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EXCLUSIVE: How Smiths Medical changed its culture from the inside out www.medicaldesignandoutsourcing.com SEPTEMBER 2016

BIG1OO

BIG100 MEDTECH'S 100 LARGEST PLAYERS • • • • • •

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Welcome Back to the Big 100 The Top Medical Device Employers R&D: Who's Spending the Most? CEO Moves: Who's In & Out of the Corner Office Medtech's Global Hotspots Ones to Watch: Who Will Make the Cut Next Year?

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EXCLUSIVE: How Smiths Medical changed its culture from the inside out www.medicaldesignandoutsourcing.com SEPTEMBER 2016

BIG1OO

BIG100 MEDTECH'S 100 LARGEST PLAYERS

• Welcome Back to the Big 100 • The Top Medical Device Employers • R&D: Who's Spending the Most? • CEO Moves: Who's In & Out of the Corner Office • Medtech's Global Hotspots • Ones to Watch: Who Will Make the Cut Next Year?

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HERE’S WHAT WE SEE

Welcome back to the Big 100 Medical Design & Outsourcing is back with its annual look at the world’s 100 largest medical technology companies. It’s September, and here at Medical Design & Outsourcing that means it’s time for the Big 100, our annual look at the largest players in the medical technology world. Actually, around here Big 100 time started months ago, when we began scouring regulatory filings and annual reports. Here you’ll find the result, information on the world’s 100 leading medical technology companies, ranked according to annual revenues, plus rankings according to R&D spend and number of employees. The Big 100 also includes a look at executives’ notable moves into – and out of – the corner office, and maps showing medical technology hotspots in the U.S. and around the world. And this year we’re providing a glimpse at 10 companies that

could make the jump to the 2017 Big 100. In compiling the issue, we used data from the most recently concluded fiscal year for each company, plus information from our own archives, corporate documents and public regulatory filings and the companies’ websites. For diversified companies like Johnson & Johnson, which have businesses in non-medical device areas, we took into account only the numbers reported for their medtechrelated businesses (J&J made that much easier this year by ditching its Ortho-Clinical Diagnostics business to focus on devices). We used the 2015 average exchange rates set by the U.S. Federal Reserve to calculate U.S. dollar conversions for companies that

Brad Perriello Executive Editor Medical Design & Outsourcing bperriello@wtwhmedia.com

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report in other currencies. Last year once again featured lots of churn along the list, as companies acquired and were acquired in an M&D feeding frenzy. Most notably, Medtronic’s acquisition of Covidien pushed it into the top spot this year, displacing Johnson & Johnson for the first time since we began compiling the list in 2011. Likewise, Becton Dickinson’s buyout of CareFusion pushed it from 37th to 8th on the list; Abbott vaulted from 45th last year to 23rd this year (and that doesn’t even account for its pending $25 billion pickup of St. Jude Medical). Other companies, such as Cook Medical, Ottobock and Hanger Orthopedic, would likely have made the list had they posted results for 2015 (the German prosthetics giant is reportedly preparing to take itself public). But again acquisitions played the largest role, taking these companies off the table: • Allergan (acquired by Actavis) • Arseus (acquired by Henry Schein) • Arthrocare (acquired by Smith & Nephew) • Biomet (acquired by Zimmer) • Endo Health Solutions (exited devices with the sale of its American Medical Systems urology business to Boston Scientific) • Hospira (acquired by Pfizer) • Medical Action Industries (acquired by Owens & Minor) • Mindray Medical (taken private by management) • Nobel Biocare (acquired by Danaher) • Symmetry Medical (acquired by Tecomet) • Toshiba Medical Systems (dealt to Canon) • Volcano (acquired by Philips) • Welch Allyn (acquired by Hill-Rom) M

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Medical Design & OUTSOURCING E D I T O R I A L EDITORIAL Founding Editor Paul Dvorak pdvorak@wtwhmedia.com @paulonmedical Executive Editor Brad Perriello bperriello@wtwhmedia.com Managing Editor Nic Abraham nabraham@wtwhmedia.com @NicsMedTechNews Senior Editor Heather Thompson hthompson@wtwhmedia.com Associate Editor Fink Densford fdensford@wtwhmedia.com C

Editorial Intern - Medical Abigail Esposito aesposito@wtwhmedia.com

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Web Development Manager B. David Miyares dmiyares@wtwhmedia.com @wtwh_webdave Digital Media Manager Patrick Curran pcurran@wtwhmedia.com @wtwhseopatrick Senior Web Developer Patrick Amigo pamigo@wtwhmedia.com @amigo_patrick Online Production Coordinator Melissa Annand mannand@wtwhmedia.com Web Production Associate Skylar Aubuchon saubuchon@wtwhmedia.com Web Production & Reporting Associate Jennifer Calhoon jcalhoon@wtwhmedia.com @wtwh_jennifer

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WTWH Media, LLC 6555 Carnegie Avenue, Suite 300, Cleveland, OH 44103 Ph: 888.543.2447 • Fax: 888.543.2447 MEDICAL DESIGN & OUTSOURCING does not pass judgment on subjects of controversy nor enter into disputes with or between any individuals or organizations. MEDICAL DESIGN & OUTSOURCING is also an independent forum for the expression of opinions relevant to industry issues. Letters to the editor and by-lined articles express the views of the author and not necessarily of the publisher or publication. Every effort is made to provide accurate information. However, the publisher assumes no responsibility for accuracy of submitted advertising and editorial information. Non-commissioned articles and news releases cannot be acknowledged. Unsolicited materials cannot be returned nor will this organization assume responsibility for their care. MEDICAL DESIGN & OUTSOURCING does not endorse any products, programs, or services of advertisers or editorial contributors. Copyright©2016 by WTWH Media, LLC. No part of this publication may be reproduced in any form or by any means, electronic or mechanical, or by recording, or by any information storage or retrieval systems, without written permission from the publisher. SUBSCRIPTION RATES: Free and controlled circulation to qualified subscribers. Non-qualified persons may subscribe at the following rates: U.S. and possessions, 1 year: $125; 2 years: $200; 3 years $275; Canadian and foreign, 1 year: $195; only U.S. funds are accepted. Single copies $15. Subscriptions are prepaid by check or money orders only. SUBSCRIBER SERVICES: To order a subscription or change your address, please visit our web site at www.medicaldesignandoutsourcing.com MEDICAL DESIGN & OUTSOURCING (ISSN 2164-7135) is published by WTWH Media, LLC, 6555 Carnegie Avenue, Suite 300, Cleveland, OH 44103.

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CONTENTS

medicaldesignandoutsourcing.com  ∞  September 2016  ∞  Vol2 No5

DEPARTMENTS 02

BIG1OO

BIG100 MEDTECH'S 100 LARGEST PLAYERS

08 CONTRIBUTORS

1OO

S S

11

BIG 100 BREAKDOWN

96

MANUFACTURING & MACHINING: Taking production costs out of medical devices starts with design

100 REIMBURSEMENT: Bundled payments are the future of healthcare 104

11

ON THE COVER:

A look at the world’s leading medtech companies, with rankings by annual revenues, R&D spend, employee headcount, featuring a roster of up-and-comers, a look at notable moves in the corner office and maps of medtech’s hotspots.

112 MATERIALS: The 6 Sciences of micro molding 116

CONTRACT MANUFACTURING: Know Thy BOM: Best practices for transitioning from design into production

78 Top R&D Spenders

121

ENGINEERING 911: A few ideas for improving supply chains

82 Top Medical Device Employers

124 REGULATORY: Adaptive designs for clinical trials can improve speed to market

Who’s putting the most into the pipeline?

86 Medtech’s Global Hotspots

126

THE CATH LAB: A robot in the cath lab takes surgeons out of radiation’s way

90 Ones to Watch

130

FDA NEW PRODUCTS: The U.S. Food & Drug Administration’s original PMA approvals for July 2016

132

DEVICE TALKS: How Smiths Medical changed its culture from the inside out

136

AD INDEX

U.S., Global

Who will make the cut next year?

91 CEO moves

Notable moves in the C suite

Medical Design & Outsourcing

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PATENT PROTECTION: Supreme Court decision raises medical device patent questions

106 CONNECTORS CORNER: A foolproof formula for customized connectors

12 Big 100 Breakdown

6

HERE’S WHAT WE SEE: The Big 100, our annual look at the largest players in medtech

9 • 2016

www.medicaldesignandoutsourcing.com

9/10/16 11:32 PM


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CONTRIBUTORS

ANASTASI

GORDON

AHLM

GREDICK

KIRSCHENBAUM

MATACHUN

GRUBB

DVORAK SUGALSKI

RANDY AHLM is CEO of NPI/Medical, an Ansonia, Conn.-based company that provides prototyping, bridge tooling, production, assembly and packaging, kitting, vendor-managed inventory (VMI) and supply chain optimization services to the medical device industry.

TYLER GRUBB is a design engineer in CPC's medical business unit. He manages the development and launch of customized fluid handling components used in surgical devices, in vitro diagnostics, patient monitoring systems and other medical applications.

VICKI ANASTASI is vice president and global head of Medical Devices & Diagnostics Research at ICON plc. She has more than 20 years of regulatory experience in the medical device space.

DR. IRA KIRSCHENBAUM is chair of Orthopedics at Bronx-Lebanon Hospital in New York. He's on the editorial board of Medscape Orthopedics, and recently published the “CJR Manual” on bundled payments.

PAUL DVORAK is the Founding Editor of Medical Design & Outsourcing. He has more than 27 years of experience writing and editing technical articles and editorials covering a variety of industries. JED GORDON is a partner in the Boston office of McDermott, Will & Emery LLP where he focuses on patent portfolio development related to medical devices, computer networking, and other electronics and software technologies. KEN GREDICK, Engineering Manager at Triangle Manufacturing, is a seasoned professional with more than 20 years of combined experience in the aerospace and medical industries.

8

Medical Design & Outsourcing

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BRIAN MATACHUN joined MTD Micro Molding in 2008, leading and developing its customer-oriented and technical sales force. Brian has nearly 20 years of business management, polymer development and plastic processing expertise. ERIC SUGALSKI is the founder and president of Smithwise. He began his career as an engineer, transitioned into project management and now focuses on Smithwise’s strategy and new partnerships.

www.medicaldesignandoutsourcing.com

9/9/16 2:18 PM


Plastic Part Validation Have You Buried? Let PTI Engineered Plastics Dig You Out. In this age of high-tech manufacturing, quality requirements have never been tougher. That’s why PTI Engineered Plastics has built their operations to support validations throughout their manufacturing and assembly processes. Our team is highly trained to define and implement all facets of IQ, OQ, PQ protocol validations, including many other quality standards required in the plastic injection molding industry.

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SMARTER TOOLS START WITH SMALLER PARTS. RING AND SPRING SIZES NOW* DOWN TO 0.165" (4 MM) FOR NEW POSSIBILITIES IN MEDICAL DESIGN. Today’s complex medical devices demand precision components that offer high performance in extraordinarily small sizes. Using materials ranging from surgical 316 Stainless Steel to implantable Titanium, Smalley engineers create wave springs and retaining rings below 0.2"—and that’s just the start. Challenge us to go even smaller on your next design. Visit smalley.com/medical for 316 stainless samples to test in your next application.

Ask Smalley. Our world-class engineering team has deep experience helping medical equipment designers. Look to us for free technical consultation, downloadable CAD models or no-charge samples for evaluation and prototyping.

THE ENGINEER’S CHOICE™ * Small part manufacturing requires close collaboration when determining design criteria. Please consult Smalley on your next application.

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Medical Design & OUTSOURCING

BIG1OO

BIG100 MEDTECH'S 100 LARGEST PLAYERS A look at the world’s leading medtech companies, with rankings by annual

revenues, R&D spend, employee headcount, featuring a roster of up-and-comers, a look at notable moves in the corner office and maps of medtech’s hotspots.

T H E B I G 1 0 0 L I S T B E G I N S O N T H E N E X T PA G E

Big 100 Breakdown p.12 Top R&D Spenders p.78 Top Medical Device Employers p.82 Medtech’s Global Hotspots p.86 Ones to Watch p.90 CEO Moves p.91 www.medicaldesignandoutsourcing.com

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S S S

COMPANIES RANKED BY REVENUE RANK COMPANY 1

Medtronic $28,833,000,000

2

Johnson & Johnson (medical device segment) $25,137,000,000

3

Philips Healthcare (Royal Philips Electronics) $19,817,952,415

4

GE Healthcare (General Electric) $17,639,000,000

5

Fresenius (medical care segment) $16,739,425,600

6

Siemens Healthineers (Siemens) $11,652,847,873

7

Cardinal Health (medical segment) $11,395,000,000

8

Becton, Dickinson (medical segment) $10,282,000,000

9

Baxter (medical products segment) $9,968,000,000

10

Stryker $9,946,000,000

11

Novartis (Alcon segment) $9,812,000,000

12

Owens & Minor $9,772,946,000

13

Danaher (life sciences & diagnostics segment) $8,213,100,000

14

Fujifilm Holdings (information solutions segment) $7,895,225,114

15

Bayer (consumer health segment) $7,792,720,800

16

Boston Scientific $7,477,000,000

THEY DON’T GIVE YOU MONEY BECAUSE THEY’RE IN LOVE WITH A STORY. THEY FUND THIS COMPANY AND THIS MISSION BECAUSE ONE THIRD OF ALL AMERICANS SUFFER FROM HEART DISEASE, WE ALL KNOW SOMEBODY THAT’S HAD A HEART ATTACK, SOMEONE THAT’S DIED FROM IT OR LIVES WITH IT CURRENTLY, THEIR FRIENDS SUFFER FROM THIS. THEY SEE THAT WE CAN DETECT OBSTRUCTIVE CORONARY DISEASE IN ABOUT 20 MINUTES AND THAT’S TAKING THE DATA TO RECEIVING THE REPORT BACK. WE DO IT QUICKLY, WE DO IT NONINVASIVELY, IT’S ACTUALLY A RELAXING TEST. IT TAKES ONLY 8 MINUTES FOR US TO COLLECT THE DATA, THE PATIENT’S LAYING ON THEIR BACK IN SUPINE POSITION. NO PHARMACEUTICALS. IT’S A NO BRAINER.

17

Essilor $7,452,073,600

18

B. Braun $6,801,626,080

19

Zimmer-Biomet $5,997,800,000

20

Hitachi (healthcare segment) $5,625,774,473

21

St. Jude Medical $5,541,000,000

22

3M Co. (healthcare segment) $5,420,000,000

23

Olympus $5,030,375,878

24

Abbott Laboratories (medical device segment) $5,000,000,000

25

Smith & Nephew $4,634,000,000

26

Cerner $4,425,000,000

27

Grifols $4,365,832,160

28

Terumo $4,043,833,127

29

Getinge $3,584,469,472

30

C.R. Bard $3,416,000,000

31

Varian Medical Systems $3,099,100,000

32

McKesson (technology solutions segment) $2,885,000,000

33

Hologic $2,705,000,000

34

Dentsply $2,674,300,000

35

Hoya (life care segment) $2,532,837,670

36

Edwards Lifesciences $2,493,700,000

37

Intuitive Surgical $2,384,400,000

38

Steris $2,238,764,000

– AUM CARDIOVASCULAR CEO

39

BioMerieux $2,180,364,000

40

Coloplast $2,067,853,054

MARIE JOHNSON

12

2015 REVENUE

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S S S

COMPANIES RANKED BY REVENUE RANK COMPANY

MOST PEOPLE DON’T REALIZE I’M VERY COMPETITIVE. I CAN’T STAND TO LOSE. – FORMER STRYKER CEO

JOHN BROWN

2014 REVENUE

41

Paul Hartmann $2,067,510,000

42

Waters $2,042,332,000

43

Bio-Rad $2,019,400,000

44

Sonova $1,994,854,204

45

Hill-Rom $1,988,200,000

46

Nipro (medical segment) $1,964,477,489

47

Draegerwerk (medical segment) $1,826,401,600

48

Teleflex $1,809,690,000

49

Cooper Cos. $1,797,060,000

50

Miraca $1,749,219,331

51

ResMed $1,678,912,000

52

ConvaTec $1,650,500,000

53

Bruker $1,623,800,000

54

IDEXX Labs $1,601,892,000

55

William Demant (hearing segments) $1,585,567,102

Two heads are better than one. Your idea. Our design. Both working together from the start to make great things possible. That’s what happens when Nason partners with customers in the medical equipment industry to create cutting-edge, fully custom switches and cylinders — and that’s why we’re proud to be a small part of something big. 14

Medical Design & Outsourcing

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9 • 2016

www.medicaldesignandoutsourcing.com

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RANK COMPANY

2014 REVENUE

56

Halyard Health $1,574,400,000

57

Nihon Kohden $1,367,385,378

58

Elekta $1,330,290,456

59

Smiths Medical (Smiths Group) $1,277,742,400

60

Agfa-Gevaert (healthcare segment) $1,219,450,400

61

Sirona Dental Systems $1,161,300,000

62

Carl Zeiss Meditec $1,154,051,686

63

Amplifon $1,147,300,879

64

Invacare $1,142,338,000

65

DJO Global* $1,113,627,000

66

Fukuda Denshi $968,376,704

67

Haemonetics $910,373,000

68

Omron (healthcare segment) $895,704,254

69

Integra Lifesciences $882,734,000

70

Cochlear $871,122,820

71

Align Technology $845,486,000

72

Kawanishi $838,166,047

73

NuVasive $811,113,000

74

Greatbatch (now Integer) $800,414,000

75

GN Store Nord (ReSound segment) $769,368,003

76

Straumann $768,892,080

77

Acelity $745,457,000

78

Konica Minolta (healthcare segment) $741,842,214

79

Conmed $719,168,000

80

LivaNova (formerly Sorin/Cyberonics) $707,265,000

81

Masimo $599,334,000

82

Fisher & Paykel Healthcare $570,923,149

83

Cantel Medical $565,004,000

84

Merit Medical Systems $542,149,000

85

Össur $483,034,000

IT'S A VERY INTERESTING COMBINATION. THERE'S VERY LITTLE OVERLAP, ALMOST NO OVERLAP IN THE PRODUCT FRANCHISES. IT'S AN EFFICIENT MERGER, THAT CREATES VERY IMPRESSIVE SCALE FOR ABBOTT, AND PUTS THEM IN A NASCENT POSITION IN SOME NEW MARKETS, INCLUDING VALVE INTERVENTION, AND INCLUDING AFIB. I SUSPECT THEY'LL ADD MORE TECHNOLOGIES OVER TIME, BUT IT'S A VERY IMPRESSIVE COMBINATION. - SV LIFE SCIENCE MANAGING PARTNER & COO

PAUL LAVIOLETTE,

ON ABBOTT’S $25 BILLION ACQUISITION OF ST. JUDE MEDICAL

THE LESSON IS THAT, AT THE END OF THE DAY, YOU'VE GOT TO DO WHAT YOU THINK IS THE RIGHT THING FOR THE RIGHT REASON, AND ULTIMATELY I'VE ALWAYS PUT PATIENTS FIRST. I'VE ALWAYS PUT THE CONCERN FOR THE PEOPLE WHOSE LIVES DEPEND ON WHAT WE DO. I'VE ALWAYS WORKED HARD AT GARNERING THE TRUST OF THE PEOPLE THAT I WORK WITH, OUR CUSTOMERS, OUR PHYSICIAN COLLABORATORS, AND SO THE MORAL IS NEVER COMPROMISE THE TRUST. - FORMER MEDTRONIC CEO WILLIAM

www.medicaldesignandoutsourcing.com

es

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HAWKINS

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Medical Design & Outsourcing  15

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S S S

COMPANIES RANKED BY REVENUE RANK COMPANY

TEN YEARS AGO, TO START A COMPANY, IN OUR CASE A PMA PRODUCT, WAS USUALLY BETWEEN 6 AND 7 YEARS BETWEEN THE LIQUIDITY EVENT AND THE PMA APPROVAL. THAT’S NOW 12 YEARS. THAT TECTONIC SHIFT HAPPENED RIGHT WHEN WE WERE ABOUT 2 OR 3 YEARS OLD. IT BECAME ONE OF THOSE NECESSARY THINGS. - COHERA CEO

PATRICK DALY

2014 REVENUE

86

Thoratec $477,560,000

87

JMS Co. 457,859,000

88

Wright Medical $415,461,000

89

DexCom $402,000,000

90

Orthofix $396,489,000

91

Accuray $379,801,000

92

Natus $375,865,000

93

Topcon (eye care segment) $362,114,829

94

Nikkiso (medical segment) $343,593,556

95

ICU Medical $341,254,000

96

CynoSure $339,462,000

97

NxStage Medical $336,123,000

98

Abiomed $329,520,000

99

Insulet $324,225,000

100

RTI Surgical $282,293,000

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THE TOP 1OO MEDTECH COMPANIES

1

T

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MEDTRONIC 710 Medtronic Parkway NE
 Minneapolis, MN 55432
 
www.medtronic.com

he past year saw Medtronic topple Johnson & Johnson as the world’s largest medical device maker, largely on the strength of its $50 billion acquisition of Covidien, which closed in January 2015. The company once again strode large along the mergers & acquisitions trail, having put at least $2.3 billion on the line in buyouts since September 2015, including the $1.1 billion acquisition of implantable pump maker HeartWare: • Medina Medical ($150 million, September 2015 – brain embolization coil) • Lazarus Effect ($100 million, September 2015 – stent retriever cover) • Twelve Inc. ($458 million, October 2015 – transcatheter mitral valve replacement) • Aircraft Medical ($110 million, November 2015 – video laryngoscope) • Baylis Medical’s OsteoCool (undisclosed, January 2016 – cooled radiofrequency tumor ablation) • Bellco (undisclosed, February 2016 – renal care) • Smith & Nephew’s gynecology business ($350 million, May 2016 – Truclear hysterectomy device) • Mazor Robotics ($42 million strategic investment, May 2016 – robot-assisted spinal surgery platform) • Responsive Orthopedics (undisclosed, June 2016 – bundled total knee replacements) • HeartWare International ($1.1 billion, August 2016 – left ventricular assist devices) Although the binge meant cuts for other, internal R&D programs, Medtronic still managed to spend some $1.6 billion on R&D during fiscal 2015. The company’s bets on diabetes and the artificial pancreas advanced during the past year, with FDA nods for its Paradigm Real-time Revel system and Enlite continuous glucose sensor; and its play in the transcatheter aortic valve replacement market gained ground with an expanded indication for its CoreValve device. CEO Omar Ishrak’s emphasis on “value-based healthcare” – read “we want to get ahead of Medicare’s bundled payments program” – continued during the year, as evidenced by the Responsive Orthopedics acquisition. M

2015 RANK: 2 Employees: 92,000 Revenue: $28,800,000,000 R&D Spend: $1,640,000,000 Fiscal year ending: April 24, 2016

KEY PERSONNEL: OMAR ISHRAK, Chairman & CEO; MICHAEL COYLE, EVP & President, Cardiac & Vascular Group; GARY ELLIS, EVP, Global Operations, IT, Facilities & Real Estate; MIKE GENAU, SVP, President, Americas; HOOMAN HAKAMI, EVP, President, Diabetes; BRYAN HANSON, EVP, President, Minimally Invasive Therapies; DR. RICK KUNTZ, SVP, Chief Scientific, Clinical, & Regulatory Officer; CHRIS LEE, SVP, President, Greater China Region; BRAD LERMAN, SVP, GC & Secretary; GEOFFREY MARTHA, EVP, President, Restorative Therapies Group; KAREN PARKHILL, EVP, CFO; LUANN PENDY, SVP, Global Quality; CAROL SURFACE, SVP, Chief HR Officer; ROB TEN HOEDT, EVP, President, EMEA; BOB WHITE, SVP & President, APac

www.medicaldesignandoutsourcing.com

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THE TOP 1OO MEDTECH COMPANIES

2 J

JOHNSON & JOHNSON 1 Johnson & Johnson Plaza 
New Brunswick, NJ 08933 
 www.jnj.com



ohnson & Johnson may have slipped a notch on this year’s Big 100 list, but the healthcare giant isn’t wavering in its focus on the medical device market – despite a full-year sales decline of -8.7% last year, compared with 2014. The commitment to the medical device business also included layoffs for some 3,000 workers in its medtech division, the company announced in January 2016. The layoffs, affecting about 2.5% of J&J’s 270,000-strong workforce or 4% to 6% of its 60,000-worker medtech headcount, are aimed at delivering annual pre-tax savings of $800 million to $1 billion, largely by the end of 2018, with $200 million saved in 2016. The cuts spared the consumer medical device, vision care and diabetes businesses, further indication of where the company’s interests lie. Johnson & Johnson is also eyeing growth through acquisition, notwithstanding a $10 billion share repurchasing program, according to CFO Dominic Caruso. As an example, take J&J’s electrophysiology business, Biosense Webster, which paid an undisclosed amount for Coherex Medical and its WaveCrest anti-stroke device in November 2015. The company also joined Edwards Lifesciences in a $28 million Series B round for V-Wave and its interarterial shunt for heart failure. In diabetes, J&J’s LifeScan inked a collaboration deal with WellDoc (and got in on a Series B round) to integrate LifeScan’s glucose monitoring tech with WellDoc’s mobile diabetes management app. Ethicon, J&J’s medical-surgical arm, in April 2016 closed a deal for soft-tissue microwave ablation system maker NeuWave Medical, for an undisclosed amount. Its DePuy Orthopaedics unit picked up BioMedical Enterprises, which makes implants for small bone fixation, for an undisclosed amount. M

2015 RANK: 1 Revenue: $24,140,000,000* Fiscal year ending: Jan. 3, 2016 * Revenues from J&J's medical device segment.

KEY PERSONNEL: ALEX GORSKY, Chairman & CEO; DOMINIC CARUSO, CFO; JOAQUIN DUATO, EVP, Chairman, Pharmaceuticals; PETER FASOLO, EVP, Chief HR Officer; JORGE MESQUITA, EVP, Chairman, Consumer; SANDRA PETERSON, EVP, Group Chairman; GARY PRUDEN, EVP, Chairman, Medical Devices; MICHAEL SNEED, VP, Global Corporate Affairs; DR. PAUL STOFFELS, EVP, Chief Scientific Officer; MICHAEL ULLMANN, EVP, GC; KATHRYN WENGEL, VP, Supply Chain


www.medicaldesignandoutsourcing.com

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100 YEARS OF INNOVATION.

For 100 years NSK has been proudly designing motion and control products that not only help increase productivity but also help make the world a more safe, reliable and comfortable place. Here’s to celebrating the past, innovating in the present and setting the future in motion. 877.994.6675

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THE TOP 1OO MEDTECH COMPANIES

3

P

PHILIPS HEALTHCARE (ROYAL PHILIPS ELECTRONICS)

BC475958 Breitner Center, Amstelplein 2, Amsterdam P7 1096 BC www.philips.com



hilips Healthcare – Royal Philips’ largest division – moved up a few slots this year, as its bid to shed its legacy lighting business to focus on healthcare began to take shape (although U.S. anti-trust regulators forced it to spike the planned sale of another lighting business, Lumileds). The retooling began in the summer of 2014 with the departure of healthcare CEO Deborah DiSanzo, who wound up landing at the helm of IBM’s Watson artificial intelligence business. The healthcare division racked up more deals with hospitals this year, signing a $90 million pact with Marin General on a so-called “enterprise managed services” model that will see the Dutch company provide imaging systems, patient monitoring devices and services ranging from telehealth, clinical informatics and education to consulting and design. An 8-year, $36 million deal with Medical University of South Carolina Health calls for Philips Healthcare to install, integrate and manage patient monitoring systems and software and provide maintenance, training and consulting services using a structured monthly payment model. Philips is also placing bets on mobile health, inking a deal with Validic to integrate personal health data from devices and apps with a platform of cloud-based HealthSuite programs. The company paid an undisclosed amount to bolster its digital pathology offering with the buyout of Irish firm PathXL in June 2016 and put down another unspecified chunk on population health management software developer Wellcentive the next month. An agreement with Qualcomm at the end of August this year aims to develop connected health solutions. M

2015 RANK: 5 Revenue: $19,800,000,000 Fiscal year ending: Dec. 31, 2015

KEY PERSONNEL: FRANS VAN HOUTEN, Chairman & CEO, Royal Philips; ABHIJIT BHATTACHARYA, EVP & CFO; JEAN BOTTI, EVP; ROB CASCELLA, EVP; MARNIX VAN GINNEKEN, EVP; DENISE HAYLOR, EVP; ANDY HO, EVP; RONALD DE JONG, EVP; PIETER NOTA, EVP; BRENT SHAFER, EVP; JEROEN TAS, EVP

www.medicaldesignandoutsourcing.com

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THE TOP 1OO MEDTECH COMPANIES

4

GE HEALTHCARE

(GENERAL ELECTRIC)

Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA U.K.

G

www3.gehealthcare.com/en/global_gateway



E Healthcare CEO John Flannery, tapped in October for his experience in global markets (not to mention the more than $26 billion in deals he oversaw as the conglomerate’s business development leader), looked to a different playbook last year “When we look at the basic position of the company, we like the portfolio,” Flannery told BloombergTechnology. “So my mandate right now is to get the earnings growth going again, and there’s a lot to just better managing the portfolio we have, align it more with customers and outcomes, for a better margin rate. “We don’t feel the need to do a major acquisition or divestiture and I don’t want the business distracted from growing earnings,” Flannery said during an investor presentation in

WE HAVE 5-YEARSPLUS OF NOT GROWING EARNINGS. WE’RE NOT GOING TO BE A PARTY TO THAT ANYMORE. March. “We have 5-years-plus of not growing earnings. We’re not going to be a party to that anymore.” The business is looking to swing an operating margin slump to a 2% increase this year, with a goal of 18% by the end of 2018. The imaging and healthcare IT business expects to post operating margins of 16.7% this year, up from 16.3% last year, he said. Full-year profits were $2.88 billion on sales of $17.64 billion, representing declines of -5.4% and -3.6%, respectively, compared with 2014. The parent company is in the middle of a retooling that saw it shed its GE Capital finance arm and lay plans to relocate its headquarters from Fairfield, Conn., to Boston. M

2015 RANK: 3 Revenue: $17,600,000,000 Fiscal year ending: Dec. 31, 2015

KEY PERSONNEL: JOHN FLANNERY, President & CEO; MAHER ABOUZEID, President & CEO, Eastern Growth Markets; SEAN BURKE, President & CEO, Asia Pacific; TERRI BRESENHAM, President & CEO, Sustainability; LEE COOPER, President & CEO, U.S. & Canada; RACHEL DUAN, President & CEO, China; JAMES RICHARDS, Chief Information Officer; CHARLES KOONTZ, President & CEO, IT & Chief Digital Officer; THIERRY LECLERQ, President & CEO, Life Care Solutions; JÖRG DEBATIN, VP & CTO; LAURENT DUBOIS, CEO, healthcare partners; KARIM KARTI, President & CEO, Imaging; RAGHU KRISHNAMOORTHY, VP, HR; JEAN-MICHEL MALBRANCQ, President & CEO, Europe; THOMAS MITCHELL, VP, Sourcing; KIERAN MURPHY, President & CEO, Life Sciences; CHUCK NUGENT, VP, Global Supply Chain; LAURA O’DONNELL, GC, Global Innovation; MONISH PATOLAWALA, VP & CFO; SUE SIEGEL, CEO, GE Ventures & healthymagination; DAURIO SPERANZINI JR, President & CEO, Latin America; THOMAS WESTRICK, VP & Chief Quality Advisor; SARAH WILLS, Chief Communications Officer; ANDERS WOLD, President & CEO, Ultrasound

www.medicaldesignandoutsourcing.com

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Every hero needs a cape.

Protecting technicians, surgeons, and patients. Go radiation-free with LCP (Liquid Crystal Polymer) monofilament. When you need an MRI-compatible braiding option, Zeus LCP is the safe alternative to metal. You be the hero, let us be the cape.

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THE TOP 1OO MEDTECH COMPANIES

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FRESENIUS Else-Kroener-Strasse 1 61352, Bad Homburg, Germany

N

www.fresenius.com 



ew Fresenius CEO Stephan Sturm, promoted from CFO after Nestlé lured Ulf Mark Schneider away, wasted no time in cementing the German dialysis giant as Europe’s largest private hospital operator with the $6.4 billion (5.8 billion) acquisition of Spain’s Quironsalud – its biggest takeover ever. Fresenius also made a major play in Japan, where it acquired that country’s largest dialysis group. The company, which rebranded its dialysis business as Fresenius Kidney Care in April 2016, was said this year to be bidding against Smiths Medical for the infusion pump business Pfizer acquired when it bought Hospira for $15 billion last year. In the U.S., Fresenius said it plans to put about $250 million over 10 years into its plant in Melrose, Ill. The company also agreed to pay $250 million to settle a spate of lawsuits brought over its GranuFlo and NaturaLyte dialysis drugs. M

2015 RANK: 15 Revenue: $16,700,000,000* Fiscal year ending: Dec. 31, 2015 * Revenues from Fresenius’ medical care segment.

KEY PERSONNEL: STEPHAN STURM, Chairman & CEO; FRANCESCO DE MEO, CEO, Fresenius Helios; JÜRGEN GÖTZ, Chief Legal & Compliance Officer & Labor Relations Director; MATS HENRIKSSON, CEO, Fresenius Kabi; RICE POWELL, CEO, Fresenius Medical Care; ERNST WASTLER, CEO Fresenius Vamed 


www.medicaldesignandoutsourcing.com

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THE TOP 1OO MEDTECH COMPANIES

6

SIEMENS HEALTHINEERS (SIEMENS)

Wittelsbacherplatz 2 80333, Munich Germany

T

www.siemens.com



he biggest news for the German industrial giant’s healthcare business was an ill-advised re-branding as Siemens Healthineers – and the mandatory concert it threw for 44,000 employees, which drew widespread scorn across the globe after a Youtube video of the concert went viral. The foofaraw may have hurt the company’s feelings, but it was the strong dollar that hurt when it came to the bottom line. Fiscal third-quarter profits for Siemens Healthineers slipped -3% to $481.1 million (€534 million) on sales growth of 2% to $2.91 billion (€3.23 billion). Although orders were strong for Siemens’ bread-and-butter diagnostic imaging business, revenue growth for the division was only modest. The company made some changes in the U.S., replacing Dr. Gregory Sorensen as president of Siemens Medical Solutions USA with Abbott executive David Pacitti. In December 2015 the healthcare business moved its Midwest HQ from Pittsburgh to Cleveland to be closer to research partners Case Western Reserve University, the Cleveland Clinic and University Hospitals. M

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2015 RANK: 4 Revenue: $11,650,000,000 Fiscal year ending: Sept. 30, 2015

KEY PERSONNEL: JOE KAESER, President & CEO, Siemens AG; RALF THOMAS, CFO, Siemens AG; BERND MONTAG, CEO, Siemens Healthineers; MICHAEL SEN, CFO, Siemens Healthineers; MICHAEL REITERMANN, CFO, Siemens Healthineers Diagnostics; DAVID PACITTI, president, Siemens Healthineers North America

www.medicaldesignandoutsourcing.com

9/9/16 2:45 PM


maxon EC motor and controller: Dynamic, intelligent, linked.

maxon drives in arm prostheses.

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Medical technology also relies on our drive systems. They are used, for instance, in modern arm prostheses which enables the wearer to make precise movements.

The maxon product range is built on an extensive modular system, encompassing: brushless and brushed DC motors with the ironless maxon winding, iron-cored flat motors, planetary, spur and special gearheads, feedback devices and control electronics.

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maxon motor is the world’s leading supplier of high-precision drives and systems of up to 500 watts power output. maxon motor stands for customer specific solutions, highest quality, innovation and a worldwide distribution network. See what we can do for you: www.maxonmotorusa.com

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THE TOP 1OO MEDTECH COMPANIES

7

CARDINAL HEALTH 7000 Cardinal Place, Dublin, OH 43017

C

www.cardinal.com



ardinal Health continued the medical device play it began with the $320 million acquisition of AccessClosure in May 2014 by putting up $1.94 billion for Johnson & Johnson’s Cordis stentmaking arm, which closed in October 2015. Cardinal put Cordis back into the drugeluting stent game via an overseas distribution agreement with Biosensors International in May 2016, inking a deal for Cordis to sell the BioFreedom, BioMatrix NeoFlex, BioMatrix Alpha and Chroma stents made by Biosensors in Europe, the Middle East, Australia and New Zealand. Cordis said it plans to gradually roll out a new private-label brand for stents: Lumeno. The company’s board approved a $1 billion share repurchasing program after Cardinal in May 2016 tightened its earnings outlook for the rest of the year, meaning nearly $1.4 billion is on the table for stock buybacks. And just before this issue went to press, Navidea agreed to deal its LymphoSeek injection for sentinel lymph node detection to Cardinal for up to $310 million. M

2015 RANK: 6 Employees: 34,500 Revenue: $11,400,000,000* R&D Spend: n/a Fiscal year ending: June 20, 2015 * Revenues from Cardinal Health’s medical segment.

KEY PERSONNEL: GEORGE BARRETT, Chairman & CEO; MICHAEL BUCK, President, Medical Products; DONALD CASEY JR., CEO, Medical; CRAIG COWMAN, EVP, Global Sourcing; JOSEPH DEPINTO, President, Specialty Health Solutions; MIKE DUFFY, President, Hospital Solutions & Global Supply Chain; BRIAN ELLIS, EVP, Enterprise Accounts; JON GIACOMIN, CEO, Pharmaceutical; SUSAN JACOBSON, Deputy GC; MIKE KAUFMANN, CFO; PAMELA KIMMET, Chief HR Officer; CRAIG MORFORD, Chief Legal & Compliance Officer; PATRICIA MORRISON, EVP, Customer Services & CIO; BILL OWAD, SVP, Operational Excellence; TIFFANY OLSON, President, Nuclear Pharmacy Services; DAVID WILSON, President, Cordis

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Medical Design & Outsourcing

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www.medicaldesignandoutsourcing.com

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Small in size, big in performance The PITTMAN Difference 12.7 mm (0.5-in) diameter. Also available: 9.5 mm (0.375-in); 20 mm (0.8-in); 28 mm (1.1-in)

Many of today’s most sophisticated analytical and medical procedures require ultra-compact, high-performance DC motor platforms that deliver responsiveness, maneuverability and extreme precision. Following established stringent design criteria, PITTMAN has developed the micro-motor “BI Series” – slotless, brushless motors for designers, developers and manufacturers looking to achieve high-performance in a confined space.

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No load speeds up to 100,000 RPM Output torque range 0.002 Nm (0.3 oz-in) up to 0.105 Nm (14.9 oz-in) Motor diameters - 9.5mm (0.375-in), 12.7mm (0.5-in), 20mm (0.8-in), and 28mm (1.1-in) Stainless steel motor body construction High energy neodymium iron boron rotor magnets Options include custom gearboxes and autoclavable versions

When evaluating DC motor choices, size matters. Brushless DC Motors

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THE TOP 1OO MEDTECH COMPANIES

8

BECTON, DICKINSON 1 Becton Drive, Franklin Lakes, NJ 07417-1880

B

www.bd.com

ecton Dickinson makes its first appearance in the Top 10 this year; fueled by its buyout of CareFusion, BD vaulted from 37th to 8th on the Big 100. In December 2015 the company released the first product to combine its technologies with CareFusion’s – an automated intravenous medication management system, using BD’s Cato medication workflow system and CareFusion’s SmartWorks platform. In March of this year the company said it’s selling a 50.1% stake in its respiratory business to private equity player Apax Partners (part of the consortium that took Kinetic Concepts Inc. private in 2011). The duo plans to run the business as a standalone joint venture.

WE’RE NOT SIZE-DRIVEN – IT’S REALLY ABOUT WHAT IS THE STRATEGY AND HOW DOES THAT CREATE VALUE. Now that the CareFusion integration is in hand, BD plans to go back to it’s pre-blockbuster M&A ways, company officials say. “What you could expect us to do is go back to a similar model that we had pre-CareFusion acquisition, where we look at tuck-in acquisitions,” CFO Christopher Reidy explained during a recent conference call with investors. “We haven’t changed our philosophy on M&A. We’re going to be very strategically driven, number one. We’re not size-driven – it’s really about what is the strategy and how does that create shareholder value. And so, just as you’ve seen us do that in the past, that’s the way we’re going to approach it in the future,” added chairman, president & CEO Vincent Forlenza. M 32

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2015 RANK: 37 Revenue: $10,280,000,000* Fiscal year ending: Sept. 30, 2015 * Revenues from Becton, Dickinson’s medical segment.

KEY PERSONNEL: VINCENT FORLENZA, Chairman, President & CEO; GARY COHEN, EVP & President, Global Health; ALEXANDRE CONROY, EVP & President, EMEA & Americas; JEROME HURWITZ, EVP & Chief HR Officer; JAMES LIM, EVP & President, Greater Asia; THOMAS POLEN, EVP & President, Medical; CHRISTOPHER REIDY, EVP, CFO & Chief Administrative Officer; NABIL SHABSHAB, EVP, Strategic Planning & Chief Marketing Officer; JEFFERY SHERMAN, EVP, GC; STEPHEN SICHAK, EVP, Supply Chain; ELLEN STRAHLMAN, EVP, R&D & Chief Medical Officer; LINDA THARBY, EVP & President, Life Sciences

www.medicaldesignandoutsourcing.com

9/9/16 2:45 PM


How much PULL do you need? Unlike other fastening components, the Bal SpringŽ canted coil spring lets you latch, lock or hold parts together with precisely controllable removal and insertion forces—from 0.5 to > 1,000 lb. Its ability to conduct current and shield against EMI can also help improve the performance and reliability of your medical device designs. For more information call or click today, and start designing for tomorrow.

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THE TOP 1OO MEDTECH COMPANIES

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BAXTER 1 Baxter Parkway, Deerfield, IL 60015-4625

B

www.baxter.com 



axter’s big news over the past year was the departure of CEO Robert Parkinson Jr. after 11 years at the helm. The Chicago-area healthcare titan, fresh from the spinout of its pharmaceuticals business as Baxalta (which didn’t last long before being snapped up by Shire this year), tapped José Almeida, who led Covidien to its $50 billion acquisition by Medtronic, to replace Parkinson in October 2015. That same month the company won a nod from the FDA for its Amia automated peritoneal dialysis system, which is designed for home use by patients with end-stage renal disease. The device won approval from Health Canada in June 2016. Amia was the subject of a deal between Baxter and Satellite Healthcare announced in August 2016 to provide the device to Satellite’s 80-site renal care network. Baxter made another bet in the dialysis sphere during the year, joining Boston Scientific in a $15 million Series C round for TVA Medical and its Everlinq EndoAVF device for minimally invasive hemodialysis access. And the company got it on an $8 million Series A round for Harvard University spinout Opsonix and the device it’s developing to remove pathogens and toxins from circulating blood. M

2015 RANK: 8 Revenue: $9,970,000,000* Fiscal year ending: Dec. 31, 2015 * Revenues from Baxter’s medical products segment.

KEY PERSONNEL: JOSÉ ALMEIDA, Chairman & CEO; GIUSEPPE ACCOGLI, President, Renal; BRIK EYRE, President, Hospital Products; ROBERT FELICELLI, VP, Business Transformation; JEANNE MASON, VP, HR; SCOTT PLEAU, VP, Operations; JAMES SACCARO VP, CFO; MARCUS SCHABACKER, VP, Chief Scientific Officer; DAVID SCHARF, VP GC; PAUL VIBERT, President, International; SCOTT BOHABOY, VP, Treasurer, Global Planning Head; CAROLINE KARP, VP, Controller; PAUL MARTIN, VP, CIO; ELLEN MCINTOSH, VP, Assoc. GC, Secretary

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www.medicaldesignandoutsourcing.com

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THE TOP 1OO MEDTECH COMPANIES

1O D

STRYKER 2825 Airview Boulevard, Kalamazoo, MI 49002 www.stryker.com 



espite the resurrection of the zombie deal that wouldn’t die – the persistent rumor that Stryker will acquire orthopedics rival Smith & Nephew – Stryker still managed to pick up quite a few other new businesses in the past year, expanding its play into a few interesting areas. The two largest deals saw the company founded in 1941 by Homer Stryker branch out into the patient safety and resuscitation arenas: The $2.7 billion buyout of never-event prevention device maker Sage Products and the $1.3 billion deal for automated external defibrillator maker Physio-Control. Stryker also bolstered its neurosurgery portfolio by picking up Spectratentics’ neuro assets for an undisclosed amount. The company was likewise coy about what it paid for SafeWire’s spine device line and for the vertebral compression fracture line Becton Dickinson divested after its purchase of CareFusion. Stryker did reveal the price for Stanmore Implants ($52 million), but most recently declined to reveal the cost of acquiring Ivy Sports Medicine and its meniscus repair device. M

2015 RANK: 9 Employees: 27,000 Revenue: $9,950,000,000 R&D Spend: $625,000,000 Fiscal year ending: Dec. 31, 2015

KEY PERSONNEL: KEVIN LOBO, Chairman & CEO; YIN BECKER, VP, Communications, Public Affairs & Strategic Marketing; STEVEN BENSCOTER, VP, Global HR; DEAN BERGY, VP, Secretary; WILLIAM BERRY JR., VP, Controller; JEANNE BLONDIA, VP, Finance & Treasurer; LONNY CARPENTER, President, Global Quality & Operations & European Business Operations; IRENE CORBE, VP, Internal Audit; DAVID FLOYD, President, Orthopedics; DAVID FURGASON, VP, Tax; MICHAEL HUTCHINSON, GC; WILLIAM JELLISON, VP, CFO; KATHERINE OWEN, VP, Strategy & Investor Relations; BIJOY SAGAR, VP, CIO; TIMOTHY SCANNELL, President, MedSurg & Neurotechnology; ELIZABETH STAUB, VP, Regulatory Affairs & Quality Assurance; RAMESH SUBRAHMANIAN, President, International; BRONWEN TAYLOR, VP, Compliance & Risk Management

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Medical Design & Outsourcing

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Merit Medical OEM offers thousands of quality components and innovative devices to meet your needs.

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THE TOP 1OO MEDTECH COMPANIES

11

ALCON (NOVARTIS) Lichtstrasse 35 4056, Basel, Switzerland

www.alcon.com

2015 RANK: 7 Revenue: $9,800,000,000* Fiscal year ending: Dec. 31, 2015

* Revenues from Novartis’ Alcon segment.

KEY PERSONNEL: MIKE BALL, CEO, Alcon; LAURENT ATTIAS, Head, Strategy, BD&L & Market Access, Alcon; ROYCE BEDWARD SVP, GC, Alcon; IAN BELL, President, EMEA, Alcon; SERGIO DUPLAN, President, North America, Alcon; DAVID ENDICOTT, COO, Alcon; CAMILA FINZI President, Latin America & the Caribbean, Alcon; FRANCK LEVEILLER, Head, Global R&D, Alcon; BETTINA MAUNZ, VP, Communications, Alcon; MERRICK MCCRACKEN, SVP, HR, Alcon; ED MCGOUGH, SVP, Manufacturing & Technical Operations, Alcon; JIM MURPHY, President, Japan, Alcon; DAVID MURRAY, CFO, Alcon; MICHAEL ONUSCHECK, Global Franchise Head, Alcon Surgical; DAVE SCHOENING, SVP, Quality, Alcon; ERIC VAN OPPENS, President, Asia & Russia, Alcon; ROBERT WARNER, Global Franchise Head, Alcon Vision Care; SUE WHITFILL, Head, Global Quality, Alcon

12

OWENS & MINOR 9120 Lockwood Boulevard, Mechanicsville, VA 23116

www.owens-minor.com

2015 RANK: n/a Revenue: $9,770,000,000 Fiscal year ending: Dec. 31, 2015

Employees:

8,100

KEY PERSONNEL: CODY PHIPPS, President & CEO; RANDY MEIER, President, International, EVP & CFO; RONY KORDAHI, EVP, North America; MARSHALL SIMPSON, EVP, Chief Commercial Officer; CHARLES COLPO, SVP, Europe; ERIKA DAVIS, SVP, Chief of Staff; GEOFF MARLATT, SVP, Manufacturer Services; RICHARD MEARS, SVP, CIO; NICHOLAS PACE, SVP, GC & Secretary; JAY ROMANS, SVP, HR

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THE TOP 1OO MEDTECH COMPANIES

13

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DANAHER

2200 Pennsylvania Avenue, NW Suite 800W Washington, DC 20037 www.danaher.com

2015 RANK: 14 Revenue: $8,200,000,000* Fiscal year ending: Dec. 31, 2015

* Revenues from Danaher’s life sciences & diagnostics segment.

KEY PERSONNEL: THOMAS JOYCE JR, President & CEO; DANIEL COMAS, EVP & CFO; MARK BECK, EVP; WILLIAM DANIEL II, EVP; JAMES LICO, EVP; JAMES DITKOFF, SVP, Finance & Tax; JONATHAN GRAHAM, SVP, GC; WILLIAM KING, SVP, Strategic Development; ANGELA LALOR, SVP, HR; ROBERT LUTZ, SVP, Chief Accounting Officer; DANIEL RASKAS, SVP, Development

14

FUJIFILM HOLDINGS 7-3, Akasaka 9-Chome, Minato-Ku, Tokyo 107-0052, Japan www.fujifilmholdings.com

2015 RANK: 10 Revenue: $7,895,000,000* Fiscal year ending: March 31, 2016

* Revenues from Fujifilm’s information solutions segment.

KEY PERSONNEL: SHIGETAKA KOMORI, chairman & CEO; KENJI SUKENO, president & COO; KOUICHI TAMAI, VP, Chief Innovation Officer; YUZO TODA, VP, CTO; MASATAKA AKIYAMA, President & CEO, Fujifilm Medical Systems U.S.A.; JOHANN FERNANDO, COO, Fujifilm Medical Systems U.S.A.; DR. DIKU MANDAVIA, Chief Medical Officer, Fujifilm Medical Systems U.S.A.; WILLIAM LACY, VP, Medical Informatics, Fujifilm Medical Systems U.S.A.; EIJI OGAWA, VP, Modality Solutions, Quality, Regulatory, Clinical Affairs, Fujifilm Medical Systems U.S.A.; KEIICHI NAGATA, al President, Endoscopy, Fujifilm Medical Systems U.S.A.; JASON HEIM, VP, Sales, Fujifilm Medical Systems U.S.A.; MARTIN SPENCE, VP, Services & Support Operations, Fujifilm Medical Systems U.S.A.; SATOSHI AMANO, VP, Finance, Fujifilm Medical Systems U.S.A.; JOHN LUCAS, Executive Director, Business Operations, Fujifilm Medical Systems U.S.A.

www.medicaldesignandoutsourcing.com

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THE TOP 1OO MEDTECH COMPANIES

15

BAYER

Bayerwerk Gebaeude, W11 Kaiser-Wilhelm-Allee, Leverkusen 2M D-51368, Germany www.bayer.com

2015 RANK: 28 Revenue: $7,790,000,000* Fiscal year ending: Dec. 31, 2015

* Revenues from Bayer’s consumer health segment.

KEY PERSONNEL: MARIJN DEKKERS, Chairman & CEO; WERNER BAUMANN, Chairman, Bayer HealthCare, Strategy & Portfolio Management, Europe/Middle East/Africa; KEMAL MALIK, Innovation, Latin America; DIETER WEINAND, Pharmaceuticals, North America; DR. HARTMUT KLUSIK, HR, Technology & Sustainability; JOHANNES DIETSCH, CFO; Erica Mann, Consumer Health; LIAM CONDON, Crop Science

16

BOSTON SCIENTIFIC 300 Boston Scientific Way, Marlborough, MA 01752-1234

www.bostonscientific.com

2015 RANK: 12 Revenue: $7,480,000,000 Fiscal year ending: Dec. 31, 2015

Employees: R&D Spend:

25,000 $876,000,000

KEY PERSONNEL: MICHAEL MAHONEY, President & CEO; KEVIN BALLINGER, SVP & President, Interventional Cardiology; SUPRATIM BOSE, EVP & President, APac, Middle East & Africa; DANIEL BRENNAN, EVP & CFO; WENDY CARRUTHERS, SVP, HR; DR. KEITH DAWKINS, EVP & Global Chief Medical Officer; JOSEPH FITZGERALD, EVP & President, Rhythm Management; EDWARD MACKEY, EVP, Operations; JEFF MIRVISS, SVP & President, Peripheral Interventions; MAULIK NANAVATY, SVP & President, Neuromodulation; MICHAEL PHALEN, EVP & President, Medsurg; DAVID PIERCE, SVP & President, Endoscopy; KAREN PRANGE, SVP & President, Urology & Women’S Health; TIMOTHY PRATT, EVP, Chief Administrative Officer, GC & Secretary; BRAD SORENSON, SVP, Manufacturing & Supply Chain; ERIC THÉPAUT, SVP & President, Europe

42

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70

YEARS Norman Noble, Inc., the world’s leading contract manufacturer of next-generation medical implants, celebrates seven decades of innovation in Northeast Ohio. Visit www.nnoble.com to learn more about our history and capabilities.

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THE TOP 1OO MEDTECH COMPANIES

17

ESSILOR

147 Rue De Paris, 94220 Charenton-Le-Pont, France www.essilorusa.com

2015 RANK: 11 Revenue: $7,450,000,000 Fiscal year ending: Dec. 31, 2015

Employees: R&D Spend:

61,000 $221,920,000

KEY PERSONNEL: HUBERT SAGNIÈRES, Chairman & CEO; JEAN CARRIER-GUILLOMET, COO; PAUL DU SAILLANT, COO; LAURENT VACHEROT, COO; TADEU ALVES, President, Latin America; ERIC BERNARD, President, AMERA; ERIC LEONARD, President, Essilor of America; CARL BRACY, Chief Marketing Officer, Essilor of America; BOB COLUCCI, President, Independent Distribution , Essilor of America; LAURI CRAWFORD, SVP, EOA Marketing, Essilor of America; STEVE CUNNINGHAM, SVP of HR & General Services, Essilor of America; GREGORY ERICSON, CIO, Essilor of America; MARC FRANCOIS, VP, North American Operations, Essilor of America; RICK GADD, SVP, Key Accounts, Essilor of America; DANIEL LIBERMAN, SVP, Strategic Initiatives, Essilor of America; MIKAEL MALAGIES, VP, EOA Supply Chain, Essilor of America; MIKE MCCOLLUM, SVP, Essilor Labs of America; DAVID MILAN GC & VP, Legal, Essilor of America; PHIL MILLER VP, North American R&D; MIKE NATHE, SVP, Essilor Laboratories of America; STEVE NUSSBAUMER, President, Essilor Lab Group; BARBARA HEFFEZ-PIPER, VP, Key Accounts Strategies & Solutions; JASON PREATOR, SVP, Finance; DR. HOWARD PURCELL, SVP, Customer Development, Essilor of America; KEVIN RUPP, EVP, CFO, Essilor of America; MATT TACKMAN, VP, Key Accounts, Essilor of America; JOHN WALBORN, VP, Integrated Retail & Prescription Safety Business, Essilor of America

18

B. BRAUN

Werkanlage Pfieffewiesen Europagebäude 34212, Melsungen, Germany www.bbraun.com

2015 RANK: 13 Revenue: $6,800,000,000 Fiscal year ending: Dec. 31, 2015

Employees: R&D Spend:

54,770 $288,000,000

KEY PERSONNEL: HEINZ-WALTER GROSSE, Chairman, Management Board, HR, Legal Affairs & Director of Labor Relations; ANNETTE BELLER, Finance, Taxes, Controlling & Central Services; OTTO PHILIPP BRAUN, Iberian Peninsula & Latin America; MARKUS STROTMANN, B.Braun Avitum ; DR. MEINRAD LUGAN, Hospital Care & OPM; CAROLL NEUBAUER, North America; HANNS-PETER KNAEBEL, Aesculap

44

Medical Design & Outsourcing

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CombiTac: Simple. Quick. Safe. www.multi-contact-usa.com

CombiTac line Industrial Connectors

Modular Connectors for Medical Devices CombiTac is Multi-Contact‘s modular connector system that allows individual configurations of power, signal, thermocouple, coaxial and bus applications. Modern surgery rooms are designed on a modular basis and fitted out specifically for the task at hand. CombiTac allows you to: ▪ Connect mobile supply units of medical diagnostic monitoring devices ▪ Provide protected contacts via its pin carrier walls, all in a compact space-saving design ▪ Meet your hightest safety and technical requirements with its modules rated up to 5000 V, 300 A

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THE TOP 1OO MEDTECH COMPANIES

19

ZIMMER-BIOMET 345 East Main St. Warsaw, IN

www.zimmer.com

2015 RANK: 18 Revenue: $5,990,000,000 Fiscal year ending: Dec. 31, 2015

Employees: R&D Spend:

17,500 $4,500,000

KEY PERSONNEL: DAVID DVORAK, President & CEO; ROBIN BARNEY, SVP, Global Operations & Logistics; TONY COLLINS, VP, Controller & Chief Accounting Officer; DEREK DAVIS, VP, Global Integration; WILLIAM (BILL) FISHER, SVP, Global HR; DANIEL FLORIN, SVP, CFO; ADAM JOHNSON, President, Spine, Dental, CMF & Thoracic; STUART KLEOPFER, President, Americas; DAVID KUNZ, SVP, Global Quality, Clinical & Regulatory Affairs; DR. KATARZYNA MAZUR-HOFSAESS, President, EMEA; DAVID NOLAN JR., President, Biologics, Extremities, Sports Medicine, Surgical, Trauma, Foot & Ankle, Bone Healing; CHAD PHIPPS, SVP, GC & Secretary; DANIEL WILLIAMSON, President, Joint Reconstruction; SANG YI, President, APac

20

HITACHI

6-6, Marunouchi 1-Chome, Chiyoda-Ku, Tokyo 100-8280, Japan www.hitachimed.com

2015 RANK: 27 Revenue: $5,630,000,000* Fiscal year ending: March 31, 2015

* Revenues from Hitachi’s healthcare segment.

KEY PERSONNEL: TOSHIAKI HIGASHIHARA, Representative Executive Officer, President & COO; MASAYA WATANABE, VP & Executive Officer, President & CEO, Healthcare Group & Healthcare Company; AKIO YAMAMOTO, EVP, Healthcare Company; YUKITOSHI KIYOMURA, EVP, Healthcare Company, Medical ; DAVID FAMIGLIETTI, President & GM; RAY KOBA, VP, Finance, Treasurer/Controller/Secretary; MATTHEW OBLON, Director of Service; THOMAS OKO, Director of Marketing; ANGELA VAN ARSDALE, Regulatory Affairs/Quality Assurance Manager; RANDY BARASO, Manager, Business Development & Strategy; KRISTEN PROVO, HR Manager; JOHN WADDELL, National Sales Manager

46

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THE TOP 1OO MEDTECH COMPANIES

21

1OO

ST. JUDE MEDICAL 1 St Jude Medical Drive, St. Paul, MN 55117 www.sjm.com

2015 RANK: 16 Revenue: $5,540,000,000 Fiscal year ending: Jan. 2, 2016

Employees: R&D Spend:

18,000 $676,000,000

KEY PERSONNEL: MICHAEL ROUSSEAU, President & CEO; DANIEL STARKS, Chairman; JOHN HEINMILLER, EVP; LISA ANDRADE, VP & Chief Marketing Advisor; PAUL BAE, VP, Global HR & Chief Compliance Officer; JOEL BECKER, President, Americas; DR. MARK CARLSON, VP, Global Clinical Affairs & Chief Medical Officer; JEFFREY DALLAGER, VP & Controller; PHILIP EBELING, VP, CTO; RACHEL ELLINGSON, VP, Strategy; DR. ERIC FAIN, President; Jeff Fecho, VP, Global Quality; DENIS GESTIN, President, International; MARK MURPHY, VP, IT & CIO; SCOTT THOME, VP, Global Operations & Supply Chain; JASON ZELLERS, VP, GC & Secretary; DONALD ZURBAY, VP, Finance & CFO

22

3M CO.

3M Center St. Paul, MN 55144-1000 www.3m.com

2015 RANK: 17 Revenue: $5,420,000,000 Fiscal year ending: Dec. 31, 2015

* Revenues from 3M Co.’s healthcare segment.

KEY PERSONNEL: INGE THULIN, Chairman, President & CEO; JAMES BAUMAN, EVP, Electronics & Energy; JULIE BUSHMAN, SVP, Information Technology; JOAQUIN DELGADO, EVP, Consumer Business; IVAN FONG, SVP, President, Legal Affairs & General Counsel; NICHOLAS GANGESTAD, SVP & CFO; PAUL KEEL, SVP, Supply Chain; ASHISH KHANDPUR, SVP, R&D & CTO; JON LINDEKUGEL, SVP, Marketing & Sales; FRANK LITTLE, EVP, Safety; MARLENE MCGRATH, SVP, HR; KIMBERLY FOSTER PRICE, SVP, Communications; MICHAEL ROMAN, EVP; HAK CHEOL SHIN, EVP; MICHAEL VALE, EVP, Healthcare Business

www.medicaldesignandoutsourcing.com

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1OO

THE TOP 1OO MEDTECH COMPANIES

23

OLYMPUS

Shinjuku Monolith, 3-1 Nishi-Shinjuku 2-Chome, Shinjuku-Ku, Tokyo 163-0914, Japan www.olympusamerica.com

2015 RANK: 19 Revenue: $5,030,375,878* Fiscal year ending: March 31, 2016

Employees: R&D Spend:

16,728 $424,500,000

* Revenues from the medical systems segment.

KEY PERSONNEL: HIROYUKI SASA, CEO & President; YASUO TAKEUCHI, VP & CFO; AKIHIRO TAGUCHI, Senior Executive Managing Officer & Head of Sales for Medical Business; SHIGEO HAYASHI, Senior Executive Managing Officer & Head of Manufacturing Group; HARUO OGAWA, Senior Executive Managing Officer & Head of R&D; YASUSHI SAKAI, Executive Managing Officer & Chief Improvement Officer; AKIRA KUBOTA, Executive Managing Officer & Head of Medical Affairs & CSR Office; NOBUHIRO ABE, Executive Managing Officer & Chief al Representative Officer, Asia Pacific; KIICHI HIRATA, Executive Managing Officer & CAO; HITOSHI KAWADA, Executive Officer & Representative Director & President, Olympus Software Technology Corporation; NAOHIKO KAWAMATA, Executive Officer & Manager, Solution Technology , Manufacturing Group Manager, Procurement ; NOBUYUKI KOGA, Executive Officer & Manager, Service Directors: SHIRO HIRUTA, SUMITAKA FUJITA, KEIKO UNOTORO, TAKAYUKI KATAYAMA, SUSUMU KAMINAGA, & MICHIJIRO KIKAWA

24

ABBOTT LABORATORIES 100 Abbott Park Road Abbott Park, IL 60064-3500 www.abbott.com

2015 RANK: 45 Revenue: $5,000,000,000* Fiscal year ending: Dec. 31, 2015

* Revenues from Abbott Laboratories medical device segment.

KEY PERSONNEL: MILES WHITE, Chairman & CEO; THOMAS FREYMAN, EVP, Finance & Administration; HUBERT ALLEN, EVP, GC & Secretary; RICHARD ASHLEY, EVP, Development; BRIAN BLASER, EVP, Diagnostics Products; JOHN CAPEK, EVP, Ventures; ROBERT FORD, EVP, Medical Devices; STEVE FUSSELL, EVP, HR; HEATHER MASON, EVP, Nutritional Products; MICHAEL WARMUTH, EVP, Established Pharmaceuticals; ROGER BIRD, SVP, U.S. Nutrition; JAIME CONTRERAS, SVP, Core Laboratory Diagnostics, Commercial Operations; THOMAS FRINZI, SVP, Vision Business; ELAINE LEAVENWORTH, SVP, Chief Marketing & External Affairs Officer; CORLIS MURRAY, SVP, Quality Assurance, Regulatory & Engineering Services; DEEPAK NATH, SVP, Abbott Vascular; JEAN-YVES PAVÉE, SVP, Developed Markets, Established Products; DANIEL SALVADORI, SVP, Established Pharmaceuticals, Latin America; JARED WATKIN, SVP, Diabetes Care; BRIAN YOOR, SVP, Finance & CFO

48

Medical Design & Outsourcing

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THE TOP 1OO MEDTECH COMPANIES

25

1OO

SMITH & NEPHEW

15 Adam Street London X0 WC2N 6LA, England www.smith-nephew.com

2015 RANK: 21 Revenue: $4,630,000,000 Fiscal year ending: Dec. 31, 2015

Employees: R&D Spend:

15,644 $222,000,000

KEY PERSONNEL: OLIVIER BOHUON, CEO; JULIE BROWN, CFO; RODRIGO BIANCHI, President, IRAMEA; JACK CAMPO, Chief Legal Officer; PHIL COWDY, SVP, Affairs & Strategic Planning; MIKE FRAZZETTE, President, Advanced Surgical Devices; GORDON HOWE, President, Global Operations; HELEN MAYE, Chief HR Officer; DIOGO CORREIA MOREIRA-RATO, President, Europe & Canada; CYRILLE PETIT, Chief Development Officer; ANTONY (TONY) RAYMENT, President, Australia, New Zealand & Japan; ARJUN RAJARATNAM, Chief Compliance Officer; SUSAN SWABEY, Secretary; GLENN WARNER, President, Advanced Wound Management

Composite Metal Wire for Medical Devices High Strength • High Conductivity Biocompatible • Radiopaque • Resilient Flexible • Kink Resistant • Cost Effective Alternative to Solid Precious Metal Wire

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THE TOP 1OO MEDTECH COMPANIES

26

CERNER

2800 Rockcreek Parkway North Kansas City, MO 64117 www.cerner.com

2015 RANK: 25 Revenue: $4,430,000,000 Fiscal year ending: Jan. 3, 2016

Employees: 22,200 R&D Spend: $685,000,000

KEY PERSONNEL: NEAL PATTERSON, Chairman & CEO; CLIFFORD ILLIG, Vice Chairman; ZANE BURKE, President; MARC NAUGHTON, EVP & CFO; MICHAEL NILL, EVP & COO; RANDY SIMS, SVP, Chief Legal Officer & Secretary; JEFFREY TOWNSEND, EVP & Chief of Staff; JULIE WILSON, EVP & Chief People Officer

27

GRIFOLS

Avinguda De La Generalitat, 152-158 Parc De Negocis Can Sant Joan Sant Cugat Del Vallès 08174, Barcelona, Spain www.grifols.com

2015 RANK: 23 Revenue: $4,370,000,000 Fiscal year ending: Dec. 31, 2015

Employees: 14,737 R&D Spend: $246,200,000

KEY PERSONNEL: VÍCTOR GRIFOLS ROURA, President & CEO; RAMÓN RIERA ROCA, EVP & President, Global Commercial; ALFREDO ARROYO GUERRA, VP & CFO; CARLOS ROURA FERNÁNDEZ, VP & President, Global Industrial; MONTSERRAT LLOVERAS CALVO, VP & Director, Accounting & Reporting; ANTONIO VIÑES PÁRES, VP & Director, Planning & Control; EVA BASTIDA TUBAU, VP & Director, Scientific & Medical Affairs; VICENTE BLANQUER TORRE, VP & Technical Director, Biological Industrial Group; MATEO FLORENCIO BORRÁS HUMBERT, VP & Director, Global HR; FRANCISCO JAVIER JORBA RIBES, VP & President, Biological Industrial; GREGORY GENE RICH, VP, President & CEO, Grifols Shared Services North America; DAVID IAN BELL, VP & GC, Grifols Shared Services North America; ALBERTO GRIFOLS ROURA, VP & Co-President, Instituto Grifols; NURIA PASCUAL LAPEÑA, VP & Director, Finance & IR Officer; SHINJI WADA, VP & President, Plasma Operations, Grifols Shared Services North America; JOEL ABELSON, VP & President, North America Commercial, Grifols Shared Services North America

28

TERUMO

2-44-1 Hatagaya, Shibuya-Ku Tokyo 151-0072, Japan www.terumo.com

2015 RANK: 20 Revenue: $4,040,000,000 Fiscal year ending: March 31, 2015

Employees: 19,934 R&D Spend: $286,900,000

KEY PERSONNEL: YUTARO SHINTAKU, President & CEO; HIROSHI MATSUMURA, EVP, PR; TAKAYOSHI MIMURA, SVP; SHINJIRO SATO, EVP, President, Cardiac & Vascular; TOSHIAKI TAKAGI, EVP & CQO; SHOJI HATANO, EVP, President, General Hospital; HIDEO ARASE, EVP; KUNIKO SHOJI, EVP & Chief Clinical and Regulatory Affairs Officer; DAVID PEREZ, EVP


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THE TOP 1OO MEDTECH COMPANIES

29

1OO

GETINGE

Theres Svenssons Gata 7 P.O. Box 8861 Se-402 72, Gothenburg, Sweden www.getingegroup.com

2015 RANK: 24 Revenue: $3,580,000,000 Fiscal year ending: Sept. 30, 2015

Employees:

15,000

KEY PERSONNEL: ALEX MYERS, President & CEO; CARSTEN BLECKER, President, EMEA; PERNILLE FABRICIUS,CFO; LENA HAGMAN, EVP, Quality, Regulatory & Compliance; HEINZ JACQUI, President, Acute Care Therapies; FELIX LARA, President, Patient & Post-Acute Care; JOACIM LINDOFF, President, Surgical Workflows; PAUL LYON, President, Asia/Pacific; REINHARD MAYER, President, Supply Chain; RAOUL QUINTERO, President, Americas; ANDREAS QUIST, EVP, HR & Sustainability; KORNELIA RASMUSSEN, EVP, Communications & Brand Management

30

C.R. BARD

730 Central Ave. Murray Hill, NJ 07974 www.crbard.com

2015 RANK: 26 Revenue: $3,420,000,000 Fiscal year ending: Dec. 31, 2015

Employees: 14,900 R&D Spend: $254,700,000

KEY PERSONNEL: MARC BRESLAWSKY, CEO, Imagistics International; ROBERT DAVIS, EVP & CFO; HERBERT HENKEL, CEO, Ingersoll-Rand Company; JOHN KELLY, Controller; GAIL NAUGHTON, CEO, Histogen; DAVID MELCHER, EVP; JOHN WEILAND, COO

31

VARIAN MEDICAL SYSTEMS 3100 Hansen Way Palo Alto, CA 94304-1000 www.varian.com

2015 RANK: 30 Revenue: $3,010,000,000 Fiscal year ending: Oct. 2, 2015

Employees: 7,300 R&D Spend: $245,200,000

KEY PERSONNEL: DOW WILSON, Chairman & CEO; JESSICA DENECOUR, EVP & CIO; ELISHA FINNEY, EVP & CFO; PATRICK JODA, EVP, Customer Support; MOATAZ KARMALAWY, EVP, Particle Therapy; KOLLEEN KENNEDY, EVP, Oncology Systems; JOHN KUO, SVP, General Counsel; FRANCO PALOMBA, SVP, Treasurer; SUNNY SANYAL, SVP, Imaging; WENDY SCOTT, SVP, Chief HR; SPENCER SIAS, SVP, Communications; RAFAEL TORRES, SVP, Business Development; VY TRAN, SVP, Quality Management; CLARENCE VERHOEF, SVP, Controller

www.medicaldesignandoutsourcing.com

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32

MCKESSON

1 Post Street San Francisco, CA 94104 www.mckesson.com

2015 RANK: 29 Revenue: $2,890,000,000* Fiscal year ending: March 31, 2016

* Revenues from McKesson’s technology solutions segment.

KEY PERSONNEL: JOHN HAMMERGREN, Chairman, President & CEO; JAMES BEER, EVP & CFO; PATRICK BLAKE, EVP & President; JORGE FIGUEREDO, EVP, HR; PAUL JULIAN, EVP & President; BANSI NAGJI, EVP, Strategy & Business Development; LORI SCHECHTER, EVP, GC & CCO

33

HOLOGIC

250 Campus Drive Marlborough, MA 01752 www.hologic.com

2015 RANK: 34 Revenue: $2,710,000,000 Fiscal year ending: Sept. 26, 2015

Employees: 5,290 R&D Spend: $213,700,000

KEY PERSONNEL: STEPHEN MACMILLAN, Chairman, President & CEO; ERIC COMPTON, SVP & COO; ROBERT MCMAHON, SVP & CFO; ALLISON BEBO, SVP & Chief HR; JOHN GRIFFIN, SVP & General Counsel; JAY STEIN, SVP & CTO

34

DENTSPLY

Susquehanna Commerce Center 221 W. Philadelphia Street, York, PA 17405 www.dentsply.com

2015 RANK: 31 Revenue: $2,670,000,000 Fiscal year ending: Dec. 31, 2015

Employees: 11,400 R&D Spend: $74,900,000

KEY PERSONNEL: JEFFREY SLOVIN, CEO; ULRICH MICHEL, EVP & CFO; CHRISTOPHER CLARK, President & CTO; JAMES MOSCH, President & COO

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HOYA

2-7-5 Naka-Ochiai, Shinjuku-Ku Tokyo 161-8525, Japan www.hoya.co

2015 RANK: 32 Revenue: $2,530,000,000* Fiscal year ending: March 31, 2015

* Revenues from Hoya’s life care segment.

KEY PERSONNEL: HIROSHI SUZUKI, Representative Executive Officer, President & CEO; RYO HIROOKA, Representative Executive Officer & CFO; EIICHIRO IKEDA, Executive Officer & COO, IT; GIRTS CIMERMANS, Executive Officer & COO, Life Care; AUGUSTINE YEE, Executive Officer, Chief Legal Officer, Head of Development & Affairs

36

EDWARDS LIFESCIENCES 1 Edwards Way Irvine, CA 92614

www.edwards.com

2015 RANK: 36 Revenue: $2,490,000,000 Fiscal year ending: Dec. 31, 2015

Employees: 9,800 R&D Spend: $383,100,000

KEY PERSONNEL: MICHAEL MUSSALLEM, Chairman & CEO; DONALD BOBO JR, EVP, Business Development; DIRKSEN LEHMAN, EVP, PR; CHRISTINE MCCAULEY, EVP, HR; JOHN MCGRATH, EVP, Quality Management; JOSEPH NUZZOLESE, EVP, Global Supply Chain; STANTON ROWE, EVP & CTO; CATHERINE SZYMAN, EVP, Critical Care; SCOTT ULLEM, EVP & CFO; AIMEE WEISNER, EVP, General Counsel; PATRICK VERGUET, EVP, Sales; HUIMIN WANG, EVP; LARRY WOOD, EVP; BERNARD ZOVIGHIAN, EVP

37

INTUITIVE SURGICAL 1020 Kifer Road Sunnyvale, CA 94086

www.intuitivesurgical.com

2015 RANK: 42 Revenue: $2,380,000,000 Fiscal year ending: Dec. 31, 2015

Employees: 3,211 R&D Spend: $197,400,000

KEY PERSONNEL: GARY GUTHART, President & CEO; DAVE ROSA, EVP & CCO; SALVATORE BROGNA, EVP, Product Operations; HENRY CHARLTON, SVP, Sales; DR. MYRIAM CURET, SVP, Chief Medical Officer; BOB DESANTIS, SVP, Instruments; MARK JOHNSON, SVP, Quality Management; CHARLES JONES, SVP, Design; MARK MELTZER, SVP, General Counsel & CCO; BRIAN MILLER, SVP, Product Development; MARSHALL MOHR, SVP & CFO; COLIN MORALES, SVP, Manufacturing; GLENN VAVOSO, SVP, Global Sales; PAIGE BISCHOFF, VP, Global PR; CRAIG CHILD, VP, HR; GILLIAN DUNCAN, VP; CATHERINE MOHR, VP; DR. DAVID STOFFEL, VP, Marketing

www.medicaldesignandoutsourcing.com

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THE TOP 1OO MEDTECH COMPANIES

38

STERIS

Chancery House, 190 Waterside Road, Hamilton Industrial Park Leicester LE51QZ, U.K. www.steris.com

2015 RANK: 49 Revenue: $2,240,000,000 Fiscal year ending: March 31, 2016

Employees: 14,000 R&D Spend: $56,700,000

KEY PERSONNEL: KATHLEEN BARDWELL, SVP & CCO; DANIEL CARESTIO, SVP, Steris Applied Sterilization Technologies & Life Sciences; ADRIAN COWARD, SVP, Healthcare Specialty Services; SUZANNE FORSYTHE, VP, HR; GULAM KHAN, SVP, Procedural Solutions; SUDHIR PAHWA, SVP, Infection Prevention Technologies; WALTER ROSEBROUGH JR., President & CEO; MICHAEL TOKICH, SVP, CFO & Treasurer; ADAM ZANGERLE, VP, GC & Secretary

39

BIOMERIEUX 69280 Marcy L’Étoile, France

www.biomerieux-usa.com

2015 RANK: 38 Revenue: $2,180,000,000 Fiscal year ending: Dec. 31, 2015

Employees: 9,375 R&D Spend: $265,300,000

KEY PERSONNEL: JEAN-LUC BÉLINGARD, Chairman; ALEXANDRE MÉRIEUX, CEO; MICHEL BAGUENAULT, VP, HR & Communications; NICOLAS CARTIER, VP, Industry Unit, Portfolio & Strategic Planning; PIERRE CHARBONNIER, VP, Manufacturing & Supply Chain; RICHARD DING, VP, APac; FRANÇOIS LACOSTE, VP, Clinical Unit; MARK MILLER, Chief Medical Officer; YASHA MITROTTI, VP, EMEA; ALAIN PLUQUET, VP, CTO & Innovation; RANDY RASMUSSEN, VP, Molecular Biology; STEFAN WILLEMSEN, CEO, Americas, Chief Legal Officer

40

COLOPLAST Holtedam 1 3050 Humlebæk, Denmark www.coloplast.us

2015 RANK: 40 Revenue: $2,070,000,000 Fiscal year ending: Sept. 30, 2015

Employees: 9,303 R&D Spend: $65,700,000

KEY PERSONNEL: LARS RASMUSSEN, President & CEO; ANDERS LONNING-SKOVGAARD, EVP, CFO; KRISTIAN VILLUMSEN, EVP, Chronic Care; ALLAN RASMUSSEN, EVP, Global Operations; ALAIN MORVAN, SVP, Sales Europe; CAROLINE VAGNER ROSENSTAND, VP, Development & Strategy; ED VEOME, SVP, North America; IAN CHRISTENSEN, VP, Investor Relations; JESPER KALENBERG, VP, Procurement; NICOLAI BUHL ANDERSEN, SVP, Wound Care; OLIVER JOHANSEN, SVP, Global R&D; PAUL MARCUN, SVP, Emerging Markets; STEFFEN HOVARD, SVP, Urology Care; THOMAS ALSBJERG, VP, HR

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41

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PAUL HARTMANN

481 Lakeshore Parkway, Rock Hill, SC 29730; Paul-Hartmann-Straße 12, 89522 Heidenheim, Germany us.hartmann.info

2015 RANK: 35 Revenue: $2,060,000,000 Fiscal year ending: Dec. 31, 2015

Employees: 10,001

KEY PERSONNEL: ANDREAS JOEHLE, Chairman & CEO; DR. FELIX FREMEREY, Chief Process Officer; MICHEL KUEHN, COO; STEPHAN SCHULZ, CFO & Labor Director; DR. WOLFGANG NEUMANN, CMO

42

WATERS

34 Maple Street Milford, MA 01757 www.waters.com

2015 RANK: 44 Revenue: $2,040,000,000 Fiscal year ending: Dec. 31, 2015

Employees: 6,600 R&D Spend: $118,500,000

KEY PERSONNEL: CHRISTOPHER O’CONNELL, President & CEO; MARK BEAUDOUIN, SVP, GC & Secretary; EUGENE CASSIS, SVP & CFO; MICHAEL HARRINGTON, SVP, Global Markets; TERRANCE KELLY, SVP & President, TA Instruments; ROHIT KHANNA, SVP, Applied Technology; IAN KING, SVP, Instrument Technology; ELIZABETH RAE, SVP, HR; DAVID TERRICCIANO, SVP, Global Operations

43

BIO-RAD

1000 Alfred Nobel Drive Hercules, CA 94547 www.bio-rad.com

2015 RANK: 41 Revenue: $2,020,000,000 Fiscal year ending: Dec. 31, 2015

Employees: 7,800 R&D Spend: $193,000,000

KEY PERSONNEL: NORMAN SCHWARTZ, Chairman, President & CEO; JOHN GOETZ, EVP, COO; GIOVANNI MAGNI, EVP, Chief Strategy Officer; CHRISTINE TSINGOS, EVP, CFO; TIMOTHY ERNST, EVP, GC & Secretary; MIKE CROWLEY, EVP, Global Commercial Operations; SHANNON HALL, EVP & President, Life Science Group; JOHN HERTIA, EVP, President, Clinical Diagnostics Group; RONALD HUTTON, VP, Treasurer; JAMES STARK, VP, Controller

www.medicaldesignandoutsourcing.com

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THE TOP 1OO MEDTECH COMPANIES

44

SONOVA

Laubisrütistrasse 28 8712 Stäfa, Switzerland www.sonova.com/en

2015 RANK: 48 Revenue: $1,990,000,000 Fiscal year ending: March 31, 2016

Employees: 10,697 R&D Spend: $125,400,000

KEY PERSONNEL: LUKAS BRAUNSCHWEILER, CEO; HARTWIG GREVENER, CFO; CLAUDE DIVERSI, GVP, Hearing Instruments Wholesale; HANSJÜRG EMCH, GVP, Medical; MARTIN GRIEDER, GVP, Phonak; SARAH KREIENBÜHL, GVP, HR & Communications; HANS MEHL, GVP, operations; JAN METZDORFF, SVP, Unitron; FRANZ PETERMANN, SVP, Connect Hearing Group; ANDI VONLANTHEN, GVP, R&D

45

HILL-ROM

1069 State Route 46 East Batesville IN 47006-8835 www.hill-rom.com

2015 RANK: 53 Revenue: $1,980,000,000 Fiscal year ending: Sept. 30, 2015

Employees: 10,000 R&D Spend: $91,800,000

KEY PERSONNEL: JOHN GREISCH, President & CEO; CARLOS ALONSO, SVP & President; ANDREAS FRANK, SVP, Development & Strategy; RICHARD KELLER, VP, Controller & Chief Accounting Officer; SUSAN LICHTENSTEIN, SVP, Affairs, Chief Legal Officer & Secretary; KENNETH MEYERS, SVP & Chief HR Officer; ALTON SHADER, SVP & President; TAYLOR SMITH, SVP & President; CARLYN SOLOMON, COO; STEVEN STROBEL, SVP & CFO

46

NIPRO

200 Crossing Blvd. Bridgewater, NJ 08807 www.nipro.com

2015 RANK: 39 Revenue: $1,960,000,000* Fiscal year ending: March 31, 2016

* Revenues from Nipro’s medical segment.

KEY PERSONNEL: YOSHIHIKO SANO, President & Representative Director; MAKOTO SATO, Managing Director; TOSHIAKI MASUDA, Managing Director; KAZUO WAKATSUKI, Managing Director; KIYOTAKA YOSHIOKA, Managing Director; KYOETSU KOBAYASHI, Managing Director

56

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DRAEGERWERK

Thomas Fischler Moislinger Allee 53-55 23558 Lübeck, Germany www.draeger.com

2015 RANK: 43 Revenue: $1,830,000,000* Fiscal year ending: Dec. 31, 2015

* Revenues from Draegerwerk’s medical segment.

KEY PERSONNEL: STEFAN DRÄGER, Executive Board Chairman; GERT-HARTWIG LESCOW, CFO & Executive Board Member, IT, Executive Board Vice-Chairman; RAINER KLUG, Executive Board Member, Production, Logistics, Purchasing, Americas; DR. REINER PISKE, Executive Board Member, HR, Europe; ANTON SCHROFNER, Executive Board Member, Innovation, Africa, Asia & Australia

www.medicaldesignandoutsourcing.com

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THE TOP 1OO MEDTECH COMPANIES

48

TELEFLEX

550 East Swedesford Rd. Suite 400 Wayne, PA 19087 www.teleflex.com/en/usa

2015 RANK: 50 Revenue: $1,810,000,000 Fiscal year ending: Dec. 31, 2015

Employees: 12,200 R&D Spend: $52,100,000

KEY PERSONNEL: BENSON SMITH, Chairman, President & CEO; LIAM KELLY, EVP & COO; THOMAS POWELL, EVP & CFO; JAY WHITE, SVP; JUSTIN MCMURRAY, SVP; JOHN TUSHAR, SVP; TIM KELLEHER, SVP, OEM; JEAN-LUC DIANDA, SVP, Sales; JAN VERSTREKEN, SVP, Sales; JAMES FERGUSON, SVP, Sales; HOWARD MILLER, SVP, Sales

49

COOPER COS.

6140 Stoneridge Mall Road Suite 590 Pleasanton, CA 94588 www.coopercos.com

2015 RANK: 52 Revenue: $1,800,000,000 Fiscal year ending: Oct. 31, 2015

Employees: 10,200 R&D Spend: $69,600,000

KEY PERSONNEL: ROBERT WEISS, President & CEO; DANIEL MCBRIDE, EVP, COO; CAROL KAUFMAN, EVP, Secretary & Chief Administrative Officer; GREG MATZ, SVP, CFO & Chief Risk Officer; ALBERT WHITE, EVP & Chief Strategy Officer; PAUL REMMELL, SVP

50

MIRACA

Shinjuku Mitsui Building, 8Th Floor, 2-1-1 Nishishinjuku Shinjuku-Ku, Tokyo 163-0408, Japan www.miraca-holdings.co.jp/eng/

2015 RANK: 46 Revenue: $1,750,000,000 Fiscal year ending: March 31, 2016 KEY PERSONNEL: HIROMASA SUZUKI, President & CEO; SHIGEKAZU TAKEUCHI, EVP; Executive Officers: HIROMITSU TAZAWA, Legal Affairs & CSR; HIROAKI KIMURA, IR, General Affairs & IT; NAOKI KITAMURA, Finance & Global CLT; SHIGETO OHTSUKI, HHR & Internal Control; TAKAAKI HATA, Strategy & Internal Audit

58

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RESMED

9001 Spectrum Center Blvd. San Diego, CA 92123 www.resmed.com

2015 RANK: 54 Revenue: $1,680,000,000 Fiscal year ending: June 30, 2015

Employees: 4,340 R&D Spend: $114,900,000

KEY PERSONNEL: MICHAEL FARRELL, CEO; ROBERT DOUGLAS, President & COO; BRETT SANDERCOCK, CFO; DAVID PENDARVIS, Chief Administrative Officer & Global General Counsel; GREG PEAKE, President, Consumer GBU; LUKE MAGUIRE, President, Cardio-Respiratory Care GBU; RAJ SODHI, President, Healthcare Informatics GBU; JIM HOLLINGSHEAD, President, Sales; ANNE REISER, President, EMEA-APAC; ANDREW PRICE, President, Innovation & Operations; HEMANTH REDDY, Chief Strategy Officer; FRANK LACAGNINA, CIO; RICHIE MCHALE, Chief HR Officer

52

CONVATEC

1160 Rte 22 Suite 201 Bridgewater, NJ 08807-2931 www.convatec.com


2015 RANK: 51 Revenue: $1,650,000,000 Fiscal year ending: Dec. 31, 2015

Employees: 9,100 R&D Spend: $41,200,000

KEY PERSONNEL: PAUL MORAVIEC, CEO; NIGEL CLERKIN, CFO; SYMERIA HUDSON, President, Global Franchises & Innovation; 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 & GC; ROBERT STEELE, EVP, Quality, Regulatory & Clinical Affairs; DOUGLAS LEFORT, SVP, Development; RON HOWELL; CEO, 180 Medical; FIONA ADAM, VP & GM, Advanced Wound Care; STEPHEN BISHOP, VP, R&D, Advanced Wound Care & Shared Services; MADS HAUGAARD, VP & GM, Continence & Critical Care; ERIK ZIMMER, VP & GM, Ostomy Care; MARC BROENDUM VP, R&D, Ostomy Care, Continence & Critical Care

53

BRUKER

40 Manning Rd. Billerica, MA 01821 www.bruker.com

2015 RANK: 56 Revenue: $1,620,000,000 Fiscal year ending: Dec. 31, 2015

Employees: 6,000 R&D Spend: $145,700,000

KEY PERSONNEL: FRANK LAUKIEN, President & CEO; MARK MUNCH, EVP & President, Bruker NANO; JUERGEN SREGA, President, Bruker CALID; RENÉ LENGGENHAGER, President, Bruker BioSpin; ANTHONY MATTACCHIONE, SVP, CFO; MICHAEL KNELL, VP, Finance & CAO

www.medicaldesignandoutsourcing.com

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IDEXX LABS 1 IDEXX Drive Westbrook, ME 04092 www.idexx.com

2015 RANK: 60 Revenue: $1,600,000,000 Fiscal year ending: Dec. 31, 2015

Employees: 6,800 R&D Spend: $99,700,000

KEY PERSONNEL: JONATHAN AYERS, Chairman, President & CEO; JAY MAZELSKY, EVP; BRIAN MCKEON, EVP, CFO & Treasurer; JACQUELINE STUDER, VP, GC & Secretary; JEFFREY THOMAS, VP; GIOVANI TWIGGE; VP & Chief HR Officer; MICHAEL WILLIAMS, EVP

55

WILLIAM DEMANT Kongebakken 9 2765 Smørum, Denmark www.demant.com

2015 RANK: 59 Revenue: $1,590,000,000 Fiscal year ending: Dec. 31, 2015

* Revenues from William Demant’s hearing segment.

KEY PERSONNEL: NIELS JACOBSEN, President & CEO; SØREN NIELSEN, COO, President, Oticon; RENÉ SCHNEIDER, CFO; SØREN ANDERSSON, VP, IR

56

HALYARD HEALTH 5405 Windward Parkway Suite 100 South Alpharetta, GA 30004 www.halyardhealth.com

2015 RANK: 55 Revenue: $1,570,000,000 Fiscal year ending: Dec. 31, 2015

Employees: 12,000 R&D Spend: $32,300,000

KEY PERSONNEL: ROBERT ABERNATHY, Chairman & CEO; CHRIS ISENBERG, SVP, Global Supply Chain & Procurement; CHRIS LOWERY, SVP & COO; JOHN WESLEY, SVP, GC & Chief Ethics & Compliance Officer; RHONDA GIBBY, SVP & Chief HR Officer; STEVE VOSKUIL, CFO; WARREN MACHAN, SVP, Business Strategy

60

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NIHON KOHDEN 1-31-4 Nishiochiai, Shinjuku-Ku Tokyo 161-8560 Japan www.nihonkohden.com

2015 RANK: 58 Revenue: $1,370,000,000 Fiscal year ending: March 31, 2016

Employees: 4,776 R&D Spend: $48,800,000

KEY PERSONNEL: FUMIO SUZUKI, Chairman & CEO; HIROKAZU OGINO, President & COO; HIROSHI AIDA, Executive Operating Officer, GM, Import Business; YOSHITO TSUKAHARA, Senior Operating Officer, GM, Recurring Business; TAKASHI TAMURA, Senior Operating Officer, GM, Sales Operations, Customer Service; TADASHI HASEGAWA, Senior Operating Officer, Accounting, Legal Affairs & HR; KAZUTERU YANAGIHARA, GM, Strategic Technology Operations; FUMIO HIROSE, GM, Ventilator & Anesthesia Device; EIICHI TANAKA, President, Nihon Kohden Tomioka; SHIGERU HIRATA, GM, Finance; TOSHIHIKO HIRAOKA, GM, IT Solutions; YASUHIRO YOSHITAKE, GM, International Operations; YOSHIAKI UEMATSU, GM, General Affairs; MAKOTO MAGARA, GM, Biomedical Instrument; SHUHEI MORINAGA, GM, Monitoring; KAZUOMI SHIMODA, President, Nihon Kohden Tokyo; MASATO SEMBA, GM, Quality Management; TAKASHI SEO, GM, Strategy; MASAHIKO KUMAKURA, President, Nihon Kohden Kansai; NAOYUKI MURAKI, GM, IT; SYUUICHI KURITA, GM, HR

58

ELEKTA

Box 7593, 10393 Stockholm V7 00000, Sweden www.elekta.com


2015 RANK: 57 Revenue: $1,330,000,000 Fiscal year ending: May 31, 2016

Employees: 3,600 R&D Spend: $126,300,000

KEY PERSONNEL: RICHARD HAUSMANN, President & CEO; HÅKAN BERGSTRÖM, CFO; IAN ALEXANDER, Chief Commercial Officer; JOHAN SEDIHN, COO; BILL YAEGER, EVP, Americas; TODD POWELL, EVP, Global Engineering; JOHN LAPRÉ, CTO; MAURITS WOLLESWINKEL, EVP, Marketing & Strategy; JONAS BOLANDER, EVP, Legal & Compliance

59

SMITHS MEDICAL (SMITHS GROUP) 1265 Grey Fox Road, St Paul, MN 55112 www.smiths.com

2015 RANK: 62 Revenue: $1,280,000,000 Fiscal year ending: July 31, 2015

Employees: 23,250 R&D Spend: $141,800,000

KEY PERSONNEL: JEFF MCCAULLEY, President; STUART BEESLEY, CIO; RUSS DAVIES, VP, RA/QA; ROB WHITE, VP, Finance; CARL STAMP, VP, Global Product Management; ADAM JONES, GC; RON LEONHARDT, VP, HR; LU ANNE GREEN, VP, Global Operations; BEN SOMMERNESS, VP, Global Strategy; BOB ARMSTRONG, VP & CTO, R&D

www.medicaldesignandoutsourcing.com

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60

AGFA-GEVAERT Septestraat 27 2640 Mortsel, Belgium www.agfa.com

2015 RANK: 61 Revenue: $1,220,000,000 Fiscal year ending: Dec. 31, 2015

* Revenues from Agfa-Gevaert’s healthcare segment.

KEY PERSONNEL: CHRISTIAN REINAUDO, President & CEO, Agfa-Gevaert; KRIS HOORNAERT, CFO; LUC DELAGAYE, President, Agfa Materials; LUC THIJS, President, Agfa Healthcare; STEFAAN VANHOOREN, President, Agfa Graphics

61

SIRONA DENTAL SYSTEMS 30-30 47th Avenue, Suite 500 Long Island City, NY 11101 www.sironausa.com

2015 RANK: 68 Revenue: $1,160,000,000 Fiscal year ending: Sept. 30, 2015

Employees: 3,458 R&D Spend: $54,800,000

KEY PERSONNEL: JEFFREY SLOVIN, CEO; ULRICH MICHEL, EVP & CFO; CHRISTOPHER CLARK, President & CTO; JAMES MOSCH, President & COO

62

CARL ZEISS MEDITEC Goeschwitzer Strasse 51-52 D-07745 Jena, Germany

www.zeiss.com/meditec/en_us

2015 RANK: 67 Revenue: $1,150,000,000 Fiscal year ending: Sept. 30, 2015

Employees: 2,888 R&D Spend: $124,200,000

KEY PERSONNEL: LUDWIN MONZ, President & CEO, Carl Zeiss Meditec; CHRISTIAN MÜLLER, CFO, Carl Zeiss Meditec; THOMAS SIMMERER, Chief Sales Officer; RALF KUSCHNEREIT, President & CEO Carl Zeiss Meditec U.S., Head, Ophthalmics

62

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AMPLIFON Via Ripamonti, 133 20141 Milano, Italy

www.amplifonusa.com

2015 RANK: 84 Revenue: $1,147,000,000 Fiscal year ending: Dec. 31, 2015

Employees: 6,333

KEY PERSONNEL: ENRICO VITA, CEO & GM; GIOVANNI CARUSO, Chief HR Officer; ANDREA FACCHINI, Chief Marketing Officer; CRISTIAN FINOTTI, Chief Procurement Officer; MASSIMILIANO GERLI, CIO; UGO GIORCELLI, CFO; JOHN PAPPALARDO, EVP, APAC; IACOPO LORENZO PAZZI, EVP, EMEA; GIULIO PIZZINI, Chief Strategic Development Officer; HEINZ RUCH, EVP, Americas


64

INVACARE 1 Invacare Way Elyria, OH 44036

www.invacare.com

2015 RANK: 64 Revenue: $1,142,000,000 Fiscal year ending: Dec. 31, 2015

Employees: 4,700 R&D Spend: $18,670,000

KEY PERSONNEL: MATTHEW MONAGHAN, Chairman, President & CEO; ROBERT GUDBRANSON, SVP & CFO; DEAN CHILDERS, SVP & GM, North America; ANTHONY LAPLACA, SVP, GC & Secretary; PATRICIA STUMPP, SVP, HR; GORDON SUTHERLAND, SVP & GM, EMEA


65

DJO GLOBAL 1430 Decision Street Vista, CA 92081

www.djoglobal.com

2015 RANK: 65 Revenue: $1,110,000,000 Fiscal year ending: Dec. 31, 2015

Employees: 5,260 R&D Spend: $35,100,000

KEY PERSONNEL: MICHAEL MOGUL, President & CEO; TOBY BOST, President, DJO Global Consumer Business; JEANINE KESTLER, EVP, Chief HR Officer; STEVEN INGEL, President, Global Bracing & Supports; JEFF NORTHERN, EVP, Global Quality & Operations; STEPHEN MURPHY, President, Sales & Marketing, Int’l Commercial Business; MIKE PETERS, EVP, CIO; BRADY SHIRLEY, President, DJO Surgical; BRAD TANDY, EVP, GC & Secretary; SHARON WOLFINGTON, President, Global Recovery Sciences

www.medicaldesignandoutsourcing.com

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FUKUDA DENSHI

39-4, Hongo 3-Chome Bunkyo-Ku, Tokyo 113-8483, Japan www.fukuda.co.jp/english

2015 RANK: 70 Revenue: $968,400,000 Fiscal year ending: March 31, 2016

Employees: 3,422 R&D Spend: $34,300,000

KEY PERSONNEL: KOTARO FUKUDA, Chairman & CEO; DAIJIRO SHIRAI, President & COO


67

HAEMONETICS 400 Wood Road Braintree, MA 02184

www.haemonetics.com

2015 RANK: 75 Revenue: $910,400,000 Fiscal year ending: March 28, 2015

Employees: 3,383 R&D Spend: $54,190,000

KEY PERSONNEL: PETER ALLEN, President; RIAN BURNS, EVP, Global Quality & Regulatory Affairs; CHRISTOPHER SIMON, President & CEO; KENT DAVIES, COO; SUSAN HANLON, VP Finance & Chief Accounting Officer; DAVID HELSEL, EVP, Global Manufacturing; SANDRA JESSE, Chief Legal Officer; CHRISTOPHER LINDOP, EVP, Business Development & CFO; DR. JONATHAN WHITE, Chief Science & Technology Officer

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Shiokoji Horikawa, Shimogyo-Ku, Kyoto 600-8530, Japan

CM

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www.omron.com

2015 RANK: 72 Revenue: $895,700,000* Fiscal year ending: March 31, 2016

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* Revenues from Omron’s healthcare segment.

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KEY PERSONNEL: FUMIO TATEISHI, Chairman; YOSHIHITO YAMADA, President & CEO; YOSHINORI SUZUKI, EVP & CFO; AKIO SAKUMIYA, EVP; KOJI NITTO, Director, Senior Managing Executive Officer

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INTEGRA LIFESCIENCES 311 Enterprise Drive Plainsboro, NJ 08536

www.integralife.com

2015 RANK: 73 Revenue: $882,700,000 Fiscal year ending: Dec. 31, 2015

Employees: 3,500 R&D Spend: $50,900,000

KEY PERSONNEL: PETER ARDUINI, President & CEO; MARK AUGUSTI, CVP, President, Orthopedics & Tissue Technologies; KENNETH BURHOP, CVP, Chief Scientific Officer; GLENN COLEMAN, CVP, CFO & Principal Accounting Officer; WILLIAM COMPTON, SVP, CIO; ROBERT DAVIS JR., VP, President, Specialty Surgical Solutions; LISA EVOLI, VP, Chief HR Officer; PAUL GONSALVES, SVP, Chief Commercial Officer; RICHARD GORELICK, VP, GC, Administration & Secretary; JOHN MOORADIAN, VP, Global Operations & Supply Chain; JUDITH O’GRADY, VP, Global Regulatory Affairs; MARIA PLATSIS, SVP, Development; DAN REUVERS, VP, President, Int’l; JOSEPH VINHAIS, VP, Global Quality Assurance

SMCLtd_MDO_Big100_0816.pdf

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CONTRACT MANUFACTURING ELECTRONIC INTEGRATION Whether you require up-front services such as electronic integration design or full manufacturing capabilities, SMC has the bandwidth to bring your finished device to realization. With global locations, we are positioned to serve your needs from a regional level. To see how we can partner with you on your next medical device visit: www.smcltd.com

715.247.3500 inquiry@smcltd.com www.medicaldesignandoutsourcing.com 9 • 2016

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70

COCHLEAR

1 University Avenue, Macquarie University NSW 2109, Australia www.cochlear.com

2015 RANK: 74 Revenue: $871,100,000 Fiscal year ending: June 30, 2016

R&D Spend: $107,600,00

KEY PERSONNEL: CHRIS SMITH, President & CEO; GREG BODKIN, SVP, Manufacturing & Logistics; RICHARD BROOK, President, Europe; DAVID HACKSHALL, CIO; DIG HOWITT, COO; JAN JANSSEN, SVP, Design & Development; AMANDA LAMPE, SVP, Affairs, Strategic Alignment & Public Health; TONY MANNA, President, North America; KATHARINE MCLENNAN, SVP, People & Culture; NEVILLE MITCHELL, CFO & Secretary; JIM PATRICK, SVP, Chief Scientist; STUART SAYERS, President, Services; DR. RICHARD TOSELLI, CMO; DEAN PHIZACKLEA, SVP, Global Marketing; ANTHONY BISHOP, President, APac


71

ALIGN TECHNOLOGY 2560 Orchard Parkway San Jose, CA 95131 www.aligntech.com

2015 RANK: 79 Revenue: $845,500,000 Fiscal year ending: Dec. 31, 2015

Employees: 4,375 R&D Spend: $61,200,000

KEY PERSONNEL: JOSEPH HOGAN, President & CEO; DAVID WHITE, CFO; SIMON BEARD, VP & Managing Director, EMEA; JENNIFER ERFURTH, VP, Global HR; ROGER GEORGE, VP, Legal Affairs & GC; TIMOTHY MACK, VP, Business Development; RAPHAEL PASCAUD, Chief Marketing Portfolio & Business Development Officer; CHRISTOPHER PUCO, VP, North America; ZELKO RELIC, VP, R&D; JULIE TAY, VP & Managing Director, APac; EMORY WRIGHT, VP, Operations

72

KAWANISHI

8th Floor, Nihon-Seimei Okayama Buildingii 1-1-3 Shimoishii, Kita-Ku, Okayama City, Okayama 700-0907, Japan www.kawanishi-md.co.jp/english

2015 RANK: 76 Revenue: $838,200,000 Fiscal year ending: June 30, 2016 KEY PERSONNEL: TOSHIYUKI MAESHIMA, Chairman & CEO; YOHEI MAESHIMA, President & COO; TAIRA TAKAI, Vice Chairman; YASUTOSHI OHATA, Managing Director, MITSURU YAMAMOTO, Managing Director

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NUVASIVE

7475 Lusk Blvd. San Diego, CA 92121 www.nuvasive.com

2015 RANK: 78 Revenue: $811,100,000 Fiscal year ending: Dec. 31, 2015

Employees: 1,600 R&D Spend: $35,900,000

KEY PERSONNEL: GREGORY LUCIER, Chairman & CEO; PATRICK MILES, President and COO; MATT LINK, President, Sales; QUENTIN BLACKFORD, EVP & CFO; JASON HANNON, EVP, International Sales; CAROL COX, EVP, PR & Marketing; PETE LEDDY, EVP, HR; JOHNSON LAI, CIO; ED ROSCHAK, EVP

74

GREATBATCH (INTEGER) 2591 Dallas Parkway, Suite 101 Frisco, TX 75034 www.greatbatch.com

2015 RANK: 82 Revenue: $800,400,000 Fiscal year ending: Jan. 1, 2016

Employees: 9,559 R&D Spend: $52,900,000

KEY PERSONNEL: THOMAS HOOK, President & CEO; MICHAEL DINKINS, EVP & CFO; KRISTIN TRECKER, EVP & Chief HR Officer; MICHAEL SPENCER, SVP & CECO; MAURICIO ARELLANO, EVP, Global Operations; TONY GONZALEZ, President, CRM; JEREMY FRIEDMAN, President, Cardio & Vascular; DECLAN SMYTH, President, Surgical & Orthopedics; JENNIFER BOLT, President, Electrochem; TIMOTHY MCEVOY, SVP & General Counsel; JOSEPH FLANAGAN, SVP, Quality Management

75

GN STORE NORD Lautrupbjerg 7 2750 Ballerup, Denmark www.gn.com

2015 RANK: 77 Revenue: $769,400,000* Fiscal year ending: Dec. 31, 2015

* Revenues from GN Store Nord’s ReSound segment.

KEY PERSONNEL: ANDERS HEDEGAARD, CEO, GN Store Nord & GN Hearing; RENÉ SVENDSEN-TUNE, CEO, GN Store Nord & GN Audio; MARCUS DESIMONI, CFO, GN Store Nord & GN Hearing

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STRAUMANN

Peter Merian-Weg 12 Ch-4002, Basel, Switzerland www.straumann.us/en/home.html

2015 RANK: 85 Revenue: $768,900,000 Fiscal year ending: Feb. 25, 2016

Employees: 3,471 R&D Spend: $221,300,000

KEY PERSONNEL: MARCO GADOLA, CEO; PETER HACKEL, CFO; WOLFGANG BECKER, Head, Central Europe Sales; GUILLAUME DANIELLOT, Head, North America Sales; ALEXANDER OCHSNER, Head, APac Sales; FRANK HEMM, Head, Customer Solutions & Education; GERHARD BAUER, Head, R&D & Operations; PETRA RUMPF, Head, Instradent & Strategic Alliances; JENS DEXHEIMER, Head, Western Europe Sales; MATTHIAS SCHUPP, Head, Latin America Sales, CEO, Neodent

77

ACELITY

12930 West Interstate 10 San Antonio, TX 78249 www.acelity.com

2015 RANK: 47 Revenue: $745,500,000 Fiscal year ending: Dec. 31, 2015

Employees: 1,000 R&D Spend: $559,500,000

KEY PERSONNEL: JOSEPH WOODY, President & CEO; GAURAV AGARWAL, President, Business; DAVID BALL, SVP, Quality Management; JOHN BIBB, EVP, General Counsel; TOM CASEY, EVP & CFO; DENNIS CROWLEY, SVP, Strategy; BUTCH HULSE, SVP & CCO; GREG KAYATA, SVP, HR; LAURA PICCININI, President, Marketing; DR. RON SILVERMAN, SVP & Chief Medical Officer

78

KONICA MINOLTA

Jp Tower, 2-7-2 Marunouchi Chiyoda-Ku, Tokyo 100-7015, Japan konicaminolta.us

2015 RANK: 80 Revenue: $741,800,000* Fiscal year ending: March 31, 2016

* Revenues from Konica Minolta’s healthcare segment.

KEY PERSONNEL: SHOEI YAMANA, President & CEO; Senior Executive Officers: NOBUYASU IEUJI, JUN HARAGUCHI, TSUKASA WAKASHIMA, KUNIHIRO KOSHIZUKA, KEN OSUGA, SEIJI HATANO, SHINGO ASAI, TOYOTSUGU ITOH, NORIYASU KUZUHARA

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CONMED 525 French Road, Utica, NY 13502

www.conmed.com

2015 RANK: 81 Revenue: $719,200,000 Fiscal year ending: Dec. 31, 2015

Employees: 3,400 R&D Spend: $27,400,000

KEY PERSONNEL: CURT HARTMAN, President and CEO; PATRICK BEYER, President, International; TERENCE BERGÉ, VP, Controller; HEATHER COHEN, EVP, HR; NATHAN FOLKERT, VP; DANIEL JONAS, EVP, Legal Affairs & General Counsel; JOHN KENNEDY, VP; JOHONNA PELLETIER, VP & Treasurer; STANLEY PETERS, VP; LUKE POMILIO, EVP & CFO; WILFREDO RUIZ-CABAN, EVP, Quality Management; PETER SHAGORY, EVP, Business

80

LIVANOVA (FORMERLY SORIN/CYBERONICS) 5 Merchant Square, North Wharf Road London W21AY U.K. www.livanova.com

2015 RANK: 71 Revenue: $707,300,000 Fiscal year ending: April 24, 2016

Employees: 4,700 R&D Spend: $95,200,000

KEY PERSONNEL: ANDRÉ-MICHEL BALLESTER, CEO; MICHEL DARNAUD, President, Cardiac Surgery; STEFANO DI LULLO, President, Cardiac Rhythm Management; JASON RICHEY, President, Neuromodulation; JACQUES GUTEDEL, President, Intercontinental; EDWARD ANDRLE, SVP, New Ventures & Business Development; VIVID SEHGAL, CFO; BRIAN SHERIDAN, SVP, GC & Secretary; PRITPAL SHINMAR, SVP, Market Access; DAVID WISE, SVP, HR & IT

81

MASIMO 52 Discovery Irvine, CA 92618

www.masimo.com

2015 RANK: 86 Revenue: $599,300,000 Fiscal year ending: Jan. 2, 2016

Employees: 2,400 R&D Spend: $56,600,000

KEY PERSONNEL: JOE KIANI, CEO & Chairman; JON COLEMAN, President, Sales; MARK DE RAAD, EVP & CFO; RICK FISHEL, President, OEM; PAUL JANSEN, EVP, Business; YONGSAM LEE, EVP & CIO; ANAND SAMPATH, COO; TOM MCCLENAHAM, EVP, General Counsel

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FISHER & PAYKEL HEALTHCARE 15 Maurice Paykel Place East Tamaki, Auckland 2013 New Zealand www.fphcare.com

2015 RANK: 87 Revenue: $570,900,000 Fiscal year ending: March 31, 2016

Employees: 3,587 R&D Spend: $51,300,000

KEY PERSONNEL: LEWIS GRADON, Managing Director & CEO; PAUL SHEARER, SVP, Sales & Marketing; TONY BARCLAY, CFO & Secretary; WINSTON FONG, VP, Information & Communication Technology; JONTI RHODES, GM, Supply Chain; BRIAN SCHULTZ, VP, Quality & Regulatory Affairs

83

CANTEL MEDICAL

Overlook At Great Notch 150 Clove Road, Little Falls, NJ 07424 www.cantelmedical.com

2015 RANK: 92 Revenue: $565,000,000 Fiscal year ending: July 31, 2015

Employees: 1,680 R&D Spend: $92,000,000

KEY PERSONNEL: JORGEN HANSEN, President & CEO; PETER CLIFFORD, EVP & CFO; SETH YELLIN, EVP, Strategy; ERIC NODIFF, EVP, General Counsel; DAVE HEMINK, President, Endoscopy; CURT WEITNAUER, President, Water Purification; GARY STEINBERG, President, Healthcare Disposables; MIKE SPICER, President, Sales; DAVID ROSEN, President, Sales; CRAIG SMITH, SVP, Quality Management; LAWRENCE CONWAY, VP, IT; PAUL HELMS, EVP, Operations; CHRIS GESCHICKTER, VP, HR; MILICENT BROOKS, VP, Communications

84

MERIT MEDICAL SYSTEMS 1600 West Merit Parkway South Jordan, UT 84095 www.merit.com

2015 RANK: 90 Revenue: $542,100,000 Fiscal year ending: Dec. 31, 2015

Employees: 3,754 R&D Spend: $40,800,000

KEY PERSONNEL: FRED LAMPROPOULOS, Chairman & CEO; BERNARD BIRKETT, CFO; JOE WRIGHT, President, International Sales; DARLA GILL, President, Merit Endotek; RONALD FROST, COO; BRIAN LLOYD; Chief Legal Officer; JUSTIN LAMPROPOULOS, EVP, Global Marketing; JOHN KNORPP, Chief Regulatory Affairs Officer; JOSEPH PIERCE, CIO; LOUISE BOTT, VP, HR; JASON TREFT, CTO

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ÖSSUR

Grjóthálsi 5, 110 Reykjavík Id-No. 560271-0189, Iceland www.ossur.com

2015 RANK: 91 Revenue: $483,000,000 Fiscal year ending: Dec. 31, 2015

Employees: 2,525 R&D Spend: $18,400,000

KEY PERSONNEL: JÓN SIGURÐSSON, President & CEO; EGILL JÓNSSON, EVP, Manufacturing & Operations; JOS VAN POORTEN, Managing Director, EMEA; MARGRÉT LÁRA FRIÐRIKSDÓTTIR, EVP, HR & Strategy; ÓLAFUR GYLFASON, EVP, Sales & Marketing; SVEINN SÖLVASON, CFO; ÞORVALDUR INGVARSSON, EVP, R&D

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THORATEC

6035 Stoneridge Dr. Pleasanton, CA 94588 www.thoratec.com

2015 RANK: 93 Revenue: $477,600,000 Fiscal year ending: Jan. 3, 2015

Employees: 1,048 R&D Spend: $105,500,000

KEY PERSONNEL: KEITH GROSSMAN, President & CEO; TAYLOR HARRIS, VP & CFO; DAVID LEHMAN, SVP & General Counsel; VASSANT PADMANABHAN, SVP, IT; NIAMH PELLEGRINI, President, Sales

87

JMS CO.

12-17, Kako-Cho, Naka-Ku Hiroshima-Shi, Hiroshima 730-8652, Japan www.jms.cc/english

2015 RANK: 88 Revenue: $457,900,000 Fiscal year ending: March 31, 2016

Employees: 6,777 R&D Spend: $13,600,000

KEY PERSONNEL: HIROAKI OKUKUBO, President & Representative Director; YASUHIRO AWANE, Executive Director, Sales & Marketing; JUN KUNITOMI, Director, Production; SHIGEMI MORIKAWA, Director, International; MASAFUMI SATO, Director, R&D; RYUJI KATSURA, Director, Planning

88

WRIGHT MEDICAL 1023 Cherry Road Memphis, TN 38117 www.wmt.com

2015 RANK: 101 Revenue: $415,500,000 Fiscal year ending: Dec. 27, 2015

Employees: 2,295 R&D Spend: $39,900,000

KEY PERSONNEL: ROBERT PALMISANO, President & CEO; LANCE BERRY, SVP & CFO; ROBERT BURROWS, SVP, Supply Chain; PETER COOKE, President, International; KEVIN CORDELL, President, Sales; WILLIAM GRIFFIN, SVP, General Manager; JAMES LIGHTMAN, SVP, General Counsel; GREGORY MORRISON, SVP, HR; WESLEY PORTER, SVP, CCO; JULIE TRACY, SVP, Communications; JENNIFER WALKER, SVP, Improvement

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DEXCOM

6340 Sequence Drive San Diego, CA 92121 www.dexcom.com

2015 RANK: 108 Revenue: $402,000,000 Fiscal year ending: Dec. 31, 2015

Employees: 1,212 R&D Spend: $137,500,000

KEY PERSONNEL: TERRANCE GREGG, Chairman; KEVIN SAYER, CEO & President; ANDREW BALO, EVP, Quality Management; RICK DOUBLEDAY, EVP & CCO; JACOB LEACH, SVP, R&D; JOHN LISTER, GM, Commerical Operations; JEFFREY MOY, SVP, Operations; STEVEN PACELLI, SVP, Strategy; JESS ROPER, SVP & CFO; JORGE VALDES, EVP & CTO; ANNIKA JIMENEZ, SVP, Data; CLAUDIA GRAHAM, AVP, Global Access

90

ORTHOFIX

7 Abraham De Veerstraat Curaçao 599-9-4658525 www.orthofix.com

2015 RANK: 94 Revenue: $369,500,000 Fiscal year ending: Dec. 31, 2015

Employees: 927 R&D Spend: $26,400,000

KEY PERSONNEL: BRAD MASON, President & CEO; DOUG RICE, CFO; MIKE FINEGAN, Chief Strategy Officer; JILL MASON, Chief Ethics & Compliance Officer; JIM RYABY, Chief Scientific Officer; BRAD NIEMANN, President, Biostim; BOB GOODWIN, President, Biologics; DAVIDE BIANCHI, President, Extremity Fixation; RAY FUJIKAWA, President, Spine Fixation; STEVE MARTIN, SVP, Operations; TIM MCGUIRE, SVP, Global Information Services

91

ACCURAY

1310 Chesapeake Terrace Sunnyvale, CA 94089 www.accuray.com

2015 RANK: 97 Revenue: $379,800,000 Fiscal year ending: June 30, 2015

Employees: 1,010 R&D Spend: $55,800,000

KEY PERSONNEL: JOSHUA LEVINE, President & CEO; KELLY LONDY, EVP & COO; KEVIN WATERS, SVP & CFO; ROBERT HILL, SVP, R&D; OLE MIKKELSEN, SVP & CIO; DARL MORELAND, SVP, Quality Management; ALALEH NOURI, SVP, General Counsel

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NATUS

6701 Koll Center Parkway Suite 120, Pleasanton, CA 94566 www.natus.com

2015 RANK: 98 Revenue: $375,900,000 Fiscal year ending: Dec. 31, 2015

Employees: 1,067 R&D Spend: $30,400,000

KEY PERSONNEL: JAMES HAWKINS, President & CEO; JONATHAN KENNEDY, SVP & CFO; AUSTIN NOLL III, VP & GM, Neurology; KENNETH TRAVERSO, VP & GM, Newborn Care; DR. CHRISTOPHER CHUNG, VP, Medical Affairs, Quality & Regulatory

93

TOPCON

75-1, Hasunuma-Cho Itabashi-Ku, Tokyo 174-8580, Japan global.topcon.com

2015 RANK: 96 Revenue: $362,100,000* Fiscal year ending: March 31, 2016

* Revenues from Topcon’s eye care segment.

KEY PERSONNEL: SATOSHI HIRANO, President & CEO; MAKOTO IWASAKI, Director, Senior Managing Executive Officer, GM, Production, General Administration & Legal; TAKASHI ETO, Director & Managing Executive Officer, GM, Sales & Marketing; YASUFUMI FUKUMA, Director & Executive Officer, GM, R&D; HARUHIKO AKIYAMA, Director & Executive Officer, GM, Accounting & Finance; HIROSHI TAGUCHI, Director and Executive Officer, GM, Procurement; TAKAYUKI YAMAZAKI, Director & Executive Officer, GM, Planning

94

NIKKISO

Yebisu Garden Place Tower, 22Nd Floor, 20-3, Ebisu 4-Chome Shibuya-Ku, Tokyo 150-6022, Japan www.nikkiso.com

2015 RANK: 66 Revenue: $343,600,000* Fiscal year ending: Dec. 31, 2015

* Revenues from Nikkiso’s medical segment.

KEY PERSONNEL: TOSHIHIKO KAI, President & CEO; AKIRA NISHIWAKI, Director, EVP, Administration & Planning, Medical ; NAOTA SHIKANO, Director, EVP, Industrial ; HISASHI HOMMA Director, Senior Executive Officer, Production & Quality Control; SHOTARO FUJII, Director, Senior Executive Officer, R&D, Engineering

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ICU MEDICAL

951 Calle Amanecer San Clemente, CA 92763-6212 www.icumed.com

2015 RANK: 99 Revenue: $341,300,000 Fiscal year ending: Dec. 31, 2015

Employees: 2,446 R&D Spend: $15,700,000

KEY PERSONNEL: VIVEK JAIN, Chairman & CEO; ALISON BURCAR, VP & GM; SCOTT LAMB, CFO; TOM MCCALL, VP & GM; STEVEN RIGGS, VP, Operations

96

CYNOSURE 5 Carlisle Road Westford, MA 01886

www.cynosure.com

2015 RANK: 102 Revenue: $339,500,000 Fiscal year ending: Dec. 31, 2015

Employees: 857 R&D Spend: $22,300,000

KEY PERSONNEL: MICHAEL DAVIN, Chairman, President & CEO; TIMOTHY BAKER, COO & CFO; DOUGLAS DELANEY, EVP, Sales

97

NXSTAGE MEDICAL 350 Merrimack Street Lawrence, MA 01843 www.nxstage.com

2015 RANK: 100 Revenue: $336,100,000 Fiscal year ending: Dec. 31, 2015

Employees: 3,600 R&D Spend: $26,200,000

KEY PERSONNEL: JEFF BURBANK, CEO; MATTHEW TOWSE, CFO; JOSEPH TURK JR, President; LISA CURTIS, SVP, International; TODD SNELL, SVP of Quality Management; ROBERT BROWN, President, NxStage Kidney Care; TOM SHEA, SVP & COO; WINIFRED SWAN, SVP, General Counsel; JEFFREY RAINS, SVP, Sales and Marketing; DARREN SCANDONE, SVP, HR; MARK WYETH, SVP, Product Development

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ABIOMED

22 Cherry Hill Drive, Danvers, MA 01923 www.abiomed.com

2015 RANK: 112 Revenue: $329,500,000 Fiscal year ending: March 31, 2016

Employees: 152 R&D Spend: $49,800,000

KEY PERSONNEL: MICHAEL MINOGUE, CEO, President & Chairman; DR. SETH BILAZARIAN, Chief Medical Officer; WILLIAM BOLT, SVP, Quality Management; ANDREW GREENFIELD, VP & GM, Marketing; MICHAEL HOWLEY, VP & GM, Sales; STEVE MCEVOY, VP, General Counsel; DR. THORSTEN SIESS, CTO; MICHAEL TOMSICEK, CFO; DR. DAVID WEBER, COO

99

INSULET

600 Technology Park, Suite 200 Billerica MA 01821 www.myomnipod.com

2015 RANK: 104 Revenue: $324,200,000 Fiscal year ending: Dec. 31, 2015

Employees: 647 R&D Spend: $43,200,000

KEY PERSONNEL: PATRICK SULLIVAN, President & CEO; AIMAN ABDEL-MALEK, SVP, IT; CHARLES ALPUCHE, SVP & COO; DAVID COLLERAN, SVP, General Counsel; DEBORAH GORDON, SVP, Communications; DANIEL LEVANGIE, EVP, Insulet Drug Delivery; MICHAEL LEVITZ , SVP & CFO; SHACEY PETROVIC, EVP, Diabetes Products; MICHAEL SPEARS, SVP, Quality Management; BRAD THOMAS, EVP, HR

100

RTI SURGICAL 11621 Research Circle Alachua, FL 32615

www.rtix.com/en_us

2015 RANK: 107 Revenue: $282,300,000 Fiscal year ending: Dec. 31, 2015

Employees: 1,169 R&D Spend: $15,100,000

KEY PERSONNEL: BRIAN HUTCHISON, President & CEO; ROBERT JORDHEIM, EVP & CFO; CAROLINE HARTILL, EVP & CSO; ROGER ROSE, EVP, RTI Surgical & President, RTI Donor Services; ERIC BALDWIN, VP & GM, Commercial Accounts; KEVIN BRANDT, VP & GM, North American Spine; LYLE LUEDEMAN, VP, HR; KEITH PELATOWSKI, VP & GM, International; RICK ROBBINS, VP & GM, Tissue-Based Implants; JOHN VARELA, VP, US Operations; WENDY CRITES WACKER, VP, Global Communications; DR. LENNOX ARCHIBALD, Medical Director; THOMAS ROSE, Secretary

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From concept, to commercialization.

Ximedica is ISO 13485:2012 Certified and FDA Registered. As a full-service development firm, Ximedica has an exclusive focus on medical products and over 25 years of experience developing medical devices, combination products and consumer healthcare products. Providence

Minneapolis

Silicon Valley

Hong Kong

REGISTERED

13485:2012 CERTIFIED

NSAI CERTIFIED

T: 401-330-3163

www.ximedica.com Depicted: Titan Medical’s robotic surgical system under commercial development. Not approved by the FDA for sale in the United States.

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TOP R&D SPENDERS

R&D ranking by total spend:* 2016 COMPANY RANK

R&D SPEND

R&D ranking by percentage of revenues:* 2016 COMPANY REVENUES ($USD) R&D SPEND RANK

% OF REVENUES

1 Medtronic $1,640,000,000

1 DexCom

$402,000,000 $137,500,000 34.2%

2 Boston Scientific $876,000,000

2 Straumann

$768,892,080 $221,340,000 28.8%

3 Cerner $685,000,000

3 Thoratec

$477,560,000 $105,475,000 22.1%

4 St. Jude Medical $676,000,000

4 Cantel Medical

$565,004,000 $92,000,000 16.3%

5 Stryker $625,000,000

5 Cerner

$4,425,000,000 $685,000,000 15.5%

6 Olympus $424,575,200

6 Edwards Lifesciences

$2,493,700,000 $383,100,000 15.4%

7 Edwards Lifesciences $383,100,000

7 Abiomed

$329,520,000 $49,759,000 15.1%

8 B. Braun $288,351,648

8 Accuray

$379,801,000 $55,752,000 14.7%

9 Terumo $286,981,780

9 LivaNova (formerly Sorin/Cyberonics) $707,265,000

10 BioMerieux $265,290,000

10 Insulet

$95,215,000

13.5%

$324,225,000 $43,208,000 13.3% $871,122,820 $107,564,600 12.3%

11 C.R. Bard $254,700,000

11 Cochlear

12 Grifols $246,205,217

12 St. Jude Medical

$5,541,000,000 $676,000,000 12.2%

13 Varian Medical Systems $245,200,000

13 BioMerieux

$2,180,364,000 $265,290,000 12.2%

14 Smith & Nephew $222,000,000

14 Boston Scientific

$7,477,000,000 $876,000,000 11.7%

15 Essilor $221,920,000

15 Smiths Medical (Smiths Group) $1,277,742,400 $141,790,000 11.1%

16 Straumann $221,340,000

16 Wright Medical

17 Hologic $213,695,000

17 Bio-Rad

$2,019,400,000 $193,000,000 9.6%

18 Intuitive Surgical $197,400,000

18 Elekta

$1,330,290,456 $126,259,632 9.5%

19 Bio-Rad $193,000,000

19 Masimo

20 Bruker $145,700,000

20 Fisher & Paykel Healthcare $570,923,149 $51,308,929 9.0%

$415,461,000 $39,855,000 9.6%

$599,334,000 $56,617,000 9.4%

21 Bruker

$1,623,800,000 $145,700,000 9.0%

22 DexCom $137,500,000

22 Olympus

$5,030,375,878 $424,575,200 8.4%

23 Elekta $126,259,632

23 Intuitive Surgical

$2,384,400,000 $197,400,000 8.3%

21 Smiths Medical (Smiths Group) $141,790,000

24 Sonova $125,409,514

24 Natus

25 Waters $118,545,000

25 Varian Medical Systems

$3,099,100,000 $245,200,000 7.9%

26 ResMed $114,865,000

26 Hologic

$2,705,000,000 $213,695,000 7.9%

27 Cochlear $107,564,600

27 NxStage Medical

$375,865,000 $30,434,000 8.1%

$336,123,000 $26,237,000 7.8%

28 Thoratec $105,475,000

28 Acelity

$745,457,000 $55,950,700 7.5%

29 IDEXX Labs $99,681,000

29 C.R. Bard

$3,416,000,000 $254,700,000 7.5%

30 LivaNova (formerly Sorin/Cyberonics) $95,215,000

30 Align Technology

$845,486,000 $61,200,000 7.2%

31 Cantel Medical $92,000,000

31 Terumo

32 Hill-Rom $91,800,000

$4,043,833,127 $286,981,780 7.1%

32 ResMed

33 Dentsply $74,900,000

$1,678,912,000 $114,865,000 6.8%

33 Orthofix

34 Cooper Cos. $69,600,000

34 Greatbatch

35 Coloplast $65,712,204

35 CynoSure

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

78

Medical Design & Outsourcing

R&D breakout_9-16_Vs6.indd 78

9 • 2016

(now Integer)

$396,489,000 $26,389,000 6.7% $800,414,000 $52,995,000 6.6% $339,462,000 $22,343,000 6.6%

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

www.medicaldesignandoutsourcing.com

9/10/16 8:55 PM


Development

Concept

FROM START TO FINISH

Delivery

Filling

Fulfillment

Packaging

From concept to fulfillment, OraTech’s turnkey contract manufacturing services provide everything you need to get your idea to market—fast. And since we do everything in-house, you know that we have your back every step of the way.

For the smarter answer to your manufacturing needs, call 800.526.6880 or visit oratech.com

800.526.6880 | oratech.com © 2016 Oratech. All Rights Reserved.

Oratech 7-16.indd 56

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

R&D SPEND

R&D ranking by percentage of revenues:* RANK COMPANY R&D SPEND REVENUES

% OF REVENUES

36 Align Technology $61,200,000

36 Sonova

$1,994,854,204 $125,409,514 6.3%

37 Steris $56,664,000

37 Stryker

$9,946,000,000 $625,000,000 6.3%

38 Masimo $56,617,000

38 IDEXX Labs

$1,601,892,000 $99,681,000 6.2%

39 Acelity $55,950,700

39 Haemonetics

40 Accuray $55,752,000

40 Waters

$910,373,000 $54,187,000 6.0% $2,042,332,000 $118,545,000 5.8%

41 Sirona Dental Systems $54,800,000

41 Integra Lifesciences

42 Haemonetics $54,187,000

42 Medtronic

$28,833,000,000 $1,640,000,000 5.7%

43 Greatbatch (now Integer) $52,995,000

43 Grifols

$4,365,832,160 $246,205,217 5.6%

$882,734,000 $50,895,000 5.8%

44 Teleflex $52,100,000

44 RTI Surgical

45 Fisher & Paykel Healthcare $51,308,929

45 Smith & Nephew

$4,634,000,000 $222,000,000 4.8%

46 Integra Lifesciences $50,895,000

46 Sirona Dental Systems

$1,161,300,000 $54,800,000 4.7%

47 Abiomed $49,759,000

47 Hill-Rom

$1,988,200,000 $91,800,000 4.6%

48 Nihon Kohden $48,822,800

48 ICU Medical

$341,254,000 $15,714,000 4.6%

49 Insulet $43,208,000

49 NuVasive

$811,113,000 $35,851,000 4.4%

50 ConvaTec $41,200,000

50 B. Braun

282293000 $15,065,000 5.3%

$6,801,626,080 $288,351,648 4.2%

RFID+ : added-value RFID Technology

Standard RFID protocols including additional customized performance Special performance in harsh environments with customized antennas

Extreme low temperatures down to -196°C

Tag-on-metal devices through frequency re-tuning

Liquid items identification with no RF errors

Special tag shapes and formats for perfect fitting

Proprietary protocols running on RFID bands for security performance

Passively LED driving tags for fast visual identification

Passively sensoring tags

IXYS SAN SEBASTIAN SA Zuatzu 3, E-20018 Donostia (Spain) Email: info@ixys.es Tel: +34 943 317 378, Fax: +34 943 317 800 80

Medical Design & Outsourcing

R&D breakout_9-16_Vs4 BP.indd 80

9 • 2016

www.ixys.es

www.medicaldesignandoutsourcing.com

9/9/16 4:04 PM


R&D ranking by total spend:* RANK COMPANY

R&D SPEND

51 Wright Medical $39,855,000

R&D ranking by percentage of revenues:* RANK COMPANY R&D SPEND REVENUES 51 Cooper Cos.

% OF REVENUES

$1,797,060,000 $69,600,000 3.9%

52 NuVasive $35,851,000

52 Conmed

$719,168,000 $27,436,000 3.8%

53 DJO Global* $35,105,000

53 Össur

$483,034,000 $18,361,000 3.8%

54 Fukuda Denshi $34,266,832

54 Nihon Kohden

$1,367,385,378 $48,822,800 3.6%

55 Fukuda Denshi

$968,376,704 $34,266,832 3.5%

55 Halyard Health $32,300,000 56 Natus $30,434,000

56 Coloplast

57 Conmed $27,436,000

$2,067,853,054 $65,712,204 3.2%

57 DJO Global*

$1,113,627,000 $35,105,000 3.2%

58 Essilor

$7,452,073,600 $221,920,000 3.0%

58 Orthofix $26,389,000 59 NxStage Medical $26,237,000

59 JMS Co.

$457,859,000 $13,605,948 3.0%

60 CynoSure $22,343,000

60 Teleflex

61 Invacare $18,677,000

$1,809,690,000 $52,100,000 2.9%

61 Dentsply

$2,674,300,000 $74,900,000 2.8%

62 Össur $18,361,000

62 Steris

63 ICU Medical $15,714,000

$2,238,764,000 $56,664,000 2.5%

63 ConvaTec

64 RTI Surgical $15,065,000

$1,650,500,000 $41,200,000 2.5%

64 Halyard Health

$1,574,400,000 $32,300,000 2.1%

65 Invacare

66 Zimmer-Biomet $4,500,000

$1,142,338,000 $18,677,000 1.6%

66 Zimmer-Biomet

67 Merit Medical Systems $40,810

$5,997,800,000 $4,500,000 0.1%

67 Merit Medical Systems $542,149,000 $40,810 0.0%

65 JMS Co. $13,605,948

68 Amplifon $0

68 Amplifon

$1,147,300,879 $0 0.0%

Custom Automation Equipment Our engineers utilize time tested platforms and new technologies to provide you the most cost-effective solution

www.arthurgrussell.com

R&D breakout_9-16_Vs4 BP.indd 81

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COMPANIES RANKED BY EMPLOYMENT RANK

Employee Count By Color

1

1

Medtronic 92,000

2

17

Essilor 61,000

3

18

B. Braun 54,770

4

10

Stryker 27,000

5

16

Boston Scientific 25,000

6

59

Smiths Medical (Smiths Group) 23,250

7

26

Cerner 22,200

8

28

Terumo 19,934

9

21

St. Jude Medical 18,000

10

19

Zimmer-Biomet 17,500

11

25

Olympus 16,728

12

24

Smith & Nephew 15,644

13

29

Getinge 15,000

14

30

C.R. Bard 14,900

15

27

Grifols 14,737

16

38

Steris 14,000

17

48

Teleflex 12,200

18

56

Halyard Health 12,000

19

34

Dentsply 11,400

20

44

Sonova 10,697

21

49

Cooper Cos. 10,200

22

41

Paul Hartmann 10,001

23

45

Hill-Rom 10,000

24

36

Edwards Lifesciences 9,800

25

74

Greatbatch (now Integer) 9,559

26

= 3000 = 1000 = 500 = 100 = 50 = 10 =5 =1 *Excluding companies with non-medical device operations that do not break out employee count by division. 82

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OVERALL COMPANY EMPLOYEES RANK

39

BioMerieux 9,375

27

40

Coloplast 9,303

28

52

ConvaTec 9,100

29

12

Owens & Minor 8,100

30

43

Bio-Rad 7,800

31

31

Varian Medical Systems 7,300

32

54

IDEXX Labs 6,800

33

87

JMS Co. 6,777

34

42

Waters 6,600

35

63

Amplifon 6,333

36

53

Bruker 6,000

37

33

Hologic 5,290

38

65

DJO Global* 5,260

39

57

Nihon Kohden 4,776

40

64

Invacare 4,700

www.medicaldesignandoutsourcing.com

9/9/16 4:07 PM


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PHONE: 661.295.1295 Cicoil_Simplify-FullPg_ad_DW.indd Cicoil 9-16.indd 56 1

12/22/15 9/9/16 10:13 1:31 PM AM


COMPANIES RANKED BY EMPLOYMENT RANK

Employee Count By Color

= 3000 = 1000 = 500 = 100 = 50 = 10 =5 =1

OVERALL COMPANY EMPLOYEES RANK

41

80

LivaNova (formerly Sorin/Cyberonics) 4,700

42

71

Align Technology 4,375

43

51

ResMed 4,340

44

84

Merit Medical Systems 3,754

45

58

Elekta 3,600

46

97

NxStage Medical 3,600

47

82

Fisher & Paykel Healthcare 3,587

48

69

Integra Lifesciences 3,500

49

76

Straumann 3,471

50

61

Sirona Dental Systems 3,458

51

66

Fukuda Denshi 3,422

52

79

Conmed 3,400

53

67

Haemonetics 3,383

54

37

Intuitive Surgical 3,211

55

70

Cochlear 2,934

56

62

Carl Zeiss Meditec 2,888

57

85

Össur 2,525

58

95

ICU Medical 2,446

59

81

Masimo 2,400

60

88

Wright Medical 2,295

61

83

Cantel Medical 1,680

62

73

NuVasive 1,600

63

89

DexCom 1,212

64

100

RTI Surgical 1,169

65

92

Natus 1,067

66

86

Thoratec 1,048

67

91

Accuray 1,010

68

77

Acelity 1,000

69

90

Orthofix 927

70

96

CynoSure 857

71

99

Insulet 647

72

98

Abiomed 152

*Excluding companies with non-medical device operations that do not break out employee count by division. 84

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www.medicaldesignandoutsourcing.com

9/9/16 4:08 PM


© 2016 Helical Products Company | www.heli-cal.com

Helical 9-16.indd 56

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GEOGRAPHIC HEATMAP - UNITED STATES

Washington COMPANIES RANK STATE PER STATE 1 2 3 4 5 5 5 5 5 5 11 11 11 11 11 11 11 11 11

California 16 Massachusetts 9 New Jersey 6 Minnesota 4 Illinois 2

No

Montana Oregon Idaho

Indiana 2 New York 2 Ohio 2 Pennsylvania 2 Texas 2 District of Columbia 1 Florida 1 Georgia 1 Maine 1 Missouri 1 South Carolina 1 Tennessee 1 Utah 1 Virginia 1

Wyoming

Nevada Utah

Colorado

California

Arizona

New Mexico

Alaska

Hawaii

86

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www.medicaldesignandoutsourcing.com

9/9/16 4:11 PM


ado

Maine New Hampshire Vermont North Dakota Minnesota

New York Wisconsin

South Dakota

Rhode Island

Michigan Pennsylvania Iowa Illinois

Kansas

Connecticut New Jersey

Ohio

Nebraska Indiana

Missouri

Massachusetts

Delaware West Virginia

Maryland

Virginia

Kentucky North Carolina Tennessee

Oklahoma

South Carolina

Arkansas Mississippi Alabama

Georgia

Texas Louisiana Florida

www.medicaldesignandoutsourcing.com

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Medical Design & Outsourcing  87

9/9/16 4:12 PM


GEOGRAPHIC HEATMAP - GLOBAL

Iceland

United States RANK COUNTRY 1 2 3 4 5 5 7 7 9 9 9 9 9 9 9 9

88

COMPANIES PER COUNTRY

United States 57 Japan 15 Germany 6 Great Britain 4 Denmark 3 Switzerland 3 France 2 Sweden 2 Australia 1 Belgium 1 Curacao 1 Holland 1 Iceland 1 Italy 1 New Zealand 1 Spain 1

Medical Design & Outsourcing

World heatmap_9-16_Vs2 BP.indd 88

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Curacao

www.medicaldesignandoutsourcing.com

9/9/16 4:13 PM


Great Britain Holland Sweden Denmark Belgium Germany Switzerland France Italy

Japan

Spain

Australia New Zealand

www.medicaldesignandoutsourcing.com

World heatmap_9-16_Vs2 BP.indd 89

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9/9/16 4:13 PM


ONES TO WATCH

Look for these companies to make a run at the Big 100 next year – they’re the next 10 on the list.

SYNERON CANDELA


K2M GROUP HOLDINGS


ANALOGIC


SPECTRANETICS 


MERGE HEALTHCARE


VASCULAR SOLUTIONS


EXACTECH 


MIMEDX


BARCO

ALPHATEC


Revenues: $277.8 million
 Fiscal Year Ending: December 31, 2015
 R&D spend: $25.3 million
 Employees: 784



Revenues: $246.0 million
 Fiscal Year Ending: December 31, 2015
 R&D spend: $64.4m million
 Employees: 892

Revenues: $241.8 million
 Fiscal Year Ending: December 31, 2015
 R&D spend: $19.4 million
 Employees: 674

Revenues: $239.8 million* Fiscal Year Ending: December 31, 2015
 Employees: 3,298 * Revenues from Barco’s healthcare division.

90

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Ones to Watch_9-16_Vs2 BP.indd 90

9 • 2016

Revenues: $216.0 million
 Fiscal Year Ending: December 31, 2015
 R&D spend: $19.9 million
 Employees: 481

Revenues: $212.3 million
 Fiscal Year Ending: December 31, 2015
 R&D spend: $28.4 million
 Employees: 800

Revenues: $154.5 million Fiscal Year Ending: July 31, 2015
 R&D spend: $17.5 million
 Employees: 1,679


Revenues: $147.2 million Fiscal Year Ending: December 31, 2015
 R&D spend: $18.4 million
 Employees: 568

Revenues: $187.3 million Fiscal Year Ending: December 31, 2015
 R&D spend: $8.4 million
 Employees: 550

Revenues: $185.3 million Fiscal Year Ending: December 31, 2015
 R&D spend: $17.8 million
 Employees: 430


www.medicaldesignandoutsourcing.com

9/9/16 4:15 PM


CEO SHUFFLE

Who’s In & Out of the Corner Office Once again there was a lot of churn among the top ranks of the medical device world in the past year. By our count, there were nearly 70 CEO transitions alone since our last Big 100 issue – including changes at two organizations with lots of sway over the industry on Capitol Hill. At the FDA, President Barack Obama’s nominee for commissioner, Dr. Robert Califf, was confirmed by Congress to succeed Dr. Margaret Hamburg, who was later named foreign secretary of the U.S. Institute of Medicine. Also in Washington, AdvaMed CEO Steven Ubl stepped down to take the top job at PhRMA, the national pharmaceuticals lobby. Ubl, who spent 17 years at AdvaMed, was replaced by former BIO executive Scott Whitaker. Two of the industry’s largest players also saw changes at the top, with Baxter’s Robert

Parkinson Jr. retiring after 11 years at the helm and St. Jude Medical’s Daniel Starks stepping down after more than a decade as CEO. At Baxter, Parkinson was replaced by former Covidien leader Jose Almeida; St. Jude elevated COO Michael Rousseau to replace Starks. Boston Scientific co-founder and chairman Peter Nicholas also moved on, albeit a year earlier than planned as the turnaround engineered by his replacement, CEO Mike Mahoney, accelerated the timetable. Asahi Kasei, the Japanese construction and chemicals giant that paid $2.3 billion for Zoll Medical, must have liked what they saw in CEO Rick Packer, having tasked him with building the healthcare business into a “3rd pillar” for the conglomerate. Here’s a look at some of the more notable leadership changes over the last 12 months in medtech:

1

2

AcuFocus: CEO James Mazzo jumps ship for Carl Zeiss Meditec. (July 2016)

AdvaMed: CEO Steve Ubl departs for PhRMA,

replaced by BIO’s Scott Whitaker. (September 2015)

3

AngioDynamics: CEO Joseph DeVivo is replaced by James Clemmer;

Baxter: Longtime CEO Robert Parkinson Jr. retires, with exCovidien CEO Jose Almeida taking the reins. (October 2015)

DeVivo later hires on as CEO of InTouch Health. (April 2016)

www.medicaldesignandoutsourcing.com

CEO Shuffle_9-16_Vs4.indd 91

4

9 • 2016

Medical Design & Outsourcing  91

9/10/16 9:03 PM


5

6

Bayer: CEO Marijn Dekkers steps down, replaced by Werner Baumann. (February 2016)

Boston Scientific: Co-founder & chairman Peter Nicholas retires, confident in the leadership of turnaround artist & CEO Mike Mahoney (April 2016)

CEO SHUFFLE

8

9

Conformis: Founder & CEO Dr. Phillip Lang announces plans to step aside, pending the selection of his replacement. (May 2016)

Cutera: Co-founder & CEO Kevin Connors retires,

10

with Ron Santilli stepping in. (August 2016)

92

Medical Design & Outsourcing

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7

FDA: Dr. Robert Cahill is confirmed as commissioner, replacing Dr. Margaret Hamburg. (February 2016)

Cardiovascular Systems: Names Scott Ward CEO after David Martin departs to battle stomach cancer; sadly, Martin loses that fight in May. (March 2016)

11

Fresenius: CEO Ulf Mark Schneider departs for the top job at Nestle, replaced by Stephan Sturm. (July 2016)

www.medicaldesignandoutsourcing.com

9/9/16 4:18 PM


12

Getinge: Alex Myers is ousted after just 18 months, replaced on an interim basis by Joacim Lindoff. (August 2016)

15

RTI Surgical: CEO Brian Hutchison announces his retirement but stays on until a replacement can be found. (August 2016)

13

Haemonetics: CEO Brian Concannon is replaced by Chris Simon. (September 2015)

14

Profound Medical: CEO Steven Plymale moves to the COO spot, replaced by ex-Novadaq chief Arun Menawat;

Novadaq names Rick Mangat as its new chief executive. (August 2016)

16

St. Jude Medical: Retiring CEO Daniel Starks is replaced by COO Michael Rousseau. (January 2016)

Sunshine Heart: CEO David Rosa steps down, replaced on an interim basis by John Erb. (January 2016)

www.medicaldesignandoutsourcing.com

CEO Shuffle_9-16_Vs2 BP.indd 93

18

17

9 • 2016

Toshiba: A massive accounting scandal leads to the ouster of CEO Hisao Tanaka and his team;

Toshiba Medical Systems head Satoshi Tsunakawa is eventually named to replace him. (May 2016)

Medical Design & Outsourcing  93

9/9/16 4:18 PM


CEO SHUFFLE

19

Wright Medical: COO David Mowry, the former CEO of Tornier until the companies merged last year, steps down. (June 2016)

20

Zoll Medical: Asahi Kasei puts CEO Rick Packer in charge of its entire healthcare business, replaced at Zoll by president Jonathan Rennert. (March 2016)

94

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9 • 2016

9/9/16 4:18 PM


Accessibility doesn’t have to be one sided…

A two-way travel slide with full extension designed to provide access from both sides of installations.

Accuride’s Model 0363 offers a unique dual-access solution for industrial, commercial, and institutional projects. It’s a two-way, full extension travel slide designed to allow access from either sides of an installation. Now, anyone from either side of the installation can easily retrieve contents from a drawer. This product is ideal for medical carts, work stations, medical instruments, interior or exterior room access in medical or dental offices, laboratories or senior living facilities.

See how we innovate at accuride.com

AD_0363_DesignWorld_v01.indd 11 Accuride_MSHandbook9-16.indd

8/19/16 1:39 PM PM 9/9/16 1:18


MANUFACTURING & MACHINING

Taking production cost out of medical devices starts with design

Ken Gredick | Manager of Manufacturing | Tr i a n g l e M a n u f a c t u r i n g C o . |

96

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9 • 2016

Design for manufacturing (DFM) is the engineering art of designing products iso that they’re easier to manufacture. There are multiple levels of DFM, but the one that affects our company the most is design for manufacturability for CNC machining. DFM is a process in which the manufacturer communicates with the designer to establish a technical data package (print and specs) that has optimal machining geometry with specs that meet the design intent. Design for Inspection (DFI), a related discipline, involves engaging designers and quality engineers to ensure that the print portrays the proper callouts to help streamline inspection techniques. With growing quality controls in the medical industry, inspection becomes a big challenge, especially when the print is not clearly defined. An approach to DFM/DFI There are many ways to approach the DFM/DFI process. Medical device engineers put hundreds of hours into designing an assembly and are justifiably proud of their new product. Eventually, they share their hard work with a manufacturer for a quote. After the quote is accepted, placing a production order kicks off the DFM/DFI process. When the manufacturer approaches the OEM with a DFM/DFI activity, the team must know its audience. After spending hundreds of hours on a design and technical data package, most engineers believe their work is just about done, or even complete. But most of the time, that’s not the case. For starters, the prints occasionally need a significant amount of cleanup. Approaching a new customer or design engineer is one of our greatest challenges. Everyone is different. We’ve found success with the following approach: First, conduct a meeting to fully understand the assembly and function of the manufactured part or set of parts. If it’s an implant, we ask the engineers to review the risks of the implant. For example, an edge round may be a simple break-edge to the manufacturer, but for an implant, it may mean that tissue gets snagged on that sharp edge which can cause irritation to the patient. www.medicaldesignandoutsourcing.com

9/9/16 4:28 PM


Little things matter.

Like making the biggest bubble. And each step that brings you to market. We focus on the vital details. Like each requirement leading up to your product’s PMA deadline. Each requirement after. And each one in between. Because we understand how much the little things matter. Bring your critical medical devices to market – with confidence. Call (651) 633-4200.

Donatelle 9-16.indd 56

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MANUFACTURING & MACHINING

Second, information from the first meeting lets the manufacturer better understand the critical dimensions and start making a list of design details that may have to be held close. The manufacturing team also gets an idea how to work with the design engineer. A positive sign is when the design team asks for feedback regarding the drawings.

APPROACHING A NEW CUSTOMER OR DESIGN ENGINEER IS ONE OF OUR GREATEST CHALLENGES. EVERYONE IS DIFFERENT. The prints should be reviewed in light of using standard tooling. For example, pay attention to: • Fillet radii. They should be large enough so an end mill or boring bar can take a normal tool cut path. • Use standard coatings as often as possible. Validations become costly when you start moving toward custom coatings.

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• Design out costly manufacturing steps, such as die-sinking EDM. In parallel, the prints should be reviewed so that everything is dimensioned – not double-dimensioned – that data are clear and the GD&T is correct. All run-outs should be trueposition (if possible) and with the understanding of the assembly, the manufacturer should request modifiers, such as Max Material Condition (MMC) and Least Material Condition (LMC), where appropriate. When used properly, these modifiers give the manufacturer more tolerance to make the part without changing the design intent. A bolt-hole pattern provides an effective example of MMC use. If you have a plate with six dowel pins pressed in, and it is to mate with another plate with holes, a true position callout with MMC would be beneficial for the plate with holes. The larger the holes, the more true position tolerance they can have with the assembly still working. Such tools are mostly overlooked but provide great value to the manufacturer. For DFI, the manufacturer should gage the print callouts to make shopfloor inspection techniques quick and effective. Automation, such as CMM and vision systems, is great, but it’s costly and cannot be at every work center. GD&T callouts must be straightforward, and both parties should have the capability to capture this data correctly and consistently. Unless you have great working relationships with the design engineers, the manufacturer should not push the boundaries by going overboard with constructive criticism. An example would be redlining all features and wanting changes to everything, even when the print is not that good. Instead, we like to organize design details into three categories for manufacturing and inspection. The designer should be able to identify each detail either as a: 1. Must-have. 2. Needs clarification. A good example of a ‘clarification’ is when a designer 98

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puts a datum on a centerline of multiple features, not one. This leaves the datum axis open for interpretation and needs clarification. 3. Nice-to-have. It’s possible, for example, to produce a 0.003-in.-max radius described on a print. However, there are benefits on tool wear and feeds and speeds if the radius is increased to a 0.018-in. max. Start with the Must Haves for print updates. Afterward, and judging how well identifying the must-haves went, follow with clarifications. These need not be print updates. But follow up with an email summary to document the discussion. Identify the Nice-to-Haves design details only when things are going well. Most of the time, the Nice-to-Haves should be left off. In one of our most successful DFM applications, we had sufficient time and got paid for experimenting with questionable drawing callouts. We experimented with a hard coat anodize thickness to get an exact deviation in both its size and color. Soon after, this project went into production with few issues. Meetings that discuss and resolve these matters can make or break a project, sometimes even a customer. The customer can either appreciate the service, find it distracting to the project’s time constraints, or even interpret the effort as an insult. It‘s imperative to correctly judge customer reactions and act appropriately. If such discussions go wrong, the customer may want to end the business relationship. When they go right, money will be saved for both the manufacturer and designer. The payoff A few benefits to a productive design and manufacturing discussion include: Cost reductions that come from: • Reducing or eliminating expensive manufacturing techniques; • Reducing scrap because of optimized print callouts • Streamlining inspection techniques; and • Standardized tooling allows using off-the-shelf verses custom. A manufacturable design and shorter lead times. DFM/DFI meetings are excellent for team-building, an exercise that helps projects get started correctly. The key is to get involved as early as possible in the design stage. Having a good working relationship and communications with the customer always helps the process go smoother. This is how customer relationships are built to have a lasting effect on the business. M

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S S

REIMBURSEMENT

Bundled payments are the future of healthcare Other medtech sectors should pay attention to Medicare’s bundled payment mandate in orthopedics.

D r. I r a K i r s c h e n b a u m | Bronx-Lebanon Hospital |

As of April 1, the federal government mandated that all Medicare cases of primary hip and knee replacements be paid through a bundled payment program, called the Comprehensive Care Joint Replacement (CJR). This mandate evolved from a voluntary bundled payment program that was going on for a number of years, called the Bundle Payment Care Initiative (BPCI). This comprehensive plan includes any diagnosis that leads to a primary hip or a primary knee replacement. Acute-care hospitals are the only entities that are allowed to be in control of the bundle. How orthopedic bundled payments work Hospitals are given a target price, somewhere between $28,000 and $36,000, for a single primary hip and knee replacement. That range is based on data from 67 regions in the country. Every hospital in those regions was required to report the numbers, so it’s pretty accurate. Medicare sets the target price for an individual hospital based on 2/3 of its historical spend over the last 3 years, and 1/3 of the regional spend from other hospitals. (It should be noted

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that this is the equation for year one – following years will see changes.) So, let’s say Medicare might assign a particular hospital $32,000 for a primary. Then, between 3 days before the surgery and for up to 90 days post-surgery, Medicare adds up all the claims for the particular person. These activities include doctor consults, hospital admission, physical therapy, etc. If those claims are less than $32,000, the hospital can say it saved Medicare money and has the opportunity to get a “bonus payment” based on that productivity. Depending on the year in the program, they can receive 10 percent to 20 percent of that difference. Now, that cost savings often comes from cutting unnecessary or less-necessary services. It’s unlikely that the patient will know the difference. If the hospital goes over the $32,000 line, it is penalized via a “reconciliation payment,” which is also 10 percent to 20 percent. Medicare is assuming, based on a lot of data, that there’s a lot of wasteful care in the system due to lack of coordination. For example, there might be too many physical therapy sessions, or too many consults. One big waste is when a

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S S

REIMBURSEMENT MaryAnn mpdo patient could go home, but is sent to a rehab hospital instead; or perhaps they are re-admitted, but should have gone to rehab in the first place. Medicare feels that hospitals can be smarter and increase quality, so that re-admissions go down to save the system money. The savings are aggregate over a year, so if hospitals are consistently saving money, they can absorb those patients who require unanticipated extra care. In addition, individual providers and people who are not connected to the hospital can go into a risk-sharing agreement with the hospital to share in their risk and loss. It’s not required, but providers might see benefit in collaborating with an acute-care hospital.

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How will CJR affect medical device manufacturers? Let’s say someone gets admitted to the hospital for a joint replacement. Under CJR, doctors get paid for seeing the patient, and the hospital gets paid a bulk sum for the admission of joint replacement, paid under a flat-fee Diagnostic Related Group (DRG). From that, they pay the device manufacturer, their nurses, their electric bills, etc. If they used an expensive device, they still get that $32,000; if they used the device at a negotiated price, they get the same $32,000. That’s made hospitals much more cost-conscious. Device manufacturers are getting phone calls – wake-up calls, really – from hospitals, who are saying, “We’re only going to get $32,000? What if we spend too much on the extended care facility? We’ll have to save money on the joint replacement to make up.” Bundled payments have made every player – doctor, nurse, extendedcare facility, physical therapist – more cost-conscious. Device companies are seeing that exponential awareness, even though the price of a joint replacement doesn’t get attached to the spend. Medtech’s response This remarkable shift is shaking out in interesting ways. A number of companies are launching or purchasing subsidiaries to get involved with the care management part of the business; 102

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Stryker formed Stryker Performance Solutions, Zimmer Biomet formed Acceleron and Medtronic bought Responsive Orthopedics. Essentially, these companies are saying, “We are not just metal parts people.” They really want to be part of the conversation, so they’re building consultancies for joint replacement care management. And it’s a good bet that companies are also preparing for the time when bundled payments move out of orthopedics and into other sectors, such as spinal surgeries. Episodic management care companies are in high demand right now. I was involved in the development of a company called SwiftPath, which creates consensus-driven protocols and an IP platform for outpatient or enhanced recovery joint replacement. Companies like this are being looked at, not only by medical device developers, but by the acute-care hospitals. Managing the episodic care as a business is a growing segment.

Next steps Bundled payments are going to be the way healthcare business is done – that horse has left the stable. Stakeholders across the healthcare spectrum need to measure quality through outcomes over cost equations. If you improve your outcomes and keep costs low, you improve value. With the bundled payment system, Medicare is saying, “Improve your outcomes.” The next step to achieving those goals is exploring commercial bundling. There are test cases going on right now to assess how integrated all stakeholders can become. The bottom line is that it’s not a good time to be just a “metal product” company, particularly a publically traded one. You can’t just provide the device and be done. Device companies need to get themselves integrated with the continuum of care. M

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PATENT PROTECTION

Supreme Court decision raises medical device patent questions A U.S. Supreme Court decision raises questions about medical device patents with diagnostic claims.

Jed Gordon | Partner | McDermott, Will & Emery LLP |

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On June 27, 2016, the U.S. Supreme Court denied Sequenom’s petition to review a decision issued by the Federal Circuit Court of Appeals, which found Sequenom’s patents related to cell-free fetal DNA (cffDNA) testing invalid as not being directed to patent-eligible subject matter. The Federal Circuit applied the test set forth in the Supreme Court’s earlier Mayo decision1, finding that the claims at issue related to the application of “well-understood, routine, and conventional activity” to a newly discovered “natural phenomenon,” i.e., the presence of cffDNA in maternal blood. This decision raises concerns that a broad class of similar patent claims may likewise be invalid. Judge Timothy Dyk of the Federal Circuit noted in his concurrence denying an en banc rehearing that “there seems to be some truth in [the] concern” that the “whole category of diagnostic claims is at risk,” and that a “crisis of patent law and medical innovation may be upon us.” According to the test set forth in Mayo and applied in the Federal Circuit Sequenom decision, a court is first to determine whether steps of a method claim are directed to a patent-ineligible subject matter, such as a natural phenomenon, a law of nature or an abstract idea. If the claim is directed to a natural phenomenon or a law of nature, the court is then to determine whether the remaining steps in the method claim transform the claimed process into an inventive application of that law or phenomenon. Steps that recite well-

understood, routine and conventional activity previously engaged in by researchers in the field cannot be used to create an “inventive application” of the law or phenomenon. For example, claim 25 of the patent at issue in Sequenom, U.S. Patent No. 6,258,540, included the following steps: • Obtaining a non-cellular fraction of a maternal blood sample • Amplifying a paternally inherited nucleic acid form the non-cellular fraction • Performing nucleic acid analysis on the amplified nucleic acid to detect paternally inherited fetal nucleic acid The Federal Circuit found that the claims were directed to the “naturally occurring phenomenon”

THERE SEEMS TO BE SOME TRUTH IN [THE] CONCERN THAT THE WHOLE CATEGORY OF DIAGNOSTIC CLAIMS IS AT RISK AND THAT A CRISIS OF PATENT LAW AND MEDICAL INNOVATION MAY BE UPON US. of cffDNA, and therefore looked to see if the above listed method steps, i.e., fractionating maternal blood, nucleic acid amplification and nucleic acid analysis, “transform[ed] the

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natural phenomenon of cffDNA into a patentable invention.” The court found otherwise, stating that the “method steps were wellunderstood, conventional and routine” and therefore, “the method of detecting paternally inherited cffDNA is not new and useful.” As a result, the claims were found invalid. The Supreme Court’s tacit approval of the Federal Circuit’s application of the Mayo test in Sequenom raises the question of how the Mayo test may be applied to patent claims directed to new medical diagnostic devices. For example, a large number of patent claims in issued patents and pending applications are directed to devices that identify one or more medical conditions or health indicators by analyzing various bio-indicators, such as electrical signal output by EEG, EKG, oximeter and other bioelectrical sensors, or image data output by MRIs, CT scans, CAT scans, OCT or other medical imaging devices. Might a court find that a correlation between a particular bio-indicator and a given medical condition is merely a natural phenomenon? If the bioindicator is collected using standard medical devices and then processed by a general-purpose processor or other conventional microprocessor, will the diagnosis based on the detection of the bio-indicator be sufficient to “transform the natural phenomenon into a patentable invention?” Would a patent claim directed to a device dedicated to searching for the particular bio-indicator (i.e., a specialized device instead of a general purpose processor) be viewed any differently by the courts? Would reciting the specific processing function steps used to identify the bio-indicator from an underlying signal be sufficient to transform the natural phenomenon into a patentable invention? These questions remain unanswered, but will likely be tested in the coming months. M Mayo Collaborative Servs. v. Prometheus Labs, 132 S. Ct. 1289 (2012)

1

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CONNECTORS CORNER

A foolproof formula for customized connectors Four steps help design a better-thanstandard fluid coupling.

Ty l e r G r u b b | Design Engineer Medical Business Unit | CPC |

Connectors – seemingly small components – have a significant impact on medical device design, function and user satisfaction. The wide capabilities of today’s couplings make devices easier and safer to operate. For instance, they can stop flow when lines are disconnected, detect the correct placement of multiple lines and even confirm the type of media being delivered. They can also relay valuable information such as temperature and pressure. Smart couplings can track batch numbers, expiration dates, and the number of uses for limited-use devices. Custom connectors enhance the performance of a growing array of medical applications, including surgical and patient monitoring devices and invitro diagnostic tools. Custom parts meet exact performance requirements, extend a device’s functional capabilities, and differentiate products from the competition. Is a custom solution right for you? Here are four key steps to follow when working with a connector specialist to provide an ideal fluid coupling for your device: 1. Define your requirements – technical, price, and timing. Do your performance requirements extend beyond the capabilities of standard catalog parts? Do you want to reduce cost by integrating multiple components? Are your engineering resources focused on other subassemblies? If

so, tap into the extensive capabilities and experience of a connector expert. Simple custom modifications include incorporating a particular O-ring, spring or tubing material to address chemical or sterilization compatibility. Other straightforward projects include accommodating multiple fluid lines or adapting to unique tubing sizes or bottle caps. More advanced connectors might feature data lines, sensors, or radiofrequency identification (RFID). Whatever the complexity, highly qualified coupling suppliers invest significant time early in the process to understand design inputs for optimal custom outputs. For example, the manufacturer of an emergency patient-monitoring system found that rough handling in the field broke the tubing connectors on their blood pressure cuff, creating leaks that required expensive service

Hybrid connectors can consolidate multiple connections between remote tools and a device, and improve patient safety by eliminating misconnections. Such connectors allow fast, easy, simultaneous connection of multiple lines for electricity, fluids, or air. 106

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CONNECTORS CORNER

calls. The unique design of a custom coupling now protects the sealing surfaces and a locking mechanism maintains the female body’s alignment on the equipment, reducing strain and damage. The customer’s requirement to speed set-up and reduce user errors also led the coupling designer to integrate a mechanical sensor that detects the connection and automatically starts air flowing to the blood pressure cuff. One leak-free, customized solution minimized service costs, increased device quality and enabled new automated functions. In addition to understanding specific design challenges, experienced connector suppliers should ask about required flow rates, inner tubing diameters, pressure and temperature parameters, intended media, potential shutoff valves, tubing interfaces, preferred materials, compatibility factors, applicable sterilization processes

and specific packaging or labeling. More complex projects might also include electrical specifications (type and number of contacts, voltage, and current) or simultaneously managing lines for power, air, or fluid. Clarifying these design inputs up front generates the most relevant solution. Broader project details are also important. For example, sharing a firstproduction delivery date, anticipated annual volumes and the targeted per-piece cost helps define suitable manufacturing methods, such as relying on machined components or investing in new injectionmold tooling. Experienced suppliers also identify the best approach to increasing volumes as you move through verificationand-validation builds to full production. Recommendations in this phase might include machining certain components or building soft aluminum tooling, to quickly evaluate injection molded parts before

investing in multi-cavity tooling. Detailed information, such as technical specs, timelines and budgets, lets a good supplier provide two or three preliminary concepts and associated unit pricing, ideally within two to three weeks – key information at go/no-go decision time. 2. Collaborate with the right design partner to offload your engineering burden. Your engineers might be swamped with other projects or unsure about how to develop the right connector quickly and efficiently. Although industrial design or prototyping firms have their place, they’re likely not connector specialists. The most qualified suppliers for a custom job focus largely, if not exclusively, on connectors. Ask potential partners for the number of custom connectors they

Considerations for custom connectors

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Description of design challenge

• What are you trying to solve? • Where and when will component be used?

Costs and timing

• Required first production delivery date • Expected annual volumes for prototypes and years 1 to 3 • Target per-piece costs • Budget for injection mold tooling

Product

• Flow or tubing ID, pressure, temperature, connect-disconnect cycle life, media (fluid or gas), mounting configurations, termination configurations, chemical compatibility, O-ring capabilities, type and location for internal shut-off valves

Materials and handling

• Materials for the seal, connector, and internal valves • Color and finish • Clean molded and controlled environment requirements • Sterilization, packaging, and labeling requirements

Hybrid

• Number of electrical contacts and fluid lines, flow or tubing ID, voltage, current and umbilical length

RFID considerations

• Memory minimum, data security needs, reader type, communication protocol, antenna counts and mounting configurations and controller interfaces

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produce on an annual basis and their experience working in your category. Close collaboration between client and vendor engineers streamlines development and increases the likelihood of success. Some suppliers offer no-cost engineering expertise and assistance as an investment in a longterm business relationship. Comprehensive connector specialists also bundle standard and customized components, often sourcing materials for connector modifications from existing inventory. This saves money and mitigates risk by using already-tested solutions proven to perform in existing applications. 3. Prototype and test first Fast feedback is critical when evaluating new design concepts for a custom connector. CAD models, 3D-printed components and other prototyping tools let multiple departments quickly assess fit, form and function. Soft injection-mold tooling – with its short lead times and ability to produce limited quantities – is another great option for comparing injection-molded parts before diving into new tooling and mass production. A risk-based approach across the entire connector life cycle also contributes to a successful product. Supplier partners versed in ISO13485 can manage the design controls process and provide documentation indicating that the finished product meets initial requirements. Process controls – such as installation, operation and performance qualification (IQ, OQ and PQ) validations – seamlessly enter the design history file (DHF) to keep the project moving along. Performance testing and in-depth material characterization confirm that a custom connector meets its intended use. For example, a standard connector made in polypropylene will fall apart when autoclaved at 250°F for 30 minutes. However, a customized stainless steel version withstands high temperatures and a longer list of disinfectants or reagent media. To mitigate leak risks, ask supplier partners for historical data and testing recommendations used in circumstances similar to your custom job. 9 • 2016

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CONNECTORS CORNER

Simplest modifications to a connector might be adjusting o-ring materials. Complexity in the design increases with each step to the right of the chart.

4. Make it “smart” – add electronics, RFID and sensors. Do you need to track batch numbers, expiration dates and the number of uses for single- or limited-use products? Maybe it’s critically important for device users to verify secure connections, correct line attachment or appropriate media. Smart connectors offer these performance characteristics. For instance, the developer for an ocular surgery system incorporated RFID-enabled connectors into the disposable lines used between the main console and a surgical handpiece. These smart couplings convey information about individual patients, their intended surgeries and, accordingly, the appropriate device settings, contributing to patient safety and procedure speed and accuracy.

Custom work demands creativity, experience, confidence, responsiveness and a readiness to address unknowns. The best suppliers listen closely to design challenges and offer in-house engineering services, extensive modeling, prototyping and production capabilities and access to thousands of existing components expertly applied to your tailor-made solution. M

Data-transmitting fluid connectors include the coupling body (right), which houses an RFID reader, and the coupling insert (left), which incorporates an RFID tag capable of reading and conveying information. 110

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Who doesn’t love a great rescue story?

Meet Zoey. She is a rescue dog enjoying a new life with one of us at MTD.

Here at MTD Micro Molding, we love rescues. In fact,

20%

of new projects come to us as “rescues” — failed attempts by others. Our success rate? 100%.

HOW? We’re the only company to focus solely on medical micromolding. We’ve made millions of micro-medical device components and implants. We specialize in permanent and bioresorbable materials. Our technology and innovation help customers achieve new product breakthroughs. RESCUE STORY #2 A client approached MTD with their bioresorbable fastener design seeking a product with minimal inherent viscosity loss and crisper features to improve functionality. While most competitors have difficulty realizing less than a 20% IV loss, MTD developed a superior fastener with an IV loss of less than 4%. competitor vs. MTD

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MATERIALS

The “6 Sciences” of micro molding

The smallest parts often carry the greatest importance relative to the functionality and safety of a medical device. MTD Micro Molding refers to its micro molding tools – its road map to success, if you will – as the company’s “6 Sciences.” Embracing this approach can yield better long-term results, both with part functionality and speed to market and, most importantly, solve the problems faced trying to manufacture a micro component with traditional molding techniques.

1) Micro materials

Select the right materials for the application. Material selection has a direct impact on the outcome of a project – it drives tolerance, dimension, strength, usability, design, speed-to-market, critical features and cost. When working with a range of thermoplastic and bioresorbable materials, it’s important to find the most appropriate material to yield the best results for the intended application. Experienced medical micromolders have the tools to characterize several materials to determine the best material for the component application.

Brian Matachun | D i r e c t o r o f Te c h n i c a l S a l e s | MTD Micro Molding |

2) Micro part design

What micro part design is feasible? Understanding what can be created in steel versus what can be manufactured in production volume is the key to being successful. In addition to a part’s reproducibility, consider the required features:

ABOVE: MTD Micro Molding’s “6 sciences of micro molding” approach decreases potential issues faced when micromolding a part. These tiny molds hold great responsibility in a medical device design.

• Does the design have wall stocks in the range of 0.002 in. to 0.004 in.? • Does it have aspect ratios in the range of 250:1? • Is the part weight so low that 520 parts could be made from a single pellet of plastic? Each of these features can be accomplished by micromolding and are generally recognized by the industry as features that require highly specialized tools. One of the greatest myths in the medical device industry, however, is that a part needs to be microscopic to be considered a micro part – this is not the case. In many instances, microscopic features on a larger part (1 in. x 1 in. max part size) require more specialized tools and techniques than are needed to

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Design with the power of small.

The finest miniature encoders for the most demanding spaces. Renishaw offers class-leading position encoders for precision motion control the world over. With their exceedingly small dimensions and lightweight design this family of high performance sensors are ideal for applications with tight spaces and even tighter tolerances. ■

ATOM—The world’s first high precision, miniature optical encoder with filtering optics 20.5 x 12.7 x 6.7 mm RLC—PCB-level magnetic position encoder designed for high volume, low cost OEM integration

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MATERIALS

create a microscopic part with a simpler geometry. In fact, some of the most difficult parts to manufacture are larger parts with micro features. Three micro technology tools are available to optimize micro part design:

Multi-Axis Communications Just Got Simpler.

1. MicroFill – Using a spiral mold at a selected melt temperature, the material’s shear sensitivity can be determined. 2. MicroFlow – Determine realistic wall thicknesses for certain materials by running multiple injection velocities while measuring flow length. 3. MicroRunner – Determine minimum runner size required to fill the volume of your part, with the goal of sizing a runner system to adequately mold a product without unnecessarily sacrificing material. This tool is particularly important when working with expensive materials.

1 READY. Use our free SMI™ software to auto detect motors.

These technologies, coupled with extreme material conditioning control, allow conventional micro runner systems to produce 10,000 shots per pound of material. If there is a struggle to maintain consistency, the importance of controlling these factors may not be understood or practiced by the micromolder.

2 SET. Set CAN addresses and baud rate.

3) Micro tooling

A successful micromolded component starts with an exact mold – the advanced workpiece accuracy target should near 42 millionths. At MTD, workpiece accuracy is defined as what the actual molded part looks like when it comes out of the machine, not what the machine itself is designed to do. A medical device OEM and molding partner might share the same plan going in, but exact execution makes all of the difference. 3D EDM milling machines are unique pieces of tooling equipment that enable extremely detailed cavity geometry in micromolding by following a tool path similar to CNC milling. The major difference is that the end mill is actually an electrode that can be as small as 5µ – just imagine the crispness of the geometry.

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4) Micro molding

Once the mold is built, it’s important to perform installation qualification on the technologically advanced micromolding cell. It is vital to ensure that the mold is functioning properly when mounted into the press. Dependable and accurate equipment is essential when working with such small numbers. The plunger resolution of a micromolding machine can be compared to a human hair: 25% of the diameter of a human hair on position is the difference between a full shot, a short shot, or a flashed shot. With in-line inspection systems, micromolders can verify the absence or presence of details down to 0.0001 in., providing peace of mind that every part is 100% correct. Other lines of defense include process monitoring and control systems for plastic injection molding applications, which speed the visual inspection process and can tighten the window on how a cavity is packed, help sort good from bad, and predict dimensions.

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Although each micro-manufacturing cell is considered autonomous, quality assurance techniques must be depended on in micromolding, in the form of micro metrology and testing. Because of the typical part size and tight tolerances of medical micro parts, it’s important that a molder’s processes and tools focus on perfecting the measurement system early in a project. Custom measurement fixtures and non-contact, optical vision systems 114

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TOP: A shot of various micromolded parts sitting atop a dime show the complexity and precision of the micromolding process. BOTTOM: MTD’s Ultra-precision micro inserts are the result of exact tooling execution.

should be created and validated for each part. Measurement systems should be validated for inspecting all critical dimensions with a passing gauge repeatability and reproducibility (gauge R&R), ensuring that the data is valid and captured with accuracy which can be extremely challenging to accomplish with ultra-tight tolerances (i.e. +/-0.001 in.). A note about GR&Rs: The goal of a gauge R&R is not to determine if parts are within specification. It tells whether a measurement system can accurately and consistently measure your parts.

6) Micro packaging

Handling, assembling and packaging micro-sized parts is far more challenging, and the solutions far different, than for macro-sized parts. Every machine should have a custom end-of-arm tool for each molded part. That way, the critical parts are always handled and packaged with extreme care and precision and no parts are simply ejected into a bin. M

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CONTRACT MANUFACTURING

“Know Thy BOM”: Best practices for transitioning from design to production For a medical device startup, selecting a contract manufacturer for part production can be difficult, especially if a company hasn’t done its research. Developing a detailed bill of materials positions a startup to receive high-quality quotes ahead of production.

Eric Sugalski | Founder & President | Smithwise |

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Here’s the story… You’ve spent countless hours refining your design and preparing for the manufacturing phase of your new medical device. Your company built low-volume prototypes, performed bench-level testing, and believes that the next step is to obtain production quotes for the manufactured units. Through your network and some secondary research, you obtain a list of contract manufacturing organizations (CMOs) that appear to be a suitable fit for your production needs. After tracking down the appropriate contacts at these CMOs, you secure non-disclosure documentation and send over your engineering data for quote. The outreach process has already been tedious and time-consuming, and you eagerly await feedback and quotations. Unfortunately, most of the CMOs that you engage decline the opportunity. They suggest that the project “isn’t the right fit.” The few CMOs that are willing to work with you take an extremely long time to generate their quotes. And when they finally arrive, the numbers are high – much higher than you anticipated. And the proposals are laden with assumptions that limit commitment to the numbers expressed in the quote. Asked how they arrived at their numbers, the CMOs are reluctant to provide much detail. Frustrated, you continue the 9 • 2016

3D Printing is becoming a viable low volume production option in certain medical device applications.

hunt, searching for new CMOs that may provide a more favorable price. This story is likely familiar to many medical device entrepreneurs. Transitioning into manufacturing is one of the hardest parts of building a new medical device business. However, it’s also one of the most critical. Before reaching out to contract manufacturers for a new medical device, it is important to “Know Thy Bill of Materials” (BOM). A BOM is the “ingredients list” that allows a contract manufacturer to efficiently understand the number of unique components and assemblies, types of fabrication processes, materials, packaging and labeling requirements and other critical manufacturing aspects involved in making your device. There are several reasons why a design team should be investing the time needed to build a comprehensive BOM, including: 1. Procuring quotes (good ones) Many manufacturing firms choose not to do business with startups. Period. CMOs are typically designed to handle volume production, meaning the management costs of transitioning a startup company from design to manufacturing may not be justified by the longer-term business opportunity and associated risks. When dealing with any CMO,

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CONTRACT MANUFACTURING

Conducting design reviews with the CMO in advance of production transfer can smooth the process.

it’s important to share details on funding milestones you’ve achieved, prior successes for the management team and any other details that build credibility with the CMO. It’s also critical to be organized when engaging CMOs. A detailed BOM reveals the level of organization a company maintains and the amount of manufacturing pre-work that will be required. A BOM (or lack thereof) also implies the degree of “handholding” that will be required throughout the design transfer and pilot production processes. In the mind of a CMO, this handholding equates to upfront development time that will be difficult to monetize. These concerns result in no-quotes, inflated unit pricing and substantial non-recurring engineering (NRE) charges. Beginning CMO conversations with a detailed BOM will result in more – and better – quotes. 2. Gaining visibility into cost drivers Preparing a comprehensive BOM does not stop with listing components and quantities. Design teams benefit from building their supply chain from the bottom up. Seeking production quotations for each custom component and assembly on the BOM provides the visibility that the design team needs to understand the product’s cost drivers. Realizing these cost drivers lets the design team concentrate on the components and assemblies that will have the most significant impact on the cost of goods sold (COGS). Identifying cost drivers also involves engagement with specialty suppliers such as machine shops, injection molders and printed circuit board (PCB) manufacturers. Often, 118

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component suppliers are more than willing to provide feedback on the design, if they believe that they’re well-suited for the volume of production work. These feedback sessions provide insights that not only reduce production costs, but also improve component quality. 3. Reducing switching costs The intent for most companies when hiring a CMO is typically to engage in a long-term, mutually beneficial relationship. However, these relationships can sour for a number of reasons, and medical device companies sometimes need to switch. If a CMO maintains the full medical device supplier list, component-level pricing and other BOM details as a proprietary material, it makes switching to an alternative CMO extremely expensive and time-intensive. Although the investment of time required to generate a bottom-up supply chain and corresponding BOM may be unattractive, it provides a valuable insurance policy that may need to be leveraged down the road. 4. Mitigating supplier risk There may be particular components in an assembly that require specialized materials or processing. The list of suppliers that can deliver the parts and assemblies required may be a short one, representing a significant business risk for a device company. Specialized suppliers may drive pricing beyond a reasonable level for the device, or have other inefficiencies that make them undesirable for the BOM. Supplier risk is a reality for many device companies, one it’s not always possible to eliminate. It is possible, however, to gain visibility into the risk and build contingency plans to mitigate any potential issues. Supplier risk is best realized and handled when a design team controls the BOM and has direct relationships with key suppliers.

minimum order quantities (MOQs), they may take much longer to plan and coordinate production. These high-volume requirements and long lead times may not be suitable for a medtech startup. Other CMOs are horizontally integrated, meaning they’re aligned with a broad network of suppliers to handle component fabrication and critical assembly processes. Some horizontally integrated CMOs focus

The direct laser metal sintering (DLMS) process has advanced considerably in recent years, and may be a viable option for prototype and low volume production needs.

5. Understanding scale Often, the CMO that can help launch a startup’s production quickly at low volume is not the same CMO that can help scale it into significantly higher volumes. CMOs are structured differently. Some are vertically integrated, meaning they have expansive in-house capabilities. Vertically integrated CMOs may provide injection molding, PCB fabrication, machining and precision assembly under one roof. Because they are typically larger organizations with larger www.medicaldesignandoutsourcing.com

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CONTRACT MANUFACTURING

entirely on assembly, subcontracting other fabrication processes to outside groups. Horizontally integrated CMOs are typically smaller, meaning the medical device startup works directly with CMO executives through the manufacturing planning phase. They often move quickly, but their capital (think tooling), unit and project management costs are likely to be higher, due to mark ups and amortization of setup time over a small number of units. Often a medical device startup will begin manufacturing with a horizontally integrated CMO to get production started quickly, then switch to a larger, vertically integrated partner as sales increase and cost reduction takes priority. The details of the BOM, such as component and assembly pricing levels at different volumes, help a medical device team understand when it may outgrow a CMO and need to plan for expansion.

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The points above needn’t mean that medical device startups should take a defensive position when working with CMOs and other vendors. Although a company needs to be focused and protective of its own interests, an environment that breeds mistrust and one-sided financial gain is counterproductive. CMOs are an integral part of bringing medical devices to market and offer much more than simply the assembly of components. CMOs provide valuable input through the design for manufacturing and assembly (DFMA) phase, to ensure that the product meets best practices. They also provide critical elements of a company’s quality management system (QMS). And CMOs serve as valuable conduits for commercial networking, since they are often engaged with large companies and medical product distributors. So, although a medical device company needs to limit their supplier risks and ensure that it has sufficient knowledge to improve its products, engagement with a CMO or any other key vendor should be viewed as a mutually beneficial partnership. While developing a comprehensive BOM may not be the most exciting part of product development, it’s certainly one of the most critical. A well-assembled BOM will communicate to CMOs that a company has done its homework and has a strong handle on the manufacturing requirements, which in turn will affect the responsiveness and pricing of CMOs. Additionally, a well-documented BOM will provide valuable insight to guide cost engineering, reduce future switching costs, mitigate supplier risks and understand how a medical device scales. “Know Thy BOM” for success in medical device manufacturing. M

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ENGINEERING 911

NPI/Medical Technical Advisor Tim Erwin inspects parts from a prototype mold.

A few Ideas for improving supply chains

Randy Ahlm | CEO | NPI/Medical |

Improving profits is every company’s goal; reducing costs is every company’s challenge. The improving profits part is almost easier: Introduce new products and expand operations into global markets. The drawback is that newer and longer supply chains produce upward cost pressures. Improving a supply chain can provide relief from those pressures. One strategy is to shorten the supply chain by minimizing suppliers. The consolidation part is made easier when a supplier stands out by exceeding expectations and delivering on time, whether the product is shipped to forecast, or shipped on a demand-driven basis without anticipated timelines. Improving a supply chain requires finding suppliers with the capability to produce parts and procure others, and then assemble, decorate, and package assemblies for delivery. Validation for this statement comes from a senior-level procurement supplier at a top-10 medical device OEM. He recently remarked that his company no longer wants “a bunch of parts” shipped to them. His company wants assemblies and finished products. The pressure of cost Hospitals – big medical device customers – provide perspective on cost pressures. Costs have forced hospitals to take a hard look at their procurement and inventory processes. Changes in internal hospital operations have had significant financial and operational impacts on medical device manufacturers. A hospital’s frequent response to costs is to drive them down within their supply chains. This has been achieved by streamlining inventory management and fulfillment, consolidating bills of material and minimizing total operating expenses such as transportation, inventory and manufacturing. While production and assembly dominate most cost-cutting discussions, inventory plays a significant role in what some call “supplychain optimization.” The market is looking for suppliers that can forecast inventory and cut costs in product distribution. Both the manufacturer and end-use customer benefit from inventory storage because it can be

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ENGINEERING 911

considered a return on investment in future sales. A well-designed supply chain can significantly improve margins for customers, support an expansion into new markets, enhance customer experience and reduce operating costs. The following case studies illustrate how several supply chains were improved through strategic efforts. The value of the single-source supplier A major supplier of laboratory products and services for the life sciences industry was experiencing problems with a molder of silicone diagnostic disposables for DNA sequencing frames. The project was behind schedule and the existing supplier was having trouble making parts that met print specifications. In addition, the company was dealing with six suppliers, all of which had various limitations, such as a lack of warehouse space, lack of suitable assembly skills and limited in-house molding. The solution seemed to be the

shortest supply chain possible: One supplier. Today our company serves that function by producing about 60% of required parts and purchasing the rest. Our experience entails progressing from prototyping parts to more complete assemblies. The life sciences company gets full-scale production, including molding other parts, procuring filters, tubes and other components, assembling, labeling, packaging, kitting and, finally, shipping to the company’s distribution centers. The value of on-time deliveries Another example of supply chain improvement comes from a company with a facility in the Dominican Republic. The site's location made shipping timeconsuming and expensive. Its on-time deliveries were suffering, which caused inefficiency, downtime and increased inventory costs to follow-on operations. Several solutions were examined to correct these issues and fortunately one was discovered nearby. The recommended solution was based on past successful experiences with Vendor Managed Inventory (VMI), a logistics concept. The nearby facility had the capability to meet all of the client’s needs, so we entered a relationship with them to serve as a third-party logistics provider. NPI/Medical presented the VMI firm as a solution to the customer. The client liked the idea, so we mapped the specific processes that would speed deliveries and helped write a guide manual for executing operations on the client’s behalf. The logistics solution to late shipments was a monthly shipment, including multiple parts from multiple vendors, packed at the same time. Thus, transit time was reduced although inventory continually ebbed and flowed. This satellite warehouse made inventory predictable. Using a min/max system, we were able to carefully monitor inventory levels and strategically ship when needed. As a result, downtime was eliminated and inventory costs were significantly 122 Medical Design & Outsourcing

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reduced. This process has been successfully used for about six years. The value of prototypes to production A final example of supply-chain improvement came from a major OEM preparing for a new product launch. Rather than deal with several suppliers, the OEM consolidated to a single partner with prototyping, tooling and full assembly capabilities. The consolidation took several steps. For instance, pad printing and

molding was brought in-house. Inventory was made to order rather than housed elsewhere. Assemblies were produced in a cleanroom and quality service for lot traceability was also enhanced. The end result was a prototype-toproduction-to-distribution operation, with fully assembled, end-user-ready products shipped directly to customers on short notice. Although about 1,000 assemblies are shipped monthly, production can be boosted to 250 assemblies daily. Meeting the challenges of supply chain optimization is best done by working with a supplier that can take a new product seamlessly from design to manufacture, while distributing products to their final destinations in the fastest, most cost-effective manner possible. This method calls for dedicated commitment and a continuous, end-to-end relationship on the part of both customer and supplier. M Clean room assemblies and packaging are performed soon after production. A single source supplier provides this service and others.

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REGULATORY

Adaptive design for clinical trials can improve speed to market

Vicki Anastasi | ICON plc |

There are increasing pressures on manufacturers to reduce the time, duration and cost of clinical trials. Those pressures are both internal – coming from within the manufacturers themselves – and external, from the healthcare industry, patient advocacy groups and regulators. Some experts believe that adaptive design is a necessary tool to deliver on those mandates. Adaptive design gives investigators the opportunity to anticipate outcomes that could lead to failure, identify regrettable design parameters and pre-plan protocol modifications. If trial designers can pre-plan and look ahead to outcomes, it could mitigate barriers to market. What is adaptive design? As defined by the FDA, an adaptive design for a medical device clinical study is a trial design that allows for prospectively planned modifications, based on accumulated study data, without undermining the study’s integrity and validity. It’s important to understand that adaptive design is not new and has been used successfully for many years in other industries. The focus on adaptive design for the medical device space comes in response to the intense pressures to cut costs, accelerate cycle times and bring more products to market. Adaptive design’s greatest utility comes not with just a single trial – although it can be used in one trial – but in trials for a portfolio of products. Companies that engage in adaptive design for clinical trials for a series of products reduce risk, accelerate cycle times to market and leverage limited financial resources. Budgets are a big part of all of our conversations today.

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Regulatory guidance In light of the benefits, regulators are surprised that adaptive designs are underutilized by industry. In July, the FDA issued guidance, “Adaptive Designs for Medical Device Clinical Studies,” to help industry plan and implement adaptive designs in clinical trials.1 The FDA and other global regulatory bodies are actively encouraging device manufacturers to look at efficiency models in their clinical evidence collection. FDA’s issued guidance documents encourage incorporating adaptive designs into our studies; it’s worth noting that the Center for Devices & Radiological Health has accepted more than 100 studies that use adaptive design. The agency says that almost all trials can benefit from the process. The FDA’s guidance should facilitate the adoption of adaptive design. Working groups and regulators are already seeing a difference. The guidance provides an overview of how to incorporate adaptive design into an FDA submission, saying it confers a benefit on manufacturers – and, of course, on patients – because it offers an opportunity to get products to market faster. Adding adaptive design Adaptive designs are not simple to understand: You need the right expertise, statistical software and experienced statisticians; you need the right data capture systems and infrastructure. There are a lot of boxes to check. But companies shouldn’t feel they have to do it on their own. The quickest way to address a lack of infrastructure is to partner with a CRO that has run adaptive trials for device companies. There are statisticians who have worked in this space for decades. There are resources available prior to building infrastructure or adaptive teams.

www.medicaldesignandoutsourcing.com

9/9/16 5:23 PM


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Best practices There are a few things that medical device companies should keep in mind: 1. Familiarize yourself with adaptive design and determine if it’s appropriate for your study. 2. Partner with organizations and groups that have the knowledge and the expertise in adaptive design. 3. Start early. The whole point of being able to adapt is that it’s planned. The process requires valid, statistical methodology. You have to plan very early to incorporate adaptive elements into trial design. 4. Work with strategists who have validated software that’s accepted by the regulatory bodies. This can help ease the conversation by ensuring everyone is approaching the nomenclature and statistical algorithms from the same platform.

IN LIGHT OF THE BENEFITS, REGULATORS ARE SURPRISED THAT ADAPTIVE DESIGNS ARE UNDERUTILIZED BY INDUSTRY.

Adaptive design is a way of looking ahead and understanding, using a valid statistical approach, where trial designers may need to adapt in order to reach the end goal. That end goal includes reaching valid end points and providing data to regulators to move the product to market. Adaptive design offers a way for device companies to plan for changes of direction in device trials. As device companies start using it more we will see more products that have reached the market at an accelerated entry due to incorporation of adaptive design. M http://www.fda.gov/ucm/groups/fdagovpublic/@fdagov-meddev-gen/documents/ document/ucm446729.pdf

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9/10/16 7:08 PM


THE CATH LAB

Robot in the cath lab takes surgeons out of radiation’s way

Paul Dvorak | Founding Editor | Medical Design & Outsourcing |

The CorPath Vascular Robotic system takes the surgeon out of the radiation field and heavy lead gear to work more comfortably.

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A recently devised robotic system aimed at cath-lab interventions reduces the radiation exposure of surgeons by 95 percent while still allowing precise sub-millimeter measurement and 1mm advancement accuracy. Physicians who have used the equipment say that by optimizing stent selection and positioning, the CorPath Vascular Robotic System lets them position the right stent in the right place. The system consists of a bedside unit and an interventional cockpit. Developer Corindus Vascular Robotics says the radiation-shielded cockpit features a control console with simple-to-use controls for the precise positioning of guidewires, balloons and stent catheters. Using joysticks and touchscreen controls, a surgeon can measure anatomy length to select an appropriate stent. The bedside unit is the “engine” of the system, translating commands into precise movements and manipulations of the coronary stents and guidewires. Working in a cath lab comes with serious occupational hazards. As percutaneous coronary intervention (PCI) procedures become more complex and longer, radiation exposure and time spent in heavy leaded gear increases. Occupational exposure to low-dose ionizing radiation has been shown to have many health consequences for interventional cardiologists, who receive the highest amounts of radiation of any medical professional. In fact, the safety concerns that plague interventionists include brain tumors, orthopedic injuries and cataracts. An interventional cardiologist loads the single use cassette and later manually introduces the guiding catheter into the coronaries. At that time, the physician can remove their lead covers and sit behind the Interventional Cockpit to perform the remainder of their procedure driving their guidewires, balloons, and stents using the system’s Control Console.

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THE CATH LAB

NOW, ROBOTIC THERAPY IS DEVELOPING A NEW STANDARD OF CARE AND TRANSFORMING HOW PHYSICIANS APPROACH THEIR PROCEDURES.

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Although there have been significant advances in the devices used during PCI, the procedure itself has remained relatively unchanged until recently. “Robotic therapy is now developing a new standard of care, transforming how physicians approach their procedures,” says Corindus Vascular president & CEO Mark Toland. Over a career, an interventionist receives about 1,000 mSv (Sievert is a unit of ionizing radiation) exposure to the head, equivalent to 50,000 chest X-rays. Increased exposure to radiation may cause incidents of cancer, specifically brain tumors. One study of self-reported brain tumors in interventionists showed that 86 percent of the tumors were left-brain – the side of the head most often exposed to radiation during procedures.

There’s also the risk of orthopedic injuries from wearing the heavy, leaded equipment used to block radiation (interventionists practicing over 21 years suffer a 60 percent incidence of spine issues) and cataracts, another effect of radiation exposure in interventionists. In a RELID study (Retrospective Evaluation of Lens Injuries and Dose), 50 percent of interventional cardiologists had posterior subcapsular lens changes (precursors to cataracts) caused by radiation exposure, versus less than 10 percent in the control group. Corindus developed the CorPath system to bring robotic assistance to interventional cardiology and create a safer work environment for cathlab teams. One trial (Percutaneous Robotically-Enhanced Coronary

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The system consists of an Interventional Cockpit, Bedside Unit, and Imaging Kit customized to each cath lab. CorPath is compatible with all imaging vendors (GE, Philips, and others) and all standard 0.014-in. guidewires and rapid exchange balloon-stent catheters.

Intervention Study) showed a 95.2 percent reduction in radiation exposure for the primary operator, 98.8 percent device success and 97.6 percent clinical success with no device-related complications. What’s more, the trial saw a 9 percent reduction in stent use as compared to historical data. Surgeons using the CorPath system perform procedures seated comfortably, without the heavy lead aprons. Three high-resolution monitors provide a sharp view of the procedure from the interventional cockpit. Corindus recently worked with Massachusetts General Hospital to launch a robot-assisted coronary intervention program with the hospital’s first CorPath System. Mass. General reports successful adoption of the program in just the first few months. “We continue to build the depth of clinical research on robotics to highlight its value. The system is cleared for use in radial access procedures and radial access has been shown to have benefits for patients,” adds Toland. M

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FDA NEW PRODUCTS

The U.S. Food & Drug Administration’s list of original approvals granted in July 2016 SUBMISSION NUMBER

130

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P150006 7/20/16 PMAO- CELT VASORUM PMA Origi ACD LTD VASCULAR CLOSURE DEVICE

Approval for the Celt ACD Vascular Closure Device. This device is indicated for the percutaneous closure ofcommon femoral artery puncture sites while reducing time-to-hemostasis in patients who have undergone diagnostic or interventional intra-arterial catheterization procedures where either 5F or 6F introducer sheaths have been used.

P150017 7/1/16 PMAO- CARTIVA CARTIVA, PMA Origi SYNTHETIC INC CARTILAGE IMPLANT

Approval for use in the treatment of patients with painful degenerative or post-traumatic arthritis (hallux limitus or hallux rigidus) in the first metatarsophalangeal joint with or without the presence of mild hallux valgus.

P150023 7/5/16 PMAO- ABSORB ABBOTT PMA Origi GT1 VASCULAR BIORESOR- INC. BABLE VASCULAR SCAFFOLD (BVS) SYSTEM

Approval for the ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) System. This device is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions >=2.5 mm to <=3.75 mm in diameter in lesions <=24 mm in length.

P150037 7/29/16 PMAO- CYPASS ALCON PMA Origi MICRO- RESEARCH STENT

Approval for the CyPass¨ System, Model 241-S. This device is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma (POAG).

P150038 7/11/16 PMAO- EXABLATE INSIGHTEC PMA Origi

Approval for the ExAblate Model 4000 Type 1.0 System (ExAblate Neuro). This device is indicated for use in the unilateral Thalamotomy treatment of idiopathic Essential Tremor patients with medication-refractory tremor. Patients must be at least age 22. The designated area in the brain responsible for the movement disorder symptoms (ventralis intermedius) must be identified and accessible for targeted thermal ablation by the ExAblate device.

P160004 7/27/16 PMAO- GORE W. L. PMA Origi TIGRIS GORE & VASCULAR ASSOCIATES, STENT INC.

Approval for the GORE TIGRIS Vascular Stent. This device is intended to improve luminal diameter in patients with symptomatic de-novo or restenotic lesions or occlusions in the native superficial femoral artery (SFA) and proximal popliteal artery (PPA) with reference vessel diameters ranging from 4.06.5 mm and lesion lengths up to 240 mm.

Medical Design & Outsourcing

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Leveraging the Flexibility of Innovative Commercialization The U.S. healthcare system is complex and ever changing, with an increased demand for improved outcomes. This commercial pressure is driving the need for an increased speed to market. Bringing a new, complex product to market in a highly regulated industry poses unique challenges. Although today’s medical device sales are dominated by developed markets, emerging markets represent much faster growth opportunities with growth rates two to five times those of developed markets. * Overcoming obstacles and accelerating industry imperative to get products to market faster and smarter takes flexibility based on the current dynamic marketplace. It is critical to have a flawless execution of a commercialization plan with the right mix of pre-planning and deployment to improve outcomes. Fortunately, many challenges can be averted and their impacts diminished. Strategies from territory planning, launch, marketing development to validating a commercialization plan prior to full scale deployment are just a few steps necessary for flawless execution.

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DEVICE TALKS

DeviceTalks: Changing Smiths Medical’s culture from the inside out   JEFF MCCAULLEY: Well, I certainly think it rings true. I think we’ve all seen great strategies fail, and I think, often times, it comes down to the culture. Because, let’s face it, we’re all typically very excited about our strategies and believe in our strategies, but often we’re less than enamored with the outcome. I think that rings true in most surveys, that most executives today feel that execution is one of the hardest things to drive. My sense is that really comes down to the culture.   JOHNSON: When you arrived at Smiths Medical, did you have in mind a particular culture you wanted to replicate?

Jeffery McCaulley came to Smiths Medical with the job of turning a flagging medical device franchise around after years of negative growth. Getting rid of the wood paneling was another story. McCaulley, a 25-year medtech veteran, held executive positions at Zimmer and Medtronic. But nothing taught him more about culture than his time at GE Healthcare. Like so many colleagues in the industry, McCaulley started his career at the corporate juggernaut, serving under now-CEO Jeff Immelt. In this interview, McCaulley talked with Medical Design & Outsourcing Publisher Brian Johnson about why he thinks corporate culture is so important and what he did to change Smiths Medical’s (including a down-to-the-studs rebuild of the company’s Minnesota HQ).   BRIAN JOHNSON: There’s a saying that “culture eats strategy for breakfast?” Is that true? 132

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  MCCAULLEY: I came to Smiths about two years ago, and through the recruiting process I was given two mandates: To reengage people and to reignite growth. The company had been flat or declining for just about five years, so I knew that I had to focus on people and understanding why growth had stalled in a company that really has great brands and a solid portfolio. There were a couple of approaches to buy the business, so there was a lot of disruption within the culture. I knew coming in that in order to reengage people, we’d need to focus a lot on the culture. I didn’t necessarily have a specific vision. So, I really spent my first three months just engaging people and listening. I was fortunate that when I came in we had just completed an employee engagement survey, so I had a lot of rich data to engage the organization around. Then we just held a lot of town halls, and really heard clear messages about why people were frustrated, what they thought was working and not working. A lot of it had to do with leadership visibility, access and communication. A lot of it had to do with empowerment. A lot of it had to do with priorities, or the lack of clear priorities, and so we really set out to tackle those things in helping the culture to thrive, and helping people to feel they could be successful and execute according to the strategic plan.

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9/9/16 5:32 PM


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DEVICE TALKS

  JOHNSON: I take it there’s a lot more involved than just taking survey, and then maybe putting in a new coffee machine?   MCCAULLEY: There are a lot of ways that people can react to these employee engagement surveys. We wanted to take it very seriously and we were very direct with employees that we took it seriously, and that we were listening, and that they were going to see us take specific action. We created a list of the things that employees told us were most challenging in the culture and we created very specific responses to those things. We did it in the context of a broader initiative that we called “Building Our Future,” which was really about building the company that everyone dreamed Smiths Medical could be.   JOHNSON: You started your career at GE, as many medical device CEOs have, under Jeff Immelt. What was it about that culture that created so many executives who went on to head companies?   MCCAULLEY: When I see a number of those [former GE employees], we talk about it a lot. It was just a really special time. I think it was a neat time within the industry and a special time within GE. The leadership was really strong. There were great role models, and great mentors to learn business and leadership from, and how to

organization could accomplish great things, and ultimately would accomplish great things. Wherever you were in the company, you owned your little piece of the enterprise. When I started, I had a very little piece of the enterprise, but you believed it was yours and you had the ability to do great things with it. If you did you’d get more, and you’d get a chance to grow. I think that was just so pervasive within the culture.   JOHNSON: I know one of the things you’re really proud of is that you revamped the entire corporate headquarters at Smiths Medical. That was a pretty ambitious undertaking. How are these values reflected when you build a new headquarters?   MCCAULLEY: I think this is probably the most visible example of changing the culture and becoming a new company. The facility very old. There was clear separation between the executives and everyone else. It was a hard place to collaborate in, because of the design, and we really wanted to move to a culture where it was much more engaging, where there were a lot more interactions throughout the day, where there was more collaboration,

LET’S FACE IT, WE’RE ALL TYPICALLY VERY EXCITED ABOUT OUR STRATEGIES AND BELIEVE IN OUR STRATEGIES, BUT OFTEN TIMES WE’RE LESS THAN ENAMORED WITH THE OUTCOME. operationalize the business. There was incredible alignment at the top, which I think was one of the most impressive aspects of GE. There was just an incredible commitment to developing people, but I think the most important thing was there was just this winning spirit about GE. You hear people talk about culture as this idea of the beliefs and mindsets that really drive people’s behaviors. There was just a belief within GE that anything was possible, that the 134

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more empowerment, and just more of a winning spirit. We really set out to create a new facility that I like to say is more like high tech than medtech – more like what you would see at Google or AT&T. In fact, we actually spent a lot of time with AT&T and their “Workspace of the Future” initiative. They’ve spent a lot of time studying how technology teams work best together,

www.medicaldesignandoutsourcing.com

9/9/16 5:33 PM


so we learned a lot from what they had done over the years and implemented a lot of that in our new facility. It’s a huge difference. We got rid of most offices. There are many, many fewer offices. All offices are very small, 10 ft. by 12 ft., 10 ft. by 14 ft. The building is predominantly collaboration space and meeting space of all different varieties, so that you give people different meeting venues and extensive use of technology. It really feels like a different company when you walk in the door today, and there’s just a different buzz within the culture. It’s had a dramatic impact on the business.   JOHNSON: What was the downgrade from the old chief executive office to the new one, in terms of square footage? MCCAULLEY: It’s probably a third of the size.

YOU HEAR PEOPLE TALK ABOUT CULTURE AS THIS IDEA OF THE BELIEFS AND MINDSETS THAT REALLY DRIVE PEOPLE’S BEHAVIORS. Read the full interview online!

  JOHNSON: Did it have wood paneling?

devicetalks.com

  MCCAULLEY: It did. It was actually an old pharma building at one point, so it had some very old designs and some legacy aspects to it. M

WE'RE BACK FOR ANOTHER SEASON OF INSIGHT FROM MEDTECH'S BRIGHTEST MINDS!

Behind the scenes. Ahead of the curve. Inside the corner office.

Medical Design & OUTSOURCING

DeviceTalks, the live interview series from MassDevice, returns in 2016 for another season of insight from the brightest leaders in medtech.

 Learn more about our events and stay tuned for more announcements on the rest of our 2016 season.

ORANGE COUNTY

Engaged B E C O M E

DECEMBER 12, 2016 VISIT US | LIKE US | TWEET US | CONNECT WITH US

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136

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LEADERSHIP TEAM Tom Lazar tlazar@wtwhmedia.com 408.701.7944 @wtwh_Tom Courtney Seel cseel@wtwhmedia.com 440.523.1685 @wtwh_CSeel Neel Gleason ngleason@wtwhmedia.com 312.882.9867 @wtwh_ngleason Jessica East jeast@wtwhmedia.com 330.319.1253 @wtwh_MsMedia

9 • 2016

Mary Ann Cooke mcooke@wtwhmedia.com 781.710.4659 Mike Francesconi mfrancesconi@wtwhmedia.com 630.488.9029 Michelle Flando mflando@wtwhmedia.com 440.670.4772 @mflando

Publisher Brian Johnson bjohnson@wtwhmedia.com 617.905.6116 Managing Director Scott McCafferty smccafferty@wtwhmedia.com 310.279.3844 @SMMcCafferty

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VP of Sales Mike Emich memich@wtwhmedia.com 508.446.1823 @wtwh_memich EVP Marshall Matheson mmatheson@wtwhmedia.com 805.895.3609 @mmatheson

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Medical Design & Outsourcing - SEPTEMBER 2016  

THE BIG 100 ISSUE: Medtech's 100 Largest Players

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