Medical Design & Outsourcing — NOVEMBER 2020

HOW

THE

PANDEMIC

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ALTERED

RELATIONSHIPS

IN

THE

OR

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MEDTECH'S 100 LARGEST PLAYERS

HOW MAJOR MEDTECH COMPANIES ARE RESPONDING TO THE LOOMING EU MDR THE TOP MEDICAL DEVICE EMPLOYERS

RESEARCH & DEVELOPMENT: WHO’S SPENDING THE MOST?

WHERE ARE THE GLOBAL MEDTECH HEADQUARTERS?

HOW

THE

PANDEMIC

HAS

ALTERED

RELATIONSHIPS

IN

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OR

www.medicaldesignandoutsourcing.com NOVEMBER 2020

MEDTECH'S 100 LARGEST PLAYERS

HOW MAJOR MEDTECH COMPANIES ARE RESPONDING TO THE LOOMING EU MDR THE TOP MEDICAL DEVICE EMPLOYERS

RESEARCH & DEVELOPMENT: WHO’S SPENDING THE MOST?

WHERE ARE THE GLOBAL MEDTECH HEADQUARTERS?

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Medical Design & OUTSOURCING medicaldesignandoutsourcing.com ∞ November 2020 ∞ Vol6 No7

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11 • 2020

Medical Design & Outsourcing

5

SolenoidSolutionsInc.com 888.825.8405

HERE’S WHAT WE SEE

How medtech has fought COVID-19

T

his year has been such a challenging time for the U.S. and the world that 2019 feels like it was 100 years ago. But even as COVID-19 claimed more than 1.3 million lives, I’m proud to cover an industry that has sought to stem the tide.

The information in this year’s annual Big 100 rankings of the world’s largest medical device companies is as interesting as ever. (I’d like to especially thank our senior editor Danielle Kirsh for combing through so many financial filings to compile much of the data.) But with many corporate fiscal years in the report ending in December 2019, it almost feels like we’re describing a land before time.

The 100 companies on this year’s list had medical device business bringing in a whopping $420.5 billion during their most recent fiscal years — a nearly 6% increase from our 2019 list.

We’ll have to wait until next year, though, to truly gauge the effect that the coronavirus and resulting recession had on the industry.

Medical device companies certainly weren’t recession-proof this time around. The pandemic has caused a curtailment of elective procedures — and sometimes even not-so-elective procedures — as health providers focus on managing COVID-19 and patients stay away in droves.

I don't want to go back. I want to go forward. As painful as it's been over the past couple of months, the new normal is exciting.

Major companies have generally reported recovery in procedure volume in the third quarter of 2020, but we’ll have to see whether the trend holds up as a new wave of coronavirus cases hits the world.

Even as medtech companies work through major challenges, though, I’m struck by the important work they’re doing to help humanity manage this crisis. Here are but a few examples that stuck out to me as I wrote short updates about the world’s 20 largest medical device companies: •

6

Medtronic publicly shared its ventilator IP to help alleviate shortages of the machines.

Medical Design & Outsourcing

11 • 2020

• •

• • •

•

•

•

Johnson & Johnson is among the companies that have COVID-19 vaccine candidates being evaluated in Phase 3 clinical trials.

The COVID-19 pandemic increased demand for patient monitors, ventilators and digital health products coming out of Philips’ Connected Care business.

GE Healthcare is also a major producer of ventilators needed to treat people with severe COVID-19 cases.

Abbott, Siemens Healthineers, BD and Danaher are among the top providers of COVID-19 tests.

3M, Medline Industries, Cardinal Health and Henry Schein are important providers of protective equipment such as masks, gowns and gloves to protect health workers from the coronavirus.

Medline agreed to reprocess tens of thousands of N95 respirators and other face masks per day in its facilities — and it started cranking out hand sanitizer at an infection-prevention products plant in Wisconsin.

Baxter is also playing a crucial role because of the need for kidney dialysis machines and infusion pumps to treat critically ill COVID-19 patients.

BD has commitments for over 800 million needles and syringes to deliver future COVID-19 vaccines in the U.S., UK, Canada and elsewhere.

It isn’t just the pandemic and recession that have made things tough this year. In the U.S., we’ve had a long-overdue reckoning with our country’s national Chris Newmarker sin of racism, a depressingly Executive Editor divisive presidential election — and Medical Design & just to make things even worse, Outsourcing huge wildfires in the West and big cne wm a rk e r@ wtwh m e di a .c o m hurricanes along the Gulf Coast.

I think that Medtronic’s new CEO Geoff Martha has the right idea when it comes to how the industry should approach 2021.

“I don’t want to go back. I want to go forward,” Martha said during The Virtual Medtech Conference hosted by AdvaMed in October. He later added: “As painful as it’s been over the past couple of months, the new normal is exciting.”

www.medicaldesignandoutsourcing.com

| | | |

MD&O THink Fist+BCCH 11-20prod.indd 1

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CONTRIBUTORS

BERTASA

BROWN

COWAN

DEL MONACO

HOLT

HOOVER

JOHNS

RACITI

RITER

SANTORO

TEANY

TELLERS

ANNA MARIA BERTASA has been global healthcare marketing manager at Solvay’s Specialty Polymers since 2016. She holds a B.S. degree in chemistry and an M.S. degree in material science.

ANGELA BROWN is global head and senior director of regulatory affairs, Icon. She has over 20 years of global regulatory affairs experience in medtech, specializing in international work with universities, startups and blue-chip companies.

NICOLE A. COWAN is director of project management, IVD operations & strategy, Icon. She has over 15 years of experience in clinical, academia, CRO and central laboratory services.

ANTHONY DEL MONACO, a partner in Finnegan’s Washington, D.C. office, focuses on patent litigation, primarily before U.S. district courts and the U.S. International Trade Commission, and arbitrations. Anthony provides strategic guidance to clients on infringement, validity, and enforceability issues along with postgrant proceedings and licensing negotiations.

MICHAEL HOLT is principal applications engineer at Integer (Plano, Texas). Holt has more than 20 years of experience in the design and development of complex catheter-based devices and holds a B.S. degree in mechanical engineering from the University of Tennessee.

TOM HOOVER has been senior medical business development manager — Americas, Assembly Technologies at Emerson in Danbury, Conn., since 2010. He has extensive experience in medical device product development and regulatory compliance.

CHRIS JOHNS, an associate in Finnegan’s Washington, D.C. office, works with domestic and international clients on strategic patent counselling — including patent prosecution, drafting strategies and portfolio management — and speaks and writes regularly on patent topics. He served as a U.S. patent examiner for nearly five years, examining applications related to business methods and software.

8

Medical Design & Outsourcing

11 • 2020

ERIC RACITI, a partner in Finnegan’s Boston office, has more than 20 years of experience advising companies on intellectual property matters. Eric’s background in IP law includes patent portfolio development, intellectual property enforcement, technology counseling, strategic commercialization strategies, corporate IP policy, technology acquisitions, risk mitigation and due diligence for fundraising and investment rounds.

JENNIFER L. RITER is senior director of global business operations and analytical services in services and solutions for West Pharmaceutical Services, Exton, Pa. Her experience blends knowledge of West’s components, containment and delivery systems with hands-on technical support and analytical solutions for packaging, delivery systems and combination products for multinational customers.

STEVE SANTORO is EVP of Micro, directing corporate technical and commercial teams. He previously held high-level operations, sales, engineering and general management positions, and is a charter board member of the School of Applied Engineering Technology at the New Jersey Institute of Technology.

DOUG TEANY is the COO of Corindus, a Siemens Healthineers company that works in robotic-assisted vascular interventions. He previously served as VP of clinical program management and operations for Boston Scientific.

CHRIS TELLERS is director of engineering at Trelleborg Sealing Solutions. He has over 20 years of experience in manufacturing, tool making, product development, information technology and automation.

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CONTENTS

medicaldesignandoutsourcing.com ∞ November 2020 ∞ Vol6 No7

• • • • • THE BIG100 ISSUE

DEPARTMENTS 6 HERE’S WHAT WE SEE:

MEDTECH'S 100 LARGEST PLAYERS

How medtech has fought COVID-19

8 CONTRIBUTORS 102 AUTOMATION:

Why you need automation for manufacturing

106 DRUG DELIVERY:

13

What you should know about combination product analysis

ON THE COVER

110 IP ISSUES:

BIG 100: THE LARGEST MEDICAL DEVICE COMPANIES IN THE WORLD

Why ‘how’ could be as important as ‘what’ for your medtech patents

Check out our annual roundup of the world’s 100 leading medical device companies, with rankings by annual revenue, R&D spending and number of employees.

114 MANUFACTURING:

How ultrasonics can improve PPE production

116 MATERIALS:

What makes medical plastics fail?

120 TELEMEDICINE:

What 5G means for healthcare

122 PRODUCT DEVELOPMENT:

FEATURES

Readying surgical instrument production for a ‘normal’ OR schedule

14

124 REGULATORY:

In vitro diagnostic manufacturers face new EU regulations

BIG 100 BREAKDOWN TOP R&D SPENDERS REVENUES PER EMPLOYEE WHERE ARE THE HEADQUARTERS?

98 MAJOR MEDTECH FIRMS SHARE HOW

THEY’RE HANDLING EU MDR

128 TUBING TALKS:

Here’s how to improve tubing development

Medtech companies that sell products in the EU have a big deadline looming — one that’s already been put off once.

132 DEVICETALKS:

How the pandemic has altered relationships in the OR

AWA R D W I N N E R S ( P G . 1 3 5 )

136 AD INDEX 10

Medical Design & Outsourcing

11 • 2020

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MEDTECH'S 100 LARGEST PLAYERS

A LOOK AT THE WORLD’S LEADING MEDTECH COMPANIES, WITH RANKINGS BY ANNUAL REVENUES, R&D SPEND, AND EMPLOYEE HEADCOUNT.

THE BIG 100 LIST BEGINS ON THE NEXT PAGE Big 100 Breakdown Top R&D Spenders Top Medical Device Employers Medtech Heatmap www.medicaldesignandoutsourcing.com

p.14 p.90 p.92 p.96 11 • 2020

Medical Design & Outsourcing

13

S S S

COMPANIES RANKED BY REVENUE

The Big 100 Ranked by Revenues RANK COMPANY

14

REVENUES ($USD)

REVENUES (INTERNATIONAL)

2019 RANK/CHANGE

1

Medtronic

$28,913,000,000

2019 rank: 1 (no change)

2

Johnson & Johnson (medical device segment)

$25,963,000,000

2019 rank: 2 (no change)

3

Royal Philips

$21,808,150,800

4

GE Healthcare (General Electric)

$19,942,000,000

5

EssilorLuxottica

6 7

€19,482,000,000

2019 rank: 3 (no change)

$19,466,366,000

€17,390,000,000

2019 rank: 10 (+5)

Siemens Healthineers

$16,186,524,000

€14,460,000,000

2019 rank: 6 (no change)

Cardinal Health (medical segment)

$15,444,000,000

2019 rank: 4 (no change)

2019 rank: 7 (no change)

8

Stryker

$14,884,000,000

2019 rank: 9 (+1)

9

Medline Industries

$13,900,000,000

n/a

10

Danaher (life sciences & diagnostics segments)

$13,512,600,000

2019 rank: 8 (–2)

11

Abbott (medical device segment)

$12,239,000,000

2019 rank: 11 (no change)

12

Baxter

$11,362,000,000

2019 rank: 12 (no change)

13

Boston Scientific

$10,735,000,000

2019 rank: 14 (+1)

14

Henry Schein

$9,985,803,000

2019 rank: 15 (+1)

15

Owens & Minor

$9,210,939,000

2019 rank: 13 (–2)

16

Becton, Dickinson (medical segment)

$8,680,000,000

17

B. Braun Melsungen

$8,363,373,220

18

Zimmer Biomet

$7,982,200,000

2019 rank: 18 (no change)

19

Alcon

$7,508,000,000

2019 rank: 19 (no change)

20

3M Co. (healthcare segment)

$7,431,000,000

21

Olympus (medical business)

$5,887,149,147

¥641,817,000,000

2019 rank: 21 (no change)

22

Terumo

$5,768,638,782

¥628,897,000,000

2019 rank: 22 (no change)

23

Smith+Nephew

$5,138,000,000

24

Fujifilm Holdings (healthcare only)

$4,600,000,000

n/a

25

Intuitive Surgical

$4,478,500,000

2019 rank: 25 (no change)

26

Edwards Lifesciences

$4,348,000,000

2019 rank: 26 (no change)

27

Fresenius Medical Care

$4,035,437,000

2019 rank: 16 (no change) €7,471,300,000

2019 rank: 17 (no change)

2019 rank: 20 (no change)

2019 rank: 23 (no change)

€3,605,000,000

n/a

28

Dentsply Sirona

$4,029,200,000

2019 rank: 24 (–4)

29

Hologic

$3,776,400,000

2019 rank: 28 (–1)

30

Hoya (life care segment)

$3,440,185,287

31

Varian Medical Systems

$3,168,200,000

32

Nipro (medical segment)

$3,079,866,080

33

Steris

$3,030,895,000

34

BioMerieux

$2,994,171,120

35

ResMed

$2,957,013,000

36

Sonova

$2,935,392,976

Medical Design & Outsourcing

11 • 2020

¥375,049,000,000

2019 rank: 27 (–3) 2019 rank: 30 (–1)

¥335,767,000,000

2019 rank: 29 (–3) 2019 rank: 34 (+1)

€2,674,800,000

2019 rank: 31 (–3) 2019 rank: 36 (+1)

CHF 2,916,900,000

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2019 rank: 33 (–3)

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S S S

COMPANIES RANKED BY REVENUE

RANK COMPANY

16

REVENUES ($USD)

REVENUES (INTERNATIONAL)

2019 RANK/CHANGE

37

Hillrom

$2,881,000,000

38

Getinge

$2,807,386,580

26,559,000,000 SEK

2019 rank: 35 (–3)

39

Coloplast

$2,780,084,854

18,544,000,000 DKK

2019 rank: 37 (–2)

2019 rank: 32 (–5)

40

Cooper Cos.

$2,653,400,000

2019 rank: 38 (–2)

41

Teleflex

$2,595,362,000

2019 rank: 40 (–1)

42

Paul Hartmann

$2,447,903,920

43

Align Technology

$2,406,796,000

€2,186,800,000

2019 rank: 39 (–3) 2019 rank: 43 (no change)

44

Bio-Rad

$2,311,659,000

45

Demant

$2,240,678,830

46

Cook Medical

$2,200,000,000

n/a

47

Bruker

$2,072,600,000

2019 rank: 45 (–2)

48

Dräger (medical business)

$1,949,770,920

€1,741,800,000

2019 rank: 44 (–4)

49

Amplifon

$1,938,912,740

€1,732,100,000

2019 rank: 49 (no change)

50

ConvaTec

$1,827,200,000

51

HU Group (previously Miraca)

$1,730,985,140

¥188,712,000,000

2019 rank: 41 (–3) 14,946,000,000 DKK

2019 rank: 42 (–3)

2019 rank: 46 (–4) 2019 rank: 47 (–4)

52

Nihon Kohden

$1,697,000,550

¥185,007,000,000

2019 rank: 48 (–4)

53

Carl Zeiss Meditec

$1,633,540,420

€1,459,300,000

2019 rank: 51 (–2)

54

Straumann

$1,606,344,973

CHF 1,596,225,000

2019 rank: 55 (+1)

55

Elekta

$1,543,380,830

14,601,000,000 SEK

2019 rank: 50 (–5)

56

Integra Lifesciences

$1,517,557,000

2019 rank: 52 (–4)

57

Dexcom

$1,476,000,000

2019 rank: 62 (+5)

58

ICU Medical

$1,266,208,000

2019 rank: 54 (–4)

59

Integer

$1,258,094,000

2019 rank: 56 (–3)

60

Fukuda Denshi

$1,223,564,484

¥133,393,000,000

2019 rank: 58 (–2)

61

Smiths Medical (Smiths Group)

$1,172,102,400

£918,000,000

2019 rank: 57 (–4)

62

NuVasive

$1,168,070,000

2019 rank: 60 (–2)

63

LivaNova

$1,084,170,000

2019 rank: 59 (–4)

64

Omron Healthcare

$1,027,325,261

65

Cantel Medical

$1,016,048,000

66

Merit Medical Systems

$994,852,000

2019 rank: 66 (no change)

67

Haemonetics

$988,479,000

2019 rank: 64 (–3)

¥111,999,000,000

2019 rank: 61 (–3) n/a

68

Conmed

$955,097,000

69

GN Hearing

$952,131,089

6,351,000,000 DKK

2019 rank: 65 (–4)

70

Cochlear

$940,118,960

AU$1,352,300,000

n/a

71

Masimo

$937,837,000

2019 rank: 67 (–1)

2019 rank: 68 (–3)

72

Invacare

$927,964,000

2019 rank: 63 (–9)

73

Wright Medical

$920,900,000

2019 rank: 70 (–3)

74

Abiomed

$840,883,000

2019 rank: 71 (–3)

75

Fisher & Paykel Healthcare

$832,904,670

76

Konica Minolta (healthcare segment)

$813,581,000

Medical Design & Outsourcing

11 • 2020

NZ$1,263,700,000

www.medicaldesignandoutsourcing.com

2019 rank: 72 (–3) 2019 rank: 69 (–7)

S S S

COMPANIES RANKED BY REVENUE

RANK COMPANY

REVENUES ($USD)

REVENUES (INTERNATIONAL)

2019 RANK/CHANGE

77

Insulet

$738,200,000

2019 rank: 75 (–2)

78

Avanos Medical

$697,600,000

2019 rank: 73 (–5)

79

Össur

$686,264,000

2019 rank: 74 (–5)

80

Agfa-Gevaert (radiology solutions segment)

$599,998,400

€536,000,000

81

Nikkiso (medical segment)

$568,702,990

¥62,000,000,000

2019 rank: 78 (–3)

82

JMS Co.

$537,231,701

¥58,569,000,000

2019 rank: 77 (–5)

83

Natus Medical

$495,175,000

84

Asahi Intecc (medical field segment)

$476,343,790

85

Orthofix

$459,955,000

86

Ambu

$422,769,591

2,820,000,000 DKK

2019 rank: 81 (–5)

87

Topcon (eye care segment)

$410,548,523

¥44,758,000,000

2019 rank: 80 (–7)

n/a

2019 rank: 76 (–7) ¥51,931,000,000

n/a 2019 rank: 79 (–6)

88

Nevro

$390,255,000

2019 rank: 82 (–6)

89

Accuray

$382,928,000

n/a

90

NovoCure

$351,318,000

n/a

91

Medacta

$347,685,640

92

Surgalign (previously RTI Surgical)

$308,384,000

93

Barco (healthcare division)

$300,865,616

94

CryoLife

$276,222,000

2019 rank: 85 (–9)

95

Glaukos

$236,984,000

2019 rank: 87 (–8)

96

Cardiovascular Systems

$236,545,000

n/a

97

AtriCure

$230,807,000

2019 rank: 86 (–11)

98

Colfax (Medical Technology segment, including DJO)

$199,000,000

n/a

99

SeaSpine

$159,083,000

2019 rank: 89 (–10)

100

Sectra (Imaging IT division)

$150,966,133

€310,600,000

n/a

€268,774,000

2019 rank: 83 (–10)

2019 rank: 84 (–8)

1,428,200,000 SEK

2019 rank: 90 (–10)

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Dublin, Ireland (operational HQ in Fridley, Minn.)

$28,913,000,000* *Fiscal year ended 4/26/2020

2019 rank: 1

R&D spend: $2,331,000,000 Employees: 90,000 Key personnel: GEOFF MARTHA, CEO; NOEL COLÓN, SVP, chief quality officer; MICHAEL COYLE, EVP & president, cardiac and vascular; ALEX GU, SVP and president, Greater China; RICHARD KUNTZ, SVP, chief medical and scientific officer; CHRIS LEE, SVP and president, Asia Pacific; BRAD LERMAN, SVP, general counsel and corporate secretary; JOHN LIDDICOAT, EVP and president, Americas region; LAURA MAURI, SVP, chief clinical and regulatory officer; KAREN PARKHILL, EVP and CFO; MARK PLOOF, SVP, global operations & business services; SEAN SALMON, EVP & president, diabetes; CAROL SURFACE, SVP & chief human resources officer; ROB TEN HOEDT, EVP & president, Europe, Middle East and Africa region; BRETT WALL, EVP & president, restorative therapies group; MIKE WEINSTEIN, SVP, strategy; BOB WHITE, EVP & president, minimally invasive therapies group

During his first year in the corner office MEDTRONIC CEO Geoff Martha has been touting plans for a “new Medtronic” that is more nimble and competitive. The world’s largest medical device company has kicked off a major restructuring — with expected annual savings of $450 million to $475 million by 2023. The goal is to reorganize the company’s current groups into empowered operating units (OUs) that each focus on specific therapy areas.

Analyst Raj Denhoy at Jefferies has described the strategy as “turning the battleship.”

Medtronic plans to file early next year for CE Mark and U.S. IDE approval for its new Hugo

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system that is meant to rival Intuitive Surgical’s da Vinci robots. And the company has already started reaping the benefits from the FDA’s January approval of its Micra AV, which greatly expanded the number of people who could potentially benefit from leadless pacemaker technology. Said Martha at The Virtual Medtech Conference hosted by AdvaMed in October: “I don’t want to go back. I want to go forward.” The company has also played an important role in helping the U.S. and other countries respond to the COVID-19 pandemic, even publicly sharing its ventilator IP to help alleviate shortages of the machines. – CN

11 • 2020

Medical Design & Outsourcing 21

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No.

2 Johnson & Johnson New Brunswick, N.J.

(medical device segment)

$25,963,000,000* *Fiscal year ended 12/29/2019

2019 rank: R&D spend:

2 $2,028,000,000

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

JOHNSON & JOHNSON’S medical device segment saw a sales decline this year as the COVID-19 pandemic caused health providers to defer medical procedures in order to focus on managing the coronavirus. It’s a situation that many medtech companies have had to face. Procedure recovery was actually better than expected during Q3, according to J&J. The company has been taking its time in the general surgery robotics space as it seeks to combine technologies that

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came out of its previous Verb Surgical collaboration with the Alphabet life sciences unit Verily — as well as its $3.4 billion purchase of Auris Health and Auris’ FDAcleared Monarch platform. Meanwhile, J&J is also playing an important role in helping the U.S. and countries around the world better manage the coronavirus: Johnson & Johnson is among the companies that have COVID-19 vaccine candidates being evaluated in Phase 3 clinical trials. – CN

11 • 2020

Medical Design & Outsourcing

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No.

3 Royal Philips Amsterdam

$21,808,150,800* *Fiscal year ended 12/31/2019

(€19,482,000,000)

2019 rank: 3

R&D spend: $2,108,949,600 Employees: 80,495 Key personnel: FRANS VAN HOUTEN, CEO; SOPHIE BECHU, EVP & COO; ABHIJIT BHATTACHARYA, EVP & CFO; ROBERT CASCELLA, EVP, strategic business development leader; MARNIX VAN GINNEKEN, EVP, chief legal officer; ANDY HO, EVP, chief market leader, Philips Greater China; ROY JAKOBS, EVP, chief business leader connected care; HENK SIEBREN DE JONG, EVP, CEO, Philips Domestic Appliances; DEEPTHA KHANNA, EVP, chief business leader, personal health; BERT VAN MEURS, EVP, chief business leader, image-guided therapy; EDWIN PAALVAST, EVP, chief of international markets; VITOR ROCHA, EVP, chief market leader; Philips North America; DANIELA SEABROOK, EVP, chief human resources officer; JEROEN TAS, EVP, chief innovation & strategy officer; KEES WESDORP, EVP, chief business leader, precision diagnosis

ROYAL PHILIPS over the past decade has transformed itself into a healthcare-focused company seeking to provide technological solutions to make hospital and clinic systems more efficient and effective, and to truly transform the continuum of care. Philips’ strategy paid off this year as the COVID-19 pandemic increased demand for patient monitors, ventilators and digital health products coming out of its Connected Care business, which saw its revenue boosted more than a fifth during the first nine months of

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2020. The company in August announced it is paying $275 million to acquire Intact Vascular and its Tack specialized implantable device that restores blood flow in small-limb vessels.

Philips isn’t just using M&A as it innovates; the company’s R&D spend last year represented a tenth of its revenue. “The company really walks the talk when it comes to committing itself to organic R&D,” Chris Landon, SVP and business leader of image-guided therapy devices at Philips, said during a DeviceTalks Weekly podcast in October. –CN

11 • 2020

Medical Design & Outsourcing 25

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4 GE Healthcare (General Electric) Chicago

$19,942,000,000* *Fiscal year ended 12/31/2019

2019 rank: 4

R&D spend: $1,000,000,000 Employees: 50,000 Key personnel: KIERAN MURPHY, president & CEO; KATYA KRUGLOVA, VP, HR; JAN MAKELA, president & CEO, imaging; ANDERS WOLD, president & CEO, ultrasound; KEVIN O’NEILL, president & CEO, pharmaceutical diagnostics; AMIT PHADNIS, VP & chief digital officer; LUIZ VERZEGNASSI, president & CEO, services; EVERETT CUNNINGHAM, president & CEO, U.S. & Canada; CATHERINE ESTRAMPES, president & CEO, EMEA; YIHAO ZHANG, president & CEO, China; ROB WALTON, president & CEO, ASEAN, Korea & ANZ; SOICHIRO TADA, president & CEO, Japan; RAFAEL PALOMBINI, president & CEO, Latin America; SHRAVAN SUBRAMANYAM, president & CEO, India & South Asia; MICHAEL MCALEVEY, VP, general counsel & business development; THOMAS WESTRICK, president & CEO, life care solutions; LAILA GURNEY, chief quality & regulatory officer; GREG GIBBONS, chief communications officer

GENERAL ELECTRIC in April completed the sale of its Biopharma business to Danaher for roughly $20 billion. “As we go forward, GE retains one of the world’s leading healthcare companies, using our global scale and technical leadership to deliver better outcomes and more capacity to a world striving for precision health,” CEO Larry Culp said at the time. The company recently noted that GE Healthcare profits during Q3 2020 were up 30% from a year earlier on a like-for-like basis (excluding the effect of the Biopharma sale). The increase was primarily due to cost reductions,

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productivity and increases in healthcare systems volume. GE in October announced FDA 510(k) clearance for its Ultra Edition package on Vivid cardiovascular ultrasound systems, which includes AI-based features to enable clinicians to consistently acquire faster, more repeatable exams. GE has also sought to make it easy for health professionals to 3D-print models from patient scans like CT and MRI that are shown on the company’s Advantage Workstation. The company is also a major producer of ventilators needed to treat people with severe COVID-19 cases. – CN

11 • 2020

Medical Design & Outsourcing 27

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No.

5 EssilorLuxottica

Charenton-le-Pont, France

$19,466,366,000* *Fiscal year ended 12/31/2019

(€17,390,000,000)

2019 rank: 10

R&D spend: $325,745,400 Employees: 150,000 Key personnel: PAUL DU SAILLANT, CEO; CHRYSTEL BARRANGER, president, Europe & photochromics; JAYANTH BHUVARAGHAN, chief mission officer; ERNESTO DIAZ, president, Latin America; RICK GADD, president, North America; NORBERT GORNY, co-COO; ERIC LEONARD, chief integration officer & corporate strategy; GRITA LOEBSACK, chief marketing officer; FRÉDÉRIC MATHIEU, corporate SVP, human resources; BERNHARD NUESSER, president, AMERA, online & digital; ARNAUD RIBADEAU DUMAS, president, Greater China & instruments; ÉRIC THOREUX, co-COO; DAVID WIELEMANS, CFO

The Franco-Italian eyeglasses giant in September announced a collaboration with Facebook to produce the next generation of smart glasses. The first product will launch under the Ray-Ban brand in 2021. “Combining a brand that is loved and worn by millions of consumers around the globe with technology that has brought the world closer together, we can reset expectations around wearables.

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We are paving the way for a new generation of products destined to change the way we look at the world,” Rocco Basilico, chief wearables officer at Luxottica, said in a news release. Other recent announcements include the launch of Stellest in China.

ESSILORLUXOTTICA describes Stellest as a revolutionary new lens to manage myopia in children. – CN

11 • 2020

Medical Design & Outsourcing 29

POROUS POLYMERS

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Safety IV catheter vents and arterial syringe vents protect healthcare workers from blood-borne pathogens Porex created the first self-sealing porous polymer IV catheter vent in the 1980s to protect healthcare workers from exposure to the HIV virus, and we have continued to expand our material and functional expertise to meet a wide spectrum of customer requirements.

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No.

6 Siemens Healthineers Erlangen, Germany

$16,186,524,000* *Fiscal year ended 9/30/2020

(€14,460,000,000)

2019 rank: 6

R&D spend: $1,502,234,800 Employees: 54,300 Key personnel: BERND MONTAG, CEO; JOCHEN SCHMITZ, CFO

SIEMENS HEALTHINEERS saw its sales tick down during its fiscal year ended Sept. 30, 2020, but company officials expect revenue growth to return as the world emerges from the COVID-19 pandemic. Officials at the German medtech giant expect 5%–8% revenue growth for the new fiscal year. “During a historically challenging environment in fiscal year 2020, Siemens Healthineers has proven to be very resilient and has performed excellently,” Siemens Healthineers CEO Bernd Montag said in a news release. “Revenue was almost at

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the very good level achieved in the previous year. We were able to lift our order backlog to a new record level, supported by major longterm contracts.” The company has started shipping out tens of millions of rapid, 15-minute COVID-19 tests to help countries better manage the coronavirus. Siemens Healthineers also isn’t shying away from major M&A deals; it’s in the process of acquiring Varian Medical Systems in a $16.4 billion deal to create what the companies said will be the most comprehensive cancer care portfolio in the industry. – CN

11 • 2020

Medical Design & Outsourcing 31

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No.

7 Cardinal Health Dublin, Ohio

(medical segment)

$15,444,000,000* *Fiscal year ended 6/30/2020

2019 rank: 7

Key personnel: STEVE MASON, CEO, medical segment

As was the case with many medical device companies, CARDINAL HEALTH has seen its medical device sales take a hit as health providers cancelled or deferred elective procedures in order to better focus on responding to the COVID-19 pandemic.

Medical segment sales ticked down –1% to $15.4 billion for the fiscal year ended June 30, 2020, even as total revenue grew 5% to $152.9 billion. Cardinal Health’s medtech

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business actually saw increased demand for personal protective equipment (PPE) such as masks, gowns and gloves to protect health workers from the coronavirus, but the cost to manufacture the PPE products also significantly increased and cut into profit margins for them. The medical segment, however, managed to achieve a 36% boost in profits in the following Q1 thanks to costsaving measures. – CN

11 • 2020

Medical Design & Outsourcing 33

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No.

8 Stryker

Kalamazoo, Mich.

$14,884,000,000* *Fiscal year ended 12/31/2019

2019 rank: 9

R&D spend: $971,000,000 Employees: 40,000 Key personnel: KEVIN LOBO, board chair & CEO; ROBERT FLETCHER, VP, chief legal officer; YIN BECKER, VP, communications, public affairs and corporate marketing; PRESTON WELLS, VP, investor relations; VIJU MENON, group president, global quality and operations; M. KATHRYN FINK, VP, chief human resources officer; SPENCER STILES, group president, orthopaedics and spine; TIMOTHY SCANNELL, president and chief operating officer; ANDY PIERCE, group president, MedSurg and neurotechnology; GLENN BOEHNLEIN, VP & CFO

Expect the world’s largest orthopedics device company to be even bigger in next year’s Big 100. STRYKER this month closed on its $4.7 billion purchase of Wright Medical — selling some of its arthroplasty systems to DJO in order to appease antitrust regulators. Stryker especially faced challenges due the COVID-19 pandemic as people and their health providers held off on hip and knee replacements and spinal procedures. Growth, however, returned during this year’s Q3, though CEO Kevin Lobo cautioned that the growth was uneven. Stryker is especially enjoying success surrounding

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its popular Mako ortho surgical robotics systems, with the 1,000th robotic system installed during Q3. During a DeviceTalks Weekly podcast over the summer, Lobo said he thought the pandemic was causing Stryker employees to gain a better understanding of tools to help them work more efficiently.

“We’ve learned new skills,” Lobo said. “We didn’t previously do physician training or even company meetings in a virtual format (before the lockdown). I think this will be part of our future offense. We’re feeling very optimistic about the future.” – CN

11 • 2020

Medical Design & Outsourcing 35

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We recognize that the products we’re manufacturing today can make a difference in the lives of those who use them. That is why we are committed to only offering high-quality plastic parts. As a premier plastic injection molder, our expertise is unmatched. We engineer and manufacture every part to the strictest of standards, delivering on our promise to provide highly reliable plastic part solutions.

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No.

9 Medline Industries Northfield, Ill.

$13,900,000,000* *Fiscal year ended 12/31/2019

Employees: 27,000 Key personnel: ANDY MILLS, president; CHARLIE MILLS, CEO; JIM ABRAMS, COO

MEDLINE touts itself as the largest privately held manufacturer and distributor of medical supplies. The family-owned company offers more than 550,000 medical products and clinical solutions ranging from surgical gloves to wheelchairs to face masks to thermometers. As the COVID-19 pandemic ramped up earlier this year, Medline agreed to reprocess tens of thousands of N95 respirators and other face masks per day in

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its facilities — and it started cranking out hand sanitizer at an infection-prevention products plant in Wisconsin. Even amid a recession, Medline also hasn’t shied away from M&A deals, paying $167.5 million to acquire the Namic fluid management business from AngioDynamics and spending $29 million to buy the SensiCare and Aloe Vesta collection of skincare product lines from ConvaTec. – CN

11 • 2020

Medical Design & Outsourcing 37

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No.

10 Danaher

(life sciences & diagnostics segments)

Washington, D.C.

$13,512,600,000* *Fiscal year ended 12/31/2019

2019 rank: 8

Key personnel: RAINER BLAIR, president & CEO; DANIEL COMAS, EVP; MATT MCGREW, EVP & CFO; JOAKIM WEIDEMANIS, EVP; BRIAN ELLIS, SVP & general counsel; WILLIAM KING, SVP, strategic development; ANGELA LALOR, SVP, human resources; ROBERT LUTZ, SVP & chief accounting officer; DANIEL RASKAS, SVP, corporate development

Even without the COVID-19 pandemic, this has been a year of change at DANAHER. The company near the end of last year completed the spinout of its dental business into a new company called Envista, closed its $20 billion purchase of GE’s Biopharma business in March, and then-EVP Rainer M. Blair moved up to the corner office after Thomas P. Joyce Jr.’s retirement as CEO on Sept. 1. The company

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has especially played an important role against the coronavirus when it comes to diagnostics.

Danaher’s Cepheid business recently launched rapid 4-in-1 combination tests for COVID-19, Flu A, Flu B and RSV from a single patient sample, and the company’s Beckman Coulter Diagnostics has assays to detect severe inflammatory response from COVID-19 as well as antibodies associated with the virus. – CN

11 • 2020

Medical Design & Outsourcing 39

No.

11 Abbott

(medical device segment)

Abbott Park, Ill.

$12,239,000,000* *Fiscal year ended 12/31/2019

2019 rank: R&D spend:

11 $1,200,000,000

Key personnel: MILES WHITE, executive board chair; ROBERT FORD, president & CEO; HUBERT ALLEN, EVP, general counsel & secretary; JOHN CAPEK, EVP, ventures; LISA EARNHARDT, EVP, medical devices; ROBERT FUNCK, EVP, finance & CFO; JOHN GINASCOL, EVP, core diagnostics; MARY MORELAND, EVP, human resources; ANDREA WAINER, EVP, rapid & molecular diagnostics; CHUCK BRYNELSEN, SVP, Abbott Vascular; MICHAEL DALE, SVP, structural heart; JAIME CONTRERAS, SVP, core laboratory, diagnostics, commercial operations; SCOTT HOUSE, SVP, quality assurance, regulatory & engineering services; MICHAEL PEDERSON, SVP, electrophysiology & heart failure; CHRISTOPHER SCOGGINS, SVP, rapid diagnostics; JARED WATKIN, SVP, diabetes care; RANDEL WOODGRIFT, SVP, cardiac rhythm management

Innovative products have enabled ABBOTT to continue to grow amid the COVID-19 pandemic. During the first nine months of 2020, Abbott sales were up 9.6% year-overyear — with diagnostics up 38.2% and medical devices up 3.4%. Abbott’s COVID-19 testing products include its BinaxNow COVID-19 Ag Card, a speedy antigen test for the coronavirus that can be directly read off the testing card.

Abbott secured an FDA EUA for the card tests in August, and the U.S. federal government soon agreed to pay $760 million for 150 million of the tests, but in early November, the FDA raised questions about the accuracy of antigen tests. Abbott also won FDA permission for the use of its FreeStyle Libre continuous glucose

40

Medical Design & Outsourcing

11 • 2020

monitoring system in hospital settings during the pandemic, opening a potential new market for the popular devices. Over the summer, the FDA cleared the FreeStyle Libre 2 system, followed by a CE Mark in September for the next-gen FreeStyle Libre 3. Another major CE Mark involved MitraClip G4, the latest version of the company’s transcatheter mitral valve repair (TMVR) system. The MitraClip, in fact, won the 2020 Prix Galien USA Award for Best Medical Technology. Abbott and Edwards Lifesciences in July settled all outstanding patent disputes related to transcatheter mitral and tricuspid repair products, hopefully allowing the companies to better focus on innovation in the space. – CN

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12 Baxter

Deerfield, Ill.

$11,362,000,000* *Fiscal year ended 12/31/2019

2019 rank: 12

R&D spend: $595,000,000 Employees: 50,000 Key personnel: JOSÉ ALMEIDA, president & CEO; GIUSEPPE ACCOGLI, SVP & president, Americas and global business units; LAURA ANGELINI, GM, renal care; DAVID BONDI, chief procurement officer; WIL BOREN, president, advanced surgery; JAMES BORZI, SVP, chief supply chain officer; ELLEN BRADFORD, SVP & corporate secretary; GAVIN CAMPBELL, GM, U.S. renal; DENNIS CROWLEY, SVP, business development & licensing; STACEY EISEN, SVP, global communications & president, Baxter International Foundation; DAVID FERGUSON, GM, medication delivery; CRISTIANO FRANZI, SVP & president, EMEA; ANDY FRYE, SVP & president, APAC; TOBI KARCHMER, VP, world medical; HEATHER KNIGHT, GM, U.S. hospital products; JACQUELINE KUNZLER, SVP, chief quality officer; KAREN LEETS, SVP & treasurer; TALVIS LOVE, SVP and CIO; SEAN MARTIN, SVP & general counsel; JEANNE MASON, SVP, human resources; LYNN PAWELSKI, VP, global regulatory affairs; SUMANT RAMACHANDRA, president, pharmaceuticals & SVP, chief science & technology officer; REAZ RASUL, GM, acute therapies; PHILIPPE REALE, VP, planning & fulfillment; DAVID ROMAN, VP, strategy & financial planning & analysis; JAY SACCARO, EVP & CFO; JOSEPH SCHWAN, deputy general counsel, global government policy & reimbursement; BRIAN STEVENS, SVP, chief accounting officer & controller; CLARE TRACHTMAN, VP, investor relations; JORGE VASSEUR, GM, clinical nutrition; SHIRLEY XU, GM, Greater China

BAXTER saw its sales tick up 2% year-over-year during the first nine months of 2020. Lower rates of hospitalizations and surgeries during the pandemic have had a negative effect, most notably on the company’s medication delivery and pharmaceuticals businesses. Baxter, though, is playing a crucial role because of the need for kidney dialysis machines and infusion pumps to treat critically ill COVID-19 patients. “Baxter’s third-quarter performance reflects ongoing demand for our medically essential products

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as well as the company’s agility and resilience amid a historic public health crisis,” Baxter CEO José Almeida said in an October news release.

“Our multiyear transformation has positioned us with the strength and adaptability to address today’s unique challenges while continuing to identify opportunities to drive additional value for patients, clinicians, communities and shareholders.” Baxter early this year acquired the Seprafilm adhesion barrier and its assets from Sanofi in a deal worth $350 million. – CN

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No.

13 Boston Scientific Marlborough, Mass.

$10,735,000,000* *Fiscal year ended 12/31/2019

2019 rank: 14 R&D spend: $1,174,000,000 Employees: 36,000

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

The COVID-19 pandemic and resulting drop in non-virus-related health procedures caused BOSTON SCIENTIFIC sales to drop 8% yearover-year during the first three quarters of 2020. Boston Sci faced extra headwinds as it switched to a consignment-based inventory model for customers of its Watchman left atrial appendage closure device. The FDA over the summer approved the next-gen version of the stroke prevention device, the Watchman FLX. “We believe the strategic

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Medical Design & Outsourcing

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shift to a consignment-based model strongly complements the launch of this highly clinically differentiated product and we are purposely making this investment, given the significant potential for FLX growth,” CEO Michael Mahoney said during the company’s Q3 earnings call in October. Other new product launches include the Exalt Model D single-use duodenoscope — an answer to the superbug problems associated with reprocessed versions of the scopes. – CN

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No.

14 Henry Schein Melville, N.Y.

$9,985,803,000* *Fiscal year ended 12/28/2019

2019 rank: 15 Employees: 19,000 Key personnel: STANLEY BERMAN, CEO; GERALD BENJAMIN, EVP, chief administrative officer; JAMES BRESLAWSKI, president; DAVID BROUS, president, strategic business units group & Asia Pacific & Brazil Dental; BRAD CONNETT, president, U.S. medical group; MICHAEL ETTINGER, SVP, corporate & legal affairs & chief of staff, secretary; JONATHAN KOCH, SVP & CEO, global dental group & interim CEO, Henry Schein One; LORELEI MCGLYNN, SVP, chief human resources officer; MARK MLOTEK, EVP, chief strategic officer; JAMES MULLINS, SVP, global services; STEVEN PALADINO, EVP & CFO; CHRISTOPHER PENDERGAST, SVP & chief technology officer; MICHAEL RACIOPPI, SVP, chief merchandising officer; WALTER SIEGEL, SVP & general counsel; RENÉ WILLI, president, global dental surgical group

Growth kicked in for HENRY SCHEIN’s medical business in Q3 2020, with quarterly sales of medical products reaching $1 billion for the first time amid growing demand for PPE and COVID-19-related products. “The pandemic caused disruption to the supply chain and as suppliers reacted to increased demand for [PPE] and shortages of raw materials, our markets experienced significant price

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Medical Design & Outsourcing

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volatility,” CEO Stanley Bergman said in a Nov. 2 news release. “As a result of the hard work and dedication of the team throughout the COVID-19 crisis, we were ready to assist our dental and medical customers, many of whom were subject to work restrictions and faced severe challenges, as they returned to their offices to provide safe, quality clinical care.” – CN

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15 Owens & Minor Mechanicsville, Va.

$9,210,939,000* *Fiscal year ended 12/31/2019

2019 rank: 13 Employees: 15,400 Key personnel: EDWARD PESICKA, president and CEO; JEFFREY JOCHIMS, EVP & COO; JONATHAN LEON, SVP & corporate treasurer; ANDY LONG, EVP & CFO; CHRISTOPHER LOWERY, president, global products; MICHAEL LOWRY, SVP, controller & chief accounting officer; SHANA NEAL, EVP, chief human resources officer; NICHOLAS PACE, EVP, general counsel & corporate secretary; MARK ZACUR, EVP & chief commercial officer

After two straight years of losses, OWENS & MINOR managed to turn a profit of $37.3 million, or 61¢ per share, during the first nine months of 2020 — even as the major medical products manufacturer and distributor saw its sales shrink –12.8%. “Our financial profile is as strong as it’s been in quite some time, and our focused execution has allowed us to invest in technology and infrastructure while

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Medical Design & Outsourcing

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deleveraging the balance sheet. Moreover, the success of our efforts gives us confidence to make additional investments to enhance our customers’ experience and drive further EPS growth. Our strategic capabilities and execution excellence boost our confidence in continued strong performance in 2020, and on-going momentum entering 2021,” CEO Edward A. Pesicka said in a Nov. 2 news release. – CN

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No.

16 Becton, Dickinson Franklin Lakes, N.J.

(medical segment)

$8,680,000,000* *Fiscal year ended 9/30/2020

2019 rank: 16 Employees: 34,000 Key personnel: VINCENT FORLENZA, executive board chair; TOM POLEN, CEO & president; SIMON CAMPION, EVP, president, interventional segment; GARY COHEN, EVP, global health; ALEXANDRE CONROY, EVP, integrated supply chain; JOHN DEFORD, EVP, chief technology officer; TONY EZELL, EVP & chief marketing officer; JERRY FLASZ, EVP, global services and chief information officer; ROLAND GOETTE, EVP & president, EMEA; PATRICK KALTENBACK, EVP & president, life sciences segment; SAM KHICHI, EVP, general counsel, public policy & regulatory affairs; BETTY LARSON, EVP & chief human resources officer; JAMES LIM, EVP & president, Greater Asia; ALBERTO MAS, EVP & president, medical segment; CHRISTOPHER REIDY, EVP, CFO & chief administrative officer; DAVID SHAN, EVP & chief quality officer; WILLIAM SIGMUND, EVP & chief medical officer; AMI SIMUNOVICH, EVP & chief regulatory officer

BECTON DICKINSON saw overall revenue tick down –1% and medical segment sales decline –4% for its most recent fiscal year ended Sept. 30, 2020. BD has grappled not only with the effects of the COVID-19 pandemic but also with a hold on shipments of its Alaris infusion pumps as it prepares a comprehensive 510(k) submission for FDA that covers a host of software fixes needed after a Class I recall. The company expects to submit the 510(k) in late Q2 or early Q3 (around spring 2021), CEO Thomas Polen said during a Nov. 5 earnings call. Meanwhile, the

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Medical Design & Outsourcing

11 • 2020

company’s revenue has been helped by the demand for COVID-19 testing, with U.S. HHS even agreeing over the summer to buy 2,000 BD Veritor Plus systems and 750,000 SARSCoV-2 antigen test kits for use in a broad, decentralized network. Polen said BD expects Veritor testing revenue in a range of $1 billion to $1.5 billion in the 2021 fiscal year. The company also has commitments for over 800 million needles and syringes to deliver future COVID-19 vaccines in the U.S., UK, Canada and elsewhere — a $100 million to $150 million opportunity. –CN

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No.

17 B. Braun Melsungen

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

$8,363,373,220* *Fiscal year ended 12/31/2019

(€7,471,300,000)

2019 rank: 17

R&D spend: $362,125,900 Employees: 64,000 Key personnel: ANNA MARIA BRAUN, CEO; JEAN-CLAUDE DUBACHER, CEO, B. Braun of America; ANNETTE BELLER, board member, finance, taxes & central services; MEINRAD LUGAN, board member, hospital care division, outpatient market division; JOACHIM SCHULZ, board member, Aesculap division; MARKUS STROTMANN, board member, Avitum division

B. BRAUN offers roughly 5,000 products, most of them made by the company, covering a wide range of areas including infusion pumps and systems, nutrition and pain therapy, disinfection products, surgical instruments, suture materials, hip and knee implants, dialysis equipment and accessories

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Medical Design & Outsourcing

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for extracorporeal blood treatment. There are also products for ostomy care, diabetes and wound management. Regulatory wins this year include FDA clearance for the SpaceStation MRI to allow Space infusion pumps to continuously deliver medications to patients within the MRI suite. – CN

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No.

18 Zimmer Biomet Warsaw, Ind.

$7,982,200,000* *Fiscal year ended 12/31/2019

2019 rank: 18

R&D spend: $449,300,000 Employees: 19,900 Key personnel: BRYAN HANSON, president & CEO; DIDIER DELTORT, president, EMEA; RACHEL ELLINGSON, SVP & chief strategy officer; DAVID KUNZ, SVP, global quality & regulatory affairs; ANGELA MAIN, SVP, global chief compliance officer & associate general counsel, Asia Pacific; KERI MATTOX, SVP, investor relations & chief communications officer; CARRIE NICHOL, VP, controller & chief accounting officer; CHAD PHIPPS, SVP, general counsel & secretary; PAMELA PURYEAR, SVP, chief human resources officer; ZEESHAN TARIQ, VP & chief information officer; IVAN TORNOS, group president, global businesses and the Americas; KENNETH TRIPP, SVP, global operations & logistics; SUKETU UPADHYAY, EVP & CFO; SANG YI, president, Asia Pacific

Like most in the implant space, orthopedic device giant ZIMMER BIOMET felt the impact of COVID-19 and the deferral of elective procedures in the early days of the pandemic.

The company lost $509 million in the first quarter and, while it made a recovery to profits of $246.1 million in the third quarter, uncertainties remain as the pandemic roars on.

“While the stronger-than-expected recovery of elective procedures in the third quarter was encouraging, we also remain focused

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11 • 2020

on ZB’s strong operational execution, which continues to drive confidence in our underlying business,” Zimmer Biomet president & CEO Bryan Hanson said after the third quarter. “It is important to note that the challenges and fluidity around COVID-19 persist as we move into the end of the year. Still, we will continue to transform our business, invest for greater value and prioritize innovation to better position the company for accelerated growth over the long term.” — SW

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No.

19 Alcon

Geneva, Switzerland

$7,508,000,000* *Fiscal year ended 12/31/2019

2019 rank: R&D spend: Employees:

19 $656,000,000 20,000

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

Eyecare products giant ALCON experienced a broad slowdown from the COVID-19 pandemic during the second quarter of 2020, with substantial recovery in the third quarter.

Worldwide sales were down –12% year-overyear, to $4.8 billion, for the first nine months of 2020, but they were only down –1% during

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Q3. “The investments we have made in our people, culture and infrastructure have gone a long way in building significant organizational resilience. Our innovation is meeting customer and patient needs as evidenced by strong market share gains,” CEO David Endicott said in a Nov. 10 news release. –CN

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No.

20 3M Co.

(healthcare segment)

Maplewood, Minn.

$7,431,000,000* *Fiscal year ended 12/31/2019

2019 rank: 20 Employees: 13,000 Key personnel: MICHAEL ROMAN, chair & CEO; JOHN BANOVETZ, SVP, innovation & stewardship, chief technology officer; IVAN FONG, SVP, general counsel & secretary; ERIC HAMMES, EVP, enterprise operations; ASHISH KHANDPUR, EVP, transportation & electronics business group; VEENA LAKKUNDI, SVP, strategy & business development; JEFFREY LAVERS, EVP, consumer business group; KRISTEN LUDGATE, SVP, human resources; MONISH PATOLAWALA, SVP & CFO; MOJDEH POUL, EVP, healthcare business group; DENISE RUTHERFORD, SVP, corporate affairs; TY SILBERHORN, SVP, transformation, technologies & service; MICHAEL VALE, EVP, safety & industrial business group; KAREN CARROLL, VP & general auditor; MICHAEL DAI, assistant secretary; SARAH GRAUZE, treasurer & VP, finance; MICHAEL DURAN, VP & chief ethics & compliance officer; THERESA REINSETH, VP, corporate controller & chief accounting officer; TED RINGSRED, assistant secretary; CHRISTINA SPENCE, assistant treasurer

3M was immediately thrust into the center of the pandemic with its N95 respirator masks becoming among the most sought-after PPE for healthcare workers and regular citizens alike. A $37.5 million contract for mask production issued by the U.S. Department of Defense on Nov. 12 brought the cumulative face value of 3M’s federal contracts to nearly $125.5 million. Much of the year has been spent resolving fraud and price gouging cases related to the N95s, but despite increased orders for products, the financial effects of the

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pandemic contributed to nearly 3,000 layoffs, mostly related to its divested drug-delivery business. “Though economic uncertainty and challenges due to the COVID-19 pandemic remain, we returned to positive organic sales growth with sequential improvement across businesses and geographies,” 3M chairman & CEO Mike Roman said in an Oct. 27 news release. “We continue to take actions to transform 3M and position us to deliver strong results as our end markets recover.” –SW

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No.

21

Olympus Tokyo

(medical business)

Key personnel:

$5,887,149,147* *Fiscal year ended 3/31/2020

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

(¥641,817,000,000)

2019 rank: 21

R&D spend: $550,220,143 Employees: 20,901

No.

22

Terumo Tokyo

Key personnel:

$5,768,638,782* *Fiscal year ended 3/31/2020

(¥628,897,000,000)

SHINJIRO SATO, president & CEO; TAKAYOSHI MIMURA, board chair; TOSHIAKI TAKAGI, director and senior managing executive officer of quality assurance, regulatory affairs, etc.; SHOJI HATANO, director and managing executive officer of corporate affairs, corporate communications, investor relations, etc.; KYO NISHIKAWA, director and senior executive officer of human resources, diversity promotion, etc.

2019 rank: 22 R&D spend: $464,135,021 Employees: 26,438

No.

23

Smith & Nephew London

Key personnel:

$5,138,000,000* *Fiscal year ended 12/31/2019

60

2019 rank: 23 R&D spend: $292,000,000 Employees: 17,500

Medical Design & Outsourcing

11 • 2020

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

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The IVDR Journey: A roadmap to meet 2022 deadlines, while navigating pandemic disruptions The COVID-19 pandemic has had an immediate impact on the medical device industry, including in vitro diagnostics (IVD). Despite this, it is unlikely that the May 2022 deadline for implementation of the In Vitro Diagnostics Regulations (IVDR) will be delayed. Manufacturers who have not begun preparations will need to adopt a strategy to address gaps in meeting the new regulation and to avoid potential EU product availability issues. Our latest whitepaper leverages ICON’s medical device and diagnostic expertise to discuss: - The current IVD landscape and impact of the COVID-19 pandemic - Challenges facing manufacturers across the IVD lifecycle - Steps for implementing a successful transition strategy

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No.

24

Fujifilm Holdings Tokyo

(healthcare only)

Key personnel:

$4,600,000,000* *Fiscal year ended 3/31/2020

R&D spend: $663,700,000 Employees: 73,906

SHIGETAKA KOMORI, chair & CEO; KENJI SUKENO, president & COO; TAKATOSHI ISHIKAWA, senior executive VP; TAKASHI IWASAKI, VP, CTO; TEIICHI GOTO, executive VP; JUNJI OKADA, SVP; NAOTO YANAGIHARA, SVP; MASARU YOSHIZAWA, SVP; MASAHIRO FUKUOKA, SVP; MASATO YAMAMOTO, corporate VP; NAOKI HAMA, corporate VP; CHISATO YOSHIZAWA, corporate VP; MASAYUKI HIGUCHI, corporate VP; MASAHIRO OTA, corporate VP; TOSHIKAZU BAN, corporate VP; SHOEI IMAI, corporate VP; AIICHIRO HIRUMA, corporate VP; KAZUHISA HORIKIRI, corporate VP; MOTOKO KAWASAKI, corporate VP; TADAHIRO SORORI, corporate VP; YASUSHI ZAMA, corporate VP; YOJI ITO, corporate VP; JUN OZAWA, corporate VP; JUNJI NAKADA, corporate VP; MAYUMI SUZUKI, corporate VP; SEIGO SUGIMOTO, corporate VP

No.

25

Intuitive Surgical Sunnyvale, Calif.

$4,478,500,000* *Fiscal year ended 12/31/2019

2019 rank: 25

R&D spend: $557,300,000 Employees: 7,326

Key personnel: GARY GUTHART, CEO; MYRIAM CURET, EVP & chief medical officer; MARSHALL MOHR, EVP & CFO; DAVE ROSA, EVP & chief business officer; BOB DESANTIS, EVP & GM, instruments, accessories & endoscopes; BRIAN MILLER, SVP & GM, systems, imaging & digital; KARA ANDERSEN REITER, SVP, general counsel & chief compliance officer; MARK JOHNSON, SVP, regulatory, quality & program management office; GILLIAN DUNCAN, SVP, professional education & program services, worldwide; COLIN MORALES, SVP & GM, secondary market equipment & service; CRAIG CHILD, SVP, human resources; JULIAN NIKOLCHEV, SVP, corporate development & strategy; HENRY CHARLTON, SVP & GM, U.S. & Europe; GLENN VAVOSO, SVP & GM, Asia & worldwide indirect; CHRIS CARLSON, VP & GM, endoluminal

No.

26

Edwards Lifesciences Irvine, Calif.

Key personnel:

$4,348,000,000* *Fiscal year ended 12/31/2019

2019 rank: 26

R&D spend: $752,700,000 Employees: 14,000

62

Medical Design & Outsourcing

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

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No.

27 Fresenius Medical Care Bad Homburg, Germany

$4,035,437,000* *Fiscal year ended 12/31/2019

(€3,605,000,000)

Thermoplastic Extrusions & Complete Custom ePTFE Solutions For Your Most Demanding Medical Applications Curved, formed, or extruded… we help solve your demanding medical application challenges & get your products to market faster.

R&D spend: $188,059,200 Employees: 30,230

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

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64

Medical Design & Outsourcing

11 • 2020

No.

28

Dentsply Sirona Charlotte, N.C.

Key personnel:

$4,029,200,000* *Fiscal year ended 12/31/2019

DONALD CASEY JR., CEO; JORGE GOMEZ, EVP & CFO; KEITH EBLING, EVP, general counsel & secretary; LISA YANKIE, SVP, chief human resources officer & communications

2019 rank: 24

R&D spend: $131,300,000 Employees: 15,200

No.

29

Hologic

Marlborough, Mass.

Key personnel:

$3,776,400,000* *Fiscal year ended 9/26/2020

2019 rank: 28

R&D spend: $222,500,000 Employees: 5,814

STEVE MACMILLAN, chair, president & CEO; ERIK ANDERSON, president, global service & breast & skeletal health service; MONICA AGUIRRE BERTHELOT, chief of staff; ALLISON BEBO, SVP, human resources; PATRICK BRADY, SVP, global supply chain, quality & regulatory; SEAN DAUGHERTY, group president, breast/skeletal health & GYN surgical solutions; JOHN GRIFFIN, general counsel; JENNIFER MEADE, president, breast & skeletal health solutions; ESSEX MITCHELL, president, GYN surgical solutions; KARLEEN OBERTON, CFO; SANJAY PRABHAKARAN, president, Asia Pacific; KEVIN THORNAL, president, diagnostic solutions; JAY STEIN, co-founder, chairperson emeritus, SVP & chief technology officer; JAN VERSTREKEN, group president International; MICHAEL WATTS, VP, investor relations & corporate communications

No.

30

Hoya Tokyo

(life care segment)

Key personnel:

$3,440,185,287* *Fiscal year ended 3/31/2020

HIROSHI SUZUKI, president & CEO; RYO HIROOKA, CFO; EIICHIRO IKEDA, CTO; AUGUSTINE YEE, chief legal officer & head, corporate development & affairs

(¥375,049,000,000)

2019 rank: 27

www.medicaldesignandoutsourcing.com

11 • 2020

Medical Design & Outsourcing 65

No.

31

Varian Medical Systems Palo Alto, Calif.

Key personnel:

$3,168,200,000* *Fiscal year ended 10/2/2020

2019 rank: 30

R&D spend: $280,600,000 Employees: 10,000

DOW WILSON, CEO; KOLLEEN KENNEDY, president, proton solutions & chief growth officer; CHRIS TOTH, president and COO; COREY ZANKOWSKI, SVP, oncology software solutions; DEEPAK KHUNTIA, SVP & chief medical officer; MICHAEL BRUFF, SVP, finance & CFO; MICHAEL HUTCHINSON, SVP, chief legal officer; TERILYN JUAREZ MONROE, SVP, people & places; RAFAEL TORRES, SVP, business development & strategy; ANDREW WHITMAN, SVP, government affairs; VY TRAN, SVP, chief compliance officer; KEVIN O’REILLY, SVP and president, Varian Oncology Systems; THOMAS RODDEN, SVP, chief information officer & finance; MAGNUS MOMSEN, SVP, chief accounting officer & corporate controller; KATHY CONNER, VP, global corporate marketing; FRANCIS FACCHINI, president, interventional solutions

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No.

32

Nipro

(medical segment)

Osaka, Japan

2.25”

Key personnel:

$3,079,866,080*

YOSHIHIKO SANO, president; TAKEHITO YOGO, CFO

*Fiscal year ended 3/31/2020

(¥335,767,000,000) 2019 rank: R&D spend: Employees:

29 $89,157,953 25,099

No.

33

Steris

Dublin, Ireland (Operational HQ in Mentor, Ohio) Key personnel:

$3,030,895,000

WALTER M. ROSEBROUGH, president & CEO; KAREN BURTON, VP, controller & chief accounting officer; DANIEL CARESTIO, SVP & COO; CARY MAJORS, SVP, North America commercial operations; RENATO TAMARO, VP, corporate treasurer; MICHAEL TOKICH, SVP & CFO; ADAM ZANGERLE, SVP, general counsel & secretary

*Fiscal year ended 3/31/2020

2019 rank: R&D spend: Employees:

34 $65,546,000 13,000

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No.

34

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BioMerieux

Marcy-l’Étoile, France

$2,994,171,120*

*Fiscal year ended 12/31/2019

(€2,674,800,000) 2019 rank: R&D spend: Employees:

31 $418,991,420 12,000

www.medicaldesignandoutsourcing.com

WWW.ALLMOTION.COM

Key personnel: ALEXANDRE MÉRIEUX, chair & CEO; PIERRE BOULUD, COO, EVP, clinical operations; GUILLAUME BOUHOURS, EVP, CFO, purchasing, information systems; PIERRE CHARBONNIER, EVP, global quality, manufacturing & supply chain; FRANÇOIS LACOSTE, EVP, R&D; VALÉRIE LEYLDÉ, EVP, human resources & communications; MARK MILLER, EVP, chief medical officer; YASHA MITROTTI, EVP, industrial microbiology; ESTHER WICK, EVP, legal, IP & compliance 11 • 2020

Medical Design & Outsourcing

67

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(408) 460-1345

No.

35

ResMed

San Diego

Key personnel:

$2,957,013,000* *Fiscal year ended 6/30/2020

2019 rank: 36 R&D spend: $201,946,000 Employees: 7,770

MICHAEL FARRELL, CEO; ROB DOUGLAS, president & COO; DAVID PENDARVIS, chief administrative officer, global general counsel; BRETT SANDERCOCK, CFO; JIM HOLLINGSHEAD, president, sleep & respiratory care business; RICHIE MCHALE, chief transformation officer; RAJ SODHI, president, SaaS business; KATRIN PUCKNAT, president, ResMed Germany; JUSTIN LEONG, president, Asia & Latin America; NUPUR BHUSHAN, chief people officer; HEMANTH REDDY, chief strategy officer; CARLOS NUNEZ, chief medical officer; BOBBY GHOSHAL, chief technology officer; ANDREW PRICE, president, global operations

No.

36

Sonova

Stäfa, Switzerland

$2,935,392,976 *Fiscal year ended 3/31/2020

(CHF 2,916,900,000)

Key personnel: ARND KALDOWSKI, CEO; HARTWIG GREVENER, CFO; CLAUDE DIVERSI, GVP, hearing instruments wholesale; VICTORIA CARR-BRENDEL, GVP, Cochlear implants; CHRISTOPHE FOND, GVP, audiological care; MARTIN GRIEDER, GVP, hearing instruments marketing; CLAUDIO BARTESAGHI, GVP, corporate HRM & communications; LUDGER ALTHOFF, GVP, operations; ANDI VONLANTHEN, GVP, R&D

2019 rank: 33 R&D spend: $168,058,770 Employees: 15,184

No.

37

Hillrom Chicago

Key personnel:

$2,881,000,000* *Fiscal year ended 9/30/2020

68

2019 rank: 32 R&D spend: $136,500,000 Employees: 10,000

Medical Design & Outsourcing

11 • 2020

JOHN GROETELAARS, president & CEO; BARBARA BODEM, CFO; FRANCISCO CANAL, president, EMEA; AMY DODRILL, president, global surgical solutions; ANDREAS FRANK, president, front line care; PAUL JOHNSON, president, patient support systems; MARY KAY LADONE, SVP, corporate development, strategy & investor relations; BRIAN LAWRENCE, CTO; TIM LAWRENCE, SVP, operations; RICHARD MARRITT, chief marketing officer; KEN MEYERS, chief human resources officer; DEBORAH RASIN, chief legal officer & secretary; ILANA SHULMAN, chief compliance officer; MARK WALLWORK, president, Asia Pacific

www.medicaldesignandoutsourcing.com

No.

38

Getinge

Gothenburg, Sweden

Key personnel:

$2,807,386,580*

*Fiscal year ended 12/31/2019

(26,559,000,000 SEK)

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

2019 rank: 35

R&D spend: $133,292,461 Employees: 10,538

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No.

39

Coloplast

Humlebæk, Denmark

$2,780,084,854* *Fiscal year ended 9/30/2020

(18,544,000,000 DKK)

Key personnel: KRISTIAN VILLUMSEN, president & CEO; ANDERS LONNINGSKOVGAARD, EVP, CFO; NICOLAI BUHL ANDERSEN, EVP, innovation; PAUL MARCUN, EVP, growth; CAMILLA G. MØHL, SVP, people & culture; ALLAN RASMUSSEN, EVP, global operations

2019 rank: 37 R&D spend: $106,142,153 Employees: 12,250

No.

40

Cooper Cos. San Ramon, Calif.

$2,653,400,000* *Fiscal year ended 10/31/2019

Key personnel: ALBERT WHITE, president & CEO; DANIEL MCBRIDE, EVP, COO & president, CooperVision; HOLLY SHEFFIELD, president, CooperSurgical; BRIAN ANDREWS, SVP, CFO & treasurer; AGOSTINO RICUPATI, chief accounting officer & SVP, finance & tax

2019 rank: 38

R&D spend: $86,700,000 Employees: 12,000

Key personnel:

No.

41

Teleflex Wayne, Pa.

$2,595,362,000* *Fiscal year ended 12/31/2019

70

2019 rank: 40 R&D spend: $113,857,000 Employees: 14,400

Medical Design & Outsourcing

11 • 2020

LIAM KELLY, chair, president & CEO; THOMAS POWELL, EVP & CFO; DAVE AMERSON, president & GM, interventional urology; MATT ANDERSON, president & GM, interventional access; PETRO BARCHUK, VP, financial planning & analysis; TYLER BINNEY, VP & GM, interventional urology; KAREN BOYLAN, corporate VP, strategic projects; GWEN CHAPMAN, corporate VP & chief compliance officer; JOHN DEREN, VP & chief accounting officer; JEANLUC DIANDA, president, EMEA & global urology; MICHAEL DIGIUSEPPE, VP, corporate accounts & respiratory; TIMOTHY DUFFY, VP & CIO; JAKE ELGUICZE, treasurer & VP, investor relations; JAMES FERGUSON, president & GM, surgical & Latin America; MICHELLE FOX, corporate VP & chief medical officer; SUNNY GOH, president, APAC; MARIE HENDRIXSON, VP, internal audit; CAMERON HICKS, corporate VP, human resources & communications; BERT LANE, VP, global logistics & distribution; JAMES LEYDEN, corporate VP, general counsel & secretary; JUSTIN MCMURRAY, VP, global strategic R&D; JAKE NEWMAN, VP & GM, vascular; DANIEL PRICE, VP, commercial finance; KEVIN ROBINSON, VP & GM, anesthesia & emergency medicine; GREGG STOTTS, VP & GM, OEM; GWENDOLYN WATANABE, corporate VP, corporate development, strategy & strategic partnerships; ED WEIDNER, VP, customer experience & commercial operations; JAY WHITE, corporate VP, Americas & EMEA; MARIO WIJKER, corporate VP, quality assurance & regulatory affairs; GREGG WINTER, VP, tax; JAMES WINTERS, corporate VP, manufacturing & supply chain www.medicaldesignandoutsourcing.com

No.

42

Paul Hartmann

Heidenheim an der Brenz, Germany

$2,447,903,920* *Fiscal year ended 12/31/2019

(€2,186,800,000)

2019 rank: 39 R&D spend: $80,149,040 Employees: 11,096

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With the advanced technology and the expertise to deliver stainless steel exactly as you want it.

Extensive tubing inventory - Eagle stocks stainless, copper, brass and aluminum in metric, hypodermic and fractional tubing in an extensive assortment of grades.

Key personnel:

Cut-to-length tubing - Eagle can cut and de-burr any diameter in quantities from 1 piece to millions from lengths of .040” and longer with a standard tolerance of ±.005 on diameters of less than 1”. Closer tolerances are met quite often.

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Bending / Coiling - Eagle craftsmen working with state-of-the-art machinery supply uniformly smooth bends, meeting the tightest customer specifications.

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Working in diameters from .030” to 2”, we’re ready to meet your most demanding requirements.

Wire EDM & Laser Machining enables Eagle to produce some of the mosdt exotic parts imaginable.

Assembly - Custom tube drawing and assembly of multiple parts to achieve a single component.

End reduction Bulging Flaring

11 • 2020

Medical Design & Outsourcing 71

End Forming - Robotic machine centers speed production and reduces cost.

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No.

43

Align Technology San Jose, Calif.

Key personnel:

$2,406,796,000* *Fiscal year ended 12/31/2019

2019 rank: 43

R&D spend: $157,400,000 Employees: 14,530

JOSEPH HOGAN, president & CEO; JOHN MORICI, CFO & SVP, global finance; SIMON BEARD, SVP & managing director, Americas; JULIE COLETTI, SVP, chief legal & regulatory officer; STUART HOCKRIDGE, SVP, global human resources; SREELAKSHMI KOLLI, SVP, chief digital officer; JENNIFER OLSON, SVP & managing director, customer success; RAJ PUDIPEDDI, chief innovation, product & marketing officer & SVP, product, R&D, IT, marketing, business development, clinical team; ZELKO RELIC, SVP & chief technology officer; MARKUS SEBASTIAN, SVP & managing director, EMEA; YUVAL SHAKED, SVP & managing director, iTero Scanner & Services business; JULIE TAY, SVP & managing director, Asia Pacific; EMORY WRIGHT, SVP, global operations

No.

44

Bio-Rad

Hercules, Calif.

Key personnel:

$2,311,659,000* *Fiscal year ended 12/31/2019

NORMAN SCHWARTZ, chair, president & CEO; ANDREW LAST, EVP, COO; ILAN DASKAL, EVP, CFO; TIMOTHY ERNST, EVP, general counsel & secretary; MIKE CROWLEY, EVP, global commercial operations; ANNETTE TUMOLO, EVP, president, life science group; DARA WRIGHT, EVP, president, clinical diagnostics group; RONALD HUTTON, VP, treasurer; AJIT RAMALINGAM, SVP, chief accounting officer.

2019 rank: 41 R&D spend: $292,710,000 Employees: 8,000

No.

45

Demant

Smørum, Denmark

$2,240,678,830*

Key personnel: SØREN NIELSEN, president & CEO; RENÉ SCHNEIDER, CFO

*Fiscal year ended 12/31/2019

(14,946,000,000 DKK)

72

2019 rank: 42 R&D spend: $167,908,490 Employees: 15,352

Medical Design & Outsourcing

11 • 2020

www.medicaldesignandoutsourcing.com

No.

46

Cook Medical Bloomington, Ind.

Key personnel:

$2,200,000,000*

CARL COOK, CEO

*Fiscal year ended 12/31/2019

Employees: 10,123

No.

47

Bruker

Billerica, Mass.

Key personnel:

$2,072,600,000* *Fiscal year ended 12/31/2019

FRANK LAUKIEN, chair, president & CEO; GERALD HERMAN, CFO; MARK MUNCH, president, Bruker Nano group; JUERGEN SREGA, president, Bruker CALID group; FALKO BUSSE, president, Bruker BioSpin group; BURKHARD PRAUSE, president, Bruker Energy & Supercon Technologies

2019 rank: 45 R&D spend: $187,700,000 Employees: 7,230

No.

48

Dräger

(medical business)

Lübeck, Germany

Key personnel:

$1,949,770,920* *Fiscal year ended 12/31/2019

STEFEN DRÄGER, chair; GERT-HARTWIG LESCOW, CFO, executive board member, IT; RAINER KLUG, executive board member, safety division; REINER PISKE, executive board member, sales & human resources; ANTON SCHROFNER, executive board member, medical division

(€1,741,800,000)

2019 rank: 44 R&D spend: $206,193,480

www.medicaldesignandoutsourcing.com

11 • 2020

Medical Design & Outsourcing 73

No.

49

Amplifon Milan

Key personnel:

$1,938,912,740* *Fiscal year ended 12/31/2019

(€1,732,100,000)

ENRICO VITA, CEO; ALESSANDO BONACINA, EVP, Americas; RICCARDO CATTANEO, chief regulatory officer; ANDREA CICCOLINI, CIO; FEDERICO DAL POZ, chief legal officer; CRISTIAN FINOTTI, chief supply chain officer; GABRIELE GALLI, CFO; FRANCESCA MORICHINI, chief HR officer; ANTHEA MUIR, EVP, APAC; IACOPO LORENZO PAZZI, EVP, EMEA; GIULIO PIZZINI, chief strategy & business development officer; GIUSEPPE VIRONDA, chief marketing officer

2019 rank: 49 Employees: 17,000

No.

50

ConvaTec

Reading, UK; Bridgewater, N.J.

$1,827,200,000* *Fiscal year ended 12/31/2019

2019 rank: 46 R&D spend: $53,800,000 Employees: 9,100

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

No.

51

HU Group (previously Miraca) Tokyo

Key personnel:

$1,730,985,140* *Fiscal year ended 3/31/2020

SHIGEKAZU TAKEUCHI, president & CEO; MASAYA WATANABE, EVP, COO & CIO; NAOKI KITAMURA, CFO

(¥188,712,000,000)

74

2019 rank: 47

Medical Design & Outsourcing

11 • 2020

www.medicaldesignandoutsourcing.com

No.

52

Nihon Kohden Tokyo

Key personnel:

$1,697,000,550* *Fiscal year ended 3/31/2020

(¥185,007,000,000) 2019 rank: R&D spend: Employees:

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

48 $61,740,965 5,357

COMPLETE CADENCE

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No.

53

Carl Zeiss Meditec Jena, Germany

Key personnel:

$1,633,540,420*

LUDWIN MONZ, president & CEO; JUSTUS FELIX WEHMER, CFO

*Fiscal year ended 9/30/2020

(€1,459,300,000)

2019 rank: 51 R&D spend: $193,992,020 Employees: 3,232

No.

54

Straumann Basel, Switzerland

$1,606,344,973* *Fiscal year ended 12/31/2019

(CHF 1,596,225,000)

2019 rank: 55 Employees: 7,200

Key personnel: GUILLAUME DANIELLOT, CEO; PETER HACKEL, CFO; WOLFGANG BECKER, head distributor & emerging markets, EMEA; JENS DEXHEIMER, head, sales, Europe; CAMILA FINZI, head, orthodontics business unit; HOLGER HADERER, head, marketing & education; MARK JOHNSON, head, research, development & operations; PATRICK LOH, head, sales, Asia/Pacific; ANDREAS MEIER, chief legal officer & head, business development; DIRK REZNIK, head, digital business unit; ALASTAIR ROBERTSON, global people management & development; PETRA RUMPF, head, dental service organizations; MATTHIAS SCHUPP, head, sales, Latin America & CEO, Neodent; ROBERT WOOLLEY, head, sales, North America

No.

55

Elekta Stockholm

Key personnel:

$1,543,380,830* *Fiscal year ended 4/30/2020

(14,601,000,000 SEK)

2019 rank: 50

R&D spend: $155,701,662 Employees: 4,117

76

Medical Design & Outsourcing

11 • 2020

GUSTAF SALFORD, acting president & CEO; KARIN SVENSKE NYBERG, EVP, human resources; MAURITS WOLLESWINKEL, president, Linac Solutions; IOANNIS PANAGIOTELIS, chief marketing & sales officer; VERENA SCHILLER, president, neuro solutions; JOHN LAPRÉ, president, brachy solutions; ANDREW WILSON, president, oncology informatics solutions; PAUL BERGSTRÖM, EVP, global services; LARRY BISCOTTI, EVP, region RNCA; ANMING GONG, EVP, China region; RENATO LEITE, EVP, Europe region; JONAS BOLANDER, general counsel & EVP; HABIB NEHME, EVP, Middle East, Africa & India; LIONEL HADJADJEBA, president, MR-Linac Solutions; JOHAN ADEBÄCK, acting CFO

www.medicaldesignandoutsourcing.com

No.

56

Integra Lifesciences Plainsboro, N.J.

Key personnel: PETER ARDUINI, president & CEO; CARRIE ANDERSON, EVP & CFO; KENNETH BURHOP, corporate VP, chief scientific officer; ANDREA CARUSO, corporate VP, business development; GLENN COLEMAN, EVP & COO; WILLIAM COMPTON, corporate VP & chief information officer; ROBERT DAVIS, executive VP & president, OTT; SRAVAN EMANY, corporate VP, commercial excellence & chief strategy officer; LISA EVOLI, EVP & chief human resources officer; STEVE LEONARD, corporate VP, global operations & supply chain; BARBARA MCALEER, corporate VP, global quality; MICHAEL MCBREEN, EVP & president, Codman Specialty Surgical; JOHN MOORADIAN, corporate VP; JUDITH O’GRADY, corporate VP, global regulatory affairs; ERIC SCHWARTZ, EVP, chief legal officer & secretary

$1,517,557,000* *Fiscal year ended 12/31/2019

2019 rank: Employees:

52 4,000

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No.

57

Dexcom San Diego

Key personnel:

$1,476,000,000* *Fiscal year ended 12/31/2019

KEVIN SAYER, president & CEO; DON ABBEY, EVP, quality & regulatory affairs; ANDREW BALO, EVP, regulatory strategy, clinical affairs & strategic partnership development; QUENTIN BLACKFORD, CFO & COO; RICK DOUBLEDAY, EVP, chief commercial officer; JAKE LEACH, EVP, chief technology officer; JEFFREY MOY, EVP, operations; PATRICK MURPHY, EVP, chief legal officer; STEVEN PACELLI, EVP, strategy & corporate development

2019 rank: 62

R&D spend: $273,500,000 Employees: 3,826

No.

58

ICU Medical

San Clemente, Calif.

$1,266,208,000* *Fiscal year ended 12/31/2019

Key personnel: VIVEK JAIN, chairperson & CEO; CHRISTIAN VOIGTLANDER, COO; DAN WOOLSON, corporate VP & GM, infusion systems; VIRGINIA SANZONE, corporate VP, general counsel; BRIAN BONNELL, CFO

2019 rank: 54 R&D spend: $48,611,000 Employees: 8,000

No.

59

Integer Plano, Texas

Key personnel:

$1,258,094,000* *Fiscal year ended 12/31/2019

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

2019 rank: 56

R&D spend: $46,500,000 Employees: 8,250

78

Medical Design & Outsourcing

11 • 2020

www.medicaldesignandoutsourcing.com

No.

60

Fukuda Denshi Tokyo

Key personnel: KOTARO FUKUDA, chairman & CEO; DAIJIRO SHIRAI, president & COO

$1,223,564,484* *Fiscal year ended 3/31/2020

(¥133,393,000,000)

2019 rank: 58

No.

61

Smiths Medical Minneapolis

(Smiths Group)

Key personnel:

$1,172,102,400* *Fiscal year ended 7/31/2020

(£918,000,000)

JEHANZEB NOOR, CEO; WILSON CONSTANTINE, president, Americas region; NIGEL BARK, VP & GM, EMEA region; GARY BARRETT, VP, global regulatory, compliance & quality systems; ABBY HOLASCHUTZ, VP, global supply chain and procurement; DARYL CALHOUN, VP, global research and development; KEVIN FITZPATRICK, SVP and chief human resources officer; JEFFREY HOHN, VP, global product and commercial excellence, strategy and M&A

2019 rank: 57 R&D spend: $69,154,042 Employees: 8,050

No.

62

NuVasive San Diego

Key personnel:

$1,168,070,000* *Fiscal year ended 12/31/2019

2019 rank: 60

R&D spend: $72,380,000 Employees: 2,800

CHRIS BARRY, CEO; BRENT BOUCHER, EVP, global commercial; MATT HARBAUGH, EVP & CFO; MASSIMO CALAFIORE, EVP global business unit; DALE WOLF, SVP, global operations; NATHANIEL SISITSKY, SVP, general counsel & corporate secretary; LUCAS VITALE, EVP and chief human resources officer; AVIVA MCPHERRON, VP, information technology; SUZANNE HATCHER, VP, internal & external affairs; KYLE MALONE, VP, clinical, medical & regulatory affairs; SEAN FREEMAN, SVP, strategy & corporate development; JAMES GARRETT, SVP, government & regulations strategy

www.medicaldesignandoutsourcing.com

11 • 2020

Medical Design & Outsourcing 79

No.

63

LivaNova London

Key personnel:

$1,084,170,000* *Fiscal year ended 12/31/2019

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

2019 rank: 59

R&D spend: $149,889,000 Employees: 4,000

No.

64

Omron Healthcare Kyoto, Japan

Key personnel:

$1,027,325,261* *Fiscal year ended 3/31/2020

ISAO OGINO, president & CEO (Japan); ANDRÉ VAN GILS, executive officer (Europe); RANNDY KELLOGG, president & CEO (US & Canada)

(¥111,999,000,000)

2019 rank: 61 Employees: 4,238

No.

65

Cantel Medical Little Falls, N.J.

Key personnel:

$1,016,048,000* *Fiscal year ended 7/31/2020

80

R&D spend: 32,372,000 Employees: 3,669

Medical Design & Outsourcing

11 • 2020

GEORGE FOTIADES, CEO; PETER CLIFFORD, president and COO; SHAUN BLAKEMAN, SVP and CFO; MIKE SPICER, president, medical business; MICHAEL DREXEL, SVP and CTO; KEN SEROTA, president, dental; NEIL BLEWITT, president, Europe; MICHAEL MCGRATH, president, Canada and Asia Pacific; JEAN CASNER, SVP and chief human resources officer; SETH YELLIN, EVP, strategy and corporate development; TERRY LUBBEN, SVP, medical; JEFF MANN, SVP, general counsel and secretary; ERIC MOORE, SVP, global quality and regulatory affairs; GREG RENY, SVP, hemodialysis water business

www.medicaldesignandoutsourcing.com

No.

66

Merit Medical Systems South Jordan, Utah

Key personnel: FRED LAMPROPOULOS, chair & CEO; RAUL PARRA, CFO; RON FROST, COO; BRIAN LLOYD, chief legal officer; JOE WRIGHT, president, International; JUSTIN LAMPROPOULOS, EVP, global sales marketing & strategy

$994,852,000* *Fiscal year ended 12/31/2019

2019 rank: 66 R&D spend: $65,600,000 Employees: 6,355

No.

67

Haemonetics Boston

Key personnel: CHRISTOPHER SIMON, president & CEO; MICHELLE BASIL, EVP, general counsel; WILLIAM BURKE, EVP, CFO; ANILA LINGAMNENI, EVP, CTO; JOSEP LLUIS LLORENS, SVP, global manufacturing & supply chain; CHAD NIKEL, president, global blood center; KEVIN O’KELLY-LYNCH, SVP, global business services; JACQUELINE SCANLAN, SVP, human resources; STEWART STRONG, president, global hospital; DAVID WILSON, president, global plasma

$988,479,000* *Fiscal year ended 3/28/2020

2019 rank: 64 R&D spend: $30,883,000 Employees: 3,004

No.

68

Conmed Utica, N.Y.

Key personnel:

$955,097,000* *Fiscal year ended 12/31/2019

2019 rank: 67

R&D spend: $45,460,000 Employees: 3,300

CURT HARTMAN, president, CEO and chair; PATRICK BEYER, president, international and global orthopedics; TERENCE BERGÉ, VP, corporate controller; HEATHER COHEN, EVP, human resources; SHANNA COTTI-OSMANSKI, EVP, IT and CIO; TODD GARNER, EVP and CFO; DANIEL JONAS, EVP, legal affairs, general counsel and secretary; JOHN KENNEDY, VP and GM, CET; SARAH OLIKER, assistant general counsel, assistant secretary; JOHONNA PELLETIER, treasurer and VP, tax; STANLEY PETERS; VP and GM, advanced surgical; PETER SHAGORY, EVP, strategy and corporate development

www.medicaldesignandoutsourcing.com

11 • 2020

Medical Design & Outsourcing 81

No.

69

No.

70

GN Hearing Ballerup, Denmark

$940,118,960*

(6,351,000,000 DKK)

(AU$1,352,300,000)

2019 rank: 65 Employees: 6,275

Key personnel:

Key personnel:

GITTE PUGHOLM AABO, CEO; RENÉ SVENDSEN-TUNE, CEO, GN Store Nord & GN Audio; MARCUS DESIMONI, CFO, GN Store Nord

DIG HOWITT, CEO & president; BRENT CUBIS, CFO; JENNIFER HORNERY, SVP, people & culture; JAN JANSSEN, CTO; TONY MANNA, president, Americas; RICHARD BROOK, president, EMEA & Latin America; ANTHONY BISHOP, president, Asia Pacific; ROM MENDEL, president, acoustics; STUART SAYERS, president, services; DEAN PHIZACKLEA, SVP, global marketing; DAVID HACKSHALL, chief information officer; GREG BODKIN, SVP, supply chain & operational excellence; BRIAN KAPLAN, SVP, clinical strategy & innovation

*Fiscal year ended 6/30/2020

R&D spend: $128,681,520 Employees: 4,000

No.

No.

72

Masimo Irvine, Calif.

Invacare Elyria, Ohio

$937,837,000*

$927,964,000*

2019 rank: 68

R&D spend: $93,295,000 Employees: 1,600

2019 rank: 63

R&D spend: $15,836,000 Employees: 3,900

Key personnel:

Key personnel:

JOE KIANI, CEO & chair; BILAL MUHSIN, COO; JON COLEMAN, president, worldwide sales & professional services and medical affairs; MICAH YOUNG, EVP & CFO; YONGSAM LEE, EVP & CIO; ANAND SAMPATH, EVP, operations & clinical research; TOM MCCLENAHAN, EVP, general counsel; TAO LEVY, EVP, business development

MATTHEW MONAGHAN, chair, president & CEO; ANGIE GOODWIN, chief information technology officer; ANTHONY LAPLACA, SVP, general counsel, chief administrative officer & secretary; RALF LEDDA, SVP & GM, Europe; KATHLEEN LENEGHAN, SVP & CFO; JOOST BELTMAN, SVP & GM, North America

*Fiscal year ended 12/28/2019

82

Sydney

$952,131,089*

*Fiscal year ended 12/31/2019

71

Cochlear

Medical Design & Outsourcing

11 • 2020

*Fiscal year ended 12/31/2019

www.medicaldesignandoutsourcing.com

No.

73

Wright Medical (acquired by Stryker in November 2020) Amsterdam (U.S. HQ in Memphis, Tenn.)

No.

74

Abiomed Danvers, Mass.

$920,900,000*

$840,883,000*

*Fiscal year ended 3/31/2020

*Fiscal year ended 12/29/2019

2019 rank: 70 R&D spend: $74,085,000 Employees: 3,030

2019 rank: 71 R&D spend: $98,759,000 Employees: 1,536

Key personnel:

Key personnel:

ROBERT PALMISANO, president & CEO; LANCE BERRY, EVP, CFO, COO; PETER COOKE, president, emerging markets, Australia & Japan; KEVIN CORDELL, EVP, chief global commercial officer; JAMES LIGHTMAN, SVP, general counsel & secretary; WESLEY PORTER, SVP, chief compliance officer; JULIE DEWEY, SVP, chief communications officer; JENNIFER WALKER, SVP, process improvement; JULIE ANDREWS, SVP, global finance; TIMOTHY LANIER, president, upper extremities; PATRICK FISHER, president, lower extremities; JASON ASPER, SVP, chief digital officer; ANDREW MORTON, SVP & chief human resources officer; KEVIN SMITH, SVP, quality & regulatory; BARRY REGAN, SVP, operations; STEVEN WALLACE, president, international

MICHAEL MINOGUE, chair, president & CEO; MARC BEGAN, VP, general counsel; CHUCK SIMONTON, chief medical officer; ANDREW GREENFIELD, VP & chief commercial officer; MICHAEL HOWLEY, VP & GM, global sales; KAREN MAHONEY, head, global human resources; MATT PLANO, VP, operations; THORSTEN SIESS, CTO; TODD TRAPP, VP & CFO; DAVID WEBER, COO

No.

75

Fisher & Paykel Healthcare Auckland, New Zealand

No.

76

$832,904,670*

Konica Minolta

Tokyo

(healthcare segment)

$813,581,000*

*Fiscal year ended 3/31/2020

*Fiscal year ended 3/31/2020

(NZ$1,263,700,000.00)

2019 rank: 72 R&D spend: $78,103,350 Employees: 5,081

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

www.medicaldesignandoutsourcing.com

2019 rank: 69

Key personnel: RICK TAYLOR, president & CEO; JOHN THIELKE, EVP & CFO; SAM ERRIGO, EVP, sales & business development; BRIAN CUPKA, EVP & general counsel; TODD CROTEAU, president, All Covered IT services; ALLAN SCHWEDOCK, SVP, operations & supply chain; DINO PAGLIARELLO, SVP, product management & planning; KAY DU FERNANDEZ, SVP, marketing; KEVIN KERN, SVP, digital transformation & emerging technologies; VICKY RINGWOOD, SVP, human resources

11 • 2020

Medical Design & Outsourcing 83

No.

No.

77

78

Insulet

Acton, Mass.

Alpharetta, Ga.

$738,200,000*

$697,600,000*

2019 rank: 75

R&D spend: $129,700,000 Employees: 1,350

2019 rank: 73

R&D spend: $37,700,000 Employees: 4,700

*Fiscal year ended 12/31/2019

*Fiscal year ended 12/31/2019

Key personnel:

Key personnel:

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

JOSEPH WOODY, CEO; DAVID BALL, SVP, global supply chain & procurement; LEE BURNES, SVP, global R&D, clinical & medical affairs; RHONDA GIBBY, SVP & chief human resources officer; MICHAEL GREINER, SVP & CFO; BILL HAYDON, SVP & GM; MIZANU KEBEDE, SVP, global quality assurance & regulatory, interim ethics & compliance officer; WARREN MACHAN, SVP, business strategy; ARJUN SARKER, SVP, international; JOHN WESLEY, SVP, general counsel; MICHAEL ACEVEDO, VP & GM, acute pain; KERR HOLBROOK, VP & GM, chronic care; TOM KUPEC, VP & GM, interventional pain; MICHELLE SCHARFENBERG, SVP, chief ethics & compliance officer

No.

79

Avanos Medical

No.

80

Össur

Reykjavík, Iceland

Agfa-Gevaert

(radiology solutions segment)

Mortsel, Belgium

$599,998,400*

$686,264,000*

*Fiscal year ended 12/31/2019

*Fiscal year ended 12/31/2019

(€536,000,000)

84

2019 rank: 74 R&D spend: $31,326,000 Employees: 3,500

Key personnel:

Key personnel:

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

PASCAL JUÉRY, president & CEO & president, digital print & chemicals & radiology solutions; LUC DELAGAYE, president, offset solutions; DIRK DE MAN, CFO; LUC THIJS, president, Agfa Healthcare

Medical Design & Outsourcing

11 • 2020

www.medicaldesignandoutsourcing.com

No.

81

No.

Nikkiso Tokyo

(medical segment)

82

Hiroshima, Japan

$568,702,990*

$537,231,701*

(¥58,569,000,000)

(¥58,569,000,000)

2019 rank: 78

2019 rank: 77 R&D spend: $12,997,615

*Fiscal year ended 12/31/2019

*Fiscal year ended 3/31/2020

Key personnel:

Key personnel:

TOSHIHIKO KAI, president & CEO; YOSHIHIKO KINOSHITA, GM, medical; SHOICHI NAGATO, GM, aerospace; MASARU YAMAMURA, GM, industrial; SUSUMU KOITO, GM, corporate

No.

83

JMS Co.

HIROAKI OKUKUBO, president & representative director; YASUHIRO AWANE, executive director, sales & marketing; MASAFUMI SATO, director, research & development; RYUJI KATSURA, director, corporate planning; SHOGO YANAGIDA, director, production

No.

Natus Medical

Pleasanton, Calif.

84

$495,175,000*

Asahi Intecc Nagoya, Japan

(medical field segment)

$476,343,790*

*Fiscal year ended 12/31/2019

*Fiscal year ended 6/30/2020

(¥51,931,000,000) 2019 rank: 76 R&D spend: $58,733,000 Employees: 1,484 Key personnel:

Key personnel:

JONATHAN KENNEDY, president & CEO; DREW DAVIES, EVP & CFO; AUSTIN NOLL, EVP & chief commercial officer; CHRISTOPHER CHUNG, VP, quality, regulatory affairs & chief medical officer; SEÁN LANGAN, VP, global operations; IVAN PANDIYAN, VP, global R&D; LISA PAUL, VP & chief people officer; WILLIAM HILL, general counsel

MASAHIKO MIYATA, president & CEO; KENJI MIYATA, EVP & COO; IPPEI YUGAWA, executive officer; YUICHI IIZUKA, executive officer; TOSHIYA OSAWA, executive officer; YUKIO WATANABE, executive officer; YO NOBUTA, executive officer; KAZUO CHIBA, executive officer; YASUYUKI KAWAHARA, executive officer; MASASHI MUTOU, executive officer; KAZUHITO ISHIHARA, executive officer

www.medicaldesignandoutsourcing.com

11 • 2020

Medical Design & Outsourcing 85

No.

85

No.

86

Orthofix

Lewisville, Texas

Ambu

Copenhagen, Denmark

$422,769,591*

$459,955,000*

*Fiscal year ended 9/30/2019

*Fiscal year ended 12/31/2019

(2,820,000,000 DKK) 2019 rank: 79 R&D spend: $34,637,000 Employees: 1,055

2019 rank: 81

R&D spend: $15,441,584 Employees: 3,108

Key personnel:

Key personnel:

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

JUAN JOSE GONZALEZ, CEO; MICHAEL HØJGAARD, EVP, CFO

No.

87

No.

Topcon Tokyo

88

(eye care segment)

$410,548,523*

Nevro

Redwood City, Calif.

$390,255,000*

*Fiscal year ended 3/31/2020

*Fiscal year ended 12/31/2019

(¥44,758,000,000) 2019 rank:

2019 rank: 82 R&D spend: $59,017,000 Employees: 853

80

Key personnel: SATOSHI HIRANO, representative director, president & CEO; MAKOTO IWASAKI, representative director, senior managing executive officer, GM, quality assurance, GM, general administration & legal, GM, corporate planning, GM, custom products business promotion; TAKASHI ETO, director managing executive officer, general manager, smart infrastructure business; HARUHIKO AKIYAMA, director, senior executive officer, GM, accounting & finance; TAKAYUKI YAMAZAKI, director, senior executive officer, GM, product development

86

Medical Design & Outsourcing

11 • 2020

Key personnel: KEITH GROSSMAN, chair, president & CEO; ROD MACLEOD, CFO; DAVID CARAWAY, chief medical officer; KASHIF RASHID, general counsel; NIAMH PELLEGRINI, chief commercial officer; LORI CIANO, chief human resources officer; MICHAEL CARTER, VP, global sales; RICHARD CARTER, VP, finance, corporate controller; CHRISTOFER CHRISTOFOROU, VP, R&D; DONALD MIDDLEBROOK, VP, clinical, regulatory & quality; PATRICK SCHMITZ, VP, operations; CLAIRE SMITH, VP, customer excellence; NEERAJ TEOTIA, VP, marketing

www.medicaldesignandoutsourcing.com

No.

No.

89

90

Accuray

Sunnyvale, Calif.

St. Helier, Jersey

$382,928,000*

$351,318,000*

R&D spend: $49,784,000 Employees: 932

Key personnel:

Key personnel:

JOSHUA LEVINE, president & CEO; SUZANNE WINTER, chief commercial officer & SVP, R&D; SHIG HAMAMATSU, SVP & CFO; SCOTT CHAPMAN, SVP, global service; JESSE CHEW, SVP, general counsel & corporate secretary; MICHAEL HOGE, SVP, global operations; PATRICK SPINE, SVP, chief administrative officer; JIM DENNISON, SVP, global quality & regulatory affairs

ASAF DANZIGER, CEO; ELY BENAIM, chief medical officer; ASHLEY CORDOVA, CFO; WILCO GROENHUYSEN, COO; FRANK LEONARD, chief development officer; TODD LONGSWORTH, general counsel; PRITESH SHAH, chief commercial officer; URI WEINBERG, chief science officer

*Fiscal year ended 6/30/2020

*Fiscal year ended 12/31/2019

No.

91

NovoCure

R&D spend: $79,003,000 Employees: 782

No.

Medacta

Castel San Pietro, Switzerland

92

Surgalign (previously RTI Surgical) Deerfield, Ill.

$308,384,000*

$347,685,640*

*Fiscal year ended 12/31/2019

*Fiscal year ended 12/31/2019

(€310,600,000)

R&D spend: $7,276,100 Employees: 1,101

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

www.medicaldesignandoutsourcing.com

2019 rank: 84

R&D spend: $16,836,000 Employees: 935 Key personnel: TERRY RICH, president & CEO; KRIS SIEMIONOW, chief medical officer; JONATHON SINGER, CFO & COO; SCOTT DURALL, chief commercial officer; BOB WATKINS, chief technology officer; DOUG BIRELEY, EVP, marketing & R&D; BRYAN CORNWALL, EVP, research & clinical affairs; ENRICO SANGIORGIO, EVP, international; JOSH DERIENZIS, general counsel & corporate secretary; RENU MENEZES, EVP, human resources

11 • 2020

Medical Design & Outsourcing 87

No.

93

No.

Barco

94

(healthcare division)

Kortrijk, Belgium

$300,865,616*

CryoLife

Kennesaw, Ga.

$276,222,000*

*Fiscal year ended 12/31/2019

*Fiscal year ended 12/31/2019

(€268,774,000)

2019 rank: 83

2019 rank: 85

R&D spend: $22,960,000 Employees: 1,200

Key personnel: JAN DE WITTE, CEO; WIM BUYENS, CEO, Cinionic; OLIVIER CROLY, SVP, APAC; GERWIN DAMBERG, CTO; ANN DESENDER, CFO; AN DEWAELE, chief HR officer; STIJN HENDERICKX, SVP, EMEA; JOHAN HEYMAN, organizational excellence/’Fit to lead’; ROB JONCKHEERE, SVP, global operations; CHANG TET JONG, managing director, Barco China; FILIP PINTELON, GM, healthcare; GEORGE STROMEYER, GM, enterprise; IAIN URQUHART, SVP, Americas; KURT VERGEGGEN, general counsel; MARC SPENLÉ, chief digital & information officer

No.

95

PATRICK MACKIN, president & CEO; PETER BARTHOLD, VP, R&D, GM, Jotec; SCOTT CAPPS, VP, clinical research; JOHN DAVIS, SVP, global sales & marketing; MATTHEW GETZ, VP, human resources; JEAN HOLLOWAY, SVP, general counsel, chief compliance officer & corporate secretary; AMY HORTON, VP, chief accounting officer; ASHLEY LEE, EVP, chief operating officer & CFO; DENNIS MAIER, VP, operations; WILLIAM NORTHRUP, VP, physician relations & education; MICHAEL SIMPSON, SVP, regulatory affairs & quality assurance

No.

96

Glaukos

San Clemente, Calif.

Cardiovascular Systems St. Paul, Minn.

$236,984,000*

$236,545,000*

2019 rank: 87

R&D spend: $68,308,000 Employees: 600

R&D spend: $43,355,000 Employees: 779

*Fiscal year ended 12/31/2019

*Fiscal year ended 6/30/2020

Key personnel:

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

88

Key personnel:

Medical Design & Outsourcing

11 • 2020

SCOTT WARD, president & CEO; RYAN EGELAND, chief medical officer; JOHN HASTINGS, VP, manufacturing & operations; JOHN NIELSEN, VP, investor relations & corporate communications; JEFFREY POINTS, CFO; STEPHEN REMPE, chief human resources officer; RHONDA ROBB, COO; ALEXANDER ROSENSTEIN, general counsel & corporate secretary; SANDRA SEDO, chief compliance officer; DAVID WHITESCARVER, VP, corporate development & intellectual property

www.medicaldesignandoutsourcing.com

No.

97

No.

98

AtriCure Mason, Ohio

Colfax

(Medical Technology segment, including DJO)

DJO HQ in Lewisville, Texas

$230,807,000*

$199,000,000*

Key personnel:

*Fiscal year ended 12/31/2019

*Fiscal year ended 12/31/2019

2019 rank: 86 R&D spend: $41,230,000 Employees: 730

MATT TREROTOLA, president and CEO; BRADY SHIRLEY, EVP and CEO of DJO

Key personnel: MICHAEL CARREL, president & CEO; ANGELA WIRICK, CFO; DOUGLAS SEITH, COO; JUSTIN NOZNESKY, SVP, marketing & business development; TONYA AUSTIN, SVP, human resources; KARL DAHLQUIST, chief legal officer; VINAYAK DORAISWAMY, SVP, clinical, regulatory, scientific & medical affairs; SALVATORE PRIVITERA, chief technology officer

No.

99

No.

100

SeaSpine Carlsbad, Calif.

$159,083,000*

Sectra

(Imaging IT division)

Linköping, Sweden

$150,966,133*

*Fiscal year ended 12/31/2019

*Fiscal year ended 4/30/2020

(1,428,200,000 SEK)

2019 rank: 89 R&D spend: $15,125,000 Employees: 386

Key personnel: KEITH VALENTINE, president & CEO; JOHN BOSTJANCIC, SVP, CFO; DENNIS CIRINO, SVP, global spinal systems; PATRICK KERAN, SVP, general counsel & corporate secretary; TYLER LIPSCHULTZ, SVP, orthobiologics & business development; LAETITIA COUSIN, VP, regulatory & quality assurance; BILL RHODA, GM, process innovation & development; CHRIS SHEN, VP, customer experience & information technology; FRANK VIZESI, VP, orthobiologics R&D & clinical affairs; JOHN WINGE, VP, sales; TROY WOOLLEY, VP, marketing

www.medicaldesignandoutsourcing.com

2019 rank: 90 Employees: 614 Key personnel: TORBJÖRN KRONANDER, CEO & president; MATS FRANZÉN, CFO; MARIE EKSTRÖM, president, imaging IT & EVP, Sectra AB; SIMO PYKÄLISTÖ, president, secure communications & EVP, Sectra AB; JOHAN CARLEGRIM, GM, medical education; GUSTAF SCHWANG, GM, orthopedics; LISA EVERHILL, chief people & brand officer; CLAES LUNDSTRÖM, research director, medical systems; PER ANDERSNÄS, chief information officer; STAFFAN BERGSTROM, senior SVP, imaging IT solutions

11 • 2020

Medical Design & Outsourcing 89

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

RANK COMPANY

R&D SPEND

R&D ranking by percentage of revenues:*

RANK COMPANY

REVENUES ($USD)

R&D SPEND

% OF REVENUES

1

Medtronic

$2,331,000,000

1

Glaukos

$236,984,000

$68,308,000

28.82%

2

Royal Philips

$2,108,949,600

2

NovoCure

$351,318,000

$79,003,000

22.49%

3

Johnson &

$2,028,000,000

3

Dexcom

$1,476,000,000

$273,500,000

18.53%

4

Siemens Healthineers

$1,502,234,800

4

Cardiovascular Systems

$236,545,000

$43,355,000

18.33%

5

Abbott (medical device segment)

$1,200,000,000

5

AtriCure

$230,807,000

$41,230,000

17.86%

6

Boston Scientific

$1,174,000,000

6

Insulet

7

GE Healthcare (General Electric)

$1,000,000,000

7

Edwards Lifesciences

8

Stryker

$971,000,000

8

Nevro

device Johnson (medical segment)

$738,200,000

$129,700,000

17.57%

$4,348,000,000

$752,700,000

17.31%

$390,255,000

$59,017,000

15.12%

9

Edwards Lifesciences

$752,700,000

9

Fujifilm Holdings (healthcare only) $4,600,000,000

$663,700,000

14.43%

10

Fujifilm Holdings (healthcare only)

$663,700,000

10

BioMerieux

$2,994,171,120

$418,991,420

13.99%

11

Alcon

$656,000,000

11

LivaNova

$1,084,170,000

$149,889,000

13.83%

12

Baxter

$595,000,000

12

Cochlear

$940,118,960

$128,681,520

13.69%

13

Intuitive Surgical

$557,300,000

13

Accuray

$382,928,000

$49,784,000

13.00%

14

Olympus (medical business)

$550,220,143

14

Bio-Rad

$2,311,659,000

$292,710,000

12.66%

15

Terumo

$464,135,021

15

Endologix

$143,370,000

$18,104,000

12.63%

16

Zimmer Biomet

$449,300,000

16

Intuitive Surgical

$4,478,500,000

$557,300,000

12.44%

17

BioMerieux

$418,991,420

17

Carl Zeiss Meditec

$1,633,540,420

$193,992,020

11.88%

18

B. Braun Melsungen

$362,125,900

18

Natus Medical

$495,175,000

$58,733,000

11.86%

19

EssilorLuxottica

$325,745,400

19

Abiomed

$840,883,000

$98,759,000

20

Bio-Rad

$292,710,000

20

Boston Scientific

$10,735,000,000 $1,174,000,000

10.94%

21

Smith+Nephew

$292,000,000

21

Dräger (medical business)

$1,949,770,920

$206,193,480

10.58%

22

Varian Medical Systems

$280,600,000

22

Elekta

$1,543,380,830

$155,701,662

10.09%

23

Dexcom

$273,500,000

23

Masimo

$937,837,000

$93,295,000

9.95%

24

Hologic

$222,500,000

24

Abbott (medical device segment)

$12,239,000,000 $1,200,000,000

9.80%

25

Dräger (medical business)

$206,193,480

25

Royal Philips

$21,808,150,800 $2,108,949,600

9.67%

26

ResMed

$201,946,000

26

SeaSpine

$159,083,000

$15,125,000

9.51%

27

Carl Zeiss Meditec

$193,992,020

27

Fisher & Paykel Healthcare

$832,904,670

$78,103,350

9.38%

28

Fresenius Medical Care

$188,059,200

28

Olympus (medical business)

$5,887,149,147

$550,220,143

9.35%

29

Bruker

$187,700,000

29

Siemens Healthineers

$16,186,524,000 $1,502,234,800

9.28%

30

Sonova

$168,058,770

30

Bruker

$2,072,600,000

$187,700,000

9.06%

31

Demant

$167,908,490

31

Varian Medical Systems

$3,168,200,000

$280,600,000

8.86%

32

Align Technology

$157,400,000

32

Alcon

$7,508,000,000

$656,000,000

8.74%

33

Elekta

$155,701,662

33

CryoLife

$276,222,000

$22,960,000

8.31%

34

LivaNova

$149,889,000

34

Medtronic

35

Hillrom

$136,500,000

35

Terumo

36

Getinge

$133,292,461

36

Wright Medical

37

Dentsply Sirona

$131,300,000

37

Johnson & Johnson

38

Insulet

$129,700,000

38

Orthofix

$459,955,000

$34,637,000

7.53%

39

Cochlear

$128,681,520

39

Demant

$2,240,678,830

$167,908,490

7.49%

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

90

Medical Design & Outsourcing

11 • 2020

$28,913,000,000 $2,331,000,000 (medical device segment)

11.74%

8.06%

$5,768,638,782

$464,135,021

8.05%

$920,900,000

$74,085,000

8.04%

$25,963,000,000 $2,028,000,000

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

www.medicaldesignandoutsourcing.com

7.81%

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

RANK COMPANY 40

R&D ranking by percentage of revenues:*

R&D SPEND

RANK COMPANY

REVENUES ($USD)

R&D SPEND

% OF REVENUES

$2,957,013,000

$201,946,000

6.83%

Teleflex

$113,857,000

40

ResMed

41

Coloplast

$106,142,153

41

$994,852,000

$65,600,000

6.59%

Abiomed

Merit Medical Systems

42

$98,759,000

42

$2,406,796,000

$157,400,000

6.54%

43

Masimo

Align Technology

$93,295,000

Stryker

$14,884,000,000

$971,000,000

6.52%

44

Nipro (medical segment)

43

$89,157,953

44

$1,168,070,000

$72,380,000

6.20%

45

Cooper Cos.

NuVasive

$86,700,000

45

$1,172,102,400

$69,154,042

5.90%

Paul Hartmann

Smiths Medical (Smiths Group)

46

$80,149,040

46

$3,776,400,000

$222,500,000

5.89%

47

NovoCure

Hologic

$79,003,000

47

$2,935,392,976

$168,058,770

5.73%

48

Fisher & Paykel Healthcare

Sonova

$78,103,350

48

$5,138,000,000

$292,000,000

5.68%

Wright Medical

Smith+Nephew

49

$74,085,000

49

$7,982,200,000

$449,300,000

5.63%

50

NuVasive

Zimmer Biomet

$72,380,000

50

Surgalign (previously RTI Surgical)

$308,384,000

$16,836,000

5.46%

$697,600,000

$37,700,000

5.40%

$11,362,000,000

$595,000,000

5.24%

51

Smiths Medical (Smiths Group)

$69,154,042

51

Glaukos

Avanos Medical

52

$68,308,000

52

53

Merit Medical Systems

Baxter

$65,600,000

GE Healthcare (General Electric) $19,942,000,000 $1,000,000,000

5.01%

54

Steris

53

$65,546,000

54

$955,097,000

$45,460,000

4.76%

Nihon Kohden

Conmed

55

$61,740,965

55

$2,807,386,580

$133,292,461

4.75%

56

Nevro

Getinge

$59,017,000

56

$2,881,000,000

$136,500,000

4.74%

57

Natus Medical

Hillrom

$58,733,000

57

$4,035,437,000

$188,059,200

4.66%

58

ConvaTec

Fresenius Medical Care

$53,800,000

58

$686,264,000

$31,326,000

4.56%

Accuray

Össur

59

$49,784,000

59

$2,595,362,000

$113,857,000

4.39%

60

ICU Medical

Teleflex

$48,611,000

60

B. Braun Melsungen

$8,363,373,220

$362,125,900

4.33%

61

Integer

$46,500,000

61

$1,266,208,000

$48,611,000

3.84%

Conmed

ICU Medical

62

$45,460,000

62

$2,780,084,854

$106,142,153

3.82%

63

Cardiovascular Systems

Coloplast

$43,355,000

63

$1,258,094,000

$46,500,000

3.70%

64

AtriCure

Integer

$41,230,000

64

$422,769,591

$15,441,584

3.65%

Avanos Medical

Ambu

65

$37,700,000

65

$1,697,000,550

$61,740,965

3.64%

66

Orthofix

Nihon Kohden

$34,637,000

66

$2,447,903,920

$80,149,040

3.27%

67

Cantel Medical

Paul Hartmann

$32,372,000

67

$2,653,400,000

$86,700,000

3.27%

Össur

Cooper Cos.

68

$31,326,000

68

$4,029,200,000

$131,300,000

3.26%

Haemonetics

Dentsply Sirona

69

$30,883,000

69

$1,016,048,000

$32,372,000

3.19%

70

CryoLife

Cantel Medical

$22,960,000

70

$988,479,000

$30,883,000

3.12%

71

Endologix

Haemonetics

$18,104,000

71

$1,827,200,000

$53,800,000

2.94%

Surgalign (previously RTI Surgical)

ConvaTec

72

$16,836,000

72

Nipro (medical segment)

$3,079,866,080

$89,157,953

2.89%

$537,231,701

$12,997,615

2.42%

73

Invacare

$15,836,000

73

74

Ambu

JMS Co.

$15,441,584

74

$3,030,895,000

$65,546,000

2.16%

SeaSpine

Steris

75

$15,125,000

75

$347,685,640

$7,276,100

2.09%

76

JMS Co.

Medacta

$12,997,615

76

$927,964,000

$15,836,000

1.71%

77

Medacta

Invacare

$7,276,100

77

EssilorLuxottica

$19,466,366,000

$325,745,400

1.67%

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

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

www.medicaldesignandoutsourcing.com

11 • 2020

Medical Design & Outsourcing

91

COMPANIES RANKED BY EMPLOYMENT

Revenues per employee

O

ne way to measure a company’s efficiency is to analyze how much revenue each of its employees brings in on average. For each company we found had reported its total medical device employees in its most recent reported fiscal year, we divided its revenues by the number of workers.

Hologic topped the list this year, with $649,536 in sales for every one of its 5,814 employees. While the company’s revenue per employee is up 26.2% yearover-year, it employed 438 fewer people than last year, a decrease in its workforce of 7%. The company also added $558.5 million in sales in its 2019 fiscal year.

COMPANY

EMPLOYEES (2020)

REVENUES (2020)

REVS/EMPLOYEE (2020)

± Y/Y (%)

150,000

$19,466,366,000

$129,776

52.54%

Hologic

5,814

$3,776,400,000

$649,536

26.20%

Integra Lifesciences

4,000

$1,517,557,000

$379,389

15.95%

Insulet

1,350

$738,200,000

$546,815

13.37%

Teleflex

14,400

$2,595,362,000

$180,233

11.89%

EssilorLuxottica

Haemonetics

3,004

$988,479,000

$329,054

9.37%

Dentsply Sirona

15,200

$4,029,200,000

$265,079

9.06%

Natus Medical

1,484

$495,175,000

$333,676

8.67%

Avanos Medical

4,700

$697,600,000

$148,426

6.94%

Edwards Lifesciences

14,000

$4,348,000,000

$310,571

6.78%

ResMed

7,770

$2,957,013,000

$380,568

5.71%

Wright Medical

3,030

$920,900,000

$303,927

5.19%

Cooper Cos.

12,000

$2,653,400,000

$221,117

4.76%

Dexcom

3,826

$1,476,000,000

$385,781

4.71%

935

$308,384,000

$329,822

4.63%

Conmed

3,300

$955,097,000

$289,423

4.37%

Bio-Rad

8,000

$2,311,659,000

$288,957

4.25%

Bruker

7,230

$2,072,600,000

$286,667

3.89%

386

$159,083,000

$412,132

3.72%

Integer

8,250

$1,258,094,000

$152,496

3.55%

Owens & Minor

15,400

$9,210,939,000

$598,113

3.35%

ConvaTec

9,100

$1,827,200,000

$200,791

3.03%

Invacare

3,900

$927,964,000

$237,939

2.78%

Merit Medical Systems

6,355

$994,852,000

$156,546

2.56%

Masimo

1,600

$937,837,000

$586,148

2.44%

Surgalign (previously RTI Surgical)

SeaSpine

92

The biggest increase in revenue per employee was logged by EssilorLuxottica, at $129,776, a 52.5% increase from the previous year, when the company made sales worth $85,075 for every one of its 150,000 employees. Although EssilorLuxottica employed the same number of workers, it logged $6.7 billion more in sales because 2019 was the first full year that the Essilor and Luxottica businesses were combined.

Cochlear saw the biggest year-over-year decrease in revenue per employee at -35%. The implantable hearing device maker earned significantly less in sales, posting $506 million less than the previous year, while employing the same number of workers.

Medical Design & Outsourcing

11 • 2020

www.medicaldesignandoutsourcing.com

COMPANIES RANKED BY EMPLOYMENT

COMPANY

EMPLOYEES (2020)

REVENUES (2020)

REVS/EMPLOYEE (2020)

± Y/Y (%)

Baxter

50,000

$11,362,000,000

$227,240

2.11%

B. Braun Melsungen

64,000

$8,363,373,220

$130,678

2.05%

Carl Zeiss Meditec

3,232

$1,633,540,420

$505,427

1.78%

Olympus (medical business)

20,901

$5,887,149,147

$281,668

1.22%

Hillrom

10,000

$2,881,000,000

$288,100

1.16%

Nihon Kohden

5,357

$1,697,000,550

$316,782

1.10%

Sonova

15,184

$2,935,392,976

$193,321

0.90%

Getinge

10,538

$2,807,386,580

$266,406

0.76%

Henry Schein

19,000

$9,985,803,000

$525,569

0.64%

Steris

13,000

$3,030,895,000

$233,146

0.56%

Össur

3,500

$686,264,000

$196,075

-0.82%

Endologix

488

$143,370,000

$293,791

-0.86%

Stryker

40,000

$14,884,000,000

$372,100

-1.50%

NuVasive

2,800

$1,168,070,000

$417,168

-1.55%

Align Technology

14,530

$2,406,796,000

$165,643

-1.78%

LivaNova

4,000

$1,084,170,000

$271,043

-2.06%

Royal Philips

80,495

$21,808,150,800

$270,926

-2.07%

BioMerieux

12,000

$2,994,171,120

$249,514

-2.32%

Abiomed

1,536

$840,883,000

$547,450

-2.45%

AtriCure

730

$230,807,000

$316,174

-2.78%

Coloplast

12,250

$2,780,084,854

$226,946

-2.84%

Boston Scientific

36,000

$10,735,000,000

$298,194

-2.86%

614

$150,966,133

$245,873

-3.07%

Demant

15,352

$2,240,678,830

$145,954

-3.38%

Terumo

26,438

$5,768,638,782

$218,195

-3.56%

CryoLife

1,200

$276,222,000

$230,185

-3.67%

Zimmer Biomet

19,900

$7,982,200,000

$401,116

-3.93%

Smith+Nephew

17,500

$5,138,000,000

$293,600

-4.21%

Straumann

7,200

$1,606,344,973

$223,103

-4.69%

600

$236,984,000

$394,973

-4.79%

5,081

$832,904,670

$163,925

-4.82%

Sectra (Imaging IT division)

Glaukos Fisher & Paykel Healthcare Nevro

853

$390,255,000

$457,509

-5.02%

Medtronic

90,000

$28,913,000,000

$321,256

-5.38%

Siemens Healthineers

54,300

$16,186,524,000

$298,094

-6.05%

Orthofix

1,055

$459,955,000

$435,976

-8.19%

ICU Medical

8,000

$1,266,208,000

$158,276

-8.43%

Elekta

4,117

$1,543,380,830

$374,880

-8.63%

Intuitive Surgical

7,326

$4,478,500,000

$611,316

-9.28%

Ambu

3,108

$422,769,591

$136,026

-10.63%

www.medicaldesignandoutsourcing.com

11 • 2020

Medical Design & Outsourcing

93

COMPANIES RANKED BY EMPLOYMENT

COMPANY

EMPLOYEES (2020)

REVENUES (2020)

REVS/EMPLOYEE (2020)

Varian Medical Systems

10,000

$3,168,200,000

$316,820

-22.14%

Cochlear

4,000

$940,118,960

$235,030

-34.99%

Fresenius Medical Care

30,230

$4,035,437,000

$133,491

n/a

3M Co. (healthcare segment)

13,000

$7,431,000,000

$571,615

n/a

Medline Industries

27,000

$13,900,000,000

$514,815

n/a

NovoCure

782

$351,318,000

$449,256

n/a

Accuray

932

$382,928,000

$410,867

n/a

GE Healthcare (General Electric)

50,000

$19,942,000,000

$398,840

n/a

Alcon

20,000

$7,508,000,000

$375,400

n/a

Medacta

1,101

$347,685,640

$315,791

n/a

779

$236,545,000

$303,652

n/a

3,669

$1,016,048,000

$276,928

n/a

Cardiovascular Systems Cantel Medical Becton,

segment) Dickinson (medical

34,000

$8,680,000,000

$255,294

n/a

Omron Healthcare

4,238

$1,027,325,261

$242,408

n/a

Paul Hartmann

11,096

$2,447,903,920

$220,611

n/a

Cook Medical

10,123

$2,200,000,000

$217,327

n/a

GN Hearing

6,275

$952,131,089

$151,734

n/a

Smiths Medical (Smiths Group)

8,050

$1,172,102,400

$145,603

n/a

Nipro (medical segment)

25,099

$3,079,866,080

$122,709

n/a

Amplifon

17,000

$1,938,912,740

$114,054

n/a

Fujifilm Holdings (healthcare only)

73,906

$4,600,000,000

$62,241

n/a

Hirers and firers HERE’S A LOOK at the companies that grew their workforce the most — and the firms with the deepest cuts to headcount:

COMPANY Varian Medical Systems

Medical Design & Outsourcing

11 • 2020

EMPLOYEES (2020)

EMPLOYEES (2019)

±Y/Y (%)

10,000

7,174

39.39%

Glaukos

600

437

37.30%

Dexcom

3,826

2,800

36.64%

Intuitive Surgical

7,326

5,527

32.55%

Align Technology

14,530

11,660

24.61%

Straumann

7,200

5,954

20.93%

Fisher & Paykel Healthcare

5,081

4,305

18.03%

730

620

17.74%

Insulet

1,350

1,169

15.48%

Ambu

3,108

2,712

14.60%

Össur

3,500

3,100

12.90%

Boston Scientific

36,000

32,000

12.50%

AtriCure

94

± Y/Y (%)

www.medicaldesignandoutsourcing.com

COMPANIES RANKED BY EMPLOYMENT

COMPANY

EMPLOYEES (2020)

EMPLOYEES (2019)

±Y/Y (%)

COMPANY

EMPLOYEES (2020)

EMPLOYEES (2019)

±Y/Y (%)

614

546

12.45%

Integer

8,250

8,250

0.00%

Abiomed

1,536

1,371

12.04%

Avanos Medical

4,700

4,700

0.00%

Stryker

40,000

36,000

11.11%

EssilorLuxottica

150,000

150,000

0.00%

Orthofix

1,055

954

10.59%

ICU Medical

8,000

8,100

-1.23%

Terumo

26,438

24,000

10.16%

Bio-Rad

8,000

8,260

-3.15%

Merit Medical Systems

6,355

5,783

9.89%

ConvaTec

9,100

9,400

-3.19%

Coloplast

12,250

11,155

9.82%

Teleflex

14,400

15,200

-5.26%

Edwards Lifesciences

14,000

12,800

9.38%

Haemonetics

3,004

3,216

-6.59%

Smith+Nephew

17,500

16,000

9.38%

Hologic

5,814

6,252

-7.01%

CryoLife

1,200

1,100

9.09%

Invacare

3,900

4,200

-7.14%

Siemens Healthineers

54,300

50,000

8.60%

Dentsply Sirona

15,200

16,400

-7.32%

Elekta

4,117

3,800

8.34%

Endologix

488

528

-7.58%

Steris

13,000

12,000

8.33%

Owens & Minor

15,400

17,000

-9.41%

NuVasive

2,800

2,600

7.69%

Integra Lifesciences

4,000

4,500

-11.11%

ResMed

7,770

7,240

7.32%

Natus Medical

1,484

1,729

-14.17%

BioMerieux

12,000

11,200

7.14%

Fresenius Medical Care

30,230

112,658

n/a

386

361

6.93%

3M Co. (healthcare segment)

13,000

n/a

n/a

27,000

n/a

n/a

Sectra (Imaging IT division)

SeaSpine Masimo

1,600

1,500

6.67%

Medline Industries

Conmed

3,300

3,100

6.45%

NovoCure

782

n/a

n/a

853

804

6.09%

Accuray

932

n/a

n/a

3,232

3,048

6.04%

GE Healthcare (General Electric)

50,000

n/a

n/a

20,000

n/a

n/a

1,101

n/a

n/a

779

n/a

n/a

Nevro Carl Zeiss Meditec Henry Schein

19,000

18,000

5.56%

Alcon

Bruker

7,230

6,870

5.24%

Medacta

Demant

15,352

14,614

5.05%

Cardiovascular Systems

935

891

4.94%

Cantel Medical

Zimmer Biomet

19,900

19,000

4.74%

segment) Becton, Dickinson (medical

Wright Medical

3,030

2,894

4.70%

Royal Philips

80,495

77,400

Surgalign (previously RTI Surgical)

3,669

n/a

n/a

34,000

n/a

n/a

Omron Healthcare

4,238

n/a

n/a

4.00%

Paul Hartmann

11,096

n/a

n/a

Nihon Kohden

5,357

5,169

3.64%

Cook Medical

10,123

n/a

n/a

Sonova

15,184

14,740

3.01%

GN Hearing

6,275

n/a

n/a

Olympus (medical business)

20,901

20,646

1.24%

Smiths Medical (Smiths Group)

8,050

n/a

n/a

B. Braun Melsungen

64,000

63,751

0.39%

Nipro (medical segment)

25,099

n/a

n/a

Getinge

10,538

10,515

0.22%

Amplifon

17,000

n/a

n/a

Medtronic

90,000

90,000

0.00%

Fujifilm Holdings (healthcare only)

73,906

n/a

n/a

Hillrom

10,000

10,000

0.00%

LivaNova

4,000

4,000

0.00%

Cochlear

4,000

4,000

0.00%

Baxter

50,000

50,000

0.00%

Cooper Cos.

12,000

12,000

0.00%

www.medicaldesignandoutsourcing.com

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GEOGRAPHIC HEATMAPS

Where are the headquarters?

T

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

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Medtech companies that sell products in the European Union have a major deadline looming — one that’s already been put off once.

How major medtech companies are responding to the looming

N A N C Y C R OT T I M A N A G I N G E DITO R

he EU Medical Device Regulation (MDR) will replace the current EU Medical Device Directive (MDD) on May 26, 2021. Companies whose products are approved for sale in Europe must decide if they want to go through the process to bring those products into compliance with EU MDR. All of this would have been timeconsuming and costly, but straightforward if it weren’t for a couple of factors: the COVID-19 pandemic and the more stringent requirements on the companies that perform the audits for each device, also known as notified bodies.

Each company seeking designation as a notified body must meet certain requirements. Because the MDR is more complex and more expensive to carry out, www.medicaldesignandoutsourcing.com

many smaller notified bodies have decided to drop out of the process, according to Gary Slack, SVP of medical devices at BSI, the EU’s largest notified body.

As of October 21, 2020, the number of notified bodies had dropped from 80 to 17, with 48 additional companies seeking notified body designation. (The 17 figure includes two listings for BSI, one for its UK headquarters and a second for its office in Amsterdam. Due to Brexit, BSI will officially cease being a notified body in the UK on December 31, 2020.)

“The bar has been raised. There’s no doubt about it. The regulatory requirements under the MDR are higher than they were under the Medical Device Directive,” Slack told Medical Design & Outsourcing in an interview. “There is a requirement to upskill and increase the competence.”

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EU MDR

The notified body fallout has left some medtech companies scrambling to find different ones. And the pandemic has put pressure on all sides as they try to complete their work toward MDR: Virtual audits have replaced in-person ones; many workers are working from home; and some have been unable to work.

The effects of the COVID-19 pandemic convinced the European Parliament to vote in April 2020 to postpone the original EU MDR deadline by one year. But the parliament held fast to the May 26, 2025, final transition date to the new system.

Some companies were counting on the delay that came in April and had eased up on MDR preparations, while others kept plugging away, according to Slack. Major companies are more likely to be ready for the new deadline, he added.

“I think the cadence of their product submissions is pretty well-established for most of the larger companies. We do an awful lot with the top 100 companies,” Slack said. “I think many of them have already set out their cadence over the next 2 or 3 years…

“The fact is that the MDR is a challenge,” he added. “We are very supportive of the MDR, but it’s a significant amount of work.

There are not-insignificant costs to go through it.”

Most of the larger companies have been evaluating which of their MDD-certified devices are worth seeking MDR certification for in terms of inventory, sales and profits. Some

The fact is that the MDR is a challenge. We are very supportive of the MDR, but it's a significant amount of work. There are not-insignificant costs to go through it. have shared that the cost of compliance, including expansion of regulatory teams, has reached “several hundred million dollars,” Slack said.

“What we have seen is most of the bigger companies are having a big inventory rationalization,” he added.

“Some of the big clients have tens of thousands of SKUs, so it’s a good opportunity to reduce it.”

For medtech companies themselves, the transition to EU MDR will result in potential changes to regulatory documents, processes, lifecycle requirements and labelling, according to Johnson & Johnson spokesperson Mindy Tinsley, who outlined the major steps companies have to take: •

•

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Bring quality management systems into compliance and have them audited by an EU MDR-certified notified body.

Parallel to that, assess and update the technical documentation supporting each product and, depending on the product’s class, have it assessed by a notified body. www.medicaldesignandoutsourcing.com

•

Ensure continuity in the supply chain, which will be affected by labelling requirements and the need for implant cards — device information cards that companies must supply to patients who have been implanted with their devices or systems.

Overall, Tinsley said, EU MDR touches every step in the product lifecycle.

Smith+Nephew started working toward MDR compliance in 2017, shortly after EU officials announced the regulatory upgrade, according to Melissa Guerdan, chief quality and regulatory affairs officer.

The London-based company formed a large cross-functional team comprised of regulatory, R&D, commercial, quality and manufacturing employees to move its CE-Marked devices toward compliance with the new requirements. The company has also tasked operations team members with supply-chain planning in terms of new labels that MDR-certified products will need. The process has been “truly, truly touching almost all areas of our company,” Guerdan said in an interview with MDO. “While there has been a contraction of the available resource of notified bodies, we have seen continuing positive interactions with each of our notified bodies (that) have seen resource constraints,” she added. “And so, our approach has been to be very proactive with them and helping them understand our plan for submissions so that they can plan their work a little better as well.”

One of the key MDR requirements is having sufficient clinical evidence for maintaining a particular product under the new regulation, according to Manoja Ranawake, VP of regulatory affairs for EMEA for Becton Dickinson (BD).

“There are a number of reasons for potentially phasing out a product, including the introduction of enhanced/ new technology or low market demand for a product,” Ranawake added in an email to MDO. “Any decision to invest in a clinical trial or other means to obtain more robust clinical evidence has to be considered against all of the abovementioned reasons.”

BD had nearly completed its compliance work when the European Parliament announced the MDR postponement, but that doesn’t mean the process was easy. New Jersey–

EU MDR

based BD is a very large company that has three segments and nine business units, and its notified bodies are headquartered in the EU. To ensure consistency across the organization, BD established an EU-based “center of excellence” to implement MDR, Ranawake explained. Its EU and U.S. teams regularly engage with notified bodies to ensure their understanding of the new regulation is in sync.

BD also works with AdvaMed, MedTech Europe other trade associations and their members to “help ensure an aligned approach for industry,” Ranawake said. “Based on these efforts, we develop internal guidance and policy documents, which help the business to implement the changes required under MDR and to remain compliant on an ongoing basis.”

One of the biggest challenges has been a lack of guidance documents available to industry, according to Brandi

Panteleon, director of regulatory affairs and quality assurance for Medline Europe.

“Under the MDD, we had the MEDDEV guidance document. However, these documents have not been updated to cover the MDR requirements,” Panteleon told MDO in an email. “To overcome the lack of guidance documents, our regulatory team participates with Medtech Europe to gain knowledge from industry. They have been an engaged and helpful resource for us. Unfortunately, the training courses that were originally planned by other ... groups have been cancelled due to COVID-19.”

Aside from the lack of guidance, Medline has carried out a fairly simple decision-making process when it comes to seeking MDR certification for approved devices.

“We estimated how much it would cost to update each file for MDR compliance and then compared it to

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both current and anticipated business,” Panteleon said. “We took the opportunity to evaluate our product portfolio carefully to assure that we would only spend valuable time and resources updating technical files to meet the MDR regulations if doing so made good business sense.”

J&J’s Tinsley added that it will take years to accomplish all the changes.

“Because we have a wide portfolio of medical devices, Johnson & Johnson Medical Devices will have both MDDcompliant and MDR-compliant devices on the market during the transition period,” Tinsley said. “This transition phase and the additional transition provisions, like continued validity of MDD CE certificates during the transition period, will help minimize disruption and ensure a smooth transition while allowing patients to have access to the medical technologies they need.”

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AUTOMATION

4 reasons you need automation for your medtech manufacturing Today’s automation capabilities are helping manufacturers improve consistency, quality and delivery, while also reducing costs.

Image courtesy of Trelleborg Healthcare & Medical

F

or a variety of reasons — quality, delivery, cost and safety — medical device component manufacturers are increasingly adding automation to their processes, especially when it comes to the molding of silicone and other materials.

Silicone’s versatility and biocompatibility make it the material of choice for many medical devices, and automation is key to the silicone molding process — delivering consistency and highvolume output for the applications that need it.

Here are four reasons you should consider automation for your operation: 1. Enhanced quality Automation helps overcome potential manufacturing issues, such as short shots (underfilling the cavity), voids in parts due to air trapped in the cavity, and parts that are out of tolerance ­— either too large or too small. Automated manufacturing lines can be carefully calibrated to produce parts with amazing accuracy and speed, and to minimize the possibility of distortion and tearing as parts are removed from molds.

Automated manufacturing is the first step toward Industry 4.0, the Industrial Internet of Things (IIoT). Sensors located on critical production equipment alert operators in real time to even fractional changes in critical processing parameters.

These alerts prevent the manufacture of hundreds or, in some cases, thousands of incorrect parts.

Today, alerts prompt human intervention to diagnose and fix the problem. Soon, sensors will notify the equipment’s programmable logic controller, which will make the necessary adjustment without human involvement. In the future, even more sophisticated systems will employ preventative maintenance to analyze trends that indicate something is likely to slip out of spec within minutes or days and make an adjustment before incorrect products are produced.

Companies manufacturing products at quantities too low to justify full automation can still take advantage of this technology. For example, product inspection and verification can be automated using cameras or automated pressure tests.

C h r i s Te l l e r s | Tr e l l e b o r g H e a l t h c a r e & Medical |

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2. Delivery improvements A second major reason to add automation to medical device manufacturing is its ability to improve delivery. For example: 11 • 2020

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AUTOMATION

•

•

•

Automated manufacturing has a constant cycle time. It does not slow down due to worker fatigue or distraction.

It allows shop-floor personnel to focus on process improvement and efficiency because they’re freed from repetitive tasks.

It can feed into analytical systems, such as overall equipment effectiveness (OEE).

OEE measures availability, performance, and quality. Thus, an OEE score of 100% represents perfect manufacturing — manufacturing only good parts, as fast as possible, with no downtime.

OEE dashboards can be created or purchased and give manufacturing engineers and others involved in manufacturing, an accurate way to gauge how an automated cell is performing. Having real-time OEE enables those with an in-depth knowledge of the manufacturing process to identify the root cause of deviations and slowdowns.

OEE and other analytic systems can also be used on semi-automated lines, with adjustments made for the type of downtime expected on such a line.

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3. Increased scalability Automated manufacturing makes financial sense for many processes used in medical device manufacturing because it can usually run faster than manual operations and has very little downtime. Maintenance, however, plays a vital role in the long-term success of any automation project, and it requires a robust and well-trained maintenance team.

The increased throughput enabled by automation can be significant, even when upgrading from a semi-automated cell to a fully automated one. For example, the number of parts produced per hour can increase by double, triple or more.

4. Safety improvements If needed, manual operations include multiple fail-safes to protect operators and so are generally safe. However, automation lessens the need for manual intervention during the manufacturing process and so is inherently safer than non-automated processes.

Even simple automation, such as a conveyor belt to transport heavy objects 104

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ISO

or boxes, can prevent a significant number of back injuries.

When evaluating molding partners, manufacturers should consider the suppliersâ&#x20AC;&#x2122; existing and planned automation capabilities, capacity,

process. So, medical device manufacturers should do their research and ask questions. The upfront time spent evaluating suppliers will pay dividends later.

Automated manufacturing is the first step toward Industry 4.0, the industrial Internet of Things (IIoT) in-house technical expertise, quality performance, certiďŹ cations and ability to add value to the product and the development process.

Selecting the right molding partner with experience in automation can improve production efďŹ ciencies and quality while reducing the total cost of ownership and reducing the time to market, especially when that partner is engaged early in the development

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DRUG DELIVERY

What you need to know about analytical testing for drug-device combinations Pharmaceutical manufacturers need to understand the compatibility and performance of the primary packaging system with both the drug and its delivery system.

A

Jennifer Riter | West Pharmaceutical Services |

s more pharmaceutical manufacturers develop combination products, they identify new and complex interactions among packaging components and delivery systems. Understanding this interplay is critical to developing a successful drug-device combination.

Different types and classes of drugs warrant varying approaches; for example, there are specific expectations around particulate in biologics due to aggregates, sub-visible and visible particles, potentially posing a risk to patient safety and product efficacy. For any drug, creating a risk-based testing strategy early in development is a key to ensuring success of a combination product.

This includes developing and applying a strategy for component and system qualification, which is critical to ensuring drug product quality, safety and efficacy. Not only do manufacturers need to understand the chemical compatibility of any given drug with its packaging components, but also how physical and functional aspects of packaging components and the device all come together and function as a system.

Key areas of consideration for analytical testing 1. Compendia assessment is typical testing required of materials to be used in the system, such as glass, plastic and elastomers. Because a material may meet compendia compliance doesnâ&#x20AC;&#x2122;t mean itâ&#x20AC;&#x2122;s qualified for its intended use.

2. Biocompatibility is required testing of combination products and their components, including cytotoxicity, sensitization, irritation and acute systemic toxicity.

Image courtesy of West Pharmaceutical Services

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DRUG DELIVERY

3. Extractables and leachables analysis is an essential part of qualifying packaging and delivery systems during drug development, as it’s well-established that packaging materials can contribute leachables to drug products. Along with primary and secondary packaging materials, interim storage containers and processing equipment must be evaluated for compounds that may leach into drug products to maintain the drug’s quality, sterility and efficacy.

4. Particle analysis is critical as particles can have a dangerous impact on drugs. They may be visible or subvisible and categorized as intrinsic, extrinsic or inherent.

Intrinsic particles may come from processing or primary packaging materials, including stainless steel components, gaskets, packaging glass, rubber components or fluid transport tubing. Extrinsic particles

are foreign to the manufacturing process, such as hair or nonprocess-related fibers. Inherent particles are associated with specific drug product formulations such as suspensions, emulsions or aggregates. Specific expectations around particulate in biologics due to aggregates, sub-visible and visible particles pose a risk to patient safety and product efficacy.

5. Container closure integrity (CCI) is the ability of a packaging system to prevent product loss. It blocks the ingress of microorganisms and limits entry of detrimental gases or other substances over the shelf life and lifecycle of the drug product — thus ensuring that the drug product meets safety and quality standards. CCI failures can include leakage, loss of product, increased concentration, contamination and pressurization issues.

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6. Performance analysis and essential performance requirements (EPRs) are required in devices and combination products. The FDA defines EPRs as a subset of design input requirements necessary for a device constituent to safely and effectively achieve the combination product’s intended use. EPRs should consider the desired level of reliability of the product and the level of risk associated with failure and should be evaluated during stability testing. Drug-filled containers like syringes, vials and cartridges typically have interfaces resulting from components such as pistons and glass barrels. For any container, these interfaces must be understood thoroughly, with fundamental performance aspects substantiated and demonstrated, often through what may appear very rudimentary tests.

Opportunity for device manufacturers Device manufacturers who offer analytical lab testing and other contract services are in a unique position to better serve customers throughout a product’s development. This includes an ability to help customers scale up combination product device and assembly, contract-manufacture parts of the device, and walk customers through development, including what needs to be tested and performing the testing for the drug manufacturer.

Operating as a one-stop-shop can help customers bring combination products to market more efficiently. This isn’t to say contract manufacturers shouldn’t have partners for certain elements of the process — in fact, it’s common and strategic to do so as a means of closing any gaps (for example, West partners with other companies for filling capabilities) and can be an integral part of a cohesive and integrated solutions approach.

Such an approach can provide seamless customer engagement and collaboration early in the development process. Device manufacturers can help guide partners and establish a roadmap for each phase of development and lifecycle management that continues through postcommercialization. This can even include human factor studies — formative followed by summative, prior to clinical trials — helping to manage processes for customers and the devices under development.

It also involves working with engineers to ensure they’re looking at materials appropriately, being involved in characterization and scaling, and deciding on the right primary packaging. With medical devices in the past, the drug product wasn’t always taken into consideration because it’s developed separately from the device. With combination products today, it’s essential to ensure all materials, such as primary packaging and fluid path materials such as tubing, are analyzed and tested, as any or all may play a role in the extractable and leachable profile of what may ultimately go into the patient.

Device manufacturers can also test and store products for stability studies and assist drug manufacturers to assess the delivery system for commercialization.

Key takeaway Combination products are still relatively new and rapidly evolving in terms of developmental requirements, patient needs and regulatory guidelines. Manufacturers must be aware of the changing landscape, technologies and guidelines to steer partners and customers in the right direction, inform what they need to be thinking of during all critical development phases, and ensure appropriate and thorough analytical testing is executed throughout a product’s lifecycle.

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IP ISSUES

Why 'how' could be as important as 'what' for your medtech patents Christopher Johns | Finnegan |

The recent Federal Circuit case American Axle Manufacturing v. Neapco Holdings LLC points out potential pitfalls for medical device manufacturers who are not cautious about how certain inventions are claimed in patents.

R

ecent U.S. Supreme Court decisions have made it more difficult to obtain patents.

The courts are now using an “I-know-it-when-I-see-it” test for patent eligibility. This test had largely been confined to computerimplemented inventions and medical diagnostics, but in recent years has infiltrated all areas of patenting.

A recent case illustrates the potential risk to medical device manufacturers because of this shift.

Careful claim drafting, however, can help to avoid the patent eligibility question.

The eligibility test (known as the “Mayo/Alice” test) can be summarized briefly as:

Anthony Del Monaco | Finnegan |

1) Determine whether the patent claims a “judicial exception” to patent eligibility, such as an abstract idea, law of nature or natural phenomenon, and

Eric Raciti | Finnegan | 110

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2) Determine whether the patent claims something “significantly more” than any identified judicial exception.

If this sounds vague to you, you are not alone. The Supreme Court failed to clarify what it meant by “significantly more,” and the lower courts and the U.S. Patent and Trademark Office have increasingly put more technological innovations in the broader “judicial exception” bin.

Most of the recent high-profile Supreme Court cases regarding patent eligibility have dealt with patents claiming concepts or properties of nature or science: software patents implementing the abstract concept of intermediated financial settlement (Alice in 2014) and hedging risk (Bilski in 2010), patents for drug administration requiring the application of a “natural law” to determine whether or not to increase dosage (Mayo in 2013),

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IP ISSUES

or patents for converting binarycoded numbers into binary numbers (Benson in 1972).

On July 31, 2020, the Court of Appeals for the Federal Circuit issued a revised opinion in American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, finding method claims drawn to manufacturing a liner assembly for a driveline system ineligible as requiring the application of a natural law.

Example liners are depicted in Figures 12-14 of the patent:

Illustration courtesy of Finnegan

The claims required, among other things, “tuning a mass and a stiffness of at least one liner” in such a way as to attenuate shell-mode vibrations and bending-mode vibrations of a driveshaft. The control of these characteristics to match a frequency would dampen vibration while the shaft rotates.

The court found that the claims required only “controlling characteristics,” such as mass and stiffness of the liner, to configure it to match a relevant frequency or frequencies. In the mind of the court, the claims didn’t specify how these characteristics would be controlled. The decision found that the claims consisted of a high-level application of Hooke’s law — the equation that describes a relationship between mass, stiffness and the frequency at which an object vibrates.

The patent owner argued that the inventors created improved processes for implementing this natural law to create these liners. The court did not agree. While there may have been some patentable refinements to prior techniques in the application, the court found that the claims didn’t include anything other than an open-ended method of liner tuning to achieve a desired result.

Could this case be a concern for medical device manufacturers? Certainly. The Federal Circuit is the solve court hearing patent appeals and the second-highest court in the country (behind the Supreme Court). Whether or not this decision is reversed, medical device manufacturers would be wise to claim the specific aspects that demonstrate the improvements in their invention and not merely recite them in the broader patent specification. Numerous cases examining claims under the Mayo/Alice framework have found that the claimed elements are the most important aspects for patent eligibility, and this case is no outlier in that respect.

One illustrative example of this need to claim a specific method or mechanism — rather than a result —came earlier this year. In CardioNet LLC v. InfoBionic, Inc., the Federal Circuit found a claim drawn to a cardiac monitor patent eligible.

The claims required, among other things, “variability determination logic to determine a variability in the beat-to-beat timing of a collection of beats” and “relevance determination logic to identify a relevance of” that variability. These claim elements provided multiple technological improvements, including improved fibrillation and flutter detection. While the court looked to the specification to confirm that the improvements were, in fact, fully described improvements, the claims were the focus: “We accept those statements [in the specification] as true and consider them important in our determination that the claims are drawn to a technological improvement.”

Cases like these are instructive to medical device manufacturers generally. When drafting a new application, avoid claiming only the result. Instead, claim the thing or steps that give that result. Here are some examples: An inventor may be able to avoid the patent-eligibility pitfall by claiming the machinery that enables a finer degree of control for her microsurgery system. A medical software developer may find success by claiming the particular algorithm that increases data throughput. A creator of medical-grade thermoplastic may do well to claim the method of creating the material that enables impact, heat and chemical resistance. While these are examples, they demonstrate that medical device companies should take a closer look at their patent claims.

11 • 2020

Medical Design & Outsourcing 113

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How ultrasonics can power infection control in nonwovens

Ultrasonic welders and tooling can cut, seam, and bond a wide variety of nonwoven fabrics with precision and repeatability.

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Creating personal protective equipment using ultrasonic technology and nonwoven materials offers several advantages over sewing, including infection control.

T

he low cost and utility of nonwoven fabrics have made them essential in the global battle to prevent the spread of infection. Whether found in packaged sterile surgical drape kits or personal protective equipment (PPE) such as surgical caps and N95 masks, gowns, scrubs and foot covers, disposable nonwovens provide an effective yet inexpensive barrier against microorganisms and contamination.

Their versatility extends into a host of other products, including hygienic and absorbent products ranging from shields and pads to diapers, underwear and disposable filters.

Experts predict that demand for surgical, medical and hygienic nonwovens will continue to grow steadily for years. Market drivers

To m H o o v e r | Emerson |

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include the hygienic needs of a growing population of older adults, infection-control, and continued advances in nonwovens production, fabric processing and assembly.

The role of ultrasonic technology Ultrasonic applied technology has played a critical role in enabling the rapid growth of nonwovens and boosted its own growth in this market segment.

Similar to ultrasonic technology used in welding rigid plastic parts, ultrasonic welders transmit highfrequency mechanical vibration via tooling through thermoplastic material to create frictional heat.

Depending on the selection of weld parameters and tooling, the frictional heat generated by ultrasonics can be focused and used to:

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• Cut or slit a large roll of nonwoven fabric into narrower strips, with cut edges simultaneously seamed and sealed by the friction.

• Bond two pieces of nonwoven fabric into the finished seam of a garment — such as a surgical gown, or a piece of protective gear, such as a surgical mask or cap.

• “Quilt” multiple layers of nonwoven material into laminated absorbent products, alone for use in some sanitary pads, or together with other absorbents such as the superabsorbent wood/paper fibers sometimes used in disposable diapers.

Tooling includes the horn, which transmits the sonics into the material, and the anvil, which goes beneath or holds the material being processed. The actuator provides the downforce needed to maintain the correct degree of contact to transmit the vibrations from the tooling to the anvil, through the fabric.

Advantages of ultrasonics Because of the speed, reliability and energy-efficiency with which ultrasonic welders complete slitting and seaming, the producers of nonwoven products continue to convert older and more energy-intensive cutting and seaming equipment, such as heat knives, over to ultrasonics.

The ultrasonic welder only consumes power when it is actually slitting or bonding. Since it generates its heat instantly through vibration, there’s no additional energy consumption needed to pre-heat a heat knife and no need to maintain it at the proper operating temperature.

When ultrasonic welding is used to create seams or laminates, it is also exceptionally fast, able to make individual bonds in a fraction of a second. It can also bond continuous seams rapidly for everything from disposable medical garments and surgical face masks and face shields to disposable hygiene products, diapers, gowns, filter media and more. The rapid, strong, and repeatable bonds remain as strong as the parent material. Quick production with a minimum of energy use keeps costs down for disposable absorbent and infection-control products.

Compared to sewing, ultrasonic creates high-strength, high-integrity seams without the need for thread, and without creating mechanical holes in the fabric that can hold and conceal microorganisms or contaminants. It also eliminates the need for adhesives, including the added effort of application, the added time required for set-up and drying and the added risk of exposure to chemical contaminants. Ultrasonic seams are ready for use as soon as they are produced.

Borrowing from other industries Ultrasonic technology for nonwovens continues to evolve and improve, often using new features and capabilities developed for other industries. For example, the latest Branson ultrasonic equipment for nonwovens production incorporates Fieldbus communication capabilities that allow multiple individual systems to link together. This allows the user not only to control the weld parameters for an individual system, but also to monitor the status of an entire process for stronger quality control. www.medicaldesignandoutsourcing.com

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MATERIALS

Why do medical plastics fail?

To avoid premature device failure, it’s essential to understand the types and causes of failure and assess each material’s strengths and weaknesses.

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mproper material choices can cause medical devices to fail. This problem has become worse with the use of aggressive disinfectants to prevent hospitalacquired infections (HAIs). The COVID-19 pandemic has further exacerbated chemical resistance issues as healthcare facilities increase disinfectant use.

There are three general types of plastic failure:

Anna Maria Bertasa | Solvay |

• Mechanical failure occurs when a product is exposed to external forces that are greater than it is designed to handle.

• Thermal failure results from exposure to extreme temperatures.

• Chemical failure affects the strength, flexibility, appearance and weight of plastic components, causing improper physical changes.

Causes of failure Medical device recalls due to material failure can often be traced back to the material selection process. Manufacturers must consider a range of factors, including mechanical, thermal, environmental and electrical.

Also, engineers may rely too heavily on material data sheets, whose listed properties are short-term, singlepoint measurements. There is often no consideration of time, temperature, environment or chemical contact.

Design choices The right design choices can lessen the likelihood of plastic failure in medical devices.

Here are some tips for improving part design:

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• Strive for uniform wall thickness. Uneven wall thicknesses can restrict material flow and greatly increase the likelihood of sink marks, warpage, voids and molded-in stress. If wall thickness must be uneven, design smooth transitions that taper over some distance.

• Avoid sharp corners. Sharp edges, such as the corners of a square hole, produce a part with high levels of molded-in stress that compromise toughness and strength. Adding radii to sharp corners redistributes the stress.

• Choose gate location carefully. Gate location can make or break a design, yet many CAD designers leave that detail to the mold designer. Weld lines, sink marks and warpage patterns are determined by gate location. For a part with both thick and thin areas, the gate should be located in the thick areas. Resin flowing through the thick area retains heat long enough to fill the adjoining thin areas.

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MATERIALS

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Role of manufacturing Even the best designs using appropriate materials can fail if processing guidelines from polymer manufacturers are disregarded. Processing success factors include drying the resin; optimizing mold temperature, fill balance, fill time, and injection and cavity pressure; and testing the molded part under exacting conditions.

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Use draft angles. Draft is the angling of otherwise vertical walls to make clean mold release easier. Draft angles greatly reduce friction between the finished, cooled part and the side of the mold.

Optimize ribs. Ribs can add strength and stiffness while minimizing material consumption. Rib thickness should never exceed the wall thickness. Thick or deep ribs can cause sink marks and filling problems, respectively, which can be resolved by using multiple thinner or shorter ribs.

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Influence of end-use conditions Medical products can fail because of incomplete understanding of enduse requirements. The actual load may be greater than expected or the disinfection protocol may be incompatible with the material.

This second scenario can lead to environmental stress cracking (ESC), a major cause of failure in healthcare applications, which commonly manifests as thin, spiderweb-like cracks called crazing around areas where stresses are concentrated.

Ever-stronger disinfectants have caused cracking of equipment housings within months of deployment.

Subsequent recalls and repairs can be costly and interrupt care delivery.

Only a few specialty polymers for healthcare provide the chemical resistance to withstand these new disinfection procedures. They include polysulfone (PSU), polyphenylsulfone (PPSU), and high-performance polyamide (HPPA), which are replacing lower-performing polycarbonate (PC), acrylonitrile butadiene styrene (ABS) and polybutylene terephthalate (PBT).

Evaluating ESC resistance Evaluating a plastic for ESC resistance begins with an understanding of 118

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ISO

how the part will be used, including exposure to different disinfectants throughout the day to clean the same surface area, or to an excessive concentration of disinfectant because mixing directions were not followed.

Stress can be caused by an external load applied during use or by residual internal stress in the molded part due to processing or part geometry. Evaluation of the finished device should include how stress and reagent interaction could lead to cracking. ASTM D543 is a standardized

method for testing the resistance of plastics to chemical reagents.

Reduce medical plastic failure Working with an experienced material solutions company will help you to better understand exactly how the right material selection can help you design tougher, longer-lasting medical components. Ultimately, careful selection of the right medical plastics for the job is key.

Medical device recalls due to material failure can often be traced back to the material selection process. Manufacturers must consider a range of factors, including mechanical, thermal, environmental and electrical.

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TELEMEDICINE

The future of telehealth, robotics and 5G The emergence of telerobotics and 5G may expand the reach of highly specialized physicians to parts of the world where no treatment options exist.

A D o u g Te a n y | Corindus |

A surgeon works at a CorPath console.

Image courtesy of Corindus.

1962 episode of the iconic cartoon series The Jetsons featured Jane Jetson calling the family doctor via a video screen to check on her son Elroy, who showed symptoms of “Venus Virus.”

Nearly 60 years after that episode aired, telehealth has established itself as a disruptive tool for remotely diagnosing conditions. But the advent of the COVID-19 pandemic has thrust telehealth to the forefront, and combining it with other groundbreaking technology will expand its capability beyond diagnostics.

Remote-operated robotics, or telerobotics, represents one of those technologies that can evolve telehealth from a primarily diagnostic tool to something that can treat patients remotely, ushering in a new era of care that we call tele-treatment. By combining existing robotic technology with high-speed broadband internet,

telerobotic treatment has the potential to dramatically lower the rate of mortality and morbidity suffered by patients who lack access to timely care.

While this may sound futuristic, remote robotic procedures have already made significant progress.

In 2019, Dr. Tejas Patel, chair and chief interventional cardiologist of the Apex Heart Institute in India, conducted the first-in-human telerobotic intervention study. Patel successfully completed five robotic-assisted percutaneous coronary intervention (PCI) procedures on patients who were 20 miles away from him in India, using a hardwired internet connection to manipulate the robot with a set of joysticks and a video monitor. The success of this study paves the way for large-scale, long-distance telerobotic treatment across the globe, which may expand patients’ access to care while reducing their time to treatment.

What 5G means for healthcare 5G is much more than a network upgrade for your cell phone. It’s a massive technological leap that will usher in a transformative era of innovation and creation. Much of the hype around 5G has to do with speed, and while speed is certainly a factor — 600 times faster than the typical 4G speeds on today’s mobile phones — there are significant benefits that extend beyond that. 5G offers greater bandwidth, which means it can handle many more connected devices than previous networks. This will be crucial as the number of internet-connected devices grows in the coming years.

In healthcare, 5G’s speed and low latency means it can support telerobotic interventional procedures in extremely remote parts of the world where hardwired internet options don’t exist. With acute ischemic stroke, for instance,

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less than 10% of all patients in the world have access to what is considered the “gold standard” of care, a minimally invasive procedure called mechanical thrombectomy to remove a clot. By expanding the reach of world-class physicians through remote intervention, including 5G-powered intervention, we hope to significantly improve the survival rate for conditions such as stroke and heart attack.

In October 2019, interventional cardiologist Dr. Ryan Madder performed the first multi-city, transcontinental telerobotic test procedures over three network connections, including a 5G network, demonstrating that the technology of the future is in fact here today. Based outside of Boston, Madder successfully completed the test procedures with stateof-the-art vascular simulators in New York and San Francisco. The test demonstrated the viability of telerobotic intervention over a variety of networks and distances up to 3,000 miles that could drastically improve access to care.

The need for tele-treatment Cardiovascular disease, including heart attack and stroke, is the most common cause of death in the world. Telerobotics represents a major disruptive force in creating treatment options for patients who lack access to care, which is particularly crucial for emergent conditions. For example, in stroke, they say time is brain. Every 90 minutes of delay in care reduces a stroke patient’s disability-free lifetime by one year. And only 55% of Americans live within 60 miles of a primary stroke center. As a result, patients are dying or living with the burden of serious long-term health effects because they did not have access to appropriate care fast enough. The advent of telerobotic intervention will expand the reach of highly specialized physicians to parts of the world where no treatment options exist, significantly reducing mortality and long-term disability rates around the world.

When telerobotic procedures become more widely adopted, the first iteration of this type of teletreatment will likely take place within the traditional “hub-and-spoke” model of care, in which a physician at a ‘hub’ hospital is directly connected to a robotic system at a second hospital through a secure fiber optics network.

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PRODUCT DEVELOPMENT

How to prepare for a return to 'normal' surgical instrument demand The right CMO can help manufacturers facing a surge in orders for surgical instruments.

W Steve Santoro | Micro |

hen elective surgeries return to pre-pandemic levels, hospitals will be gearing up to stock their shelves with medical instruments. Single-use surgical devices such as scissors, graspers, forceps and dissectors will be in high demand due to their inherent benefit of reducing spread of infection.

One of the most critical components of these instruments is the shaft, which must meet strict diameter requirements while housing critical-to-function subassemblies. Most often, these shafts are made from stainless steel tubing, which may be manufactured from drawn tubing or by using an innovative stamped-and-rolled technique. Features and volume help to determine which approach will be better suited to a given project.

The tubing approach Drawn tubing allows for better control of some features such as straightness or diameter consistency, particularly when tightly controlled dimensions are required throughout the entire length of the metal tube shaft. This method of tubing also produces a more robust result when creating specific end features such as expansions or reductions, flaring and flanging, and end sharpening. In addition, drawn tubing enables other processes, such as piercing and slotting, precision sharpening, electropolishing and laser welding, coupled with customer assemblies and environmentally friendly cleaning systems.

Rolled tubing is a revolutionary process in which a “rolled” tube is manufactured using a progressive stamping die, allowing for a finished tube to drop from a high-speed press at a rate of one per second. Features such as windows and slots can be added in the flat blank stage, before being “rolled” into a

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Image courtesy of Micro

finished tube. Rolled tube technology is best suited for high-volume orders such as those greater than 300,000 pieces. This approach to tubing helps to reduce production time, component costs and secondary operations for the manufacturing of endoscopic subassemblies. Innovative technologies such as rolled tubing can provide a cost-effective and efficient way to achieve more advanced features such as holes, slots and windows on larger-volume projects.

Design for manufacturability For OEMs that need to rapidly bring products to market, design for manufacturability (DFM) will be essential.

DFM provides an effective approach to identifying issues or product challenges as early as the design stage. The pressures are even higher on design engineers because they face cost targets, time-to-market and other factors.

DFM can help cut down on the number of times additional prototype iterations are required and help to smooth out the manufacturing process by removing unwarranted steps, which saves on

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production time, costs, and reduces the likelihood of a miscommunication or breakdown in communication. There is less wasting of significant resources, all while speeding up time to market. Finally, DFM helps to prevent the risk of “underdesigning” a product, which could lead to functional issues, or “over-designing” a product, which could result in the inability to manufacture efficiently.

Experienced partner OEMs that need to act quickly to meet demand should work with contract manufacturer organizations (CMOs) that offer a variety of cost-effective, highquality tubing solutions. An experienced partner can help with producing the most cost-effective and efficient product that will be profitable. OEMs and their CMO partners must collaborate, especially early in the development cycle to ensure a product can be manufactured in a way that meets the OEM’s goals.

A successful partnership is essential for

ensuring quality and value in product development and production. Situations such as this prove that value is not only about the lowest price.

Given the economic, technological and regulatory pressures of today’s medtech market, OEMs understandably look for ways to decrease development cycles, production time and costs to maximize value and profitability.

Outsourcing with a credible partner is one viable option, as it allows companies to focus on core competencies internally and free up resources that fall outside their core competencies for maximum competitive advantage.

Investing in the Latest Technologies Medbio is committed to the reduction of part to part variation with the use of robots and automation

www.medbioinc.com www.medicaldesignandoutsourcing.com

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REGULATORY

What will pandemic disruptions mean for EU IVDR? Certification under the old EU In Vitro Diagnostic Directive (IVDD) cannot be grandfathered into IVDR. IVD manufacturers must start prioritizing product portfolios and conducting gap assessments now to ensure compliance by the May 2022 deadline.

A Angela Brown | Icon |

s the deadline for the EU In Vitro Diagnostics Regulation (IVDR) remains at May 2022, regulators, industry and notified bodies (NBs) have much to prepare for over the coming months. The coronavirus pandemic could add to an already tight deadline.

Alongside the EU’s Medical Device Regulation (MDR), IVDR provides a harmonized regulatory framework to ensure the safety and performance of devices, putting greater responsibility on manufacturers to demonstrate that products have met the requirements to be placed on the market by performing conformity assessments. IVDR also brings increased oversight to the in vitro diagnostic industry, including an expanded scope of requirements for performance, design and manufacturing, encompassing greater risk-control measures and heightened metrological traceability.

Manufacturers also face pressure to quickly develop rapid and at-home diagnostics to

support the COVID-19 crisis.

According to MedTech Europe, 85% of the more than 50,000 IVDs currently on the market will require certification by a designated NB in less than 20 months, which presents a considerable challenge in meeting the deadline. The European trade group has urged regulatory authorities to delay IVDR due to the COVID-19 pandemic to no avail.

IVD manufacturers that have not begun preparations for IVDR urgently need to secure a strategy to address gaps in meeting the new regulation to avoid potential EU product availability issues. Here, we discuss steps that can be implemented to ensure a successful transition by the May 2022 deadline.

Assess product portfolios and quality systems over the IVD development lifecycle The IVDR affects the entire IVD lifecycle, and additional requirements impose significant increases in workloads.

Nicole A. Cowan | Icon |

Image courtesy of Icon

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Comparing the NEMA 5-15 Hospital-Grade vs. the Standard 5-15 While both NEMA 5-15 standard and hospital-grade cord sets have similarities, there are differences.

Both 5-15 cord sets are grounded Class I, 125V cord sets.

The “5” states a rating of 125V, and the “15” states the cord set is rated at 15 amps. Both plugs can be “hand-wired” instead of molded, and both come in gray, black, or clear colors. However, the hospital-grade plug is significantly larger to provide better protection.

Though both cords endure testing, the hospital-grade plug is subjected to the UL 817 Abrupt Removal Test where a 10-lb weight is attached to an inserted plug and then dropped to check for electrical continuity. The standard NEMA 5-15 endures the Abrupt Pull Test where a 2 ½ pound weight is dropped 25 times from the inserted plug.

Only the NEMA 5-15 hospital-grade plugs and receptacles bear the “green dot” which signifies they meet standards UL 817 and CAN/CSA C22.2 no. 21 requirements for Hospital-Grade status.

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REGULATORY

As manufacturers begin to calculate potential roadblocks and timeline constraints, market access priorities may begin to shift as a result. As there is no grandfathering of products, manufacturers must conduct an extensive gap assessment of their entire product portfolio for the purpose of evaluation and prioritization. Gap assessments should consider scope, sales, new product pipeline, financial impact and resources. Performing a gap analysis is integral to helping maintain and build market share through the transition.

While evaluating product portfolios, manufacturers will also need to: •

• •

Assess current specifications and standards including requirements for regulatory purposes, such as quality management systems (QMS).

Establish a transition plan for updated processes driven by IVDR. Bolster quality systems to allow for emergency-use processes driven by

diagnostic development associated with the pandemic.

Next, manufacturers will need to implement the transition plan through updating or creating new standard operating procedures to comply with the IVDR. These procedures should incorporate several elements of medical device ISO standards, including the requirement that manufacturers operate a QMS. This would include device-specific design and development information, such as production and service controls, risk management and control measures, performance in alignment with intended use, and product interoperability and compatibility.

They must also assess new roles for economic operators (e.g., manufacturers, authorized representatives, importers and distributors who share the duties of ensuring compliance) and persons responsible for regulatory compliance evaluation.

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Plan and implement technical file remediation After assessing portfolios and identifying gaps, manufacturers should define a remediation plan to create the required records for compliance. Once they implement a plan, manufacturers will need to update not only their QMS but also their design history file (DHF), which contains the records necessary to demonstrate that the design was developed according to approved design plans. In addition, they will need to develop a device master record, which comprises all the instructions, drawings and other records that must be used when producing a product.

If applicable, manufacturers will need to create periodic safety update reports (PSUR), post-market surveillance (PMS) plans and reports, post-market performance follow-up (PMPF), and a summary of safety and clinical performance. Sponsors will also need to gather data to be submitted to the

European Databank on Medical Devices (EUDAMED), as well as begin audit preparation.

Lastly, manufacturers will need to maintain their DHF, along with any technical files, while implementing PMS activities, including updates to PMPF and PSUR, in addition to data maintenance for the EUDAMED. What lies ahead for 2021 For products in development and early in their lifecycle, manufacturers should ensure they are working toward IVDR requirement for EU approval. To maintain market share, manufacturers will need to address new clinical data, including technical file requirements; assess product portfolios for profitability, marketability and patient need; and finally, involve executive management and strategic partnerships in compliance efforts.

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TUBING TALKS

6 ways the right tubing supplier can improve product development Partnering with a vertically integrated manufacturer can help engineers optimize designs, improve manufacturability and accelerate new product development.

Michael Holt | Integer |

M

edtech design engineers face extraordinary opportunities and challenges created by rapidly advancing clinical markets. To quickly bring innovative new products to market, it is important for medical tubing manufacturers to understand thermoplastics, thermosets, filmcast, extrusion and value-added downstream processes vital to the production sequence.

Electrophysiology catheters, structural heart delivery systems, microcatheters and other tube-based medical devices use a range of polymer tubing constructions and materials, including polyimide, urethanes, nylons, PTFE and PEBAX. Combining different materials and constructs is vital to achieving the desired balance of strength, flexibility, torque response, kink resistance and other performance characteristics required in the finished assembly. A vertically integrated manufacturer can work with all of these to improve supply chain coordination and control over inputs.

Here are six critical, value-added capabilities that enhance the development process for medical tubing: 1. Catheter assembly Assembly of finished tube-based devices requires a variety of services. Contract manufacturers with a full complement of secondary operations, assembly, packaging, and sterilization capabilities provide additional value and supply chain leverage to medical device OEMs and startups.

2. Design for manufacturability (DFM) The application of DFM as an engineering discipline optimizes the design of complex catheter shafts and other medical tubing assemblies to reduce manufacturing costs.

DFM enables correcting potential problems in the design phase, the least expensive point in the development process to address issues.

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TUBING TALKS

3. Reinforced composite tubes Catheters and other tube-based medical devices requiring high torque response, burst pressure, pushability, steerability and kink resistance typically feature a braid or coil-reinforced shaft design.

Multiple variables are at play when designing reinforced shafts. Generally, a reinforced shaft has an inner liner, a braid or coil reinforcement layer(s) and an outer jacket. These elements must be married together to achieve required dimensions while accounting for inherent physical limitations such as liner thickness, outer jacket thickness, and wire density (defined as pic per inch for braid or pitch for coils).

Trade-offs are inherent in designing reinforced shafts. For example, optimizing the device shaft for torque response may result in a braid pattern that is not optimal for flexural stiffness. Modeling these complex reinforced shafts in the virtual space can cut weeks or months off the development timeline.

4. Reflow shafts Reflow is a manufacturing process that produces multi-layer shafts by reflowing (or melting) inner and outer jacket materials to construct a composite shaft. Various wall thicknesses, durometers and support structures can be incorporated into a composite shaft to optimize strength, kink-resistance, steerability and torsion control to the shaft design. The reflow process enables all layers of the complex, engineered shaft to be integrated and accommodates a broad range of configurations spanning 2 Fr to 36 Fr.

Combining different materials and constructs is vital to achieving the desired balance of strength, flexibility, torque response, kink resistance, and other performance characteristics required in the finished assembly.

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5. Secondary operations Secondary operations can create different tubing features and profiles. These can include hub molding, overmolding, heat treating/annealing, flaring, hole drilling, skiving, pad printing, thermoplastic flattening/shaping forming, tipping, sealing, etching, welding, bonding and swaging.

As a precursor to final device assembly, working with a contract manufacturer who provides such

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secondary operations may cost less than sending components through multiple manufacturers and thus simplify the supply chain.

6. Virtual tubing model analysis Conventional medical device prototyping relies on a manual, timeconsuming trial-and-error process involving multiple rounds of material procurement, prototype assembly and bench testing. Using virtual tubing model analysis dramatically decreases the time and resources needed for physical prototyping of medical tubing â&#x20AC;&#x201C; enabling engineers to model complex, multilayer braided tubes in minutes versus hours, and to quickly and easily predict performance.

Design engineers face numerous pressures to deliver on aggressive development timelines. The right polymer tubing manufacturing partner can enhance innovation and project execution.

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DEVICETALKS

Tech bridges gap between sales reps and surgeons The pandemic has changed the relationship between surgeons and medtech sales reps, possibly for good.

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

M

edtech sales reps often are an essential presence during surgeries. But worries about the spread of the coronavirus and the availability of personal protective equipment have pushed most reps out of the operating rooms, leaving surgeons without a resource to which they’ve grown accustomed.

Technology startups are stepping forward to reunite surgeons and sales reps virtually while medical device companies seek solutions through collaboration or acquisition. We interviewed several principals in recent episodes of our DeviceTalks Weekly podcast.

Chris Landon, SVP and business leader of image-guided therapies at Philips, says the adoption of new technologies is going to “change the way that we interact with physicians for the better. Philips is completely committed to telehealth.”

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The commitment to finding a permanent solution led Philips in July to acquire Montreal-based company Reacts, which had supplied technology for Philips’ Lumify point-of-care ultrasound solution. The Reacts tech allows for the remote sharing of the ultrasound stream used during a procedure.

“We’ve created our own virtual presence in the cath lab,” Landon said, adding that the stream could connect physicians and reps over long distances. “We certainly see a new type of sales rep-physician interface happening.”

Dr. Neil Moat, chief medical officer and divisional vice president of Abbott’s structural heart business, told us he sees a similar transition. Abbott is working with outside companies to provide telemedicine connections for its sales reps.

“We’re intimately involved in looking at remote technologies or virtual technologies for training and for supporting procedures,” he said. Moat declined to identify the companies.

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Smith+Nephew recently announced it would be working with Avail Medsystems, a startup that has secured $100 million from a venture investor to build out a telemedicine network. Skip Kiil, president of orthopedics, said Smith+Nephew is “really excited” about the potential, though he didn’t want to share details. “I would say hang tight,” he said when asked about working with Avail. “We won’t get out ahead of ourselves. We want to crawl before we walk and learn to run. Then, we’ll bring something really meaningful.”

Avail Medystems and ExplOrer Surgical are two of the higher-profile startups in the space, taking very different approaches to the problem.

We're intimately involved in looking at remote technologies or virtual technologies for training and for supporting procedures.

When Avail MedSystems CEO Daniel Hawkins joined the company in 2017, he saw a crack forming in the foundation of medical device sales. Hawkins, who previously had been CEO of Shockwave Medical, said the rise of surgical sites including ambulatory surgery centers has created more demand than the existing medical sales forces can handle.

Hawkins said he saw Avail’s technology approach as a way to help medical device sales teams reach more surgeons with less travel and logistics.

Avail’s procedural telemedicine “enables somebody remotely to have all of the capabilities they would have in being in the procedure room and then many new ones, including abilities to freeze frames, and an ability to draw on screens and the like, and that, we think, creates a very rich experience and opportunity to convey medical techniques.”

Avail’s solution includes a console consisting of a camera, a screen and a two-way audio system that allows for real-time collaboration. Avail is providing the equipment for free to hospitals and will charge medical device companies for access to the telemedicine network.

ExplOrer Surgical initially focused on bringing efficiencies to the operating 134

Medical Design & Outsourcing

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room. CEO and co-founder Jennifer Fried was driven to start the company after consulting with co-founder and CMO Dr. Alex Langerman.

At the time, Langerman directed the Operative Performance Research Institute at the University of Chicago, which studied OR efficiencies. Fried said she was shocked when the surgeon told her that half the time, he didn’t have the OR set up as he needed before surgery. ExplOrer developed the cloud-based platform to allow for better OR management, including remote connections.

The remote capability became essential when COVID-19 hit, convincing the start-up to accelerate the introduction of features that allowed sales reps to communicate with surgeons inside the operating room. Unlike Avail, ExplOrer is deploying a “mobile-first” solution that doesn’t require equipment to be installed in the room.

“We wanted our tool to be available right away so if a rep said, `I can’t get in the room but I’m here in the hospital right now,’ We wanted the rep to be able to text the rep (to) say, `Just download this app and I’m going to be there in a HIPPAcompliant way in two-minutes.’”

Even if concerns over spreading the virus abate, medical device companies will have little incentive to commit to the expense of travel and face-to-face time if the burgeoning infrastructure of telemedicine tools deliver on the promises offered during recent interviews broadcast on the DeviceTalks Weekly podcast.

“I don’t think healthcare will ever quite go back to the way it was before remote [technology],” Abbott’s Moat told us. “Things will never go completely back to the way they were before.”

We've created our own virtual presence in the cath lab. We certainly see a new type of sales repphysician interface happening.

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CONGRATULATIONS PRESENTED BY

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A D VA N CED MATERI A L S Medical Design & Outsourcing is excited to release the

CA B L ES CO N TRA CT MA N U FA CTU RI N G

winners of our annual

D ESI G N SERVI CES

Leadership in Medical Technology program. Since we announced the nominees in our January 2020 issue and online, our user community has voted on what companies they feel best exemplify medical

D IG I TA L MA N U FA CTU RI N G EL ECTRICA L FA STEN IN G & JO I N IN G F L U ID PO W ER

technology leadership in 12 categories. We are happy to celebrate the winners here.

MA CH IN IN G MO TIO N CO N TRO L PRO D U CT D EVEL O PMEN T SO F TWA RE www.medicaldesignandoutsourcing.com

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Statement of Ownership, Management, and Circulation (Requester Publications Only) 1. Publication Title

Medical Design & Outsourcing 4. Issue Frequency

7 issues: January, March, May, July, September, October, November

2. Publication Number

5. Number of Issues Published Annually

7

10/18/2020 6. Annual Subscription Price (if any)

$125.00

7. Complete Mailing Address of Known Office of Publication (Not printer) (Street, city, county, state, and ZIP+4®)

Contact Person

Bruce A. Sprague

WTWH Media, LLC 1111 Superior Ave., Suite 2600, Cleveland, OH 44114

Telephone (Include area code)

(888) 543-2447

8. Complete Mailing Address of Headquarters or General Business Office of Publisher (Not printer)

WTWH Media, LLC 1111 Superior Ave., Suite 2600, Cleveland, OH 44114

9. Full Names and Complete Mailing Addresses of Publisher, Editor, and Managing Editor (Do not leave blank) Publisher (Name and complete mailing address)

Mary Ann Cooke; WTWH Media, LLC 1111 Superior Ave., Suite 2600, Cleveland, OH 44114 Editor (Name and complete mailing address)

Chris Newmarker; WTWH Media, LLC 1111 Superior Ave., Suite 2600, Cleveland, OH 44114 Managing Editor (Name and complete mailing address)

Nancy Crotti; WTWH Media, LLC 1111 Superior Ave., Suite 2600, Cleveland, OH 44114

10. Owner notpublication leave blank.

If the publication is owned bythe a corporation, give theofname and address of the corporation followed by the Owner(Do (If the is owned by a corporation, give name and address the corporation immediately followedimmediately by the names and addresses of all stockholders owning holding 1 percent or or more of the amount of stock. not owned corporation, give names and addresses the names and addresses of allorstockholders owning holding 1 total percent or more of theIftotal amountbyofastock.

If not owned by a corporation, giveofthe individual If owned a partnership or other unincorporated firm, give its name and address as give well as those of each individual owner.

If theof names andowners. addresses of theby individual owners.

If owned by a partnership or other unincorporated firm, its name and address as well as those publication is published by a nonprofit organization, give its name and address): each individual owner. If the publication is published by a nonprofit organization, give its name and address.)

Complete Mailing Address Full Name

WTWH Media, LLC

1111 Superior Ave., Suite 2600, Cleveland, OH 44114

Scott McCafferty

1111 Superior Ave., Suite 2600, Cleveland, OH 44114

Mike Emich

1111 Superior Ave., Suite 2600, Cleveland, OH 44114

Marshall Matheson

1111 Superior Ave., Suite 2600, Cleveland, OH 44114

11. Known Bondholders, Mortgagees, and Other Security Holders Owning or Holding 1 Percent or More of Total Amount of Bonds, Mortgages, or Other Securities. If none, check box None

�

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N/A

Has Not Changed During Preceding 12 Months Has Changed During Preceding 12 Months (Publisher must submit explanation of change with this statement)

PS Form , September 2007 (Page 1 of 3 (Instructions Page 3)) PSN: 7530-09-000-8855 PRIVACY NOTICE: See our privacy policy on www.usps.com PS Form3526-R 3526-R, August 2012

13. Publication Title

Medical Design & Outsourcing

15. Extent and Nature of Circulation

14. Issue Date for Circulation Data Below

September 2020

Average No. Copies Each No. Copies of Single Issue Published Issue During Preceding Nearest to Filing Date 12 Months

a. Total Number of Copies (Net press run) Outside County Paid/Requested Mail Subscriptions stated on PS Form 3541.

(Include direct written request from recipient, telemarketing and Internet re(1) quest s from recipient, paid subscriptions including nominal rate subscriptions, employer requests, advertiser’s proof copies, and exchange copies.) b. Legitimate Paid and/or 13. Publication Title In-County Paid/Requested Mail Subscriptions stated on PS Form 3541.

Requested (Include direct written request from recipient, telemarketing and Internet reDistribution (2) quests from recipient, paid subscriptions including nominal rate subscriptions, (By Mail employer requests, advertiser’s proof copies, and exchange copies.)

15.and Extent and Nature of Circulation Outside Sales Through Dealers and Carriers, Street Vendors, Counter the Mail) (3) Sales, and Other Paid or Requested Distribution Outside USPS®

11,276

7,822

8,583

0

Nonrequested Distributed Outside the on MailPS (Include Pickup Stands, Outside CountyCopies Nonrequested Copies Stated Form 3541 (include (4) Shows, Showrooms and Other Sources) Sample copies, Requests Over 3 years old, Requests induced by a (1) Trade Premium, Bulk Sales and Requests including Association Requests, Names obtained from Business Directories, Lists, and other sources) Total Nonrequested Distribution (Sum of 15d (1), (2), (3) and (4))

d. Nonref.

In-County Nonrequested Copies Stated on PS Form 3541 (include Total Distribution (Sum of 15c and e) quested (2) Sample copies, Requests Over 3 years old, Requests induced by a Distribution Premium, Bulk Sales and Requests including Association Requests, g. (By Copies (See Instructions to Publishers #4, (page #3))and other sources) Mail not Distributed Names obtained from Business Directories, Lists, and Outside h. the Total (Sum of 15f and g) Mail) Nonrequested Copies Distributed Through the USPS by Other Classes of (3) Mail (e.g. First-Class Mail, Nonrequestor Copies mailed in excess of 10% Requested Limit mailed atCirculation Standard Mail® or Package Services Rates) i. Percent Paid and/or (15c divided by f times 100)

0

0

0

0

7,822

8,583

3,166

2,415

0

0

0

0

352

276

3,518

2,961

11,340

11,274

28

Nonrequested Copies Distributed Outside the Mail (Include Pickup Stands, (4) Trade Shows, Showrooms and Other Sources) Electronic Copy Circulation 16. Publication 16. of Statement of Ownership for a Requester Publication is required and will be printed in the issue of this publication. e. a.

Total Nonrequested Distribution (Sum of 15d (1), (2), (3) and (4)) Requested and Paid Electronic Copies 17. Signature and Title of Editor, Publisher, Business Manager, or Owner

2

11,368

11,276

69.0%

76.1%

0 7,822

Total Distribution (Sum 15cPrint and e) b.

Total Requested andofPaid Copies (15c) + Requested/Paid Electronic copies (16a)

Date

11,340

11,274

69.0%

76.1%

PS Form 3526-R, September 2007 (Page 2 of 3) i. Percent Paid and/or Requested Circulation (15c divided by foftimes 100) X I certify that 50% all my distributed copies (electronic and print) are legitimate requests or paid copies.

17. Signature and Title of Editor, Publisher, Business Manager, or Owner 18.

November 2020

Pat Curran, Senior Digital Media Manager

Key Tech...........................................................4 Keystone Electronics Corp..............................7 Keystone Solutions Group............................32 KNF Neuberger, Inc.....................................104 LEMO USA...................................................109 Master Bond.................................................115 maxon......................................cover/corner, 51 Medbio.........................................................123 MICRO..........................................................121 Microlumen..........................................130, 131 MTD Micromolding.......................................41 Nelipak...........................................................28 Nelson Laboratories, LLC.............................55 New England Wire Technologies & New England Tubing Technologies......129 NextPhase......................................................24 OKAY Industries...........................................126 Orchid Orthopedic Solutions.......................12 Parvalux........................................................107 Penn United Technologies Inc......................11 Porex Corporation.........................................30 PTI Engineered Plastics.................................36 Resonetics.................................................... IFC Smalley Steel Ring...........................................9 Smart Products USA........................................1 Solar Atmospheres Inc................................118 Solenoid Solutions, Inc....................................5 Spectrum Plastics Group.............................108 STEUTE Meditech, Inc...................................15 Stock Drive Products/ Sterling Instrument...................................59 Tegra Medical..............................................IBC TRACO Power North America, Inc.............103

Mike Caruso mcaruso@wtwhmedia.com 469.855.7344

Neel Gleason ngleason@wtwhmedia.com 312.882.9867 @wtwh_ngleason

Jami Brownlee 224.760.1055 jbrownlee@wtwhmedia.com

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0 8,583

Total Requested Copy distribution (15f) + Requested/Paid Electronic copies (16a) g. c.

Copies not Distributed (See Instructions to Publishers #4, (page #3)) I certify that all information furnished on this form is true and complete. I understand that anyone who furnishes false or misleading information on this form d. or Percent who omits material information requested on the form may be subject to criminal sanctions (including fines and imprisonment) and/or civil Paid and/ororRequested Circulation h. Total (Sum of & 15f and g) copies (16b divided By 16c x 100) sanctions (including civil penalties).

(Both print electronic

17.

16. Publication of Statement of Ownership for a Requester Publication is required and will be printed in the issue of this publication.

Accumold.......................................................17 AllMotion........................................................67 Altech Corporation......................................2, 3 Azoth.............................................................117 B. Braun.........................................................BC Bay Associates Wire Technologies, Inc........69 Binder USA.....................................................38 Bird Precision...............................................113 BMP Medical..................................................47 Bodine Electric Company...........................111 Boston Centerless.......................................105 Cadence ........................................................75 Carclo..............................................................22 Celestica.........................................................34 CGI Inc............................................................19 Chieftek Precision........................................101 Clippard..........................................................53 CPC-Colder Products Company..................57 Eagle Stainless Tube......................................71 Eurofins Medical Device Testing..................26 Fabco-Air Inc................................................119 FAULHABER MICROMO...............................63 Freudenberg Medical....................................43 Halkey | Roberts.............................................66 Hobson & Motzer..........................................49 ICON...............................................................61 Instron.............................................................45 International Polymer Engineering..............64 Interpower....................................................125 Introtek International.....................................77 Isometric Micro Molding...............................20 J.W. Winco, Inc............................................113 John Evans’ Sons, Inc..................................112

SALES

0

Average No. Copies Each No. Copies of Single Issue Published Issue During Preceding Nearest to Filing Date 12 Months

Outside County Paid/Requested Mail Subscriptions stated on PS Form 3541. c. Total Paid and/or Requested Circulation of 15b (2), (3),telemarketing and (4)) (Include direct written (Sum request from(1), recipient, and Internet re(1) quest s from recipient, paid subscriptions including nominal rate subscriptions, employer requests, advertiser’s proof copies, and exchange copies.)

Outside County Nonrequested Copies Stated on PS Form 3541 (include b. Legitimate Sample copies, Requests Over 3 years old, Requests induced by a (1) Paid and/or In-County Paid/Requested Mail Subscriptions stated on PS Form 3541.

Premium, Bulk Sales and Requests including Association Requests, Requested (Include direct written recipient,Lists, telemarketing Internet reNames obtained from request Businessfrom Directories, and otherand sources) Distribution (2) quests from recipient, paid subscriptions including nominal rate subscriptions, (By Mail employer requests, advertiser’s proof copies, and exchange copies.) and d. NonreIn-County Nonrequested Copies Stated on PS Form 3541 (include Outside quested copies, Dealers Requests Over 3 years old, Requests induced by a Sales Through and Carriers, Street Vendors, Counter (2) Sample the Mail) Distribution (3) Premium, Sales Requests including Association Requests, Sales, andBulk Other Paidand or Requested Distribution Outside USPS® (By Mail Names obtained from Business Directories, Lists, and other sources) and (4) Requested Copies Distributed by Other Mail Classes Through the USPS Outside (e.g. First-Class Mail®) the Mail) Nonrequested Copies Distributed Through the USPS by Other Classes of (3) Mail (e.g. First-Class Mail, Nonrequestor Copies mailed in excess of 10% c. Total Paid and/or Requested Circulation (Sum of 15b (1), (2), (3), and (4)) Limit mailed at Standard Mail® or Package Services Rates)

f.

11,368

14. Issue Date for Circulation Data Below

a. Total Number of Copies (Net press run) (4) Requested Copies Distributed by Other Mail Classes Through the USPS (e.g. First-Class Mail®)

e.

AD INDEX

3. Filing Date

2 1 6 4 -_ 7 1 3 5

Date

LEADERSHIP TEAM Managing Director Scott McCafferty smccafferty@wtwhmedia.com 310.279.3844 @SMMcCafferty

VP of Sales Mike Emich memich@wtwhmedia.com 508.446.1823 @wtwh_memich

10/20/2020

I certify that all information furnished on this form is true and complete. I understand that anyone who furnishes false or misleading information on this form or who omits material or information requested on the form may be subject to criminal sanctions (including fines and imprisonment) and/or civil sanctions (including civil penalties).

PS Form Form3526-R, 3526-R, September July 2014 2007 (page(Page 2 of 2 4)of 3)

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EVP Marshall Matheson mmatheson@wtwhmedia.com 805.895.3609 @mmatheson

MD&O_FP_nails_07.2020_pdfx1a.pdf 1 7/1/2020 10:54:03 AM

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