Medical Design & Outsourcing – SEPTEMBER 2019

H O W T H E E I TA N G R O U P A I M S T O D I S R U P T T H E I N F U S I O N P U M P I N D U S T R Y www.medicaldesignandoutsourcing.com SEPTEMBER 2019

THE TOP MEDICAL DEVICE EMPLOYERS

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RESEARCH & DEVELOPMENT: WHO’S SPENDING THE MOST?

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HAVE GOVERNMENT SCIENTISTS SOLVED THE ARTIFICIAL HIPS CORROSION PROBLEM?

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Medical Design & OUTSOURCING EDITORIAL Executive Editor Brad Perriello bperriello@wtwhmedia.com Editor Chris Newmarker cnewmarker@wtwhmedia.com @newmarker Associate Editor Danielle Kirsh dkirsh@wtwhmedia.com Senior Editor Nancy Crotti ncrotti@wtwhmedia.com Program Manager DeviceTalks Sarah Faulkner sfaulkner@wtwhmedia.com

VP Lifesciences Mary Ann Cooke mcooke@wtwhmedia.com 781.710.4659

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HERE’S WHAT WE SEE

The Big 100 continues to evolve

T

he consolidation trend that’s dominated the medical device industry for the past few years only seemed to accelerate in 2018, according to our annual look at the world’s largest medtech operations, The Big 100.

Even as the bar to making the list is continuously dropping, collectively this roster put up higher sales this year than in last year’s issue. Although last year’s revenue cut-off was $40.2 million (EDAP), this year Ra Medical Systems made the list at $6.2 million. But Big 100 companies in total brought in a little more than $397.5 billion in revenues, up about $13.4 billion (3.5%) over the previous year.

Once again acquisitions played a lead role: • 3M’s takeout of wound care giant Acelity for $6.7 billion • Boston Scientific’s $4 billion acquisition of BTG • Johnson & Johnson’s buyout of Auris Health for $3.6 billion • Fresenius (finally) closing the $2 billion buy of NxStage Medical • Medtronic acquiring Mazor Robotics for $1.7 billion • Boston Scientific buying Vertiflex for $465 million • Stryker acquiring OrthoSpace for $220 million

Finally, this year we added a new aspect, examining revenues earned per employee as a proxy measure for efficiency. The results were surprising – turn to page 100 for the results. M Some notes on our methodology: We begin the process of compiling companies’ annual reports early each year, as soon as the prior year’s financials begin to trickle in.

We compile the listings and rank the companies according to annual revenues, then R&D spending and number of employees. Once the numbers are collected, we attempt to contact each of the 100 companies to confirm our findings.

Using data from the most recent fiscal year, we turn to our own archives, corporate documents and public regulatory filings. For companies with non-medical device businesses, we exclude those divisions’ results from our calculations. For currency conversions, we use the average exchange rates from the previous year as set by the U.S. Federal Reserve.

Once the results are in we take a closer look at the top 20 firms on the list, providing a brief review of their news from the past year. We take a deeper dive into the numbers, looking at R&D spends, workforce counts and revenues per employee.

Big 100 companies in total brought in a little more than $397.5 billion in revenues, up about $13.4 billion over the previous year.

Here’s another trend that stuck out: IPOs are back and, combined with the accelerated consolidation trend, added a clutch of companies to the list that included Ambu, Brainsway, Endologix, Glaukos, Inspire Medical, Nevro, SiBone and TransEnterix.

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Danielle Kirsh Associate Editor Medical Design & Outsourcing dki rsh@wtwhmedi a .c o m

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©2018 Intuitive Surgical, Inc.

AT THE HEART OF

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CONTRIBUTORS

MASON BERHENKE received his bachelor’s degree in computer engineering from Iowa State. He joined Texas Instruments in 2016, where he currently works as a product marketing engineer for the SimpleLink connected MCU team.

BERHENKE

LOUIS COLUMBUS is a principal at manufacturing enterprise resource planning company IQMS (now Delmiaworks, part of the Dassault Systèmes family).

MCGREW

COLUMBUS

MIKE MCGREW is the VP of operations at WuXi Medical Device Testing.

WOZNIAK

EMILY WOZNIAK is product manager for the peripheral vascular divisions products at Integer Holdings. She supports neurovascular product development and customer program execution, and develops and executes commercial strategy. Wozniak’s previous roles included the development and execution of commercial strategy for biologic contract manufacturers and startup medical device companies.

CONNECT WITH US! CHECK US OUT ON ISSUU.com!

Search Medical Design & Outsourcing

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CONTENTS

medicaldesignandoutsourcing.com ∞ September 2019 ∞ Vol5 No5

• • • • • THE BIG100 ISSUE

15

DEPARTMENTS

ON THE COVER

6 HERE’S WHAT WE SEE:

BIG 100: THE LARGEST MEDICAL DEVICE COMPANIES IN THE WORLD

The Big 100 continues to evolve

8 CONTRIBUTORS:

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.

122 IP ISSUES:

How medical device patent litigation is changing

126 CATH LAB:

Tiny ‘mirrors’ could make tracking catheters easier

130 MANUFACTURING &

MACHINING:

Improving smart manufacturing with real-time monitoring

134 NEURO:

Overcoming neurovascular device delivery challenges

FEATURES

138 REGULATORY:

Knowing your MDR options

142 SOFTWARE:

15

How to protect medtech from cyber attacks

146 TUBING TALKS:

How to make adhesives work for your medical tubing

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

108 HOW THE EITAN GROUP AIMS TO DISRUPT

THE INFUSION PUMP INDUSTRY

150 DEVICETALKS:

Applying AI in the ER with CEO Gene Saragnese

Can the privately held Eitan Group compete against the established players?

116

152 AD INDEX

HAVE GOVERNMENT SCIENTISTS SOLVED THE ARTIFICIAL HIP CORROSION PROBLEM?

Argonne National Laboratory researchers tested metal alloys that ortho device companies have used in artificial hips for decades.

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Medical Design & Outsourcing

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Take Control with Cordis E L E C T R O N I C P R E S S U R E R E G U L AT I O N

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Medical Design & OUTSOURCING

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 p.16 Top R&D Spenders p.96 Top Medical Device Employers p.100 Medtech Heatmap p.106 www.medicaldesignandoutsourcing.com

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COMPANIES RANKED BY REVENUE

The Big 100 Ranked by Revenues

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RANK

COMPANY

REVENUES ($USD)

REVENUES (INTERNATIONAL)

1

Medtronic

$30,557,000,000

2018 rank: 1 (no change)

2

Johnson & Johnson (medical device segment)

$27,000,000,000

2018 rank: 2 (no change)

3

Royal Philips

$21,413,585,700

2018 rank: 4 (+1)

4

GE Healthcare (General Electric)

$19,784,000,000

2018 rank: 5 (+1)

5

Fresenius (medical care segment)

$19,553,589,900

(€16,547,000,000)

2018 rank: 3 (-2))

6

Siemens Healthineers

$15,864,322,500

(€13,425,000,000)

2018 rank: 7 (+1)

7

Cardinal Health (medical segment)

$15,633,000,000

(€18,121,000,000)

2018 RANK/CHANGE

2018 rank: 6 (-1)

8

Danaher (life sciences, diagnostics & dental segments)

$15,573,500,000

2018 rank: 8 (no change)

9

Stryker

$13,600,000,000

2018 rank: 10 (+1)

10

EssilorLuxottica

$12,761,178,300

2018 rank: 15 (+5))

11

Abbott (medical device segment)

$11,400,000,000

(€10,799,000,000)

2018 rank: 14 (+3)

12

Baxter

$11,127,000,000

2018 rank: 11 (-1)

13

Owens & Minor

$9,838,708,000

2018 rank: 12 (-1)

14

Boston Scientific

$9,823,000,000

2018 rank: 13 (-1)

15

Henry Schein

$9,400,000,000

2018 rank: 9 (-6)

16

Becton, Dickinson (medical segment)

$8,616,000,000

2018 rank: 16 (no change)

17

B. Braun Melsungen

$8,163,301,770

2018 rank: 18 (+1)

18

Zimmer Biomet

$7,932,900,000

2018 rank: 17 (-1)

19

Novartis (Alcon segment)

$7,149,000,000

2018 rank: 19 (no change)

20

3M Co. (healthcare segment)

$6,021,000,000

2018 rank: 20 (no change)

21

Olympus (medical business)

$5,745,480,072

(¥634,301,000,000)

2018 rank: 21 (no change)

22

Terumo

$5,430,081,522

(¥599,481,000,000)

2018 rank: 23 (+1)

23

Smith & Nephew

$4,904,000,000

(€6,908,099,000)

2018 rank: 22 (-1)

24

Dentsply Sirona

$3,986,300,000

2018 rank: 24 (no change)

25

Intuitive Surgical

$3,724,200,000

2018 rank: 28 (+3)

26

Edwards Lifesciences

$3,722,800,000

2018 rank: 26 (no change)

27

Hoya (life care segment)

$3,382,137,681

2018 rank: 27 (no change)

(¥373,388,000,000)

28

Hologic

$3,217,900,000

2018 rank: 29 (+1)

29

Nipro (medical segment)

$3,026,114,130

2018 rank: 33 (+4)

30

Varian Medical Systems

$2,919,100,000

2018 rank: 34 (+4)

31

BioMerieux

$2,860,895,700

2018 rank: 36 (+5)

(¥334,083,000,000) (€2,421,000,000)

32

HillRom

$2,848,000,000

2018 rank: 30 (-2)

33

Sonova

$2,824,202,780

2018 rank: 32 (-1)

34

Steris

$2,782,170,000

2018 rank: 35 (+1)

35

Getinge

$2,780,148,370

2018 rank: 31 (-4)

36

ResMed

$2,606,572,000

Medical Design & Outsourcing

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(CHF2,763,200,000) (kr24,172,000,000)

2018 rank: 38 (+2)

www.medicaldesignandoutsourcing.com

9/14/19 11:14 PM

Improving the quality of patient lives is our vital purpose Now offering Class 7 cleanroom manufacturing

NextPhase™ is dedicated to delivering high-quality medical devices utilizing LEAN principles and manufacturing in a highly controlled environment. Our investment in a new ISO Class 7 cleanroom located in New Hampshire demonstrates our commitment to serving the increasing demands of our customers. We maintain tight environmental controls on our Class 7 and Class 8 cleanrooms to ensure that temperature, positive pressure, humidity, and bioburden are held within limits necessary to maintain control of our processes. We routinely take particle counts for both viable and non-viable particulate, verifying that they are below our alert and action limits.

Whether you are a small start-up or a large, multinational customer, you will benefit from our dedicated Value Streams, which are customer-focused and prepared to meet your every need. LEAN principles are embedded in the culture of the Value Stream team. Once your product becomes part of our manufacturing operation, the Value Stream is dedicated to identifying and reducing waste, improving cycle times, and tracking important metrics with objective evidence of productivity, on-time delivery, lot acceptance, and supplier quality. Our customers have benefited from up to a 50% reduction in production costs on our mature product lines.

Looking for a single partner capable of supporting all of your complex EMS and disposable device needs? nextphasemed.com l 1-877-639-2673 © Copyright 2019 NextPhase Medical Devices LLC. The name “NextPhase” is a registered trademark of NextPhase Medical Devices LLC. All rights reserved.

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18

COMPANIES RANKED BY REVENUE

RANK

COMPANY

REVENUES ($USD)

REVENUES (INTERNATIONAL)

37

Coloplast

$2,605,534,523

(kr16,449,000,000)

38

Cooper Cos.

$2,532,800,000

2018 rank: 42 (+4)

39

Paul Hartmann

$2,504,022,300

2018 rank: 39 (no change)

(€2,119,000,000)

2018 RANK/CHANGE 2018 rank: 37 (no change)

40

Teleflex

$2,448,383,000

2018 rank: 41 (+1)

41

Bio-Rad

$2,289,415,000

2018 rank: 40 (-1)

42

Demant

$2,207,631,750

2018 rank: 43 (+1)

43

Align Technology

$1,966,492,000

44

Drägerwerk (medical business)

$1,941,533,100

45

Bruker

$1,895,600,000

2018 rank: 45 (no change)

46

ConvaTec

$1,832,000,000

2018 rank: 46 (no change)

47

Miraca

$1,643,251,812

(¥181,415,000,000)

2018 rank: 47 (no change)

(kr13,937,000,000) (€1,643,000,000)

2018 rank: 49 (+6) 2018 rank: 44 (no change)

48

Nihon Kohden

$1,619,556,159

(¥178,799,000,000)

49

Amplifon

$1,609,751,918

(€1,372,700,000)

2018 rank: 50 (+1)

50

Elekta

$1,559,031,572

(kr13,555,000,000)

2018 rank: 52 (+2)

51

Carl Zeiss Meditec

$1,513,639,530

(€1,280,860,000)

2018 rank: 54 (+3)

2018 rank: 48 (no change)

52

Integra Lifesciences

$1,472,441,000

2018 rank: 59 (+7)

53

Cochlear

$1,446,100,000

2018 rank: 53 (no change)

54

ICU Medical

$1,400,040,000

2018 rank: 55 (+1)

55

Straumann

$1,393,663,123

2018 rank: 62 (+7)

56

Integer

57

Smiths Medical

58 59

(CHF1,363,560,000)

$1,215,012,000

2018 rank: 61 (+5)

$1,182,625,500

(£885,000,000)

2018 rank: 56 (-1)

Fukuda Denshi

$1,175,498,188

(¥129,775,000,000)

2018 rank: 57 (-1)

LivaNova

$1,106,961,000

2018 rank: 64 (+5)

(Smiths Group)

60

NuVasive

$1,101,714,000

2018 rank: 63 (+3)

61

Omron (healthcare segment)

$1,047,690,217

2018 rank: 66 (+5)

62

Dexcom

$1,031,600,000

2018 rank: 75 (+13)

63

Invacare

$972,347,000

2018 rank: 67 (+4)

(¥115,665,000,000)

64

Haemonetics

$967,579,000

2018 rank: 68 (+4)

65

GN Hearing

$923,951,783

2018 rank: 70 (+5)

66

Merit Medical Systems

$882,753,000

2018 rank: 74 (+8)

67

Conmed

$859,634,000

2018 rank: 72 (+5)

(kr5,833,000,000)

68

Masimo

$858,289,000

2018 rank: 71 (+3)

69

Konica Minolta (healthcare segment)

$837,862,319

2018 rank: 69 (no change)

70

Wright Medical

$836,190,000

2018 rank: 73 (+3)

71

Abiomed

$769,432,000

2018 rank: 77 (+6)

(¥90,900,000,000)

72

Fisher & Paykel Healthcare

$741,403,000

73

Avanos Medical

$652,300,000

2018 rank: 76 (+3)

74

Össur

$612,876,000

2018 rank: 78 (+4)

75

Insulet

$563,823,000

2018 rank: 82 (+7)

76

Natus Medical

$530,891,000

2018 rank: 80 (+4)

Medical Design & Outsourcing

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(NZ$1,070,000,000)

n/a

www.medicaldesignandoutsourcing.com

9/14/19 11:14 PM

Don’t just take our word for it.

Listen to Christine.

“We Need Wireless Foot Switches In The OR!” “Wireless foot switches are the way to go for some vitally important reasons. They can be placed in fully contained covers during a procedure making them much easier to keep clean. They are a lot more cost-effective for hospitals because there isn’t the expense of replacing damaged cables or even replacing cabled foot switches entirely. And they prevent slip trip falls, which is a significant safety issue.”

– Christine Gagnon, BSN, RN, OR Nurse

Selling your customers an inferior-grade industrial cabled foot switch will eventually cost you business. Call Steute today and see why we are the world leader in wireless technology and why we are so price-competitive with other wireless brands.

www.steutemeditech.com/worldclasswireless

Direct Contact: Maurizio Lauria, Brand Manager 203.244.6302/maurizio.lauria@steuteusa.com

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S S S

COMPANIES RANKED BY REVENUE

RANK

COMPANY

REVENUES ($USD)

REVENUES (INTERNATIONAL)

2018 RANK/CHANGE

77

JMS Co.

$511,956,522

(¥56,520,000,000)

2018 rank: 79 (+2)

78

Nikkiso (medical segment)

$504,637,681

(¥55,712,000,000)

2018 rank: 81 (+3)

79

Orthofix

$453,042,000

80

Topcon (eye care segment)

$432,182,971

(¥47,713,000,000)

2018 rank: 84 (+4)

81

Ambu

$412,792,447

(kr2,606,000,000)

new entrant

82

Nevro

$387,289,000

new entrant

83

Barco (healthcare division)

$289,523,590

2018 rank: 90 (+7)

(€245,006,000)

2018 rank: 83 (+4)

84

RTI Surgical

$280,855,000

2018 rank: 89 (+5)

85

CryoLife

$262,841,000

2018 rank: 93 (+8)

86

AtriCure

$201,630,000

2018 rank: 94 (+8)

87

Glaukos

$181,278,000

new entrant

88

Endologix

$156,473,000

new entrant

89

SeaSpine

$143,443,000

2018 rank: 95 (+6)

90

Sectra (imaging IT division)

$138,501,351

2018 rank: 96 (+6)

91

Conformis

$89,789,000

(kr1,204,200,000)

2018 rank: 98 (+7)

92

Alphatec

$83,656,000

2018 rank: 97 (+5)

93

Si-Bone

$55,380,000

new entrant

94

Inspire Medical Systems

$50,593,000

new entrant

95

EDAP

$46,302,551

2018 rank: 100 (+5)

(€39,183,000)

96

Utah Medical Products

$41,998,000

2018 rank: 99 (+3)

97

Retractable Technologies

$33,275,000

2018 rank: 101 (+4)

98

TransEnterix

$24,102,000

new entrant

99

Brainsway

$16,397,000

new entrant

100

Ra Medical Systems

$6,257,000

new entrant

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1

Medtronic

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

$30,557,000,000* *Fiscal year ended 4/26/2019

2018 rank:

R&D spend: Employees: Revenues/employee:

1 $2,330,000,000 90,000 $339,522

Key personnel: OMAR ISHRAK, chairman & CEO; MICHAEL COYLE, EVP & president, cardiac & vascular; ALEX GU, SVP & president, greater China; HOOMAN HAKAMI, EVP & president, diabetes; DR. RICHARD KUNTZ, chief medical & scientific officer; CHRIS LEE, SVP & president, Asia Pacific; BRAD LERMAN, SVP, GC & corporate secretary; DR. JOHN LIDDICOAT, EVP & president, Americas; GEOFF MARTHA, EVP & president, restorative therapies; KAREN PARKHILL, EVP & CFO; LUANN PENDY, SVP, chief quality & regulatory affairs officer; MARK PLOOF, SVP, global operations & business services; CAROL SURFACE, SVP & chief HR officer; ROB TEN HOEDT, EVP & president, Europe, Middle East, & Africa; BOB WHITE, EVP & president, minimally invasive therapies

MEDTRONIC closed out 2018 with the sad news of the death of Earl Bakken, who in 1949 co-founded the company in an unheated boxcar behind his brother-in-law’s house.

Bakken led the company for four decades, until his 1989 retirement. The year also saw a big-splash entry into the orthopedic robotics pool, with the $1.7 billion acquisition of Mazor Robotics, and a brief glimpse of the company’s plans to compete in robotic internal surgery against Intuitive Surgical’s da Vinci SP. On the financial front, Medtronic’s fiscal 2019 beat the consensus forecast, with profits surging 49.2% to $4.63 billion on sales growth of 2.0% to $30.56 billion. Although challenged along with other paclitaxel-eluting device makers by a JAMA study suggesting

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higher risk of late death for peripheral artery disease patients treated with those devices, the company was buoyed by the FDA’s decision to expand the approval for its TAVR devices to include low-risk patients. And just before this issue went to print, the company revealed a CEO succession plan that will see Omar Ishrak depart next year, to be replaced by longtime lieutenant Geoff Martha. During his eight-year tenure, Ishrak doubled annual revenues, added $100 billion to Medtronic's market cap and sustained early turns toward global markets and value-based healthcare.

But it’s acquisitions — including the largestever medtech merger, Medtronic’s $50 billion buyout of Covidien in early 2015 ­for which he’ll be most be remembered. – BP M

9 • 2019

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No.

2 Johnson & Johnson New Brunswick, N.J.

(medical device segment)

$27,000,000,000* *Fiscal year ended 12/31/2018

2018 rank: 2 R&D spend: $1,764,000,000

Key personnel: ALEX GORSKY, chairman & CEO; JOAQUIN DUATO, vice chairman; PETER FASOLO, EVP, chief HR officer; ASHLEY MCEVOY, EVP, chairwoman, medical devices; THIBAUT MONGON, EVP, chairman, consumer; MICHAEL SNEED, EVP, global corporate affairs & chief communications officer, PAUL STOFFELS, vice chairman, chief scientific officer; JENNIFER TAUBERT, EVP, chairwoman, pharmaceuticals; MICHAEL ULLMANN, EVP, GC; KATHY WENGEL, EVP & chief global supply chain officer; JOSEPH WOLK, EVP, CFO.

JOHNSON & JOHNSON made inroads into one of medtech’s hottest areas during the year, spending $3.4 billion on Auris Health and its Monarch robot-assisted bronchoscopy platform in a move to complement the robotassisted general surgery program it has with Verb Surgical and the Orthotaxy orthopedic platform it acquired. And it went after robotics pioneer Intuitive Surgical, with the U.S. International Trade Commission agreeing to examine its complaint that Intuitive’s imported surgical stapler cartridges infringe a quintet of J&J patents. J&J continued its restructuring of the medical device segment with a pair of divestitures: the sale of its Advanced

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Sterilization Products biz to Fortive for $2.8 billion and the $2.1 billion deal for its LifeScan blood glucose monitoring subsidiary with Platinum Equity. In legal news, the first lawsuit filed by a state attorney general over pelvic mesh products went to trial, alleging that subsidiary Ethicon concealed the potential risks of mesh from the public and physicians. In April J&J settled a similar case in Washington for $10 million; Kentucky is also suing Ethicon.

And most of the remaining metal-on-metal hip cases facing its DePuy Synthes subsidiary could be settled for about $1 billion. Full-year profits were $15.30 billion on sales of $81.58 billion, beating the consensus on Wall Street. – BP M

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No.

3 Royal Philips Amsterdam

$21,413,585,700* *Fiscal year ended 12/31/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

(€18,121,000,000)

4 $2,079,792,000 77,400 $276,661

Key personnel: FRANS VAN HOUTEN, CEO; SOPHIE BECHU, EVP, COO; ABHIJIT BHATTACHARYA, EVP, CFO; ROB CASCELLA, EVP, chief business leader, precision diagnosis; MARNIX VAN GINNEKEN, EVP, chief legal officer; ANDY HO, EVP, CEO, Philips Greater China; ROY JAKOBS, EVP, chief business leader, personal health; HENK SIEBREN DE JONG, EVP, chief of international markets; RONALD DE JONG, EVP, chief HR officer & chairman, Philips Foundation; CARLA KRIWET, EVP, chief business leader, connected care; BERT VAN MEURS, EVP, chief business leader, image guided therapy; VITOR ROCHA, EVP, CEO, Philips North America; JEROEN TAS, EVP, chief innovation & strategy officer

ROYAL PHILIPS rejiggered in January, shifting its sleep & respiratory segment from personal health to the new connected care division and moving healthcare informatics into the diagnosis & treatment segment. Under the new structure Philips has three divisions: diagnosis & treatment, connected care and personal health. It made some buys during the year as well, acquiring teleradiology platform developer Direct Radiology, Carestream Health’s imaging IT business, pulse oximetry sensor maker Xhale Assurance and Bostonbased patient navigation platform Medumo — all for undisclosed amounts. Although it sold its Andover, Mass.-based U.S. headquarters for

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$36 million, in June 2019 Philips opened a new R&D center in Rochester, Minn., to facilitate its collaboration with the Mayo Clinic. A pair of Foreign Corrupt Practices Act cases made international headlines, with the U.S. Securities & Exchange Commission investigating Philips, Siemens and GE Healthcare for allegedly using local middlemen to bribe Chinese officials and hospital officials and federal prosecutors in Brazil claiming Philips’ involvement in a medical equipment price-fixing scheme as part of an international health-care cartel. Full-year profits were down -41.3% to €1.10 billion, or €1.75 per share, on sales growth of 1.9% to €18.12 billion. – BP M

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Medical Design & Outsourcing 27

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No.

4 GE Healthcare (General Electric) Chicago

$19,784,000,000* *Fiscal year ended 12/31/2018

2018 rank: 5

Key personnel: KIERAN MURPHY, president & CEO; MONISH PATOLAWALA, CFO; Katya Kruglova, VP, HR; JAMES BORZI, VP, chief supply chain officer; MICHAEL MCALEVEY, VP, GC & business development; EHREN POWELL, CIO; THOMAS WESTRICK VP & CQO; GREG GIBBONS, chief communications officer; AMIT PHADNIS, chief digital officer; TERRI BRESENHAM, chief innovation officer; TOM MCGUINNESS, president & CEO, imaging; ANDERS WOLD, president & CEO, clinical care solutions; EMMANUEL LIGNER, president & CEO, life sciences; KEVIN O’NEILL, president & CEO, pharmaceutical diagnostics; JAN MAKELA, president & CEO, global services; LAURENT DUBOIS, CEO healthcare partners

GE HEALTHCARE still wound up under the umbrella of troubled parent General Electric after a tumultuous year. GE announced in June 2018 that it was looking to sell off a 20% stake and by January was said to be eyeing an even bigger carveout, of as much as 49.9%. But in February new CEO Larry Culp, the former Danaher chief hired in October 2018 to engineer a turnaround, tabled the healthcare spinout so the industrial conglomerate could focus on the $21 billion

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sale of its biopharmaceuticals business. In June of this year GE was said to be shopping its venture capital portfolio of more than 100 startups across the healthcare, tech and energy sectors, looking to rein in its $110 billion debt load. GE Healthcare logged fullyear profit growth of 6.0% to $3.70 billion on sales growth of 4.0% to $19.78 billion, while its parent’s full-year losses rose 155.6% to -$22.80 billion on sales growth of 2.3% to $113.54 billion. – BP M

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Medical Design & Outsourcing 29

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No.

5 Fresenius

(medical care segment)

Bad Homburg, Germany

$19,553,589,900* *Fiscal year ended 12/31/2018

2018 rank:

R&D spend:

Employees: Revenues/employee:

(€16,547,000,000)

3 $158,347,800 112,658 $173,566

Key personnel: RICE POWELL, chairman & CEO; MICHAEL BROSNAN, CFO; DR. KATARZYNA MAZUR-HOFSÄSS, CEO, EMEA; OLAF SCHERMEIER, CEO, global R&D; KENT WANZEK, CEO, global manufacturing, quality & supply; HARRY DE WIT, CEO, Asia-Pacific; BILL VALLE, CEO, North America; MIKE ASSELTA, president, Fresenius Kidney Care; JEFF BURBANK, CTO, Fresenius Medical Care North America; CHRIS CHURCHILL, SVP, corporate strategy & innovation, Fresenius Medical Care North America; MARK COSTANZO, president, Fresenius Renal Therapies; KATE DOBBS, SVP, marketing & communications, Fresenius Medical Care North America; LISA ESTRADA, chief compliance officer, Fresenius Medical Care North America; BRIAN GAUGER, chief development officer, Fresenius Medical Care North America; PETER GLADITSCH, CFO, Fresenius Medical Care North America; KAREN GLEDHILL, GC, Fresenius Medical Care North America; RAVI KALATHIL, CIO, Fresenius Medical Care North America; CAMERON LYNCH, SVP, government affairs, Fresenius Medical Care North America; DR. ROSS KOSSMAN, chief medical officer, Fresenius Medical Care North America; ANGELA MCCLURE, chief experience officer, Fresenius Medical Care North America; WILLIAM MCKINNEY, president, integrated care; BRIAN SILVA, chief HR officer, Fresenius Medical Care North America; JEFF SNODGRASS, president, Azura Vascular Care; JOE TURK, president, home & critical care therapies, Fresenius Medical Care North America

The biggest news for FRESENIUS was the long-delayed closing of its $2 billion NxStage Medical buyout, bringing the home hemodialysis pioneer under its umbrella after 21 months of scrutiny by anti-trust regulators. In June 2018 Fresenius closed the sale of its Sound Inpatient Physician Holdings unit to an investment consortium led by Summit Partners for approximately $2.2 billion (E.U. €1.9 billion), as part of its self-stated goal of “sharpening the profile of the company’s care coordination portfolio.” The German renal health giant also agreed to pay $231 million to the U.S. Securities & Exchange Commission to resolve self-reported violations of the Foreign Corrupt Practices Act in Saudi Arabia,

Morocco, Angola, Turkey, Spain, China, Serbia, Bosnia, Mexico and eight countries in West Africa. The company’s stock took a hit in July 2019 on news that the Trump administration plans to overhaul the kidney treatment market, seeking to lower the federal government’s annual $100 billion kidney care tab. The strategy involves new payment models from the U.S. Health & Human Services Dept. designed to move patients out of dialysis clinics — a bread-and-butter business for Fresenius — and into their own homes for treatment; HHS also plans to increase prevention and screening for kidney disease. For 2018, net income rose 55% to €1.98 billion on a -7% sales decline to €16.55 billion. – BP M

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9 • 2019

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No.

6 Siemens Healthineers Erlangen, Germany

$15,864,322,500* *Fiscal year ended 9/30/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

(€13,425,000,000)

7 $1,513,757,700 50,000 $317,286

Key personnel: BERND MONTAG, CEO; JOCHEN SCHMITZ, CFO; MICHAEL REITERMANN, president, diagnostics

Count SIEMENS HEALTHINEERS among the medical device companies making big plays in surgical robotics. In August, there was news that the company’s Siemens Medical Solution subsidiary planned to spend $1.1 billion to acquire Corindus Vascular Robotics, maker of the FDA-cleared CorPath GRX Vascular Robotic System. Mark Toland, Corindus’ CEO, said at the time that the deal would combine the company’s precision robotics with Siemens Healthineers’ imaging, digital and artificial intelligence tools. The Siemens Group subsidiary is a major manufacturer of medical imaging systems, including computed tomography, MRI, molecular imaging, X-rays and ultrasound. The company also makes

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angiography systems, mobile C-arms and hybrid ORs for image-guided therapy — as well as diagnostic testing systems. Other offerings include software and clinical consulting. The company’s R&D efforts have been especially focused on artificial intelligence, according to the Siemens Group’s annual report for fiscal 2018. Company officials think AI could improve the handling of medical information, find hidden patterns and enable better clinical decisions. Revenue and profits were a bit down for Siemens Healthineers for the fiscal year ended Sept.

30, 2018, with company officials blaming “significant negative effects from currency translation.” – CN M

9 • 2019

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No.

7 Cardinal Health Dublin, Ohio

(medical segment)

$15,633,000,000* *Fiscal year ended 6/30/2019

2018 rank: 6 Employees: 49,500 Revenues/employee: $315,818 Key personnel: MICHAEL KAUFMANN, CEO, CFO; VICTOR CRAWFORD, CEO, pharmaceutical; STEPHEN MASON, CEO, medical; MICHELE HOLCOMB, EVP, strategy & corporate development; OLA SNOW, chief HR officer; JESSICA MAYER, chief legal & compliance officer; BRIAN RICE, EVP, CIO & customer support services

CARDINAL HEALTH appears to have a lot of work to do when it comes to its medical segment. Revenue was flat and profits were down for the segment during the company’s most recent fiscal year, which ended June 30. It’s been about four years since Cardinal Health spent $1.94 billion to acquire Cordis from Johnson & Johnson, but the company is still working through challenges related to the maker of stents, balloons and other interventional cardiology products. CEO Mike Kaufmann claimed in an August earnings call that Cordis is on the path to profitability,

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TOP 10 100 List_9-19_Vs3-BP-FINAL.indd 35

citing top-line growth in many geographies and improvement in fill rates and back orders. Cardinal Health recently introduced a new sales structure for its medical business and is engaged in a lengthy process of transforming its manufacturing, supply chain and data capabilities. The focus for now is on execution versus M&A around product acquisition, Kaufmann said. The company in August promoted Stephen Mason, previously president of the Cardinal Health At-Home Solutions business, to become CEO of the medical segment. – CN M

9 • 2019

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No.

8 Danaher

(life sciences, diagnostics & dental segments)

Washington, D.C.

$15,573,500,000* *Fiscal year ended 12/31/2018

2018 rank: 8

Key personnel: THOMAS JOYCE JR., president & CEO; DANIEL COMAS, EVP; MATT MCGREW, EVP, CFO; RAINER BLAIR, EVP; WILLIAM DANIEL II, EVP; JOAKIM WEIDEMANIS, EVP; BRIAN ELLIS, SVP, GC; WILLIAM KING IV, SVP, strategic development; ANGELA LALOR, SVP, HR; ROBERT LUTZ, SVP, chief accounting officer; DANIEL RASKAS, SVP, corporate development

DANAHER remains on track to turn its dental business into a new publicly traded company called Envista before the end of the year. The dental business makes dental prosthetics, orthodontic bracket systems and much more.

Washington, D.C.-based Danaher is also moving forward with its planned $21 billion acquisition of

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GE Biopharma. The diagnostics business makes analytical instruments, reagents, consumables, software and services. The life sciences business makes research tools to study genes, proteins, metabolites and cells, as well as filtration, separation and purification technologies used in medical and other sectors. – CN M

9 • 2019

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No.

9 Stryker

Kalamazoo, Mich.

$13,600,000,000* *Fiscal year ended 12/31/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

10 $862,000,000 36,000 $377,778

Key personnel: KEVIN LOBO, chairman & CEO; MICHAEL HUTCHINSON, GC; YIN BECKER, VP, communications, public affairs & strategic marketing; BIJOY SAGAR, VP & CIO; KATHERINE OWEN, VP, strategy & IR; LONNY CARPENTER, president, global quality & business operations; KATHRYN FINK, VP, HR; DAVID FLOYD, president, orthopedics; TIMOTHY SCANNELL, president, MedSurg & neurotechnology; WILLIAM JELLISON, VP & CFO

The world’s largest orthopedic device company is enjoying strong momentum this year, after a 2018 in which its bottom line more than tripled to $3.6 billion and sales grew 9.3% to $13.6 billion. STRYKER officials see the company bolstering its position in the spine market as it integrates K2M, which the company acquired for about $1.4 billion in November 2018. Demand also remains high

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TOP 10 100 List_9-19_Vs3-BP-FINAL.indd 39

for Stryker’s Mako systems for robot-assisted knee and hip surgery. SVB Leerink analysts wrote during the AAOS annual meeting in March that Mako remains best-in-class in an expanding category. Stryker this month announced it would further bolster its early position in robotics with a $500 million allcash bid for Mobius Imaging and its Cardan Robotics subsidiary. – CN M

9 • 2019

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No.

10 EssilorLuxottica

Charenton-le-Pont, France

$12,761,178,300* *Fiscal year ended 12/31/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

(€10,799,000,000)

15 $224,523,000 150,000 $85,075

Key personnel: LAURENT VACHEROT, CEO; JAYANTH BHUVARAGHAN, chief mission officer & communication; JEAN CARRIER-GUILLOMET, co-COO; NORBERT GORNY, chief R&D officer, IP; HILARY HALPER, CFO; GRITA LOEBSACK, chief marketing officer; FRÉDÉRIC MATHIEU, corporate SVP, HR; BERNHARD NUESSER, president, online; PAUL DU SAILLANT, deputy CEO; JEREMY TEO, chief strategy officer; ÉRIC THOREUX, Co-COO, president, sun, readers & China

Touted as a merger of eyeglass lenses with frames, the combination last year of French lens manufacturer ESSILOR with Italian eyewear maker LUXOTTICA created the world’s 10th largest medical device company.

EssilorLuxottica boasts nearly 150,000 employees and consolidated reported

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TOP 10 100 List_9-19_Vs3-BP-FINAL.indd 41

annual revenue equal to nearly $12.8 billion.

EssilorLuxottica is seeking further dominance of the eyewear market, announcing over the summer that it intended to spend the equivalent of billions of dollars to acquire GrandVision and its 7,200 eyewear stores around the world. – CN M

9 • 2019

Medical Design & Outsourcing 41

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No.

11 Abbott

(medical device segment)

Abbott Park, Ill.

$11,400,000,000* *Fiscal year ended 12/31/2018

2018 rank: 14

Key personnel: MILES WHITE, chairman & CEO; ROBERT FORD, president & COO; HUBERT ALLEN, EVP, GC & secretary; JOHN CAPEK, EVP, ventures; LISA EARNHARDT, EVP, medical devices; JOHN GINASCOL, EVP, core diagnostics; ANDREW LANE, EVP, established pharmaceuticals; MARY MORELAND, EVP, HR; DANIEL SALVADORI, EVP, nutritional products; ANDREA WAINER, EVP, rapid & molecular diagnostics; BRIAN YOOR, EVP, finance & CFO; ROGER BIRD, SVP, U.S. nutrition; CHUCK BRYNELSEN, SVP, Abbott Vascular; JAIME CONTRERAS, SVP, core laboratory diagnostics, commercial operations; ROBERT FUNCK, SVP, finance & controller; SAMMY KARAM, SVP, emerging markets established pharmaceuticals; JOSEPH MANNING, SVP, international nutrition; CORLIS MURRAY, SVP, quality assurance, regulatory & engineering services; MICHAEL PEDERSON, SVP, cardiac arrhythmias & heart failure; CHRISTOPHER SCOGGINS, SVP, rapid diagnostics; JARED WATKIN, SVP, diabetes care; ALEJANDRO WELLISCH, SVP, established pharmaceuticals, Latin America; RANDEL WOODGRIFT, SVP, CRM

ABBOTT got behind the diabetes market in a big way this year, investing heavily in its FreeStyle Libre system, with CEO Miles White staking a claim on sensor-based CGMs as the future standard of care. White ignited speculation on a possible succession plan when he tapped Abbott veteran Robert Ford as president and

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COO — the first second-in-command at Abbott in more than a decade. The company added to its structural heart portolio by exercising the option on Cephea Valve Technologies and its transcatheter mitral valve device. Full-year profits surged 396.4% to $2.37 billion, on sales growth of 11.6% to $30.58 billion. – BP M

www.medicaldesignandoutsourcing.com

9/14/19 11:26 PM

Providing High Speed Solutions... ...in a High Paced Market.

In this industry, the demand for new products can rise in a heartbeat. And if you’re not first to market, you may as well be last. That’s why more OEMs turn to PTI Engineered Plastics. We specialize in complex, low volume plastic injection molding. We can design, engineer and manufacture any part to your specifications and deliver it in record time — without ever missing a beat.

To learn more, call 586.263.5100 or visit teampti.com Prototype | Design | Engineering | 3D CAD Modeling | Tooling | Molding | Manufacturing | Cleanroom Molding

PTI Engineering 9-19.indd 56

9/13/19 3:04 PM

No.

12 Baxter

Deerfield, Ill.

$11,127,000,000* *Fiscal year ended 12/31/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

11 $655,000,000 50,000 $222,540

Key personnel: JOE ALMEIDA, chairman, president & CEO; GIUSEPPE ACCOGLI, SVP & president, Americas; LAURA ANGELINI, GM, renal care; SCOTT BOHABOY, SVP, finance, global business & R&D & treasurer; WIL BOREN, president, advanced surgery; DENNIS CROWLEY, SVP, business development & licensing; STACY EISEN, SVP, global communications & president, Baxter International Foundation; DAVID FERGUSON, GM, medication delivery; CRISTIANO FRANZI, SVP & president, EMEA; ANDREW FRYE, SVP & president, APAC; HEATHER KNIGHT, GM, U.S. hospital products; JACQUELINE KUNZLER, SVP, CQO; PAUL MARTIN, SVP & CIO; SEAN MARTIN, SVP & GC; JEANNE MASON, SVP, HR; ELLEN MCINTOSH, SVP & corporate secretary; DR. SUMANT RAMACHANDRA, SVP, chief science & technology officer; REAZ RASUL, GM, acute therapies; PHILIPPE REALE, VP, global supply chain; DAVID ROMAN, VP, strategy; JAMES SACCARO, EVP & CFO; CATHY SKALA, VP, business transformation office; BRAIN STEVENS, SVP, chief accounting officer & controller; CLARE TRACHTMAN, VP, IR; JORGE VASSEUR, GM, clinical nutrition.

BAXTER was all in on renal care during the year, looking to leverage its already significant kidney resources to exploit a CMS plan to overhaul the way kidney disease is treated in the U.S. CEO Joe Almeida pledged to invest $500 million toward increasing Baxter’s home dialysis footprint

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Medical Design & Outsourcing

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and the company inked deals with Biomérieux (to develop biomarkers for acute kidney injury) and the Mayo Clinic (for a new renal care center).

Full-year profits surged 126.5% to $1.62 billion, or $2.97 per share, on sales growth of 5.4% to $11.27 billion, compared with 2017. – BP M

www.medicaldesignandoutsourcing.com

9/14/19 11:26 PM

ENGAGING THE PROCESS

1

EARLIER 2

Tool Design

All tool designs are done in 3D CAD. Once completed, AIM will first conduct an on-line meeting with the customer to review the tool design ensuring all critical criteria is addressed.

Design for Manufacturability

AIM’s mold designers review part details to ascertain tool complexity, cycle time, and possible cosmetic and physical issues in the part.

Recommendations are made to reduce cost and increase process stability and consistency of the final product.

3

Tool Construction

AIM employs a large state-ofthe-art toolroom to utilize the Prototype Plus™ process.

4

Injection Molding SIM & FAI

5

Quality Validation

Process development starts with Scientific Injection Molding. This ensures long term capability of the molding process, followed by a 100% FAI... confirming part to print.

With our highly trained staff and well equipped lab, AIM Plastics is prepared to handle any level of validation that is required!

TYPICAL DURATION

TYPICAL DURATION

TYPICAL DURATION

TYPICAL DURATION

TYPICAL DURATION

2 - 5 days

Concurrent

1 - 4 weeks

1 - 2 weeks

Job Specific

DFM FEEDBACK

TOOLING CHANGE

PROTOTYPE LEAD-TIMES FOR A PRODUCTION CAPABLE PART AND VALIDATION CAPABLE PROCESS!” IT ALL STARTS WITH TOOL DESIGN AND CONSTRUCTION. AIM’s Design for Manufacturability (DFM) assistance is the cornerstone of every part. Our experienced mold designers help ensure that your design will produce consistent, superior results.

AIM’s toolroom is much more than just state-of-the-art equipment. Our expert mold makers are the difference. AIM employs some of the most skilled tradesmen in the nation who are experienced in complex tool construction.

A FLAWLESS MOLD IS JUST THE BEGINNING. Our Scientific Injection Molding (SIM) process combined with the validation master plan assures that your mold produces a capable part... EVERY TIME! INNOVATIVE CONTRACT MANUFACTURING DESIGN FOR MANUFACTURABILITY

IN-HOUSE TOOLING

ISO 13485: 2016 CERTIFIED CLEAN ROOM MOLDING

AUTOMATED ASSEMBLY

CUSTOM PACKAGING

CONTACT AIM: (586) 954-2553 | rfq@aimplastics.com | aimplastics.com AIM Plastics 9-19.indd 56

9/13/19 3:58 PM

No.

13 Owens & Minor Mechanicsville, Va.

$9,838,708,000* *Fiscal year ended 12/31/2018

2018 rank: 12 Employees: 17,000 Revenues/employee: $578,748 Key personnel: EDWARD PESICKA, president & CEO; JEFFREY JOCHIMS, EVP, strategy & solutions; JONATHAN LEON, SVP, corporate treasurer; CHRISTOPHER LOWERY, president, global products; MICHAEL LOWRY, SVP, controller & chief accounting officer; SHANA NEAL, SVP, chief HR officer; NICHOLAS PACE, EVP, GC & corporate secretary; JOSEPH PEKALA, SVP & CIO; ROBERT SNEAD, EVP & CFO; MARK ZACUR, SVP, chief procurement officer

OWENS & MINOR this year named former Thermo Fisher chief commercial officer Edward Pesicka as its new CEO, replacing interim chief Robert Sledd, who kept the chairman’s seat. Full-year losses grew some

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500% as the company digested the $710 million acquisition of the surgical & infection prevention business from Halyard Health (now Avanos), to –$437 million, on sales growth of 5.6% to $9.84 billion. – BP M

www.medicaldesignandoutsourcing.com

9/14/19 11:27 PM

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No.

14 Boston Scientific Marlborough, Mass.

$9,823,000,000* *Fiscal year ended 12/31/2018

2018 rank:

R&D spend:

Employees: Revenues/employee:

13 $1,113,000,000 32,000 $306,969

Key personnel: MICHAEL MAHONEY, chairman & CEO; KEVIN BALLINGER, EVP & president, interventional cardiology; DANIEL BRENNAN, EVP & CFO; ART BUTCHER, SVP & president, endoscopy; WENDY CARRUTHERS, SVP, HR; JODI EDDY, SVP & CIO; JOSEPH FITZGERALD, EVP & president, rhythm management; EDWARD MACKEY, EVP, global operations; DR. IAN MEREDITH, EVP & global chief medical officer; JEFF MIRVISS, SVP & president, peripheral interventions; MAULIK NANAVATY, SVP & president, neuromodulation; DAVID PIERCE, EVP & president, MedSurg; DESIREE RALLSMORRISON, SVP, GC & corporate secretary; BRAD SORENSON, SVP, manufacturing & supply chain; ERIC THÉPAUT, SVP & president, EMEA, WARREN WANG, SVP & president, Asia Pacific

BOSTON SCIENTIFIC closed out 2018 with plans for a three-year restructuring program that’s slated to slash annual pre-tax operating expenses by $100 million, to $150 million, by the end of 2022. Boston said it expects to maintain roughly the same number of workers, although there will be some churn as new jobs are created. Between the August

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Medical Design & Outsourcing

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2018 buyout of Claret Medical ($270 million) and the August 2019 pickup of BTG ($4 billion), the company also added Vertiflex ($465 million), Millipede ($450 million), Augmenix ($600 million) and Veniti ($160 million). Full-year profits were $1.7 billion, up a whopping 1,506%, on sales growth of 8.6% to $9.8 billion. – BP M

www.medicaldesignandoutsourcing.com

9/14/19 11:28 PM

MEDICAL DEVICE DESIGN & DEVELOPMENT SERVICES A Modular Based Approach for Your Entire Product Lifecycle

Concept Generation & Ideation

Human Factors & Usability Engineering

Single-use Interventional Devices

DFX

Phase Gate Product Development

Minimally Invasive Surgical Devices

Clinical

Commercialization

Technical Expertise with Clinical Devices

A Flexible Approach To Meet Your Goals Meddux has the ability to take you from concept-to-product launch or help support task specific projects to meet your goals. Founded on making a significant impact in patients' lives, our team helps to bring your innovative technologies to market quickly and effectively.

We work as an extension of your company’s team to solve your hardest challenges.

ISO 13485:2016

720-675-7154 • meddux.com

© 2019 Meddux Development Corporation. All rights reserved. The name “Meddux” is a registered trademark of Meddux Development Corporation.

Meddux 9-19.indd 56

9/13/19 2:51 PM

No.

15 Henry Schein Melville, N.Y.

$9,400,000,000* *Fiscal year ended 12/30/2018

2018 rank: 9 Employees: 18,000 Revenues/employee: $522,222 Key personnel: STANLEY BERGMAN, chairman & CEO; GERALD BENJAMIN, EVP, chief administrative officer; JAMES BRESLAWSKI, president; DAVID BROUS, president, strategic business units & Asia Pacific & Brazil dental; BRAD CONNETT, president, U.S. medical; MICHAEL ETTINGER, SVP, corporate & legal affairs, chief of staff, secretary; JAMES HARDING, CEO, Henry Schein One; JONATHAN KOCH, SVP, CEO, global dental group; LORELEI MCGLYNN, SVP, chief HR officer; MARK MLOTEK, EVP, chief strategic officer; JAMES MULLINS, SVP, global services; STEVEN PALADINO, EVP, CFO; CHRISTOPHER PENDERGAST, SVP, CTO; MICHAEL RACIOPPI, SVP, chief merchandising officer; WALTER SIEGEL, SVP, GC

HENRY SCHEIN this year closed its acquisition of survivability and casualty-care medical product maker North American Rescue and the $5 billion spinout of its animal health business, Covetrus, in a merger with Vets First Choice. Schein also

50

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partnered with Uber Health to enable doctors to have portable medical microcarts driven to people’s homes for remote examinations. Fullyear profits grew 31.9% to $535.9 million on sales growth of 5.9% to $13.2 billion. – BP M

www.medicaldesignandoutsourcing.com

9/14/19 11:28 PM

Always thinking.

Our solutions don’t come in a box.

Why would our ideas?

KahleÂŽ is dedicated to providing custom automation machinery solutions for the Medical Device, Pharmaceutical, and Healthcare Industries.

Visit www.KahleAutomation.com or contact Kahle@KahleAutomation.com Kahle 9-19.indd 56

9/13/19 2:48 PM

No.

16 Becton, Dickinson Franklin Lakes, N.J.

(medical segment)

$8,616,000,000* *Fiscal year ended 9/30/2018

2018 rank: 16

Key personnel: VINCENT FORLENZA, chairman & CEO; THOMAS POLEN, president & COO; SIMON CAMPION, EVP, president, interventional; ALEXANDRE CONROY, EVP, chief integrated supply chain officer; ROLAND GOETTE, EVP, president, EMEA; PATRICK KALTENBACH, EVP, president, life sciences; SAMRAT KHICHI, EVP, GC, public policy & regulatory affairs; BETTY LARSON, EVP, chief HR officer; JAMES LIM, EVP, president, Greater Asia; ALBERTO MAS, EVP, president, medical; CHRISTOPHER REIDY, EVP, CFO & chief administrative officer; PIERRE BOISIER, EVP, CQO; GARY COHEN, EVP, global health & president, BD Foundation; JOHN DEFORD, EVP, CTO, R&D; GEORGE PARR; EVP, chief marketing officer; WILLIAM SIGMUND, EVP, chief medical officer; LINDA THARBY, EVP, customer experience; CHARLES BODNER, SVP, corporate finance & chief accounting officer; GARY DEFAZIO, SVP, corporate secretary & associate GC; JOHN GALLAGHER, SVP, treasurer & CFO, medical; MICHELLE QUINN, SVP, chief ethics & compliance officer; ANTOINETTE SEGRETO, SVP, taxes; AMI SIMUNOVICH, SVP, chief regulatory officer

More than two-thirds of the revenues for BD’s medical segment involved medication delivery and management — important growth drivers for the business. Products in this category include a whole range of catheters, infusion pumps and systems, syringes and needles, medication compounding workflow systems and

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Medical Design & Outsourcing

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9 • 2019

automated medication dispensing devices.

BD also has a diabetes care business manufacturing syringes, pen needles and other products related to injection or infusion of insulin and other drugs. Its pharmaceutical systems business makes prefillable drug delivery systems including syringes, safety, shielding and self-injection systems. – CN M

www.medicaldesignandoutsourcing.com

9/14/19 11:28 PM

At Ximedica, we are trusted advisors to the healthcare industry’s top innovators, developing medical products that transform the lives of patients, caregivers, and clinicians every day.

From concept to commercialization, we guide our clients through every stage of the development process to bring innovative products to market faster, more consistently, and more efficiently than ever before.

ximedica.com

Ximedica 9-19.indd Advert Device Ximedica 56 Talks 9x10.875 AW.indd 1

9/16/19 PM 9/17/19 10:36 9:23 AM

No.

17 B. Braun Melsungen Melsungen, Germany

$8,163,301,770* *Fiscal year ended 12/31/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

18 $375,820,778 63,751 $128,050

Key personnel: ANNA MARIA BRAUN, CEO, chief HR officer, director, labor relations, Asia Pacific; ANNETTE BELLER, board member, finance, taxes & controlling, central service departments; MEINRAD LUGAN, board member, hospital care, outpatient market; CAROLL NEUBAUER, board member, North America; DR. JOACHIM SCHULZ, board member, B. Braun Aesculap; MARKUS STROTMANN, board member, B. Braun Avitum

B. BRAUN sells 5,000 medical products, most of which are manufactured by the company. Braun’s products include infusion pumps and systems, disinfection products,

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Medical Design & Outsourcing

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9 • 2019

surgical instruments, suture materials, hip and knee implants, dialysis equipment and accessories, and stoma, diabetes and wound care products. – CN M

www.medicaldesignandoutsourcing.com

9/14/19 11:28 PM

Quality goes up.

Headaches go down.

That changes everything.

Quality isn't just a box you check. It’s not limited to a process or even a department. It’s the ultimate differentiator. The MasterControl Platform helps you digitize, automate and connect critical processes, documents and data so you can improve quality across your entire product life cycle.

Explore how quality changes everything at www.mastercontrol.com

Master Control 5-19.indd 56

9/13/19 2:49 PM

No.

18 Zimmer Biomet Warsaw, Ind.

$7,932,900,000* *Fiscal year ended 12/31/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

17 $391,700,000 19,000 $417,521

Key personnel: BRYAN HANSON, president & CEO: AURE BRUNEAU, president, spine, CMF, thoracic & surgeryassisting technology; DIDIER DELTORT, president, EMEA; RACHEL ELLINGSON, SVP, strategy; DAVID KUNZ, SVP, global quality & regulatory affairs; COLE LANNUM, SVP, IR; ANGELA MAIN, SVP, global chief compliance officer & associate GC, Asia Pacific; PEDRO MALHA, president, dental; CHAD PHIPPS, SVP, GC & secretary; PAMELA PURYEAR, SVP, chief HR officer; ZEESHAN TARIQ, VP & CIO; IVAN TORNOS, group president, orthopedics; KENNETH TRIPP, SVP, global operations & logistics; SUKETU UPADHYAY, EVP & CFO; SANG YI, president, Asia Pacific

ZIMMER BIOMET in July raised its 2019 outlook after reporting Q2 results that beat Wall Street expectations. The orthopedic device giant reported that an ongoing turnaround is six months ahead of schedule. The company in 2018 won FDA clearance for its Persona revision knee implant and its customized components to match

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Medical Design & Outsourcing

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each patient’s anatomy. Early this year, Zimmer Biomet won clearance for the Rosa Knee robotassisted total knee replacement surgery platform, followed by clearance for the Rosa One robotic spine system. Zimmer Biomet is also touting Mymobility, its patient care management app for the Apple Watch and iPhone. – CN M

www.medicaldesignandoutsourcing.com

9/14/19 11:29 PM

Custom Packaging Solutions Focused 100% on Healthcare Nelipak provides total package, custom thermoformed solutions, value engineered to deliver ergonomic packaging fit-for-purpose reducing the cost of ownership and waste throughout the product lifecycle. Nelipak® develops award-winning packaging solutions using in-house design innovation, development, prototyping, tooling and production to ISO:13485 certified standards.

For more information, contact us: email: info@nelipak.com | phone: +1.401.946.2699

Nelipak 9-19.indd 56

SEALING MACHINES

HANDLING TRAYS

A range of custom-built medical tray and blister heat sealing machines

For high-speed production and automated pick-and place assembly and transit

MEDICAL DEVICE AND PHARMACEUTICAL PACKAGING Full-service solutions that provide superior quality and protection

9/20/19 10:11 AM

No.

19 Alcon

Fort Worth, Texas

$7,149,000,000* *Fiscal year ended 12/31/2018

2018 rank: 19

Key personnel: DAVID ENDICOTT, CEO; LAURENT ATTIAS, SVP, head global corp dev strategy, BD&L & M&A; HEATHER ATTRA, SVP, head global quality; JEANNETTE BANKES, president & GM, global surgical; ROYCE BEDWARD, SVP, GC & corporate secretary; IAN BELL, president, international; SERGIO DUPLAN, president, North America; SOPHIE DUTILLOY, president, EMEA; CAMILA FINZI, president, LACAR; KAREN KING, SVP, IR & communications; FRANCK LEVEILLER, SVP, head global R&D; SUE-JEAN LIN, SVP, CIO; ROGER LOPEZ, president, Japan; MERRICK MCCRACKEN, SVP, head global HR; ED MCGOUGH, SVP, head global manufacturing & technical operations; RAJKUMAR NARAYANAN, SVP, operational strategy & chief transformation officer; MICHAEL ONUSCHECK, president, global business & innovation; ANDY PAWSON, president & GM, global vision care franchise; TIM STONESIFER, SVP, CFO

Novartis in April completed the spinout of its ALCON vision care business, which is now its own publicly traded company. “For more than 70 years, Alcon has been dedicated to helping people see

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brilliantly and now, as an independent company, we are pursuing even more opportunities to further that mission,” CEO David Endicott said in prepared remarks at the time. – CN M

www.medicaldesignandoutsourcing.com

9/14/19 11:29 PM

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No.

20 3M Co.

(healthcare segment)

Maplewood, Minn.

$6,021,000,000* *Fiscal year ended 12/31/2018

2018 rank: 20

Key personnel: MICHAEL ROMAN, chairman & CEO; JOHN BANOVETZ, SVP, R&D, CTO; JULIE BUSHMAN, EVP, international operations; IVAN FONG, SVP, GC & secretary; NICHOLAS GANGESTAD, SVP & CFO; ERIC HAMMES, SVP, manufacturing & supply chain; PAUL KEEL, EVP, consumer; ASHISH KHANDPUR, EVP, transportation & electronics; KRISTEN LUDGATE, SVP, HR; MOJDEH POUL, EVP, healthcare; DENISE RUTHERFORD, SVP, corporate affairs; STEPHEN SHAFER, SVP, business development & marketing-sales; TY SILBERHORN, SVP, business transformation & IT; MICHAEL VALE, EVP, safety & industrial

3M is often associated with its popular consumer products such as Post-it Notes and Scotch tape, but it also happens to be one of the largest medical device companies in the world. 3M’s healthcare segment sells products and services including medical and surgical supplies, skin health and infection prevention

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Medical Design & Outsourcing

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products, dental and orthodontic products, health IT, and inhalation and transdermal drug delivery systems. 3M is also a major supplier to the medical device industry in general, helping medical device creators come up with solutions related to materials and adhesives. – CN M

www.medicaldesignandoutsourcing.com

9/14/19 11:29 PM

YOUR CUSTOM SOLUTIONS ARE CGI STANDARD PRODUCTS

Advanced Products for Medical Applications CGI Motion standard products are designed with customization in mind. Our team of experts will work with you on selecting the optimal base product and craft a unique solution to help differentiate your product or application. So when you think customization, think standard CGI assemblies. Connect with us today to explore what CGI Motion can do for you.

800.568.GEAR (4327) • www.cgimotion.com

copyright©2018 cgi inc. all rights reserved. 0516spd

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No.

21

Olympus Tokyo

(medical business)

Key personnel:

$5,745,480,072* *Fiscal year ended 3/31/2019

(¥634,301,000,000)

2018 rank: 21 Employees: 20,646 Revenues/employee: $278,285

YASUO TAKEUCHI, chairman, CEO & CFO; NACHO ABIA, president & CEO, Olympus Corp. of the Americas; PIERRE LACROIX, COO, CFO, Olympus Corp. of the Americas; TOMOHISA SAKURAI, president, Olympus Surgical Technologies America, corporate EVP, Olympus Corp. of the Americas, executive officer, Olympus Corp.; FABRICE CANCRE, president, Olympus Scientific Solutions Americas; RANDY CLARK, president, medical systems, Olympus Corp. of the Americas; GEORGE FIGUEROA, corporate VP, HR, Olympus Corp. of the Americas; STEPHEN FROEHLE, VP, GC, Olympus Corp. of the Americas; THOMAS GLAVIN, chief compliance officer, Olympus Corp. of the Americas; JULIEN SAUVAGNARGUES, president, Scientific Solutions & Consumer Products, Olympus America

No.

22

Terumo Tokyo

Key personnel:

$5,430,081,522* *Fiscal year ended 3/31/2019

(¥599,481,000,000)

2018 rank: 23

Employees: 24,000 Revenues/employee: $226,253

SHINJIRO SATO, president & CEO; TOSHIAKI TAKAGI, senior managing executive officer, CQO; SHOJI HATANO, managing executive officer, president, general hospital products; KYO NISHIKAWA, senior executive officer, chief HR officer; KAZUAKI KITABATAKE, managing executive officer, IR & corporate communication; HIKARU SAMEJIMA, managing executive officer, president, cardiac & vascular; TSUYOSHI TOMITA, senior executive officer, GM, general hospital products; MASATAKA HARAGUCHI, senior executive officer, GM sales promotion (Japan); TAKANORI SHIBAZAKI, senior executive officer, China; JUICHI TAKEUCHI, senior executive officer, president & CEO, Terumo Americas; TOSHIHIKO OSADA, senior executive officer, GM, strategic planning; TETSUYA KUMEI, senior executive officer, president, Alliance division; KAZUNORI HIROSE, senior executive officer, chief manufacturing officer; RICHARD CAPPETTA, executive officer, neurovascular

No.

23

Smith & Nephew London

Key personnel:

$4,904,000,000 *Fiscal year ended 12/31/2018

2018 rank: 22

R&D spend: $246,000,000

Employees: 16,000 Revenues/employee: $306,500

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NAMAL NAWANA, CEO; GRAHAM BAKER, CFO; BRAD CANNON, president, sports medical & ENT; CATHERYN O’ROURKE, chief legal & compliance officer; ELGA LOHLER, chief HR officer; MARK GLADWELL, president, global operations; MASSIMILIANO COLELLA, president, EMEA; MELISSA GUERDAN, chief quality & regulatory affairs officer; MYRA ESKES, president, Asia Pacific; PHIL COWDY, EVP, business development & corporate affairs; SIMON FRASER, president, advanced wound management; SKIP KIIL, president, orthopedics; SUSAN SWABEY, company secretary; VASANT PADMANABHAN, president, R&D

www.medicaldesignandoutsourcing.com

9/16/19 12:54 PM

Copyright © 2019 Vaupell Molding & Tooling Inc. All rights reserved.

REAL PEOPLE. TRUE INGENUITY.

THERE’S NO CONFUSION — Vaupell Molding and Tooling Inc. is your one-stop, diverse manufacturing partner for highly engineered injection molded plastic components, devices, and assemblies.

Our experienced engineers and fresh talent collaborate with you on delivering unexpected and practical ways of solving your unique project challenges.

Our range of in-house processes makes us an agile partner that can improve efficiency, enhance quality, shorten time to market, and reduce costs.

NO MORE “HE SAID, SHE SAID.”

We offer: • • • • • •

Near Net Shape Manufacturing In-house Tooling Prototype Design High-Temperature Molding Micromolding Insert Molding

• • • • • •

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Pick a partner that brings ingenuity, exibility, and trust to everything they do.

LIFE SCIENCES Vaupell 9-19.indd 56

I

IMPLANTABLES & BIOABSORBABLES

I

SINGLE�USE INSTRUMENTS & DISPOSABLES 9/13/19 3:14 PM

No.

24

Dentsply Sirona York, Pa.

Key personnel:

$3,986,300,000* *Fiscal year ended 12/31/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

DONALD CASEY, CEO; NICK ALEXOS, EVP, CFO; KEITH EBLING, EVP, GC & secretary; MAUREEN MACINNIS, SVP, chief HR officer & communications

24 $160,500,000 16,400 $243,067

No.

25

Intuitive Surgical Sunnyvale, Calif.

Key personnel:

$3,724,200,000* *Fiscal year ended 12/31/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

GARY GUTHART, CEO; SAL BROGNA, EVP, COO; MYRIAM CURET, EVP, chief medical officer; MARSHALL MOHR, EVP, CFO; DAVE ROSA, EVP, chief business officer; BOB DESANTIS, SVP, GM, instruments & accessories; MARK JOHNSON, SVP, regulatory, quality & program management officer; BRIAN MILLER, SVP, GM, systems & vision; COLIN MORALES, SVP, GM, secondary market equipment & service; KARA ANDERSEN REITER, SVP, GC & chief compliance officer; SURESH SATHYAMURTHY, SVP, global marketing

28 $418,100,000 5,527 $673,819

No.

26

Edwards Lifesciences Irvine, Calif.

Key personnel:

$3,722,800,000* *Fiscal year ended 12/31/2018

2018 rank: 26

R&D spend: $622,200,000 Employees: 2,800 Revenues/employee: $290,844

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MICHAEL MUSSALLEM, CEO; DONALD BOBO, VP, strategy & corporate development; TODD BRINTON, VP, advanced technology & chief scientific officer; DAVEEN CHOPRA, VP, surgical structural heart; DIRKSEN LEHMAN, VP, public affairs; JEAN-LUC LEMERCIER, VP, EMEA, Canada & Latin America; CHRISTINE MCAULEY, VP, HR; JOHN MCGRATH, VP, quality, regulatory, clinical; JOSEPH NUZZOLESE, VP, global supply chain; KATIE SZYMAN, VP, critical care; SCOTT ULLEM, VP, CFO; HUIMIN WANG, VP, Japan, Asia & Pacific; AIMEE WEISNER, VP, GC; LARRY WOOD, VP, TAVR; BERNARD ZOVIGHIAN, VP, transcatheter mitral & tricuspid therapies

www.medicaldesignandoutsourcing.com

9/14/19 11:43 PM

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No.

27 Hoya

Tokyo

(life care segment)

$3,382,137,681* *Fiscal year ended 3/31/2019

Your EMS Partner Dedicated to Medical Devices

(¥373,388,000,000)

2018 rank: 27

Key personnel:

From Design & Development to Industrialization & Manufacturing Main Expertise • • • • •

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

Miniaturization & Downsizing Complex Turnkey Medical Devices Microelectronic Assembly Volume Manufacturing Manual Assembly

Main Markets Served

• • • • • •

Neuromodulation Drug Delivery Endoscopy Imaging Technologies Blood Processing Urology & Renal

Guiding Innovation to Succcess

R&D Teams in the U.S.A., and Switzerland Production in the U.S.A., Switzerland, and Morocco FDA Registered, ISO 13485 & ISO 9001 Providing over 35 years of Experience www.valtronic.com 1-440-349-1239

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66

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No.

28

Hologic

Marlborough, Mass.

Key personnel:

$3,217,900,000* *Fiscal year ended 9/30/2018

2018 rank:

R&D spend:

Employees: Revenues/employee:

29 $218,700,000 6,252 $514,699

STEPHEN MACMILLAN, president & CEO; ERIK ANDERSON, president, Cynosure; MONICA AGUIRRE BERTHELOT, chief of staff; ALLISON BEBO, SVP, HR; PATRICK BRADY, SVP, global supply chain, quality & regulatory; SEAN DAUGHTERY, president, GYN surgical solutions; JOHN GRIFFIN, GC; KARLEEN OBERTON, CFO; SANJAY PRABHAKARAN, president, Asia Pacific; KEVIN THORNAL, president, diagnostics; JAY STEIN, co-founder, SVP, chief technology officer; PETER VALENTI, president, breast & skeletal health solutions; JAN VERSTREKEN, president, EMEA & Canada; MICHAEL WATTS, VP, IR & corporate communications

No.

29

Nipro

(medical segment)

Osaka, Japan; Bridgewater, N.J.

Key personnel: YOSHIHIKO SANO, president & CEO

$3,026,114,130* *Fiscal year ended 3/31/2019

(¥334,083,000,000)

2018 rank: 33

No.

30

Varian Medical Systems Palo Alto, Calif.

Key personnel:

$2,919,100,000 *Fiscal year ended 9/29/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

34 $233,900,000 7,174 $406,900

DOW WILSON, president & CEO; KOLLEEN KENNEDY, president, proton solutions & chief growth officer; CHRIS TOTH, president, Varian Oncology Systems; COREY ZANKOWSKI, SVP, Oncology Software Solutions; DEEPAK KHUNTIA, SVP, chief medical officer; GARY BISCHOPING, SVP, finance & CFO; JOHN KUO, SVP, GC & secretary; TERILYN JUAREZ MONROE, SVP, people & places; RAFAEL TORRES, SVP, business development & strategy; ANDREW WHITMAN, SVP, government affairs; VY TRAN, SVP, regulatory affairs & QA; KEVIN O’REILLY, SVP, global operations; TOM RODDEN, SVP, IT operations; MAGNUS MOMSEN, SVP, controller

www.medicaldesignandoutsourcing.com

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No.

31

BioMerieux

Marcy-l’Étoile, France

Key personnel:

$2,860,895,700* *Fiscal year ended 12/31/2018

(€2,421,000,000)

2018 rank:

R&D spend: Employees: Revenues/employee:

36 $386,415,900 11,200 $255,437

MEDICAL MOLDED CABLE ASSEMBLIES

Alexandre Mérieux, chairman & CEO; Michel Baguenault, secretary, VP, HR & communications; Pierre Boulud, VP, Asia Pacific, portfolio & strategic planning; Nicolas Cartier, VP, industry unit; Pierre Charbonnier, VP, manufacturing & supply chain; Claire Giraut, VP, CFO; François Lacoste, VP, clinical unit; Mark Miller, VP, chief medical officer; Yasha Mitrotti, VP, Europe, Middle East, Africa, global commercial performance; Alain Pluquet, VP, chief data officer; Randy Rasmussen, VP, Molecular Biology; Kirk Ririe, VP, chief innovation officer; Stefan Willemsen, VP, Americas, chief legal officer

Cables:

Turn your design challenges into next-generation, marketleading medical devices with our extensive manufacturing capabilities and engineering expertise. We have facilities in Fremont, CA and Santa Ana Sonora Mexico.

Cardiac Monitoring Device Generator Interface Cable

46840 LAKEVIEW BOULEVARD, FREMONT, CA 94538

TOP 21-100 100 List_9-19_Vs5.indd 68

•

510-933-3800

Endoscopy Camera

Molding Materials Include: • Silicone Rubber • PVC • Polyurethane • TPE • Polyester • Santoprene

Product Categories: • Video Cables • Patient Monitoring Cables • Sensor Probe Cables • RF Generator Cables • Robotic Surgery System Cables • Aesthetic Surgery Cables • Single Use Cables

•

•

bayinfo@baycable.com

ISO 9001:2015; ISO 13485:2016 WWW.BAYCABLE.COM

9/14/19 11:44 PM

Key personnel:

No.

32

HillRom

John Groetelaars, president & CEO; Carlos Alonso, SVP, president, international; Barbara Bodem, SVP, CFO; Francisco Canal, SVP, president, global surgical solutions; Andreas Frank, SVP, president, front line care; Anjana Harve, CIO; Paul Johnson, SVP, president, patient support systems; Mary Kay Ladone, SVP, development, strategy & IR; Brian Lawrence, SVP, chief technology officer; Tim Lawrence, SVP, operations; Richard Marritt, SVP, chief marketing officer; Ken Meyers, SVP, chief HR officer; Michael Murphy, SVP, QA & regulatory affairs; Deborah Rasin, SVP, chief legal officer & secretary; Ilana Shulman, chief

Chicago

$2,848,000,000 *Fiscal year ended 9/30/2018

2018 rank: 30

R&D spend: $135,600,000 Employees: 10,000 Revenues/employee: $284,800

compliance officer

No.

33

Sonova

Stäfa, Switzerland

$2,824,202,780* *Fiscal year ended 3/31/2019

(CHF2,763,200,000)

2018 rank: 32

R&D spend: $152,698,283 Employees: 14,740

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

No.

34

Steris

Dublin, Ireland; Mentor, Ohio

$2,782,170,000* *Fiscal year ended 3/31/2019

2018 rank:

R&D spend:

Employees: Revenues/employee:

35 $63,038,000 12,000 $231,848

www.medicaldesignandoutsourcing.com

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Key personnel: WALTER ROSEBROUGH JR., president & CEO; MICHAEL TOKICH, SVP, CFO; DANIEL CARESTIO, SVP, COO; ADAM ZANGERLE, SVP, CGC & secretary; CARY MAJORS, VP, North American commercial operations

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No.

35

Getinge

Gothenburg, Sweden

$2,780,148,370* *Fiscal year ended 12/31/2018

(kr24,172,000,000)

Key personnel: 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, HR & sustainability

2018 rank: 31

R&D spend: $79,475,531

Employees: 10,515 Revenues/employee: $264,398

No.

36

ResMed San Diego

Key personnel:

$2,606,572,000* *Fiscal year ended 6/30/2019

2018 rank:

R&D spend: Employees: Revenues/employee:

38 $180,651,000 7,240 $360,024

Michael Farrell, CEO; Rob Douglas, president & COO; David Pendarvis, chief administrative officer & global GC; Brett Sandercock, CFO; Jim Hollingshead, president, sleep business; Richie McHale, president, respiratory care business; Raj Sodhi, president, SaaS business; Katrin Pucknat, CEO, ResMed Healthcare, Germany; Justin Leong, president, Asia growth market; 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.

37

Coloplast

Humlebæk, Denmark

$2,605,534,523* *Fiscal year ended 9/30/2018

Key personnel: Kristian Villumsen, president & CEO; Anders Lonning-Skovgaard, EVP, CFO; Paul Marcun, EVP, chronic care; Allan Rasmussen, EVP, global operations

(kr.16,449,000,000)

2018 rank:

R&D spend: Employees: Revenues/employee:

70

Medical Design & Outsourcing

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37 $101,376,503 11,155 $233,575

9 • 2019

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9/14/19 11:44 PM

No.

38

Cooper Cos. Pleasanton, Calif.

Key personnel:

$2,532,800,000* *Fiscal year ended 10/31/2018

Albert White, president & CEO; Daniel McBride, EVP, COO & president CooperVision; Holly Sheffield, EVP, chief strategy officer; Brian Andrews, SVP, CFO & treasurer; Agostino Ricupati, chief accounting officer & SVP, finance & tax; Randal Golden, VP, GC & secretary; Robert Auerbach, president, CooperSurgical

2018 rank: 42

R&D spend: $84,800,000 Employees: 12,000 Revenues/employee: $211,067

LASER EVERYTHING laser welding

laser tube cutting

laser cutting

laser machining

laser drilling

laser ablation

laser marking

laser anything

Cadence proudly announces the acquistion of cadenceinc.com /arcor | 800.252.3371 www.medicaldesignandoutsourcing.com

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No.

39

Paul Hartmann

Heidenheim, Germany; Rock Hill, S.C.

$2,504,022,300* *Fiscal year ended 12/31/2018

Key personnel: BRITTA FÜNFSTÜCK, CEO; RAYMUND HEINEN, chief process officer; MICHEL KUEHN, chief commercial officer, hygiene; STEPHAN SCHULZ, CFO, labor relations director

(€2,119,000,000)

2018 rank: 39

No.

40

Key personnel:

Teleflex Wayne, Pa.

$2,448,383,000* *Fiscal year ended 12/31/2018

2018 rank:

R&D spend:

Employees: Revenues/employee:

41 $106,208,000 15,200 $161,078

LIAM KELLY, president & CEO; THOMAS POWELL, EVP, CFO; DAVE AMERSON, president, GM, interventional urology; PETRO BARCHUK, VP, finance planning & analysis; KAREN BOYLAN, VP, global strategic projects; GWEN CHAPMAN, VP, chief compliance officer; JOHN DEREN, VP, chief accounting officer; JEAN-LUC DIANDA, president, EMEA & global urology; MICHAEL DIGIUSEPPE, VP, corporate accounts & respiratory; TIMOTHY DUFFY, VP, chief information officer; JAKE ELGUICZE, treasurer, VP, IR; JAMES FERGUSON, president, GM, surgical & Latin America; MICHELLE FOX, VP, clinical & medical affairs; SUNNY GOH, president, APAC; MARIE HENDRIXSON, VP, internal audit; CAMERON HICKS, VP, global HR & employee communications; TIM KELLEHER, president & GM, OEM; BERT LANE, VP, global logistics & distribution; JAMES LEYDEN, VP, GC & secretary; JUSTIN MCMURRAY, president, GM, anesthesia & emergency medicine; JAKE NEWMAN, VP, GM, vascular; DANIEL PRICE, VP, commercial finance; STEWART STRONG, president, GM, interventional; GWENDOLYN WATANABE, VP, global corporate development, strategy & strategic partnerships; ED WEIDNER, VP, customer experience & commercial operations; JAY WHITE, president, Americas; GREGG WINTER, VP, tax; JAMES WINTERS, VP, manufacturing

No.

41

Bio-Rad

Hercules, Calif.

Key personnel:

$2,289,415,000* *Fiscal year ended 12/31/2018

NORMAN SCHWARTZ, president & CEO; ANDREW LAST, EVP, COO; GIOVANNI MAGNI, EVP, chief strategy officer; ILAN DASKAL, EVP, CFO; TIMOTHY ERNST, EVP, GC & secretary; MIKE CROWLEY, EVP, global commercial operations; ANNETTE TUMOLO, EVP, president, life science; JOHN HERTIA, EVP, president, clinical diagnostics; RONALD HUTTON, VP, treasurer; JAMES STARK, VP, corporate controller

2018 rank: 40

R&D spend: $119,196,000

Employees: 8,260 Revenues/employee: $277,169

72

Medical Design & Outsourcing

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www.medicaldesignandoutsourcing.com

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No.

42

Demant

Smørum, Denmark

Key personnel: SØREN NIELSEN, president & CEO, Oticon; RENÉ SCHNEIDER, CFO; NIELS CHRISTIANSEN, chairman; NIELS JACOBSEN, deputy chairman

$2,207,631,750* *Fiscal year ended 12/31/2018

(DKK kr13,937,000,000)

2018 rank:

R&D spend: Employees: Revenues/employee:

43 $159,826,393 14,614 $151,063

When it comes to precision manufacturing of medical components and assemblies, close is not good enough. Steven Kmiec, our Director of Manufacturing, agrees. Steven and his team are dedicated to finding the

“CLOSE ONLY COUNTS IN HORSESHOES”

best way to produce your most challenging designs. Our expert team will help you design for manufacturability, optimize performance and maintain cost targets. You can count on the passion and commitment of everyone at OKAY Industries to deliver the highest quality components for your application.

What we manufacture is Part of Something Greater.

Learn more about this project at okayind.com/horseshoe.

Steven Kmiec Director of Manufacturing

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

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

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

www.medicaldesignandoutsourcing.com

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860-225-8707 okayind.com

9 • 2019

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No.

43

Align Technology San Jose, Calif.

Key personnel: JOSEPH HOGAN, president & CEO; YUVAL SHAKED, SVP, managing director, iTero scanner & services business; JOHN MORICI, CFO, SVP, global finance; SIMON BEARD, SVP, managing director, Americas; MARKUS SEBASTIAN, SVP, managing director, EMEA; STUART HOCKRIDGE, SVP, global HR; JULIE COLETTI, SVP, chief legal & regulatory officer; SREELAKSHMI KOLLI, SVP, global information technology; JENNIFER OLSON, SVP, managing director, customer success; RAPHAEL PASCAUD, SVP, business development & strategy; ZELKO RELIC, CTO, SVP, global R&D; JULIE TAY, SVP, managing director, Asia Pacific; EMORY WRIGHT, SVP, global operations; RAJ PUDIPEDDI, SVP, chief marketing officer

$1,966,492,000* *Fiscal year ended 12/31/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

49 $128,899,000 11,660 $168,653

No.

44

Drägerwerk Lübeck, Germany

(medical segment)

Key personnel:

$1,941,533,100* *Fiscal year ended 12/31/2018

(€1,643,000,000)

STEFAN DRÄGER, chairman; GERT HARTWIG LESCOW, CFO & executive board member for IT; RAINER KLUG, executive board member for purchasing, production, logistics & quality; REINER PISKE, executive board member for HR; ANTON SCHROFNER, executive board member, chief officer of innovation, segment & product management

2018 rank: 44

R&D spend: $29,802,474 Employees: 1,417 Revenues/employee: $1,370,172

No.

45

Bruker

Billerica, Mass.

Key personnel:

$1,895,600,000* *Fiscal year ended 12/31/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

74

Medical Design & Outsourcing

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FRANK LAUKIEN, chairman, president & CEO; GERALD N. HERMAN, CFO; MARK MUNCH, president, Bruker NANO; JUERGEN SREGA, president, Bruker CALID; FALKO BUSSE, president, Bruker BioSpin; BURKHARD PRAUSE, president, Bruker energy & supercon technologies

45 $173,400,000 6,870 $275,924

9 • 2019

www.medicaldesignandoutsourcing.com

9/14/19 11:45 PM

SOLENOID VALVES

No.

46

ConvaTec

Key personnel:

Reading, U.K.; Bridgewater, N.J.

$1,832,000,000* *Fiscal year ended 12/31/2018

2018 rank:

R&D spend:

Employees: Revenues/employee:

46 $49,900,000 9,400 $194,894

PAUL MORAVIEC, CEO; NIGEL CLERKIN, CFO; RON HOWELL, CEO, 180 Medical; TIM MORAN, president, Americas; ANTONIO LA REGINA, president, EMEA; JOHN LINDSKOG, president, B2B & infusion devices; GEORGE POOLE, president, APAC; MICHAEL SGRIGNARI, EVP, operations; MARC REUSS, EVP, HR; ADAM DEUTSCH, EVP, general counsel; ROBERT STEELE, EVP, quality, regulatory & clinical affairs; DOUGLAS LEFORT, SVP, corporate development; FIONA ADAM, VP, GM, wound therapeutics; STEPHEN BISHOP, VP, R&D; MADS HAUGAARD, VP, GM, continence & critical care; CHRISTIAN HOENGAARD, VP, GM, ostomy care

Designed for Medical Applications

BUILT-TO-SPEC at Catalog Prices!

No.

47

Miraca Tokyo

$1,643,251,812* *Fiscal year ended 3/31/2019

(¥181,415,000,000)

2018 rank: 47

Key personnel: SHIGEKAZU TAKEUCHI, director, president & CEO; NAOKI KITAMURA, director, executive officer & CFO

• FREE Engineering Services!

• Fast Quotes • 5-Day Prototypes

No.

48

Nihon Kohden Tokyo

$1,619,556,159* *Fiscal year ended 3/31/2019

(¥178,799,000,000)

2018 rank:

R&D spend: Employees: Revenues/employee:

48 $65,606,884 5,169 $313,321

www.medicaldesignandoutsourcing.com

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Key personnel: HIROKAZU OGINO, CEO & president; TAKASHI TAMURA, executive operating officer, general manager, sales operations; TADASHI HASEGAWA, senior operating officer, chief compliance officer; KAZUTERU YANAGIHARA, senior operating officer, general manager, strategic technology operations; FUMIO HIROSE, senior operating officer, general manager, IVD business operations; MASATO SEMBA, senior operating officer, general manager, IT solutions business operations

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SolenoidSolutionsInc.com 888.825.8405 9/14/19 11:45 PM

No.

49

Amplifon Milan

Key personnel:

$1,609,751,918*

*Fiscal year ended 12/31/2018

(€1,372,700,000)

ENRICO VITA, CEO; ALESSANDRO BONACINA, chief marketing officer; RICCARDO CATTANEO, chief regulatory officer; GABRIELE CHIESA, CIO; FEDERICO DAL POZ, chief legal officer; CRISTIAN FINOTTI, chief supply chain officer; GABRIELE GALLI, CFO; MARC LUNDEBERG, EVP, Americas; FRANCESCA MORICHINI, chief HR officer; IACOPO LORENZO PAZZI, EVP, EMEA; GIULIO PIZZINI, chief strategic development officer; CRAIG STEVENS, EVP, APAC

2018 rank: 50

No.

50

Elekta Stockholm

Key personnel:

$1,559,031,572* *Fiscal year ended 4/30/2019

(kr13,555,000,000)

2018 rank: 52

R&D spend: $159,411,122 Employees: 3,800 Revenues/employee: $410,271

RICHARD HAUSMANN, president & CEO; GUSTAF SALFORD, CFO; KARIN SVENSKE NYBERG, EVP, HR; MAURITZ WOLLESWINKEL, president, Linac solutions; IOANNIS PANAGIOTELIS, chief marketing & sales officer; STEVEN WORT, COO; JOHN LAPRÉ, president, Brachy solutions; OSKAR BOSSON, EVP, corporate communications & public affairs; PAUL BERGSTRÖM, EVP, global services; PETER GACCIONE, EVP, North & Latin America; ANMING GONG, EVP, China; RENATO LEITE, EVP, Europe; JONAS BOLANDER, EVP, general counsel; CAROLINE MOFORS, SVP, chief compliance & integrity officer; HABIB NEHME, EVP, Middle East, Africa & India; SUKKHVEER SINGH, president oncology informatics solutions

No.

51

Carl Zeiss Meditec Jena, Germany

Key personnel:

$1,513,639,530* *Fiscal year ended 9/30/2018

LUDWIN MONZ, president & CEO; JUSTUS FELIX WEHMER, CFO; JAN WILLEM DE CLER, chief HR officer

(€1,280,860,000)

2018 rank:

R&D spend: Employees: Revenues/employee:

76

Medical Design & Outsourcing

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54 $188,632,408 3,048 $496,601

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No.

52

Integra Lifesciences Plainsboro, N.J.

Key personnel:

$1,472,441,000* *Fiscal year ended 12/31/2018

2018 rank:

R&D spend:

Employees: Revenues/employee:

59 $78,000,000 4,500 $327,209

PETER ARDUINI, president & CEO; CARRIE ANDERSON, VP, CFO; KENNETH BURHOP, VP, chief scientific officer; GLENN COLEMAN, VP, COO; WILLIAM COMPTON, SVP, CIO; ROBERT DAVIS JR., VP, president, orthopedics & tissue technologies; SRAVAN EMANY, SVP, strategy, treasurer & IR; LISA EVOLI, VP, chief HR officer; PAUL GONSALVES, SVP, chief commercial officer; MICHAEL MCBREEN, SVP, president, international; JOHN MOORADIAN, VP, global operations & supply chain; JUDITH O’GRADY, VP, global regulatory affairs; MARIA PLATSIS, SVP, development; DAN REUVERS, VP, president, Codman specialty surgical; ERIC SCHWARTZ, VP, GC & secretary; JOSEPH VINHAIS, VP, global QA

Expanding the universe of motion MICROMO is now FAULHABER MICROMO

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No.

53

Cochlear Sydney

Key personnel:

$1,446,100,000* *Fiscal year ended 6/30/2019

2018 rank:

R&D spend:

Employees: Revenues/employee:

DIG HOWITT, CEO, president & managing director; BRENT CUBIS, CFO; JENNIFER HORNERY, SVP, people & culture; JAN JANSSEN, chief technology officer; TONY MANNA, president, Americas; RICHARD BROOK, president, EMEA & Latin American; 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

53 $184,400,000 4,000 $361,525

No.

54

ICU Medical

San Clemente, Calif.

$1,400,040,000* *Fiscal year ended 12/31/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

Key personnel: VIVEK JAIN, chairman & CEO; SCOTT LAMB, CFO; CHRISTIAN VOIGTLANDER, COO; DAN WOOLSON, VP, infusion systems GM; TOM MCCALL, VP, marketing & communications, critical care GM; VIRGINIA SANZONE, VP, GC

55 $52,867,000 8,100 $172,844

No.

55

Straumann Basel, Switzerland

$1,393,663,123* *Fiscal year ended 12/21/2018

(CHF1,363,560,000)

Key personnel: MARCO GADOLA, CEO; PETER HACKEL, CFO; GERHARD BAUER, R&D, operations head; WOLFGANG BECKER, distributor, emerging markets, EMEA head; GUILLAUME DANIELLOT, North America sales head; JENS DEXHEIMER, Europe sales head; FRANK HEMM, marketing & education head; PATRICK LOH, Asia/Pacific sales head; ALASTAIR ROBERTSON, global people management & development; PETRA RUMPF, dental service organizations head; MATTHIAS SCHUPP, Latin America sales head, Neodent CEO; PETER ZIHLA, digital business unit head

2018 rank: 62 Employees: 5,954 Revenues/employee: $234,072

78

Medical Design & Outsourcing

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No.

56

Integer (formerly Greatbatch) Plano, Texas

Key personnel: JOSEPH DZIEDZIC, president & CEO; JASON GARLAND, EVP, CFO; JOSEPH FLANAGAN, EVP, quality & regulatory affairs; KIRK THOR, EVP, chief HR officer; JOEL BECKER, president, CRM & neuromodulation; PAYMAN KHALES, president, cardio & vascular; JENNIFER BOLT, SVP, operations; ELIZABETH GIDDENS, SVP, GC, chief ethics & comliance officer, corporate secretary; TONY BOROWICZ, VP, strategy, business development & IR; CARTER HOUGHTON, president, portable medical & electrochem solutions

$1,215,012,000* *Fiscal year ended 12/28/2018

2018 rank: 61

R&D spend: $48,604,000 Employees: 8,250 Revenues/employee: $147,274

TOUGHENED, BIOCOMPATIBLE EPOXY for bonding, sealing, coating & encapsulation Adhesive System EP30DPBFMed

Standard Parts.

Winco.

Hygienic Design ■ ■ ■ ■

For use in hygienically sensitive areas Quick and easy cleaning No dead space due to functional seals Certified according to 3-A SSI and EHEDG guidelines

88-00

J.W. Winco Inc. Phone 800-877-8351 Email sales@jwwinco.com www.jwwinco.com

• USP Class VI approved • Elongation at break, 75°F 20-40% • Dielectric strength, 75°F 450 volts/mil • Complies with RoHS3 Directive (EU) 2015/863

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

www.masterbond.com www.medicaldesignandoutsourcing.com

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No.

57

Smiths Medical (Smiths) Plymouth, Minn.

Key personnel:

$1,182,625,500* *Fiscal year ended 7/31/2018

JEHANZEB NOOR, CEO; GARY BARRETT, VP, global regulatory, compliance & quality systems; BRETT LANDRUM, CTO & SVP, R&D; JOHN KOWALCZYK, SVP global sales; GRETCHEN RANDALL, GC

(£885,000,000)

2018 rank: 56 R&D spend: $68,592,279

No.

58

Fukuda Denshi Tokyo

Key personnel:

$1,175,498,188*

KOTARO FUKUDA, chairman & CEO; DAIJIRO SHIRAI, president & COO

*Fiscal year ended 3/31/2019

(¥129,775,000,000)

2018 rank: 57 Employees: 24,000

No.

59

LivaNova London

Key personnel:

$1,106,961,000* *Fiscal year ended 12/31/2018

2018 rank:

R&D spend:

Employees: Revenues/employee:

80

Medical Design & Outsourcing

TOP 21-100 100 List_9-19_Vs5.indd 80

DAMIEN MCDONALD, CEO; THAD HUSTON, CFO; KEYNA SKEFFINGTON, SVP, GC; EDWARD ANDRLE, GM, neuromodulation; PAUL BUCKMAN, president, North America, GM, transcatheter mitral valve replacement; MATTHEW DODDS, SVP, corporate development; MARCO DOLCI, global operations head, president, Europe; TRUI HEBBELINCK, chief HR officer; ROY KHOURY, president, international; RYAN MILLER, VP, strategy; BRYAN OLIN, SVP, clinical, QA & regulatory affairs; ALISTAIR SIMPSON, GM, cardiac surgery

64 $146,024,000 4,000 $276,740

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No.

60

NuVasive San Diego

Key personnel: CHRIS BARRY, CEO; RAJESH ASARPOTA, EVP, CFO; PAUL MCCLINTOCK, president, U.S. commercial; NATHANIEL SISITSKY, SVP, GC & corporate secretary; LUCAS VITALE, chief HR officer; MATT LINK, president

$1,101,714,000*

*Fiscal year ended 12/31/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

63 $61,695,000 2,600 $423,736

No.

61

Omron

Kyoto, Japan

(healthcare segment)

Key personnel:

$1,047,690,217* *Fiscal year ended 3/31/2019

(¥115,665,000,000)

2018 rank: 66

YOSHIHITO YAMADA, president & CEO; YUTAKA MIYANAGA, EVP, president, industrial automation; KIICHIRO MIYATA, senior managing executive officer, CTO; KOJI NITTO, senior managing executive officer, CFO & senior GM, global Strategy; KATSUHIRO WADA, managing executive officer, president & CEO, Omron Automotive Electronics; SHIZUTO YUKUMOTO, managing executive officer, president, electronic & mechanical components; TOSHIO HOSOI, managing executive officer, president & CEO, Omron Social Solutions; ISAO OGINO, managing executive officer, president & CEO, Omron Healthcare; NIGEL BLAKEWAY, managing executive officer, chairman & CEO, Omron Management Center; SEIGO KINUGAWA, managing executive officer, CEO, Omron Europe, industrial automation; MASAHIKO TOMITA, managing executive officer, senior GM, global HR & administration; JUNTA TSUJINAGA, managing executive officer, senior GM, product business division, industrial automation

No.

62

Dexcom San Diego

Key personnel:

$1,031,600,000* *Fiscal year ended 12/31/2018

KEVIN SAYER, chairman, president & CEO; DON ABBEY, EVP, quality & regulatory affairs; HEATHER ACE, SVP, HR; ANDREW BALO, EVP, clinical affairs, regulatory strategies & global access; QUENTIN BLACKFORD, CFO; RICK DOUBLEDAY, EVP, chief commercial officer; ANNIKA JIMENEZ, SVP, data; JAKE LEACH, CTO; JEFFREY MOY, SVP, operations; PATRICK MURPHY, CGC, chief compliance officer; STEVEN PACELLI, EVP, strategy & corporate development

2018 rank: 75

R&D spend: $199,700,000 Employees: 2,800 Revenues/employee: $368,429

www.medicaldesignandoutsourcing.com

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No.

63

Invacare Elyria, Ohio

Key personnel:

$972,347,000*

*Fiscal year ended 12/31/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

MATTHEW MONAGHAN, chairman, president & CEO; DARCIE KAROL, SVP, HR; ANTHONY LAPLACA, SVP, GC & secretary; RALF LEDDA, SVP, GM, Europe; KATHLEEN LENEGHAN, SVP, CFO

67 $17,377,000 4,200 $231,511

No.

64

Haemonetics Braintree, Mass

Key personnel:

$967,579,000* *Fiscal year ended 3/30/2019

2018 rank:

R&D spend:

Employees: Revenues/employee:

CHRISTOPHER SIMON, president & CEO; MICHELLE BASIL, EVP, GC; SAID BOLORFOROSH, EVP, CTO; WILLIAM BURKE, EVP, CFO; JOSEP LLUIS LLORENS, SVP, global manufacturing & supply chain; CHAD NIKEL, president, Global Blood Center; KEVIN O’KELLY-LYNCH, SVP, global business services; IAN PURDY, SVP, global quality & regulatory affairs; JACQUELINE SCANLAN, SVP, HR; DAVID WILSON, president, Global Plasma

68 $35,714,000 3,216 $300,864

No.

65

GN Hearing Ballerup, Denmark

$923,951,783*

*Fiscal year ended 12/31/2018

Key personnel: JAKOB GUDBRAND, CEO, GN Hearing; RENÉ SVENDSEN-TUNE, CEO, GN Store Nord & GN audio; MARCUS DESIMONI, CFO, GN Store Nord

(DKK kr5,833,000,000)

82

2018 rank: 70

Medical Design & Outsourcing

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No.

66

Merit Medical Systems South Jordan, Utah

Key personnel: FRED LAMPROPOULOS, chairman & CEO; JOE WRIGHT, president, international; RONALD FROST, COO; RAUL PARRA, CFO; BRIAN LLOYD, chief legal officer & corporate secretary; JUSTIN LAMPROPOULOS, EVP, commercial; JOHN KNORPP, chief regulatory affairs officer; JOSEPH PIERCE, CIO; LOUISE BOTT, VP, global HR; JASON TREFT, CTO; DR. NICOLE PRIEST, chief wellness officer

$882,753,000* *Fiscal year ended 12/31/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

74 $59,532,000 5,783 $152,646

No.

67

Conmed Utica, N.Y.

Key personnel:

$859,634,000* *Fiscal year ended 12/31/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

72 $42,188,000 3,100 $277,301

CURT HARTMAN, president, CEO & director; PATRICK BEYER, president, international; TERENCE BERGE, VP, corporate controller; HEATHER COHEN, EVP, HR; NATHAN FOLKERT, VP, GM, U.S. Orthopedics; DANIEL JONAS, EVP, legal affairs, GC & secretary; JOHN KENNEDY, VP, GM, CET; JOHANNA PELLETIER, treasurer & VP, tax; STANLEY PETERS, VP, GM, Advanced Surgical; WILFREDO RUIZ-CABAN, EVP, regulatory affairs/quality assurance & operations; PETER SHAGORY, EVP, strategy & corporate development; TODD GARNER, EVP, CFO; SARAH OLIKER, assistant GC & assistant secretary

No.

68

Masimo Irvine, Calif.

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

$858,289,000* *Fiscal year ended 12/29/2018

2018 rank: 71

R&D spend: $76,967,000 Employees: 1,500 Revenues/employee: $572,193

www.medicaldesignandoutsourcing.com

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No.

69

Konica Minolta Tokyo

(healthcare segment)

$837,862,319*

*Fiscal year ended 3/31/2019

(¥90,900,000,000)

2018 rank: 69

Key personnel: SHOEI YAMANA, president, CEO & representative executive officer, diversity enhancement; KIYOTAKA FUJI, SVP, executive officer, division president, healthcare business HQ & precision medicine business unit, chairman & CEO, KINOCA MINOLTA Precision Medicine; TSUKASA WAKASHIMA, senior executive officer, HR & general affairs; SEIJI HATANO, senior executive officer, business management, accounting, finance & risk; NORIYASU KUZUHARA, senior executive officer, division president of material & component business HQ & general manager, corporate R&D HQ; YUJI ICHIMURA, senior executive officer, division president of industrial opitcal system business HQ & Business Innovation Center & external affairs; MASAFUMI UCHIDA, senior executive officer, technologies & GM, quality management HQ; TOSHIMITSU TAIKO, senior executive officer, lead officer, business technologies & division president, office business HQ; IKUO NAKAGAWA, senior executive officer, digital workplace business, DX branding & IT; KAZUYOSHI HATA, senior executive officer, GM, corporate planning division & Kansaial director & IR, corporate communications, One KM business promotion; RICHARD TAYLOR, CEO, Kinoca Minolta Business Solutions USA

No.

70

Wright Medical

Amsterdam; Memphis, Tenn.

$836,190,000* *Fiscal year ended 12/30/2018

2018 rank:

R&D spend:

Employees: Revenues/employee:

73 $59,142,000 2,894 $288,939

Key personnel: ROBERT PALMISANO, president & CEO; LANCE BERRY, EVP, CFO & operations officer; PETER COOKE, president, emerging markets, Australia & Japan; KEVIN CORDELL, EVP, chief global commercial officer; JAMES LIGHTMAN, SVP, GC & secretary; J. WESLEY PORTER, SVP, chief compliance officer; JULIE DEWEY, SVP, chief communications officer; JENNIFER WALKER, SVP, process improvement; JULIE ANDREWS, VP, chief accounting officer; TIMOTHY LANIER, president, Upper Extremities; PATRICK FISHER, president, Lower Extremities; JASON ASPER, SVP, strategy & corporate development; ANDREW MORTON, SVP, chief HR officer; KEVIN SMITH, SVP, quality & regulatory; BARRY REGAN, SVP, operations; STEVEN WALLACE, president, International

No.

71

Abiomed Danvers, Mass.

Key personnel:

$769,432,000* *Fiscal year ended 3/31/2019

2018 rank:

R&D spend:

Employees: Revenues/employee:

84

Medical Design & Outsourcing

TOP 21-100 100 List_9-19_Vs5.indd 84

MICHAEL MINOGUE, CEO, president & chairman; MARC BEGAN, VP, GC; DR. SETH BILAZARIAN, CMO; WILLIAM BOLT, SVP, global quality, regulatory & clinical operations; ANDREW GREENFIELD, VP, CCO; MICHAEL HOWLEY, VP, GM, global sales; MATT PLANO, VP, operations; DR. DANIEL RAESS, VP, senior medical director; THORSTEN SIESS, CTO; TODD TRAPP, VP, CFO; DAVID WEBER, COO

77 $93,503,000 1,371 $561,220

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No.

72

Fisher & Paykel Healthcare Auckland, New Zealand

$741,403,000* *Fiscal year ended 3/31/2019

(NZ$1,070,000,000)

Key personnel: LEWIS GRADON, managing director & 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, HR & privacy officer; JONTI RHODES, GM, supply chain; NICHOLAS FOURIE, VP, information & communication technology; MARCUS DRILLER, VP, corporate

R&D spend: $69,567,160 Employees: 4,305 Revenues/employee: $172,219

No.

73

Avanos Medical Alpharetta, Ga.

Key personnel: JOSEPH WOODY, CEO; DAVID BALL, SVP, global supply chain & procurement; LEE BURNES, SVP, global R&D, clinical & medical affairs; RHONDA GIBBY, SVP, chief HR officer; SHIVANI KAUL, SVP, chief ethics & compliance officer; MIZANU KEBEDE, SVP, global QA & regulatory affairs; WARREN MACHAN, SVP, business strategy & interim CFO; ARJUN SARKER, SVP, International; JOHN TUSHAR, president, global franchises; JOHN WESLEY, SVP, GC

$652,300,000* *Fiscal year ended 12/31/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

76 $41,800,000 4,700 $138,787

No.

74

Össur

Reykjavík, Iceland

Key personnel: JON SIGURDSSON, president & CEO; EGILL JONSSON, EVP, manufacturing & operations; GUDJON KARASON, EVP, clinics; MARGRET LARA FRIÐRIKSDÓTTIR, EVP, HR & corporate strategy; KIM DE ROY, EVP, R&D; OLAFUR GYLFASON, EVP, sales & marketing; SVEINN SOLVASON, CFO

$612,876,000

*Fiscal year ended 12/31/2018

2018 rank: 78

R&D spend: $31,356,000 Employees: 3,100 Revenues/employee: $197,702

www.medicaldesignandoutsourcing.com

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No.

75

Insulet

Acton, Mass.

Key personnel:

$563,823,000* *Fiscal year ended 12/31/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

SHACEY PETROVIC, director, president & CEO; CHARLES ALPUCHE, EVP, COO; ERIC BENJAMIN, SVP, R&D; BRET CHRISTENSEN, EVP, CCO; DEBORAH GORDON, VP, IR & corporate communications; JOHN KAPPLES, SVP, secretary & GC; DR. TRANG LY, SVP, medical director; WAYDE MCMILLAN, EVP, CFO & treasurer; MICHAEL SPEARS, SVP, quality & regulatory affairs

82 $88,606,000 1,169 $482,312

No.

76

Natus Medical Pleasanton, Calif.

Key personnel:

$530,891,000*

*Fiscal year ended 12/31/2018

2018 rank:

R&D spend:

Employees: Revenues/employee:

JONATHAN KENNEDY, president & CEO; DREW DAVIES, EVP, CFO; AUSTIN NOLL, EVP, chief commericial officer; CHRISTOPHER CHUNG, VP of 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

80 $61,482,000 1,729 $307,051

No.

77

JMS Co.

Hiroshima, Japan

$511,956,522*

*Fiscal year ended 3/31/2019

(¥56,520,000,000)

86

2018 rank: 79 R&D spend: $13,722,826

Medical Design & Outsourcing

TOP 21-100 100 List_9-19_Vs5.indd 86

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No.

78

Nikkiso Tokyo

(medical segment)

Key personnel: TOSHIHIKO KAI, president & CEO; HIROSHI NAKAMURA, EVP; HISAKAZU NAKAHIGASHI, GM, research & engineering institute; YOSHIHIKO KINOSHITA, GM, medical business

$504,637,681*

*Fiscal year ended 12/31/2018

(¥55,712,000,000)

2018 rank: 81

No.

79

Orthofix

Lewisville, Texas

Key personnel: BRAD MASON, president & CEO; JON SERBOUSEK, president, global Orthofix spine; DOUG RICE, CFO; MIKE FINEGAN, chief strategy officer; KIMBERLEY ELTING, chief legal & administrative officer; JILL MASON, chief ethics & compliance officer; JAMES RYABY, chief scientific officer; TIM MCGUIRE, CIO; DAVIDE BIANCHI, president, global Orthofix extremities

$453,042,000* *Fiscal year ended 12/31/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

83 $33,200,000 954 $474,887

No.

80

Topcon Tokyo

(eye care segment)

Key personnel:

$432,182,971*

*Fiscal year ended 3/31/2019

(¥47,713,000,000)

SATOSHI HIRANO, president & CEO; MAKOTO IWASAKI, senior managing executive officer, GM, QA, general administration & legal, corporate planning, custom products promotion; TAKASHI ETO, managing executive officer, GM, smart infrastructure; YASUFUMI FUKUMA, managing executive officer, GM, R&D; HARUHIKO AKIYAMA, senior executive officer, GM, accounting & finance; TAKAYUKI YAMAZAKI, senior executive officer, GM, product development

2018 rank: 84

www.medicaldesignandoutsourcing.com

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No.

81

Ambu

Copenhagen, Denmark

$412,792,447*

*Fiscal year ended 9/30/2018

Key personnel: JUAN JOSE GONZALEZ, president & CEO; MICHAEL HØJGAARD, EVP, global finance, IT & IR; HENRIK ANKJÆ, EVP, global operations; MÅNS BARSNE, EVP, chief innovation officer

(DKK kr2,606,000,000)

R&D spend: $17,582,487 Employees: 2,712 Revenues/employee: $152,210

No.

82

Nevro

Redwood City, Calif.

$387,289,000*

*Fiscal year ended 12/31/2018

R&D spend: $48,459,000

Employees: 804 Revenues/employee: $481,703

Key personnel: KEITH GROSSMAN, chairman, CEO & president; ANGREW GALLIGAN, CFO; DAVID CARAWAY, chief medical officer; NIAMH PELLEGRINI, chief commercial officer; LORI CIANO, chief HR officer; DOUG ALLEAVITCH, VP, quality; MICHAEL CARTER, VP, global sales; RICHARD CARTER, VP, finance, corporate controller; CHRISTOFER CHRISTOFOROU, VP, R&D; JULIET CUNNINGHAM, VP, IR; BRADFORD GLINER, VP, clinical & regulatory affairs; KATHERINE NEUENFELDT, VP, market access; KASHIF RASHID, general counsel; PATRICK SCHMITZ, VP, operations; CLAIRE SMITH, VP, therapy optimization; NEERAJ TEOTIA, VP, marketing

No.

83

Barco

(healthcare division)

Kortrijk, Belgium

$289,523,590*

*Fiscal year ended 12/31/2018

(€245,006,000)

88

JAN DE WITTE, CEO; XAVIER BOURGOIS, information technologies; WIM BUYENS, CEO, Cinionic; NEY CORSINO, Americas; OLIVIER CROLY, APAC; GERWIN DAMBERG, chief technology officer; ANN DESENDER, CFO; AN DEWAELE, chief HR officer; STIJN HENDERICKX, EMEA; JOHAN HEYMAN, organizational excellence; ROB JONCKHEERE, global operations; CHANG TET JONG, MD Barco China; FILIP PINTELON, GM, healthcare; GEORGE STROMEYER, GM, enterprise; NICOLAS VANDEN ABEELE, GM, entertainment; KURT VERHEGGEN, general counsel

2018 rank: 90

Medical Design & Outsourcing

TOP 21-100 100 List_9-19_Vs5.indd 88

Key personnel:

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No.

84

RTI Surgical Alachua, Fla.

Key personnel: CAMILLE FARHAT, president & CEO; JONATHON SINGER, CFO & chief administrative officer LENNOX ARCHIBALD, medical director; TONY LEMUS, VP, global R&D, clinical & regulatory; PAUL MONTAGUE, VP, HR; TOM POPECK, VP, GM, spine; ENRICO SANGIORGIO, VP, GM, international markets; JOHN VARELA, EVP, global operations; OLIVIER VISA, VP, OEM, sports & donor services

$280,855,000* *Fiscal year ended 12/31/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

89 $14,410,000 891 $315,213

No.

85

CryoLife

Kennesaw, Ga.

Key personnel: PATRICK MACKIN, president & CEO; THOMAS BOGENSCHÜTZ, SVP, EMEA, VP, GM, Jotec; SCOTT CAPPS, VP, clinical research; JOHN DAVIS, SVP, global sales & marketing; JEAN HOLLOWAY, SVP, general counsel, chief compliance officer & corporate secretary; AMY HORTON, VP, chief accounting officer; ASHLEY LEE, EVP, COO & CFO; DENNIS MAIER, VP, Kennesaw operations; WILLIAM NORTHRUP, VP, physician relations & education; MICHAEL SIMPSON, SVP, regulatory affairs & QA

$262,841,000*

*Fiscal year ended 12/31/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

93 $23,100,000 1,100 $238,946

No.

86

AtriCure Mason, Ohio

Key personnel: MICHAEL CARREL, president & CEO; ANDREW WADE, SVP, CFO; DOUGLAS SEITH, COO; JUSTIN NOZNESKY, SVP, marketing & business development; TONYA AUSTIN, SVP, HR; KARL DAHLQUIST, SVP, general counsel & chief legal & compliance officer; VINI DORAISWAMY, SVP, clinical, regulatory & scientific affairs; SAM PRIVITERA, chief technology officer

$201,630,000* *Fiscal year ended 12/31/2018

2018 rank: 94

R&D spend: $34,723,000 Employees: 620 Revenues/employee: $325,210

www.medicaldesignandoutsourcing.com

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No.

87

Glaukos

San Clemente, Calif.

$181,278,000*

*Fiscal year ended 12/31/2018

Key personnel: THOMAS BURNS, president & CEO; CHRIS CALCATERRA, COO; JOSEPH GILLIAM, CFO, SVP, corporate development; ROBERT DAVIS, SVP, general counsel & quality affairs; MICHELE ALLEGRETTO, SVP, HR; DAVID HAFFNER, SVP, new technologies; JAY KATZ, chief medical officer; JUDY GORDON, SVP, regulatory affairs; GABRIELLA SZEKELY, VP, R&D, combination pharmaceutical products

R&D spend: $49,676,000 Employees: 437 Revenues/employee: $414,824

No.

88

Endologix Irvine, Calif.

Key personnel:

$156,473,000*

*Fiscal year ended 12/31/2018

JOHN ONOPCHENKO, CEO; VASEEM MAHBOOB, CFO; MATTHEW THOMPSON, chief medical officer; REYNA FERNANDEZ, chief HR officer; JEREMY HAYDEN, general counsel; JEFF BROWN, COO; JEFFRY FECHO, chief quality officer; JOHN ZEHREN, chief commercial officer; MICHAEL CHOBOTOV, chief technology officer; ELISA HEBB, VP, clinical & regulatory affairs; VALERIE TANSLEY, VP, global program management; BRIAN CHAMBLESS, VP, U.S. sales

R&D spend: $20,793,000

Employees: 528 Revenues/employee: $296,350

No.

89

SeaSpine Carlsbad, Calif.

Key personnel:

$143,443,000*

*Fiscal year ended 12/31/2018

2018 rank:

R&D spend:

Employees: Revenues/employee:

90

Medical Design & Outsourcing

TOP 21-100 100 List_9-19_Vs5.indd 90

KEITH VALENTINE, president & CEO; JOHN BOSTJANCIC, SVP, CFO; DENNIS CIRINO, SVP, global spinal systems; TYLER LIPSCHULTZ, SVP, orthobiologics & business development; LAETITIA COUSIN, VP, regulatory & QA; PATRICK KERAN, general counsel & corporate secretary; 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

95 $12,058,000 361 $397,349

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No.

90

Sectra

(Imaging IT division)

Linköping, Sweden

Key personnel:

$138,501,351*

*Fiscal year ended 4/30/2019

(SEK1,204,200,000)

TORBJÖRN KRONANDER, president & CEO; MATS FRANZÉN, CFO; MARIE EKSTRÖM, EVP, president, imaging IT solutions; SIMO PYKÄLISTÖ, EVP, president, secure communications; SOFIA BERTLING, GM, medical education; GUSTAF SCHWANG, GM, orthopedics; LISA EVERHILL, chief people & brand officer; CLAES LUNDSTRÖM, research director, medical systems; PER ANDERSNÄS, VP, operational excellence & IT; STAFFAN BERGSTRÖM, senior EVP, imaging IT solutions

2018 rank: 96 Employees: 546 Revenues/employee: $253,665

No.

91

Conformis Billerica, Mass.

Key personnel: MARK AUGUSTI, president & CEO; PAUL WEINER, CFO; BRENT ALLREDGE, chief legal officer; EMMANUEL NYAKAKO, SVP, quality & regulatory affairs; JOHN SLAMIN, SVP, product engineering; MARC QUARTULLI, VP, clinical affairs; ED KILGALLEN, VP, operations

$89,789,000*

*Fiscal year ended 12/31/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

98 $16,869,000 268 $335,034

No.

92

Alphatec Carlsbad, Calif.

Key personnel: PATRICK MILES, CEO & chairman; CRAIG HUNSAKER, EVP, people & culture & general counsel; JEFF BLACK, EVP, CFO; BRIAN SNIDER, EVP, marketing & development; KELLI HOWELL, EVP, clinical strategies; MARK OJEDA, EVP, cervical & biologics; DAVE SPONSEL, EVP, sales

$83,656,000*

*Fiscal year ended 12/31/2018

2018 rank: 97

R&D spend: $9,984,000 Employees: 195 Revenues/employee: $429,005

www.medicaldesignandoutsourcing.com

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No.

93

Si-Bone

Santa Clara, Calif.

Key personnel:

$55,380,000*

*Fiscal year ended 12/31/2018

R&D spend: $5,376,000 Employees: 183 Revenues/employee: $302,623

JEFFREY DUNN, chairman, president & CEO; LAURA FRANCIS, CFO, COO; ANTHONY RECUPERO, chief commercial officer; MICHAEL PISETSKY, general counsel & chief compliance officer; CARLTON RECKLING, chief medical officer & VP, medical affairs; SCOTT YERBY, chief technology officer; MICHAEL BLANCHARD, VP, operations; DANIEL CHER, VP, clinical affairs; NIKOLAS KERR, VP, product management; JENNIFER MAGGIO, VP, corporate controller; ANDREA MERCANTI, VP, EMEA; JOSEPH POWERS, VP, marketing; BRUCE PROTHRO, VP, regulatory affairs; TROY WAHLENMAIER, VP, U.S. sales; JEFFREY ZIGLER, VP, market access & reimbursement

No.

94

Inspire Medical Systems Golden Valley, Minn.

$50,593,000*

*Fiscal year ended 12/31/2018

Key personnel: TIM HERBERT, president & CEO; RICHARD BUCHHOLZ, CFO; MARTIN ABRAMS, VP, marketing & customer experience; STEVE JANDRICH, VP, HR; IVAN LUBOGO, SVP, sales; QUAN NI, VP, research & clinical affairs; JOHN RONDONI, VP, product development, operations & quality; ANDREAS HENKE, VP, European operations; KATHY SHERWOOD, VP, global market access

R&D spend: $7,388,000

Employees: 165 Revenues/employee: $306,624

No.

95

EDAP

Vaulx-en-Velin, France

Key personnel: MARC OCZACHOWSKI, CEO; FRANÇOIS DEITSCH, CFO

$46,302,551*

*Fiscal year ended 12/31/2018

(€39,183,000)

2018 rank:

R&D spend:

Employees: Revenues/employee:

92

Medical Design & Outsourcing

TOP 21-100 100 List_9-19_Vs5.indd 92

100 $4,844,970 215 $215,361

9 • 2019

www.medicaldesignandoutsourcing.com

9/16/19 2:04 PM

No.

96

Utah Medical Products Midvale, Utah

Key personnel: KEVIN CORNWELL, CEO

$41,998,000*

*Fiscal year ended 12/31/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

99 $454,000 173 $242,763

No.

97

Retractable Technologies Little Elm, Texas

Key personnel: THOMAS SHAW, president & CEO; MICHELE LARIOS, VP, GC; JOHN FORT III, VP, CFO, treasurer; RUSSELL KUHLMAN, VP, sales development; KATHRYN DUESMAN, VP, clinical affairs; JOHN MADAY, production manager; LAWRENCE SALERNO, director of operations; JUDY NI ZHU, R&D manager

$33,275,000*

*Fiscal year ended 12/31/2018

2018 rank:

R&D spend: Employees: Revenues/employee:

101 $621,365 125 $266,200

No.

98

TransEnterix Morrisville, N.C.

Key personnel: TODD POPE, president & CEO; WOUTER DONDERS, GM, EMEA/CIS; ANTHONY FERNANDO, COO, CTO; STEPHANIE FITTS, VP, clinical, quality & regulatory affairs; KATHLEEN FROST, VP, intellectual property; SHANNON GARDNER, global head of HR; MOHAN NATHAN, VP, global clinical marketing; JOSEPH SLATTERY, EVP, CFO; ERIC SMITH, chief commercial officer; JOSHUA WEINGARD, chief legal officer

$24,102,000*

*Fiscal year ended 12/31/2018

R&D spend: $21,823,000 Employees: 189 Revenues/employee: $127,524

www.medicaldesignandoutsourcing.com

TOP 21-100 100 List_9-19_Vs5.indd 93

9 • 2019

Medical Design & Outsourcing 93

9/14/19 11:50 PM

No.

99

Brainsway Jerusalem

Key personnel:

$16,397,000*

*Fiscal year ended 12/31/2018

R&D spend:

YAACOV MICHLIN, CEO; HADAR LEVY, CFO; YIFTACH ROTH, founder; MORIA ANKRY, VP, R&D; AMIT GINOU, VP, field & clinical operations; JOSEPH PEREKUPKA, VP, sales operations, North America; JOSHUA HEXTER, chief business officer

$6,156,000

No.

100 If left to your own devices, this is where you hope the pumps & compressors were sourced.

NittoKohki.com

Ra Medical Systems

Carlsbad, Calif.

$6,257,000*

*Fiscal year ended 12/31/2018

R&D spend: $2,776,000 Employees: 118 Revenues/employee: $53,025 Key personnel: ANDREW JACKSON, interim CEO & principal executive officer, CFO; JEFFREY KRAWS, president; DAN HORWOOD, GC & secretary; THOMAS FOGARTY, chief commercial officer

Take heart engineers: • Exceptional reliability y • Low noise & vibration n • Long service life • DC-motor driven

94

Medical Design & Outsourcing

TOP 21-100 100 List_9-19_Vs5.indd 94

9 • 2019

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9/14/19 11:50 PM

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9/13/19 8/21/18 3:08 9:06 PM AM

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 $2,330,000,000

1 TransEnterix

$24,102,000 $21,823,000 90.5%

2

Royal Philips $2,079,792,000

2 Ra Medical Systems

$6,257,000 $2,776,000 44.4%

3

device

Johnson & Johnson (medical segment)

3 Brainsway

$16,397,000 $6,156,000 37.5%

4

Siemens Healthineers $1,513,757,700

4 Glaukos

5

Boston Scientific $1,113,000,000

5 Dexcom

6

Stryker $862,000,000

6 Conformis

$89,789,000 $16,869,000 18.8%

7

Baxter $655,000,000

7 AtriCure

$201,630,000 $34,723,000 17.2%

8

Edwards Lifesciences $622,200,000

9

Intuitive Surgical $418,100,000

9 Insulet

10

Zimmer Biomet $391,700,000

10 Inspire Medical Systems $50,593,000 $7,388,000 14.6%

$1,764,000,000

8

Edwards Lifesciences

$181,278,000 $49,676,000 27.4% $1,031,600,000 $199,700,000

$3,722,800,000 $622,200,000

19.4%

16.7%

$563,823,000 $88,606,000 15.7%

11 BioMerieux $386,415,900

11 BioMerieux

12 B. Braun Melsungen $375,820,778

12 Endologix

13 Smith & Nephew $246,000,000

13 LivaNova

$1,106,961,000 $146,024,000

13.2%

14 Varian Medical Systems $233,900,000

14 Cochlear

$1,446,100,000 $184,400,000

12.8%

15 EssilorLuxottica $224,523,000

15 Nevro

16 Hologic $218,700,000

16 Carl Zeiss Meditec

17 Dexcom $199,700,000

17 Abiomed

$769,432,000 $93,503,000 12.2%

18 Carl Zeiss Meditec $188,632,408

18 Alphatec

$83,656,000 $9,984,000 11.9%

19 Cochlear $184,400,000

19 Natus Medical

$530,891,000 $61,482,000 11.6%

20 ResMed $180,651,000

20

Boston Scientific

$9,823,000,000 $1,113,000,000

11.3%

21 Bruker $173,400,000

21

Intuitive Surgical

$3,724,200,000 $418,100,000

11.2%

22 Dentsply Sirona $160,500,000

22 EDAP

23 Demant

23 Elekta

$1,559,031,572 $159,411,122

10.2%

24 Elekta $159,411,122

24

$21,413,585,700 $2,079,792,000

9.7%

25 Fresenius (medical care segment) $158,347,800

25 Si-Bone

$159,826,393

26 Sonova $152,698,283 27 LivaNova $146,024,000 28 HillRom $135,600,000 29 Align Technology $128,899,000 30 Bio-Rad $119,196,000 31 Teleflex $106,208,000 32 Coloplast $101,376,503 33 Abiomed $93,503,000 34 Insulet $88,606,000 35 Cooper Cos. $84,800,000 36 Getinge $79,475,531 37 Integra Lifesciences $78,000,000 The color codes correspond to the top 10 R&D spenders.

96

Medical Design & Outsourcing

R&D breakout_9-19_Vs2-BP-FINAL.indd 96

9 • 2019

26

Royal Philips Siemens Healthineers

$2,860,895,700 $386,415,900

13.5%

$156,473,000 $20,793,000 13.3%

$387,289,000 $48,459,000 12.5% $1,513,639,530 $188,632,408

$46,302,551

$4,844,970

12.5%

10.5%

$55,380,000 $5,376,000 9.7% $15,864,322,500 $1,513,757,700

9.5%

27 Fisher & Paykel Healthcare $741,403,000 $69,567,160

9.4%

28 Bruker

9.1%

$1,895,600,000 $173,400,000

29 Masimo

$858,289,000 $76,967,000

9.0%

30 CryoLife

$262,841,000 $23,100,000

8.8%

$143,443,000 $12,058,000

8.4%

31 SeaSpine 32 Varian Medical Systems

$2,919,100,000 $233,900,000

8.0%

33

$30,557,000,000 $2,330,000,000

7.6%

Medtronic

34 Orthofix 35 Demant

$453,042,000 $33,200,000 $2,207,631,750

36 Wright Medical 37 ResMed

$159,826,393

$836,190,000 $59,142,000 $2,606,572,000 $180,651,000

7.3% 7.2% 7.1% 6.9%

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

www.medicaldesignandoutsourcing.com

9/14/19 11:52 PM

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TOP R&D SPENDERS

R&D ranking by total spend:*

RANK COMPANY

R&D SPEND

38 Masimo $76,967,000 39 Fisher & Paykel Healthcare $69,567,160 40 Smiths Medical (Smiths Group) $68,592,279 41 Nihon Kohden $65,606,884 42 Steris $63,038,000 43 NuVasive $61,695,000 44 Natus Medical $61,482,000 45 Merit Medical Systems $59,532,000 46 Wright Medical $59,142,000 47 ICU Medical $52,867,000 48 ConvaTec $49,900,000 49 Glaukos $49,676,000 50 Integer $48,604,000 51 Nevro $48,459,000 52 Conmed $42,188,000 53 Avanos Medical $41,800,000 54 Haemonetics $35,714,000 55 AtriCure $34,723,000 56 Orthofix $33,200,000 57 Össur $31,356,000 58 Drägerwerk (medical business) $29,802,474

59 CryoLife $23,100,000 60 TransEnterix $21,823,000 61 Endologix $20,793,000 62 Ambu $17,582,487 63 Invacare $17,377,000 64 Conformis $16,869,000 65 RTI Surgical $14,410,000 66 JMS Co. $13,722,826 67 SeaSpine $12,058,000 68 Alphatec $9,984,000 69 Inspire Medical Systems $7,388,000 70 Brainsway $6,156,000 71 Si-Bone $5,376,000 72 EDAP

$4,844,970

73 Ra Medical Systems $2,776,000 74 Retractable Technologies $621,365 75 Utah Medical Products $454,000 The color codes correspond to the top 10 R&D spenders.

98

Medical Design & Outsourcing

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9 • 2019

R&D ranking by percentage of revenues:*

RANK COMPANY

REVENUES ($USD)

38 Hologic

$3,217,900,000 $218,700,000

39 Merit Medical Systems 40 Align Technology 41

device

Johnson & Johnson (medical segment)

R&D SPEND

% OF REVENUES

$882,753,000 $59,532,000

6.8% 6.7%

$1,966,492,000 $128,899,000

6.6%

$27,000,000,000 $1,764,000,000

6.5%

42 Avanos Medical

$652,300,000 $41,800,000

6.4%

43

Stryker

$13,600,000,000 $862,000,000

6.3%

44

Baxter

$11,127,000,000 $655,000,000

5.9%

45 Smiths Medical (Smiths Group)

$1,182,625,500 $68,592,279

5.8%

46 NuVasive

$1,101,714,000 $61,695,000

5.6%

47 Sonova

$2,824,202,780 $152,698,283

5.4%

48 Integra Lifesciences

$1,472,441,000 $78,000,000

5.3%

49 Bio-Rad

$2,289,415,000 $119,196,000

5.2%

50 RTI Surgical

$280,855,000 $14,410,000

5.1%

51 Össur

$612,876,000 $31,356,000

5.1%

52 Smith & Nephew

$4,904,000,000 $246,000,000

5.0%

53

$7,932,900,000 $391,700,000

4.9%

Zimmer Biomet

54 Conmed

$859,634,000 $42,188,000

4.9%

55 Hill-Rom

$2,848,000,000 $135,600,000

4.8%

56 B. Braun Melsungen

$8,163,301,770 $375,820,778

4.6%

57 Teleflex

$2,448,383,000 $106,208,000

4.3%

58 Ambu

$412,792,447 $17,582,487

4.3%

59 Nihon Kohden

$1,619,556,159 $65,606,884

4.1%

60 Dentsply Sirona

$3,986,300,000 $160,500,000

4.0%

61 Integer (formerly Greatbatch)

$1,215,012,000 $48,604,000

4.0%

62 Coloplast

$2,605,534,523 $101,376,503

3.9%

63 ICU Medical

$1,400,040,000 $52,867,000

3.8%

64 Haemonetics

$967,579,000 $35,714,000

3.7%

65 Cooper Cos.

$2,532,800,000 $84,800,000

3.3%

66 Getinge

$2,780,148,370 $79,475,531

2.9%

67 ConvaTec

$1,832,000,000 $49,900,000

2.7%

68 JMS Co. 69 Steris

$511,956,522 $13,722,826

2.7%

$2,782,170,000 $63,038,000

2.3%

70 Retractable Technologies $33,275,000 $621,365

1.9%

71 Invacare

1.8%

$972,347,000 $17,377,000

72 EssilorLuxottica

$12,761,178,300 $224,523,000

1.8%

73 Drägerwerk (medical business)

$1,941,533,100 $29,802,474

1.5%

74 Utah Medical Products $41,998,000 $454,000 1.1% 75 Fresenius (medical care segment)

$19,553,589,900 $158,347,800

0.8%

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

www.medicaldesignandoutsourcing.com

9/14/19 11:52 PM

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COMPANIES RANKED BY EMPLOYMENT

Revenues per employee ONE WAY TO MEASURE A COMPANY’S EFFICIENCY is to look at how much revenue each employee brings in, on average. For the companies we found who reported their total medical device employees, we divided their revenues by the number of workers.

By that simple measure, at the top of this year's list lies Intuitive Surgical, with $673,819 in sales for every one of its 5,527 employees. Although that tops our list of revenues per employee, it’s actually a -4.3% decline for the robot-assisted surgery pioneer compared with 2017. Intuitive increased its workforce by 24% in 2018 and added almost $600 million in sales.

COMPANY

EMPLOYEES (2019)

The biggest increase in revenue per employee was logged

by Avanos Medical, at $138,787, a 195% increase from the previous year. That figure is skewed, however, due to layoffs and the sale of its surgical & infection prevention business to Owens & Minor (conversely, the latter slid -46.6% to $578,748 in sales for each of its 17,000 employees).

Similarly, Conformis saw a 50% increase in revenue per employee on the heels of a late-2018 announcement that it would be laying off 10% of its workforce.

The biggest decrease was put up by Fisher & Paykel Healthcare, at -47.9%. Amid patent spats with ResMed, the company earned significantly less in medical device sales this year than the previous year while increasing its workforce by 3.1%. M

REVENUES (2019)

REVS/EMPLOYEE (2019)

Intuitive Surgical

5,527 $3,724,200,000 $673,819 -4.3%

Owens & Minor

17,000 $9,838,708,000 $578,748 -46.6%

Masimo

1,500 $858,289,000 $572,193 0.4%

Abiomed

1,371 $769,432,000 $561,220 8.0%

Henry Schein

18,000 $9,400,000,000 $522,222 -7.8%

Hologic

6,252 $3,217,900,000 $514,699

4.9%

Carl Zeiss Meditec

3,048 $1,513,639,530 $496,601

9.2%

Insulet

1,169 $563,823,000 $482,312 -10.9%

Orthofix

954 $453,042,000 $474,887 -6.1%

Alphatec

195 $83,656,000 $429,005 -41.8%

NuVasive

2,600 $1,101,714,000 $423,736

Zimmer Biomet

19,000 $7,932,900,000 $417,521 -2.9%

Elekta

3,800 $1,559,031,572 $410,271 10.8%

Varian Medical Systems 7,174 $2,919,100,000 $406,900 SeaSpine

7.0%

0.6%

361 $143,443,000 $397,349 -1.4%

Stryker

36,000 $13,600,000,000 $377,778

Dexcom

2,800 $1,031,600,000 $368,429 17.4%

Cochlear

4,000 $1,446,100,000 $361,525 -6.4%

ResMed

7,240 $2,606,572,000 $360,024 -7.7%

Medtronic

90,000 $30,557,000,000 $339,522

Conformis Integra Lifesciences

0.2%

-2.5%

268 $89,789,000 $335,034 50.1% 4,500 $1,472,441,000 $327,209 21.2%

AtriCure

620 $201,630,000 $325,210 6.1%

RTI Surgical

891 $280,855,000 $315,213 6.2%

Natus Medical

100

± Y/Y (%)

Medical Design & Outsourcing

Employer Rank_9-19_Vs2-BP-FINAL.indd 100

9 • 2019

1,729 $530,891,000 $307,051 5.8%

www.medicaldesignandoutsourcing.com

9/15/19 12:01 AM

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8/21/19 9/13/19 10:15 3:12 AM PM

COMPANIES RANKED BY EMPLOYMENT

Hirers and firers

COMPANY

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

EMPLOYEES (2019)

EMPLOYEES (2018)

EssilorLuxottica

150,000

67,000 123.9%

Owens & Minor

17,000

8,600 97.7%

195

138 41.3%

Insulet

1,169

857 36.4%

Össur

3,100

2,290 35.4%

Align Technology

11,660

8,715 33.8%

Intuitive Surgical

5,527

4,444 24.4%

ConvaTec

9,400

9,500 -1.1%

Getinge

10,515 10,684 -1.6%

Alphatec

RTI Surgical

891

Retractable Technologies 125 Henry Schein Conformis Avanos Medical

COMPANY

EMPLOYEES (2019)

REVENUES (2019)

942 -5.4% 150

22,000 -18.2%

268

350 -23.4%

4,700

13,000 -63.8%

REVS/EMPLOYEE (2019)

± Y/Y (%)

32,000 $9,823,000,000 $306,969 -1.6%

Smith & Nephew

16,000 $4,904,000,000 $306,500 -3.5%

Haemonetics

3,216 $967,579,000 $300,864 4.4%

Edwards Lifesciences

12,800 $3,722,800,000 $290,844

3.3%

Wright Medical

2,894 $836,190,000 $288,939 3.7%

Hill-Rom

10,000 $2,848,000,000 $284,800

Conmed

3,100 $859,634,000 $277,301 7.9%

Bio-Rad

8,260 $2,289,415,000 $277,169

4.6%

LivaNova

4,000 $1,106,961,000 $276,740

9.4%

Royal Philips

77,400 $21,413,585,700 $276,661

1.8%

Bruker

6,870 $1,895,600,000 $275,924 -3.1%

Retractable Technologies 125

3.8%

$33,275,000 $266,200 15.8%

Getinge

10,515 $2,780,148,370 $264,398

3.8%

BioMerieux

11,200 $2,860,895,700 $255,437

2.7%

Dentsply Sirona

-16.7%

18,000

Boston Scientific

Sectra (imaging IT division)

±Y/Y (%)

546 $138,501,351 $253,665 -2.7% 16,400 $3,986,300,000 $243,067 -2.0%

Utah Medical Products 173 $41,998,000 $242,763 0.8%

102

Medical Design & Outsourcing

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9 • 2019

www.medicaldesignandoutsourcing.com

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COMPANIES RANKED BY EMPLOYMENT

COMPANY

EMPLOYEES (2019)

REVENUES (2019)

REVS/EMPLOYEE (2019)

± Y/Y (%)

CryoLife

1,100 $262,841,000 $238,946 26.0%

Straumann

5,954 $1,393,663,123 $234,072

2.5%

Coloplast

11,155 $2,605,534,523 $233,575

3.4%

Steris

12,000 $2,782,170,000 $231,848

6.2%

Invacare

4,200 $972,347,000 $231,511 0.6%

Terumo

24,000 $5,430,081,522 $226,253 15.0%

Baxter

50,000 $11,127,000,000 $222,540

EDAP

215

$46,302,551

$215,361

-1.0% 6.6%

Cooper Cos.

12,000 $2,532,800,000 $211,067 16.4%

Össur

3,100 $612,876,000 $197,702 -20.4%

ConvaTec

9,400 $1,832,000,000 $194,894

4.9%

Sonova

14,740 $2,824,202,780 $191,601

1.5%

ICU Medical

8,100 $1,400,040,000 $172,844 -9.0%

Fisher & Paykel Healthcare 4,305

$741,403,000

$172,219

-47.9%

Align Technology

11,660 $1,966,492,000 $168,653 -0.2%

Teleflex

15,200 $2,448,383,000 $161,078

8.1%

Merit Medical Systems 5,783 $882,753,000 $152,646 13.2% Demant

14,614

Integer

8,250 $1,215,012,000 $147,274

Avanos Medical

4,700 $652,300,000 $138,787 195.0%

B. Braun Melsungen

63,751 $8,163,301,770 $128,050

EssilorLuxottica

150,000 $12,761,178,300 $85,075

$2,207,631,750

$151,063

0.3% 3.7% 2.8% -32.7%

Medical Design & OUTSOURCING

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GEOGRAPHIC HEATMAPS

Where are the headquarters?

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

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How the

EITAN GROUP

Privately held Eitan Group wants to bring more infusion pumps into people’s homes.

Can it compete against the established players?

DAN I ELL E K I R S H ASSOCI ATE ED I TO R

aims to disrupt the infusion pump industry OFFICIALS AT THE EITAN GROUP want to disrupt the infusion pump market by selling devices that are more connected and software-based — able to be used not only in hospitals but in the home.

Eitan is probably best known for its Q Core Medical company that makes Sapphire infusion pumps, which have been around for more than a decade. But Netanya, Israel-based Eitan also has its Avoset Medical business, marketing what it describes as simple, easy-to-use pumps for home healthcare settings. Sorrel Medical, Eitan’s third subsidiary, makes a wearable injector device that delivers biological drugs for chronic diseases.

Eitan in coming years is looking to grow the $50 million in annual sales it’s averaged over the past three years. The company in March hired Roger Massengale, previously VP & GM of Avanos Medical (formerly Halyard Health) as its North American CEO. Eitan opened its U.S. headquarters in Aliso Viejo, Calif., in June and is expanding its team there.

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Q Core Medical currently has over 100,000 Sapphire infusion pumps circulating in the world market.

Image courtesy of Eitan Group

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THE EITAN GROUP

Seeking to make waves in the infusion pumps business is no light matter. The market’s established players are some of the largest companies in the medical device industry, including Medtronic, BD, Baxter, Smiths Medical and ICU Medical. (Representatives at BD, Baxter and Medtronic could not be reached or declined to participate in this article.)

Massengale thinks Eitan has an edge because of its vision and deep knowledge of the market — and its small size, which allows a flexibility and boldness that larger firms have difficulty achieving.

“If you understand what the customer is trying to do and you have an intimate knowledge of what the customer is trying to do, you can act more quickly and more boldly on a limited basis of knowledge and trust your gut and knowledge. I think that’s what small companies can do,” Massengale told Medical Design & Outsourcing.

If you understand what the customer is trying to do and you have an intimate knowledge of what the customer is trying to do, you can act more quickly and more boldly on a limited basis of knowledge and trust your gut and knowledge. I think that's what small companies can do.

Julie Utterback, senior equity analyst for healthcare at Morningstar, sees a potential opportunity for Eitan Group in the global infusion pump market, which Research and Markets last year valued at about $12 billion.

“Technologies that can successfully move patients from an in-hospital care setting to an at-home care setting could be a powerful force in certain niches of the infusion pump market, like cancer care,” Utterback told MDO.

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Roots with Q Core and Sapphire When Boaz Eitan started the group in 2005, he didn’t want to be in the medical device industry. He was looking to invest in the technology market and had three criteria: a market bigger than $1 billion, an interesting technology and specifically no medical devices because the space was so regulated. And yet, after he and son Shaul Eitan looked at hundreds of companies, the only one that caught their attention was Q Core, an infusion pump maker then on the verge of bankruptcy.

Years later, that initial acquisition prompted an interesting insight for Boaz Eitan.

“We realized that regulation is not a bad thing. It’s a great thing,” he told us.

“Two reasons: One, it makes your product much better. They really know what they’re asking for. It’s not a nuisance and it’s really important. Second, once you are in, your competitors normally have a great difficulty in crossing the regulatory barrier.”

Q Core scored a major break in early 2013, when Hospira agreed to exclusively distribute the company’s Sapphire multi-therapy infusion system in key markets. Later in the year, Hospira introduced Sapphire in the U.S. after its FDA clearance.

After Pfizer bought Hospira for $15 billion in 2015, then sold the infusion pumps business to ICU Medical in 2017, the SapphirePlus infusion system came under the ICU Medical umbrella, temporarily constricting global distribution.

Eitan arranged fresh terms that ultimately led expanded footprints in new markets.

These days, Q Core Medical says it has more than 100,000 Sapphire pumps in use around the world, distributing to 26 countries.

“Sapphire has a broad portfolio of devices — I would say three main infusion 110

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device platforms, but it’s been on the market well over 10 years,” Massengale said. “It’s got a very substantial install base. It’s in hospitals and in-home care settings and home care facilities and alternate site facilities as well.”

New innovations One of the Eitan Group’s latest innovations comes out of its Sorrel Medical wearablesinjector-focused subsidiary. The idea is to turn terminal illnesses like cancer into chronic diseases, with the patient only having to take the drug once every one to four weeks at home, according to Boaz Eitan.

“The drug company experience is that normally, if you make it trivial to use for the patient and you’re asking them to become a semi-technician, to do many steps in the delivery, normally the adherence rate is really low,” he said. “Currently, overall in the industry

it’s about 50% and they want to increase this adherence. What we are doing is providing a disposable pump called a pre-sealed injector where the drug and the pump comes together in one.”

All a user has to do is take it out of its packaging and attach it to the body.

After pressing the start button, the pump is designed to take over, injecting the needle into the subcutaneous space to deliver the drug. Once complete, the injector alerts the user, who removes it and throws it away. The pump is also Internetconnected, able to send the information to a doctor for remote monitoring.

Pumping large-molecule biologicals poses challenges. Aggressive pumping mechanisms may cut the molecules, meaning patients won’t receive a full dose and the split molecules could become poisonous. A second problem is sterilization — most electronics can’t tolerate gamma radiation so they have

Sorrel Medical is making a wearable injector device that delivers biological drugs for chronic diseases.

Eitan Group

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THE EITAN GROUP

to use ethylene oxide gas instead, meaning that when pump and drug are combined, there’s always one component that isn’t sterile.

We realized that regulation is not a bad thing. It's a great thing.

“Before you deliver the drug, you cannot go through a non-sterilized area because that can infect the patient,” Eitan explained. “The specific area of the pump that is not sterilized, we have a chamber that, before we deliver the drug, we do disinfection. The disinfection is done automatically, and the patient doesn’t have to know about it. It’s done with a UV LED. We added UV LED into our product so the drug company doesn’t have to change anything in the sealing process or the sterilization process. We can assemble the full pump, test the pump and combine the pump and drug in a clean room. That makes it very easy to come to the market.”

Also, he said, although most injectable drugs are delivered in a vial, most pumping solutions or for wearable injectors only accept cartridges.

“We can deliver from the vial directly, so that the pharma companies don’t have to go through three years of transferring the drug from one container, which is normally the vial, into another container, which is the cartridge,” Eitan told us.

Overcoming cybersecurity and other challenges Cybersecurity is always an issue in the medical device industry and infusion pumps are no exception. In 2015, it was revealed that Hospira's Symbiq system could be accessed remotely through a hospital's network. The FDA warned that hackers could make unauthorized changes to the dosage delivered by the pump. Hospira later confirmed the vulnerability and said it planned to phase out Symbiq later that year.

“Authorities are putting much more emphasis on cybersecurity,” Eitan

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THE EITAN GROUP

said. “That goes without saying across the board. That’s not just special to infusion pumps. It’s everything that is connected can be scrutinized on that end. We feel this is great because some of the older and less-safe devices are either not going to get in the market or are going to get removed from market.”

As companies continue to innovate and the infusion pump market continues to grow, data and connectivity will be a driver.

“People want data. People want their devices to be connected because they want to extract data, not data for the sake of data. They’re looking for data that improves outcomes,” Massengale said. “The only kind of data that improves outcomes is data that provide you with an actionable insight, something that really, truly you can act on.” M

Avoset Medical’s home healthcare infusion pumps can help patients adhere to various treatment options.

Eitan Group

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HAVE GOVERNMENT

SCIENTISTS SOLVED THE

ARTIFICIAL HIP

PROBLEM? Argonne National Laboratory researchers tested metal alloys that ortho device companies have used in artificial hips for decades.

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MATERIALS SCIENTISTS at the U.S. Energy Dept.’s Argonne National Laboratory usually test metal alloys for their ability to confine nuclear waste for millions of years. A couple of years ago, two of them decided to apply their expertise to evaluate metal alloys used in artificial hips.

Now they’re seeking to patent a method that they say does a better job than standard ASTM tests of showing how well hip implants will

N AN CY CR OTTI SEN I OR EDI TO R

endure conditions in the human body before corrosion sets in.

Their work could matter because the orthopedic device industry has been facing a crisis over materials: Corrosion of the metals used in artificial hips have been linked to metallosis, or metal poisoning.

Symptoms include bone and tissue death, implant failure and severe pain. Implant makers have reached billions of dollars in legal settlements and researchers continue to study and test alternatives.

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Argonne metals scientist Vineeth Kumar Gattu prepares a medical implant sample for corrosion testing.

Image courtesy of Argonne National Laboratory

Argonne’s Vineeth Kumar Gattu began testing metal alloys used in artificial hips after attending a conference on corrosion in 2017. Gattu found that conventional tests are too short and lack the rigor needed to gauge how materials truly perform in the body, partly because they don’t represent the environmental conditions within the body.

Conventional tests may not take into account the range of conditions that can occur within the body and corresponding

changes in the material surface, Gattu told Medical Design & Outsourcing.

Materials scientists test for oxidation, or corrosion, using different techniques, such as by measuring a material’s electrochemical responses to its environment. In one type of electrochemical test, scientists apply voltages to the material and measure the resulting electrical currents. The current shows how quickly the material is oxidizing. These tests tend to focus

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on the short-term response at one voltage level, representing just one electrochemical scenario, Gattu said.

“Every biological environment has a redox (reduction-oxidation) strength that changes with physical activity,” he said. “Oxygen levels in the blood are different when you are walking, running or resting. The oxygen saturation levels determine the redox strength and could drive the corrosion rates higher than those observed in the standard tests.”

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ARTIFICIAL HIPS

Oxygen levels in the blood are different when you are walking, running, or resting. The oxygen saturation levels determine the redox strength and could drive the corrosion rates higher than those observed in the standard tests.

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Gattu and fellow Argonne scientist William Ebert said they applied many voltage levels to hip implant material, sometimes for several days — much longer than standard tests. They also said that the implant material made of cobalt, chromium and molybdenum corroded at high voltages, whereas the other alloy material made of titanium, aluminum, and vanadium remained stable under the same conditions.

Johnson & Johnson’s DePuy Synthes division declined comment on the Argonne research. Other major manufacturers of artificial hips — Zimmer Biomet, Stryker, Smith & Nephew — did not respond to requests for comment.

The metal-on-metal issue Ortho device companies have been wrestling with major challenges involving materials since the high-profile August 2010 recall of DePuy Orthopaedics’ ASR XL acetabular and ASR hip resurfacing

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systems. Parent company Johnson & Johnson pulled the implants after receiving reports that a higher-than-normal number of patients required surgeries to correct or remove defective implants. Other device makers have found themselves pulled into the controversy since 2010.

Reports have warned of hundreds of thousands of patients potentially exposed to toxic compounds from the implants, putting them at risk of developing cancer, cardiomyopathy, muscle and bone destruction and changes to their DNA. Metal-on-metal hips are no longer sold in the U.S., but many patients still have the devices implanted. Interim results from postmarket studies show significantly higher blood levels of metal ions (cobalt and chromium) in patients with metal-on-metal hip implants compared to those without metal implants. However, some patients with higher blood levels had no complications while others with low blood levels reported severe symptoms.

The FDA has said other factors such as device design or surgical placement may have contributed to greater weardown of the devices and elevated metal ion levels. Hip implants may be affected by infection, fracture or a combination of normal tribological (related to the synergism between wear and corrosion) and biological processes, such as loosening and wear.

About 58% of patients may expect a hip implant to last 25 years, according to a recent study published in The Lancet.

The FDA is working with standards development organizations, such as the American Society for Testing & Materials (ASTM), to develop new standards to improve how metal-on-metal hips are evaluated and identify additional testing protocols for new metal-on-metal devices that are submitted to the FDA for review.

The agency will also hold an advisory committee meeting this fall to discuss metal implants and the potential risk for certain patients to have exaggerated immune and inflammatory reactions to the metals in medical devices.

Research continues The average lifespan of an implanted artificial hip is about 10 to 15 years, according to recent orthopedics research, although some fail after six months while others last for 30 years. One limitation of 118

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ARTIFICIAL HIPS

the implants’ success is the synergistic interaction of wear and corrosion, or tribocorrosion, at the implant interfaces, according to Mathew T. Mathew, associate professor of biomedical science at the University of Illinois at Chicago and a longtime metal alloy researcher. He and colleague Ernesto Indacochea, professor emeritus of civil and materials engineering, are collaborating with Gattu and Ebert.

Mathew and Indacochea are studying the properties of load-bearing and hardness in alloys of cobalt-chromium and molybdenum. They believe one reason for patients’ bodies to react differently to metal implants may be the polarization of cells within each individual’s body, which can cause chemical corrosion in a microor nano-area.

“That leads to severe corrosion,” Mathew said. “We are working on predicting the mechanisms of accelerated corrosion due to the influence of mechanical and biochemical environments.

Right now, there is no good/optimized test model or implant simulators to investigate such complex processes.”

The University of Illinois teams are also trying to recreate what Indacochea called “the real environment that you have in the body” and performing corrosion tests based on fluctuations in biochemistry, such as pH levels, which change with physical activity.

Another possible corrosion suspect: the pro-inflammatory cytokine Interleukin-17A (IL-17). A 2017 study at hospitals in England

and Switzerland found that 10% of 152 end-stage osteoarthritis patients who underwent hip or knee arthroplasty had elevated levels of IL-17 in the friction-reducing synovial fluid around their affected joints. But such biochemical changes are highly unpredictable and cannot be measured during activity. That’s why it’s important to develop artificial hips that can withstand a wide variety of environments, Gattu said.

We are working on predicting the mechanisms of accelerated corrosion due to the influence of mechanical and biochemical environments. Right now, there is no good/ optimized test model or implant simulators to investigate such complex processes.

It’s complicated Robin Pourzal is an assistant professor of orthopedic surgery at Rush University Medical Center in Chicago, which has a long-standing orthopedic implant retrieval program. With their permission, Rush collects explanted artificial hips from living and deceased donors for testing purposes. An engineer and a materials scientist, Pourzal has published several papers on the topic and is collaborating with researchers from The Advanced Photon Source at Argonne on the nature of wear and corrosion products within biological tissue around hip replacements.

“We want to see what was caused by wear, what was caused by corrosion and what was the tissue response to wear and corrosion debris,” Pourzal said. “The truth is, it’s complicated. … We want to blame something for certain failures. But there’s a lot going into this — the implant itself, its material and design, the manufacturer, the surgeon and the patient. Some patients react differently to foreign debris than other patients.”

Vilupanur Ravi chairs the chemical and materials engineering department at California State Polytechnic University, Pomona (Cal Poly Pomona).

Ravi and his students have been developing and testing metallic alloys 120

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ARTIFICIAL HIPS

for bio-corrosion for more than 15 years.

They’ve subjected the alloys to different electrochemical tests in a variety of solutions relevant to human body environments. They’ve also explored the response of the materials to different voltages, exposure times and pH conditions.

Ravi has developed a collaboration with Cal Poly Pomona biology professor Steve Alas to examine the response of macrophages to the metals. The team has also been investigating biofilm formation on different alloys in order to analyze how different microbes may colonize the implant after surgery.

The Cal Poly Pomona team has had good results from adding boron to titanium and titanium alloys. Boron is a non-toxic element that in trace amounts can aid in bone maintenance and growth. None of the boron-containing alloys failed the ASTM F2129, the standard corrosion test for small

implants, according to Ravi. In addition, the boron-containing alloys elicited a lower level of inflammatory response as measured by lower levels of Interleukin1β (IL-1β) being secreted. IL-1β is one of the inflammatory cytokines that could provide insights into long-term implant compatibility.

“We have found out that some of the boron-containing alloys had outstanding corrosion behavior and excellent mechanical properties,” he said.

The Argonne scientists have not published their work while awaiting the patent process, so there’s not much for others to go on by way of comparison.

Ravi said that, judging from an Argonne press release and video, the national lab’s scientists are on the same track as his team.

Gattu expects the Argonne team’s patent to be approved in 2020. The team is also working with a couple of implant makers, whom Gattu declined to identify.

“Argonne is claiming they have found a new method to predict longterm implant performance and while that is great, I would advocate a cautious approach” Ravi said. “The thing is that, in the human body, there are a lot of events going on that involve live cells as well.

So when you do an in vitro test… it’s only one piece of the puzzle.”

Pourzal agreed. “Unfortunately, the only true environment that puts the implant really to the test is the human body,” he said. “Establishing better, more realistic preclinical testing methods is key.” M

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IP ISSUES

Here's how medical device patent litigation is changing As medical devices become more connected and digital, the shift is changing the game when it comes to IP lawsuits.

A

fter nearly 18 years at Greenberg Traurig, Scott Bornstein is the most tenured patent lawyer at the firm. He’s served as lead counsel in more than 100 patent litigations in a variety of industries.

Bornstein is co-chair of the firm’s Global Intellectual Property & Technology Practice and Global Patent Litigation Group. He helps oversee 220 IP attorneys and about 120 registered patent attorneys in what he describes as an inclusive and dynamic work environment.

His position and experience have allowed him to witness firsthand how the digitization of medtech is profoundly changing medical device patent litigation.

Bornstein recently spoke with Medical Design & Outsourcing to explain the transformation — and much more:

Chris Newmarker | Editor |

MDO: You’ve worked on patent litigation cases in a variety of industries. Is there anything that makes the medical device industry especially unique when it comes to patent lawsuits?

Bornstein: With a couple of exceptions, medical device litigation is probably the most contentious, the most heavily litigated.

It can be very expensive. There’s obviously a lot of money being made in the medical device industry, and the companies fiercely protect their technology as you would expect and hope. There remains a great deal of competitor litigations that are very heavily fought out and I think tend to go more frequently to trial than other areas.

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MDO: Because the medtech space is heavily regulated, it can take years to get a medical device cleared or approved. How much does that play into the fierceness of the litigation?

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Bornstein: I think that’s a huge factor.

You see it with both medical device and with pharma, which are obviously both regulated industries. After you spend the time to get not only the patents but also the FDA approval, which can cost millions of dollars, you’re naturally going to try to fiercely protect it.

MDO: When it comes to medical device patent lawsuits, what is different now versus five or 10 years ago?

Bornstein: I think one of the things that’s been changing is the influx of technology as part of medical devices. I think that’s brought some new entrants into the field. It’s also opened up pathways which maybe didn’t exist before. We’re seeing the use of artificial intelligence and connected medical devices that are giving real time data to the patients and to medical care providers, which is greatly increasing the quality of care that doctors and nurses can provide to patients. But it also brings interesting and unique patent challenges which didn’t exist before.

MDO: What kind of challenges?

Bornstein: Section 101 is the section of the patent laws which essentially determines what is patentable subject matter. You’re not permitted, for example, to patent a law of nature.

Typically, 101 patentability challenges were largely the domain of the software, business methods, financial services world. In the medical device space, Section 101 was historically not really an issue, but it has definitely crept in. Data collection, transmitting data, providing data in a unique form, storing data on a computer — those types of things that

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IP ISSUES

historically weren’t really done in the medical device space are now being done quite frequently. And those concepts of just storing and transmitting data are not considered patentable subject matter. While that’s a developed area of law, in the medical device space it’s still emerging. I think there’s still some questions about how to apply it one-on-one in the medical context.

As a result, you’re seeing a lot of courts grappling with that.

MDO: How is the world of medical device patent litigation shifting in this new environment?

I think one of the things that's been changing is the influx of technology as part of medical devices. I think that's brought some new entrants into the field.

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Bornstein: You saw a pretty dramatic dropoff in litigation a couple of years back. And I think that in part has to do with [Alice Corp. v. CLS Bank International, a 101-related case decided by the U.S. Supreme Court in 2014].

Right around 2012–13 there was a kind of a break-off, where the litigation started to diminish and the patent prosecution cases still continued to expand. There were several factors: the Alice decision eventually and the introduction of [inter partes review (IPR)] into the mix. Venue cases occurred which limited forum shopping to Texas and elsewhere.

You’ve seen a lot of things that I think change the field generally.

MDO: How are the IPRs reducing litigation?

Bornstein: Implemented by Congress several years ago, the IPR is an alternative way to challenge the validity of patents. Not only can you do it in the district court when you’re sued for infringement, but you can oftentimes contemporaneously challenge the validity of the patent before the Patent Trial and Appeals Board, PTAB. It’s become very common to challenge patents using IPRs, 124

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and it’s much less expensive than district court litigation. Historically, there’s been a very high success rate in using IPRs to invalidate claims that are otherwise serving as litigation. For a fraction of the cost of litigation, you can challenge the patent and, if you succeed, the litigation will ultimately go away. The other advantage of IPRs is that often the district court litigation will be stayed or put on ice pending resolution of the IPR. MDO: When it comes to protecting medtech IP, are there assumptions that are just no longer valid?

And there are very different laws about patentability, specifically of software and computer-related inventions. It’s much more difficult at this stage to get them in Europe, for example, than it is in the U.S. And it’s a challenge in the U.S., let me be clear. But in Europe, there really has to be a technical aspect of the invention for it to be patentable.

You have to be cognizant not only of your strategy in the U.S. but about your global patent strategy, particularly in the medical device-connected space. M

Bornstein: Certainly 101 is a big part of it. Historically you didn’t have to write your claims carefully to avoid 101 issues, and now you have to focus on whether or not the claims that you’re drafting are going to overcome those challenges.

The other issue is that with medical devices, the applications are not only filed in the U.S., they’re filed worldwide.

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THE CATH LAB

These tiny 'mirrors' could make tracking catheters easier

Nancy Crotti | Senior Editor |

Fraunhofer MEVIS researchers think they’ve developed a cost-effective way to reduce the need for X-rays during catheter procedures.

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Researchers Torben Pätz (left) and Jan Strehlow (right) demonstrate the intelligent catheter on a 3D model.

Image from Fraunhofer MEVIS

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linicians around the world perform millions of endovascular procedures per year, using catheters and guided by X-rays to place stents or remove blood clots. That’s a lot of radiation for patients and physicians to endure, and the X-rays don’t even provide the most precise images, according to Torben Pätz, a mathematician at the Fraunhofer Institute for Digital Medicine (MEVIS) in Bremen, Germany.

Fraunhofer MEVIS is developing a system to remedy these problems.

The “intelligent catheter navigation” or Intellicath method uses a catheter equipped 9 • 2019

with a special optical fiber containing tiny “mirrors.” When light passes through the fiber, the mirrors reflect a portion of the light. Whenever the fiber bends, the reflected light changes color. Sensors can then measure the change in color.

“The signal from the sensors gives us information about the intensity and direction of the curvature,” Pätz said in a news release. “To some extent, the fiber knows how it is formed.”

An additional element is needed, however, for precise navigation through the vascular system. Before the procedure, physicians obtain CT or MR images of

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THE CATH LAB

a patient. Based on this image data, IntelliCath software creates a 3D model of the vessel system and displays it on a monitor. During the endovascular procedure, live data from the fiber navigation is fed into the model. The doctor views the monitor to see how the device moves through the vascular labyrinth live and in 3D. MEVIS experts have already been able to test the method’s feasibility using a prototype, according to Pätz. “We connected several silicone hoses into a curved labyrinth,” he said.

“Then, we inserted our device containing an optical fiber into the labyrinth.” On the monitor, they were able to locate the catheter’s position in real-time with precision approaching 5mm. The researchers have already applied for two patents.

Although several medical device companies have similar projects, “they expend a great deal of technical effort into trying to reconstruct the shape of

the entire catheter, which can be up to 2m long,” Pätz said. “Our algorithm, however, only needs a fraction of the data to localize the catheter in a known vascular system.”

As a result, the MEVIS approach promises cost-effective technology without special fibers and measurement systems and is less sensitive to measurement errors than previous approaches, according to the institute.

The signal from the sensors gives us information about the intensity and direction of the curvature. To some extent, the fiber knows how it is formed.

Better Together

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The researchers will next test the IntelliCath system on both a full-body phantom of the human vascular system and on a pig lung. Toward the end of the current project phase in 2020, a prototype will be ready to serve as the foundation for a clinical trial.

Pätz and his team are also developing acoustic feedback to relieve doctors of the constant need to look at the monitor. The idea is to employ various indication sounds to signal how far the next vessel junction is and in which direction the catheter should be inserted.

“It is similar to a car’s parking assistance system, where you also receive acoustic indications about the distance to the next obstacle,” Pätz said. M

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MANUFACTURING & MACHINING

6 ways to improve smart manufacturing with real-time monitoring Real-time monitoring can provide the end-to-end visibility across production centers that medical device manufacturers need to excel.

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Louis Columbus | IQMS |

he challenge every medical products manufacturer faces in attempting to excel at smart manufacturing is knowing which data produced by operations is the most and least valuable — and why. However, instead of attempting to capture every one of the many diverse data streams their operations produce, manufacturers successfully making progress on their smart manufacturing initiatives take a focused, precise approach to capturing data. To support these efforts, they increasingly rely on real-time monitoring.

A recent Decision Analyst survey conducted in conjunction with IQMS/Dassault Systemes quantifies how a precise focus on real-time monitoring improves manufacturing outcomes. In interviews with 151 North American manufacturers, 81% said realtime monitoring is improving their business.

Further, 69% rely on real-time monitoring to

increase the accuracy of tracking production time, downtime, total parts created, rejects and parts to be produced. Other reasons cited for adopting real-time monitoring included improving schedule accuracy, achieving better levels of inventory control and improving order cycle times.

Among the medical product manufacturers surveyed, 87% said real-time monitoring is improving their business, and 90% reported that the main reason they rely on real-time monitoring data is to pilot entirely automated production shifts and then move them into full production.

Meanwhile, 63% said that real-time monitoring improves track-and-traceability.

Beyond the survey statistics, followup interviews with the medical product producers uncovered six ways in which they depend on real-time monitoring to help them excel with their smart manufacturing initiatives:

Source: Where ERP Is Making The Greatest Contributions To Growth, IQMS Manufacturer’s Survey Results Q2, 2018

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1. Removing production bottlenecks that other sources of data don’t catch By far, the most frequently mentioned benefit of real-time process monitoring is its ability to capture data on why bottlenecks are happening and why.

One medical products manufacturer said they were able to reduce scrap by 39% while improving on-time deliveries by more than 60% because of the realtime monitoring data now included as part of their quality management and compliance systems. There was also mention of cycle times, perfect order performance, yield rates by the process and return material authorization (RMA) rate drops — suggesting that realtime monitoring can provide the truest measure of machinery yield.

2. Reducing hard and soft fault errors.

This is about knowledge of online tool conditions and improving mean time between failure (MTBF) and mean time to repair (MTTR). Real-time monitoring down to the tool and machine level reduces hard fault errors, including tool breakage, door closure, tool presence and workpiece presence. Additionally, it helps manufacturers to troubleshoot and solve soft faults attributable to machinery acceleration, temperature variation, force and vibration.

3. Improving track-and-trace accuracy in production plants Real-time monitoring enables medical device manufacturers to achieve and stay in compliance with the FDA’s 21 CFR Part 821 requirement, in addition to many additional customer-driven audit requests regarding track-and-trace. Today, mid-tier medical device manufacturers typically can expect to host between 70 to 90 audits each quarter, further making real-time monitoring essential for meeting FDA and customer requirements. Better track-and-trace accuracy can also lead to greater real-time logistics synchronization.

4. Improving product quality in mixedmode manufacturing environments Medical device manufacturers are pursuing new business models by broadening the base of products they produce, often relying on configure, price, quote (CPQ) and product configuration strategies.

But taking on more customized product manufacturing means having to navigate between mixed-mode and customized 132

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order requirements. Real-time monitoring gives device makers the flexibility to track how each workflow is performing and know if there’s a problem with a specific, customized production run.

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By far, the most frequently mentioned benefit of real-time process monitoring is its ability to capture data on why bottlenecks are happening and why.

5. Gaining valuable feedback on product and process simulations Real-time monitoring is also invaluable in getting insights into how simulated production runs will perform before an actual product is ever produced. It also can provide the data needed to define the optimal shop floor instruction and machinery combinations based on realtime data analyzed as a simulation to see which will deliver the optimal new product.

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Real-time monitoring enables the end-toend visibility across production centers that is empowering medical device manufacturers. M

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NEURO

Neurovascular device delivery: A big challenge on a small scale First-generation devices used in the neurovasculature mimicked those designed for the coronary or peripheral vasculature. They proved that not all vessels are alike, and device design shouldnâ&#x20AC;&#x2122;t be either.

A neurovascular stent delivery system Image courtesy of Integer Holdings

Emily Wozniak | Integer Holdings |

T

he vasculature in the brain presents a unique problem for interventionalists: Bulky, complex devices must wind through small, tortuous vessels to reach their target with minimal trauma. Since medtech companies first designed devices for this part of the anatomy, they have learned to scale them down from those made for coronary or peripheral vasculature.

Wire-based delivery systems Self-expanding stents designed for peripheral vascular applications are often delivered using a 6 or 8 Fr catheter and a pusher for deployment, which is too large for the narrow anatomy of the neurovasculature. Engineers minimized device profile by downsizing to wire-based delivery systems that deliver stents and flow diverters through microcatheters as small as 2 Fr. These wire-based systems achieve the ultra-low profile and flexibility needed for navigating the vasculature of the brain.

The stent delivery wires are specially designed, polymer-jacketed or nitinol guidewires with intricate bumper protrusions that push or pull the

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implant to deploy or re-deploy through a microcatheter. These wires must perfectly balance pushability to reach increasingly distal regions with the flexibility to navigate tortuous anatomy. Vessels in the brain are narrower and more sensitive than the periphery, so it is also critical to ensure these delivery systems have soft, atraumatic tips.

Complex devices require complex manufacturing Achieving the right design is only part of the challenge. The other critical piece is developing the right manufacturing technologies that consistently and efficiently produce the intricate geometries required of wire-based delivery systems at commercial scale.

Case in point, the distal tip of the stent delivery wire is typically modified by grinding, coiling, soldering and laser welding to achieve the precise features that engage the stent to move it through the microcatheter. These processes can be difficult to develop, automate and scale, so considering the right manufacturing strategy and engaging with experts is critical early in the product design.

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NEURO

Achieving the right design is only part of the challenge. The other critical piece is developing the right manufacturing technologies that consistently and efficiently produce the intricate geometries required of wire-based delivery systems at commercial scale.

Micro-grinding: Think small A corewire grinding process is often employed for two critical design features of the stent delivery wire: the taper of the distal tip and the creation of the protrusions that engage the implant. The distal tip taper determines the stiffness profile while maintaining flexibility without compromising navigation through tortuous vasculature. The design of the stent’s push/pull feature is usually simple: the distal end of the core wire is ground down to create two or more protruding

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“bumps” with 90-degree angles that catch on the implant to push or pull it through the microcatheter.

The difficulty is in the miniaturized scale. The wire’s distal tip may need grinding to diameters as small as 0.007 in., with the protrusions ranging from 0.010 in. to 0.025 in. It may also be necessary to use complementary processes such as microdeburring methods alongside micro-grinding to round out the corners of the protrusions and ensure the device design is atraumatic.

The development of micro-grinding processes with tolerances tight enough to reliably achieve complex geometry requires significant engineering expertise.

Another common challenge is that standard, automated equipment that can achieve these complex grind geometries doesn’t exist. To solve this problem, manufacturers have had to build their own custom equipment to automate precision micro-grinding.

Micro-coiling: Precision matters Some stent-delivery wire designs incorporate small coils on the distal tip to minimize trauma during deployment.

The efficient and cost-effective coiling of wires around tips as small as 0.007 in. is a manufacturing challenge that takes specialized skill and insight.

Like precision micro-grinding, coiling on this scale requires specialized equipment capable of achieving extremely tight tolerances. Coils must be wound around the ground distal tip and seamlessly integrated with the surrounding geometry.

Laser welding or soldering are used when attaching the coils to the wire in order to achieve seamless integration.

This not only poses a challenge because of the small scale, but also because it often involves joining two different types of metals. Specialized lasers with small spot sizes and precision fixtures are critical to join the coils to the wire.

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Finishing touches Corewire design is not the only design and manufacturability consideration for neurovascular stent delivery wires. Many systems may also include a tapered polymer jacket to improve lubricity and ease movement in the microcatheter.

Radiopaque micro-coils or marker bands are sometimes added near the protrusions, allowing physicians to visualize the location of the implant while still positioned on the wire. Other complex design features may be added to the delivery wire to allow for re-capture and re-deployment of a partially deployed stent if a physician wants to adjust the stent position. These design decisions must be made with the end goal of commercial-scale manufacturing strategy in mind.

Find experts you can trust Companies that design neurovascular interventional devices focus on perfecting the product design from a clinical perspective. However, the challenges of manufacturing wire-based delivery systems make it necessary to factor in commercial manufacturing strategies early. Contract manufacturers have the specialized expertise and equipment needed to help ensure the manufacturing strategy for neurovascular product commercialization is efficient and reliable, ultimately maximizing speed to market and cost-effective commercial production. M

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REGULATORY

Countdown to MDR: Do you know your options?

Image courtesy of WuXi AppTec

The E.U.’s new medtech regulations are scheduled to go into effect in 2020, giving manufacturers who want to continue selling their devices in Europe lots of work to do.

Mike McGrew | WuXi Medical Device Te s t i n g |

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ith the E.U.’s Medical Device Regulation (MDR) coming into effect in less than a year, medical device manufacturers are scrambling to prioritize their product lines and work through testing. Many manufacturers are hoping the E.U. will delay implementation, but don’t count on it. If your company is behind, there’s still time to catch up, but it’s imperative to get organized now.

The first step, if you haven’t started planning for MDR, is to rationalize your product portfolio. One common challenge in the rationalization process is a lack of clinical experience reports, particularly for older products. The need to unearth relevant 5 • 2019

documents presents a time-consuming obstacle requiring your team to either dive into literature or actively seek client input to satisfy reporting requirements. This extra work is one reason legacy products should be prioritized in the rationalization process.

Get organized Every company’s approach to rationalization will differ, but here are a few questions that every manufacturer should ask themselves during the process: • Do your products have multiple generations on the market? If your answer is “yes,” prioritize your options with return on investment (ROI) in mind.

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REGULATORY

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• Will the cost incurred to keep this product on the market satisfy your desired ROI? If your answer is “no,” it may be time to stop selling the product in Europe. Conducting a cost-benefit analysis will be important to align with business objectives.

• Can you group any devices into product families for evaluation? Group devices together and test a smaller sample to cover the worst-case scenarios of a broad category. This will help increase efficiency.

• Have you rectified any quality issues in your devices?

Take the time to review your quality checks and any clinical feedback that has surfaced. Any evidence of past performance problems that have put patients at risk will be an automatic issue for regulators if you are unable to show that the issues have been resolved.

Understand your options Once you’ve rationalized your product portfolio, you have three options for what to do with each device. First is moving forward with registering the device under MDR. Second is to end the life of the device in Europe. Third is to develop the next generation under MDR and extend the current product life under the Medical Device Directive (MDD). Each option has unique considerations.

Register your device under MDR For products that have a healthy ROI and wouldn’t benefit from an upgrade or redesign, registering the device under MDR is likely the best path forward. To start, your internal team should compile existing data on the materials that make up the device, including adhesives, additives, colorants, polymers, manufacturing aids and more. Procedures used in the manufacturing and sterilization processes should also be reported. This data will help you and your lab evaluate which tests are necessary to verify safety.

There are three phases involved in a complete biological evaluation under ISO 10993-1 and MDR: chemical characterization, toxicological risk assessment and biocompatibility testing. Chemical characterization involves exposing the device to aggressive solvents that identify and quantify chemical constituents contained within the device; this is called an extractables study. Extractables studies are followed by toxicological risk assessments, which use the information found in chemistry reports to establish a margin of safety for each chemical and determine which additional tests are needed to further mitigate any safety concerns. The last stage is biocompatibility testing, which looks at how living cells react to the device.

Chemical characterization studies might meet some biocompatibility endpoints, which may eliminate the need to do biocompatibility tests. Using your chemistry data and risk assessment to drive your biocompatibility test plan can also help you avoid unnecessary animal testing and reduce the number of devices needed for testing. Together, these evaluations generate data on the physical and chemical makeup of the device to support and prove its safety and achieve MDR compliance.

End the life of the device in Europe Reasons to consider ending a device’s lifecycle in Europe include ROI considerations, quality issues or obsolescence due to the existence of next-generation devices. Be aware that there may be liability risks that arise as a result of devices remaining in-market in 140

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Europe, even after they’re no longer sold there. Consulting your quality, regulatory and legal teams is essential to pulling out of market effectively and with low risk.

Develop the next generation under MDR Developing the next generation of a device under MDR and extending the current product’s life under the MDD is fitting when you are addressing quality issues, enhancing features and/ or considering alternative sterilization methods. Consider this option if the device has created patient safety issues, is falling behind competitors’ products, or if it employs an ethylene oxide (EO) sterilization method but could undergo an alternative method. EO is hazardous to the environment, expensive and has proven to be unreliably available.

Other sterilization methods, such as radiation, can be more cost-effective and environmentally friendly.

Partner with a lab Working with a contract research organization (CRO) to complete your testing needs can help your organization maintain efficiency and catch up with the competition. Communication is key.

Provide a forecast to your CRO and tell them which samples they can expect and when; this will allow the lab to reserve testing space and adjust capacity, if possible, to better meet your needs.

Next, you must provide thorough technical information, so the lab is able to set appropriate testing parameters and have access to the right equipment and solvents. Be prepared for CROs to ask highly detailed questions about specifications like device surface area, patient contact time and whether the device can be cut into sections.

Finally, provide a device for testing that is truly representative of the devices produced by manufacturing.

Using a prototype, for example, could yield inaccurate results and put your submission’s approval at risk because prototypes may be made of different materials or employ a different manufacturing process.

Getting organized, understanding your options and working collaboratively with a CRO can put you on the right path toward MDR compliance, even if you’re getting a late start. Don’t sit idle and hope MDR will be delayed. M 9 • 2019

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SOFTWARE

How to protect medtech from cyber attacks The use of mobile devices continues to put healthcare data at risk. A federal government standard could offer more protection.

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ealthcare is undergoing a technological renaissance, with untethered medical devices, more data-gathering and ever-improving accessibility. As more devices become mobile, there is extra opportunity to hijack equipment.

The more data gathered, the more data is vulnerable. As accessibility improves, so does the potential threat of an attack.

To address the increasing cybersecurity risks that these trends bring, vendors implement whatever best practice they see fit. But are these best practices good enough? Given the number of recent data breaches, the answer is no.

9 • 2019

Making data safer Medtech vendors could implement stronger crypto algorithms or software that securely transfers data from devices to the cloud, but how can they be certain that their implementations are actually secure?

This uncertainty represents a security gap, and the best way to fill that gap is to use government-approved security.

From a medical perspective, the term “government-approved security” seems a bit vague. Regulators such as the FDA and the HHS have rules related to cybersecurity, but the rules don’t specify any feature standards. The FDA’s 2016 postmarket regulations provide guidance on how to manage “cybersecurity vulnerabilities for marketed and distributed medical

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Check out our webinar archives to view previous presentations: www.medicaldesignandoutsourcing.com

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SOFTWARE

From a medical perspective, the term 'governmentapproved security' seems a bit vague.

Regulators such as the FDA and the HHS have rules related to cybersecurity, but the rules don't specify any feature standards. devices,” including how to assess, contain and prevent threat sources in existing products. In October 2018, the agency issued an updated draft premarket guidance that includes some postmarket information. It also held a public workshop in January 2019 to get feedback on that guidance and worked on a joint security plan.

The HHS’s Health Insurance Portability and Accountability Act (HIPAA) Security Rule defines those to whom it applies as “health plans, healthcare clearinghouses and any healthcare provider who transmits health information in electronic form.” When it comes to technical safeguards, there are no requirements for exact security features. The rule only states to implement encryption “whenever deemed appropriate.”

Seeking clarity elsewhere Without clear guidance from healthcare regulators, the de-facto guidance falls on the National Institute of Standards and Technology (NIST), the top authority for security standards in the U.S. NIST is a non-regulatory agency that operates several programs to validate aspects of security from the algorithm level all the way to cloud computing. The Federal Information Processing Standards (FIPS) 140-2 is one of these programs used to certify cryptographic security of electronic hardware.

FIPS is a requirement in several government agencies that transmit data from unclassified all the way to topsecret. If FIPS is trusted by government agencies for handling sensitive data, 144

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medical technology vendors should see it as a design requirement for their devices all the way down to the wireless microcontrollers (MCU).

With core hardware like wireless MCUs, FIPS pertains to the cryptographic algorithms and codes used to store and transmit the data. NIST-approved algorithms such as secure hash (SHA) or advanced encryption standard (AES) all have publications dictating the standard for implementing the algorithms correctly. Any silicon manufacturer can take the standards and try to include them in the chips.

9 • 2019

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NIST provides validation procedures There is still a problem of certainty with the implementation of these algorithms.

Healthcare professionals and patients may not use wireless medical devices without knowing their data is secure. This is where NIST comes with procedures for thirdparty validation of the FIPS algorithms.

“Third-party” is an important distinction. Silicon manufacturers surely do some sort of validation, but this validation could be flawed. For example, a manufacturer could implement AES that technically works and passes their tests, but in reality, the algorithm does not randomize the data enough. If this flaw ends up being implemented in a medical device, it leaves room to crack transmitted data or even take over devices.

To avoid these potential flaws, NIST requires silicon manufacturers to submit their designs to accredited third-party testing labs in order to earn the moniker “FIPS Validated.” This label truly means government-approved security. “FIPS Validated” is the standard that medical technology vendors should be thinking of from concept to production of their devices.

Making government-approved, “FIPS Validated” security a mainstay in medical devices is a worthwhile investment. With it, healthcare professionals and patients can be assured that their data are handled by the highest standard of security. It means that the trend of untethered devices can continue instead of being stifled by fear.

The consequences without validation are obvious: The medical technology sector is handling lives, and any security flaw could mean life or death. Today’s technological trends in healthcare are improving the industry, and it is worthwhile for vendors to observe a high level of security to keep these improvements moving forward. M

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TUBING TALKS

How to make adhesives work for your medical tubing

Image courtesy of Dymax

Medical device companies have many factors to consider when deciding which adhesives to use with tubing. An adhesives manufacturer explains them.

T

he best tubing in the world won’t help a medical device to work if it won’t adhere properly.

Determining the right adhesive technology for your medical tubing depends on several factors, according to Dymax, a Torrington, Conn.-based manufacturer of advanced light-curable adhesives, coatings, oligomers, light-curing equipment and fluid dispense systems.

Factors to consider include:

Nancy Crotti | Senior Editor |

• What is the tubing made of?

• What will it be used for?

• How much volume will you need to produce?

• What is the device’s design?

• How will it be sterilized?

Thermoplastic materials such as nylons and their derivatives can resist harsh chemicals and environmental end-use conditions.

They’re strong and can withstand a variety of sterilization methods. Polyether block amide (PEBA) is a lightweight material that offers low friction properties, kink and pressure

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resistance, softness and flexibility and is chemically, fatigue- and impact-resistant.

Cyclic olefin polymers and copolymers (COC and COP) are amorphous polymers that offer an alternative to glass for prefilled syringes and serum vials due to their purity, moisture resistance, clarity and sterilization compatibility.

Medtech companies that manufacture devices that use small, lightweight tubing may need an alternative to mechanical fasteners to assemble their plastic parts.

Their device’s intended use may not allow for gaps produced by ultrasonic welding or fusion bonding, or the cracks that may develop in plastic substrates subjected to solvent welding.

That’s where adhesives come in, according to Michelle Evanoski, medical adhesives product manager for Dymax.

Adhesive technologies can deliver highstrength bonding, sealing, gap-filling and inline processing. Although they require time to set and cure, some adhesives can easily bond a variety of dissimilar substrates, as well as sealing the bond line, Evanoski said.

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BRYCE G. RUTTER

Founder &CEO; Metaphase Design Group, Inc.

MOHAN NATHAN

Vice President, Global Clinical Marketing; TransEnterix, Inc.

SAVE THE DATE:

DECEMBER 9-10, 2019

Santa Clara, CA

Santa Clara Convention Center presented by:

west.devicetalks.com

@DeviceTalks

For more Exhibit/Sponsorship information, contact Mary Ann Cooke. 781.710.4659 | maryann@massdevice.com For info on Speaking Opportunities, contact Sarah Faulkner. 216.978.5261 | sfaulkner@wtwhmedia.com

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TUBING TALKS

Certain plastics bond more easily than others. Nylon, COC/COP and PEBA are all difficult-to-bond thermoplastics because of their low surface energies and smooth or glossy surfaces, Evanoski explained.

Adhesives are also polymers and can either spread out, in a process called “wetting,” or bead up on the surface of a plastic substrate. The ones that bead up will not fill in irregularities on the substrate surface, making chemical bonding difficult. Manufacturers can use a variety of techniques to activate a substrate or change its surface to improve adhesion: grit blasting, micro blasting and sanding will scratch the surface to expose crystalline microstructures within the substrate with different wetting characteristics.

While these abrasion methods remove a layer of the substrate’s surface, others such as corona discharge add a layer. Plasma treatment shoots argon, nitrogen, oxygen or helium onto the

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surface to add acetal, carboxyl or hydroxl groups to it, increasing surface energy and thus bonding strength. Chromic acid can etch the substrate to drastically improve wetting for a stronger bond.

Flame treatments will melt the surface and add a reactive layer of oxidation.

All these techniques can make a smooth substrate more amenable to bonding when using an adhesive, Evanoski said.

Once the adhesive is applied, it must cure. Adhesives cured with light rather than heat offer unlimited time for manufacturers to adjust parts. Then the adhesives can

Medtech companies that manufacture devices that use small, lightweight tubing may need an alternative to mechanical fasteners to assemble their plastic parts.

That's where adhesives come in.

www.medicaldesignandoutsourcing.com

9/15/19 12:45 AM

cure on-demand when exposed to the appropriate light wavelength, hastening the assembly process.

For high-volume, high-speed, automated production, UV/visiblelight-curable adhesives can fully cure in seconds into thermoset polymers, Evanoski said. These form lasting bonds to different types of plastics, including those that are difficult to bond. These adhesives can come with fluorescing properties that enable easy inspections to detect bonding, coverage and volume. Some adhesives can change color to help manufacturers confirm they have cured completely.

Many light-curable adhesives are formulated to enable visual confirmation of their placement, either by the human eye or by automated vision systems.

These include formulations that change from a bright color when uncured to colorless when they’re cured. Those formulated with fluorescent dyes remain colorless until they are exposed to a

black light, which will cause them to fluoresce either red or blue. Adhesives that fluoresce red work well with substrates that naturally fluoresce blue, such as PVC and PET, and allow for easy inspection of bond lines, Evanoski said.

With so many factors to consider in choosing an adhesive technology, medtech manufacturers should look for a partner who can offer guidance through engineering, R&D, sales and technical service, she added. Thorough testing of prototypes on simulated production lines can include dispense/ dwell times, wavelength selection and cure time, and pull evaluations to ensure successful assembly and a wellperforming device. M

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DEVICETALKS

Applying AI in the ER with CEO Gene Saragnese MaxQ AI chairman & CEO Gene Saragnese talked to DeviceTalks’ program manager about the company’s software that uses AI to interpret medical images and patient data. Want to see these interviews live?

Join us at DeviceTalks.

Sarah Faulkner: Digital health, artificial intelligence and machine learning — these terms represent a lot of the buzz emerging from the medtech industry this year. And as is often the case with buzz-worthy technologies, there are plenty of companies touting the next big innovation.

It’s safe to say that AI has not yet fundamentally disrupted the healthcare industry - at least in the ways that many predicted it would - but MaxQ AI CEO Gene Saragnese pointed out to me in our interview that for doctors and patients to reap the benefits of AI-enabled tech, it has to be applied to the right problems.

Gene Saragnese: The technology at MaxQ is based upon machine learning, machine vision technology, and machine learning technologies have had a huge impact on virtually every industry, except for healthcare and applying that technology to healthcare has its unique problems – data is less available. Amazon has millions of customers and millions of pieces of data, so that part is easy. In healthcare, it’s not so easy. The data is sparse, it’s corrupt. You have to think differently when you apply this technology to healthcare but I am confident that applying it correctly to the right problems will have a tremendous effect.

Gene Saragnese | MaxQ AI |

Saragnese: Time-sensitive, life-threatening conditions are places where we often either don’t act quick enough or have the expertise at the bedside to make good crisp decisions. It turns out that stroke and trauma are two areas where if you make the right decisions, patients get better. If you make the wrong decisions, they may not.

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Faulkner: At MaxQ, Gene and his team have honed in on a very specific set of problems that bring patients to the emergency room. The first several software products emerging from MaxQ are focused on addressing intracranial hemorrhage and stroke detection.

9 • 2019

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9/16/19 2:09 PM

Faulkner: The company’s software is designed to reduce misdiagnosis and healthcare costs by helping doctors to make faster and more accurate decisions when diagnosing things like stroke and brain trauma. When building its products, the company follows a few major design considerations, according to Gene.

Saragnese: We want to augment the physicians with AI/machine learning so they can make good decisions at the bedside. We must integrate in a very seamless manner. Our goal is zero clicks - we process all of our information in the background. When a physician sits down to read the images or diagnose the

the impression that eventually people who have jobs like radiologists will be replaced

by AI-enabled tech. So I asked Gene: does he envision a future where that could be a reality?

Saragnese: No, I don’t believe in the concept of replacement.

I believe that the tools work together with physicians. The word augmentation is designed to really embrace this concept of helping and aiding a physician, allowing a community hospital physician to make decisions that perhaps a neuro-radiologist would.

We want to augment the physicians with AI/ machine learning so they can make good decisions at the bedside. patients, that information is available, no buttons, no clicks, no nothing.

Our overall goal is to redefine diagnostic quality, accuracy and speed and that’s the overall business that we’re in. Lastly, we must solve an economic problem. Why? Because we can’t afford to give care to the people that are out there today. We’re still making errors on the order of 30% in the diagnostic space, which creates a lot of waste, both social as well as economic waste. So as I said, the problems we’re focusing on must have an economic impact and we must impact those economics through quality and outcomes.

The other thing I really want to point out in particular to radiologists of the world is that this actually represents, I think, an opportunity. Radiologists have been incredibly forward-thinking in terms of technology. You think about CT machines as being high tech, yeah but informatics in hospitals really have their origins in radiology. They’re the first ones to really bring informatics to the bedside. I look at this as an opportunity and I think the discipline is going to evolve over time from reading images to interpreting the full nature and diagnosing patients.

Faulkner: One thing that really stood out to me in this interview with Gene is his use of the phrase ‘augment physicians’ – that his company’s tech was built to augment physicians, not replace them. This was so interesting to me because I think a lot of folks have

Faulkner: And while some are wondering if AI will eventually replace doctors, others are wondering if it will have any impact at all. That’s likely thanks to a number of products on the market that haven’t exactly lived up to all they promised to be. Here’s what Gene had to

say when I asked him how he separates the hype from legitimate innovations.

Saragnese: AI/machine learning is a tool. It’s a remarkable tool. It’s had a huge impact, as I said earlier, in other industries. That having been said, in healthcare, it still comes down to what do you do with it? And I see people creating tools using AI that quite frankly, I shipped as product 15 years ago. To simply use AI to solve a problem that’s already been solved, makes really no sense. And what worries me deeply is that everybody thinks about AI as AI. It’s not and for whoever knows what C++ is, it’s just a software language. Who cares?

Nobody sells or presents for value based upon C++. In time, as important as the technology is, people shouldn’t care. What you do with it is really what matters and because it’s so new in healthcare, I worry a little bit that we get caught up in the buzz of ‘it’s AI,’ when we really should be thinking about, what does it do? How reliably does it do it? And is it really solving a really hard problem that needs to be solved?

I sat across the table for 20 years from a major payer-provider and I would brief them on technology that was coming. And in the beginning, it was all about exciting new technologies that were coming. But about four or five years ago, I had the same conversation and the chair of that committee said to me, “What I’m being asked to do is to treat 10% more patients with 10% less cost.” It wasn’t about technology anymore. It wasn’t about what was new and exciting. It was about how do you solve that problem. That’s a very simple and straightforward statement and that’s what healthcare is about today. You have to look at this holistically and that’s at the heart of what we’re doing here at MaxQ. M This conversation has been edited and condensed for length.

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AD INDEX

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152

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EVP Marshall Matheson mmatheson@wtwhmedia.com 805.895.3609 @mmatheson

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