Medical Design & Outsourcing; BIG 100; September 2015

EXCLUSIVE: Inside the Boston Scientific turnaround with CEO Mike Mahoney www.medicaldesignandoutsourcing.com SEPTEMBER 2015

Medical Design & OUTSOURCING

BIG1OO M E D T E C H ' S 1 0 0 L A R G E S T P L AY E R S

• The Top Medical Device Employers • R&D: Who's Spending the Most?

• The Year Medtech M&A Exploded • CEO Moves: Who's In & Out of the Corner Office • Medtech's Global Hotspots • Ones to Watch: Medtech's Up-and-Comers

Cover_SEPTEMBER 2015_Vs7.indd 1

9/15/15 2:45 PM

Some people think there’s an art to stripping wire with a razor blade.

At Resonetics, we prefer to treat it as a science.

Whether you need to remove 100% of a polymer coating to expose metal or only want to remove one layer of a multi-layered coating, Resonetics has the solution. Using laser workstations equipped with our patented ASSURE End Point Detection™ technology, we can compensate for changes in coating thicknesses and concentricity to produce consistent results, in reel-to-cut or reel-to-reel formats.

We mastered the science of polymer removal and combined it with reel-to-reel processing, improving yields and lowering costs so you can automate your downstream manufacturing processes safely and efficiently.

IDEAL WIRE Symmetric layers of uniform thickness

REAL-LIFE WIRE With non-uniform layers REAL-LIFE WIRE Stripped by an open-loop laser ablation REAL-LIFE WIRE Stripped using our patented closed-loop end-point detection method

Learn more at www.resonetics.com/assure or call 603.886.6772.

Copyright © 2015 Resonetics. All rights reserved.

RESO_MPO_outsource_04.29.15.indd 1 Resonetics 6-15.indd 56

5/19/15 9/15/15 2:41 2:53 PM PM

BIMBA MEDICAL

FLUID MANAGEMENT

MECHANICAL MOTION LAB AUTOMATION STERILIZATION CLEAN ROOM DOSING

FLUID AND MOTION CONTROL COMPONENTS

TO BRING YOUR DEVICE TO LIFE. From the operating room to the manufacturing floor, Bimba offers a variety of pneumatic, electric and hydraulic solutions to help you tackle your medical device applications. Whether you are designing a new system or improving an existing one, learn more about how our investment in medical device components can support your medical device needs at bimba.com/medical

PINCH VALVES Designed for disposable tubing to maintain sterility, each pinch valve is calibrated for pinch force, pinch gap and stroke to ensure optimal performance.

STANDARD AND CUSTOM MANIFOLDS

SOLENOID OPERATED VALVES

Multiple connection manifolds provide a convenient junction point for the distribution of fluids or gases.

Single or double solenoid operations internally piloted for high flow and lower power consumption.

FITTINGS Corrosion resistant stainless steel barbed and pushto-connect style fittings available in a wide variety of shapes and sizes for virtually any application.

Š Copyright 2015 Bimba Manufacturing Company. All Rights Reserved. ISO 13485 Certified.

BIM-2488 Bimba Resizes_2015_MDO_New 2015 Medical Ad_090115.indd 1 Bimba 9-15.indd 15

8/26/15 2:53 1:52 PM PM 9/15/15

HERE’S WHAT WE SEE

The Year Medtech M&A Exploded

Welcome back to the Big 100, our annual look at the largest players in medical devices. Once again we’ve scoured the financial filings and annual reports of hundreds of companies dating back to the start of 2014.

The medtech landscape has changed significantly in the two years since our last edition of the Big 100, as mergers & acquisitions exploded.

Some of the industry’s biggest names are off the table after a surge in megasized deals, and the activity extended on down the food chain to even the smallest players.

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

2

Medical Design & Outsourcing

Editorial Sept 2015_Vs4.indd 2

9 • 2015

| | | |

Inside you’ll find information on the world’s leading medical technology companies, ranked according to annual revenues. We also took a look at spending on research and development, the top employers in medtech, and an exciting roster of up-and-comers you’ll want to keep a close eye on.

The Big 100 also includes a look at notable moves in the corner office, as once again there was considerable churn. And be sure to check out our look at medtech’s hotspots.

Some notes on how we put this report together: For the Big 100 rankings, we looked at either calendar 2014 or the company’s most recently concluded fiscal year.

We gleaned our information from our internal archives; corporate documents and public regulatory filings; and information from the companies’ websites.

To account for the diversified conglomerates that play in the medtech space, such as Johnson & Johnson, we did our best to isolate the revenues from their medical technology segments (e.g., J&J’s medical device & diagnostics business).

For companies based outside the U.S. that report their numbers in other currencies, we used the 2014 exchange rates established by the U.S. Federal Reserve to convert the figures into U.S. dollars.

And finally, a pair of companies that would normally have made the list – Toshiba and Hanger Orthopedics – were left out because, as of press time, they had yet to file their annual reports for their most recent fiscal years. M

www.medicaldesignandoutsourcing.com

9/17/15 4:21 PM

INNOVATING TOGETHER Freudenberg Medical, formerly Helix Medical and MedVenture Technology, brings 30 years of creativity and innovation to medical OEM customers all over the world. With 220 engineers and the resources to stay at the forefront of materials and processing technology, we offer our customers comprehensive

capabilities in 11 medtech locations worldwide. As your global partner for the design, development and manufacture of specialty components, minimally invasive solutions, and finished devices − let’s innovate together.

www.freudenbergmedical.com

Fruedenberg 9-15.indd 15

9/15/15 3:30 PM

Medical Design & OUTSOURCING E D I T O R I A L EDITORIAL

NEW MEDIA/WEB/ BUSINESS DEVELOPMENT

MARKETING

Founding Editor Paul Dvorak pdvorak@wtwhmedia.com @paulonmedical

Web Development Manager B. David Miyares dmiyares@wtwhmedia.com @wtwh_webdave

Marketing Manager Stacy Combest scombest@wtwhmedia.com @wtwh_stacy

Executive Editor Brad Perriello bperriello@wtwhmedia.com

Web Development Specialist Patrick Amigo pamigo@wtwhmedia.com @amigo_patrick

Marketing Coordinator Carli Evilsizer cevilsizer@wtwhmedia.com @wtwh_carli

Integrated Media Specialist John Hansel jhansel@wtwhmedia.com @wtwh_jhansel

Marketing & Event Coordinator Nicole Loepp nloepp@wtwhmedia.com @wtwh_nicole

Managing Editor Nic Abraham nabraham@wtwhmedia.com @WPE_Nic

I need a functional seal for a PCR tube with a ventilation channel in medical grade PVC and it must be produced in a clean room.

The parts you need. The risk you don’t. Caplugs engineers work with you to design a solution and ensure all your specs are met. Our comprehensive ISO quality management system offers the traceability, record retention and strict process controls needed to support your audit requirements.

S T A F F

Publisher Brian Johnson bjohnson@wtwhmedia.com 617.905.6116

Director, Creative Services Mark Rook mrook@wtwhmedia.com @wtwh_graphics Visual Design Manager Matthew Claney mclaney@wtwhmedia.com @wtwh_designer Graphic Designer Margaret Schneider mschneider@wtwhmedia.com @wtwh_meg

Traffic Manager Mary Heideloff mheideloff@wtwhmedia.com

Video Coordinator Joshua Jones jjones@wtwhmedia.com @wtwh_josh

Business Development Manager Patrick Curran pcurran@wtwhmedia.com @wtwhseopatrick

Marketing & Event Coordinator Jen Kolasky jkolasky@wtwhmedia.com @wtwh_jen Marketing Coordinator Lexi Korsok lkorsok@wtwhmedia.com @wtwh_lexi

Online Coordinator Jennifer Calhoon jcalhoon@wtwhmedia.com @wtwh_jennifer

Director, Audience Development Bruce Sprague bsprague@wtwhmedia.com

CONNECT WITH US! Follow the whole team on twitter @WTWH_Medical

For more than 65 years, Caplugs has been the ideal choice for medical device protection and molded components. Twenty-five of the top 30 medical device manufacturers trust us with their critical projects.

In te rp he B M oo x P D& th ue Bo M P #2 rto ot hil 12 R h ad ic #4 e o, l 26 ph ia , Staff page_MDO_9-15_Vs3.indd 4

Crain’s Cleveland Business Fast 50 2014

2011, 2012, 2013, 2014

www.caplugs.com/medical • 1.888.CAPLUGS

2014 Winner

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©2015 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.

4

Medical Design & Outsourcing

9 • 2015

9/17/15 12:33 PM

840-11201 THK Medical Ad(DW)

6/15/11

4:35 PM

Page 1

CRITICAL MEDICAL

APPLICATIONS REQUIRE

THK QUALITY

D N A

L M

A N A LY Z E R S

G U I D E S

S C A N N E R S

B A L L

X - R A Y

S C R E W S

E Q U I P M E N T

A C T U A T O R S

THK offers consistent ultra-precision linear motion components and systems that deliver tight tolerances for our medical, lab automation and equipment manufacturing customers. The confidence our customers have in the reliability and quality offered by THK makes us work even harder to innovate and achieve the ultimate in precision and quality.

To learn more, give us a call at 1-800-763-5459 or visit www.thk.com.

THK 11-14.indd 1

9/15/15 2:54 PM

CONTENTS

medicaldesignandoutsourcing.com ∞ September 2015 ∞ Vol1 No2

DEPARTMENTS 02 EDITORIAL: Welcome back to the Big 100

ON THE COVER:

06 CONTRIBUTORS

96

11

99 REGULATORY: Are the BRIC markets still worth the effort?

Medtech’s 100 LARGEST PLAYERS 17 Big 100 Breakdown 74 Top R&D Spenders

Who’s putting the most into the pipeline?

78 Top Medical Device Employers

102

PUMPS & TUBING TALKS: Peristaltic pumps can deliver fluids with remarkable precision with this simple adjustment.

106

CONNECTOR & CABLES CORNER: A guide to selecting plastic circular medical connectors.

108 SECURITY:

Electronic monitors can keep the unauthorized out of a secure cabinet, and more.

111

VALIDATION SERVICES: Here’s how to show an ethylene oxide sterilization process will do its job.

114

MOTION CONTROL: Precise positioning is necessary for this spectrophotometer.

117

FDA & NEW PRODUCTS: Raising the bar on FDA guidelines, along with some of the pre-market approvals the U.S. Food & Drug Administration granted in June 2015.

82 Medtech’s Global Hotspots

119

PATENT PROTECTION: A few basic steps can ensure companies own their intellectual property.

90 CEO moves

122

DEVICE TALKS: An exclusive one-on-one interview with Boston Scientific CEO Mike Mahoney.

128

AD INDEX

Medical Design & Outsourcing

TOC_SEPT 2015_Vs7-BP.indd 6

U.S., Global

86 Ones to Watch

6

MANUFACTURING & MACHINING: Lasers have evolved significantly over the past 15 years.

Medtech’s Up-and-Comers

Notable moves in the C suite

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 4:19 PM

3

1 2 0 l/min!

10 Flows to

5

4

1 Next Gen Electronic ectronic Valves with Fl Flows to 100 l/min!

2 ”GV” Series High Flow Poppet Valves 3 New Series Miniature Pressure Regulators 4 New Stainless Steel Push-Quick Fittings 5 “EGV” Electronic High Flow Poppet Valves 6 ”EFB“ Electronic Fill & Bleed Circuits 7 High Flow “E” Electronic Valves 8 All Stainless Steel Pneumatic Cylinders 9 Electronic Valves for Oxygen Applications

Introducing

6

new products new solutions

8 7

9

Clippard Instrument Laboratory, Inc. Providing innovative solutions for today’s engineering challenges.

877-245-6247 • www.clippard.com more info

Clippard 9-15.indd 15

9/15/15 2:55 PM

CONTRIBUTORS

FINE

HUDSON

GAUMER

EISENHART

GORDON

SPATIG

LEBLANC

DAVID BACH, with BST-Bach Solutions & Technology , is a seasoned technology professional with experience in developing medical equipment, consumables and instruments. Currently, he is expanding the utility of peristaltic-pump technology and has identified products for BST. David earned an Associate’s Degree from Hartford State Technical Institute, Bachelor’s Degree from the University of Delaware, and a Master’s Degree from Nichols College. Reach him at david@bachengg.com.

STEWART EISENHART is a Senior Regulatory Analyst for Emergo, a regulatory consulting firm serving more than 2,800 medical device and IVD companies worldwide. He can be reached at se@ emergogroup.com.

KENNETH A. FINE, is President and Co-Founder of Proven Process Medical Devices. Mr. Fine has over 31 years of experience in the design and development of Class II and critical Class III electromechanical medical devices and equipment. His major areas of expertise include electrical and software design for medical systems; medical software development processes and quality systems; international and domestic quality standards; FDA GMP, new product development and product improvement management. Mr. Fine holds an MS degree in electrical engineering from Northeastern University and a BS degree in biomedical engineering from Boston University.

8

Medical Design & Outsourcing

Contributor_SEPT 2015_Vs6.indd 8

9 • 2015

JEFF GAUMER, is a new product development manager for Molex Incorporated. Jeff has over 35 years of experience in the Interconnect industry spanning various roles in Sales, Global Account Management, Industry Marketing, and Product Marketing and Development.

The past 12 years have been with a Medical Industry focus.

EDWARD (JED) GORDON is a partner and intellectual property lawyer with Foley & Lardner LLP, where he advises clients regarding strategic portfolio development and counsels them in relation to patent enforcement strategies and defense against threatened patent infringement litigation. He can be reached at 617.342.4047 or egordon@foley.com.

DAVE HUDSON is president and CEO of Joining Technologies, one of the nation’s leading precision fusion companies.

Reach him at dhudson@ joiningtech.com.

BACH

MIKE LEBLANC, a Senior Account Manager and Applications Engineer for MICROMO, began his career with the company in 2002.

After graduating from the University of Rhode Island in 1997 with a Bachelors of Science in Mechanical Engineering degree, Mike worked for five years as a Sales Engineer with Maxon Precision Motors.

Mike has over 18 years of experience matching precise motion solutions to the needs of diverse, high-tech applications such as drug delivery systems, military vision systems, laboratory automation equipment, and various robotics systems. Today he is responsible for providing technical assistance and sales support to OEMs in the Mid-Atlantic region of North America.

STEVE SPATIG, General Manager of Electronic Access Solutions, Southco As General Manager of Southco’s Electronic Access Solutions, Steve Spatig oversees Southco’s state of the art electronic latching product line. Spatig has over 15 years of experience with Southco working in various design engineering and product management capacities. He holds a Bachelors in Mechanical Engineering from Northwestern University and a Bachelors in Marketing Management from Virginia Tech.

www.medicaldesignandoutsourcing.com

10/8/15 11:57 AM

™

C ATA L O G M 6 5

• Easy to use, 152-page Catalog • Details more than 5,000 quality products • Featuring hundreds of new products • Illustrated with engineering drawings, specifications and product photographs • Imperial and Metric dimensions * Call or visit our website to request your free catalog www.keyelco.com

MD&O-THiNK CatM65_9-15.indd 1 Keystone 9-15.indd 15

•

(718) 956-8900

•

(800) 221-5510

*For FREE Catalog Contact Keystone Today!

8/5/15 4:13 9/15/15 2:57 PM PM

We Turn Ideas Into Results.

Advanced Material Technologies

Every day at Minnesota Rubber and Plastics we produce high tolerance medical components and assemblies for the most demanding applications.

Our experience in advanced material formulation enables us to be compliant with FDA, ISO 10993 and ISO 13485 to meet your unique product requirements.

Our over 60 year history in the design and manufacture Precision Molded Medical Components and Assemblies

1100 Xenium Lane North Minneapolis, MN 55441-7000 (952) 927-1400 Fax (952) 927-1470 e-mail: webmaster@mnrubber.com www.mnrubber.com

155 route de Paris 27120 Pacy sur Eure FRANCE Tel: +33 (0) 2 32 22 24 26 INDIGO +33 (0) 820 320 751 Fax: +33 (0) 2 32 22 24 27 e-mail: commercial@mnrubber.com www.mnrubber.com

21, Bukit Batok Crescent 17-75, Wcega Tower Singapore 658065 011-65-6795 6725 U.S.: 952-927-1400 e-mail: mrap@mnrubber.com www.mnrubber.com

Block 10, Unit A No. 333 Xingpu Road Xian Dai Industrial Square Suzhou Industrial Park Jiangsu, China 215021 China: +86-512 6273 2700 U.S.: 952-927-1400 e-mail: asiainfo@mnrubber.com www.mnrubber.com

17651 Armstrong Avenue Irvine, CA 92614 (714) 546-0994 Fax (714) 546-7614 e-mail: globalexpress@mnrubber.com www.mnrubber.com 21-90-3320-50

For a project evaluation call : 952-927-1400.

Email requests to medical2@mnrubber.com Download our complete literature and design guide at mnrubber.com/medical2

Engineered to improve performance.

Designed to reduce costs.

MR&PRubber Medical ad Medical Minn 6-15.indd 15Design & Outsourcing.indd 1

of complex devices makes us the preferred partner for industry leaders throughout the world. The next time your component or assembly project seems impossible, there’s no one better to partner with than Minnesota Rubber and Plastics. We’ll make your tough application a reality.

Leader in Advanced Material Technologies

5/5/15 10:25 AM 9/15/15 3:19 PM

Medical Design & OUTSOURCING

BIG1OO M E D T E C H ' S 1 0 0 L A R G E S T P L AY E R S 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.17 Top R&D Spenders p.74 Top Medical Device Employers p.78 Medtech’s Global Hotspots p.82 Ones to Watch p.86 CEO Moves p.90

BIG 100 INTRO_9-15_Vs4.indd 11

9/17/15 2:23 PM

S S S

COMPANIES RANKED BY REVENUE RANK COMPANY 1

Johnson & Johnson $27,500,000,000

2

Medtronic $20,261,000,000

3

GE Healthcare (General Electric) $18,299,000,000

4

Siemens Healthcare (Siemens AG) $16,526,841,300

5

Philips Healthcare (Royal Philips Electronics) $12,214,624,200

6

Cardinal Health (medical segment) $11,400,000,000

7

Alcon (Novartis) $10,827,000,000

8

Baxter International (Medical Products segment) $9,972,000,000

9

Stryker Corp $9,675,000,000

10

Fujifilm Holdings (Information Solutions segment) $9,017,788,916

11

Essilor International $7,539,399,000

12

Boston Scientific $7,380,000,000

13

B. Braun Melsungen $7,219,739,120

14

Danaher (Life Sciences & Diagnostics segment) $7,185,700,000

15

Fresenius Medical Care (Fresenius Kabi division) $6,842,636,200

16

St. Jude Medical $5,622,000,000

17

3M Co. (healthcare division) $5,572,000,000

18

Zimmer (pre-Biomnet merger) $4,673,300,000

19

Olympus Corp. $4,655,759,410

20

Terumo

21

Smith & Nephew $4,617,000,000

22

Hospira $4,463,700,000

23

Grifols $4,461,654,105

A FEW YEARS AGO WE HADN’T GROWN FOR ABOUT FOUR YEARS IN A ROW, AND WE’VE GROWN, I DON'T KNOW HOW MANY QUARTERS IN A ROW NOW, EIGHT OR NINE OR SO. WE GAVE A PRETTY STRONG GUIDANCE FOR 2015 AND ‘16, ‘17 AND ‘18.

24

Getinge Group $3,888,969,902

25

Cerner

26

C.R. Bard $3,323,600,000

$4,629,336,107

$3,402,703,000

27 Hitachi (healthcare business) $3,195,574,050 28

Bayer (medical care division) $3,138,092,000

29

McKesson $3,069,000,000

30

Varian Medical Systems $3,049,800,000

31

Dentsply International $2,922,620,000

"WE TALK ABOUT A TURNAROUND, I GUESS WE DID TURN AROUND THE PERFORMANCE, BUT REALLY WHAT WE DID IS UNLOCK THE POTENTIAL AND THE CAPABILITIES OF THE TEAM OF 25,000 EMPLOYEES HERE.

32

Hoya (Life Care segment) $2,900,066,200

33

Ship Healthcare Holdings $2,584,896,917

34

Hologic $2,530,700,000

35

Paul Hartmann Group $2,475,901,400

36

Edwards Lifesciences $2,322,900,000

37

Becton, Dickinson & Co. (BD Medical segment) $2,307,000,000

38

BioMerieux $2,257,830,600

- BOSTON SCIENTIFIC CEO

39

Nipro $2,248,694,912

40

Coloplast $2,213,317,661

MIKE MAHONEY

12

2014 REVENUE

Medical Design & Outsourcing

Revenue Rank_9-15_Vs7-BP.indd 12

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 5:19 PM

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

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

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

PTI 9-15.indd 15

9/15/15 3:26 PM

S S S

COMPANIES RANKED BY REVENUE RANK COMPANY

2014 REVENUE

41

Bio-Rad $2,175,044,000

42

Intuitive Surgical $2,131,700,000

43

Draegerwerk (Medical segment) $2,108,106,380

44

Waters $1,989,344,000

45

Abbott Laboratories $1,958,000,000

46

Miraca Holdings $1,935,568,375

47 Acelity $1,866,339,000 48

Sonova Holding $1,861,505,970

49 Steris $1,850,263,000

MEDICAL TECHNOLOGY IS EVOLVING, AND WE NEED TO TAKE A LOOK AT HOW TO BRING VALUE TO OUR CUSTOMERS THROUGH SERVICES. FOR EXAMPLE, TO MINIMIZE LOST ITEMS IN THE SYSTEM, CUT INVENTORY AND REDUCE COSTS, WE’LL SEE AN INCREASE IN SOLUTIONS LIKE RFID TAGGING OF INVENTORY, WHICH IS AN INVENTORY MANAGEMENT SOLUTION THAT HELPS HOSPITALS TRACK HIGH-PRICE PRODUCTS AS WELL AS COMMODITY ITEMS. - CARDINAL HEALTH MEDICAL SEGMENT CEO

DON CASEY

14

Medical Design & Outsourcing

Revenue Rank_9-15_Vs7-BP.indd 14

9 • 2015

50

Teleflex $1,839,832,000

51

ConvaTec $1,735,500,000

52

The Cooper Cos. $1,717,776,000

53

Hill-Rom Holdings $1,686,100,000

54

ResMed $1,678,912,000

55

Halyard Health $1,672,100,000

56

Bruker $1,571,900,000

57

Elekta $1,559,437,704

58

Nihon Kohden $1,520,739,550

59

William Demant Holding (hearing segments) $1,490,801,589

60

IDEXX Labs $1,485,807,000

61

Agfa-Gevaert (AGFA Healthcare segment) $1,421,449,300

62

Smiths Medical $1,325,313,600

63

Mindray Medical $1,322,814,000

64

Invacare $1,270,163,000

65

DJO Global $1,229,166,000

66

Nikkiso (Medical division) $1,222,385,096

67

Carl Zeiss Meditec $1,209,036,374

68

Sirona Dental Systems $1,171,100,000

69

Ottobock (healthcare business) $1,025,198,700

70

Fukuda Denshi $1,023,917,155

71

Sorin $993,152,930

72

Omron (healthcare segment) $951,390,202

73

Integra Lifesciences $928,305,000

74

Cochlear Ltd. $925,630,000

75

Haemonetics $910,373,000

76

Kawanishi Holdings $893,843,389

77

GN Store Nord (ReSound division) $795,889,655

78

NuVasive $762,415,000

79

Align Technology $761,653,000

80

Konica Minolta Holdings (healthcare division) $742,386,987 www.medicaldesignandoutsourcing.com

9/17/15 5:20 PM

RANK COMPANY

2014 REVENUE

81

Conmed $740,055,000

82

Greatbatch $687,787,000

83

Welch Allyn $683,772,000

84

Amplifon $670,024,066

85

Straumann $649,711,410

86

Masimo $586,643,000

87

Fisher & Paykel $558,882,990

88

JMS Co. $523,936,070

89

Analogic $517,500,000

90

Merit Medical Systems $509,689,000

91

Össur $509,000,000

92

Cantel Medical $488,749,000

93

Thoratec $477,560,000

94

Orthofix International $402,277,000

95

Symmetry Medical/Tecomet $399,992,000

96

Topcon (eye care division) $390,013,240

97

Accuray $369,419,000

98

Natus $355,834,000

99

ICU Medical $309,260,000

100

NxStage Medical $301,501,000

TO DATE, WE HAVE CHOSEN TO ABSORB THE [MEDICAL DEVICE TAX] INTERNALLY. WE HAVE NOT NEEDED TO REDUCE OUR WORKFORCE OR IMPLEMENT A PRICE INCREASE TO OUR CUSTOMERS AS A DIRECT RESULT OF THE TAX. WHILE WE DO NOT BELIEVE THE TAX WILL DIMINISH OLYMPUS' ABILITY TO DELIVER INNOVATIVE MEDICAL PRODUCTS, THE TAX HAS CHALLENGED OUR ABILITY TO REINVEST FUNDS, EITHER DIRECTLY OR THROUGH OUR COMMUNITY BASED PARTNERS, TO GROW THE BUSINESS. - EXECUTIVE VICE PRESIDENT - SALES, MARKETING & SHARED SERVICES, MEDICAL SYSTEMS GROUP AT OLYMPUS CORPORATION OF THE AMERICAS

RICHARD REYNOLDS

WHAT DO YOU THINK? Connect and discuss this and other medical issues with thousands of professionals online

www.medicaldesignandoutsourcing.com

Revenue Rank_9-15_Vs7-BP.indd 15

9 • 2015

Medical Design & Outsourcing 15

9/17/15 5:20 PM

Build. Deploy. Manage. Measure.

“

We build & manage world class contract sales, clinical support & field service teams for the medical device and diagnostic industries.

What our program can do for you

What we do Build 1 With an existing base of

2000+ consultants and a robust recruiting and screening program we can build the team you need, whenever you need it.

3 Manage Enterprise wide scheduling

tools, expense management, mobile time and attendance supported by a dedicated Account Manager.

2 Deploy A multi-channel support

platform: field teams, contact center and video chat support.

4 Measure On-demand analytics

measuring sales call activity, clinical support and trend analysis, giving you a 360 view of each account.

Scale with your business needs

Provide clinical product support in any environment

Minimize SG&A Costs

Increase Geographical Reach

Provide Detailed Analytics on effectiveness

Field Corrective Action Teams OR Case Coverage

Open Territory Teams

Our Consultant Teams can support your products and initiatives where and when it matters.

To schedule a capabilities assessment, please contact:

3207 Grey Hawk Court Suite 100 Carlsbad CA 92010

1-888-899-NOVA (6682) With the highest quality and detailed analytics platform, you’ll be able to review data on a granular level while our consultants are supporting your initiatives. Our analytics allow you to track effectiveness so that you may scale your business to maximize outcomes.

Novasyte 9-15.indd 15

info@novasyte.com www.novasyte.com

9/15/15 3:28 PM

THE TOP 1OO MEDTECH COMPANIES

1

1OO

JOHNSON & JOHNSON One Johnson & Johnson Plaza New Brunswick, New Jersey 08933 (732) 524-0400

www.jnj.com

Although Johnson & Johnson last year said it was eyeing acquisitions to bolster its "subscale" cardiovascular business, particularly its electrophysiology business, the world's largest medical device maker instead sold off a pair of assets: Its Cordis stent-making arm, under agreement for $1.94 billion to Cardinal Health; and its Ortho-Clinical Diagnostics business, to private equity giant Carlyle Group for $4 billion. J&J also committed to a $2.5 billion deal to settle a rash of lawsuits filed over its DePuy ASR metal-on-metal hip implant and pulled its laparoscopic power morcellators after the devices were implicated in the unintentional spread of uterine cancers.

The company began the year with a transparency pledge for data from its clinical trial programs and launched a robot-assisted surgery pilot program with Google.

“Our work with Google illustrates how we’re aiming to pioneer the operating room of the future with robotic surgical tools that will increase surgical precision, minimize trauma for patients, and deliver efficiencies to hospitals,” the company tells us,

MARKETS: Orthopedics, Aortic, Bariatric/ gastroenterology, Brachytherapy, Cardiac Assist Devices, Cardiac Rhythm Management

Employees: 126,500 Revenue: $27,500,000,000* R&D Spend: $1,652,000,000 Fiscal year ending: Dec. 31, 2014

KEY PERSONNEL: DOMINIC J. CARUSO, VP Finance, CFO PETER M. FASOLO, VP Global HR ALEX GORSKY, Chairman & CEO SANDRA E. PETERSON, Worldwide Chairwoman PAULUS STOFFELS, Chief Scientific Officer, Chairman Pharmaceuticals MICHAEL H. ULLMANN, VP, General Counsel

* Revenues from J&J's medical device & diagnostic segment.

www.medicaldesignandoutsourcing.com

TOP 10 100 List_9-15_Vs4-BP.indd 17

9 • 2015

Medical Design & Outsourcing 17

9/17/15 5:34 PM

Water Rules!

Let our water-based medical coatings empower you.

Coatings2go, LLC provides hydrophilic and other coatings that are quickly delivered to you hassle-free, and in a cost-effective manner.

Our coatings are perfect for on-site manufacturing, eco-friendly, and can be controlled by your employees, in your own facility, and are FDA Master Filed.

5 coating solutions • 3 available sizes • 4, 12, or 32 oz.

• easy to customize • great performance & versatility ORDER ONLINE TODAY!

• no license fees or royalty costs • quick & secure online ordering • purchase domestically or internationally • ISO 13485 certified

© 2015 Surface Solutions Laboratories, Inc. All Rights Reserved. SURFACE SOLUTIONS LABORATORIES is a trademark of Surface Solutions Laboratories, Inc., registered in the United States Patent and Trademark Office. COATINGS2GO is a trademark of Coatings2Go, LLC, registered in the United States Patent and Trademark Office.

Let us show you how you can benefit from having a medical device coating partner that brings precision, quality, and speed to all they do.

978.369.7411 • www.Coatings2Go.com • info@coatings2go.com Coatings2Go 9-15.indd 15

C2G00074

9/15/15 3:29 PM

THE TOP 1OO MEDTECH COMPANIES

2

1OO

MEDTRONIC 7000 Central Ave NE Fridley, MN 55432 (800) 328-2518

www.medtronic.com

Medtronic made the biggest splash of 2014 when it said it would acquire Covidien in the largest merger medtech has ever seen. Ultimately the price tage for the deal, which closed in January 2015, reached $50 billion. The lofty amount didn't prevent the world's largest pureplay medtech company from making other acquisitions, though: Medtronic spent more than $1 billion during the summer of 2015 alone, including a $458 million deal for mitral valve maker Twelve Inc. Medtronic was also responsible for the 2nd-largest headline in recent memory, when it revealed that the expected slam-dunk for its Symplicity renal denervation device instead clanked off the rim. The bad news was balanced by good, in the form of FDA nods for the In.Pact Admiral drug-eluting balloon and the CoreValve transcatheter aortic valve implant, and European approval of its tiny Micra pacemaker. Medtronic also settled its long-running patent infringement beef with Edwards Lifesciences for $750m plus royalties.

MARKETS: Aortic, Peripheral Vascular, Cardiac Rhythm Management, Cardiovascular, Structural Heart, Diabetes, Neuromodulation/ neurostimulation, Spinal, Surgical

Employees: 92,000 Revenue: $20,261,000,000 R&D Spend: $1,640,000,000 Fiscal year ending: April 24, 2015

KEY PERSONNEL: OMAR ISHRAK Chairman & CEO BILL BURKE Chief Integration Officer MICHAEL J. COYLE EVP & President, Cardiac & Vascular Group GARY ELLIS EVP & CFO MIKE GENAU SVP & President, Americas HOOMAN HAKAMI EVP & President, Diabetes BRYAN HANSON EVP & President, Covidien DR. RICHARD KUNTZ SVP & Chief Scientific, Clinical, & Regulatory Officer CHRIS LEE SVP & President, Greater China BRAD LERMAN SVP, General Counsel & Secretary GEOFFREY S. MARTHA SVP, EVP & President, Restorative Therapies DR. STEPHEN N. OESTERLE SVP, Medicine & Technology LUANN PENDY SVP, Global Quality CAROL A. SURFACE SVP & Chief HR Officer ROB TEN HOEDT EVP & President, EMEA BOB WHITE SVP & President, Asia Pacific

www.medicaldesignandoutsourcing.com

TOP 10 100 List_9-15_Vs4-BP.indd 19

9 • 2015

Medical Design & Outsourcing 19

9/17/15 5:35 PM

Rapid Manufacturing That’s a Real Lifesaver Tech-driven injection molding, CNC machining and 3D printing for those who need parts tomorrow

Proto Labs is the world’s fastest source for on-demand, low-volume manufacturing. We make quick-turn prototypes and production parts including device handles, housings, strain reliefs and other components used in the medical industry.

Got a project? Get 1 to 10,000+ plastic, metal or liquid silicone rubber parts in 1 to 15 days.

Download your free Medical Prototyping white paper at

go.protolabs.com/DWM5MF ISO 9001:2008 Certified | ITAR Registered Major Credit Cards Accepted | © 2015 Proto Labs, Inc.

Proto Labs 9-15.indd 15

ADDITIVE MANUFACTURING CNC MACHINING INJECTION MOLDING

9/15/15 3:30 PM

THE TOP 1OO MEDTECH COMPANIES

3

1OO

GE HEALTHCARE Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA, United Kingdom http://www3.gehealthcare.com/en/global_gateway

GE Healthcare's biggest move of the year involved the corner office, which saw GE vet John Flannery take over the CEO role from John Dineen. GE Healthcare also got rid of its Vital Signs business, selling it to CareFusion for $500 million late in 2013, and laid plans to get out of the electronic medical records business. It won FDA approval in 2014 for its SenoClaire 3D breast tomosynthesis device and inked a deal with Abbott to integrate its CardioLab electrophysiology recording system into the RhythmView mapping software Abbott acquired along with Topera Medical.

MARKETS: Imaging/radiology, Healthcare IT, Patient monitoring, Diagnostics

Employees: Revenue: R&D Spend: Fiscal year ending:

KEY PERSONNEL:

JOHN L. FLANNERY, President & CEO JÖRG DEBATIN, VP & Chief Technology Officer JAN DE WITTE, President & CEO, Healthcare IT RACHEL DUAN, President & CEO, China LAURENT DUBOIS, CEO, Partners CARRIE EGLINTON MANNER, President & CEO, Detection & Guidance Solutions MARKUS EWERT, EVP, Business Development RANDY FOX, VP & CIO JASON HANSON, Chief Risk Officer & VP, General Counsel HENRY HUMMEL, President & CEO, Molecular Imaging (MI) & Computed Tomography (CT) KARIM KARTI, VP & Chief Marketing Officer RAGHU KRISHNAMOORTHY, VP, HR AKIHIKO KUMAGAI, President & CEO, Asia Pacific THIERRY LECLERCQ, President & CEO, Life Care Solutions JEAN MICHEL MALBRANCQ, President & CEO, Europe SKANDER MALCOLM, President & CEO, Eastern & Africa Growth Markets (EAGM) BRIAN MASTERSON, VP, Global Supply Chain DEE MELLOR, Chief Quality Officer MARCELO MOSCI, President & CEO, U.S. & Canada KIERAN MURPHY, President & CEO, Life Sciences

51,000 $18,299,000,000* $5,273,000,000 Dec. 31, 2014

MONISH PATOLAWALA, VP & CFO GUSTAVO PEREZ-FERNANDEZ, President & CEO, Surgery MILAN RAO, President & CEO, South Asia JOE SHRAWDER, resident & CEO, Global Services ERIC STAHRE, President & CEO, Global MRI ANDERS WOLD, President & CEO, Ultrasound

* Revenues and employees include GE Healthcare only.

www.medicaldesignandoutsourcing.com

TOP 10 100 List_9-15_Vs4-BP.indd 21

9 • 2015

Medical Design & Outsourcing 21

9/17/15 5:36 PM

@ MachinedSprings.com

SOLUTIONS FOR SURGICAL TOOLS, MEDICAL DEVICES AND IMPLANTS

For more information on Machined Springs, including custom applications, go to MachinedSprings.com or call (877) 435-4225 Š 2015 Helical Products Company | www.heli-cal.com

Helical 9-15.indd 15

9/15/15 3:31 PM

THE TOP 1OO MEDTECH COMPANIES

4

1OO

SIEMENS HEALTHCARE Siemens AG Wittelsbacherplatz 2 Munich, Germany 80333 +49 89 636-33443

www.siemens.com/about/en/businesses/healthcare.htm

Siemens Healthcare underwent a sea change in 2014 as new Siemens CEO Joe Kaeser ousted healthcare CEO Hermann Requardt, promoting imaging & therapy systems leader Bernd Montag to CEO in his stead; Siemens then announced plans to establish a separate business structure for the healthcare unit. In May 2015 Siemens added 4,500 job cuts to the 7,400 layoffs already under way. Last summer, Siemens Healthcare shed a trio of assets, dealing its clinical microbiology business to Danaher's Beckman Coulter subsidiary for an undisclosed amount; selling its hearing aid business to EQT for $2.68 billion; and selling its healthcare IT business to Cerner for $1.3 billion.

MARKETS: Healthcare IT, Imaging/radiology, Laboratory, Diagnostics

Employees: 43,000 Revenue: $16,526,841,300* R&D Spend: $5,405,230,500 Fiscal year ending: Sept. 30, 2014

KEY PERSONNEL: BERND MONTAG CEO MICHAEL SEN CFO DR. GREGORY SORENSEN, President & CEO, Siemens Healthcare North America MICHAEL REITERMANN CEO, Siemens Healthcare Diagnostics

* Revenues and employees from Siemens Healthcare only.

www.medicaldesignandoutsourcing.com

TOP 10 100 List_9-15_Vs4-BP.indd 23

9 • 2015

Medical Design & Outsourcing 23

9/17/15 5:36 PM

HOW DO I KNOW IF I’M TALKING TO AN ENGINEER OR A SALESMAN? Ask Smalley. We have nothing against sales people. But when it comes to differentiating Inconel from Elgiloy or overcoming dimensional variations within a complex assembly, wouldn’t you rather work with an engineer?

Our customers would. That’s why they collaborate directly with our world-class team of Smalley engineers—experienced professionals whose only focus is helping you specify or design the ideal wave spring, Spirolox® retaining ring or constant section ring for your precision application.

Smalley wave springs reduce spring operating height by 50%, saving space and weight, fitting tight radial and axial spaces. We offer more than 4,000 stock sizes in carbon and stainless steel.

Visit smalley.com for your no-charge test samples.

Smalley Wave Spring

Coil Spring

THE ENGINEER’S CHOICE™

38139_Smalley_BrandAd_MedicalDesignAndOutsourcing.indd 1 Smalley 9-15.indd 15

8/5/15 2:52 9/15/15 3:31 PM PM

THE TOP 1OO MEDTECH COMPANIES

5

1OO

PHILIPS HEALTHCARE BC475958BREITNER CENTER AMSTELPLEIN 2 AMSTERDAM P7 Netherlands 1096 BC 31 20 59 77777

www.usa.philips.com

Philips Healthcare, the Dutch conglomerate's largest business, was bedeviled by the closure of a Cleveland CT scanner plant last year but got the facility back online in 2015. In September 2014, Philips announced plans to sell off its legacy lighting business and merge its consumer and healthcare operations. In April 2015 Philips Healthcare tapped former Hologic CEO Rob Cascella to lead its imaging business. Zoll Medical agreed in November 2014 to acquire Philip Healthcare's InnerCool. The move toward managed care didn't escape its eye either, as the company formed a $500 million, 15-year partnership with Westchester Medical Center Health Network to develop new value-based healthcare solutions for the Hudson Valley hospital system.

MARKETS: Imaging/radiology, Patient monitoring, Healthcare IT

Employees: 37,000 Revenue: $12,214,624,200* R&D Spend: $2,174,059,500 Fiscal year ending: Dec. 31, 2014

KEY PERSONNEL: FRANS VAN HOUTEN, Chairman & CEO, Royal Philips JIM ANDREW, EVP Royal Philips, Chief Strategy & Innovation Officer MARNIX VAN GINNEKEN: EVP, Chief Legal Officer DENISE HAYLOR: EVP, Chief HR Officer RONALD DE JONG: EVP Royal Philips, Chief Market Leader PATRICK KUNG: EVP Royal Philips, CEO Greater China PIETER NOTA: EVP & CEO, Philips Consumer Lifestyle ERIC RONDOLAT: EVP & CEO, Philips Lighting RON WIRAHADIRAKSA: EVP & CFO, Royal Philips

* Revenues from Philips Healtchare only.

www.medicaldesignandoutsourcing.com

TOP 10 100 List_9-15_Vs4-BP.indd 25

9 • 2015

Medical Design & Outsourcing 25

9/17/15 5:37 PM

1OO

THE TOP 1OO MEDTECH COMPANIES

6

CARDINAL HEALTH 7000 Cardinal Place Dublin, Ohio 43017 (614) 757-5000

www.cardinal.com

Cardinal Health in May 2014 closed the $320 million acquisition of AccessClosure and its Mynx extravascular closure technology. In April 2015, the company agreed to disgorge nearly $27 million to settle charges that it exercised an illegal monopoly on low-energy radiopharmaceuticals. A month later, Johnson & Johnson accepted Cardinal's binding offer worth about $2 billion for its Cordis stent-making arm.

Cardinal Health told us it also inked a long-term strategic agreement with Henry Schein, acquired advanced wound care systems developer Innovative Therapies, and unveiled its PRO negative pressure wound therapy line.

MARKETS: Surgical, Laboratory

Employees: 34,000 Revenue: $11,400,000,000* Fiscal year ending: June 30, 2015

KEY PERSONNEL: NICK AUGUSTINOS SVP, Health Information Services & Strategy GEORGE S. BARRETT Chairman & CEO DONALD M. CASEY JR. CEO, Medical Segment CRAIG COWMAN EVP, Global Sourcing JOSEPH DEPINTO President, Cardinal Health Specialty Solutions MIKE DUFFY President, Medical Products BRIAN ELLIS EVP, Enterprise Corporate Accounts & Strategic Account Teams STEVE FALK EVP, General Counsel & Secretary MEGHAN M. FITZGERALD President, Specialty Solutions JON GIACOMIN CEO, Pharmaceutical STEVE INACKER President, Hospital Sales & Services MIKE KAUFMANN CFO CRAIG MORFORD Chief Legal & Compliance Officer PATRICIA MORRISON EVP, Customer Shared Services, CIO TIFFANY OLSON President, Nuclear Pharmacy Services BILL OWAD SVP, Operational Excellence MICHAEL PETRAS President, Cardinal Health at Home CAROLE WATKINS Chief HR Officer * Revenues from Cardinal Health’s medical segment only.

26

Medical Design & Outsourcing

TOP 10 100 List_9-15_Vs5.indd 26

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 5:45 PM

Hands-Free Storage HANDS-ON ENGINEERING

Enhanced

3832HDTR TOUCH RELEASE for hands-free operation - no glove removal!

Perfect for lab environments, medical carts, or anywhere requiring quick access to contents.

• Mechanism propels drawers open • Load rating up to 100 lbs.

• Full extension • Easy to download CAD drawings

FIND A DISTRIBUTOR

accuride.com DESIGN IDEAS + PRODUCT UPDATES

Accuride 9-15.indd 15

9/15/15 3:32 PM

1OO

THE TOP 1OO MEDTECH COMPANIES

7

ALCON LICHTSTRASSE 35 BASEL, Switzerland 4056 011 41 61 324 1111

www.novartis.com

Alcon's AcrySof IQ PanOptix trifocal intraocular lens won a recommendation for approval from and FDA advisory panel in November 2014; in June 2015 the device won CE Mark approval in the European Union. Pharma giant Novartis, Alcon's Swiss parent, struck a deal in July 2014 for Alcon to license Google's smart lens technology for medical use. In May 2014 Novartis replaced Kevin Buehler, who retired, with Sandoz chief Jeff George.

MARKETS: Vision

Employees: 100,000 Revenue: $10,827,000,000* R&D Spend: $9,030,000,000 Fiscal year ending: Dec. 31, 2014 KEY PERSONNEL: JOSEPH JIMENEZ CEO, Novartis JEFF GEORGE Global Head of Alcon CHRISTINA ACKERMANN SVP, General Counsel, Alcon PAUL VAN ARKEL Head of Corporate Strategy & Healthcare Systems; LAURENT ATTIAS Head, Strategy, Business Development & Market Access, Alcon SERGIO DUPLAN Region President, Latin America & Canada, Alcon FREDERIC GUERARD Global Franchise Head, Alcon Pharmaceutical DAVID NIETO CFO BETTINA MAUNZ VP, Global Head Communications, Alcon MERRICK MCCRACKEN SVP, HR, Alcon ED MCGOUGH SVP, Global Manufacturing & Technical Operations, Alcon JIM MURPHY Region President, Japan, Alcon MICHAEL ONUSCHECK Global Franchise Head, Alcon Surgical RIAD SHERIF President, EMEA, Alcon ERIC VAN OPPENS President, Asia & Russia, Alcon ROBERT WARNER President, United States, Alcon SUE WHITFILL Head, Global Quality, Alcon * Revenues from Alcon segment only.

28

Medical Design & Outsourcing

TOP 10 100 List_9-15_Vs5.indd 28

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 5:45 PM

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

Fits almost any linear or rotary feedback design you can imagine

20 x 13.5 x 3.3 mm

Available in PCB-ready configuration or as stand-alone cabled option

RLB—A PCB-level magnetic encoder designed for high volume low cost OEM integrations with added flex cable option

Powerful magnetic and optical scale technology for uncompromising accuracy Exceptional dirt immunity and the highest signal stability

Explore the wide range of options, configurations and applications at:

www.renishaw.com/encoders

8 x 3.3 x 14 mm RoLin—An environmentally hardened, packaged miniature magnetic encoder for OEM system integration 12 x 8.5 x 5 mm

Renishaw Inc Hoffman Estates, IL www.renishaw.com

MiniEncoder 9_18 Medical Renishaw 9-15.indd 15 Design & O.indd 1

8/5/15 1:08 9/15/15 3:33 PM PM

1OO

THE TOP 1OO MEDTECH COMPANIES

8

BAXTER INTERNATIONAL One Baxter Parkway Deerfield, Illinois 60015-4625 (800) 422-9837

www.baxter.com

As it digested 2013's $4 billion buyout of Gambro, the big news for Baxter last year and in 2015 was the spinout of part of its pharmacy business as Baxalta.

Baxter also sold off its vaccines business last year, to pharma giant Pfizer for $365 million, and closed the sale of its continuous renal replacement therapy business to Nikkiso. The company recalled some of its Sigma Spectrum infusion pumps in 2014, but won 510(k) clearance from the FDA for a next-generation version of the Sigma Spectrum a little while later.

MARKETS: IV Supplies, Hospital Supplies, Intensive Care, Dialysis, Drug Delivery, Diabetes

Employees: 66,000 Revenue: $9,972,000,000* R&D Spend: $1,421,000,000 Fiscal year ending: Dec. 31, 2014 KEY PERSONNEL: ROBERT L. PARKINSON JR. Chairman & CEO BRIK V. EYRE VP & President, Hospital Products ROBERT FELICELLI VP, Quality TIMOTHY P. LAWRENCE VP, Operations JEANNE K. MASON VP, HR JAMES K. SACCARO VP & CFO JILL M. SCHAAF VP & President, Renal MARCUS SCHABACKER VP & Chief Scientific Officer DAVID P. SCHARF VP, General Counsel & Secretary PAUL VIBERT VP & President, International

* Revenues from Baxter International’s medical products segment only.

30

Medical Design & Outsourcing

TOP 10 100 List_9-15_Vs5.indd 30

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 5:45 PM

MEETING YOUR NEEDS FOR PRECISION STAINLESS STEEL • Extensive inventory of Tubing, Bar Stock, Hollow Bar, Flanges, Pipe, Fittings • Cut-to-length stainless tubing • CNC machined stainless parts • Bending and coiling of stainless and other materials • Redrawing of stainless tubing, rod and bar stock

ISO 9001 ISO 13485 AS 9100

EAGLE STAINLESS Tube & Fabrication Inc. 10 Discovery Way Franklin Massachusetts phone 800-528-8650 fax. 800-520-1954 ask for a copy of the Eagle catalog and designers guide today

The performance leader in fabricated products in Stainless Steel, Nickel Alloys, Aluminum, & Titanium

www.eagletube.com Visit us at AUVSI in Denver, Booth #2333

Eagle Stainless 8-14_Aerospace Supp.indd 101

9/18/15 2:39 PM

1OO

THE TOP 1OO MEDTECH COMPANIES

9

STRYKER CORP 2825 Airview Boulevard Kalamazoo, Michigan 49002 (269) 385-2600

www.stryker.com/en-us/index.htm

Stryker closed out 2013 by closing out its $1.7 billion acquisition of robot-assisted surgery company Mako Surgical and began 2014 with a flurry of other buyouts: Hip arthoplasty device maker Pivot Medical; Patient Safety Technologies for $120 million; Berchtold Holding, a German medtech manufacturer specializing in hospital equipment, for $172 million. Later in the year Stryker closed a deal for Small Bone Innovations worth up to $375 million. But the biggest deal of all - Stryker's rumored takeover of British rival Smith & Nephew never materialized. Stryker also began 2015 with an acquisition, buying Canadian hospital bed maker CHG, and CEO Kevin Lobo has said that M&A is the company's top priority for the $2.59 billion in ready cash it’s carrying on its balance sheet. The company also agreed to settle thousands of product liability lawsuits over recalled Rejuvenate and ABG-II metal-on-metal hip implants for more than $1 billion. Late in the year Stryker put to rest another legal case it inherited when it bought Otismed, agreeing to pony up $80 million after the company and its former CEO pleaded guilty to distributing knee replacement surgery cutting guides without FDA clearance.

MARKETS: Orthopedics, Patient Care & Mobility, Neuromodulation/neurostimulation, Surgical

Employees: Revenue: R&D Spend: Fiscal year ending:

26,000 $9,675,000,000* $614,000,000 Dec. 31, 2014

KEY PERSONNEL: KEVIN A. LOBO Chairman & CEO YIN C. BECKER VP, Communications, Public Affairs & Strategic Marketing STEVEN P. BENSCOTER VP, Global HR DEAN H. BERGY VP, Secretary WILLIAM E. BERRY JR. VP, Controller JEANNE M. BLONDIA VP, Finance & Treasurer LONNY J. CARPENTER President, Global Quality & Operations & European Business Operations IRENE B. CORBE VP, Internal Audit DAVID K. FLOYD President, Orthopedics DAVID G. FURGASON VP, Tax MICHAEL D. HUTCHINSON General Counsel WILLIAM R. JELLISON VP, CFO KATHERINE A. OWEN VP, Strategy & Investor Relations BIJOY SAGAR VP, CIO TIMOTHY J. SCANNELL President, MedSurg & Neurotechnology ELIZABETH A. STAUB VP, Regulatory Affairs & Quality Assurance RAMESH SUBRAHMANIAN President, International BRONWEN R. TAYLOR VP, Compliance & Risk Management 32

Medical Design & Outsourcing

TOP 10 100 List_9-15_Vs5.indd 32

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 5:46 PM

C

M

Y

CM

MY

CY

MY

K

Schneider 5-15.indd 56

9/15/15 3:34 PM

1OO

THE TOP 1OO MEDTECH COMPANIES

1O

FUJIFILM HOLDINGS 7-3, Akasaka 9-chome Minato-ku, Tokyo, Japan 107-0052 03-6271-1111

Fujifilm's medical systems division is built on the company's diagnostic imaging technologies, including its foundational digital X-ray diagnostics business (the firm launched its first X-ray film product in 1936 and introduced the world's first digital X-ray imaging and diagnostic system in 1983). Its brands include Fuji Computed Radiography and the Synapse digital image sharing system, and it operates in 3 segments: Imaging solutions, information solutions and document solutions. In July 2015 the company submitted the 1st module in its premarket approval application for digital breast tomosynthesis as an upgrade for its Aspire Cristalle mammography system.

www.fujifilmholdings.com/en/index.html

MARKETS: Imaging/radiology, Radiopharmaceuticals

Employees: Revenue: R&D Spend: Fiscal year ending:

79,235 $9,017,788,916* $1,523,964,441 March 31, 2015

KEY PERSONNEL: SHIGETAKA KOMORI Chairman & CEO SHIGEHIRO NAKAJIMA President & COO KOUICHI TAMAI VP KENJI SUKENO VP KAZUHIKO FURUYA VP MASAHIRO ASAMI VP HIROSHI TANAKA VP HARUHIKO YOSHIDA VP RYUTARO HOSODA VP TORU YAMADA VP MASARU YOSHIZAWA VP SHIGENOBU INENAGA VP

* Revenues from Fujifilm Holdings’ Information Solutions segment only.

34

Medical Design & Outsourcing

TOP 10 100 List_9-15_Vs5.indd 34

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 5:46 PM

Trust is impossible to design, manufacture or engineer. It has to be

earned.

Quality, integrity and value-added project performance are features built in to every medical device development program managed by Proven Process. We have served the industry for over twenty years and today, we are trusted by start-ups,emerging companies and large, diversified OEMs, all of whom are driven to improve patient outcomes.

Our services include: Early Stage Technology Development • Requirements Analysis • Proof of Concept Analysis • Rapid Prototyping Product Development • Mechanical Engineering • Electrical Engineering • Software Development • Systems Engineering • Manufacturing Engineering • Quality Engineering Contract Manufacturing • Pilot and Full Scale Manufacturing • Class 10,000 Clean Room Let us earn your trust. Visit our website at provenprocess.com or call our Sales Engineer, Mike Kanis at 508-261-0849.

TM

110 Forbes Blvd., Mansfield, MA 02048 508-261-0849 mkanis@ProvenProcess.com www.ProvenProcess.com

Proven Process 9-15.indd 15

Above: Pneumatic driver for a total artificial heart designed and manufactured by Proven Process Medical Devices

© 2015 Proven Process Medical Devices, all rights reserved.

9/15/15 4:14 PM

1OO

THE TOP 1OO MEDTECH COMPANIES

11

ESSILOR INTERNATIONAL 147 rue de Paris, Charenton-le-Pont, France 94220 +33(0)1 49 77 42 24

www.essilorusa.com/EN/Pages/default.aspx

Employees: 58,000 Revenue: $7,539,399,000 R&D Spend: $249,983,600 Fiscal year ending: Dec. 31, 2014

MARKETS: Vision

KEY PERSONNEL: HUBERT SAGNIÈRES Chairman and CEO PAUL DU SAILLANT COO LAURENT VACHEROT COO JEAN CARRIER-GUILLOMET COO TADEU ALVES President Latin America ERIC BERNARD COO Africa, Middle East, Russia, Asia JAYANTH BHUVARAGHAN Chief Corporate Mission Officer CARL BRACY VP Marketing & Business Development, Essilor of America PATRICK CHERRIER President, Africa, Middle East, Russia, Asia LUCIA DUMAS SVP Comm​unications BERNARD DUVERNEUIL CIO NORBERT GORNY President Satisloh, Equipment & Consumables REAL GOULET SVP, Rx Sunwear LENA HENRY Chief Strategy Officer ERIC LÉONARD President Essilor of America ALEXANDER LUNSHOF Chief Legal Officer FRÉDÉRIC MATHIEU SVP HR BERNHARD NUESSER President Europe ERIC PERRIER SVP R&D GÉRALDINE PICAUD CFO PATRICK PONCIN SVP Global Engineering ALAIN RIVELINE SVP, Strategic Marketing THIERRY ROBIN “Digital Surfacing Strategic Opportunity” Project Director BERTRAND ROY SVP Strategic Partnerships KEVIN RUPP CFO and VP Finance and Administration Essilor of America ERIC THOREUX President Sun, Reader and Photochromic CAROL XUEREF Secretary General

12

BOSTON SCIENTIFIC

300 BOSTON SCIENTIFIC WAY MARLBOROUGH, MASSACHUSETTS 01752-1234 (508) 683-4000

www.bostonscientific.com/en-US/home.html

MARKETS: Cardiovascular, Cardiac Rhythm Management, Pulmonary/bronchoscopy, Vascular, Urological, Women’s Health, Chronic Pain, Neuromodulation/neurostimulation

KEY PERSONNEL:

Employees: 24,000 Revenue: $7,380,000,000 R&D Spend: $817,000,000 Fiscal year ending: Dec. 31, 2014

MICHAEL F. MAHONEY, President & CEO KEVIN BALLINGER, SVP & President Interventional Cardiology SUPRATIM BOSE, EVP & President, Asia-Pac, Middle East and Africa DANIEL J. BRENNAN, EVP & CFO WENDY CARRUTHERS, SVP HR DR. KEITH D. DAWKINS, EVP & Global Chief Medical Officer JOSEPH M. FITZGERALD, EVP & President, Rhythm Management EDWARD MACKEY, EVP, Operations JEFF MIRVISS, SVP & President, Peripheral Interventions MAULIK NANAVATY, SVP & President, Neuromodulation MICHAEL P. PHALEN, EVP & President, MedSurg DAVID A. PIERCE, SVP & President, Endoscopy KAREN PRANGE, SVP & President, Urology & Women’s Health TIMOTHY A. PRATT, EVP, Chief Administrative Officer, General Counsel & Secretary BRAD SORENSON, SVP, Manufacturing & Supply Chain ERIC THÉPAUT, SVP & President, Europe

36

Medical Design & Outsourcing

TOP 11-25 100 List_9-15_Vs4.indd 36

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 6:04 PM

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

Learn more at MeritOEM.com

Merit 9-15.indd 15

9/15/15 3:34 PM

1OO

THE TOP 1OO MEDTECH COMPANIES

13

B. BRAUN MELSUNGEN

Werkanlage Pfieffewiesen Europagebäude Melsungen, Germany 34212 +49 (0 56 61) 71-0

www.bbraun.com

Employees: 54,017 Revenue: $7,219,739,120 R&D Spend: $290,672,420 Fiscal year ending: Dec. 31, 2014

MARKETS: IV Supplies, Intensive Care, Surgical, Orthopedics, Dialysis, Wound Care

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

14

DANAHER

2200 Pennsylvania Avenue, NW Suite 800W Washington, DC 20037 1 (202) 828-850

www.danaher.com

Employees: 71,000 Revenue: $7,168,968,000* R&D Spend: $507,000,000 Fiscal year ending: Dec. 31, 2014

MARKETS: Laboratory, Diagnostics, Dental

KEY PERSONNEL:

STEVEN M. RALES, Chairman MITCHELL P. RALES, Chairman, Executive Committee THOMAS P. JOYCE JR., President & CEO DANIEL L. COMAS, EVP & CFO MARK A. BECK, EVP WILLIAM K. DANIEL II, EVP JAMES A. LICO, EVP JAMES H. DITKOFF, SVP – Finance & Tax JONATHAN P. GRAHAM, SVP – General Counsel WILLIAM H. KING, SVP – Strategic Development ANGELA S. LALOR, SVP – HR ROBERT S. LUTZ, SVP – Chief Accounting Officer DANIEL A. RASKAS, SVP – Corporate Development * Revenues from Danaher’s Life Sciences & Diagnostics segment only.

38

Medical Design & Outsourcing

TOP 11-25 100 List_9-15_Vs4.indd 38

9 • 2015

www.medicaldesignandoutsourcing.com

© 20

9/17/15 6:04 PM

15

FRESENIUS MEDICAL CARE Else-Kroener-Strasse 1 Bad Homburg v.d.H, Germany 61352 +49 (0) 6172 608-0

www.fresenius.com

Employees: 32,899 Revenue: $6,842,636,200* R&D Spend: $485,340,200 Fiscal year ending: Dec. 31, 2014

MARKETS: Dialysis

KEY PERSONNEL:

ULF M. (MARK) SCHNEIDER, Chairman; 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; STEPHAN STURM, CFO; ERNST WASTLER, CEO Fresenius Vamed * Revenues from Fresenius Medical Care’s Fresenius Kabi division only.

Smart fluid handling to take you forward, faster.

Non-spill

RFID-enabled

Connector and quick disconnect solutions to meet your needs.

CPC thinks beyond the point of connection to improve patient safety and provide leak-free connections for your medical device and equipment designs.

• Designs prevent misconnections • Thousands of proven standard product choices • Custom connectors, including hybrids that transfer signal and fluid in one step Download the white paper at cpcworldwide.com/medical.

Fluid/signal hybrid © 2015 Colder Products Company

TOP 11-25 100 List_9-15_Vs4.indd 39

9/17/15 6:05 PM

1OO

THE TOP 1OO MEDTECH COMPANIES

16

ST. JUDE MEDICAL ONE ST JUDE MEDICAL DRIVE ST. PAUL, MINNESOTA 55117 (651) 756-2000

www.sjm.com/corporate.aspx

Employees: 16,000 Revenue: $5,622,000,000 R&D Spend: $692,000,000 Fiscal year ending: Jan. 3, 2015

MARKETS: Cardiovascular, Structural Heart, Chronic Pain, Neuromodulation/neurostimulation

KEY PERSONNEL:

DANIEL J. STARKS, Chairman, President & CEO JOHN C. HEINMILLER, EVP MICHAEL T. ROUSSEAU, COO LISA M. ANDRADE, VP, Chief Marketing Officer I. PAUL BAE, VP, Global HR & Chief Compliance Officer JOEL D. BECKER, President, Americas DR. MARK D. CARLSON, VP, Global Clinical Affairs & CMO JEFFREY A. DALLAGER, VP & Controller RACHEL H. ELLINGSON, VP, Global Communications DR. ERIC S. FAIN, President JEFF A. FECHO, VP, Global Quality DENIS M. GESTIN, President, International Division MARK W. MURPHY, VP, IT & CIO SCOTT P. THOME, VP, Global Operations & Supply Chain JASON A. ZELLERS, VP, General Counsel & Secretary DONALD J. ZURBAY, VP, Finance & CFO

17

3M CO.

3M Center St. St. Paul, MN 55144-1000 USA (651) 733-1110

www.3m.com/3M/en_US/health-care-us/?WT.mc_id=www.3m.com/healthcare

MARKETS: Hospital Supplies, Surgical, Infection Prevention, Dermatology, Drug Delivery, Dental, Healthcare IT

KEY PERSONNEL:

Employees: 89,800 Revenue: $5,572,000,000* R&D Spend: $1,770,000,000 Fiscal year ending: Dec. 31, 2014

INGE G. THULIN, Chairman, President & CEO JAMES L. BAUMAN, SVP, Business Transformation, Americas JULIE L. BUSHMAN, SVP, Business Transformation & Information Technology JOAQUIN DELGADO, EVP, Healthcare IVAN K. FONG, SVP, Legal Affairs & General Counsel NICHOLAS C. GANGESTAD, SVP & CFO IAN F. HARDGROVE, SVP, Corporate Communications & Enterprise Services PAUL A. KEEL, SVP, Supply Chain MICHAEL A. KELLY, EVP, Electronics & Energy ASHISH K. KHANDPUR, SVP, Research & Development & Chief Technology Officer JON T. LINDEKUGEL, SVP, Business Development FRANK R. LITTLE, EVP, Safety & Graphics Business Group MARLENE M. MCGRATH, SVP, HR MICHAEL F. ROMAN, EVP, Industrial Business Group HAK CHEOL SHIN, EVP, International Operations JESSE G. SINGH, SVP, Marketing & Sales MICHAEL G. VALE, EVP, Consumer * Revenues from 3M’s Healthcare division only.

40

Medical Design & Outsourcing

TOP 11-25 100 List_9-15_Vs4.indd 40

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 6:05 PM

18

ZIMMER-BIOMET 345 East Main Street Warsaw, IN 46580

(574) 267-6131

www.zimmer.com

MARKETS: Orthopedics, Prosthetic, Surgical, Hospital Supplies

KEY PERSONNEL:

Employees: 10,000 Revenue: $4,673,300,000 R&D Spend: $188,300,000 Fiscal year ending: Dec. 31, 2014

DAVID DVORAK President & CEO ROBIN T. BARNEY SVP, Global Operations & Logistics AUDREY BECKMAN SVP, Strategic Quality Initiatives TONY COLLINS, VP, Controller & Chief Accounting Officer DEREK DAVIS VP, Global Integration WILLIAM P. (BILL) FISHER SVP, Global HR DANIEL P. FLORIN: SVP & CFO ADAM R. JOHNSON President, Spine, Bone Healing, Dental, CMF & Thoracic STUART G. KLEOPFER: President, Americas DAVID J. KUNZ VP, Global Quality, Clinical & Regulatory Affairs KATARZYNA MAZUR-HOFSAESS, M.D., PH.D. President, EMEA DAVID A. NOLAN JR. President, Biologics, Extremities, Sports Medicine, Surgical, Trauma, Foot & Ankle CHAD PHIPPS SVP, General Counsel & Secretary DANIEL E. WILLIAMSON President, Joint Reconstruction, SANG YI: President, Asia Pacific

19

OLYMPUS CORP

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

MARKETS: Bariatric/gastroenterology, Surgical, Pulmonary/bronchoscopy, Urological, Women’s Health, ENT, Orthopedics, Endoscopic/arthroscopic

Employees: 30,702 Revenue: $4,655,721,581 R&D Spend: $631,700,397 Fiscal year ending: March 31, 2015

KEY PERSONNEL: YASUYUKI KIMOTO Chairman HIROYUKI SASA President & Representative Director YASUO TAKEUCHI Director, Senior Executive Managing Officer SHIGEO HAYASHI Director, Executive Managing Officer AKIHIRO TAGUCHI Senior Executive Managing Officer HARUO OGAWA; YASUSHI SAKAI; AKIRA KUBOTA; NOBUHIRO ABE: Executive Managing Officers SHINICHI NISHIGAKI; HITOSHI KAWADA; NAOHIKO KAWAMATA; NOBUYUKI KOGA; HISAO YABE; MASAMICHI HANDA; KEN YOSHIMASU; MASAHITO KITAMURA; TETSUO KOBAYASHI; KIICHI HIRATA; TOSHIHIKO OKUBO; MITSUHIRO HIKOSAKA; YOSHIHITO SHIMIZU; KATSUHIKO INADOMI; HIDENAO TSUCHIYA; YOSHITAKE SAITO: Executive Officers

www.medicaldesignandoutsourcing.com

TOP 11-25 100 List_9-15_Vs4.indd 41

9 • 2015

Medical Design & Outsourcing 41

9/17/15 6:05 PM

1OO

THE TOP 1OO MEDTECH COMPANIES

20

TERUMO

2-44-1 Hatagaya, Shibuya-ku, Tokyo, 151-0072 Japan +81-3-3374-8111

www.terumo.com

Employees: 19,934 Revenue: $4,629,336,107 R&D Spend: $278,040,477 Fiscal year ending: March 31, 2015

MARKETS: Cardiovascular, Vascular, Hospital Supplies, Blood Management

KEY PERSONNEL: KOJI NAKAO, Chairman YUTARO SHINTAKU, President HIROSHI MATSUMURA, President, General Hospital Co. TAKAYOSHI MIMURA, President & CEO, Terumo (China) Holdings AKIRA OGUMA, Senior Managing Executive Officer, General Affairs SHINJIRO SATO, President, Cardiac & Vascular HIDEO ARASE, Senior Executive Officer, Regional Representative, India and Asia Pacific KUNIKO SHOJI, General Manager, Regulatory Affairs Clinical Development Dept. TOSHIAKI TAKAGI, Senior Executive Officer, Quality Assurance DAVID PEREZ, President, Blood Management, President & CEO, Terumo BCT SHOUJI HATANO, General Manager, Strategic Planning KAZUAKI KITABATAKE, Senior Executive Officer, International, Investor Relations, Communications, Legal NARUSHIGE TODA, General Manager, Sales (Japan) YOSHIAKI AKAIKE, Vice President TSUYOSHI TOMITA, Vice President RYO NISHIHATA, General Manager, Treasury MARK SUTTER, President & CEO, Terumo Cardiovascular SOMSAK JARASVIRIYAGUL, Representative Director, Thailand KYO NISHIKAWA, Chairman, Terumo Europe HIROSHI NAKAGOMI, General Manager, Quality Assurance MASATAKA HARAGUCHI, Branch Manager, Tokyo JUICHI TAKEUCHI, President & CEO, Terumo Americas RICHARD CAPPETTA, President, Neurovascular, President & CEO, MicroVention SEIJI KAWABATA, General Manager, Business Promotion (Japan) MASATO NISHIMURA, General Manager, Production Technology Center HIRAKU MURAYAMA, Vice President, Interventional Systems KOSUKE MATSUMOTO, General Manager, HR MASANORI HOSHINO, President, Terumo Clinical Supply HIROSHI NAGUMO, SVP & General Manager (Japan), Terumo BCT JAMES RUSHWORTH, Regional President (U.S.), President & CEO, Terumo Medical HIROAKI KASUKAWA, General Manager, R&D headquarters YOSHIHIRO KIMURA, General Manager, Internal Audit TAKANORI SHIBAZAKI, General Manager, Supply Chain Management HIKARU SAMEJIMA, President, Interventional Systems KAZUHIRO UCHIDA, GM, Intellectual Property TETSUYA KUMEI, President, D&D Division

21

SMITH AND NEPHEW 15 ADAM STREET LONDON ENGLAND X0 WC2N 6LA www.smith-nephew.com

MARKETS: Orthopedics, Prosthetic, Surgical, Wound Care

KEY PERSONNEL:

Employees: 13,468 Revenue: $4,617,000,000 R&D Spend: $235,000,000 Fiscal year ending: Dec. 31, 2014

OLIVIER BOHUON CEO JULIE BROWN CFO RODRIGO BIANCHI President, IRAMEA JACK CAMPO Chief Legal Officer PHIL COWDY SVP, Corporate 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 Corporate Development Officer ANTONY (TONY) RAYMENT President, Australia, New Zealand & Japan ARJUN RAJARATNAM Chief Compliance Officer SUSAN SWABEY Secretary GLENN WARNER President, Advanced Wound Management

42

Medical Design & Outsourcing

TOP 11-25 100 List_9-15_Vs4.indd 42

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 6:43 PM

22

HOSPIRA

275 North Field Drive Lake Forest, Illinois 60045 (224) 212-2000

www.hospira.com/en/

MARKETS: IV Supplies, Drug Delivery, Healthcare IT

KEY PERSONNEL:

Employees: 19,000 Revenue: $4,463,700,000 R&D Spend: $344,300,000 Fiscal year ending: Dec. 31, 2014

F. MICHAEL BALL CEO ROYCE R. BEDWARD SVP, General Counsel and Secretary DAVID J. ENDICOTT President, Medical Devices RICHARD J. DAVIES SVP & Chief Commercial Officer MARY A. GENDRON SVP & CIO ZENA G. KAUFMAN SVP, Quality KENNETH F. MEYERS SVP, Chief HR Officer DR. SUMANT RAMACHANDRA SVP, Chief Scientific Officer BRIAN J. SMITH VP, Special Counsel MATTHEW R. STOBER SVP, Operations THOMAS E. WERNER SVP, Finance & CFO MARC J. YOSKOWITZ SVP, Strategy & Corporate Development RICHARD J. HOFFMAN Vice President, Controller & Chief Accounting Officer

23

GRIFOLS

Avinguda de la Generalitat, 152-158 Parc de Negocis Can Sant Joan Sant Cugat del Vallès Barcelona, Spain 08174 www.grifols.com/en/web/international/home

Employees: 13,980 Revenue: $4,461,654,105 R&D Spend: $240,347,264 Fiscal year ending: Dec. 31, 2014

KEY PERSONNEL:

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

www.medicaldesignandoutsourcing.com

TOP 11-25 100 List_9-15_Vs4.indd 43

9 • 2015

Medical Design & Outsourcing 43

9/17/15 6:06 PM

1OO

THE TOP 1OO MEDTECH COMPANIES

24

GETINGE GROUP

P.O. Box 8861, SE-402 72, Gothenburg E-mail: info@getinge.com Phone: +46 10 335 0000

www.getingegroup.com

Employees: 15,839 Revenue: $3,888,969,902 R&D Spend: $3,937,238 Fiscal year ending: Sept. 30, 2014

MARKETS: Surgical, Intensive Care, Infection Prevention, Patient Care and Mobility, Wound Care

KEY PERSONNEL: ALEX MYERS, President & CEO ULF GRUNANDER, CFO HEINZ JACQUI, EVP, Medical Systems JOACIM LINDOFF, EVP, Infection Control ANDREAS QUIST, EVP, HR & Sustainability HARALD F. STOCK, EVP, Extended Care business area

25

CERNER

2800 Rockcreek Parkway North Kansas City, MO 64117 +1-816-221-1024

MARKETS: Healthcare IT

KEY PERSONNEL:

www.cerner.com

Employees: 15,800 Revenue: $3,402,703,000 R&D Spend: $392,805,000 Fiscal year ending: January 3, 2015

NEAL L. PATTERSON, Chairman & CEO CLIFFORD W. ILLIG, Vice Chairman ZANE M. BURKE, President MARC G. NAUGHTON, EVP & CFO MICHAEL R. NILL, EVP & COO RANDY D. SIMS, SVP, Chief Legal Officer & Secretary JEFFREY A. TOWNSEND, EVP & Chief of Staff JULIE M. WILSON, EVP & Chief People Officer

44

Medical Design & Outsourcing

TOP 11-25 100 List_9-15_Vs4.indd 44

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 6:06 PM

Bishop Wisecarver 9-15.indd 15

9/16/15 10:15 AM

1OO

THE TOP 1OO MEDTECH COMPANIES

26

C.R. BARD

730 CENTRAL AVE MURRAY HILL, NJ 07974

www.crbard.com

(908) 277-8000

MARKETS: Hospital Supplies, Imaging/radiology, Urological, Women’s Health, Bariatric/gastroenterology, Patient Monitoring, Respiratory, Wound Care, Vascular, Peripheral Vascular, Endoscopic/arthroscopic, Surgical

KEY PERSONNEL:

Employees: 13,900 Revenue: $3,323,600,000 R&D Spend: $302,000,000 Fiscal year ending: Dec. 31, 2014

TIMOTHY M. RING, Chairman & CEO JOHN H. WEILAND, President & COO CHRISTOPHER S. HOLLAND, SVP & CFO JIM C. BEASLEY, Group President TIMOTHY P. COLLINS, Group President JOHN P. GROETELAARS, Group VP SHARON M. LUBOFF, Group VP JOHN A. DEFORD, SVP, Science, Technology & Clinical Affairs SAMRAT S. KHICHI, SVP, General Counsel & Secretary PATRICIA G. CHRISTIAN, VP, Quality, Regulatory & Medical Affairs BETTY D. LARSON, VP, HR FRANK LUPISELLA JR., VP & Controller

27

HITACHI

6-6, Marunouchi 1-chome, Chiyoda-ku, Tokyo, 100-8280

www.hitachimed.com

+81-3-3258-1111

Employees: 5,700 Revenue: $3,195,574,050* R&D Spend: $3,172,876,868 Fiscal year ending: March 31, 2015

MARKETS: Imaging/radiology

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 Division DAVID R. FAMIGLIETTI, President & General Manager 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 R. BARASO, Manager, Business Development & Strategy KRISTEN PROVO, HR Manager JOHN WADDELL, National Sales Manager

* Revenues from Hitachi’s Healthcare Business segment only.

28

BAYER

BAYERWERK, GEBAEUDE W11 KAISER-WILHELM-ALLEE LEVERKUSEN 2M D-51368

www.bayer.com/en/homepage.aspx

492143081933

Employees: 60,700 Revenue: $3,138,092,000* R&D Spend: $3,059,639,700 Fiscal year ending: Dec. 31, 2014

MARKETS: Vision, Infection Prevention

KEY PERSONNEL:

MARIJN DEKKERS, Chairman & CEO WERNER BAUMANN, Chairman, Bayer HealthCare AXEL BOUCHON, Head of Business Development & Licensing DR. MICHAEL DEVOY, Chief Medical Officer, Bayer HealthCare ANDREAS GÜNTHER, Head, HR, Bayer HealthCare ALAN MAIN, Head, Medical Care Division

* Revenues from Bayer’s Medical Care division only.

46

Medical Design & Outsourcing

TOP 26-100 100 List_9-15_Vs5.indd 46

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 8:19 PM

29

MCKESSON

One Post Street, San Francisco, California 94104 (415) 983-8300

www.mckesson.com/

Employees: 70,400 Revenue: $3,069,000,000 R&D Spend: $392,000,000 Fiscal year ending: March 31, 2015

MARKETS: Healthcare IT

KEY PERSONNEL:

JOHN H. HAMMERGREN, Chairman, President & CEO JAMES BEER, EVP & CFO PATRICK J. BLAKE, EVP & Group President JORGE L. FIGUEREDO, EVP, HR PAUL C. JULIAN, EVP & Group President BANSI NAGJI, EVP, Corporate Strategy & Business Development LORI A. SCHECHTER, EVP, General Counsel & Chief Compliance Officer

30

VARIAN MEDICAL SYSTEMS 3100 HANSEN WAY PALO ALTO CA 94304-1000 (650) 424-5834

www.varian.com

Employees: 6,800 Revenue: $3,049,800,000 R&D Spend: $234,800,000 Fiscal year ending: Sept. 26, 2014

KEY PERSONNEL:

DOW R. WILSON, President & CEO ELISHA W. FINNEY, EVP, Finance & CFO KOLLEEN T. KENNEDY, EVP, Oncology Systems JOHN W. KUO, SVP, General Counsel & Corporate Secretary SUNNY S. SANYAL, SVP & President, Imaging Components Business CLARENCE R. VERHOEF, SVP, Finance & Corporate Controller

31

DENTSPLY INTERNATIONAL

Susquehanna Commerce Center 221 W. Philadelphia St. York, PA 17405 (717) 845-7511

www.dentsply.com/en-us

Employees: 11,600 Revenue: $2,922,620,000 R&D Spend: $80,800,000 Fiscal year ending: Dec. 31, 2014

MARKETS: Dental

KEY PERSONNEL:

BRET W. WISE, Chairman of the Board & CEO CHRISTOPHER T. CLARK, President & CFO JAMES G. MOSCH, EVP & COO; DEBORAH M. RASIN, VP, General Counsel & Secretary ROBERT J. SIZE, SVP; Albert J. Sterkenburg, SVP MAUREEN J. MACINNIS, VP, Chief HR Officer WILLIAM E. REARDON, VP & Treasurer ROBERT J. WINTERS, VP, Tax Richard M. Wagner, VP & Corporate Controller DEREK W. LECKOW, VP, Investor Relations TERESA A. DOLAN, DDS, MPH, VP & Chief Clinical Officer

www.medicaldesignandoutsourcing.com

TOP 26-100 100 List_9-15_Vs5.indd 47

9 • 2015

Medical Design & Outsourcing 47

9/17/15 8:22 PM

1OO

THE TOP 1OO MEDTECH COMPANIES

32

HOYA

2-7-5 Naka-Ochiai, Shinjuku-ku, Tokyo 161-8525 Japan

www.hoya.co.jp/english/index.html

MARKETS: Vision, Endoscopic/arthroscopic

Employees: 36,605 Revenue: $2,900,066,200 R&D Spend: $175,250,615 Fiscal year ending: March 31, 2015

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

* Revenues from Hoya’s Life Care segment only.

33

SHIP HEALTHCARE HOLDINGS INC. 3-20-8 Kasuga Suita Osaka, 565-0853 Japan

www.bloomberg.com/profiles/companies/3360:JP-ship-healthcare-holdings-inc

MARKETS: Hospital Supplies

Employees: 7,600 Revenue: $2,584,896,917 Fiscal year ending: March 31, 2015

KEY PERSONNEL: KUNIHISA FURUKAWA, Chairman & CEO; HIROTAKA OGAWA, President & COO FUTOSHI OHASHI, EVP KOICHI OKIMOTO, Senior Managing Director HIROYUKI KOBAYASHI, Senior Managing Director JUN MASUDA, Senior Managing Director HIROSHI YAMAMOTO, Senior Managing Director HIROSHI YOKOYAMA, Managing Director

34

HOLOGIC

35 CROSBY DRIVE BEDFORD MA 01730 www.hologic.com

MARKETS: Wound Care, Diagnostics, Women’s Health

KEY PERSONNEL:

Employees: 5,351 Revenue: $2,530,700,000 R&D Spend: $203,200,000 Fiscal year ending: Sept. 27, 2014

STEPHEN P. MACMILLAN, Chairman, President & CEO ROBERT W. MCMAHON, CFO ALLISON BEBO, SVP, HR; ERIC B. COMPTON, COO CLAUS EGSTRAND, President, International JOHN M. GRIFFIN, General Counsel JAY A. STEIN, Co-founder, Chairman Emeritus, SVP & CTO PETER J. VALENTI III, President, Breast & Skeletal Health THOMAS A. WEST, President, Diagnostics Solutions

48

Medical Design & Outsourcing

TOP 26-100 100 List_9-15_Vs5.indd 48

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 8:22 PM

35

PAUL HARTMANN GROUP PAUL HARTMANN AG Paul-Hartmann-Straße 12 89522 Heidenheim

us.hartmann.info

+49-7321 36-0

Employees: 10,216 Revenue: $2,475,901,400 Fiscal year ending: Dec. 31, 2014

MARKETS: Wound Care, Ostomy Care, Infection Prevention, Surgical

KEY PERSONNEL:

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

36

EDWARDS LIFESCIENCES One Edwards Way Irvine, CA 92614

www.edwards.com/Pages/Default.aspx

Employees: 9,100 Revenue: $2,322,900,000 Foreign Revenue: ¥337,900,000,000 R&D Spend: $346,500,000 Fiscal year ending: Dec. 31, 2014

MARKETS: Surgical, Structural Heart

KEY PERSONNEL:

MICHAEL A. MUSSALLEM, Chairman & CEO SCOTT B. ULLEM, VP, CFO DIRKSEN J. LEHMAN, VP, Public Affairs DONALD E. BOBO JR., VP, Heart Valve Therapy, Strategy & Development RICH LUNSFORD, VP, Healthcare Solutions CHRISTINE Z. MCCAULEY, VP, HR JOHN P. MCGRATH, VP, Quality, Regulatory, Clinical STANTON J. ROWE, VP, Advanced Technology & Chief Scientific Officer KATIE SZYMAN, VP, Critical Care & Vascular PATRICK B. VERGUET, VP, EMEA, Canada & Latin America DR. HUIMIN WANG, VP, Japan, Asia & Pacific AIMEE S. WEISNER, VP, General Counsel LARRY L. WOOD, VP, Transcatheter Heart Valves

37

BECTON, DICKINSON & CO. 1 Becton Drive Franklin Lakes, New Jersey 07417-1880 www.bd.com

MARKETS: Urological, Robot-assisted Surgery, IV Supplies, Intensive Care, Diagnostics, Hospital Supplies

KEY PERSONNEL:

Employees: 30,619 Revenue: $2,307,000,000* R&D Spend: $550,000,000 Fiscal year ending: Sept. 30, 2014

VINCENT A. FORLENZA, Chairman, President & CEO; GARY M. COHEN, EVP & President, Global Health; ALEXANDRE CONROY, EVP & President, Europe & EMA & Americas; JEROME V. HURWITZ, EVP & Chief HR Officer; WILLIAM A. KOZY, EVP & COO; JAMES LIM, EVP & President, Greater Asia; THOMAS POLEN, EVP & President, Medical Segment; CHRISTOPHER R. REIDY, CFO & EVP, Administration; NABIL SHABSHAB, EVP & Chief Marketing Officer; JEFFREY S. SHERMAN, EVP & General Counsel; STEPHEN SICHAK, EVP & Chief Integrated Supply Chain Officer; ELLEN R. STRAHLMAN, EVP, R&D & CMO; LINDA THARBY, EVP & President, Life Sciences; PIERRE BOISIER, EVP & Chief Quality Officer; RICHARD J. NAPLES, EVP & Chief Regulatory Officer; GARY M. DEFAZIO, VP & Secretary; JOHN E. GALLAGHER, VP, Finance, Treasurer & Controller; DAVID W. HIGHET, VP, Chief Intellectual Property Counsel & Assistant Secretary; PATTI E. RUSSELL, VP & Chief Ethics & Compliance Officer; ANTOINETTE F. SEGRETO, VP, Tax; DAVID SINGER, Assistant Secretary; ROBERT THIBEAULT, Assistant Secretary; PATRICIA A. WALESIEWICZ, Assistant Secretary

* Revenues from Becton, Dickinson’s BD Medical segment only. www.medicaldesignandoutsourcing.com

TOP 26-100 100 List_9-15_Vs5.indd 49

9 • 2015

Medical Design & Outsourcing 49

9/17/15 8:23 PM

1OO

THE TOP 1OO MEDTECH COMPANIES

38

BIOMERIEUX 69280 Marcy l’Etoile, France

33 04 78 87 20 00

www.biomerieux-usa.com/

Employees: 8,935 Revenue: $2,257,830,600 Fiscal year ending: Dec. 31, 2014

MARKETS: Diagnostics

KEY PERSONNEL:

JEAN-LUC BELINGARD, Chairman ALEXANDRE MÉRIEUX, CEO MICHEL BAGUENAULT, VP, HR & Communications NICOLAS CARTIER, VP, Industry Unit, Group Portfolio & Strategic Planning PIERRE CHARBONNIER, VP, Manufacturing & Supply Chain RICHARD DING, VP, Asia Pacific CLAIRE GIRAUT, VP & CFO 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, VP, Americas, Chief Legal Officer

39

NIPRO

3-9-3 HONJO-NISHI KITA-KU OSAKA 531-8510 JAPAN (908) 393-7030

MARKETS: Dialysis, Hospital Supplies

KEY PERSONNEL:

200 Crossing Blvd.

Bridgewater, NJ 08807 www.nipro.com

Employees: 2,831 Revenue: $2,248,694,912 Fiscal year ending: March 31, 2015

YOSHIHIKO SANO, President, Representative Director TOSHIAKI MASUDA, Managing Director, Director of General Research Institute MAKOTO SATO, Managing Director, Chief Director of Medicine Business, Director of Business Promotion, Chairman of the Board in Subsidiary, Director KAZUO WAKATSUKI, Managing Director, Director of International Business KIYOTAKA YOSHIOKA, Managing Director, Director of Domestic Business, Manager of Business Strategy Office KENJU FUJITA, Director of Medical Sales in Main Domestic Business Unit, Director MASAYUKI ITO, Director of 1st Product Development & Sales in Main Product Development & Sales Unit of Domestic Business Unit, Director YASUSHI KUTSUKAWA, Chief Director of Medical Sales in Domestic Business Unit, Director AKIO SHIRASU, Director of Product Development & Sales in International Business Unit, Director MITSUTAKA UEDA, Chief Director of Product Development & Sales in Domestic Business Unit, Director of Medical Equipment Development & Sales, Director

40

COLOPLAST Holtedam 1 3050 Humlebæk Denmark www.coloplast.us

MARKETS: Continence Care, Vascular, Wound Care, IV Supplies, Ostomy Care

KEY PERSONNEL:

Employees: 9,250 Revenue: $2,213,317,661 R&D Spend: $69,455,575 Fiscal year ending: Sept. 30, 2014

LARS RASMUSSEN, President & CEO; ANDERS LONNINGSKOVGAARD, EVP; ALLAN RASMUSSEN, EVP; Kristian Villumsen, EVP

50

Medical Design & Outsourcing

TOP 26-100 100 List_9-15_Vs5.indd 50

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 8:23 PM

41

BIO-RAD

1000 Alfred Nobel Drive, Hercules, California 94547 (510) 724-7000

www.bio-rad.com/

Employees: 7,600 Revenue: $2,175,044,000 R&D Spend: $220,333,000 Fiscal year ending: Dec. 31, 2014

KEY PERSONNEL:

NORMAN SCHWARTZ, Chairman, President & CEO JOHN GOETZ, EVP, COO GIOVANNI MAGNI, EVP, Chief Strategy Officer CHRISTINE TSINGOS, EVP, CFO SHAWN M. SODERBERG, EVP, General Counsel & 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, Corporate Controller

42

INTUITIVE SURGICAL 1020 KIFER ROAD SUNNYVALE CA 94086 (408) 523-2100

www.intuitivesurgical.com

Employees: 2,978 Revenue: $2,131,700,000 R&D Spend: $178,000,000 Fiscal year ending: Dec. 31, 2014

MARKETS: Robot-assisted Surgery

KEY PERSONNEL:

GARY S. GUTHART, President & CEO; MARSHALL L. MOHR, SVP & CFO; JAMIE E. SAMATH, VP, Corporate Controller, & Principal Accounting Officer; LONNIE M. SMITH, Chairman

43

DRAEGERWERK Thomas Fischler Moislinger Allee 53-55 23558 Lübeck 1-800-437-2437

Draeger Medical Inc. 3135 Quarry Road Telford, PA 18969

www.draeger.com/sites/enus_us/Pages/default.aspx

MARKETS: Respiratory, Pediatrics, Patient Monitoring, Hospital Supplies, Patient Care and Mobility, Healthcare IT, OEM

KEY PERSONNEL:

Employees: 7,458 Revenue: $2,108,106,380* R&D Spend: $201,715,490 Fiscal year ending: Dec. 31, 2014

STEFAN DRÄGER, Chairman GERT-HARTWIG LESCOW, Member, Executive Board, Finance ANTON SCHROFNER, Member, Executive Board WOLFGANG REIM, Head, Medical Technology

* Revenues from Draegerwerk’s Medical segment only.

www.medicaldesignandoutsourcing.com

TOP 26-100 100 List_9-15_Vs5.indd 51

9 • 2015

Medical Design & Outsourcing 51

9/17/15 8:23 PM

1OO

THE TOP 1OO MEDTECH COMPANIES

44

WATERS

34 Maple Street, Milford, Massachusetts 01757

www.waters.com/waters/home.htm?locale=en_US

Employees: 6,200 Revenue: $1,989,344,000 R&D Spend: $107,726,000 Fiscal year ending: Dec. 31, 2014

MARKETS: Laboratory

KEY PERSONNEL:

CHRISTOPHER J. O’CONNELL, President & CEO; EUGENE G. CASSIS, VP & CFO; ARTHUR G. CAPUTO, EVP & President, Waters Division; ELIZABETH B. RAE, VP, HR; EUGENE G. CASSIS, VP, CFO; MARK T. BEAUDOUIN, VP & General Counsel; TERRENCE P. KELLY, President, TA Instruments

45

ABBOTT LABORATORIES 100 ABBOTT PARK ROAD D-322 AP6D ABBOTT PARK IL 60064-3500 (847) 937-6100

www.abbott.com

Employees: 77,000 Revenue: $1,958,000,000 R&D Spend: $1,345,000,000 Fiscal year ending: Dec. 31, 2014

MARKETS: Diagnostics, Veterinary, Women’s Health, Vascular, Diabetes, Structural Heart

KEY PERSONNEL:

MILES D. WHITE, Chairman & CEO; HUBERT L. ALLEN, EVP, General Counsel & Secretary; RICHARD W. ASHLEY, EVP, Corporate Development; BRIAN J. BLASER, EVP, Diagnostics Products; JOHN M. CAPEK, EVP, Medical Devices; THOMAS C. FREYMAN, EVP, Finance & CFO; STEPHEN R. FUSSELL, EVP, HR; HEATHER L. MASON, EVP, Nutritional Products, Global Commercial Operations; MICHAEL J. WARMUTH, EVP, Established Pharmaceuticals; JAIME CONTRERAS, SVP, Core Laboratory Diagnostics, Commercial Operations; GEORGES H. DE VOS, SVP, Established Pharmaceuticals, Emerging Markets; CHARLES D. FOLTZ, SVP, Abbott Vascular; ROBERT FORD, SVP, Diabetes Care; JEAN-YVES F. PAVEE, SVP, Established Pharmaceuticals, Developed Markets; DANIEL SALVADORI, SVP, Established Pharmaceuticals, Latin America; MURTHY V. SIMHAMBHATLA, SVP, Abbott Medical Optics; J. SCOTT WHITE, SVP, International Nutrition; ROBERT E. FUNCK, VP, Controller

46

MIRACA HOLDINGS

Shinjuku Mitsui Building 8th floor, 2-1-1 Nishishinjuku, Shinjuku-ku, Tokyo 163-0408 +81-3-5909-3335

MARKETS: Diagnostics, Laboratory, Sterilization

KEY PERSONNEL:

www.miraca-holdings.co.jp/eng/

Employees: 6,104 Revenue: $1,935,568,375 R&D Spend: $51,068,659 Fiscal year ending: March 31, 2015

HIROMASA SUZUKI, President & CEO SHINJI OGAWA, Representative Senior Executive Officer (Assistant to CEO) HIROMITSU TAZAWA, Senior Executive Officer (Legal Affairs & CSR) TAKESHI KOYAMA, Managing Executive Officer (Global IVD) HIROAKI KIMURA, Executive Officer (IR, General Affairs, & Information Technology) NAOKI KITAMURA, Executive Officer (Finance & Corporate Strategy) SHIGETO OHTSUKI, Executive Officer (HR & Internal Control)

52

Medical Design & Outsourcing

TOP 26-100 100 List_9-15_Vs5.indd 52

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 8:24 PM

47

ACELITY

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

Employees: 5,740 Revenue: $1,866,339,000 R&D Spend: $69,321,000 Fiscal year ending: Dec. 31, 2014

KEY PERSONNEL:

JOE WOODY, President & CEO JOHN BIBB, EVP & General Counsel PETER HUNTLEY, SVP, Emerging Markets DAVID BALL, SVP, Operations, Acelity DR. RON SILVERMAN, SVP & CMO LAURA PICCININI, President, Developed Markets BUTCH HULSE Chief Compliance Officer & SVP, Enterprise Risk Management GREG KAYATA, SVP, HR TOM CASEY, EVP & CFO GAURAV AGARWAL, President, Businesses & Innovation

48

SONOVA HOLDING Laubisrütistrasse 28 8712 Stäfa Switzerland +41 58 928 33 33

www.sonova.com/en

Employees: 9,960 Revenue: $1,861,505,970 R&D Spend: $119,731,486 Fiscal year ending: March 31, 2015

MARKETS: Hearing

KEY PERSONNEL:

LUKAS BRAUNSCHWEILER, CEO HARTWIG GREVENER, CFO CLAUDE DIVERSI, VP Wholesale, Europe & South America HANSJÜRG EMCH, Group VP, Medical MARTIN GRIEDER, Group VP, Phonak SARAH KREIENBÜHL, Group VP, HR & Communications STEFAN LAUNER, VP, Science & Technology ALBERT CHIN-HWEE LIM, VP, Wholesale, Asia/Pacific HANS MEHL, VP, Operations JAN METZDORFF, VP, Unitron FRANZ PETERMANN, VP, Connect Hearing Group PAUL THOMPSON, VP, Wholesale, North & Central America ANDI VONLANTHEN, VP, R&D

49

STERIS

5960 HEISLEY ROAD MENTOR OH 44060 US www.steris.com

Employees: 7,600 Revenue: $1,850,263,000 R&D Spend: $54,139,000 Fiscal year ending: March 31, 2015

MARKETS: Sterilization, Laboratory

KEY PERSONNEL:

KATHLEEN L. BARDWELL, SVP & Chief Compliance Officer SUZANNE V. FORSYTHE, VP, HR DAVID A. JOHNSON, SVP, Surgical Solutions ROBERT E. MOSS, SVP & President, Steris Isomedix Services & Life Sciences SUDHIR K. PAHWA, SVP, Infection Prevention Technologies WALTER M ROSEBROUGH JR., President & CEO MICHAEL J. TOKICH, SVP, CFO & Treasurer J. ADAM ZANGERLE, VP, General Counsel & Secretary

www.medicaldesignandoutsourcing.com

TOP 26-100 100 List_9-15_Vs5.indd 53

9 • 2015

Medical Design & Outsourcing 53

9/17/15 8:24 PM

1OO

THE TOP 1OO MEDTECH COMPANIES

50

TELEFLEX

550 E Swedesford Rd Suite 400 Wayne Pa 19087 US

www.teleflex.com/en/usa/index.html

Employees: 11,700 Revenue: $1,839,832,000 R&D Spend: $61,040,000 Fiscal year ending: Dec. 31, 2014

MARKETS: Cardiovascular, Respiratory, Surgical, Urological, Vascular, OEM

KEY PERSONNEL:

BENSON F. SMITH, Chairman, President & CEO LIAM KELLY, EVP & President, Americas THOMAS E. POWELL, EVP & CFO TONY KENNEDY, SVP, Global Operatons CAMERON HICKS, VP, Global HR JAMES J. LEYDEN, VP, General Counsel & Secretary KAREN BOYLAN, Global Regulatory Affairs & Quality Assurance JOHN DEREN, VP, Finance & Corporate Controller TIMOTHY F. DUFFY, VP & CIO JAKE ELGUICZE, Treasurer & VP, Investor Relations GWEN WATANABE, VP, Business Development & Technical Resources GREGG W. WINTER, VP, Tax

51

CONVATEC

200 Headquarters Park Drive Skillman, NJ 08558

Mühlentalstrasse 36 8200 Schaffhausen Switzerland

1-800-422-8811; +0041 52 630 54 00; +45 4816 7000

Åholmvej 1-3, Osted 4320 Lejre Denmark

www.convatec.com/

Employees: 9,000 Revenue: $1,735,500,000 R&D Spend: $37,200,000 Fiscal year ending: Dec. 31, 2014

MARKETS: Ostomy Care, Wound Care, Hospital Supplies, Dermatology

KEY PERSONNEL:

PAUL MORAVIEC, CEO; Nigel Clerkin, CFO TODD BROWN, CEO & Founder, 180 Medical ROBBIE HEGINBOTHAM, SVP, Operations JOHN MAGNUS LINDSKOG, President, Infusion Devices, Asia Pacific, & CCC MARK VALENTINE, President, Americas FIONA ADAM, VP & General Manager, Wound Therapeutics STEPHEN BISHOP, VP, R&D MADS HAUGAARD, VP & General Manager, Continence & Critical Care DOUGLAS LEFORT, VP & General Manager, Ostomy Care ADAM DEUTSCH, SVP & General Counsel ROBERT STEELE, VP, Quality, Regulatory & Clinical Affairs JOSEPH ROLLEY, VP, Government Affairs & Health Policy

52

THE COOPER COS.

6140 Stoneridge Mall Road, Suite 590 Pleasanton, CA 94588 (925) 460-3600

MARKETS: Women’s Health, Vision

KEY PERSONNEL:

www.coopercos.com

Employees: 9,000 Revenue: $1,717,776,000 R&D Spend: $66,259,000 Fiscal year ending: Oct. 31, 2014

ROBERT S. WEISS, President & CEO DANIEL G. MCBRIDE, EVP, COO & President, CooperVision CAROL R. KAUFMAN, EVP, Secretary, Chief Administrative Officer & Chief Governance Officer GREG W. MATZ, SVP, CFO & Chief Risk Officer ALBERT G. WHITE III, SVP & Chief Strategy Officer PAUL L. REMMELL, President & CEO, CooperSurgical

54

Medical Design & Outsourcing

TOP 26-100 100 List_9-15_Vs5.indd 54

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 8:24 PM

53

HILL-ROM HOLDINGS 1069 State Route 46 East Batesville, Indiana (812) 934-7777

www.hill-rom.com/usa/

Employees: 7,000 Revenue: $1,686,100,000 R&D Spend: $71,900,000 Fiscal year ending: Sept. 30, 2014

MARKETS: Patient Care and Mobility, Hospital Supplies, Healthcare IT

KEY PERSONNEL:

JOHN J. GREISCH, President & CEO CARLOS ALONSO, SVP & President, Hill-Rom International MICHIEL DE ZWAAN, SVP, Chief HR Officer ANDREAS G. FRANK, SVP, Corporate Development & Strategy RICHARD G. KELLER, VP, Controller & Chief Accounting Officer BRIAN LAWRENCE, CTO SUSAN R. LICHTENSTEIN, SVP, Corporate Affairs & Chief Legal Officer MICHAEL MACEK, Treasurer MICHAEL J. MURPHY, SVP, Quality Assurance & Regulatory Affairs BLAIR A. (ANDY) RIETH, VP, Investor Relations ALTON SHADER, SVP & President, Hill-Rom North America ILANA SHULMAN, Chief Compliance Officer TAYLOR SMITH, SVP & President, Surgical & Respiratory Care CARLYN D. SOLOMON, COO STEVEN J. STROBEL, SVP, CFO

54

RESMED

9001 Spectrum Center Blvd.

San Diego, CA 92123 (858) 836-5000

www.resmed.com/us/en/consumer.html

Employees: 4,100 Revenue: $1,678,912,000 R&D Spend: $114,865,000 Fiscal year ending: June 30, 2015

MARKETS: Respiratory

KEY PERSONNEL:

MICHAEL J. FARRELL, CEO Robert Douglas, President & COO GREG PEAKE, President, Sleep Disordered Breathing & Consumer LUKE MAGUIRE, President, Cardio-Respiratory Care RAJ SODHI, President, Healthcare Informatics JIM HOLLINGSHEAD, President, Americas ANNE REISER, President, Europe & Asia Pacific DON DARKIN, President, Innovation & Operations BRETT SANDERCOCK, CFO DAVID PENDARVIS, Chief Administrative Officer & Global General Counsel

55

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

Employees: 12,000 Revenue: $1,672,100,000 R&D Spend: $33,600,000 Fiscal year ending: Dec. 31, 2014

KEY PERSONNEL:

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

www.medicaldesignandoutsourcing.com

TOP 26-100 100 List_9-15_Vs5.indd 55

9 • 2015

Medical Design & Outsourcing 55

9/17/15 8:24 PM

1OO

THE TOP 1OO MEDTECH COMPANIES

56

BRUKER

40 MANNING RD BILLERICA MA 01821

MARKETS: Laboratory

KEY PERSONNEL:

(978) 663-3660

www.bruker.com

Employees: 6,200 Revenue: $1,571,900,000 R&D Spend: $174,200,000 Fiscal year ending: Dec. 31, 2014

FRANK H. LAUKIEN, Chairman, President & CEO CHARLES F. WAGNER JR., EVP & CFO MICHAEL G. KNELL, VP, Finance & Chief Accounting Officer THOMAS W. BACHMANN, President, BioSpin Group MARK R. MUNCH, President, NANO Group JUERGEN SREGA, President, CALID Group

TOP 26-100 100 List_9-15_Vs5.indd 56

9/17/15 8:24 PM

57

ELEKTA

BOX 7593 10393 STOCKHOLM SWEDEN V7 00000 (858) 836-5000

www.elekta.com

MARKETS: Imaging/radiology, Neuromodulation/neurostimulation, Oncology, Healthcare IT, Brachytherapy

KEY PERSONNEL:

Employees: 3,800 Revenue: $1,559,437,704 R&D Spend: $126,283,248 Fiscal year ending: May 31, 2015

TOMAS PUUSEPP: President & CEO IAN ALEXANDER: EVP, Europe, Africa, Latin America, Middle East HÅKAN BERGSTRÖM: CFO JAMES P. HOEY: EVP, North America JOHN LAPRÉ: EVP Elekta Brachytherapy TODD POWELL: EVP Elekta Software JOHAN SEDIHN: COO GILBERT WAI: EVP Region Asia Pacific MAURITS WOLLESWINKEL: EVP Elekta Neuroscience BILL YAEGER: EVP Elekta Oncology

58

NIHON KOHDEN 1-31-4 Nishiochiai, Shinjuku-ku, Tokyo 161-8560

+81 (3) 5996-8036 www.nihonkohden.com

Employees: 4,616 Revenue: $1,520,739,550 Fiscal year ending: March 31, 2015

MARKETS: Patient Monitoring, Surgical, Veterinary

KEY PERSONNEL:

FUMIO SUZUKI: Chairman & CEO HIROKAZU OGINO: President & COO, General Manager, Marketing Strategy Department HIROSHI AIDA: Executive Operating Officer, General Manager, Import Business Operations YOSHITO TSUKAHARA: Senior Operating Officer, General Manager, Wellcare Business Division TAKASHI TAMURA: Senior Operating Officer, General Manager, Customer Service Operations TADASHI HASEGAWA: Senior Operating Officer, Responsible for Accounting, Legal Affairs & HR

59

WILLIAM DEMANT HOLDING Kongebakken 9 DK-2765 Smørum Denmark +45 3917 7300

www.demant.com

Employees: 9,799 Revenue: $1,490,801,589* R&D Spend: $121,102,028 Fiscal year ending: Dec. 31, 2014

MARKETS: Hearing

KEY PERSONNEL: NIELS JACOBSEN, President & CEO SVEND THOMSEN, Head of Finance

* Revenues from William Demant Holding’s hearing segments only.

www.medicaldesignandoutsourcing.com

TOP 26-100 100 List_9-15_Vs5.indd 57

9 • 2015

Medical Design & Outsourcing 57

9/17/15 8:24 PM

1OO

THE TOP 1OO MEDTECH COMPANIES

60

IDEXX LABS

1 Idexx Drive, Westbrook, Maine 04092

www.idexx.com/corporate/home.html

(207) 556-0300

Employees: 6,000 Revenue: $1,485,807,000 R&D Spend: $98,263,000 Fiscal year ending: Dec. 31, 2014

MARKETS: Veterinary

KEY PERSONNEL:

JONATHAN AYERS, Chairman, President & CEO JAY MAZELSKY, EVP; Brian McKeon, EVP, CFO & Treasurer JOHNNY POWERS, EVP JACQUELINE STUDER, Corporate VP, General Counsel & Secretary MICHAEL WILLIAMS, EVP

61

AGFA-GEVAERT Setestraat 27, B-2640 Mortsel, Belgium

+81 (3) 5996-8036 www.agfa.com/global/en/main/index.jsp

Employees: 4,621 Revenue: $1,421,449,300* R&D Spend: $128,980,900 Fiscal year ending: Dec. 31, 2014

MARKETS: Imaging/radiology

KEY PERSONNEL:

CHRISTIAN REINAUDO, President & CEO KRIS HOORNAERT, CFO LUC DELAGAYE, President, Agfa Materials LUC THIJS, President, Agfa HealthCare STEFAAN VANHOOREN, President, Agfa Graphics

* Revenues from AGFA Healthcare segment only.

62

SMITHS MEDICAL 1265 Grey Fox Road, St Paul, MN 55112

1500 Eureka Park, Lower Pemberton,

Ashford, Kent, TN25 4BF 600 Cordwainer Drive,

3rd Fl, Norwell, MA 02061

(651) 633-2556; +44 (0)845 850 0445; (781) 792-2500 info.asd@smiths-medical.com; www.smiths.com/media.aspx

MARKETS: Respiratory, Women’s Health, Diabetes, Hospital Supplies, Surgical, Drug Delivery, Imaging/ radiology, Chronic Pain, Patient Monitoring, Vascular

KEY PERSONNEL:

Employees: 7,850 Revenue: $1,325,313,600 R&D Spend: $192,862,800 Fiscal year ending: July 31, 2014

JEFF MCCAULLEY, President; Stuart Beesley, CIO RUSS DAVIES, VP, RA/QA ROB WHITE, VP Finance CARL STAMP, VP Global Product Management ADAM JONES, Divisional General Counsel RON LEONHARDT, VP, HR LU ANNE GREEN, VP, Global Operations BEN SOMMERNESS, VP, Global Strategy BOB ARMSTRONG, VP & CTO, R&D

58

Medical Design & Outsourcing

TOP 26-100 100 List_9-15_Vs5.indd 58

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 8:25 PM

63

MINDRAY MEDICAL

Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen 518057 The People’s Republic of China www.mindray.com/en/homepage/index.html

Employees: 8,300 Revenue: $1,322,814,000 R&D Spend: $146,997,000 Fiscal year ending: Dec. 31, 2014

MARKETS: Patient Monitoring, Intensive Care, Diagnostics, Imaging/radiology

KEY PERSONNEL:

XU HANG, Chairman LI XITING, Executive Chairman, President & Co-CEO CHENG MINGHE, Co-CEO & Chief Strategic Officer WANG JIANXIN, COO ALEX LUNG, CFO FANNIE LIN FAN, Group General Counsel, Secretary

64

INVACARE

ONE INVACARE WAY P O BOX 4028 ELYRIA OH 44036 www.invacare.com/cgi-bin/imhqprd/default.jsp

Employees: 5,200 Revenue: $1,270,163,000 R&D Spend: $23,149,000 Fiscal year ending: Dec. 31, 2014

MARKETS: Patient Care and Mobility, Bariatric/ gastroenterology, Respiratory, Vascular

KEY PERSONNEL:

MATTHEW E. MONAGHAN: Chairman, President & CEO ROBERT K. GUDBRANSON: SVP & CFO ANTHONY C. LAPLACA: SVP & General Counsel PATRICIA STUMPP: SVP, HR

65

DJO GLOBAL 1430 Decision Street Vista, California (800) 336-5690

www.djoglobal.com

Employees: 4,940 Revenue: $1,229,166,000 R&D Spend: $37,742,000 Fiscal year ending: Dec. 31, 2014

MARKETS: Orthopedics, Prosthetic

KEY PERSONNEL:

MICHAEL P. MOGUL: President & CEO TOBY BOST: President, DJO Global Consumer Business JEANINE KESTLER: EVP & Chief HR Officer SUSAN CRAWFORD: EVP, CFO STEVEN INGEL: President, Global Bracing & Supports JOE MCCLUNG: SVP & General Manager, DJO Global Vascular GERRY MCDONNELL: EVP, Global Operations STEPHEN J. MURPHY: President, Sales & Marketing, International Commercial Business MIKE PETERS: EVP, Chief Information Officer BRADY R. SHIRLEY: President, DJO Surgical DONALD M. ROBERTS: EVP, General Counsel & Secretary SHARON WOLFINGTON: President, Global Recovery Sciences

www.medicaldesignandoutsourcing.com

TOP 26-100 100 List_9-15_Vs5.indd 59

9 • 2015

Medical Design & Outsourcing 59

9/17/15 8:25 PM

1OO

THE TOP 1OO MEDTECH COMPANIES

66

NIKKISO

Yebisu Garden Place Tower 22nd Floor, 20-3, Ebisu 4-Chome, Shibuya-ku, Tokyo 150-6022, Japan www.nikkiso.com/index.html

Employees: 6,389 Revenue: $1,222,385,096* Fiscal year ending: March 31, 2015

MARKETS: Dialysis, Diabetes

KEY PERSONNEL:

TOSHIHIKO KAI, President & CEO NAOTA SHIKANO, Executive Officer, LEWA, CEO SHOICHI NAGATO, Executive Officer, General Manager, Aerospace NOBUHIKO BAN, Executive Officer, Corporate Planning Department, Administration SUSUMU KOITO, Executive Officer, General Manager, Administration Division, Environment Promotion SHOTARO FUJII, Executive Officer, General Manager, Shizuoka Plant, General Manager, Biomedical Engineering Center HISAKAZU NAKAHIGASHI, Executive Officer, General Manager, Kanazawa Plant, General Manager, Medical Factory TAKASHI OZEKI, Executive Officer, Nikkiso Vietnam, President HIROSHI BAMBA, Executive Officer, General Manager, Global Information Management Department

* Revenues from Nikkiso’s Medical division only.

67

CARL ZEISS MEDITEC www.zeiss.com/meditec/en_us/home.html

Employees: 2,972 Revenue: $1,209,036,374 R&D Spend: $75,017,673 Fiscal year ending: Sept. 30 2014

MARKETS: Vision, Neuromodulation/neurostimulation, ENT, Spinal, Surgical, Dental, Women’s Health, Oncology

KEY PERSONNEL:

LUDWIN MONZ, President & CEO CHRISTIAN MÜLLER, Management Board, Finance & Controlling, Investor Relations, & Legal & Taxes THOMAS SIMMERER, Global Sales & Service

68

SIRONA DENTAL SYSTEMS 30-30 47Th Ave Suite 500 Long Island City Ny 11101 www.sironausa.com/us/

Employees: 3,327 Revenue: $1,171,100,000 R&D Spend: $64,600,000 Fiscal year ending: Sept. 30, 2014

MARKETS: Dental

KEY PERSONNEL:

JEFFREY T. SLOVIN, President & CEO MICHAEL AUGINS, President, Sirona Dental & EVP, Sirona Dental Systems ULRICH MICHEL, EVP & CFO WALTER PETERSOHN, EVP Sales RAINER BERTHAN, EVP JONATHAN FRIEDMAN, General Counsel & Secretary

60

Medical Design & Outsourcing

TOP 26-100 100 List_9-15_Vs5.indd 60

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 8:25 PM

69

OTTOBOCK

Max-Näder-Straße 15 D-37115 Duderstadt Germany

11501 Alterra Parkway Suite 600 Austin, TX 78758 USA

+49 5527 848-0; +1 800 328 4058 www.ottobock.com/cps/rde/xchg/ob_com_en/hs.xsl/index.html

MARKETS: Prosthetic, Patient Care and Mobility

Goeschwitzer Strasse 51-52 D-07745 Jena Germany

KEY PERSONNEL:

Employees: 7,329 Revenue: €1,025,198,700* R&D Spend: $74,463,200 Fiscal year ending: Dec. 31, 2014

HANS GEORG NÄDER, owner, president & CEO HARRY WERTZ, CFO HANS DIETL, CTO CHRISTIN GUNKEL, Chief Marketing Officer SÖNKE RÖSSING, Chief Strategy & HR Officer THORSTEN SCHMITT, COO MICHAEL HASENPUSCH, Head, BU MedicalCare HELMUT PFUHL, Head, BU Prosthetics GUNTER RÖPER, Head, BU Mobility Solutions PETER KRAUTGARTNER, Head, BU Neurorehabilitation FRANK BÖMERS, Head, BU Orthotics PHILIP HILGERS, Head, Group Controlling & Pricing GAURAV MISHRA, Head, Global Sales RALF STUCH, Head, Group Finance & Treasury & President, Asia/Pacific REGINA THUMS, Head, Legal KARL-HEINZ BURGHARDT, President, Eastern Europe, Middle East, Africa RALF STUCH, Head, Group Finance & Treasury & President, Asia/Pacific TARAS REBET, President, Western Europe ANDREAS SCHULTZ, President, North America & CFO WILSON ZAMPINI, President, Latin-America

* Revenues from Ottobock’s healthcare business only.

Stainless Steel Machine Components

J.W. Winco, Inc. offers stainless steel parts for industry with very high corrosion resistance, hygienic properties, and the ultimate in material quality. Pictured is just a sampling of our products.

Explore our full line at www.jwwinco.com or contact us with your application requirements.

2815 S. Calhoun Road New Berlin, WI 53151 Phone: 800-877-8351 Fax: 800-472-0670 Sales@jwwinco.com

www.medicaldesignandoutsourcing.com

TOP 26-100 100 List_9-15_Vs5.indd 61

9 • 2015

Medical Design & Outsourcing 61

9/17/15 8:25 PM

1OO

THE TOP 1OO MEDTECH COMPANIES

70

FUKUDA DENSHI 39-4, Hongo 3-chome, Bunkyo-ku,Tokyo 113-8483

+81-3-5684-1455 www.fukuda.co.jp/english/index.html

Employees: 2,949 Revenue: $1,023,917,155 Fiscal year ending: March 31, 2015

MARKETS: Patient Monitoring, Imaging/radiology, Cardiac Rhythm Management

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

71

SORIN

Via Benigno Crespi 17 20159 Milan, Italy

www.sorin.com/home.action

MARKETS: Cardiac Rhythm Management, Cardiovascular, Structural Heart, Patient Monitoring

KEY PERSONNEL:

Employees: 3,815 Revenue: $993,152,930 R&D Spend: $106,774,910 Fiscal year ending: Dec. 31, 2014

ROSARIO BIFULCO, Chairman ANDRÉ-MICHEL BALLESTER, CEO MICHEL DARNAUD, President, Cardiac Surgery STEFANO DI LULLO, President, Cardiac Rhythm Management JACQUES GUTEDEL, VP, Intercontinental PRITPAL SHINMAR, VP, Market Access BRIAN SHERIDAN, General Counsel DEMETRIO MAURO, CFO STÉPHANE BESSETTE, VP, HR EDWARD ANDRLE, VP, Strategy & Business Development

72

OMRON

53, Kunotsubo, Terado-cho, Muko, Kyoto 617-0002 Japan www.omron.com

MARKETS: Patient Monitoring, Respiratory, Neuromodulation/neurostimulation

KEY PERSONNEL: ISAO OGINO, President & CEO, Omron Healthcare

Employees: 4,955 Revenue: $951,390,202* R&D Spend: $453,120,862 Fiscal year ending: March 31, 2015

* Revenues from Omron’s healthcare segment only.

62

Medical Design & Outsourcing

TOP 26-100 100 List_9-15_Vs5.indd 62

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 8:25 PM

73

INTEGRA LIFESCIENCES 311 Enterprise Drive Plainsboro NJ 08536 US www.integralife.com

MARKETS: Neuromodulation/neurostimulation, Orthopedics, Surgical, Cosmetic/aesthetic, Wound Care, Chronic Pain, Dental

KEY PERSONNEL:

Employees: 3,400 Revenue: $928,305,000 R&D Spend: $51,596,000 Fiscal year ending: Dec. 31, 2014

PETER J. ARDUINI: President & CEO GLENN G. COLEMAN: VP & CFO STUART M. ESSIG: Chairman MARK AUGUSTI: VP, President, Orthopedics & Tissue Technologies KENNETH BURHOP: VP, Chief Scientific Officer ROBERT T. DAVIS JR.: VP, President, Specialty Surgical Solutions RICHARD D. GORELICK: VP, General Counsel, Administration & Secretary JOHN MOORADIAN: VP, Global Operations & Supply Chain JUDITH E. O’GRADY: VP, Global Regulatory Affairs DAN REUVERS: VP, President, International JOSEPH VINHAIS: VP, Global Quality Assurance

74

COCHLEAR LTD.

1 University Avenue, Macquarie University NSW 2109 Australia

+612 9428 6555 www.cochlear.com/wps/wcm/connect/intl/home

Employees: 2,632 Revenue: $925,630,000 R&D Spend: $127,985,000 Fiscal year ending: June 30, 2015

MARKETS: Hearing

KEY PERSONNEL:

CHRIS ROBERTS, President & CEO RICHARD BROOK, President, Europe JAN JANSSEN, SVP, Design & Development, Clinical & Regulatory NEVILLE MITCHELL, CFO & Secretary MARK SALMON, President, Asia Pacific CHRIS SMITH, President, Americas

75

HAEMONETICS 400 Wood Road Braintree Ma 02184 US

www.haemonetics.com

Employees: 3,383 Revenue: $910,373,000 R&D Spend: $54,187,000 Fiscal year ending: March 28, 2015

MARKETS: Blood Management

KEY PERSONNEL:

BRIAN CONCANNON: President & CEO CHRISTOPHER LINDOP: CFO & EVP Business Development SUSAN HANLON: VP Finance BRIAN BURNS: EVP, Global Quality & Regulatory Affairs KENT DAVIES: COO DAVID FUSCO: EVP, Global HR SANDRA L. JESSE: EVP, Chief Legal Officer CHRISTOPHER LINDOP: CFO & EVP Business Development BYRON SELMAN: President, Global Markets DR. JONATHAN WHITE: Chief Science & Technology Officer

www.medicaldesignandoutsourcing.com

TOP 26-100 100 List_9-15_Vs5.indd 63

9 • 2015

Medical Design & Outsourcing 63

9/17/15 8:26 PM

1OO

THE TOP 1OO MEDTECH COMPANIES

76

KAWANISHI HOLDINGS

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

MARKETS: Cardiovascular, Cosmetic/aesthetic, Surgical, Laboratory, Diagnostics, Patient Care and Mobility, Healthcare IT

KEY PERSONNEL:

Employees: 1,082 Revenue: $893,843,389 Fiscal year ending: June 30, 2015

TOSHIYUKI MAESHIMA, Chairman & CEO TAIRA TAKAI, President & COO

77

GN STORE NORD Lautrupbjerg 7 2750 Ballerup Denmark

+45 45 75 00 00 www.gn.com

Employees: 3,383 Revenue: $795,889,655* R&D Spend: $110,950,829 Fiscal year ending: Dec. 31, 2014

MARKETS: Hearing

KEY PERSONNEL:

ANDERS HEDEGAARD, President & CEO, GN ReSound ANDERS BOYER, CFO, GN Store Nord RENÉ SVENDSEN-TUNE, President & CEO, GN Netcom

* Revenues from GN Store Nord’s ReSound division only.

78

NUVASIVE

7475 Lusk Blvd.

San Diego CA 92121 www.nuvasive.com

MARKETS: Neuromodulation/neurostimulation, Orthopedics, Spinal

KEY PERSONNEL:

Employees: 1,500 Revenue: $762,415,000 R&D Spend: $37,986,000 Fiscal year ending: Dec. 31, 2014

GREGORY T. LUCIER: Chairman & CEO QUENTIN S. BLACKFORD: EVP & CFO PATRICK MILES: President & COO MATT LINK: President, U.S. Commercial JASON M. HANNON: EVP, International & General Counsel CAROL COX: EVP, Strategy, Corporate Development & External Affairs PETE LEDDY, PH.D.: EVP, HR & Corporate Integrity RUSSELL POWERS: EVP JOHNSON LAI: Chief Information Officer

64

Medical Design & Outsourcing

TOP 26-100 100 List_9-15_Vs5.indd 64

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 8:26 PM

79

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

Employees: 3,580 Revenue: $761,653,000 R&D Spend: $52,799,000 Fiscal year ending: Dec. 31, 2014

MARKETS: Dental

KEY PERSONNEL:

JOSEPH M. HOGAN: President & CEO DAVID L. WHITE: CFO SIMON BEARD: VP & Managing Director, EMEA JENNIFER ERFURTH: VP, Global HR ROGER E. GEORGE: VP, Legal Affairs & General Counsel TIM MACK: VP, Scanner & Services RAPHAEL S. PASCAUD: Chief Marketing Portfolio & Business Development Officer CHRIS PUCO: VP, North American Sales ZELKO RELIC: VP, Research & Development JULIE TAY: VP & Managing Director, Asia Pacific EMORY WRIGHT: VP, Operations

80

KONICA MINOLTA HOLDINGS

JP TOWER, 2-7-2 Marunouchi, Chiyoda-ku, Tokyo 100-7015

(81) 3-6250-2111 konicaminolta.us

Employees: 40,000 Revenue: $742,386,987* R&D Spend: $40,344,241 Fiscal year ending: March 31, 2015

MARKETS: Imaging/radiology, Healthcare IT

KEY PERSONNEL:

SHOEI YAMANA, President & CEO, Representative Executive Officer TAKASHI SUGIYAMA, Senior Managing Executive Officer NOBUYASU IEUJI, Senior Executive Officer YOSHITSUGU SHIRAKI, Senior Executive Officer JUN HARAGUCHI, Senior Executive Officer TSUKASA WAKASHIMA, Senior Executive Officer KUNIHIRO KOSHIZUKA, Senior Executive Officer KEN OSUGA, Senior Executive Officer SEIJI HATANO, Senior Executive Officer SHINGO ASAI, Senior Executive Officer TOYOTSUGU ITOH, Senior Executive Officer

* Revenues from Konica Minolta Holdings’ healthcare division only.

81

CONMED

525 French Road Utica NY 13502

www.conmed.com

MARKETS: Cardiovascular, Intensive Care, Endoscopic/arthroscopic, Bariatric/ gastroenterology, Pulmonary/bronchoscopy, Imaging/radiology, Orthopedics

KEY PERSONNEL:

Employees: 3,500 Revenue: $740,055,000 R&D Spend: $27,779,000 Fiscal year ending: Dec. 31, 2014

CURT R. HARTMAN: President & CEO PATRICK J. BEYER: President, International TERENCE M. BERGÉ: VP, Corporate Controller HEATHER L. COHEN: EVP, HR & Secretary DANIEL S. JONAS: EVP, Legal Affairs & General Counsel GREGORY R. JONES: EVP, Quality Assurance/Regulatory Affairs JOHN E. (JED) KENNEDY: VP & General Manager CET JOHONNA PELLETIER: Treasurer & VP, Tax STANLEY W. (BILL) PETERS: VP & General Manager Advanced Surgical LUKE A. POMILIO: EVP, Finance & CFO PETER K. SHAGORY: EVP, Strategy & Corporate Development MARK D. SNYDER: EVP, Operations & Business Systems

www.medicaldesignandoutsourcing.com

TOP 26-100 100 List_9-15_Vs5.indd 65

9 • 2015

Medical Design & Outsourcing 65

9/17/15 8:26 PM

1OO

THE TOP 1OO MEDTECH COMPANIES

82

GREATBATCH

2591 Dallas Parkway, Suite 101 Frisco Tx 75034 www.greatbatch.com

MARKETS: Cardiac Rhythm Management, Neuromodulation/ neurostimulation, Vascular, Orthopedics, OEM

KEY PERSONNEL:

Employees: 3,690 Revenue: $687,787,000 R&D Spend: $49,845,000 Fiscal year ending: Jan. 2, 2015

THOMAS J. HOOK: President & CEO MICHAEL DINKINS: EVP & CFO MAURICIO ARELLANO: EVP, Global Operations ANDREW P. HOLMAN: EVP, Global Sales & Marketing THOMAS K. HICKMAN: EVP, Global Sales & Marketing, QiG Group GEORGE M. CINTRA: EVP & Chief Technology Officer;TIMOTHY G. MCEVOY: SVP, General Counsel & Secretary

83

WELCH ALLYN*

4341 State Street Road Skaneateles Falls, NY 13153

1.800.535.6663 www.welchallyn.com/

Employees: 2,600 Revenue: $683,772,000 R&D Spend: $49,787,000 Fiscal year ending: Dec. 31, 2014

MARKETS: Diagnostics, Patient Monitoring, Hospital Supplies, Veterinary

KEY PERSONNEL:

STEVE MEYER, President & CEO JOSEPH HENNIGAN, EVP & COO MIKE EHRHART, EVP, Product Development DAN FISHER, EVP, HR & Organization Leadership JANIE GODDARD, EVP, Strategic Business Units & Marketing GREGORY PORTER, EVP, General Counsel JON SODERBERG, EVP, Corporate Development JOHN TIERNEY, Region President, Americas HISHAM HOUT, Region President, Europe, Middle East & India SUNNY GOH, Region President, Japan & Asia Pacific

84

AMPLIFON

Via Ripamonti, 133 20141 Milano +39 02.574721 www.amplifon.com/English/Pages/default.aspx

Employees: 5,789 Revenue: $670,024,066 Fiscal year ending: Dec. 31, 2014

MARKETS: Hearing

KEY PERSONNEL:

FRANCO MOSCETTI - CEO ENRICO BORTESI - Chief Supply Chain & Purchasing Officer GIOVANNI CARUSO - Chief HR Officer ANDREA FACCHINI - Chief Marketing Officer MASSIMILIANO GERLI - Chief Information Officer UGO GIORCELLI - CFO JOHN PAPPALARDO – EVP APAC HEINZ RUCH - EVP Americas ENRICO VITA – COO

66

Medical Design & Outsourcing

TOP 26-100 100 List_9-15_Vs5.indd 66

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 8:26 PM

85

STRAUMANN 60 Minuteman Road Andover, MA 01810

(800) 448-8168; (978) 747-2500

www.straumann.us

Employees: 2,387 Revenue: $649,711,410 R&D Spend: $32,485,571 Fiscal year ending: Dec. 31, 2014

MARKETS: Dental

KEY PERSONNEL: MARCO GADOLA, CEO PETER HACKEL, CFO WOLFGANG BECKER Head Sales Central Europe GUILLAUME DANIELLOT Head Sales Western Europe ANDY MOLNAR Head Sales North America ALEXANDER OCHSNER Head Sales Asia/Pacific FRANK HEMM Head Customer Solutions & Education GERHARD BAUER Head Research, Development & Operations PETRA RUMPF Head of Instradent & Strategic Alliances

Precision Injection Molds Design - Build - Repair

small part molds and repairs

Hospital Grade Powercords and DC to DC Converters

.025” pins 63 x

3D Design - Machining - Wire EDM - Sinker EDM Micro Laser Welding - Laser Marking/Engraving Assembly fixturing/automation 34 Tower Street - Hudson, MA 01749 www.maynardtool.com

Upon your next requirement, please keep MEGA in mind.

MEGA Electronics Inc. 4B Jules Lane New Brunswick.New Jersey. 08901 tel. 732.249.2656 fax. 732.249.7442 www.megaelectronics.com medicalsales@megaelectronics.com

978-568-1900

www.medicaldesignandoutsourcing.com

TOP 26-100 100 List_9-15_Vs5.indd 67

When power is critical to your equipment as well as your patients, you can rely on MEGA Electronics to deliver. Produced in ISO9000 facilities, our line of hospital grade powercords, related components and DC to DC converters all conform to the highest standards.

9 • 2015

Medical Design & Outsourcing 67

9/17/15 8:26 PM

1OO

THE TOP 1OO MEDTECH COMPANIES

86

MASIMO

52 Discovery Irvine CA 92618 United States www.masimo.com

Employees: 2,400 Revenue: $586,643,000 R&D Spend: $56,581,000 Fiscal year ending: January 3, 2015

MARKETS: Patient Monitoring

KEY PERSONNEL:

JOE KIANI, Chairman & CEO MARK P. DE RAAD: EVP & CFO JON COLEMAN, President, Worldwide Sales, Professional Services & Medical Affairs RICK FISHEL, President, Worldwide OEM Business & Blood Management PAUL JANSEN, EVP, Business Development YONGSAM LEE, EVP & CIO ANAND SAMPATH, COO TOM MCCLENAHAN, EVP, General Counsel

87

FISHER AND PAYKEL 15 Maurice Paykel Place East Tamaki, Auckland www.fphcare.com

2013 PO Box 14 348 Panmure, Auckland 1741 New Zealand Employees: 2,000 Revenue: $558,882,990 R&D Spend: $54,034,990 Fiscal year ending: March 31, 2015

MARKETS: Respiratory, Intensive Care

KEY PERSONNEL: TONY CARTER, Chairman MICHAEL DANIELL, CEO LEWIS GRADON, SVP, Products & Technology PAUL SHEARER, SVP, Sales & Marketing ANTONY BARCLAY, CFO & Secretary DEBORAH BAILEY, VP, HR, Group Privacy Officer, Diversity & Inclusion Manager WINSTON FONG, VP, Information & Communication Technology

88

JMS CO.

2-38-9 Kawauchi, Asaminami-ku, Hiroshima 731-0102 +81-82-962-0532 www.jms.cc/ENGLISH/INDEX.HTML

MARKETS: Drug Delivery, Dialysis cardiovascular, Hospital Supplies

KEY PERSONNEL:

Employees: 6,955 Revenue: $523,936,070 R&D Spend: $11,490,448 Fiscal year ending: March 31, 2015

HIROAKI OKUKUBO, President MASAKI ENDO, Executive Officer, Head of Business Administrative Office KATSUHIRO MURAKAMI, Senior Managing Director & Director

68

Medical Design & Outsourcing

TOP 26-100 100 List_9-15_Vs5.indd 68

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 8:26 PM

89

ANALOGIC

8 CENTENNIAL DRIVE PEABODY MA 01960 www.analogic.com

Employees: 1,700 Revenue: $517,500,000 R&D Spend: $73,800,000 Fiscal year ending: July 31, 2014

MARKETS: Imaging/radiology

KEY PERSONNEL:

JAMES W. GREEN: President & CEO JOHN J. FRY: SVP, General Counsel, & Secretary MERVAT FALTAS: SVP & General Manager Medical Imaging Business FARLEY PEECHATKA JR.: SVP & General Manager Ultrasound Segment MICHAEL BOURQUE: Interim CFO SHALABH CHANDRA: SVP & General Manager, Analogic Asia J ACQUES COUMANS: VP, Chief Marketing Officer & Chief Scientific Officer JOYCE KILROY: VP, Global Quality Assurance, Regulatory Affairs, & Compliance DOUGLAS B. ROSENFELD: VP, Global HR & Administration JIM RYAN: SVP, Global Operations YASH SINGH: VP, Corporate Strategy & Development ERIC ZANIN: SVP & General Manager, Security Systems Business

90

MERIT MEDICAL SYSTEMS

1600 West Merit Parkway South Jordan UT 84095 USA www.merit.com

Employees: 3,105 Revenue: $509,689,000 R&D Spend: $36,632,000 Fiscal year ending: Dec. 31, 2014

MARKETS: Cardiovascular, Surgical, Hospital Supplies, Drug Delivery

KEY PERSONNEL:

FRED P. LAMPROPOULOS: President & CEO KENT W. STANGER: CFO, Secretary, Treasurer JOE WRIGHT: President, Merit Technology Group JUSTIN LAMPROPOULOS: EVP, EMEA RONALD FROST: COO RASHELLE PERRY: Chief Legal Officer JOSEPH PIERCE: Chief Information Officer GREG BARNETT: Chief Accounting Officer JOHN KNORPP: Chief Regulatory Affairs Officer DARLA GILL: President, Merit Endotek

91

ÖSSUR

Grjothals 1-5 110 Reykjavik Iceland www.ossur.com/americas

Employees: 2,300 Revenue: $509,000,000 R&D Spend: $19,428,000 Fiscal year ending: Dec. 31, 2014

MARKETS: Prosthetic, Orthopedics

KEY PERSONNEL:

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

www.medicaldesignandoutsourcing.com

TOP 26-100 100 List_9-15_Vs5.indd 69

9 • 2015

Medical Design & Outsourcing 69

9/17/15 8:27 PM

1OO

THE TOP 1OO MEDTECH COMPANIES

92

CANTEL MEDICAL

OVERLOOK AT GREAT NOTCH 150 CLOVE ROAD LITTLE FALLS NJ 07424 www.cantelmedical.com

Employees: 1,534 Revenue: $488,749,000 R&D Spend: $68,000 Fiscal year ending: July 31, 2014

MARKETS: Sterilization, Infection Prevention

KEY PERSONNEL:

CHARLES M. DIKER: Chairman ANDREW A. KRAKAUER: CEO JORGEN B. HANSEN: President & COO ERIC W. NODIFF: EVP, General Counsel & Secretary PETER G. CLIFFORD: EVP - CFO STEVEN C. ANAYA: SVP & Chief Accounting Officer SETH YELLIN: SVP - Corporate Development

93

THORATEC

6035 Stoneridge Dr Pleasanton Ca 94588 US www.thoratec.com

Employees: 1,048 Revenue: $477,560,000 R&D Spend: $105,475,000 Fiscal year ending: Jan. 3, 2015

MARKETS: Cardiac Assist Devices

KEY PERSONNEL:

D. KEITH GROSSMAN: President & CEO TAYLOR C. HARRIS: VP & CFO DAVID A. LEHMAN: SVP & General Counsel VASANT PADMANABHAN: SVP, Technical Operations NIAMH PELLEGRINI: President, North America

94

ORTHOFIX INTERNATIONAL

7 ABRAHAM DE VEERSTRAAT CURACAO NETHERLANDS ANTILLES P8 00000 www.orthofix.com

MARKETS: Prosthetic, Orthopedics, Neuromodulation/neurostimulation

KEY PERSONNEL:

Employees: 922 Revenue: $402,277,000 R&D Spend: $24,994,000 Fiscal year ending: Dec. 31, 2014

BRADLEY R. MASON: President & CEO; DOUG RICE: CFO RONALD A. MATRICARIA: Chairman MIKE FINEGAN: Chief Strategy Officer JEFF SCHUMM: Chief Administrative Officer, General Counsel, & Corporate Secretary JIM RYABY, PHD: Chief Scientific Officer MARK ATKINSON: Chief People Officer STEVE MARTIN: SVP of Operations TIM MCGUIRE: VP, Global Information Services RAY FUJIKAWA: Sr. VP, Commercial Strategy BRAD NIEMANN: President, BioStim DAVIDE BIANCHI: President, Extremity Fixation

70

Medical Design & Outsourcing

TOP 26-100 100 List_9-15_Vs5.indd 70

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 8:27 PM

95

SYMMETRY MEDICAL/TECOMET 3724 N STATE ROAD 15 WARSAW IN 46582

www.symmetrymedical.com

Employees: 2,560 Revenue: $399,992,000 R&D Spend: $4,572,000 Fiscal year ending: Dec. 28, 2013

MARKETS: Orthopedics, Surgical, Sterilization

96

TOPCON

75-1,Hasunuma-cho, Itabashi-ku, Tokyo 174-8580 +81-3-3966-3141

global.topcon.com/

Employees: 3,977 Revenue: $390,013,240* R&D Spend: $101,191,602 Fiscal year ending: March 31, 2015

MARKETS: Vision

KEY PERSONNEL:

SHIGEYUKI SAWAGUCHI, Senior Managing Executive Officer General Manager, Smart Infrastructure Company MAKOTO IWASAKI, Managing Executive Officer General Manager, General Administration & Legal Div. General Manager, Operational Reforms Div. YASUFUMI FUKUMA, Executive Officer General Manager, Research & Development Div. HIROSHI TAGUCHI, Executive Officer General Manager, General Production Div. TAKASHI ETO, Executive Officer General Manager, Eye Care Company HARUHIKO AKIYAMA, Executive Officer General Manager, General Accounting & Finance Div. KAZUYUKI MATSUMOTO, Outside Director AKIRA SUDO, Outside Director

* Revenues from Topcon’s eye care division only.

97

ACCURAY

1310 Chesapeake Terrace Sunnyvale CA 94089 www.accuray.com

Employees: 1,026 Revenue: $369,419,000 R&D Spend: $53,724,000 Fiscal year ending: June 30, 2014

MARKETS: Imaging/radiology

KEY PERSONNEL:

JOSHUA H. LEVINE: President & CEO GREGORY E. LICHTWARDT: EVP & CFO KELLY J. LONDY: EVP, Chief Commercial Officer THERESA L. DADONE: SVP, HR ROBERT W. HILL: SVP, Research & Development OLE S. MIKKELSEN: SVP & Chief Information Officer DARL S. MOREL: SVP, Regulatory, Quality & Compliance ALALEH NOURI: SVP, General Counsel & Corporate Secretary

www.medicaldesignandoutsourcing.com

TOP 26-100 100 List_9-15_Vs5.indd 71

9 • 2015

Medical Design & Outsourcing 71

9/17/15 8:27 PM

1OO

THE TOP 1OO MEDTECH COMPANIES

98

NATUS

6701 KOLL CENTER PARKWAY, SUITE 120 PLEASANTON CA 94566 www.natus.com

MARKETS: Pediatrics, Women’s Health, Intensive Care

KEY PERSONNEL:

Employees: 948 Revenue: $355,834,000 R&D Spend: $31,788,000 Fiscal year ending: Dec. 31, 2014

JAMES B. HAWKINS: President & CEO JONATHAN KENNEDY: SVP & CFO AUSTIN F. NOLL III: VP & General Manager, Neurology SBU KENNETH M. TRAVERSO: VP & General Manager, Newborn Care DR. D. CHRISTOPHER CHUNG, VP Medical Affairs, Quality & Regulatory AJAY A. BHAVE: VP, Global Engineering

DW-MDO-HPAD-PC Valves - Sept 2015.indd 1

72

Medical Design & Outsourcing

TOP 26-100 100 List_9-15_Vs5.indd 72

7/13/15 4:53 PM

9 • 2015

www.medicaldesignandoutsourcing.com

9/17/15 8:27 PM

99

ICU MEDICAL

951 CALLE AMANECER SAN CLEMENTE CA 92763-6212 www.icumed.com

MARKETS: Drug Delivery, IV supplies, Pediatrics, Oncology, Pulmonary/bronchoscopy, Cardiovascular, Patient Monitoring, Dialysis, Veterinary

KEY PERSONNEL:

Employees: 2,280 Revenue: $309,260,000 R&D Spend: $18,332,000 Fiscal year ending: Dec. 31, 2014

VIVEK JAIN: Chairman & CEO SCOTT E. LAMB: CFO KEVIN J. MCGRODY: Controller

100

NXSTAGE MEDICAL

350 MERRIMACK STREET LAWRENCE MA 01843 www.nxstage.com

Employees: 3,400 Revenue: $301,501,000 R&D Spend: $22,635,000 Fiscal year ending: Dec. 31, 2014

MARKETS: Dialysis

KEY PERSONNEL:

JEFFREY H. BURBANK: Co-Founder & CEO MATTHEW W. TOWSE: CFO & SVP ROBERT G. FUNARI: Chairman JOSEPH E. TURK JR.: President WINIFRED L. SWAN: SVP & General Counsel TODD M. SNELL: SVP, Quality Assurance, Regulatory & Clinical Affairs TOM SHEA: SVP, COO JEFFREY RAINS: SVP, Sales & Marketing DARREN SCANDONE: SVP, HR LISA CURTIS: SVP , International ROBERT S. BROWN: President, NxStage Kidney Care MARK WYETH: SVP, Product Development & Innovation

C O N G R AT U L AT I O N S T O M E D T E C H ' S 1 0 0 L A R G E S T P L AY E R S

BIG1OO www.medicaldesignandoutsourcing.com

TOP 26-100 100 List_9-15_Vs5.indd 73

9 • 2015

Medical Design & Outsourcing 73

9/17/15 8:27 PM

R&D ranking by total spend:* RANK COMPANY 1

R&D SPEND

Johnson and Johnson $1,652,000,000

(MDDI segment only)

2

Medtronic $1,640,000,000

3

Boston Scientific $817,000,000

4

St. Jude Medical $692,000,000

5

Stryker Corp $614,000,000

6

Cerner $392,805,000

7

McKesson $392,000,000

(Technology Solutions segment)

8

Edwards Lifesciences $346,500,000

9

Hospira $344,300,000

10

C.R. Bard $302,000,000

11

B. Braun Melsungen $290,672,420

12

Terumo $278,040,477

13

Essilor International $249,983,600

14

Smith and Nephew $235,000,000

15

Varian Medical Systems $234,800,000

16

Bio-Rad $220,333,000

17

Hologic $203,200,000

18

Draegerwerk $201,715,490

(Medical segment)

19

Zimmer-Biomet $188,300,000

20

Intuitive Surgical $178,000,000

21

Bruker $174,200,000

22

Mindray Medical $146,997,000

23

Agfa-Gevaert $128,980,900

(AGFA Healthcare segment)

24

Cochlear Ltd. $127,985,000

25

Elekta $126,283,248

26

Sonova Holding $119,731,486

27

ResMed $114,865,000

28

Waters $107,726,000

29

Sorin $106,774,910

30

Thoratec $105,475,000

31

IDEXX Labs $98,263,000

32

Dentsply International $80,800,000

33

Carl Zeiss Meditec $75,017,673

74

Medical Design & Outsourcing

R&D breakout_9-15_Vs5.indd 74

9 • 2015

*Excluding companies with non-medical device operations that do not break out R&D spend by division. The color codes correspond to the top 10 R&D spenders.

TOP R&D SPENDERS

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

% OF REVENUES

1 Thoratec

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

2

$346,500,000 $2,322,900,000 14.9%

Edwards Lifesciences

3 Accuray

$53,724,000 $369,419,000 14.5%

4 Analogic

$73,800,000 $517,500,000 14.3%

5 Cochlear Ltd.

$127,985,000 $925,630,000 13.8%

6

(Technology Solutions segment)

McKesson

$392,000,000 $3,069,000,000 12.8%

7

St. Jude Medical

$692,000,000 $5,622,000,000 12.3%

8

Cerner

$392,805,000 $3,402,703,000 11.5%

9 Mindray Medical

$146,997,000 $1,322,814,000 11.1%

10 Bruker

$174,200,000 $1,571,900,000 11.1%

11

$817,000,000 $7,380,000,000 11.1%

Boston Scientific

12 Sorin

$106,774,910 $993,152,930 10.8%

13 Bio-Rad

$220,333,000 $2,175,044,000 10.1%

14 Fisher and Paykel

$54,034,500 $558,882,990 9.7%

15 Masimo

$56,581,000 $586,643,000 9.6%

16 Draegerwerk

$201,715,490 $2,108,106,380 9.6%

(Medical segment)

17

C.R. Bard

$302,000,000 $3,323,600,000 9.1%

18 Agfa-Gevaert

$128,980,900 $1,421,449,300 9.1%

19 Natus

$31,788,000 $355,834,000 8.9%

20 Intuitive Surgical

$178,000,000 $2,131,700,000 8.4%

(AGFA Healthcare segment)

21 Elekta 22

Medtronic

$126,283,248 $1,559,437,704 8.1% $1,640,000,000 $20,261,000,000 8.1%

23 Hologic

$203,200,000 $2,530,700,000 8.0%

24

$344,300,000 $4,463,700,000 7.7%

Hospira

25 Varian Medical Systems $234,800,000 $3,049,800,000 7.7% 26 NxStage Medical

$22,635,000 $301,501,000 7.5%

27 Welch Allyn

$49,787,000 $683,772,000 7.3%

28 Greatbatch

$49,845,000 $687,787,000 7.2%

29 Merit Medical Systems $36,632,000 $509,689,000 7.2% 30 Align Technology

$52,799,000 $761,653,000 6.9%

31 ResMed

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

32 IDEXX Labs

$98,263,000 $1,485,807,000 6.6%

33 Sonova Holding

$119,731,486 $1,861,505,970 6.4%

www.medicaldesignandoutsourcing.com

9/19/15 3:15 PM

We enable medical excellence.

CGI precision gearheads and custom assemblies are used in medical applications ranging from cardiac support to medical robotics.

Your custom gearbox solutions are CGI standard products.

CGI Motion standard products are designed with customization in mind. We understand most off-the-shelf products or a complete inhouse design may not fit your application, so our standard products are designed for functional flexibility. Our team of experts will work with you on selecting the optimal base product and craft a unique solution to help differentiate your product or application. So when you think customization, think standard CGI gearbox assemblies. Connect with us today to explore what CGI Motion can do for you.

copyrightŠ2015 cgi inc. all rights reserved. 913mdo

CGI 9-15.indd 15

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

9/17/15 11:16 AM

RANK COMPANY

R&D SPEND

34

Analogic $73,800,000

35

Hill-Rom Holdings $71,900,000

36

Coloplast $69,455,575

37

Acelity $69,321,000

38

The Cooper Cos. $66,259,000

39

Sirona Dental Systems $64,600,000

40

Teleflex $61,040,000

41

Masimo $56,581,000

42

Nihon Kohden $54,340,836

43

Haemonetics $54,187,000

44

Steris $54,139,000

45

Fisher and Paykel $54,034,500

46

Accuray $53,724,000

47

Align Technology $52,799,000

48

Integra Lifesciences $51,596,000

49

Miraca Holdings $51,068,659

50

Greatbatch $49,845,000

51

Welch Allyn $49,787,000

52

NuVasive $37,986,000

53

DJO Global* $37,742,000

54

ConvaTec $37,200,000

55

Merit Medical Systems $36,632,000

56

Halyard Health $33,600,000

57

Straumann $32,485,571

58

Natus $31,788,000

59

Conmed $27,779,000

60

BioMerieux $26,594,000

61

Orthofix International $24,994,000

62

Invacare $23,149,000

63

NxStage Medical $22,635,000

64

Össur $19,428,000

65

ICU Medical $18,332,000

66

JMS Co. $11,490,448

67

Cantel Medical $10,813,000

68

Symmetry Medical/Tecomet $4,572,000

69

Getinge Group (Maquet) $3,937,238

76

Medical Design & Outsourcing

R&D breakout_9-15_Vs5.indd 76

9 • 2015

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

R&D ranking by total spend:*

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

TOP R&D SPENDERS

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

34

Stryker Corp

% OF REVENUES

$614,000,000 $9,675,000,000 6.3%

35 Orthofix International

$24,994,000 $402,277,000 6.2%

36 Carl Zeiss Meditec

$75,017,673 $1,209,036,374 6.2%

37 Terumo

$278,040,477 $4,629,336,107 6.0%

38

Johnson and Johnson

(MDDI segment only)

$1,652,000,000 $27,522,000,000 6.0%

39 Haemonetics

$54,187,000 $910,373,000 6.0%

40 ICU Medical

$18,332,000 $309,260,000 5.9%

41 Integra Lifesciences

$51,596,000 $928,305,000 5.6%

42 Sirona Dental Systems

$64,600,000 $1,171,100,000 5.5%

43 Waters

$107,726,000 $1,989,344,000 5.4%

44 Smith and Nephew

$235,000,000 $4,617,000,000 5.1%

45 Straumann

$32,485,571 $649,711,410 5.0%

46 NuVasive

$37,986,000 $762,415,000 5.0%

47 Hill-Rom Holdings

$71,900,000 $1,686,100,000 4.3%

48 Zimmer-Biomet

$188,300,000 $4,673,300,000 4.0%

49 B. Braun Melsungen

$290,672,420 $7,219,739,120 4.0%

50 The Cooper Cos.

$66,259,000 $1,717,776,000 3.9%

51 Össur

$19,428,000 $509,000,000 3.8%

52 Conmed

$27,779,000 $740,055,000 3.8%

53 Acelity

$69,321,000 $1,866,339,000 3.7%

54 Nihon Kohden

$54,340,836 $1,520,739,550 3.6%

55 Teleflex

$61,040,000 $1,839,832,000 3.3%

56 Essilor International

$249,983,600 $7,539,399,000 3.3%

57 Coloplast

$69,455,575 $2,213,317,661 3.1%

58 DJO Global*

$37,742,000 $1,229,166,000 3.1%

59 Steris

$54,139,000 $1,850,263,000 2.9%

60 Dentsply International

$80,800,000 $2,922,620,000 2.8%

61 Miraca Holdings

$51,068,659 $1,935,568,375 2.6%

62 Cantel Medical

$10,813,000 $488,749,000 2.2%

63 JMS Co.

$11,490,448 $523,936,070 2.2%

64 ConvaTec

$37,200,000 $1,735,500,000 2.1%

65 Halyard Health

$33,600,000 $1,672,100,000 2.0%

66 Invacare

$23,149,000 $1,270,163,000 1.8%

67 BioMerieux

$26,594,000 $2,257,830,600 1.2%

68 Symmetry Medical/Tecomet $4,572,000

$399,992,000

1.1%

69 Getinge Group (Maquet) $3,937,238 $3,888,969,902 0.1% www.medicaldesignandoutsourcing.com

9/18/15 10:37 AM

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

maxon drives in arm prostheses.

When it really matters.

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.

Maxon Motors 9-15.indd 15 234.95x282.57.indd 1

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

9/15/15 3:35 PM 31.08.2015 10:08:19

COMPANIES RANKED BY EMPLOYMENT

RANK COMPANY OVERALL EMPLOYEES

RANK

Employee Count By Color

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

78

Medical Design & Outsourcing

Employer Rank_9-15_Vs3.indd 78

9 • 2015

1

Medtronic

2 92,000

2

Essilor International

11 58,032

3

B. Braun Melsungen

13 54,017

4

GE Healthcare (General Electric)

3 51,000

5

Stryker Corp

9 26,000

6

Boston Scientific

12 24,000

7

Terumo

20 19,934

8

Hospira

22 19,000

9

St. Jude Medical

16 16,000

10

Cerner

25 15,800

11

Getinge Group (Maquet)

24 15,639

12

C.R. Bard

26 13,900

13

Smith and Nephew

21 13,468

14

Halyard Health

55 12,000

15

Teleflex

50 11,700

16

Dentsply International

31 11,600

17

Paul Hartmann Group

35 10,216

18

Sonova Holding

48 10,184

19

Zimmer-Biomet

18 10,000

20

Coloplast

40 9,250

21

Edwards Lifesciences

36 9,100

22

ConvaTec

51 9,000

23

The Cooper Cos.

52 9,000

24

BioMerieux

38 8,935

25

Mindray Medical

63 8,300

26

Smiths Medical

62 7,850

27

Ship Healthcare Holdings

33 7,600

28

Bio-Rad

41 7,600

29

Steris

49 7,600

30

Draegerwerk (Medical segment)

43 7,458

31

Hill-Rom Holdings

53 7,325

32

JMS Co.

88 6,955

33

Varian Medical Systems

30 6,800

34

Nikkiso (Medical division)

66 6,389

35

Ottobock (healthcare business)

69 6,309

36

Waters

44 6,200

37

Bruker

56 6,200

38

IDEXX Labs

60 6,000

39

Amplifon

84 5,789

40

Acelity

47 5,740

www.medicaldesignandoutsourcing.com

9/19/15 3:16 PM

Medical_Design_Ad_June_2015.qx_Layout 1 5/19/15 1:20 PM Page 1

Sapa Extrusions North America

SHAPING A HEALTHIER FUTURE

Advanced Aluminum Solutions for Medical Device Development Building a better future means innovation and finding new ways to solve product design challenges. Extruded aluminum is already a part of many of the most exciting advances in healthcare. Aluminum gives today’s design engineers the ability to develop parts and products which are strong, lightweight, and easier to produce and machine.

www.sapagroup.com/NA

SAPA 6-15.indd 56

With complete engineering and design assistance plus full fabrication capabilities at multiple locations across North America and the globe, Sapa can provide finished components for all of your needs.

Contact us for more about Sapa and designing with aluminum!

NorthAmerica.Sales@sapagroup.com • (877) 710-7272

9/15/15 3:39 PM

COMPANIES RANKED BY EMPLOYMENT

RANK COMPANY OVERALL EMPLOYEES

RANK

Employee Count By Color

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

41

Hitachi (healthcare business)

27 5,700

42

Hologic

34 5,351

43

Invacare

64 5,200

44

Omron (healthcare segment)

72 4,955

45

DJO Global*

65 4,940

46

Agfa-Gevaert (AGFA Healthcare segment)

61 4,621

47

Nihon Kohden

58 4,616

48

ResMed

54 4,100

49

GN Store Nord (ReSound division)

77 4,075

50

Sorin

71 3,815

51

Elekta

57 3,800

52

Greatbatch

82 3,690

53

Align Technology

79 3,580

54

Conmed

81 3,500

55

Integra Lifesciences

73 3,400

56

NxStage Medical

100 3,400

57

Haemonetics

75 3,383

58

Sirona Dental Systems

68 3,327

59

Merit Medical Systems

90 3,105

60

Intuitive Surgical

42 2,978

61

Carl Zeiss Meditec

67 2,972

62

Fukuda Denshi

70 2,949

63

Cochlear Ltd.

74 2,632

64

Welch Allyn*

83 2,600

65

Symmetry Medical/Tecomet

95 2,560

66

Masimo

86 2,400

67 Straumann

85 2,387

68

Össur

91 2,300

69

ICU Medical

99 2,280

70

Analogic

89 1,700

71

Cantel Medical

92 1,534

72

NuVasive

78 1,500

73

Thoratec

93 1,048

74

Accuray

97 1,026

75

Natus

98 948

76

Orthofix International

94 922

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

80

Medical Design & Outsourcing

Employer Rank_9-15_Vs3.indd 80

9 • 2015

www.medicaldesignandoutsourcing.com

9/18/15 4:42 PM

Moving medical technology.

Linear motion...it’s what our people do.

The technology and design teams at Nook Industries help create the products that contribute to the success of innovative medical advancements that require precise positioning and linear motion.

With the products and people to move medical technology along, it’s no wonder the medical industry consults with Nook on their most vital projects.

Let’s solve this. Together.

medical.nookinfo.com 800•321•7800 Nook Industries, Cleveland, OH USA

NOO-014_3.indd 1 NOOK 9-15.indd 15

5/8/15 9:57 AM 9/15/15 3:36 PM

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

No

Montana

California 14 Massachusetts 9 New Jersey 7 Minnesota 4

Oregon Idaho

Illinois 3 Indiana 3 New York 3 Ohio 3 Pennsylvania 3 Texas 3 District of Columbia 1 Maine 1 Michigan 1 Missouri 1 Tennessee 1 Utah 1

Wyoming

Nevada Utah

Colorado

California

Arizona

New Mexico

Alaska

Hawaii

82

Medical Design & Outsourcing

US heatmap_9-15_Vs3.indd 82

9 • 2015

www.medicaldesignandoutsourcing.com

9/19/15 3:17 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

US heatmap_9-15_Vs3.indd 83

9 • 2015

Medical Design & Outsourcing  83

10/23/15 4:50 PM

GEOGRAPHIC HEATMAP - GLOBAL

Iceland United States

RANK COUNTRY

1 2 3 4 5 5 5 5 5 5 11 11 11 11 11

84

COMPANIES PER COUNTRY

United States 58 Japan 16 Germany 6 Denmark 3 France 2 Great Britain 2 Italy 2 Netherlands 2 Sweden 2 Switzerland 2 Australia 1 Belgium 1 China 1 Iceland 1 New Zealand 1

Medical Design & Outsourcing

World heatmap_9-15_Vs2.indd 84

9 • 2015

www.medicaldesignandoutsourcing.com

9/19/15 3:18 PM

Great Britain Denmark

Sweden

France

Netherlands Belgium Germany Switzerland Italy

China

Japan

Australia

New Zealand

www.medicaldesignandoutsourcing.com

World heatmap_9-15_Vs2.indd 85

9 • 2015

Medical Design & Outsourcing  85

9/19/15 3:18 PM

ONES TO WATCH MARKET

WE TRIED TO UNDERSTAND WHY PEOPLE BECAME OVER-WEIGHT AND OBESE, AND WHAT WAS THE UNDERLYING MECHANISM. WE ACTUALLY TREAT A PATIENT’S PROBLEM, WHICH IS THE HUNGER AND THE FEELING OF FULLNESS, SO THAT THEY CAN IMMEDIATELY START CHANGING THEIR RELATIONSHIP TO FOOD AND MAKE A LIFELONG CHANGE WHILE NOT HAVING THEIR WHOLE LIFESTYLE INTERRUPTED. - ENTEROMEDICS CEO

MARK KNUDSON

86

Medical Design & Outsourcing

Ones to Watch_9-15_Vs3.indd 86

9 • 2015

COMPANY

DESCRIPTION

1 Cardiovascular: Abiomed

Makes the Impella cardiac assist device, the world's smallest heart pump.

2 Cardiovascular: CVRx

Is developing neurostimu lation technology to treat heart disease.

3 Cardiovascular: Sunshine Heart

Is developing the C-Pulse implantable heart failure device.

4 Cardiovascular: Aum Cardiovascular

Makes the Cadence hand held device to detect heart disease.

5 Cardiovascular: Reva Medical

Is developing a bioabsorb able cardiac stent.

6 Diabetes: Bigfoot Biomedical

Is developing fully functional, automated insulin delivery system for Type I diabetes.

7 Diabetes: CeQur

Is developing a three-day insulin infusion device for Type II diabetes.

8 Diabetes: Glooko

Makes remote monitoring software for Type I and Type II diabetes.

9 Dialysis: NxStage Medical

Makes the System One home hemodialysis system.

10 Dialysis: Outset Medical

Is developing the Tablo allin-one dialysis system.

11 ENT: Entellus

Makes the PathAssist.

XprESS and XeroGel devices for treating sinusitis.

12 ENT: Intersect ENT

Makes the Propel mometasone furoate implant for treating sinusitis.

13 Neuro: Nevro

Makes the Senza chronic pain neurostimulation device.

14 Neuro: Tal Medical

Is developing an MR-based treatment for depression.

15 Neuro: EnteroMedics

Makes the Maestro weight loss nuerostimulation device.

16 Organ preservation: TransMedics

Makes the Organ Care System for preserving and perfusing organs before transplantation.

17 Organ preservation: Paragonix Technologies

Makes the SherpaPak organ transport device.

www.medicaldesignandoutsourcing.com

9/19/15 3:18 PM

New Small Hollow Shaft Servo Actuator Surgical Robots • Medical Imaging • Exoskeleton • Lab Automation

Compact, Hollow Shaft Design The new SHA-20A servo actuator is the smallest in the SHA series.

• High Accuracy: Zero-backlash Harmonic Drive® Gear Reducer • High Torque Density: ~ 60 Nm/kg (for 161:1 ratio) • Maximum Torque: 73~120 Nm

Lightweight Precision Gearheads

High-Precision Gears

Ideally suited for robotic and machine tool applications, the new CSG-LW and CSF-LW gearheads are 30% lighter than previous

Harmonic Drive® CSD Component Sets provide unparalleled torque to weight ratio, zerobacklash, and accuracy

designs without reducing the torque rating or significantly

better than 1 arc-minute.

Gear reduction ratios of

changing interface dimensions.

The CSG high-torque gearhead delivers 30% more torque and 40% longer life while maintaining zero-back-

30:1 through 160:1 are available without change in weight or form factor. CSD

lash, 1 arc-min accuracy, and ± 5 arc-sec repeatability.

Component Sets are offered in five different component

A high capacity cross roller bearing and output flange is used to support the driven load. A wide variety of sizes and reduction ratios are available with maximum peak

sizes with peak output torques ranging from 1.8 Nm to 9,180 Nm, depending on unit size and ratio. Custom configurations are available with minimal cost to meet

torques ranging from 9 Nm to 3,400 Nm.

your application requirements.

TM

Made 247 Lynnfield Street, Peabody. MA • 800•921•3332 • www.HarmonicDrive.net in USA The majority of the products we sell are proudly made at our US headquarters and manufacturing facility in Massachusetts.

Harmonic Drive is a registered trademark of Harmonic Drive LLC.

SHA-20A_V2_FP_DW.indd Harmonic Drive 9-15.indd 151

4/15/15 AM 9/15/15 10:17 4:19 PM

ONES TO WATCH MARKET

WHAT WE’RE DOING IS ADDRESSING THE BIOLOGY OF THE TENDON. OUR BIOINDUCTIVE IMPLANT ACTUALLY HELPS INDUCE NEW TISSUE GROWTH, CREATING A THICKER [ROTATOR CUFF] TENDON AND THEREBY HEALING THE TISSUE. - CEO, ROTATION MEDICAL

MARTHA SHADAN

88

Medical Design & Outsourcing

Ones to Watch_9-15_Vs2.indd 88

9 • 2015

COMPANY

DESCRIPTION

18 Orthopedics: ConforMIS

Makes customized knee implants and is developing the technology for other joints.

19 Orthopedics: Rotation Medical

Is developing a regenerative treatment for rotator cuff repair.

20 Pulmonary/Respiratory: Airing

Is developing a micro-CPAP device for sleep apnea.

21 Pulmonary/Respiratory: Sanovas

Is developing a suite of products to treat pulmonary disease.

22 Regenerative Medicine: InVivo Therapeutics

Is developing a scaffold to treat spinal cord injuries.

23 Robotics: Titan Medical

Is developing the Sport single-port orifice platform for use in minimally invasive surgery.

24

Makes the Magellan

Robotics:

Hansen Medical

platform for vascular procedures and the Sensei system for arrhythmia procedures.

25 Robotics: Medrobotics

Makes the Flex robotic transoral surgery system.

26 Robotics: Mazor Robotics

Makes the Renaissance system for spine surgeries.

27 Structural heart: Neovasc

Is developing the Tiara transcatheter mitral valve implant and the Reducer refractory angina treatment.

28 Structural heart: Keystone Heart

Is developing the Triguard embolic cerebral protection device.

29 Structural heart: Direct Flow Medical

Is developing the Direct Flow transcatheter aortic valve implant.

30 Structural heart: JenaValve

Is developing the JenaValve transcatheter aortic valve implant.

31 Structural heart: Claret Medical

Makes the PathAssist, XprESS and XeroGel devices for treating sinusitis.

32 Structural heart: Symetis

Is developing the Acurate transcatheter aortic valve implant.

33 Urology: Augmenix

Makes the SpaceOAR prostate treatment device.

www.medicaldesignandoutsourcing.com

9/18/15 11:15 AM

MARKET

COMPANY

DESCRIPTION

34 Urology: Profound Medical

Makes the Tulsa MRIguided ultrasound prostate treatment.

35 Vascular: Cardiovascular Systems

Makes the Stealth 360 and Diamondback 360 orbital atherectomy systems.

36 Vascular: Vascular Solutions

Makes a portfolio of vascular intervention products.

37 Vision: Staar Surgical

Makes the Visian implantable collamer lens and the NanoFlex and Afinity intraocular lenses.

38 Vision: Second Sight

Makes the Argus II retinal prosthesis for retinosis pigmentosa and is developing the Orion visual cortical prosthesis.

39 Vision: AcuFocus

Makes the Kamra inlay device for presbyopia.

40 Vision: Glaukos

Makes the iStent trabecular micro-bypass stent for treating glaucoma.

41 Vision: Transcend Medical

Makes the Transcend Vold Goniolens for treating glaucoma

42 Vision: InnFocus

Makes the MicroShunt glaucoma eye-drainage implant.

43 Vision: Ivantis

Makes the Hydrus microstent for treating glaucoma.

OUR GOAL IS REALLY TO TRANSFORM THE WAY THAT PATIENTS AND THE HEALTHCARE TEAM INTERACT AND MANAGE DIABETES.

WE KNOW THE MAPPING, MORE OR LESS, IN HUMANS. THE THOUGHT IS THAT WE CAN TAKE THE SAME IMPLANT THAT WE HAVE IN THE RETINA AND PLACE IT, WITH A BIGGER ELECTRODE ARRAY, ON THE SURFACE OF THE BRAIN. WITH THAT WE’LL BE ABLE TO TREAT PATIENTS WHOSE OPTIC NERVE HAS BEEN DAMAGED. THE ONLY ONES WE WOULDN’T BE ABLE TO TREAT WOULD BE SOMEONE WHO HAD A STROKE THAT DAMAGED THAT PART OF THEIR BRAIN TISSUE.

- CEO, GLOOKO

- SECOND SIGHT MEDICAL CEO

RICK ALTINGER

DR. ROBERT GREENBERG www.medicaldesignandoutsourcing.com

Ones to Watch_9-15_Vs3.indd 89

9 • 2015

Medical Design & Outsourcing 89

9/19/15 3:19 PM

CEO SHUFFLE

Who’s In & Out of the Corner Office The ferment in the M&A space last year was echoed in the human resources department. By our rough count there were at least 80 CEO moves among medical device companies from the beginning of 2014 until July 2015.

The splashiest move in the C-suite was NuVasive’s bombshell firing of CEO Alex Lukianov for expense reimbursement and personnel policy violations. Lukianov was replaced by former Life Technologies honcho Greg Lucier.

Some moves were due to mergers (for example, Biomet’s Jeff Binder moved to Immucor, replacing former Medtronic chief Bill Hawkins, who stayed on as lead director; Zimmer Biomet’s new leader is David Dvorak, who led Zimmer until the crosstown rivals’ union).

Steve MacMillan, whose ouster from the top spot at Stryker in early 2012 shocked medtech,

1

2

Thomas Prescot retires

David Pyott retires after $70.5 billion Actavis buyout (March 2015)

took the same job at Hologic after that company moved on from Rob Cascella (Hologic brought back former CEO Jack Cummings in the interim). Curt Hartman, former Stryker CFO – and interim CEO after MacMillan’s departure – landed at ConMed after a proxy battle led to led to the retirement of founder Gene Corasanti and the resignation of his son Joseph Corasanti (the elder Corasanti passed away in March 2015).

JenaValve went through 3 CEOs when David Drachman, the former AtriCure CEO brought in to replace Helmut Straubinger, stepped down for health reasons after just 7 months on the job. Medtech veteran Jan Keltjens took over in the interim, until Victoria Carr-Brendel, former general manager of Boston Scientific‘s Bayer Interventional business, was tapped in June 2015.

Here’s a look at some of the most notable moves affecting the CEO spot:

3

4

Frank Pignatelli is ousted after a proxy war, replaced by Jeffrey Nugent; Nugent steps down in July 2015, replaced by former Zimmer Dental president Harold Flynn

Tim McCarthy is replaced by Charles Carignan

replaced by Joseph Hogan (March 2015)

90

Medical Design & Outsourcing

CEO Shuffle_9-15_Vs2-BP.indd 90

9 • 2015

who leaves the corner office at NinePoint Medical to former NeuroTherm chief Chris von Jako (July 2014)

www.medicaldesignandoutsourcing.com

9/18/15 12:01 PM

CUSTOM HOSPITAL-GRADE CORDS IN 1-WEEK! Interpower manufactures North American and international hospital-grade power cords and cord sets. The United States, Canada, Australia, Denmark, and Japan are the countries that have hospital or medical requirements for their plugs and cords. For other countries there are no special performance or construction requirements for medical applications. From 1 piece to 1,000 pieces or more, we offer no minimum order requirements and just a 1-week U.S. manufacturing lead-time on non-stock cords. 100% of Interpower cords are tested.

We offer a variety of lengths with an extensive range of clear, black, and gray North American plugs. Value-added options such as custom packaging and custom labeling are available upon request.

• • • • •

1-week U.S. manufacturing lead-time on non-stock Interpower products No minimum order requirements Same day shipments available for stock cords Over 4 million parts in stock Free technical support

NEW UNIQUE DEVICE IDENTIFICATION SYSTEM Due to increasing concerns about product recalls, counterfeit devices, and patient safety, the FDA has started the process of developing a Unique Device Identification System in regards to most medical devices. This system is a unique numeric or alphanumeric code which includes a list of product identifiers. Currently identification methods are fragmented and it’s sometimes difficult to trace the original product back to the manufacturer. While medical cords are not classified as a medical device by the FDA, at Interpower we can provide serial numbers on medical cords per your specific requirements.

Order Online! www.interpower.com ORDER A FREE CATALOG TODAY! E-mail catalog@interpower.com or call toll-free.

Business Hours: 7 a.m.–6 p.m. Central Time

INTERPOWER | P.O. Box 115 | 100 Interpower Ave | Oskaloosa, IA 52577 | Toll-Free Phone: (800) 662-2290 | Toll-Free Fax: (800) 645-5360 | info@interpower.com

Interpower 9-15.indd 15

9/15/15 4:19 PM

5

CEO SHUFFLE

6

7

Kieran Gallahue retires after the $12 billion acquisition by Becton Dickinson (March 2015)

A proxy war leads to the July 2014 ouster of founder Gene Corasanti and son & CEO Joseph Corasanti, who’s replaced by former Stryker CFO Curt Hartman.

Jeff Binder moves to Immucor after Zimmer’s $13.4 billion merger, replacing ex-Medtronic chief Bill Hawkins (who stays at Immucor as lead director) (July 2015)

8

Jose Almeida retires after the $50 billion Medtronic merger closes in January 2015.

92

Medical Design & Outsourcing

CEO Shuffle_9-15_Vs2-BP.indd 92

The elder Corasanti passes away in March 2015.

9

10

11

Medtronic veteran Pat Mackin

Stuart Randle is replaced by former ATS Medical chief Michael Dale (August 2014)

Bruce Barclay is replaced by former Teleflex executive Cary Vance (May 2014)

replaces Steven Anderson, who stays as chairman (July 2014)

9 • 2015

www.medicaldesignandoutsourcing.com

9/18/15 12:01 PM

12

13

14

Duane DeSisto is replaced by ex-Cytyc CEO Patrick Sullivan (September 2014)

Helmut Straubinger is replaced by ex-AtriCure chief David Drachman, who steps down for health reasons in February 2015; medtech veteran Jan Keltjens, tapped as interim CEO, is replaced by Boston Scientific and Bayer vet Victoria CarrBrendel in June 2014.

Former Stryker chief Steve MacMillian lands the top job, replacing interim CEO Jack Cumming, who was brought in after the ouster of Rob Cascella (later tapped by Philips Healthcare to lead its imaging business (December 2013)

15

Alexander Lukianov is fired after violating reimbursement & personnel policies, replaced by former Life Technologies chief Gregory Lucier (March 2015)

16

17

18

Deborah DiSanzo is out as Royal Philips shuffles the deck at its biggest division (July 2014)

Dr. Robert Greenberg resigns but stays on as chairman, ceding the corner office to Will McGuire (June 2015)

Andre Michel Ballester is tapped to lead LivaNova, the new entity resulting from Sorin’s $1.4 billion merger with Cyberonics, with exCyberonics CEO Dan Moore as chairman (planned September 2015)

www.medicaldesignandoutsourcing.com

CEO Shuffle_9-15_Vs2-BP.indd 93

9 • 2015

Medical Design & Outsourcing 93

9/18/15 12:01 PM

Peel it off.

Peel it ALL off.

Introducing FluoroPEELZ™ Peelable Heat Shrink

One simple linear tear is all it takes.

Groundbreaking FluoroPEELZ™ peelable heat shrink from Zeus offers medical device manufacturers the revolutionary way to increase yield and improve safety.

Visit Zeus at MDM East Booth 1703 for more information, contact us at support@zeusinc.com.

Request a sample today at www.zeusinc.com/fluoropeelz

US +1 (803) 268-9500 | Europe +353 (0)74 9109700 Asia +86 13922204986 | Latin America +1 (803) 268-9500 www.zeusinc.com

Zeus 6-15.indd 1

9/18/15 12:02 PM

CEO SHUFFLE

19

Gary Burbach is replaced by Keith Grossman, who leads Thoratec to a $3.4 billion merger with St. Jude Medical announced in July 2015 (October 2014)

ELECTROFORMED BELLOWS TECHNOLOGY

Medical Bellows

20 Applications:

Scott Huennekens is named chairman at EndoChoice after Volcano’s $1 billion acquisition by Philips Healthcare cloese in February 2015 (April 2015) 9 • 2015

Medical Design & Outsourcing 95

CEO Shuffle_9-15_Vs2-BP.indd 95

ISO 9001:2008 Certified RoHS Compliant

• Catheters for Therapies • Infusion Pumps • Implantable Devices • Surgical Instruments • Blood Pump Circulators • Drug Delivery • Seals for Harmonic Scapels • MRI and Imaging Equipment • Intravascular Tubing

Contact us for Engineering Assistance Making the Impossible....Possible!

(973) 785-4630 | servometer.com 9/18/15 12:01 PM

MANUFACTURING & MACHINING

Using lasers to build a better medical device The healthcare industry is being transformed by the accelerated introduction of smaller and more effective medical devices developed over the past generation. An important factor in this ongoing medical device revolution has been the availability of better and less costly lasers. Advances in laser technology have, in turn, led to the development of better and less costly medical devices.

Dave Hudson | President and CEO | J o i n i n g Te c h n o l o g i e s |

96

Medical Design & Outsourcing

Manufac-Machine_SEPT 2015_Vs7.indd 96

9 • 2015

Improved lasers Lasers have evolved significantly over the past 15 years. One reason is due to improvements in the laser resonator. The laser beam originates in the resonator and the lasing medium there determines an operating wavelength.

A common wavelength for industrial laser processing is one micron. Until about 10 years ago, one-micron industrial lasers were incredibly inefficient, with just 3% of the energy from the wall plug ever making its way into the laser beam.

The rest was wasted as heat. Over the past decade, however, power efficiency, not to mention reliability and power scaling, has increased with the introduction of two competing resonator designs known as disk and fiber. These designs represent major breakthroughs in laser technology, and they compete with each other, which drives laser costs down.

This progression ultimately benefits medical device original equipment manufacturers (OEMs) by providing them access to lower-cost laser processing (in our case, welding) systems and services. The savings are then passed on to healthcare providers who obtain equipment and components from the OEMs at more affordable prices.

Laser welding creates a smooth sphere on the tips of a twisted wire brush used in cytology.

www.medicaldesignandoutsourcing.com

9/19/15 3:20 PM

In 2006, Joining Technologies bought and installed the first 2-kilowatt disk laser for manufacturing in North America. Within 18 months, an upgraded laser was selling for 30% less, confirming the harsh realization that the disruptive technology the company adopted early had become available to the masses at a lower price. These developments were also a reminder that laser technologies are evolving and advancing at a rapid rate.

The disk and fiber lasers have had a major impact on medical device development. These new lasers are replacing outmoded lamp-pumped lasers at an extraordinary rate because the new designs are smaller, more powerful and efficient, and easier to use. They are also less expensive to purchase than their predecessors.

What’s more, new and improved optics coupled with modern power supplies deliver higher power onto smaller focal points, producing deeper penetration welds at faster speeds. Laser beam scanning simplifies part fixturing and boosts weld speeds with previously unheard of positional accuracy.

Consider the impact of these advances on the manufacture of high-volume, single-use medical devices. Small, delicate materials are stamped, cut, machined and joined (welded) to create new and improved devices, some of which are near-microscopic in size. The new lasers are pulling cost out of supply chains while at the same time enabling the development of products that would otherwise be impossible to manufacture. And because the technology is affordable and accessible, more companies are offering laser processing as a service. Medical device OEMs are seeing an expanding pool of laser service providers competing for a place in their supply chains.

9 • 2015

Medical Design & Outsourcing  97

Manufac-Machine_SEPT 2015_Vs7.indd 97

9/18/15 12:15 PM

MANUFACTURING & MACHINING

The Apollo Endosurgery Overstich System has 12-laser weld points, seven of which are visible here.

Cheaper and enhanced When it comes to laser technology and services, costs have significantly decreased. Current lasers are less expensive to purchase and easier to operate, which has led to an explosion in the number of laser OEMs and service subcontractors peddling their equipment and services to medical device OEMs. The inevitable result of this new competition has been historically low manufacturing costs.

Interestingly, one byproduct of this trend has been a growing chasm in the world of laser-welding specialists. Well established laser-service providers with large engineering staffs have shifted their focus to the advanced technical space, providing highvalue engineering services to medical device OEMs and assisting in product design, prototype development and early production.

Conversely, newcomers, or companies with smaller engineering budgets, find themselves competing for higher-volume production work during the most mature phases of a product’s lifecycle. M

98 Medical Design & Outsourcing

Manufac-Machine_SEPT 2015_Vs7.indd 98

9 • 2015

9/19/15 3:20 PM

REGULATORY

Are the BRIC markets still worth the effort?

If the title of this article sounds pessimistic, it’s for a reason.

Compared to the highly evolved medical device markets in the U.S., Europe and Japan, the growing BRIC markets – Brazil, Russia, India and China – continue to perplex new entrants.

The BRIC markets have long been pursued by device manufacturers as attractive alternatives for generating new business.

But these emerging markets are presenting their own challenges, in terms of regulatory structures and enforcement, transparency (or lack thereof), and associated costs.

Stewart Eisenhart | Senior Regulatory Analyst | Emergo |

RECENT MOVES BY ANVISA, BRAZIL’S MEDICAL DEVICE MARKET REGULATOR, SUGGEST THAT THE AGENCY HAS GROWN MORE AWARE OF REGISTRATION CHALLENGES AND BEGUN LOOSENING SOME REQUIREMENTS FOR APPLICANTS.

Brazilian regulators may ease quality system audit requirements Brazil’s medical device market is the biggest and most dynamic in South America, but the country’s registration process is anything but easy for foreign manufacturers. Recent moves by ANVISA, Brazil’s medical device market regulator, suggest that the agency has grown more aware of registration challenges and begun loosening some requirements for applicants.

Brazil’s participation in the Medical Device Single Audit Program (MDSAP), under which regulators in the U.S., Canada, Brazil and Australia will accept quality system audit reports from one another, should prove particularly beneficial for foreign manufacturers eager to register with ANVISA but not so eager to undertake the effort and cost of Brazilian Good Manufacturing Practice (BGMP) compliance.

Once the MDSAP is fully implemented, manufacturers with devices already registered in the U.S., Canada or Australia will be able to submit their ISO 13485 certificate (or FDA inspection report) without having to meet additional BGMP requirements. Implementation dates remain unknown, but now it’s a question more of “when” than “if.”

Russia’s regulatory process still enigmatic Medical device registration requirements in Russia often strike foreign manufacturers as highly complicated or highly opaque – and sometimes both. Although the government recently shook up leadership and staff at the Russian medical device regulatory agency Roszdravnadzor (RZN), the sometimes arbitrary process of obtaining approval to sell devices there can still befuddle first-time registrants.

This year, Roszdravnadzor implemented a plan to make market registration for low-risk Class I devices easier, but also introduced rules making its change and amendment approval process more difficult: • First, Class I devices submitted for RZN approval now only undergo one round of quality and safety review, rather than two as was previously the case. The new rule also exempts Class I devices from “clinical trial” requirements, which pertain to both clinical data and actual clinical trials conducted in Russia; but registrants must include any previous clinical data in their

www.medicaldesignandoutsourcing.com

Regulatory_SEPT 2015_Vs4.indd 99

9 • 2015

Medical Design & Outsourcing 99

9/18/15 12:20 PM

REGULATORY

GIVEN DISPARATE MARKET AND REGULATORY CHARACTERISTICS ACROSS THE BRIC COUNTRIES, DECIDING WHETHER OR WHEN TO UNDERTAKE DEVICE REGISTRATION IN ONE OR ANY OF THESE MARKETS SHOULD INVOLVE SEVERAL CAREFUL CONSIDERATIONS. submissions to Roszdravnadzor. This change was made primarily to lessen the huge backlog of applications awaiting RZN review.

• On the other hand, manufacturers whose devices are already registered for sale in Russia must meet additional requirements if and when they need to amend their instructions for use or technical documentation. Under the new rule, all modification requests must undergo review by Expertise Centers just like new registrations do. These review requirements may lead to longer approval times and additional costs for manufacturers needing to change or modify their Roszdravnadzor registrations.

Based on the example of these two recent developments, it appears that Russia will continue to be one of the more challenging markets going forward; additional reforms similar to that for Class I device registrations would, however, attract greater interest from foreign firms.

India: Signs of a formal regulatory system on the horizon?

Will 2015 be the year that the Indian government actually establishes a formal medical device registration system? Signs are encouraging, but then again, India has been talking about regulating a broader array of devices for many years.

The country’s latest moves in this direction include, most notably, plans to establish the National Medical Devices Authority, or NMDA, to regulate India’s highly fragmented medical device market. Pending Indian parliamentary approval, the NMDA would take over market oversight duties from the Central Drugs Standard Control Organization (CDSCO). Unlike the CDSCO, the NMDA would be solely responsible for medical device regulation, not drugs as well, indicating that the Indian government is willing to devote more discrete resources to overseeing the country’s medical device sector.

Current CDSCO regulations apply to an odd mix of only 22 devices and IVDs, requiring proof of prior registration in the U.S., Canada, Europe, Australia or Japan, as well as home country approval. Expanding its regulatory system to include a broader array of medical devices and IVDs would lead to a more predictable process for registrants in India.

100

Regulatory_SEPT 2015_Vs4.indd 100

Medical Design & Outsourcing

6 • 2015

www.medicaldesignandoutsourcing.com

9/18/15 12:20 PM

Higher costs for Chinese market entry Although the Chinese Food and Drug Administration (CFDA) has taken steps to address challenges such as poor transparency and unpredictability in the Chinese medical device registration process, satisfying Chinese registration requirements will remain difficult for many foreign manufacturers.

One major barrier to market entry in China was introduced recently in 2015 by the CFDA: The regulator raised its fees significantly for Class II and III device registrations. Class II registrations now cost roughly $30,000 for imported devices, while Class III registrations cost about $50,000.

Although successful commercialization in China can prove highly lucrative for foreign device manufacturers, ongoing challenges in terms of meeting CFDA requirements, now coupled with heftier application fees, may cause additional difficulties particularly for smaller Class II device companies lacking the resources needed for Chinese market entry. Companies looking to enter the Chinese market are well advised to seek a professional opinion to determine what, if any, clinical data will be required to support their registration.

Conclusion: Look before leaping Given disparate market and regulatory characteristics across the BRIC countries, deciding whether or when to undertake device registration in one or any of these markets should involve several careful considerations.

Whether it makes good business sense for a medical device manufacturer to expand into one or more BRIC markets depends on that firm’s individual resources, growth strategies and cost-benefit analytical foresight. M

It’s Not Magic.

Web Industries takes the mystery out of commercializing your medical devices. Our automated high-volume IVD and LFI manufacturing, assembly, and packaging solutions make the pain of bringing your tests to market disappear.

We understand the unique challenges of being a medical CMO, and we know what it takes to get medical devices right every time. Contact us to make your next product launch a success.

© 2015 Web Industries, Inc. All rights reserved.

ISO 9001:2008 & 13485

+1 508.573.7979 • sales@webindustries.com Medical Design & Outsourcing 101

Regulatory_SEPT 2015_Vs4.indd 101

9/18/15 12:21 PM

TUBING TALKS

Positioning peristaltic rollers allows more precise dispensing Accurate dispensing affects a great deal of drug development and delivery. For instance, leading-edge pharmaceuticals, biotech “designer molecules,” and high-potency compounds are tremendously expensive and come with difficult safety concerns that require accurate dispensing and aspirations. Many of these compounds are composed of proteins or synthetic molecular chains that are extremely fragile and highly susceptible to shear. In addition, setup time must be reduced, and maintaining the product within a dispensing tube must meet or exceed safety and contamination concerns. For these reasons, peristaltic pumps have found wide application.

A basic three roller peristaltic pump draws liquid in bottom tube and expels it through the top tube.

David Bach | B S T- B a c h S o l u t i o n s & Te c h n o l o g y , L L C |

The basics Hospitals use peristaltic pumps to circulate blood during bypass surgery and as a critical part in heart-lung machines because the pump’s design does not cause significant hemolysis – the rupture or destruction of red blood cells. The design uses a compressible polymer tube to hold the fluid that requires dispensing. The arrangement also allows pumping aggressive chemicals, slurries with a high solid content, and other materials when it is critical to isolate the fluid from the environment. However, the peristaltic pump suffers from pulsations because its rollers move on and off a pressure shoe as the tube is compressed. The pulsations plotted in 3 Roller Dispense can be reduced by adding more rollers to a peristaltic pump. But there is a better idea.

If the peristaltic pump can start each dispense with one roller in the same starting position, the amount of fluid-dispensing variance can be greatly reduced. When the pump has three rollers and the starting position is repeated every 180°, the plot in Half Revolution Indexes, shows the two positions representing half and full revolutions.

The drive motor can also be used with other pump systems, such as with the Cole Parmer Miniflex peristaltic pump. The three roller Miniflex pump demonstrates the same performance from roller positioning and no-roller positioning.

102

Medical Design & Outsourcing

Tubing_SEPT 2015_Vs6.indd 102

9 • 2015

A Lexium MDrive series 23 motor drives a Watson-Marlow 313 pump with the red cover.

www.medicaldesignandoutsourcing.com

9/18/15 12:46 PM

Wiring - Roller Positioning

The wiring diagram was used for the setup that provided the half-revolution indexes of the previous image.

3 Roller Dispense

The volume versus dispense cycle – the amount of liquid pushed out by one roller – varies with time.

Half Revolution Indexes - 3 Roller

It is possible to greatly reduce the variation in the amount of fluid dispensed when the peristaltic pump can start each dispense with one roller in the same starting position. The plot indicates the results when three rollers are used and the start position repeats every 180°. The dispensing data comes from a WatsonMarlow 520 peristaltic pump with and without roller positioning.

A solution for fluid accuracy The Lexium MDrive, an integrated solution, includes signal inputs and outputs for roller positioning. The design allows dispense volumes made from multiple revolutions plus some fraction of a revolution. Roller positioning takes into consideration the fraction of a revolution and ignores the complete revolutions.

External valves are used so the peristaltic pump can dispense fluid and then control the starting position of the next peristaltic roller without dispensing.

Connecting a Lexium MDrive motor according to the accompanying electrical diagram lets it dispense and then control the valves so the rollers are positioned to the same starting point for each dispense cycle. This allows dispensing a precise and repeatable quantity.

When the number of peristaltic rollers does not divide evenly into the number of microstepping-motor counts, a round-off error occurs. For example: A threeroller system will not divide without a fraction into 51,200 microsteps per revolution. The number of steps between rollers would be 17,066.6667 steps. The motors will only recognize 17,066 steps for each of two rollers and need to add 2 steps to the final roller, making it 17,068. Each dispense must end with the total movement of rollers equaling 51,200 steps per revolution. Each move during the dispense cycle can be verified by using the motor encoder. When the Lexium MDrive is set to MS = 180 it will use 36,000 steps per revolution, allowing even roller divisions. There are up to 20 software-selectable resolutions within the Lexium MDrive.

A few pump and valve setups The circuit described in A in A few pump and valve setups, uses an external pinch valve as a normally open dispense and normally closed position valve. One of the rollers is positioned relative to the encoder Z pulse.

The pump dispense is selected and fluid would then be dispensed. A drip retention is used to bring the fluid back into the tube so that closing the dispense valve does not cause a drip. The dispense valve is then closed, and the position valve opened. The next roller is moved into the same position as previously used for dispensing. This will result in a small amount of fluid waste. After the first roller position move, the next roller can be positioned either in a positive or negative direction, minimizing fluid waste. Using the various directions for roller positioning minimizes fluid waste.

The system shown in B represents a two-tube peristaltic system in which the rollers are offset and the two tubes combined. A six-roller system effectively becomes a 12-roller system, minimizing pulsations.

Both peristaltic tubes are combined using an “x”

www.medicaldesignandoutsourcing.com

Tubing_SEPT 2015_Vs6.indd 103

9 • 2015

Medical Design & Outsourcing 103

9/18/15 12:46 PM

TUBING TALKS

connector, where one leg becomes the waste tube. The dispense valve must be placed after the dispense tube “x.” The roller positioning takes place with the dispense valve closed and the position valve open. The pressure shoes could be different, so it is recommended that one tube-and-shoe combination be used for roller positioning.

For system in figure C, a robotic arm would move the pipette tip to a microtitre plate. The tip just enters the fluid and track its level while fluid is removed. The tip then moves from the fluid and drip retention is applied before moving it. At the delivery position, fluid is removed and blown out by positioning the roller to the starting point. The tip could be exchange and the process repeats.

This set up was used for other experiments but yielded similar results for roller positioning and no-roller positioning.

Four-roller configuration – Watson-Marlow 313 pump A four-roller pump is used with a series 23 Lexium MDrive motor and two Bio-Chem pinch valves.

The on-and-off switch allows a standby configuration. The motor drive is coupled to the pump using a Helical coupling, or equivalent, so that reverses do not adversely affect performance. The mounting block between the motor and pump controls heat transfer.

Two-roller configuration – Watson-Marlow 520 pump The plots in Volume versus dispense cycle show an embodiment of a system that uses a Lexium series 34 ac motor drive. A small tube was used along with the Bio-Chem pinch valves and a similar coupling.

A FEW PUMP AND A few pump and valve setups VA LV E S E T U P S Supply

Supply

Waste

Waste Roller Inline Peristaltic Pump

Offset Roller Peristaltic Pump

Roller Positioning Valve

Roller Positioning Valve

A

Medical Design & Outsourcing

Tubing_SEPT 2015_Vs6.indd 104

Peristaltic Pump

Dispense Valve

Dispense Valve

104

Supply

B

9 • 2015

C

www.medicaldesignandoutsourcing.com

9/18/15 12:46 PM

YOUR DESIGN · OUR MOTOR

A PERFECT FIT CUSTOM MOTOR MANUFACTURING If the motor you need does not yet exist, we’ll bring it into existence. Nippon Pulse manufactures custom

Four roller peristaltic pump

• tin-can steppers • synchronous motors

• linear steppers • linear servos

to meet your application’s exact specifications.

STANDARD MOTOR RE-DESIGN In addition to completely custom motors, we also offer customizations for our 380+ standard motors.

• Custom windings • Custom flanges • Added bearings The orange line, from a four-roller pump, shows a similar output variation to that of a three-roller pump. The blue line, at about 0.35 ml, plots the output from a position controlled four roller pump.

• Pinions • Long lead screws • Connectors

Just a few of the hundreds of motor modifications we offer!

NO ORDER SIZE TOO BIG OR SMALL Volume versus Dispense cycle for a 520 pump with 1.6-mm silicon tubing

We can create custom options for you whether you need one motor or thousands per month. We offer superior custom prototyping with fast delivery.

TECHNICAL CONSULTING Contact us to speak with an applications engineer, who will be able to take your specifications and make recommendations for your application. Our engineers have extensive product knowledge and can consult on your application from the entire motion control system standpoint.

Another example of Volume versus Dispense cycle comes from a 520 pump with 1.6-mm silicon turbine. The blue line is from a system with roller positioning.

Summary Various pumps, valves, and motors can be used for roller positioning, depending on the application. It should be noted that starting in the same position works extremely well for through-the-pump applications as well as aspirations into a pipette tip or other device such as a flow cell. BST offers roller positioning for any peristaltic-pump system that needs greater dispensing accuracy. The use of peristaltic pump systems, pinch valves, and integrated motor/motion lets the BST approach solve accuracy problems opening up new peristaltic opportunities.

BST has filed a United States patent for the use of roller positioning. The motor systems can also be configured to use an optical or proximity device for control for a correct roller position. M 9 • 2015

Tubing_SEPT 2015_Vs6.indd 105

Medical Design & Outsourcing 105

SYSTEM INTEGRATION Nippon Pulse offers other motion control products, including controller and driver chips and boards and encoders, so we can provide full system integration for your application.

EXCEEDING YOUR EXPECTATIONS Since our founding in 1952, we have been manufacturing superior motion control products.

We deliver innovative products of the highest quality, and offer exceptional service and support.

Call today for a free consultation!

Nippon Pulse Your Partner in Motion Control nipponpulse.com | info@nipponpulse.com | 1-540-633-1677

9/18/15 12:47 PM

CONNECTOR & CABLES CORNER

A brief guide to selecting plastic circular medical connectors

Jeff Gaumer | Product Manager | Molex |

MediSpec MPC connectors are examples of off-the-shelf connectors that address issues of off-the-shelf shortcomings. It will be available in a range of diameters including D1 (up to eight contacts), D2 (up to 17 contacts, pictured), D3 (up to 35 contacts) and D4 (up to 59 contacts), plus four keying positions and six color options for each diameter.

106

Medical Design & Outsourcing

Cable_Corner_SEPT 2015_Vs4-BP.indd 106

The effectiveness and reliability of healthcare devices and systems rely on the robust design, engineering, and performance of their underlying electronics. As medical equipment manufacturers work to reduce device cost, without sacrificing reliability, connector choice is one of many decisions that require striking a balance. A wide range of connector options make the choice more challenging.

For instance, a custom or hybrid connector may be appropriate in particular applications, but these would typically require higher upfront engineering and tooling fabrication time and expense. Fully customized designs are somewhat costly, but allow for almost any required specification. A hybrid connector, on the other hand, is essentially an offthe-shelf connector with custom features, such as an overmolded grip or strain relief. Design and tooling costs are lower, and a hybrid has the look and feel of a custom connector. However, when developing a list of power connector requirements, design engineers should not rule out viable and more economical offthe-shelf connectors.

Of course there are a few things to consider when selecting or specifying a connector. For example, the connector’s mechanical interface, including the friction

9 • 2015

between each pin and socket, determines mating force and its important role in how a medical device performs in the real world.

Some overly tight, off-the-shelf connectors are a risk in medical care environments.

Conversely, loose or unstable connections in some devices are also a risk in healthcare environments.

Moisture creates another set of problems. Medical device I/O connectors may be susceptible to the ingress of moisture and other contaminants. A solution would be to pot the connectorcontact interface for both plug and receptacle, to prevent ingress of flux into the contact zone during soldering, as well as to prevent ingress through the pin field during use in a hospital or clinical setting. Because moisture protection is a consideration in medical connectors, an additional IP64-rated sealing option should be available to provide protection to a splash-proof specification.

As a solution, Molex offers a “semi-customized,” off-the-shelf power connector. MediSpec Medical Plastic

www.medicaldesignandoutsourcing.com

9/18/15 12:56 PM

A checklist of specs for a medical connector We suggest specifying these features before selecting a connector for a medical device. Identify the: Number and type of contacts (pins or sockets and specifications for each) Cable configuration (power, ECG, defibrillator, analog, digital bandwidth, pneumatic, fiber optic, or combination of two or more) Cable diameter, materials, and shape Circular (MPC) connectors and cable assemblies meet stringent industry standards and provide exceptional performance at a fraction of the cost of machinedcontact systems and custom circular connectors. The MPC connector system has a 10,000-cycle durability rating, which makes it ideal for I/O applications in medical imaging equipment, patient monitoring, surgical equipment and devices, and telehealth remote patient monitoring systems.

MediSpec MPC connectors balance the need for high mating cycles and low mating forces. Employing the proven low-force helix, stamped-and-formed contact design, the MPC connectors ensure a reliable electrical interface over multiple insertions. The simple, push-pull engagement mechanism provides easy handling, even when wearing surgical gloves.

MediSpec MPC cable assemblies provide between 15 and 20N unmating force. An optional locking sleeve can ensure the cables will remain mated to a force that complies with ANSI/AAMI-EC53 specification (>90N) to prevent accidental un-matings.

Fully functional and tested generic pig-tail harnesses will also be offered to facilitate early system R&D and design activity. These will provide a quick and easy means to build early prototypes of new medical devices. M

Regulatory and environmental ratings (RoHS, REACH, ISO 10993, UL) Strain relief requirements Shielding requirements for connector and cable Voltage and current requirements Space and size constraints, a preferred connector diameter Ingress protection (IP) rating Number of mate and un-mate cycles required Locking mechanism, when required Keying requirements Required mate and un-mate force Cleaning, disinfection, and sterilization requirements Color, logos, markings, and serialization

www.medicaldesignandoutsourcing.com

Cable_Corner_SEPT 2015_Vs4-BP.indd 107

9 • 2015

Medical Design & Outsourcing  107

9/18/15 12:56 PM

SECURITY

Securing mobile medical equipment with electronic access

Steve Spatig | General Manager of Electronic Access Solutions | Southco |

Single-package electronic locking solutions, like Southco’s Self-Contained Electronic Locking System, can be used with existing employee credentials to protect access to valuable medical supplies.

108

Medical Design & Outsourcing

Security_SEPT 2015_Vs5.indd 108

9 • 2015

In modern medical practice, efficiency is key. Newer technologies allow for the mobility of medical equipment, letting personnel bring medical supplies and machines closer to patients, whether they are in the emergency room or an emergency vehicle. But with this improved accessibility, how can hospitals and healthcare facilities ensure that valuable medical equipment and narcotics are properly secured?

Making patient-care supplies available from mobile medical equipment while protecting them against unauthorized access is a challenge hospital administrators face on a daily basis. Pharmaceuticals, biologics, and other valuable or hazardous medical materials stored within mobile carts and cabinets must be locked away when not in use to prevent theft, or idle or malicious tampering.

In addition, privacy concerns and increasing enforcement of Health Insurance Portability & Accountability Act (HIPAA) regulations dictate that patient information, such as electronic medical records, must also be accessible only to legitimate users.

Finding a practical way to secure these items is imperative. Engineers designing for the medical environment, from hospital rooms to ambulances, are equally aware of the challenge.

Intelligent electronic locking mechanisms Integrating intelligent electronic locking mechanisms into mobile medical equipment, such as medication dispensing carts, can significantly improve security and accountability in healthcare settings. Concealed electronic locks and latches, when combined with access-control devices such as digital keypads or RFID devices, provide an effective solution for upgrading the security of existing carts, cabinets, and workstations.

Successful electronic access systems comprise four basic elements: An access control device, an electronic lock, remote monitoring, and manual override. Consistent operation dependents on a high-quality, reliable electronic lock. The associated access controller, or user interface, validates the user credential and signals the cabinet to open. Once the electronic signal triggers access, a digital signature is created and archived for an audit trail, and can be accessed locally or remotely.

Electronic locks can operate through a variety of access control devices, such as digital keypads, Bluetooth controllers, RFID, and biometric readers.

Audit trail capability and regulatory compliance When controlling valuable pharmaceuticals and potentially dangerous medical supplies such as narcotics or biohazards, audit trails are critical for tracking access and inventory.

Hospital dispensing and storage equipment, refrigerators and warming cabinets for biologics and IV fluids, and blood banks all present security risks. Security of confidential patient information is also a priority, with medical facilities www.medicaldesignandoutsourcing.com

9/18/15 1:08 PM

facing large fines and penalties for noncompliance with HIPAA and the HITECH Act. Intelligent and concealed electronic locks offer a unique and efficient way to control access and maintain security of valuable information and medical supplies.

Electronic locking devices can provide a record of which user gained access, when, and for how long. With complete control of credentialing, a hospital administrator can have indisputable evidence of when records were accessed, and by whom.

The alternative – manual recordkeeping – is often less convenient. A digital record can facilitate production of audit trail reports and can assist with investigations of discrepancies or potential security breaches. With an electronic access system in place, electronic credentials may be easily granted or revoked, eliminating key management issues. Additionally, electronic locks can be networked with a medical facility’s existing security system to monitor and control access remotely.

A solution for security The security of mobile medical equipment applies to carts and equipment within a medical facility, as well as to mobile providers of healthcare services. Specialty vehicles such as ambulances, mobile medical aid units, and home healthcare service providers operate under the same requirements as hospitals with regard to tracking medications and supplies.

Unfortunately, these entities may experience greater security challenges than hospitals. Criminals are known to target emergency vehicles in search of narcotics, entering a vehicle while the medical team is attending to an emergency. In many cases, EMS personnel may not be aware of theft until vehicle supplies are inventoried later. Shift changes among emergency workers makes controlling access even more difficult.

Depending on the needed level of access control, there are many options for securing medical equipment and supplies on the go. They include:

FEATURING:

COATED GUIDEWIRE

Fully-Validated, Zero PFOA PTFE Coatings

The Leader in High-Performance Medical Coatings

51 Parmenter Road, Hudson, MA 01749 (800) 258-0110 | www.boydcoatings.com/MDO

Ask us about our full line of other medical grade coatings/finishes for medical components and devices.

9 • 2015 Medical Design & Outsourcing 109

Security_SEPT 2015_Vs6.indd 109

9/19/15 8:51 PM

SECURITY

• Self-contained systems An installation of fully self-contained electronic locking systems constitutes a highly effective, economical solution for controlling access to emergency vehicles.

New or existing storage cabinets within a vehicle are easily outfitted with these battery-operated, audit-trail-capable locks.

• Electronic rotary locks Emergency vehicles have numerous doors and compartments, which may need to be unlocked and re-locked one by one – a time-consuming task during an emergency. For faster, easier control, intelligent electronic rotary locks connected to an RF controller can be used to open or close multiple doors simultaneously with a single key fob click.

• Networked access solutions Depending on the hospital or healthcare facility’s security requirements, fully networked access controllers can also be installed. These devices communicate wirelessly with a hospital’s existing network, so that when the vehicle approaches the building, updated

audit-trail and credential information is instantly registered.

Simplified electronic access control A self-contained electronic locking system is a simple and cost-effective option for protecting new enclosures or upgrading existing equipment. Self-contained solutions typically incorporate an access-control device, electronic lock, electrical override and power supply into a single unit. This solution installs easily with drop-in assemblies that can be mounted into standard panel preps without additional wiring, and feature simple battery operation.

Self-contained electronic access systems work with existing building security systems across the medical facility to control access, in that the same ID badges used with an RFID-based, card-access system for building access can be used with cabinets, carts, and equipment across the medical facility.

Each time a cabinet equipped with a selfcontained solution is opened using an RFID badge, it stores a signal that confirms and logs access. In addition, audit trail data can be downloaded onto a separate utility key, which can then be read via any computer USB

EACH TIME A CABINET EQUIPPED WITH A SELFCONTAINED SOLUTION IS OPENED USING AN RFID BADGE, IT STORES A SIGNAL THAT CONFIRMS AND LOGS ACCESS.

110

Medical Design & Outsourcing

Security_SEPT 2015_Vs5.indd 110

9 • 2015

port. This digital record of information can then be used to demonstrate compliance with regulatory requirements.

Consider electronic access Installing electronic locks with audit-trail capabilities can be a simple, economical and highly effective upgrade that can improve security and accountability in medical supply containment. Monitoring and controlling pharmaceuticals, biologics, and other valuable or hazardous materials that are at risk of theft or tampering, as well as HIPAA-protected data, is easily achieved by implementing the appropriate electronic access solution.

Electronic access solutions combine intelligent locking and access control to protect patient information and medical supplies, offering an effective solution for safeguarding sensitive materials a healthcare setting. Hospital and healthcare administrators, as well as medical design engineers, may find electronic access a viable solution for today’s security and accesscontrol challenges. M

Intelligent electronic locks offer a unique and efficient way to control access and maintain security of valuable information and medical supplies.

www.medicaldesignandoutsourcing.com

9/18/15 1:09 PM

VALIDATION

Validating sterilization processes by ethylene oxide

Paul Dvorak | Founding Editor | Medical Design & Outsourcing | This process challenge device is a strip holding bacteria enclosed in a capped tube. If the PCD can be deactivated or sterilized, then a device of lesser resistance would also be considered sterile.

The FDA’s expectation is that validating a sterilization process follows the traditional validation and verification model, commonly referred to as “V&V.” An installation qualification verifies that the sterilization equipment has been installed to manufacturer’s specification, while the operational qualification verifies that the machinery is working as intended. The final step in a validation process is a performance qualification, which validates that products exposed to the sterilization process meet the required sterility assurance level (SAL).

“That’s it in a nutshell,” says Nelson Laboratories Consulting Manager Paul Littley. “When we talk about V&V, the installation qualification, more of a verification, is making sure the equipment is installed correctly, for example electrical and plumbing is correctly installed,” says Littley, noting that operation and performance qualifications are a bit more in-depth.

“An operation qualification ensures the chamber is functional for a generic process. Once we get to performance qualification, you are looking for repeatability and reproducibility of the cycle for a particular process challenge,” he explains.

The common approach for EO sterilization validation

www.medicaldesignandoutsourcing.com

Validation_SEPT 2015_Vs4-BP.indd 111

is referred to as the “Overkill Approach,” in which a biological indicator, placed in the most resistant location of the device, is deactivated or killed in one-half the time of the routine sterilization cycle.

The half cycle’s lethality must be demonstrated a minimum of three times to be considered adequate or validated. Additionally, a full cycle is performed to demonstrate that the defined cycle is capable of maintaining the process parameters for the entirety of the routine production cycle.

The equipment and process EO chambers are basically pressure vessels which work under sub-atmospheric conditions (i.e., below atmospheric pressure).

Some EO sterilization processes which use a gas blend, such as carbon dioxide, are performed at a positive pressure, but most proesses are 100% EO and are subatmospheric due to flamibility concerns.

“The chambers will pull a particular vacuum, commonly referred to as deep or shallow vacuum. A deep vacuum is typically below six psia, pounds per square inch absolute,” says Littley.

Most sterilization processes are batch operations. Some of the smaller test chambers are in the 9-ft3 range, but larger industrial units handle 30 pallets, a full load for a tractor trailer.

EO sterilization proceeds through a three-phase process. The first phase, preconditioning, conditions the load to an even temperature and relative humidity, often for 24 hours at 115°F and 65% RH. “This does several things. Because the product is in packages, the heat and humidity condition the packaging material so the gas can penetrate easier. The actual sterile barrier is typically Tyvek, a breathable layer that provides a difficult pathway for microorganisms to enter, yet it lets EO and other gases through,” he says. EO’s penetration is unique in that it is a small molecule which can diffuse through plastics quite readily, says Littley.

9 • 2015

Medical Design & Outsourcing 111

9/18/15 1:28 PM

VALIDATION

EO chambers come in a variety of sizes from smaller than this one to those that hold palletts of products. Validating a process requires killing a sample of bacteria placed in the most difficult to reach nooks in a package or produduct.

The second purpose is to condition the microorganisms on the device, as well as the Biological Indicator (BI) used to measure the process, for gassing.

Humidity helps condition the cellular wall and reduces the organism’s resistance to sterilization. The BI contains a minimum of one million organisms of the EO sterilization indicator organism Bacillus atrophaeus, a spore-forming organism.

“These spore-forming organisms exist in two states. One is a dormant state in which they are called endospores. The organism forms a shell-like structure to protect itself until a nutrient-rich environment becomes available, at which time it can sporulate, grow, and reproduce. When the organism is in this second state of growth and reproduction, we call it the vegetative state. Endospores are so durable some have been pulled off of ancient mummies making them at least 4,000 years old. Spore-forming microorganisms are used as the indicator because they are difficult to kill,” Littley says.

After the pre-conditioning phase, operators quickly load the product into the sterilization chamber so as to not lose heat from preconditioning.

“Once in the chamber, the system pulls a vacuum to evacuate the air. Typical cycles pull deep vacuums down to 1 psia. EO in air raises an issue, because it is flammable at about 10% oxygen concentration, so it is important to remove the air from the chamber and the product. Depending on the cycle and product, there might be a few nitrogen washes during the initial stages to flush the residual oxygen. This is more common in shallow vacuums of 6 psia or greater. Next the EO gas is injected and it is absorbed into the nooks and crannies of the devices, referred to as restricted pathways or mated surfaces which are void of air,” he says.

From there, the process goes into a dwell state, typically 3 to 5 hours, of static conditions in which the gas is allowed to penetrate deep into the load and devices.

THE HALF CYCLE’S LETHALITY MUST BE DEMONSTRATED AT LEAST THREE TIMES BEFORE CONSIDERING IT ADEQUATE OR VALIDATED.

112

Medical Design & Outsourcing

Validation_SEPT 2015_Vs4-BP.indd 112

9 • 2015

www.medicaldesignandoutsourcing.com

9/18/15 1:28 PM

WE SPEAK

GEEK

IF THE PCD CAN BE DEACTIVATED OR SERILIZED, THEN A DEVICE OF LESSER RESISTANCE WOULD ALSO BE CONSIDERED STERILE. “When the dwell period ends, it is important to exhaust the EO out of the load and devices due to the flammability as well as because it is a carcinogen,” says Littley. To remove most of the EO gas before opening the chamber, the load is washed with an inert gas such as nitrogen or steam, until most of the EO is out. Once below flammable concentrations, air is typically used for additional washes. Finally, the product goes into a heated aeration chamber where it dwells at approximately 110°F to 115°F with air circulation, to further reduce the residual EO absorbed into the product.

In general, sterilization validation is required to demonstrate that the devices are free of viable microorganisms. As a first step in the validation process, the resistance of the device must be determined. There are two ways to verify the resistance, Littley says.

“One is direct innoculation of the product, where a BI is placed in the most difficult-to-sterilize location of the device, such as restricted pathways, mated surfaces, or long narrow lumens. In theory, the process should kill a given population of that organism. The biological indicator, with a minimum of one million organisms on a paper strip, is our ‘meter stick’ for determining the sterility-assurance level.

Naked, by themselves, the organisms are not difficult to kill. But placing the BI inside a device relatively compares to how other microbes may or might not survive during EO exposure,” Littley notes.

Another approach to validating the process is via a process-challenge device (PCD), which provides an additional avenue for products which are expensive or not easily accessible. In these cases, the manufacturer would prefer not to destroy a $5,000 product, for example. Instead, an easy-tohandle, inexpensive PCD, like a coupon, is

Bi-Link® is redefining the role of contract manufacturer and earning the trust of leading medical device OEM’s across the globe. Bi-Link helps product engineers solve complex design challenges to reduce lifecycle costs and speed time to market.

qualified for use in the sterilization validation to simulate the product. Common PCD configuration might be a sealed a polybag, sealed tubing, or 5cc to 10cc capped nonvented syringe, with a BI placed inside. The average cost of a PCD is in the $10 to $15 range. The PCD is then used in the validation process instead of the inoculated device.

If the PCD can be deactivated or sterilized, then a device of lesser resistance would also be considered sterile.

How often to revalidate a product?

Revalidation would not always be necessary for a design change. For example, if a design change increases an inner diameter, making a pathway easier for a gas to infiltrate, a requalification would not be required.

“But if the pathway or inner diameters are reduced in size and made more restrictive, that would call for a revalidation.

Also, as production ramps up and loads become larger or perhaps more dense, or if the packaging significantly changes, that would also require a revalidation,” says Littley.

However, once the validation process is defined and the device and sterilization process does not change, there is no reason to revalidate.

Annual requalification of the sterilization process, however, is required by ISO and the FDA. This can be a pen-and-paper-change assessment, or actual testing.

“During requalification it is not uncommon for the device manufacturer to reach out to the contract sterilization facility and ask if anything has changed with the process, paying special attention to unscheduled maintenance or equipment changes. At minimum, there should be some level of testing every two years, say a half cycle with a full cycle to be conservative,” adds Littley. M

9 • 2015

Validation_SEPT 2015_Vs5.indd 113

MIND TO MARKET™

Medical Design & Outsourcing 113

LET’S COLLABORATE. Call us at 630.858.5900 Visit Bi-Link.com

9/18/15 4:31 PM

MOTION CONTOL

Motors make spectrophotometer foolproof Scientists working in genomics and proteomics need results at the touch of a button, so they can set about their real work – drug discovery, advanced diagnostics, understanding the stuff of life. When DeNovix set out to develop a spectrophotometer for life science analysis, they focused on designing a fast, simple, foolproof instrument that could extract accurate, repeatable output in seconds. With the help of small dc motors from MICROMO, the DS-11 automatically sets the optimal measurement parameters for samples as small as 0.5 µL, letting users capture quality data sets every time.

In spectrophotometry, the amount and wavelength of light absorbed by a sample reveals the type and concentration of molecules present. Microvolume spectrophotometers such as the DS-11 let researchers obtain fast and accurate results, use the minimum amount of sample, and move more rapidly to answering the questions the research is trying to address.

For the optimal absorbance measurement, an optical path length (OPL) must be scaled for the size and characteristics of each sample. Unfortunately, the conversion factors typically used in these calculations assume a 10-mm OPL. As a result, the OPL must be adjusted for each sample and measurement, then scaled to provide the true value. The more accurate and repeatable the OPL, the more accurate the results of the analysis. The key innovation of the DS-11 is DeNovix’ SmartPath Technology, which automatically optimizes the OPL to ensure trustworthy, usable results.

Mike LeBlanc | Applications Engineer | MICROMO |

The DS-11 spectrophotometer delivers high-dynamic-range measurements with the touch of the screen. (All photos from DeNovix)

114

Medical Design & Outsourcing

MotionControl_SEPT 2015_Vs5.indd 114

without needing an additional PC. It consists of a 20 x 33-cm base with sample mounts available for microvolume and cuvette modes. In the microvolume design, an optical fiber carries the signal from a xenon lamp in the base of the instrument to the tip of the sample mount.

During a measurement, the user lowers a hinged measurement arm that puts a fiberoptic cable into contact with the sample.

At the touch of the screen, the analysis algorithm begins running, continually fine tuning the mount position throughout a data-acquisition period. Electromagnetic energy (190 to 840 nm) passes through fiber and optical junctions, propagating to the spectrometer, where a 2,048-pixel linear CCD detector reads out counts for analysis.

Design efficiency From the outset, the DeNovix team designed the DS-11 for ease of use. The instrument incorporates an Android operating system for touchscreen operation and analysis

9 • 2015

www.medicaldesignandoutsourcing.com

9/18/15 1:48 PM

SmartPath Technology uses real-time absorbance measurements to determine the optimal OPL for the sample under analysis. A servomotor with closed-loop feedback cantilevers the sample arm to its target position.

SmartPath Technology uses an initial absorbance measurement to adjust the position of the sample mount to optimize the OPL. The system is based on sophisticated algorithms, but to work effectively, they require an accurate, closed-loop opto-mechanical positioning system capable of multiple iterations in a matter of seconds. As if this weren’t challenging enough, the DeNovix team set themselves an ambitious product development timeline. They needed innovative engineering but also efficient design.

A first step was to simplify the design process by relaxing constraints. Instead of trying to optimize the OPL in three dimensions, they focused on positioning the sample mount along the z axis while letting it “float” in other dimensions. This removed components from the final device, reducing cost, integration time, and points of failure.

For z-axis positioning, the design drives a fine-threaded screw using a servo motor operating with closed-loop feedback. A planetary gearhead introduces a reduction ratio so that one rotation of the motor corresponds to a fractional rotation of the screw. A high-resolution magnetic encoder provides feedback to let the system iterate through the SmartPath algorithm and determine optimum OPL. Picking a motor The DeNovix team needed a motion solution that would do the job reliably and economically while letting them focus on their core value proposition, the spectrophotometer, and on getting their product to market as quickly as possible. The application called for intermittent short, quick motions with micron-level accuracy. After research and testing, they chose a coreless dc brushed motor module with an encoder and an all-plastic planetary gearhead, produced by MICROMO. The brushed motor significantly simplified the design-and-integration process. A standard brushless servo motor would have been more complicated. It would require eight connections: Three power phases, three for the Hall-effect sensors, and two lines for powering the electronics. In contrast, a brushed motor only

requires two connection points, making the drive scheme, assembly, and overall system more straightforward.

“Going with a brushed dc motor really uncomplicated our world,” says Dave Ward, engineering manager at DeNovix. “That also meant that we had conventional braking capabilities. We wanted the best of both worlds.

A passive system would be stable while it was taking measurements, and it let us develop an active braking algorithm. The combination gave us what the instrument needs: Rapid, repeatable, and precise motion.”

Many designers assume that a brushless motor gives the best performance, making it their first choice. But it isn’t always the ideal solution. It’s true that a brushed motor will probably fail eventually, due to wear between the brushes and commutator, but it’s a question of time. Coreless dc motors with low inductance can last many thousands of hours, far beyond what most applications will ever need. The intermittent motions of the DS-11 gave the motion system a low-duty cycle, letting a brushed dc motor solve the problem.

The choice of motor also helped the team achieve another design goal: Speed of operation. Individual adjustments to the z-axis position of the sample mount take 0.25 to 0.5 sec, for a total data acquisition time of less than 4 sec. By selecting a coreless motor, the DeNovix

THE BRUSHED MOTOR RADICALLY SIMPLIFIED THE DESIGN AND INTEGRATION PROCESS.

The illustrations provides a close-up of the top if the DS-11.

An excitation signal from a xenon flash lamp passes through the sample and is conveyed by a series of optical connections to the spectrometer.

www.medicaldesignandoutsourcing.com

MotionControl_SEPT 2015_Vs5.indd 115

9 • 2015

Medical Design & Outsourcing 115

9/18/15 1:51 PM

MOTION CONTROL

Inside the solution The DS-11 spectrophotometer measures the absorbance of biological samples to determine the presence and concentration of RNA, DNA, and key proteins. Those results depend on a precise, robust, easy to integrate positioning system.

Choosing a supplier that could take responsibility for the motion control allowed the DeNovix design team to focus on making the best possible optical instrument, not on becoming electromechanical specialists.

Several motors and gearheads were selected but the final configuration included: • 1515-SR 00 series dc motor • 15A plastic planetary gearhead • IE2 magnetic encoder

When the measurement arm is lowered, light travels up through the sample mount and sample to reach the collection fiber that transfers the signal to the spectrometer and detector.

team minimized inertia, enabling the motion axis to position rapidly and reliably without overshoot or ringing. “That’s where the motor comes into play,” says Kevin Kelley, Business Director at DeNovix.

“The system makes a lot of real-time decisions and the reaction speed of the motor lets it precisely control the path length, which is the most critical part of the apparatus.”

Integrated modules Once the team determined what it wanted, the next question was how to source it. They started with off-the-shelf components and offloaded some of the headaches by choosing a complete, pre-integrated gear motor from MICROMO that arrives ready to install.

“The biggest challenge was trying to get the product to market as quickly as possible, so the fact that several prototype motor assemblies were available for quick evaluation made this part of the project easy to deal with,” says Kelley. The motor company machined flats on the gearhead shaft in the

116

Medical Design & Outsourcing

MotionControl_SEPT 2015_Vs5.indd 116

9 • 2015

prototype stage to aid with assembly. Now that it has ramped to production volume, the flats are machined at the factory.

Taking delivery on a motion module lets DeNovix focus on the optics, streamlining manufacturing and eliminating the risk of damaging motion components during integration.

“We didn’t want to build it piece-meal,” says Ward, “so the integrated package was important.”

With the aid of SmartPath Technology, powered by precision motion, the DS-11 can measure samples with OPLs as low as 0.03 mm. This correlates to 500 absorbance units at the standard 10-mm equivalent OPL, which represents a BSA protein concentration of 750 mg/mL or dsDNA concentration of 25,000 ng/µL. Powered by the reliable motion system, the instrument demonstrates a repeatability of better than 1%.

The system survived rigorous lifetime testing. To date, DeNovix has had no reported motor failures in the field, a fact they credit in part to the performance of the motion control module. M

www.medicaldesignandoutsourcing.com

9/18/15 1:51 PM

FDA

Raising the bar on FDA guidelines

Kenneth A. Fine | President and Co-Founder | Proven Process Medical Devices |

The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of medical devices, among other things. Its role includes advancing public health by helping to speed innovations that make treatments more effective, safer, and more affordable.

As such, when breakthroughs in medical device design and engineering enable safety improvements, those innovations help inform the evolution of FDA standards and guidance. The FDA and the medical device industry have a symbiotic relationship, while their independent governance makes room for innovation and regulation to coexist and drive advancements in public health and safety.

Sometimes the limitations of available technology constrain the FDA’s purview.

THE FDA AND THE MEDICAL DEVICE INDUSTRY HAVE A SYMBIOTIC RELATIONSHIP, WHILE THEIR INDEPENDENT GOVERNANCE MAKES ROOM FOR INNOVATION AND REGULATION TO COEXIST AND DRIVE ADVANCEMENTS IN PUBLIC HEALTH AND SAFETY.

The Langford “LIC” machine is an example of how device engineering and FDA standards evolve in tandem.

For example, recent deaths resulted from infections transmitted during medical procedures through bacteriallycontaminated duodenoscopes – even though the reusable scopes had been cleaned according to protocol, using the best available technology, and in keeping with existing FDA standards.

The FDA issued new guidance for the labeling, validation and verification of medical devices a few months ago, which also covered instructions to be provided for reprocessing reusable devices. The guideline clearly states that existing reprocessing instructions “may not be consistent with state-of-the-art science www.medicaldesignandoutsourcing.com

FDA_SEPT 2015_Vs6.indd 117

and therefore may not ensure that device is clean, disinfected or sterile.” It also recommends that new 510(k) submissions address any inadequacies in current methods. This important guidance exposes the need for medical device designers to lead the way in improving disinfection protocols for the sake of patient safety.

To this end, the FDA set a standard for acceptable levels of cleanliness, measured by the amount of protein left on surfaces after cleaning. The standard requires cleaning to eliminate all but 6.4 mcg of protein per centimeter squared (6.4 mcg/cm2). None of the machines currently available can achieve that level of cleanliness without extensive additional procedures. This reality is raising the bar and driving innovations out of necessity.

While med-device companies struggle to meet the standard, one company says it has developed a cleaning machine that not only meets but exceeds it.

In validation studies for the FDA, the new machine, invented by Langford IC Systems and developed in partnership with Proven Process Medical Devices, reduced leftover residue to an average of 2.5 mcg/cm2, and in some cases lower than 1 mcg/cm2. The new cleaning machine dramatically improves sanitation of surgical instruments, endoscopes, and implantable devices, significantly reducing the probability of reusable medical devices spreading disease between patients in clinical settings.

The Langford “LIC” machine is but one example of how device engineering and FDA standards evolve in a parallel dynamic that improves healthcare and patient safety. The FDA develops guidance that drives innovation, and inventors and engineers work to meet and exceed those specifications while raising the bar for continued advancement. M 9 • 2015

Medical Design & Outsourcing 117

9/18/15 2:07 PM

FDA NEW PRODUCTS

Medtech approvals: FDA releases June 2015 PMAs The FDA today released its list of the pre-market approvals it granted for medical devices in June 2015:

PMA Original Approvals

Summary of PMA Originals & Supplements Approved Originals: 5 Supplements: 80 Summary of PMA Originals Under Review Total Under Review: 53 Total Active: 22 Total On Hold: 31

Summary of PMA Supplements Under Review Total Under Review: 575 Total Active: 418 Total On Hold: 157 Summary of All PMA Submissions Originals: 4 Supplements: 72

Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 80 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 115.2 FDA Time: 97.1 Days MFR Time: 18.1 Days

APPLICATION DEVICE TRADE NAME NUMBER / DATE OF APPROVAL

COMPANY NAME DEVICE DESCRIPTION / INDICATIONS CITY, STATE, & ZIP

P120024 6/11/15

activL® Artificial Disc

Aesculap Implant Systems, LLC Center Valley, PA 18034

Approval for the activL® Artificial Disc. This device is indicated for reconstruction of the disc at one level (L4-L5 or L5- S1) following single-level discectomy in skeletally mature patients with symptomatic degenerative disc disease (DDD) with no more than Grade I spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. The activL® Artificial Disc is implanted using an anterior retroperitoneal approach. Patients receiving the activL® Artificial Disc should have failed at least six months of nonoperative treatment prior to implantation of the device.

P140009 6/12/15

Brio Neurostimulation System

St. Jude Medical Plano, TX, 75024

Approval for the Brio Neurostimulation System. This device is indicated for the following conditions: 1) Bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinson’s disease that are not adequately controlled by medications; and 2) Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability.

P140021 6/11/15

Elecsys® Anti-HCV II Immunoassay and Elecsys® PreciControl Anti-HCV

Roche Diagnostics Indianapolis, IN 46250

Approval for the Elecsys Anti-HCV II Immunoassay and Elecsys PreciControl Anti-HCV. This device is indicated for: Elecsys Anti-HCV II Immunoassay Immunoassay for the in vitro qualitative detection of antibodies to hepatitis C virus (HCV) in human adult and pediatric (ages 18 months through 21 years) serum and plasma (potassium EDTA, lithium heparin, sodium heparin, and sodium citrate). Assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of HCV infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection. The test does not determine the state of infection or associated disease. The electroluminescence Immunoassay “ECLIA” is intended for use on the Roche cobas e 601 immunoassay analyzer. Elecsys PreciControl Anti-HCV Elecsys PreciControl Anti-HCV is used for quality control of the Elecsys Anti-HCV immunoassay on the cobas e 601 and cobas e 602 immunoassay analyzers and the Elecsys Anti-HCV II immunoassay on the cobas e 601 immunoassay analyzer.

P140025 6/12/15

VENTANA ALK (D5F3) CDx Assay

Ventana Medical Systems, Inc. Tucson, AZ 85755

Approval for the VENTANA ALK (D5F3) CDx Assay. This device is indicated for the following: VENTANA ALK (D5F3) CDx Assay is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue stained with a BenchMark XT automated staining instrument.

It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib).

P140031 6/17/15

Edwards SAPIEN 3™ Transcatheter Heart Valve, model 9600TFX, 20, 23, 26, and 29 mm, and accessories (Edwards Commander™ delivery system, models 9600LDS20, 9600LDS23, 9600LDS26, and 9600LDS29, with crimp stopper and Qualcrimp crimping accessory; Edwards eSheath Introducer Set, models 914ES and 916ES; and Edwards crimper, model 9600CR)

Edwards Lifesciences, LLC Irvine, CA 92614

Approval for the Edwards SAPIEN 3 Transcatheter Heart Valve, model 9600TFX, and accessories. This device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score ≥8% or at a ≥15% risk of mortality at 30 days).

For a detailed look at the products granted pre-market approval by the FDA in June, please visit dwo.me/1gmQVNG.

118

Medical Design & Outsourcing

FDA_SEPT 2015_Vs6.indd 118

9 • 2015

www.medicaldesignandoutsourcing.com

9/18/15 2:07 PM

PATENT PROTECTION

Five questions for early-stage companies looking to protect their IP

Jed Gordon | Partner and IP lawyer | Foley & Lardner LLP |

For many early-stage companies, their most valuable asset besides their management team is their intellectual property. This is particularly true in the world of medical devices, where significantly larger levels of investment and time may be necessary before a product clears all regulatory hurdles and enters the marketplace. Investors, as a result, demand more substantial intellectual property protection to ensure their return on investment.

Unfortunately, intellectual property is one of the most difficult asset classes to understand, preserve, and extract value from, particularly for 1st-time, early-stage ventures. This article addresses five of the most common intellectual property quandaries facing early-stage medical device companies: 1. Does my company own and control its intellectual property?

Most early-stage companies have little registered intellectual property, such as issued patents, that they can tout to potential investors. For most, at best they may have a provisional or nonprovisional patent application, with claims that have yet to have been tested by a patent office.

These patent applications represent a hope for defensible protection, but cannot provide an investor with any degree of certainty. The most this company can truthfully tell its investors is that the company owns its IP.

TO ENSURE THAT YOUR COMPANY OWNS ITS INTELLECTUAL PROPERTY, THERE ARE FEW BASIC STEPS TO FOLLOW.

To ensure that your company owns its intellectual property, there are few basic steps to follow. First and foremost, all employees, including the founders, should sign invention assignment agreements. The company should www.medicaldesignandoutsourcing.com

Patent_SEPT 2015_Vs5.indd 119

carefully evaluate the existing IP assignment obligations of new employees to ensure no other entity can lay claim to owning the IP developed for the company. All contractor and consultant agreements should be read with care to ensure that the company owns the IP generated under those agreements. Finally, the company should diligently document its innovations as they are developed, and especially before entering any form of collaboration, to avoid clouding questions of inventorship.

2. What should my IP strategy be?

Given the large costs associated with protecting one’s intellectual property through patent protection, it’s useful for a company to develop a patent strategy early on. This strategy can be used to evaluate whether the costs for protecting a given innovation makes sense. The most important inventions to protect early are those that drive market demand, are easier to reverse-engineer, and which must be disclosed to investors, regulators, or customers to move the business forward. For example, mechanical structures and circuit designs are prime targets for patent protection, while the details of a complex software algorithms may better be protected as trade secrets.

A clearly elucidated strategy also helps ensure a company doesn’t bite off more than it can chew. In the medical device industry, international patent protection is essential. At the same time, it’s incredibly expensive. A company should expect to spend between $16,000 and $18,000 per patent application in the first year to have it drafted and filed with the U.S. Patent Office and PCT to preserve patent rights. (A full third of these costs are patent office fees!)

While early provisional patent applications may be filed at relatively low cost, the rest of these costs cannot be deferred without risking loss of rights. Note these costs do not even include the cost of entering the application into any non-U.S. countries. Such filings will need to be made within two-and-a-half years from your original filing and 9 • 2015

Medical Design & Outsourcing 119

10/6/15 1:30 PM

PATENT PROTECTION

can cost between $2,000 and $10,000 per country. Developing a strategy at the outset can ensure that your company is spending its patent budget intelligently, instead of reactively, instinctively attempting to protect every innovation at tremendous cost.

3. Under What Conditions Can I Discuss My Technology With Others?

A common dilemma faced by many early-stage medical device companies is that their success depends on being able to explain their technology to third parties, including investors, doctors, and regulators. Doing so under the wrong conditions risks added competition and potential loss of patent rights. Ideally, a company would have a well- thought-out patent application on file, or a signed NDA with the recipient of information before disclosing their technology – and preferably both. Of course, this is not always possible. In such scenarios, any written documentation should clearly be labeled as “Confidential.” The information being disclosed should also be carefully vetted to limit disclosure of the most sensitive information. If the disclosure is part of a larger event, such as a conference, at a minimum a provisional application including the subject matter should be filed. In the worst-case scenario, a cover sheet can be added to the presentation or paper and filed, nearly as is, before the presentation is given, though a review by a patent attorney prior to filing is strongly encouraged.

A COMMON DILEMMA FACED BY MANY EARLY-STAGE MEDICAL DEVICE COMPANIES IS THAT THEIR SUCCESS DEPENDS ON BEING ABLE TO EXPLAIN THEIR TECHNOLOGY TO THIRD PARTIES, INCLUDING INVESTORS, DOCTORS, AND REGULATORS. 4. Should I file a Provisional Patent Application?

To many early-stage companies, the option of filing a provisional patent application appears to be a saving grace, solving their patent problems. Although provisional patent applications have a number of valuable benefits, they’re not appropriate in all cases.

Provisional patent applications provide a number of benefits.

They grant a patent applicant a priority date with respect to 120

Medical Design & Outsourcing

Patent_SEPT 2015_Vs5.indd 120

9 • 2015

the subject matter in the application relative to what might otherwise be prior art. A provisional patent application can extend the life of a patent by a year, because the term of patent is calculated from the date of the earliest non-provisional patent filing. This is particularly useful for those medical device innovations in which market acceptance is expected to take more time and when demand is expected to increase toward the end of the life of the patent. Finally, the provisional patent application need not be as formal as a non-provisional patent application, allowing for faster, less expensive filings.

Taking advantage of this last benefit, though, carries risks. Many patent applicants become complacent after filing a provisional, forgetting that the informal document they filed was not as complete as it would have been had they taken the time to prepare a full application. Important features that would have been included in a full patent application are then publicly disclosed prior to the non-provisional filing, jeopardizing the company’s rights to protect those features. In addition, informal provisionals may not provide enough support for an applicant’s claims under the stricter standards for enablement and explicit textual support of various jurisdictions around the world.

Informal provisionals can also lead to budget woes. Many companies file multiple provisional applications, because they can – forgetting that non-provisional U.S. and PCT (if desired) patent applications will need to be filed within one year, close to a $20,000 expense per provisional filing. Preparing an informal provisional does little to reduce the cost of the final application. If the company publicly discloses the subject matter during that year and then cannot afford to make these filings, the opportunity to protect the technology again may be lost.

Accordingly, provisional applications are best used when the primary goal is to delay the expiration of patent term, or when the filing is

www.medicaldesignandoutsourcing.com

10/6/15 1:30 PM

INFORMAL PROVISIONALS CAN ALSO LEAD TO BUDGET WOES.

Endlessly Inventive.

Precise, uniform heat.

Cartridge Heaters

necessitated by an impending public disclosure or a limited budget. In the latter circumstances, a patent applicant should prepare an updated filing as soon as possible to limit the applicant’s exposure to the risks identified above.

5. How can I budget for an intellectual property portfolio?

An important aspect of patent strategy is budget management. Budgeting for an IP portfolio should take into account more than just the costs of preparing patent applications. After the first few years of developing a portfolio, more than half the cost of a portfolio can be attributed to filing fees. International filing costs, including translation fees, foreign associate fees, and foreign patent office fees, quickly mount.

A well-thought-out patent budget modulates which countries each patent application is filed in, based on strategic importance, to help manage these costs. As a company matures, room should be left in an IP budget to address issues raised by third-party intellectual property rights. These funds can be used to analyze third-party patents to demonstrate the company’s freedom to operate, to design around a patent, or obtain a license if needed. Finally, costs should be set aside to manage the company’s non-patent IP, including trade secrets, trademarks, and copyrights.

While often less expensive to protect than patent rights, trademark protection is not free and can often become one of a company’s most valuable IP assets. M 9 • 2015

Thick Film Heaters

Flexible Heaters

NEW!

Thick Film Circuits

ISO 9001:2008 Registered

www.heatron.com 913.651.4420 sales@heatron.com

Medical Design & Outsourcing 121

Patent_SEPT 2015_Vs5.indd 121

10/6/15 1:31 PM

DEVICE TALKS

DeviceTalks: Boston Scientific CEO Mike Mahoney

I GUESS WE DID TURN AROUND THE PERFORMANCE, BUT REALLY WHAT WE DID IS UNLOCK THE POTENTIAL AND THE CAPABILITIES OF THE TEAM OF 25,000 EMPLOYEES HERE.

122

Medical Design & Outsourcing

Device_Talks_Sept 2015_Vs3.indd 122

9 • 2015

Four years ago, when Mike Mahoney was just another rising star in the Johnson & Johnson universe, the powers-that-be at Boston Scientific knew they needed a game-changer.

Times were not good at the Natick, Mass.based medical device giant. For several years following the $27 billion Guidant acquisition, Boston Scientific had been mired in a prolonged slump. Crippling debt from the Guidant deal pushed the company from stock market darling to “Fallen Angel” – Wall Street parlance for once-high-flying firms whose credit rating is reduced to junk bond status.

If that wasn’t bad enough, regulatory issues, a series of costly, high-profile recalls and a slowdown across key product lines had all but halted the growth trajectory at Boston Scientific.

Although share prices by 2011 were mired under $6 apiece (down roughly -87% from a peak of nearly $45 per share in 2004), a series of moves by CEO Ray Elliot, a renowned turnaround artist who helped reverse the fortunes of Zimmer Biomet, laid the foundation for a recovery. Boston Scientific refinanced the debt load and, in a surprise move that September, announced that Mahoney would be its new CEO after serving a yearlong stint as president to comply with a non-compete agreement with J&J. With the stock at about $5.14 per share in early November 2012, Mahoney officially took the reins like a character straight out of central casting and set about transforming Boston Scientific.

Starting with a bold decision to sell its Natick, Mass., headquarters and move to smaller digs in nearby Marlborough, Mahoney spearheaded a three-year drive that’s seen BSX shares rebound more than 262%. The stock posted a high of $18.62 apiece June 1, and the company is guiding for consistent top-line growth.

Mahoney was ready to look back at the turnaround and declare it closed when MassDevice.com sat down this June in Marlborough for our DeviceTalks show, which attracted 200 industry executives. Interestingly,

he told that the most important move he made didn’t directly concern the balance sheet: Instilling a corporate culture that got employees excited about improving patients’ lives proved to be key.

Below is a transcript of Mike’s conversation with publisher Brian Johnson at the June DeviceTalks event, edited for clarity.

BRIAN JOHNSON: We met three years ago, when you were just about to take this job. Or you were in the job, but you weren’t ready or weren’t yet the CEO, the big guy.

MIKE MAHONEY: When you say I wasn’t ready, what do you mean? What exactly do you mean by that? What exactly are you talking about? [laughter] JOHNSON: You weren’t ready to be called CEO. How about that?

You’ve now spent two years as CEO of Boston Scientific. I’m just wondering, personally what has this experience been like for you?

MAHONEY: You are going to make me cry. Is that the goal? [laughter] What’s the experience like? I love it.

When I joined almost three and a half years ago, it was a tough decision. I left a great company, but I was very excited about the opportunity here, and to this day I can say I just love what I do. As I mentioned before, we all get to impact patients, and it’s a wonderful industry, and I work with a fantastic team here.

There is nothing I’d rather do than work for Boston Scientific and help drive innovation and work with this team. I hope I’m here for a long time, so I’m hoping this isn’t the last interview.

www.medicaldesignandoutsourcing.com

9/18/15 2:35 PM

JOHNSON: I think you will be judged by your performance, so you should be here for a long time.

You had a mandate: Return the company to growth.

What were some of the ways you said, “I’m going to achieve those goals,” and have you met them?

MAHONEY: We definitely delivered on that, the commitments we made externally, and at our Investor Day recently we gave longer-term commitments that were pretty bold and talked about growing faster than our competition and growing in the strong mid-single digits and driving operating margin improvement and driving double-digit EPS growth. That’s all good. We talk about a turnaround, I guess we did turn around the performance, but really what we did is unlock the potential and the capabilities of the team of 25,000 employees here.

We did some structural things, we enabled the organization to move a little bit faster by expanding the number of reports and the speed of the company. We did a lot of simple things on just reinvigorating what it means to work here, we established values for the company. I can talk about that all night long. Of couse you want to make money, but most employees want to feel great about the company they work for, proud of the

www.medicaldesignandoutsourcing.com

Device_Talks_Sept 2015_Vs3.indd 123

company, pride when they are talking about the company with their family and friends, and they want to have a career.

They want to feel really good about it.

A lot of what we did to turn around the company, a lot of portfolio things we can talk about, most of it was the culture of the company. How do we hire great leaders? How do we enable greater speed in the company, faster decisionmaking, more empowerment, more pride in the company and a winning spirit?

The biggest element of the turnaround was, I think, the cultural impact and really unleashing the talent in the company.

That’s always been there. It went through some dark days for a few years, but it’s always there – it’s just more bringing that out again.

JOHNSON: How much of that did you discover during the year you spent learning the company before taking the CEO role?

MAHONEY: I was in a detention for a year, I wasn’t able to take the job because I wasn’t ready, apparently [laughter].

Then I got my badge, and I was ready to go. I learned a lot – it was actually

9 • 2015

Medical Design & Outsourcing 123

9/18/15 2:36 PM

DEVICE TALKS

a very unusual circumstance to be guaranteed the job, but technically not having the job. I worked with [interim CEO] Hank Kucheman, he was terrific, and the one year was terrific because I was able to focus just on our businesses and learn our portfolio and learn our people and learn our talent and our capabilities.

I didn’t have to work with investors, analysts, lots of those things that take up a lot of time. I was just able to focus purely on the talent of the company. When you can dig in that way and put your time there, it was a big advantage.

JOHNSON: I guess it’s safe to say you’ve met the objectives you set for yourself in the first three years.

MAHONEY: We have. A few years ago, we hadn’t grown for about four years in a row, and we’ve grown, I don’t know how many quarters in a row now, eight or nine or so. We gave a pretty strong guidance for 2015 and ’16, ’17 and ’18. The company is growing and really what we focused on, like a lot of you do, we focus first of all on talent and we made some changes to the senior leadership team, brought in great local leaders for the emerging markets and in Asia and in Europe.

We sped up the operating processes of the company, we reduced down a lot of bureaucracy in terms of the amount of reporting and decision-making and things that had to take place to improve decision-making. We spent a ton of time in the 124

Medical Design & Outsourcing

Device_Talks_Sept 2015_Vs3.indd 124

9 • 2015

pipeline, we took some bets that have worked out great in the pipeline in CRM with the S-ICD device, with Watchman, the only product that helps patients reduce the risk of stroke who have afib. We’ve got a great structural heart program that’s really early on. We’ve got a very exciting pipeline that we worked on.

I spent most of my time focused on the culture of the people and the pipeline. That’s what we do, and we were growing, we are investing in a lot of emerging markets because we were a little bit late in some of those markets.

Now we are doing very well, we are building lot of capabilities there with market-appropriate products and training and leveraging capabilities across BSC. We reinvigorated our BSC venture firm, and we made about 20 investments in smaller, really promising exciting companies over the past two years.

To answer your question, we have delivered on our commitments in terms of the turnaround, and are essentially raising the bar. Our third value is high performance. Part of the performance we have met, but that’s yesterday’s news.

The performance expectations we have now are much higher than they were three years ago.

JOHNSON: Right, because I know you said the turnaround is complete.

MAHONEY: We don’t like to talk about it anymore because it’s old news.

www.medicaldesignandoutsourcing.com

www.m

9/18/15 2:36 PM

Sometimes even the best ideas need a little help.

JOHNSON: Right, but I do think it’s such a good story, you probably want to keep banging that way for awhile.

MAHONEY: I’m proud of it, but I’m sincerely more happy for the employees who have been here for a long time.

I had the honor of meeting, I can’t remember her name, but she was a clinical employee for Boston Scientific in her thirty-year anniversary of the company. I was able to give her a plaque, and I had never given somebody a thirtyyear award before.

The company had always been great, and we went through a downturn, and we are really on a great run that will be sustainable. I’m really happy for the employees who had been here for a long time, because they tell me that. They say it’s so great to be part of a company that’s winning again, that’s fast, that’s innovating. That’s what’s most fun for me. It sure feels good for me, but when you give somebody a thirtyyear award, she gives you a big bear hug, that’s much better.

JOHNSON: How about personal goals? I know you’ve led divisions, you’ve also been CEO of another company, never one as big as this, so did you have personal goals, like “I don’t want to become this type of person.”

MAHONEY: You don’t want to be “That Guy.” When I took the job, I had a lot of goals.

To this day I still say this is the dream job for me, and I really want to be here for quite a while. My goals when I first started were really simple: They were to return the company to growth, restore what I call the winning spirit among our employee base, and develop a pipeline again where customers can count on us and really need us. www.medicaldesignandoutsourcing.com

Device_Talks_Sept 2015_Vs3.indd 125

I think we’ve really established that. The company is growing nicely, we were 6% in the first quarter, we have the guidance this year for about 6% again.

There is a lot of margin improvement of the company, so we are delivering it financially. I’d say I’m excited about the goals that we established.

JOHNSON: And you haven’t become “That Guy.” MAHONEY: No, no, I don’t think so.

JOHNSON: Winning spirit. It’s a motto that’s all over this building. But beyond the motivational phrase, what is it, what does it mean to you?

MAHONEY: It’s funny, a couple of quick stories. When I first joined the company, we had our headquarters in Natick. The first day I showed up for work – I couldn’t interview at Boston because I was at a competitor – my first day, I showed up at the job at Natick, and I didn’t have a badge so I couldn’t get through security. So I had to call my admin, and she came down to pick me up. The Natick building was a nice facility at one time, but it was essentially half empty. It was a bit outdated, and it didn’t have a vibrancy and a speed and a culture that you want.

My first board meeting, I said, “We want to make these changes in personnel, and we want to sell that corporate headquarters and move.”

That was the first board meeting. That went well [laughter].

But I felt that, culturally, that’s a big deal. It was a place that when you walked around, it wasn’t a team that was winning and there wasn’t transparency and there wasn’t collaboration, and it was really old-school. Thankfully we got MathWorks to buy the property. Our headquarters is now a third of the size it used to be.

9 • 2015

Medical Design & Outsourcing 125

Service

Tegra Medical can turn your bright ideas into great products.

The GENESIS Tech Center® is a dedicated manufacturing space where we help get your products to market.

• Quick turnaround prototyping and pilot production — using the same type of manufacturing equipment as our lean production environment.

• Design for manufacturability and assembly — reduce costs, increase quality and shorten the development cycle.

• Robust engineering and quality processes — ensuring adherence to all requirements and specifications.

• Complete project management — we’ll ease you through all phases, from design to assembly and beyond.

Tegra Medical: innovative solutions, comprehensive service and speedy turnaround to launch your prototypes.

Orthopaedics — Minimally-Invasive Interventional — And More

Where medical devices come to life.

Boston —Memphis—Costa Rica www.tegramedical.com or 508.541.4200 Tegra Medical and GENESIS Tech Center are trademarks of Tegra Medical.

Copyright © 2015 Tegra Medical. All rights reserved.

Tegra_Big100_1/3p_tintots_09.04.15.indd 1

9/18/15 2:36 PM 9/3/15 12:44 PM

DEVICE TALKS

TO THIS DAY I STILL SAY THIS IS THE DREAM JOB FOR ME, AND I REALLY WANT TO BE HERE FOR QUITE A WHILE. Before it was just much too large.

That’s important, but back to the winning spirit. What I quickly saw in the company was an opportunity, it sounds old-school, to re-establish what Boston Scientific means. We worked together to create a fresh mission statement, “Advancing science for life,” and we worked with the team to create values, much like many small companies would do. At Boston Scientific, we talk about caring, we talk about meaningful innovation, we talk about high performance, globalization, diversity. And then the team said, “We only use five.”

I said, “Winning spirit is my favorite one, so I’m just going to throw in the winning spirit as number six.”

But we did that, and it sounds weird for a larger company like Boston

Scientific, but the chance to re-create that in the very beginning with our employees and establish that we are a special company and we are going to make great things happen and help patients and win in the market, and drive the heck out of stock performance as well for a long time.

What I often say is only a maybe a small percentage of employees really care about the stock price. Most employees want to be part of a great company, where they have engagement and they are proud of it. The winning spirit was important to me, because the first few meetings I went to, we are very, very heavy in bureaucracy. We would do a business review and the binders were two feet thick, and I’ve got a lot of ADD, I couldn’t get through it. Things were just slow, and so we added the winning spirit.

It’s a phrase I learned from Jeff Immelt years ago at GE. What it really means to me is we want employees who are leaders, whether they are in supply-chain, quality, R&D, regulatory clinical, who see opportunities everywhere, who aren’t afraid to take chances, who are willing to make tough decisions and are comfortable with being a power. There are a few companies that are bigger than ours, but I think we can be the fastest-moving company in device.

We pushed that winning spirit attitude, and some folks weren’t comfortable with making decisions quickly and not having the two-foot binder. We use that winning spirit as a way to see opportunities, and have courage to make decisions, and move faster as a company.

I think speed wins, not size wins. I think we are starting to generate that momentum.

JOHNSON: That came from Jeff Immelt, that phrase? The winning spirit, you didn’t coin that.

M E D T E C H ’ S B R I G H T E S T M I N D S M E E T AT

D E V I C E TA L K S W E S T 2 0 1 5 Since 2011, DeviceTalks, the live interview series from MassDevice, has brought you the best insight from the brightest leaders in medtech at intimate one-evening gatherings across the country.

DEC. 9 126

Learn more about this event and stay tuned for more announcements on the rest of our 2015 season.

THE IRVINE MARRIOTT IN IRVINE, CALIF.

Medical Design & Outsourcing

Device_Talks_Sept 2015_Vs3.indd 126

This season of conversation with the leaders in medicine takes you inside the corner office of Boston Scientific, Johnson & Johnson, Merit Medical Systems, Entellus Medical, Tal Medical, Rotation Medical, Sunshine Heart, Aum Cardiovascular and more.

9 • 2015

www.medicaldesignandoutsourcing.com

9/18/15 2:36 PM

MAHONEY: No, I actually stole it [laughter].

JOHNSON: That’s worked for you.

MAHONEY: I love it, I like it.

JOHNSON: You live that in your personal life as well?

MAHONEY: I came in 95th in a 5K in our town out of about 110 people. I was fast [laughter].

I’m like many of you in this business. It changes a lot. I’m very competitive, and I want so much for a company to be uniquely good. That’s what motivates me, and I’m very restless about the performance of our company, and I care about employees. I guess I live it pretty well.

JOHNSON: Let’s switch a little bit to the market. You’ve spent a considerable amount of time in your career dealing with the interaction between hospitals and suppliers. In particular I’m referring to your time running the global healthcare exchange. Recently you said, “We are not going to pretend to be a solutions company.” But clearly the industry is moving toward the service model – we are seeing it from a lot of your competitors, frankly – and we saw that big Philips Healthcare deal recently, where they’re moving beyond just selling imaging equipment and bundling services in there. What’s driving this push toward the service model?

MAHONEY: The reason I said it is, I just want to be clear with our employees and our team that we are a medical device company and we make disruptive innovation to help patients, and that’s going to a drive a significant portion of our revenue and income forever.

Regarding solutions and services, I worked for GE when I first came out of school, and that company is very advanced, from servicing competitors’ equipment, to financing equipment, to outsourcing radiology labs, providing lean

optimization. I’m very familiar with it, and also from being at J&J. At Boston Scientific, we are medical device company, but many of our businesses, before solutions became more the buzzword, have been very active in providing services and solutions within their business unit. We do have a capability at Boston Scientific called Advantix – we offer a number of solutions. We don’t market it as heavily as some companies do, but our solutions are really pointed at the businesses.

In our urology business, whether you talk about our remote stent trackers – because believe it or not, physicians forget to pull urethral stents out – you actually can track them remotely.

There’s all kinds of things in our heart failure business, our CRM business.

We do a lot with heart failure analytics with our remote monitoring capabilities, we’ve done two or three recent joint ventures to provide cardiovascular analytics to customers.

We have heart failure projects going on at that same hospital involved with Philips. We have a number of solutions within our Advantix portfolio, but they are aimed toward logical services or productivity benefits that are tied to our products.

They are typically focused on cardiovascular for our ICD business and our PI business.

Whether it be lean optimization, billing practices that we assist with, we help our patients with Watchman, help develop their stroke programs.

We enabled these, but we don’t have a vision for outsourcing, we don’t have a vision of buying hospitals or buying cath labs or outsourcing cath labs. We don’t think most customers want that, and so we focus on other services that make sense for our portfolio. M

Read the full interview online!

devicetalks.com

Behind the scenes.

Ahead of the curve.

Inside the corner office.

www.medicaldesignandoutsourcing.com

Device_Talks_Sept 2015_Vs3.indd 127

9 • 2015

Medical Design & Outsourcing 127

9/18/15 2:36 PM

AD INDEX SALES

Accu-Mold LLC.............................................................................. IBC Accuride International Inc............................................................... 27 B. Braun Medical Inc......................................................................BC BellowsTech, LLC............................................................................. 95 Bi-Link Corp...................................................................................113 Bimba Manufacturing Co.................................................................. 1 Bishop-Wisecarver Corp................................................................. 45 Boyd Coatings Research Co., Inc................................................. 109 Caplugs.............................................................................................. 4 CGI, Inc............................................................................................. 75 Clippard Instrument Laboratory, Inc................................................ 7 Coatings2Go, LLC...........................................................................18 CPC — Colder Products Company................................................ 39 Eagle Stainless Tube & Fabrication, Inc........................................ 31 Freudenberg Medical, LLC...............................................................3 Harmonic Drive LLC........................................................................ 87 Heatron Inc. .................................................................................. 121 Helical Products Co......................................................................... 22 Humphrey Products Corp............................................................... 72 Interpower Corp. ............................................................................ 91 J.W. Winco, Inc................................................................................. 61 Keystone Electronics Corp. ............................................................. 9 Master Bond, Inc............................................................................. 61 Maynard Tool and Engineering Inc................................................ 67 maxon precision motor, inc............................................................ 77 MEGA Electronics, Inc.................................................................... 67 Merit Medical Systems, Inc. ........................................................... 37 MICROMO....................................................................................... 56 Minnesota Rubber and Plastics .....................................................10 Nabtesco Motion Control, Inc........................................................98 Nelson Laboratories Inc................................................................100 Nippon Pulse America Inc............................................................ 105 NOOK Industries, Inc...................................................................... 81 Novasyte.......................................................................................... 16 Phase 2 Medical Manufacturing, Inc............................................123 Proto Labs, Inc.................................................................................20 Proven Process Medical Devices, Inc............................................. 35 PTI Engineered Plastics, Inc............................................................13 Renishaw Inc.................................................................................... 29 RenyMed.......................................................................................... 97 RESONETICS................................................................................. IFC SAPA Extrusions North America..................................................... 79 Schneider Electric............................................................................33 Servometer....................................................................................... 95 Smalley Steel Ring Co..................................................................... 24 Tegra Medical................................................................................. 125 THK America, Inc. ............................................................................. 5 Web Industries, Inc. ...................................................................... 101 Zeus.................................................................................................. 94 128

Medical Design & Outsourcing

Ad_Index_SEPT 2015_Vs2.indd 128

9 • 2015

VP Sales Todd Tidmore ttidmore@wtwhmedia.com 512.626.8263 @wtwh_ttidmore

Regional Sales Manager Tom Lazar tlazar@wtwhmedia.com 408.701.7944 @wtwh_Tom

VP of EE Product Development Mike Caruso mcaruso@wtwhmedia.com 469.855.7344

Regional Sales Manager Courtney Seel cseel@wtwhmedia.com 440.523.1685 @wtwh_CSeel

VP, Business Development Michael Ference mference@wtwhmedia.com 408.769.1188 @mrference General Manager Todd Christenson tchristenson@wtwhmedia.com 440.381.9048 @wtwh_todd VP, Business Development David Geltman dgeltman@wtwhmedia.com 516.510.6514 @wtwh_david Key Account Manager Jim Powers jpowers@wtwhmedia.com 312.925.7793 @jpowers_media

Regional Sales Manager Neel Gleason ngleason@wtwhmedia.com 312.882.9867 @wtwh_ngleason Regional Sales Manager Jessica East jeast@wtwhmedia.com 330.319.1253 @wtwh_MsMedia Regional Sales Manager Megan Hollis mhollis@wtwhmedia.com 440.821.2941 @wtwh_Megan Key Accounts Manager MaryAnn Cooke mcooke@wtwhmedia.com 781.320.8533 Business Development Michelle Flando mflando@wtwhmedia.com 440.670.4772 @mflando

LEADERSHIP TEAM Publisher Brian Johnson bjohnson@wtwhmedia.com 617.905.6116

EVP Mike Emich memich@wtwhmedia.com 508.446.1823 @wtwh_memich

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

EVP Marshall Matheson mmatheson@wtwhmedia.com 805.895.3609 @mmatheson

CONNECT WITH US!

Follow the whole team on twitter @WTWH_Medical

www.medicaldesignandoutsourcing.com

9/19/15 3:23 PM

Accumold 10-14.indd 56

9/15/15 4:20 PM

If you’re looking for a single-source v, how about one that has a full range of parenteral

pharmaceutical solutions? Or one with a catalog of valves as thick as a phone book? Or one that

carries all the admixture accessories you could ever pack into a custom kit for your drug or device?

& there’s more. Besides a line containing hundreds of products, we offer a full range of capabilities.

Project management puts your product on a fast track to market without compromising quality.

Our engineering and quality systems maintain exacting standards of excellence. Other services under our roof include full sterilization capabilities and regulatory expertise to ensure compliance in this country and around the world. It all adds up to a single-source supplier that goes far beyond being a vendor to being a true partner.

B. Braun Medical | OEM Division | USA ©2015 B. Braun Medical Inc. Bethlehem, PA. All rights reserved. OEM 15-4993 6/15 LMN

B Braun 9-15.indd 15

9/15/15 4:21 PM