekta
57
4,353 (down 4%)
61
Embla Medical
78
4,328 (up 8%)
62
Conmed
67
3,900 (no change)
63
LivaNova
66
3,300 (up 14%)
64
Haemonetics
69
3,009 (down 1%)
65
Tandem Diabetes Care
74
2,500 (down 6%)
66
iRhythm
85
2,400 (up 20%)
67
Avanos Medical
86
2,287 (up 3%)
68
Masimo (now part of Danaher)
61
2,200 (down 39%)
69
Medacta
83
2,165 (up 14%)
70
Embecta
73
1,850 (down 12%)
71
Artivion
95
1,800 (up 13%)
72
Novocure
88
1,605 (up 8%)
72
Orthofix
81
1,605 (down 1%)
74
AtriCure
90
1,350 (up 4%)
75
Inspire Medical Systems
80
1,333 (up 7%)
76
Glaukos
93
1,094 (up 10%)
77
Accuray
94
990 (up .3%)
78
Alphatec Holdings (ATEC Spine)
84
913 (up 5%)
79
TransMedics
89
898 (up 23%)
80
OrthoPediatrics
99
602 (up 7%)
81
Si-Bone
100
376 (up 8%)
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EDWARDS LIFESCIENCES
This
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Medical Design & Outsourcing
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9 • 2026
www.medicaldesignandoutsourcing.com
9/3/26 6:06 PM
may have solved the leading cause of tissue valve failure
RESILIA’S CO-INVENTOR DISCUSSES THE TISSUE, HOW IT WAS DEVELOPED AND HOW IT’S MADE. BY SKYLER RIVERA ASSOCIATE EDITOR
Edwards Lifesciences heart valve implants with Resilia tissue limit leaflet calcification, the leading cause of implant failure in tissuebased heart valves. (Turn the page for a side-by-side comparison.) Image courtesy of Edwards Lifesciences
CALCIFICATION IS THE LEADING cause of implant failure in tissue-based heart valves, and new durability data from Edwards Lifesciences shows its Resilia tissue development is paying off. The anti-calcification tech’s 10-year results are “mind-boggling,” says one of the novel tissue technology’s co-inventors, Edwards Lifesciences R&D SVP Greg Wright. “If I was asked at 10 years in a clinical trial what would I be happy with, I’d have been happy with better than 90% freedom from structural valve deterioration,” he said in a Medical Design & Outsourcing interview. “We were almost at 98%.” Made from bovine pericardial tissue, Resilia was first implanted in a human in 2011 and commercially launched in 2016. It’s just one R&D project from the industry’s pioneer of transcatheter aortic valve replacement (TAVR), but it’s an example of how R&D drives growth at the world’s largest medical device companies. Over the last decade, Edwards has nearly tripled its revenue to $6.1 billion while growing R&D spending 182% to $1.1 billion. At the same time, the company has increased R&D spending as a share of total sales from 15% to 18%. And when it comes to its rank among the world’s largest medical device companies, Edwards has climbed 14 spots on the MDO Medtech Big 100 in that time, along with other medtech innovators like Intuitive Surgical (up 21 spots) and Abbott (up 18 spots). To date, more than 500,000 patients have received Edwards surgical and transcatheter valve implants with Resilia tissue technology. Nearly all patients in the company’s Commence aortic valve trial have avoided reoperation due to structural valve deterioration (SVD) at 10 years. “As patients live longer and expect to remain active, structural heart therapies must be designed with lifetime care in mind,” Edwards Lifesciences CEO Bernard Zovighian said while announcing the 10-year results, calling the study “the latest addition to our breadth of long-term data reflecting our commitment to advancing durable valve technologies through continuous evidence development.” >>
“We want to provide solutions for our patients that don’t exist today, and that’s all we care about.”
9 • 2026
FEAT COVER_9-26_Vs3.indd 45
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9/3/26 6:06 PM
EDWARDS LIFESCIENCES
The quest for the holy grail of valve tissue Anti-calcification technology was the “holy grail” of next-generation tissue technology when Edwards started on the journey, says Dr. Joseph Bavaria, a paid Edwards consultant who has performed more than 11,500 open-heart surgeries and led IDE trials studying TAVR and other cardiac innovations.
Durability issues have plagued artificial tissue heart valves for decades. Scientists and engineers tried various chemical methods to reduce calcification of the valve leaflets without sustained success, resulting in implanted valves that lasted only five to 20 years. Then came Resilia. “We want to provide solutions for our patients that don’t exist today, and that’s all we care about,” Wright said.
blocks residual aldehyde groups known to bind with calcium. “This was brand new chemistry, brand new concepts, brand new scientific thought,” said Bavaria, who led the fiveyear Resilia study as lead author.
really focused on residual aldehydes in the tissue that are left behind after we cross-link the tissue in glutaraldehyde [and decided] if we’re going to use a chemistry that effectively blocks these aldehyde groups, we don’t want to go back to glutaraldehyde.” Developing a dry storage solution Edwards needed the technology for Wright joined Edwards in 2005, working the Konect aortic valved conduit it was with a team focused on developing at the time. Konect’s aortic root graft, attached to the system’s artificial aortic valve, can’t be submerged in solution. So Wright and his team developed a glycerolization Radiographic imaging shows an Edwards Lifesciences process to treat valves with valve with Resilia tissue (right) a glycerol and ethanol mix. with significantly less leaflet The mix displaces most of calcification compared to a the water present in the control valve (left). pericardial tissue and replaces Images courtesy of Edwards the liquid with glycerol, Lifesciences mitigating calcium-attracting glutaraldehyde residuals and allowing for dry storage. next-generation tissue technology. “We wanted to learn what the competition did, what is the industry doing to address this, what have they done well, and what can we learn from it and even make it better,” he said. Before Resilia, artificial heart valves were treated with and packaged in glutaraldehyde to stabilize the porcine leaflets and restrict endothelialization.
“When we were focused on Resilia, we were looking at two different paths: improving the durability by reducing the calcification … and creating a situation where we could store the valve dry.” “When we were focused on Resilia, we were looking at two different paths: improving the durability by reducing the calcification … and creating a situation where we could store the valve dry.” Resilia tissue introduced a novel preservation technology that resists calcification and allows for valve dry storage by incorporating a stablecapping anti-calcification process that 46
Medical Design & Outsourcing
FEAT COVER_9-26_Vs3.indd 46
9 • 2026
When the valves were implanted, residual aldehydes remained. “When you leave behind these residual aldehydes, they eventually go down a path where their chemistry changes, they eventually begin to attract calcium, and calcification begins to start at some of those spots,” Wright said. “ … The technology we developed to reduce calcification was
Reducing calcification with a proprietary capping technology During their research, Wright’s team learned competitors were implementing capping technology, which blocks a chemical reaction to avoid generating by-products, but it wasn’t stable. “Stable capping is a chemical process that puts a chemical cap on those aldehyde groups, and it permanently blocks that cap from becoming a spot where calcification can generate,” Wright said. “The capping took us a long time to develop a consistent process where we felt it was robust enough to consistently reduce calcification as we were running our studies and assessing the technology.” Wright and his team eventually developed a proprietary stable-capping process that blocked calcium and also enabled better blood flow. “We noticed that the motion of the leaflets was better,” he said. “We were getting better opening, better leaflet kinematics. Not only are you now getting a reduction in calcification and increased durability, you’re getting better hemodynamics for the patients.” Wright said Edwards is seeing durability and increased hemodynamic function across surgical valves and transcatheter valves like the
www.medicaldesignandoutsourcing.com
9/3/26 2:29 AM
EDWARDS LIFESCIENCES
Edwards R&D SVP Greg Wright
Edwards Sapien 3 Ultra Resilia valve. But there’s room for improvement and more innovation. “As successful as Resilia has been, you’re going to have a patient that doesn’t last as long as another patient, and that has a lot to do with the patient factors,” he said. “That’s what we’re thinking about in terms of what the next steps for our next generation of Resilia are. Maybe there are patient factors that we can focus on.” Looking forward with Resilia Resilia’s 10-year data is “better than we’ve ever had before,” said Bavaria, who’s already looking forward to longer-term results. “Durability for tissue valves is going to be continuing to understand the deep science about what actually happens to these leaflets,” he said. “We’ll get better and better — which we have been — at designing leaflets from an engineering standpoint: making the valves more hemodynamic, making them cleaner, making them have less gradients, making them close faster, open faster. All that kind of stuff is in the engineering realm, and that’s being done. At this stage it’s pretty innovative.” He continued, “But just like Resilia, we need another … really big step in our understanding of the actual chemistry and biology of heart valve failure.”
Edwards’ proprietary stable-capping technology permanently blocks free aldehydes to prevent calcium binding within the tissue. Illustration courtesy of Edwards Lifesciences
Edwards Lifesciences makes a simple change for a first-of-its-kind tricuspid valve Triformis Resilia is the first surgical valve designed and approved for the tricuspid position. BY SKYLER RIVERA ASSOCIATE EDITOR
THE FIRST-OF-ITS-KIND Edwards Lifesciences Triformis Resilia doesn’t look all that different from the structural heart device developer’s other prosthetic valves, but a simple yet critical design change allows it to address an unmet patient need. Edwards earned FDA approval for Triformis Resilia in May 2026. It’s the first surgical valve designed for the tricuspid position. Surgeons previously used mitral valves for tricuspid valve replacement because there were no surgical replacement tricuspid valves approved for use. “Due to a relatively small market and challenges in conducting prospective clinical studies of dedicated surgical tricuspid valves, manufacturers have not innovated on these devices,” Edwards said in its FDA Summary of Safety and Effectiveness Data for Triformis Resilia. The new valve “introduces a purpose-built surgical option for a long-underserved area of structural heart care and extends Edwards’ Resilia tissue technology to the tricuspid position,” the 9 • 2026
FEAT COVER_9-26_Vs3.indd 47
company said in a statement shared with Medical Design & Outsourcing. A tricuspid-specific design Triformis looks quite similar to the Edwards Mitris Resilia surgical mitral valve and has the same stented tri-leaflet prosthetic heart valve design and Resilia tissue technology. Like the other valves, Triformis Resilia is a low-profile stented prosthetic with three Resilia bovine pericardial tissue leaflets attached to a lightweight nitinol wireform. But the Triformis valve has a new sewing ring design meant to match the native tricuspid anatomy for replacing native or prosthetic heart valves. The Edwards Mitris implant has a “saddleshaped” sewing cuff with an atrialized cuff design to reduce ventricular protrusion in mitral valves. But the new Triformis valve has a sewing ring with a flat profile that mimics the tricuspid annulus for optimal seating. The sewing ring’s flattened section along the septal region was designed to avoid antrioventricular (AV) node disruption. >> Medical Design & Outsourcing
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9/3/26 2:30 AM
The Edwards Lifesciences Triformis Resilia tricuspid valve has nitinol stent posts that can fold 55° during implantation to avoid suture looping.
EDWARDS LIFESCIENCES
Image courtesy of Edwards Lifesciences
The AV node is located near the septal leaflet of the tricuspid valve, connecting the electrical systems of the heart’s upper and lower chambers. AV node disruption (also known as AV block) can cause abnormal heart rhythms, chest pain, shortness of breath, dizziness and fatigue. Edwards said its pre-clinical study of Triformis in the tricuspid position resulted in no significant conduction abnormalities, no evidence of structural or nonstructural dysfunction and demonstrated optimal seating. Triformis’ structure and materials The Triformis Resilia tricuspid valve comes in five sizes: 25 mm, 27 mm, 29 mm, 31 mm and 33 mm. Edwards chose nitinol for the wireform because the nickel-titanium alloy’s superelastic characteristics allow the stent posts to fold 55° during implantation, avoiding suture looping. The wireform is covered in polyester fabric.
S H O CK
& VIB
A cobalt-chromium alloy band and a polyester band that surround the base of the valve below the wireform provide structural support for the valve’s orifice. Like other Edwards structural heart valves, the nitinol wireform and cobaltchromium alloy band are visible on
SOLU RATION
T IONS
fluoroscopy to help the surgeon identify the valve’s inflow and outflow edges to determine a landing zone. The tricuspid-specific Triformis sewing ring is made of compliant silicone-rubber and covered with a porous, seamless polytetrafluoroethylene (PTFE) cloth. It’s attached to the valve’s wireform frame and facilitates tissue ingrowth and encapsulation. To aid orientation of the valve during implant, single black lines along the sewing ring mark the posteroseptal and anteroseptal commissures and an ’S’ marks the anterior septal segment. Edwards said a pre-clinical study of the valve showed good hemodynamic performance and good leaflet mobility. The company has said it plans to launch the Triformis Resilia valve in the second half of 2026.
Online Design Guide Calculators for working with Sorbothane
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MADE IN THE U.S.A.
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1/10/24 1:30 PM
9/3/26 3:24 PM
BY JIM HAMMERAND MANAGING EDITOR
J&J’S ROBOTICS R&D HEAD DISCUSSES
FOLDING ARMS, SOOTHING SOUNDS AND HAPTICS CAPABILITY J&J MEDTECH GLOBAL HEAD OF ROBOTICS & DIGITAL R&D NEDA CVIJETIC SHARES WHAT IT TOOK TO WIN FDA DE NOVO AUTHORIZATION FOR THE SURGICAL ROBOT. JOHNSON & JOHNSON MEDTECH unveiled its Ottava surgical robotics system at the July 2026 Society of Robotic Surgery (SRS) annual meeting after winning FDA de novo authorization. “These teams have built a categorydefining, soft-tissue surgical robot, and our regulatory pathway is a testament to that. There is no precedent here,” J&J MedTech Global Head of Robotics & Digital R&D Neda Cvijetic said in a Medical Design & Outsourcing interview. “A category-defining path on something
so sophisticated and technologically complex, it’s never a purely linear path,” Cvijetic continued, saying it took “ingenuity to solve these problems that are unprecedented, it took determination, discipline, commitment, functional excellence in every single area of engineering.” After getting our first good look at the long-awaited robotics system, we discussed Ottava’s design, features and product development journey with Cvijetic. The following has been lightly edited for space and clarity.
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FEAT OTTAVA_9-26_Vs3.indd 49
MDO: You’ll never get too technical for the engineers in our audience. Do you have any examples you could share of a solution to a particularly hard problem during Ottava’s development? Cvijetic: “If we think about that categorydefining aspect of it, the first thing that comes to mind is that table-mounted architecture. What’s really challenging in achieving that is simultaneously being able to fully stow the robotic arms under the table while at the same time when they are deployed, ensuring they achieve >> 9 • 2026
Medical Design & Outsourcing
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J&J MEDTECH’S OTTAVA
J&J MedTech Global Head of Robotics & Digital R&D Neda Cvijetic the full reach and access that is needed for clinical procedures. That is a very challenging engineering problem and we’re incredibly proud we were able to solve that and bring this incredible robot to the market. “That took engineering excellence across all different disciplines, whether it’s mechanical, electrical, human factors, clinical workflow understanding, software across all different parts of the software stack. Even systems integration of a problem like that is incredibly challenging. And the other thing that I would say about these arms is that it’s not simply that physical aspect of it. They were built from the ground up for automation, and as part of solving that problem we also made the design decision to fully motorize those arms and include sensors in them that provide us a very high degree of spatial awareness to get us ready for compelling automation from day one. “It’s a lot of different technical challenges, not only one. But the motors part is really, really important because we did make the decision as we were solving that problem to also motorize every single joint of every single arm. And that now solves that problem also from that digital dimension, because once the arms are fully motorized and once we also empower them with sensors that provide a very high degree of spatial precision and spatial awareness, we are not only able to stow them underneath the table and have them deploy and have proper reach and access, but we open up a whole universe of digital and software capabilities. From day one, that is manifested in the form of our predefined procedure poses, where at the push of a button the arms can deploy and not only deploy but get into a predefined procedure pose, whether that’s related to setup, a portion of the clinical workflow or teardown. And that is incredibly empowering for clinical 50
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teams. We hear this all the time. What’s also inspiring about that design decision is that it sets up a foundation for continuous innovation. So think about a cadence of future software releases at pace. That design decision to not only design for stowage and for reach and access, but for motorization, for spatial awareness, gives us the ability to create over time a cadence of differentiated software releases that are very compelling.” What kind of sensors is Ottava equipped with, and what are they collecting? Cvijetic: “The sensors provide spatial awareness. It’s incredibly important that the arms understand where they are with respect to each other, with respect to the table, with respect to the patient, and then with that spatial awareness data we’re able to use both real-world data and simulation data to compute
this set of predefined procedure poses. It’s that spatial awareness, spatial information that we’re able to obtain from the from those sensors. “And then in terms of the Polyphonic digital ecosystem, I’m at SRS and so much of the conversation at the robotics conference has been about digital capabilities. We hear from surgeons and from our clinical partners all the time that they want more access to their data. This is now available with Ottava from day one, that ability to curate data, to access metrics, to access metadata, and it’s open. Monarch is part of the Polyphonic digital ecosystem, Ottava too, and it’s open to other devices as well.” What kind of sensor are you using to track that spatial location? Does it have a particular name? Cvijetic: “It’s a sensor that provides spatial awareness [but] in the interest of intellectual property protection, I am not able to discuss at that level of detail.”
Find more from this interview in our Big100 special report at wtwh.me/big100 soon.
Johnson & Johnson MedTech’s Ottava is the world’s first table-integrated soft-tissue robotics system. Photo courtesy of Johnson & Johnson
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J&J MEDTECH’S OTTAVA
How else are you collecting case data to feed into Polyphonic? Cameras and microphones? Cvijetic: “We have advanced visualization capabilities and a camera, as you might expect in a surgical robotics system, and then the system has audio capabilities as well.” What about haptic feedback or some form of force indication? Does Ottava have it, and what was the thinking about whether to include it? Cvijetic: “We listen to our customers a lot and we pay attention to the new technologies that are out there in the field, and that’s going to continue being the case. We’re going to continue listening, continue innovating based on their feedback, and continue prioritizing how we innovate based on
their feedback. On the instrumentation in general, we have a full intention to make our full Ethicon pipeline available on Ottava, and that listening to our customers and experience from Ethicon all comes together in that way.” What were your customers saying about force feedback? There’s an interesting conversation in robotics right now about whether it’s needed. Cvijetic: “You’re exactly right. What you’re hearing is similar to what we’re hearing, and we continue listening, we continue really closely understanding what is most important to them compared to some other aspects and challenges they’re facing in the OR, other types of innovation they would like to see, and that directly informs our innovation roadmap.”
Does Ottava have the ability to be upgraded with haptic feedback later? Cvijetic: “We have that capability.” I’ve been reading about your team’s work with expert sound designers on this system to create calming sounds in the OR. Can you tell me more about that? Cvijetic: “For us, no matter the type of technology — whether it’s automation, digital ecosystem, or sound — it’s about empowering that human clinical expert in the OR. Sound can be very soothing for humans. It’s a very calming sound. The OR can be a very busy, noisy environment. I would describe it as a calming, reassuring sound that that instills confidence in our system. … To me, it sounds like a very soothing, hightech spa.”
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CARDIOVASCULAR
Manny Villafaña and his team at Medical 21 have developed an artificial artery called Maverics, pictured here in animal testing. Photo courtesy of Medical 21
St. Jude Medical founder Manny Villafaña says his newest device will be bigger than anything he’s ever done His previous companies sold for billions to Abbott, Boston Scientific and Medtronic. Can Villafaña do it again?
M By Skyler Rivera Associate Editor
Medical 21 founder and CEO Manny Villafaña 52
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anny Villafaña says his latest medical device will be “the single biggest product ever developed to be put in the human body.” After founding three device developers acquired by major OEMs for a combined $57.4 billion — Cardiac Pacemakers Inc. (CPI, purchased by Boston Scientific for $27 billion), St. Jude Medical (purchased by Abbott for $30 billion) and ATS Medical (purchased by Medtronic for $400 million) — the serial medtech entrepreneur and his new Minneapolis-area team at Medical 21 have developed a first-of-its-kind regenerative artificial artery. Made of nitinol and an absorbable polymer, the graft is designed to eliminate blood vessel harvesting in coronary artery bypass grafting (CABG) procedures. CABG is the most commonly performed major surgery worldwide, with an estimated 800,000 procedures annually. Villafaña says his novel Maverics artificial graft could have a total addressable market of $15 billion to $20 billion. “That’s my market, and that’s only in the heart,” he said in a Medical Design & Outsourcing interview. “… This device can be used in other parts
of the body: peripheral, dialysis, brain, urology, pediatric.” Villafaña said the graft could save $4 billion to $8 billion annually in Medicare expenditures, decrease patient morbidity and recovery time, expand patient access to CABG and slash procedure time. “[Traditionally] from the moment the patient is rolled into the OR to the time a doctor finally got a vessel to put on the heart was over two hours,” he said. “I can get a vessel into your hands to put on the heart in less than 10 seconds. … You’ve eliminated pain, infection, rehabilitation, [and learning] how to walk again.” The percentage of CABG surgeries performed has decreased over the past 30 years as patients opt for less invasive, alternative options like medication and percutaneous coronary intervention. But Medical 21 says the increasing prevalence of obesity, diabetes mellitus, hypertension, drug abuse, and chronic medical conditions — plus increases in the geriatric population — will fuel growth in the years ahead. “Everybody tried to do this,” he said. “Medtronic, St. Jude, etc. have all tried to do this over the last 60 years and no one’s done it.”
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Maverics’ design elements In its current design, Maverics is a 4 mm graft incorporating a reabsorbable synthetic polymer scaffold and nitinol wire designed to function as a flexible blood conduit. It’s engineered to integrate with a patient’s cells after implantation and support natural healing while avoiding rejection. Villafaña said 4 mm is the “ideal size” for a graft, and its materials enable the surgeon to shorten the graft as needed for an individual patient. Maverics could also expand access to CABG for patients with diabetes or amputations who were once ineligible for the procedure. Maverics also offers predictability that autologous vessels can’t provide, he said. Surgeons don’t know what size vessels are available for harvesting from the patient until beginning the procedure, he said, and those vessels could be damaged or diseased.
“You don’t know what you’re going to get,” Villafaña said. “Here, you know exactly what you’re going to get every single time.” The graft is shipped sterile in final packaging for on-the-shelf storage at hospitals for up to two years until a surgeon needs it. Maverics is still in the preclinical development stage. Early animal testing has yielded positive results, the company said, with histology showing host tissue remodeling and a maintained luminal pathway in sheep at two years postimplant, demonstrating graft integration across the implant length. In another ovine study, three-year angiograms showed sustained patency of the graft. >>
The Medical 21 Maverics device is made of nitinol wire and a synthetic, absorbable polymer. Photo courtesy of Medical 21
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CARDIOVASCULAR
Histology showed host tissue remodeling and a maintained luminal pathway in sheep at two years post-implant, demonstrating graft integration across the implant length. Image courtesy of Medical 21
“When the doctors look at [the preclinical results], they say, ‘Manny, that’s it, when can we get it?” Villafaña said. “Right now we’re getting ready to begin our human clinical work.” Medical 21 plans to complete an additional sheep study before submitting an investigational device exemption (IDE) request to the FDA in the second quarter of 2027 and pursuing an early feasibility study in the U.S., according to a filing with the U.S. Securities and Exchange Commission ahead of a planned initial public offering (IPO). “I’ve done seven IPOs. … We were all set and ready to go in March, and bingo, on Feb. 28, somebody starts dropping bombs and the IPO market for small companies was shut down,” Villafaña said. “It’s still shut down, so right now we’re running out of cash. And I’m looking for people to help us be able to continue while we wait for the IPO window to open or carry our clinical trial to the point where some investors, some
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strategics will be interested.” The first-in-human study will evaluate procedural feasibility, graft handling, early patency, and key safety outcomes in patients undergoing CABG for bypassing severely diseased coronary arteries with insufficient vessels to complete revascularization.
Villafaña says Maverics will be more revolutionary than pacemakers, heart valves, stents and defibrillators combined, if Medical 21 can bring it to market. And from our interview, it’s clear he’s got plenty of fight left in him. “I’m in the middle of my career, not the end of my career,” he said.
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IMPLANTS
The first-of-its-kind Medtronic Aurora EV-ICD system is FDA-approved for treating sudden cardiac arrest and abnormal heart rhythms with defibrillation and antitachycardia pacing. Illustration courtesy of Medtronic
Medtronic R&D VP James Coles offers a defib pipeline preview Extravascular implantable cardioverter defibrillator technology “is going to be the future,” he says.
W By Jim Hammerand Managing Editor
Medtronic Defibrillation Solutions VP of R&D James Coles
hen James Coles learned his Medtronic team’s OmniaSecure won FDA approval in March 2026, it reminded him of the same milestone three years earlier for the Medtronic Aurora EV-ICD (which stands for extravascular implantable cardioverter defibrillator). “It was a big, monumental moment,” said Coles, VP of R&D for defibrillation solutions in Medtronic’s Cardiac Rhythm Management (CRM) business. “… It’s great to see these get out to patients. But for us, it’s been a long journey to get there, and now for the rest of the world, the journey just starts.” In an interview after that most recent milestone, Coles offered a look into his group’s pipeline, saying EV-ICD technology “is going to be the future.” “If we can remove leads from the heart and the vasculature, there is a huge benefit for patients,” he said. “What we need to do is to continue to iterate on that platform, to continue to add more functionality to those devices so eventually the first selection [for a patient] would be extravascular, not a device that goes in the heart and the vasculature.” “Medtronic released an algorithm on our implantable cardiac monitors
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a number of years ago called AccuRhythm AI,” Coles said. “It showed a huge benefit of helping clinicians prioritize what arrhythmias they need to pay attention to that were coming through and being transmitted to them from patients. “The next step is to bring that into ICD patients,” he continued. “ICDs are constantly monitoring arrhythmias. If there’s a way we can use AI to improve our overall specificity, help determine what therapy would be appropriate and at what time for the patient, I think that would be the holy grail of ICD therapy. So there is some work going on now to see how can we expand the use of AI into other product lines.” When Coles refers to AI, he said he mostly means machine learning, “where we’re teaching an AI algorithm using data on how to interpret whether something is A or B, helping us make decisions.” “I think we’re further out on generative AI and deep language learning, at least for implantable medical devices,” he continued. “We do see that being used in clinics for other reasons, so we’re watching that very closely to see if there’s something we can partner with on the clinician side.” 9 • 2026
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MATERIALS
Why Boston Scientific is betting $1.5 billion on this superalloy The “uniquely strong,” nickel-free metal could help the device developer finally break into the TAVR market.
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By Skyler Rivera Associate Editor
n May 2026, Boston Scientific invested $1.5 billion in MiRus, the developer of the novel, balloonexpandable Siegel transcatheter aortic valve replacement (TAVR) implant featuring a proprietary molybdenumrhenium alloy frame. Also known as MoRe, that “superalloy” (a heat-resistant, highperformance alloy) is a big part of what’s special about the investigational MiRus Siegel valve and why Boston Scientific is betting big on it. Boston Scientific unsuccessfully tried twice to break into the TAVR market — dominated by Edwards Lifesciences and Medtronic — with its Accurate and Lotus Edge platforms. Boston Scientific is trying again with its $1.5 billion deal, which gives it a 34% equity stake in MiRus and the exclusive option to acquire the
What makes Siegel TAVR different The Siegel TAVR frame is constructed with MiRus’ proprietary MoRe and coated with nitric oxide. Boston Scientific said that makes it the “first nickel-free, balloon-expandable TAVR valve intended to restore function and normal blood flow of severely narrowed aortic valves.” MiRus describes MoRe as having “a radial strength greater than cobalt or titanium,” while Boston Scientific says MoRe is “fatigue resistant, biofriendly and generates low levels of metal ions in tissue.” “The MiRus technology leverages a uniquely strong, proprietary alloy that is entirely nickel-free, providing a differentiated offering with the potential to disrupt the TAVR market,” Boston Scientific said in a presentation to investors. MiRus says Siegel is the “only nickel-free transcatheter heart valve >>
The MiRus Siegel balloonexpandable TAVR implant uses molybdenum-rhenium, a superalloy that is “entirely nickelfree, providing a differentiated offering with the potential to disrupt the TAVR market,” Boston Scientific said after investing $1.5 billion in the technology. Photo courtesy of MiRus
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Siegel TAVR device for another $3 billion in cash if MiRus hits clinical and regulatory milestones. “The Siegel valve is a promising technology and has received enthusiastic feedback from physician investigators for its less invasive delivery, nickel-free construct, precise placement resulting from a lack of foreshortening and excellent hemodynamics,” MiRus founder and CEO Dr. Jay Yadav said in an announcement of the deal. “We believe the distinctive design and impressive early clinical results of the Siegel valve may set it apart from currently available technology, potentially providing physicians an advanced option to treat a wide array of patients,” Boston Scientific Interventional Cardiology and Vascular Therapies EVP and President Lance Bates said in the same release.
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MATERIALS
MiRus says its MoRe superalloy is “far stronger, more fatigue resistant, more biofriendly” than current medical alloys. Photo courtesy of MiRus
(THV), allowing treatment of the 20% of Americans suffering from nickel allergies.” Nitinol (nickel-titanium alloy) is commonly used in catheter-delivered heart valves for its superelasticity. A significant share of patients have nickel sensitivity, so nickel leaching must be minimized through how nitinol is manufactured for medical devices. The novel MoRe alloy allows for optimal expansion and function of Siegel’s dry porcine tissue leaflets, Boston Scientific said, and improved transvalvular pressure gradients leading to increased valve durability. Siegel’s open-cell rhenium alloy frame is designed to eliminate foreshortening during device implantation and aid precise valve positioning, MiRus said. The valve comes crimped and pre-mounted on the balloon, a design feature that Boston Scientific says “aids procedural efficiency.”
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“OUR INVESTMENT IN MIRUS CONTINUES OUR PURSUIT TO BRING A DIFFERENTIATED TAVR SYSTEM INTO OUR PORTFOLIO THAT WE ANTICIPATE MAY IMPROVE OUTCOMES FOR PATIENTS LIVING WITH THIS LIFE-THREATENING DISEASE.”
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Siegel can be delivered through an 8F expandable sheath, which is 50% smaller than currently available TAVR delivery systems, MiRus said, and could reduce the risk of vascular complications and broaden patient access, particularly for women. An early feasibility study treated 15 patients with severe, symptomatic aortic stenosis. After 30 days, MiRus reported none of the patients experienced vascular complications, paravalvular leak or required a permanent pacemaker. There were zero deaths, strokes or re-hospitalizations reported during the study. MiRus is enrolling patients for its pivotal trial. Data from the trial will be used to support regulatory submissions in the U.S., Japan and Europe, the Middle East, and Africa (EMEA), Boston Scientific said. If Boston Scientific exercises the option to purchase MiRus’ TAVR business, it will also have the option to acquire mitral and tricuspid valve replacement assets from the company for an additional amount. “The occurrence and recognition of aortic stenosis is growing rapidly and our investment in MiRus continues our pursuit to bring a differentiated TAVR system into our portfolio that we anticipate may improve outcomes for patients living with this life-threatening disease,” Bates said.
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NITINOL
First Look: Boston Scientific’s next-gen Farawave Ultra PFA catheter The device developer’s first-gen Farawave is already the most prescribed PFA catheter in the world. Boston Scientific’s investigational Farawave Ultra pulsed-field ablation (PFA) and mapping catheter is shown here in the flower configuration. Image courtesy of Boston Scientific
B By Jim Hammerand Managing Editor
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oston Scientific‘s working on an investigational pulsed-field ablation (PFA) catheter that could expand the Farapulse system’s lead over the competition. The device developer plans to launch its third-generation Farawave Ultra PFA catheter in the first half of 2027, following up on the Farawave PFA catheter that won FDA approval in January 2024 and the Farapoint PFA catheter that was approved in January 2026. Boston Scientific is also developing the investigational Faraflex PFA catheter that combines ablation and mapping, with the goal of making it commercially available in 2028. “Electrophysiologists love mapping,” Boston Scientific EVP and Atrial Fibrillation Solutions President Nick Spadea-Anello said in a Medical Design & Outsourcing interview. “They love to map because it gives them more information, and they feel like they get more precision in being able to ablate these arrhythmia,” he continued. “The next-gen Farawave Ultra will have higher-definition fidelity for mapping as well as the excellence and the experience we’ve seen with hundreds of thousands of patients.” Boston Scientific will soon — if it hasn’t already — hit 1 million patients treated with its PFA technology. The company’s Farawave device is the most prescribed catheter in the world for PFA, a minimally invasive catheter procedure EPs use to treat atrial fibrillation (AF or AFib) by scarring heart tissue to block
irregular heart signals. The nitinolenabled catheter uses the nickeltitanium alloy’s superelastic properties to deploy inside the heart in the shape of a flower or a basket. PFA is one of the fastest growing medtech markets and still relatively new. Medtronic’s PulseSelect PFA system won the race to FDA approval in December 2023 and added to its portfolio with Affera catheters as Johnson & Johnson MedTech and Abbott developed and launched their own systems. “We initially came out with that flower basket Farawave catheter that was mostly just a therapeutic catheter,” Spadea-Anello said. “Then we made it integrated, and each one of those splines had one electrode on the petal that allowed you to get an image and map. But you were only able to get a certain level of fidelity in the mapping system. Ultra has 20 electrodes, or five electrodes per spline on the pentaspline design. Those 20 electrodes will give you a higher-definition mapping capability when doing PFA with an all-inone catheter: a therapeutic catheter and a mapping catheter.” The following has been lightly edited for length and clarity. MDO: You’re selling PFA catheters against competing technology. Why should EPs pick yours? Spadea-Anello: “It’s a highly strategic, competitive space. We transformed the space a few years ago. For decades, people were using radiofrequency energy — for the most part, some
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Boston Scientific is also developing the investigational Faraflex PFA and mapping catheter pictured here. Image courtesy of Boston Scientific
people were using cryo energy — to ablate cells in the heart that were acting erratically. But we knew there was a purpose for a safer modality. We had a better solution, we felt, that could be safer and more effective. That’s when we made a bet over a decade ago on Farapulse and PFA energy or electroporation, being more targeted on the cells you want to terminate, versus terminating cells in the esophagus or other areas when you’re ablating the heart. Because every year, if there were a million AF ablations throughout the world that were being conducted, 200 or 300 people were expiring because of an atrial esophageal fistula where when you were terminating those cells in the heart it would penetrate through the esophagus and patients had catastrophic events. It was a low number, and in medicine, you’re going to have some sort of consequences. Well, we’ve treated over a half a million
patients, and I’d say the field treated probably a million patients, and we have yet to see an atrial esophageal fistula. And it’s as effective as RF energy and it happens to be even more efficient. An average RF ablation would take anywhere from 60 to 90-plus minutes. You can do a Farapulse procedure in relatively 30 minutes. “Why us? We’ve done the most. We were the pioneer of the technology. We were the first in the world to offer it to patients and it’s the most studied device in the world. It’s not just the catheter and the energy, but the waveform in the generator that actually allows that to work differently. All RF energy pretty much works the same in terms of the energy, but the catheters may be slightly different and the mapping may be slightly different. We’ve disrupted the space because it was primarily RF with some cryo, and now you’re looking at high percentages — we think 70%
plus to be PFA, and that’s going to be probably approaching 80% plus PFA in the U.S. here in the coming year or two. We’re excited because we were behind all of that and we transformed the space. We like for people to believe that what we know in creating the waveform that’s safe and effective is truly differentiating, and the body of evidence that we have that supports that.” >>
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NITINOL The Boston Scientific Farapoint PFA catheter won FDA approval in January 2026. Image courtesy of Boston Scientific
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Everyone likes to keep the details of their waveform secret, but what’s special about yours? Spadea-Anello: “If I told you that, I’d get in big trouble. There’s only a few people in the company that really understand the algorithm. All of these algorithms work in a specific way, but some of it is obvious, and it’s the catheter design and where the electrodes live. In our Farawave flower catheter, for example, we’ve got on the pentaspline design catheter electrodes that live on each of those petals, and how that energy is sent to those petals or those electrodes and how it interacts with other electrodes, the design of how it communicates from one electrode to the next spline, the sequence of that, the pulse width associated with that, the engineering behind that, is unique to our catheter. So the catheter and the waveform is truly what gets you the results as well as the applications. They’re the three key factors that give you efficacy in PFA. “We’ve got engineers that have Ph.D.s who are specifically focused on just waveform development at the cellular level. And we’ve been lucky because there are electroporation specialists throughout the world, and we happen to have a lot of them who are Ph.D.s who work at our company because it’s not just about today’s waveform. We always say that not all PFA is the same — and I believe all the strategics would tell you that — because every catheter is designed a little bit different and how that energy comes out, whether it’s slightly different in the pulse width of when you send the stimuli from the generator to the catheter, and how it interacts with the electrodes, is quite frankly what makes a catheter or an energy efficacy different from one catheter the next. So even our Faraflex catheter we’re developing and our Farapoint catheter, they’re different because of the different catheter designs and waveforms to get the depths we need to terminate these cells.”
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ORTHOPEDICS
How ZB’s Paragon 28 created a novel curved foot nail system At Paragon 28, now part of Zimmer Biomet, engineers asked if there was a better implant shape to support foot and ankle anatomy. It took three novel instruments and a novel implant to make it a reality.
W By Skyler Rivera Associate Editor
hen Paragon 28 Director of Engineering Ken Roggow and his team approached the drawing board to design a next-generation tibiotalocalcaneal (TTC) arthrodesis nail system, they asked themselves a simple question: If the implant fused bones that follow a natural arc, why are we putting a straight implant into the hindfoot? Roggow’s team wanted to engineer an implant that matched the arched hindfoot anatomy instead of forcing anatomy to match the implant system. They knew they needed to design a curved nail system, but traditionally, TTC
Paragon 28’s Phantom curved TTC nail system includes three novel instruments: a reaming outrigger, reaming template and curved reamer set. Illustration courtesy of Paragon 28
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systems implant a straight nail system. A curved system was an ideal concept without a practical solution. “I’m speculating, but I think other folks who had thought of this in the past thought we’ll never figure out how to drill that curved path, so why even dream about a curved nail?” Roggow said in a Medical Design & Outsourcing interview “This hasn’t been done before [because] it’s really a technically challenging problem to drill and ream a curved path,” he continued. “Drills are historically straight, and you match an implant to match the hole you made.” Determined to answer the question they first posed and create a novel anatomy-driven curved TTC system, Roggow and his team engineered a novel instrument that could drill and ream an arched path for the curved, titanium alloy implant. And in February 2026, Paragon 28, acquired the year before for $1.2 billion to become Zimmer Biomet’s orthopedic foot and ankle business segment, commercially launched its solution, the Phantom curved TTC nail system. “We cracked open a door that wasn’t previously open, not only in foot and ankle, but outside of foot and ankle where we may have had a similar problem,” Roggow said. “What we’ve done here is the first step into opening the flood gates of asking the question, ’Is there a better shape of an implant to better support the anatomy?’” How Paragon 28 designed its novel system Traditional hindfoot TTC systems fuse the tibia, talus and calcaneus bones (the bones making up the hindfoot >> 9 • 2026
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ORTHOPEDICS
and ankle) with a straight intramedullary nail system, implanted through the bones’ natural structure on a non-anatomical trajectory from the calcaneus into the tibia. But a one-size-fits-all straight nail system falls short in complex cases. The Phantom curved TTC nail system was designed to address traditional straight system’s shortcomings and improve patient outcomes by matching the patient’s anatomy. It follows the anatomic arc of the foot, extending from the posterior calcaneus through the subtalar joint, into the talus and along the tibial metaphysis. “In this case, it is a curved radius,” Roggow said. “That comes with a big challenge of drilling and reaming a curved path, which I don’t think has been done in a meaningful way in this indication.” Roggow’s team took a risk-based approach in engineering the system and its instrumentation. At each step in the
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design process, the engineers asked themselves where the surgeon might make a misstep and how to design something to prevent that. “When you’re doing something new and novel, you’ve got to really think about the risks to the patient, and of course, how that could affect the outcomes of the surgery,” he said. The implant’s design feasibility relied on Roggow and his team’s solution to creating instruments that could ream a curved implant path. “The instrumentation was the largest challenge,” Roggow said. “The implant is beautifully designed, but it’s really the instrumentation.” Over several years of trial and error, Roggow and his team were challenged to design instruments that could efficiently cut through bone to create a curved arc while limiting patient harm. “There’s a limit to how much heat you can put into bone before it necroses,” Roggow said. “Being very cognizant and patient first, [we asked] how can we put a tool into someone’s hand that creates this path, but also make sure our patients walk away from the procedure with minimal trauma or any other ancillary damage.” Rather than create just one novel instrument, Roggow and his team redesigned the TTC’s system’s implantation tool lineup to include three novel instruments — reaming outrigger, reaming template and curved reamer set — and the novel nail implant in today’s commercially available curved system. “We [were] designing an implant to match the anatomy, rather than the other way around,” he said. “It’s about reproducibility, trusting the instruments of the system to get a surgeon through the procedure, and then addressing risk at every step.” How the Phantom curved TTC system differs from traditional systems The Phantom curved TTC nail system was designed to increase torsional stability, preserve soft tissue and help surgeons achieve more alignment reproducibility in the most complex TTC fusion cases. Roggow said straight nail systems fall short in creating torsional stability, but the new system’s design addresses this shortcoming. The curved implant aims to strengthen fixation and improve fusion outcomes in complex cases with built-in torsional stability from its anatomical fit.
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The curved system preserves tissue and the plantar neurovascular bundle with a posterior incision. Illustration courtesy of Paragon 28
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“An arced implant has inherently more torsional stability,” Roggow said. “If we can stabilize the bones, we give ourselves a better shot at fusion. The ultimate outcome here is fusion.” The curved system alleviates concerns about poor healing and minimizes soft-tissue disruption with its unique incision point. In traditional straight systems, the intramedullary nail is implanted into the plantar aspect (bottom) of the foot, creating a soft tissue incision that’s difficult to heal, Roggow said. The curved system preserves tissue and the plantar neurovascular bundle with a posterior incision.
“In cases with more complex hindfoot fusions like revisions, where that alignment really matters, this gives a surgeon their best opportunity at success,” Roggow said. With the arced system’s unique incision point and implant trajectory, the curved system could circumvent prior straight nail tunnels and compromised cortical pathways and improve alignment. In engineering the Phantom curved TTC nail system and the novel instruments that make it possible, Roggow and his team ushered Paragon 28 into a new era, he says, one focused on “anatomy-driven procedures and less one-size-fits-all” solutions. “We’ll continue to see that in the future and how we can tailor devices to our patients, regardless of what anatomical challenges there are,” Roggow said. “We’re just scratching the surface.”
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PEDIATRICS
Said Philips’ Dr. Atul Gupta about incorporating Disney characters into Ambient Experience for MRI, “We found, with the clinical data, that it’s significantly lowering the patient anxiety levels.” Photo courtesy of Philips
How Philips and Disney are improving children’s MRI experience By Chris Newmarker E d i t o r- i n - C h i e f
“Kids aren’t just little adults. … It has to be fine-tuned and tweaked just for them.”
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new MRI partnership between Philips and Disney is but the latest example of the Dutch medtech giant’s efforts to better tailor its medtech to children. Philips Ambient Experience has been around since the early 2000s, but the company is now integrating Mickey Mouse, Yoda and many more Disney characters and stories into medical facilities in 87 countries. Disney is providing the art and imagery to Philips at no cost. Making MRI scans less stressful
for children enables efficient, highquality imaging, according to Dr. Atul Gupta, chief medical officer of diagnosis and treatment at Philips. Health providers can conduct more scans if kids have less anxiety, he said in an interview with Medical Design & Outsourcing. Incorporating Disney into Ambient Experience is a great example of how medtech for children needs to be designed specifically for them “Kids aren’t just little adults. … It has to be fine-tuned and tweaked just for them,” Gupta said.
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Philips held off on announcing the incorporation of Disney characters until it had clinical data to back up the move. According to Philips, research shows about twothirds of children report feeling anxious during MRI scans. A recently completed study involving 175 child patients (about half boys and half girls, ages 6–10, at six pediatric hospitals in Europe) examined whether Ambient Experience with Disney themes could help. It found the Ambient Experience with Disney themes reduced post-scan pediatric patient stress levels by 43% compared to pre-exam. Pauses during scans were down by 63% compared to procedures without intervention. Here’s more of what Philips’ Gupta had to say about the incorporation of Disney characters into Philips Ambient experience. The following has been lightly edited for space and clarity. MDO: How does Philips Ambient Experience improve the MRI experience for children? Gupta: “When kids go to the hospital, part of the reason they’re stressed is there’s nothing they have control over. Everything is done to them. We recognized this and we’ve studied this for two decades. “So they pick the environment they want, whether it’s a winter wonderland or a seascape or being in outer space, or now Mickey Mouse and Minnie Mouse and Pooh or Yoda or Spider-Man and many other characters. They pick it, and then the visuals of that animation are
Can you tell me more about how Philips worked with Disney to bring the company’s characters to Ambient Experience? Gupta: “In the case of this solution, it’s not just putting up a movie. There are some very unique aspects that we knew at Philips because we’ve been doing this for two decades, and we worked with the Disney designers to understand, for instance, when you do a scan, you need to keep the character in the center of the screen. They need to be in the center because if you’re in that MRI and your eyes have rapid eye movement looking left and right, tracking something, it causes an artifact on the MRI. You need to have a much slower pace than kids are used to. Kids like fast-paced, quick cuts. That doesn’t work in MRI. We need them to have a lower heart rate, a lower breathing rate, lower adrenaline to keep them much more relaxed. We need to sync the ambient lighting that we’ve developed to the sound and the animation. “There are rules of the game that help create this environment
“[KIDS] PICK THE ENVIRONMENT THEY WANT... WE FOUND WITH THE CLINICAL DATA THAT IT’S SIGNIFICANTLY LOWERING PATIENT ANXIETY LEVELS. IT’S ALSO HELPING THE STAFF AND TECHNOLOGISTS BECAUSE IT’S REDUCING SCAN PAUSES AND INTERRUPTION.” synchronized to sound and the ambient lighting in the room in a very clinically designed way. We found with the clinical data that it’s significantly lowering patient anxiety levels. It’s also helping the staff and technologists because it’s reducing scan pauses and interruption.”
that we’ve learned through two decades of working on this, and people are using Ambient Experience not just for kids — in this case, this study was for kids — but Ambient Experiences is working for kids and adults.” www.medicaldesignandoutsourcing.com
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What else has Philips done to improve the MRI experience for children? Gupta: “It’s just one piece of what we call pediatric coaching. When a kid is coming in for an MRI, for instance, we actually have designed a solution that starts at home. We have an app called Scan Buddy, and the kid can see favorite characters like Ollie Elephant. It familiarizes themselves with what to
Philips is integrating Mickey Mouse, Yoda and many more Disney stories and characters into MRI systems using its Philips Ambient Experience in medical facilities in 87 countries. Image courtesy of Philips
expect for the MRI. In fact, they can even do it with augmented reality. It’s an app that we have had for some time. Then, when they come into the waiting room of the hospital, we have something called a KittenScanner mini MRI, and they pick a character like Chris Crocodile or Doris Chicken, and they put the character through this mini scanner in the waiting room. Again, this is about empowering kids so they know what to expect. Then, before they get an MRI, they get to pick the character that they want, whether it’s one of the 21 Philips ambient experiences or the Disney characters, to join them in that MRI. It’s a holistic approach to empower kids, and one that I think is very helpful to get kids much more comfortable.” 9 • 2026
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DEVICETALKS
Advice from the pros for building a medtech career The secrets for success are similar to several steps of device development.
B B y To m S a l e m i D e v i c e Ta l k s Editorial Director
uilding a medtech career has more in common with developing a medical device than you might think. Our DeviceTalks Weekly podcast interviews with successful medtech leaders show that anyone wanting to build a career in medical devices will have to check many of the same boxes used by entrepreneurs. We’ve done more than 300 podcast episodes, and I’ve selected a few where we unpacked the hows and whys of a successful medtech career with professionals ranging from startup CEOs to business leaders at major OEMs. The steps they suggest will look familiar to anyone who has designed, developed and built a medical device. Find the unmet need in your resume Amaza Reitmeier says medtech professionals need to ask what’s missing. She credited Medtronic’s talent development ethos for creating opportunities, but the onus falls upon the employee to “be extremely cleareyed about what you don’t know how to do,” she said.
Intuitive Global VP of Cardiac Surgery Darla Hutton
Be comfortable taking risks Any successful innovation requires a risk of capital or time. Risk is also essential to finding career success, and the good news is tolerance for risk can be taught. Successful people don’t learn by just reading and observing, Reitmeier said. They step into the fray and, often, learn the hard way. “You have to go in [and] you have to make mistakes,” she said. “You have to screw up. You have to have people help you and just be super humble about things you don’t know.” >>
Pharaoh Neuro CEO Amaza Reitmeier
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“I had a little matrix of basically 10 skills I knew I would need to have to run a business,” Reitmeier said. “And I got advice from my mentors saying, ‘Here’s the things you’re good at, but here are the things you know nothing about.’” Reitmeier built her career at Medtronic with a large corporate career in mind, but she recently took the CEO job at startup Pharaoh Neuro, which is developing a way to filter cerebrospinal fluid.
OrthAlign CEO Eric Timko
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Eric Timko built a career at large and small companies, successfully selling a handheld robotic surgery company to Smith+Nephew a decade ago. Now, as the CEO of orthopedics surgical guidance tool maker OrthAlign, he says people can learn to build a tolerance for risk by learning how to sell. “You’re going to get a ton of nos,” Timko said. “But then you start figuring out what a yes looks like and what it took to get there. And I think once you figure that out, it gets a little bit easier. I tell my team all the time, ‘Let’s try to open doors. The ones that close, don’t leave them closed. Keep hitting them.’”
But young people need to focus on the moment, even if you’re working in a field that isn’t a long-term fit, said Darla Hutton, global VP of cardiac surgery at Intuitive. She joined the surgical robotics giant to build out a cardiac surgery franchise, but when Intuitive changed direction to focus on urology, Hutton set out to excel in that field. “Bloom where you’re planted. You must take every chance you get,” says Hutton. “Take advantage of that, and you can move into different roles.” Eventually, your career path may steer back to your original course “because you’re focused on skill development and experience versus just title and job.”
Stay focused on the big picture When developing medical devices or a medtech career, there will be setbacks and sidetracks.
Collect honest data Kelsey Mayo never held a corporate job before becoming CEO of Armor Medical. She spent most of her career
Armor Medical CEO Kelsey Mayo
in academics before making the leap to lead the medtech startup, which is developing a wearable device to measure real-time early warning system for obstetric hemorrhage. Medical device entrepreneurs
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Medtronic VP of U.S. Commercial for Acute Care and Monitoring Blake Tatum need to know whether they’re chasing a real signal, she says, and medtech professionals should aggressively seek feedback. “You have to leave your ego on the table a little bit and be willing to throw your ideas out in the world to people who are going to challenge them,” Mayo said. “You have to be willing to have them take their red pen out and mark all over your ideas and give it back to you, bleeding essentially on a sheet of paper, and go, ‘OK, we can make it better.’” Be sure you add value Blake Tatum, VP of U.S. commercial for acute care and monitoring at Medtronic, has been with Medtronic (and with Covidien before Medtronic bought it) for most of his career. Beyond learning what you don’t know, he advises making sure you’re always adding value. “Stay curious and aggressive and become a specialist in whatever space you’re in,” Tatum said. If your expertise is in respiratory but you need to talk with a cardiac surgeon, ask questions and study enough to ask the right questions so you’re a valuable part of the team. “You’ve got to be able to understand a given space within medtech and execute strategically.” Whether you’re building a career in medtech or building new medical devices (most likely, you’re doing both at the same time), you need identify what needs fixing, take the risk to fix it, stay focused on your larger mission, test assumptions, and bring real value. And if you do that, someday on the podcast I’ll be interviewing you! Medical Design & Outsourcing
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