Medical Design & Outsourcing; BIG 100; September 2015

Medical Design& OUTSOURCING

SEPTEMBER 2015www.medicaldesignandoutsourcing.com

E X C L U S I V E : I n s i d e t h e B o s t o n S c i e n t i f i c t u r n a r o u n d w i t h C E O M i k e M a h o n e y

BIG1OOMEDTECH'S 100 LARGEST PLAYERS

• 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

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2 Medical Design & Outsourcing 9 • 2015 www.medicaldesignandoutsourcing.com

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 mega-sized deals, and the activity extended on down the food chain to even the smallest players.

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

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02 EDITORIAL: Welcome back to the Big 100

06 CONTRIBUTORS

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

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

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.

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

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

128 AD INDEX

CONTENTS medicaldesignandoutsourcing.com ∞ September 2015 ∞ Vol1 No2

DEPARTMENTS

Medtech’s 10011

ON

TH

E C

OV

ER

:

LARGEST PLAYERS

17 Big 100 Breakdown74 Top R&D Spenders Who’s putting the most into the pipeline?

78 Top Medical Device Employers

82 Medtech’s Global Hotspots U.S., Global

86 Ones to Watch Medtech’s Up-and-Comers

90 CEO moves Notable moves in the C suite

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CONTRIBUTORS

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 [email protected].

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 [email protected].

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.

HUDSON

BACH

GORDON

GAUMER

FINE

EISENHART

SPATIG

LEBLANC

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 [email protected].

DAVE HUDSON is president and CEO of Joining Technologies, one of the nation’s leading precision fusion companies. Reach him at [email protected].

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, SouthcoAs 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.

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MEDTECH'S 100 LARGEST PLAYERSA 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.

Big 100 Breakdown p.17Top R&D Spenders p.74Top Medical Device Employers p.78Medtech’s Global Hotspots p.82Ones to Watch p.86CEO Moves p.90

THE BIG 100 LIST BEGINS ON THE NEXT PAGE

BIG 100 INTRO_9-15_Vs4.indd 11 9/17/15 2:23 PM


COMPANIES RANKED BY REVENUE

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 $4,629,336,107

21 Smith & Nephew $4,617,000,000

22 Hospira $4,463,700,000

23 Grifols $4,461,654,105

24 Getinge Group $3,888,969,902

25 Cerner $3,402,703,000

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

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

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

39 Nipro $2,248,694,912

40 Coloplast $2,213,317,661

RANK COMPANY 2014 REVENUE

SSS

A FEW YEARS AGO WE HADN’T GROWN FOR ABOUT FOUR YEARS IN A ROW,

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AND ‘16, ‘17 AND ‘18.

"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.

- BOSTON SCIENTIFIC CEO MIKE MAHONEY

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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

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

COMPANIES RANKED BY REVENUE

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

SSS



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 AMERICASRICHARD REYNOLDS

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(732) 524-0400 www.jnj.com

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

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,

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

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2MEDTRONIC7000 Central Ave NEFridley, 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 pure-play 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.

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

KEY PERSONNEL:

OMAR ISHRAK Chairman & CEOBILL BURKE Chief Integration OfficerMICHAEL J. COYLE EVP & President, Cardiac & Vascular GroupGARY ELLIS EVP & CFOMIKE GENAU SVP & President, AmericasHOOMAN HAKAMI EVP & President, DiabetesBRYAN HANSON EVP & President, CovidienDR. RICHARD KUNTZ SVP & Chief Scientific, Clinical, & Regulatory OfficerCHRIS LEE SVP & President, Greater ChinaBRAD LERMAN SVP, General Counsel & SecretaryGEOFFREY S. MARTHA SVP, EVP & President, Restorative TherapiesDR. STEPHEN N. OESTERLE SVP, Medicine & TechnologyLUANN PENDY SVP, Global QualityCAROL A. SURFACE SVP & Chief HR OfficerROB TEN HOEDT EVP & President, EMEABOB WHITE SVP & President, Asia Pacific

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


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3GE HEALTHCAREAmersham 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.

* Revenues and employees include GE Healthcare only.

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


KEY PERSONNEL:

JOHN L. FLANNERY, President & CEOJÖRG DEBATIN, VP & Chief Technology OfficerJAN DE WITTE, President & CEO, Healthcare ITRACHEL DUAN, President & CEO, ChinaLAURENT DUBOIS, CEO, PartnersCARRIE EGLINTON MANNER, President & CEO, Detection & Guidance SolutionsMARKUS EWERT, EVP, Business DevelopmentRANDY FOX, VP & CIOJASON HANSON, Chief Risk Officer & VP, General CounselHENRY HUMMEL, President & CEO, Molecular Imaging (MI) & Computed Tomography (CT)KARIM KARTI, VP & Chief Marketing OfficerRAGHU KRISHNAMOORTHY, VP, HRAKIHIKO KUMAGAI, President & CEO, Asia PacificTHIERRY LECLERCQ, President & CEO, Life Care SolutionsJEAN MICHEL MALBRANCQ, President & CEO, EuropeSKANDER MALCOLM, President & CEO, Eastern & Africa Growth Markets (EAGM)BRIAN MASTERSON, VP, Global Supply ChainDEE MELLOR, Chief Quality OfficerMARCELO MOSCI, President & CEO, U.S. & CanadaKIERAN MURPHY, President & CEO, Life Sciences

MONISH PATOLAWALA, VP & CFOGUSTAVO PEREZ-FERNANDEZ, President & CEO, SurgeryMILAN RAO, President & CEO, South AsiaJOE SHRAWDER, resident & CEO, Global ServicesERIC STAHRE, President & CEO, Global MRIANDERS WOLD, President & CEO, Ultrasound


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4SIEMENS HEALTHCARESiemens 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: 43,000Revenue: $16,526,841,300*R&D Spend: $5,405,230,500Fiscal year ending: Sept. 30, 2014

KEY PERSONNEL:

BERND MONTAG CEOMICHAEL SEN CFODR. GREGORY SORENSEN, President & CEO, Siemens Healthcare North AmericaMICHAEL REITERMANN CEO, Siemens Healthcare Diagnostics

* Revenues and employees from Siemens Healthcare only.


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5PHILIPS HEALTHCAREBC475958BREITNER CENTER AMSTELPLEIN 2 AMSTERDAM P7 Netherlands 1096 BC

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


* Revenues from Philips Healtchare only.

KEY PERSONNEL:

FRANS VAN HOUTEN, Chairman & CEO, Royal PhilipsJIM ANDREW, EVP Royal Philips, Chief Strategy & Innovation OfficerMARNIX VAN GINNEKEN: EVP, Chief Legal OfficerDENISE HAYLOR: EVP, Chief HR OfficerRONALD DE JONG: EVP Royal Philips, Chief Market LeaderPATRICK KUNG: EVP Royal Philips, CEO Greater ChinaPIETER NOTA: EVP & CEO, Philips Consumer LifestyleERIC RONDOLAT: EVP & CEO, Philips LightingRON WIRAHADIRAKSA: EVP & CFO, Royal Philips

31 20 59 77777 www.usa.philips.com



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6CARDINAL HEALTH7000 Cardinal PlaceDublin, 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: 34,000Revenue: $11,400,000,000*Fiscal year ending: June 30, 2015

KEY PERSONNEL:

NICK AUGUSTINOS SVP, Health Information Services & StrategyGEORGE S. BARRETT Chairman & CEODONALD M. CASEY JR. CEO, Medical SegmentCRAIG COWMAN EVP, Global SourcingJOSEPH DEPINTO President, Cardinal Health Specialty SolutionsMIKE DUFFY President, Medical ProductsBRIAN ELLIS EVP, Enterprise Corporate Accounts & Strategic Account TeamsSTEVE FALK EVP, General Counsel & SecretaryMEGHAN M. FITZGERALD President, Specialty SolutionsJON GIACOMIN CEO, PharmaceuticalSTEVE INACKER President, Hospital Sales & ServicesMIKE KAUFMANN CFOCRAIG MORFORD Chief Legal & Compliance OfficerPATRICIA MORRISON EVP, Customer Shared Services, CIOTIFFANY OLSON President, Nuclear Pharmacy ServicesBILL OWAD SVP, Operational ExcellenceMICHAEL PETRAS President, Cardinal Health at HomeCAROLE WATKINS Chief HR Officer

* Revenues from Cardinal Health’s medical segment only.

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7ALCONLICHTSTRASSE 35BASEL, 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


KEY PERSONNEL:

JOSEPH JIMENEZ CEO, NovartisJEFF GEORGE Global Head of AlconCHRISTINA ACKERMANN SVP, General Counsel, AlconPAUL VAN ARKEL Head of Corporate Strategy & Healthcare Systems;LAURENT ATTIAS Head, Strategy, Business Development & Market Access, AlconSERGIO DUPLAN Region President, Latin America & Canada, AlconFREDERIC GUERARD Global Franchise Head, Alcon PharmaceuticalDAVID NIETO CFOBETTINA MAUNZ VP, Global Head Communications, AlconMERRICK MCCRACKEN SVP, HR, AlconED MCGOUGH SVP, Global Manufacturing & Technical Operations, AlconJIM MURPHY Region President, Japan, AlconMICHAEL ONUSCHECK Global Franchise Head, Alcon SurgicalRIAD SHERIF President, EMEA, AlconERIC VAN OPPENS President, Asia & Russia, AlconROBERT WARNER President, United States, AlconSUE WHITFILL Head, Global Quality, Alcon

* Revenues from Alcon segment only.


Renishaw Inc Hoffman Estates, IL www.renishaw.com

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8BAXTER INTERNATIONALOne Baxter ParkwayDeerfield, Illinois 60015-4625

(800) 422-9837 www.baxter.com

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

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


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


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9STRYKER CORP2825 Airview BoulevardKalamazoo, 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: 26,000Revenue: $9,675,000,000*R&D Spend: $614,000,000Fiscal year ending: 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, OrthopedicsDAVID G. FURGASON VP, TaxMICHAEL D. HUTCHINSON General CounselWILLIAM R. JELLISON VP, CFOKATHERINE A. OWEN VP, Strategy & Investor RelationsBIJOY SAGAR VP, CIOTIMOTHY J. SCANNELL President, MedSurg & NeurotechnologyELIZABETH A. STAUB VP, Regulatory Affairs & Quality AssuranceRAMESH SUBRAHMANIAN President, InternationalBRONWEN R. TAYLOR VP, Compliance & Risk Management


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1O FUJIFILM HOLDINGS7-3, Akasaka 9-chomeMinato-ku, Tokyo, Japan 107-0052

03-6271-1111 www.fujifilmholdings.com/en/index.html

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.

MARKETS: Imaging/radiology, Radiopharmaceuticals

* Revenues from Fujifilm Holdings’ Information Solutions segment only.

Employees: 79,235Revenue: $9,017,788,916*R&D Spend: $1,523,964,441Fiscal year ending: March 31, 2015

KEY PERSONNEL:

SHIGETAKA KOMORI Chairman & CEOSHIGEHIRO NAKAJIMA President & COOKOUICHI TAMAI VPKENJI SUKENO VPKAZUHIKO FURUYA VP MASAHIRO ASAMI VPHIROSHI TANAKA VP HARUHIKO YOSHIDA VP RYUTARO HOSODA VP TORU YAMADA VPMASARU YOSHIZAWA VPSHIGENOBU INENAGA VP


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11

12

ESSILOR INTERNATIONAL

BOSTON SCIENTIFIC

147 rue de Paris, Charenton-le-Pont, France 94220

300 BOSTON SCIENTIFIC WAY MARLBOROUGH, MASSACHUSETTS 01752-1234

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


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

KEY PERSONNEL:

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

+33(0)1 49 77 42 24 www.essilorusa.com/EN/Pages/default.aspx

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MARKETS: Vision

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

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13B. BRAUN MELSUNGENWerkanlage Pfieffewiesen Europagebäude Melsungen, Germany 34212


+49 (0 56 61) 71-0 www.bbraun.com

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 DANAHER2200 Pennsylvania Avenue, NW Suite 800W Washington, DC 20037

1 (202) 828-850 www.danaher.com

* Revenues from Danaher’s Life Sciences & Diagnostics segment only.

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

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

© 2015 Colder Products Company

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15FRESENIUS MEDICAL CAREElse-Kroener-Strasse 1 Bad Homburg v.d.H, Germany 61352

+49 (0) 6172 608-0 www.fresenius.com

* Revenues from Fresenius Medical Care’s Fresenius Kabi division only.


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

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16ST. JUDE MEDICALONE ST JUDE MEDICAL DRIVE ST. PAUL, MINNESOTA 55117

(651) 756-2000 www.sjm.com/corporate.aspx

Employees: 16,000Revenue: $5,622,000,000R&D Spend: $692,000,000Fiscal 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 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

* Revenues from 3M’s Healthcare division only.

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


KEY PERSONNEL:

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

3M CO.


18 ZIMMER-BIOMET345 East Main Street Warsaw, IN 46580

(574) 267-6131 www.zimmer.com

MARKETS: Orthopedics, Prosthetic, Surgical, Hospital Supplies Employees: 10,000Revenue: $4,673,300,000R&D Spend: $188,300,000Fiscal year ending: Dec. 31, 2014

KEY PERSONNEL:

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

19OLYMPUS CORPShinjuku 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: 30,702Revenue: $4,655,721,581R&D Spend: $631,700,397Fiscal 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 OfficersSHINICHI 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






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 AffairsSHINJIRO SATO, President, Cardiac & Vascular HIDEO ARASE, Senior Executive Officer, Regional Representative, India and Asia PacificKUNIKO SHOJI, General Manager, Regulatory Affairs Clinical Development Dept. TOSHIAKI TAKAGI, Senior Executive Officer, Quality AssuranceDAVID PEREZ, President, Blood Management, President & CEO, Terumo BCT SHOUJI HATANO, General Manager, Strategic PlanningKAZUAKI KITABATAKE, Senior Executive Officer, International, Investor Relations, Communications, LegalNARUSHIGE TODA, General Manager, Sales (Japan) YOSHIAKI AKAIKE, Vice President TSUYOSHI TOMITA, Vice PresidentRYO NISHIHATA, General Manager, Treasury MARK SUTTER, President & CEO, Terumo CardiovascularSOMSAK JARASVIRIYAGUL, Representative Director, Thailand KYO NISHIKAWA, Chairman, Terumo EuropeHIROSHI NAKAGOMI, General Manager, Quality Assurance MASATAKA HARAGUCHI, Branch Manager, TokyoJUICHI TAKEUCHI, President & CEO, Terumo Americas RICHARD CAPPETTA, President, Neurovascular, President & CEO, MicroVentionSEIJI KAWABATA, General Manager, Business Promotion (Japan) MASATO NISHIMURA, General Manager, Production Technology CenterHIRAKU MURAYAMA, Vice President, Interventional Systems KOSUKE MATSUMOTO, General Manager, HRMASANORI HOSHINO, President, Terumo Clinical Supply HIROSHI NAGUMO, SVP & General Manager (Japan), Terumo BCTJAMES RUSHWORTH, Regional President (U.S.), President & CEO, Terumo Medical HIROAKI KASUKAWA, General Manager, R&D headquartersYOSHIHIRO KIMURA, General Manager, Internal Audit TAKANORI SHIBAZAKI, General Manager, Supply Chain ManagementHIKARU SAMEJIMA, President, Interventional Systems KAZUHIRO UCHIDA, GM, Intellectual Property TETSUYA KUMEI, President, D&D Division

20TERUMO2-44-1 Hatagaya, Shibuya-ku, Tokyo, 151-0072 Japan

+81-3-3374-8111 www.terumo.com

MARKETS: Cardiovascular, Vascular, Hospital Supplies, Blood Management

21SMITH AND NEPHEW15 ADAM STREET LONDON ENGLAND X0 WC2N 6LA

www.smith-nephew.com

MARKETS: Orthopedics, Prosthetic, Surgical, Wound Care Employees: 13,468Revenue: $4,617,000,000R&D Spend: $235,000,000Fiscal year ending: Dec. 31, 2014

KEY PERSONNEL:

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



22HOSPIRA275 North Field Drive Lake Forest, Illinois 60045

(224) 212-2000 www.hospira.com/en/

KEY PERSONNEL:

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

MARKETS: IV Supplies, Drug Delivery, Healthcare IT Employees: 19,000Revenue: $4,463,700,000R&D Spend: $344,300,000Fiscal year ending: Dec. 31, 2014

23GRIFOLSAvinguda 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


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 AffairsVICENTE 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




24GETINGE GROUPP.O. Box 8861, SE-402 72, Gothenburg E-mail: [email protected]

Phone: +46 10 335 0000 www.getingegroup.com

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

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

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

25CERNER2800 Rockcreek Parkway North Kansas City, MO 64117

+1-816-221-1024 www.cerner.com

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

KEY PERSONNEL:

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


Bishop Wisecarver 9-15.indd 15 9/16/15 10:15 AM



C.R. BARD

HITACHI

BAYER

730 CENTRAL AVE MURRAY HILL, NJ 07974

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

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


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

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

KEY PERSONNEL:

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

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

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

(908) 277-8000 www.crbard.com

+81-3-3258-1111 www.hitachimed.com

492143081933 www.bayer.com/en/homepage.aspx

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

MARKETS: Imaging/radiology

MARKETS: Vision, Infection Prevention

26

27

28* Revenues from Hitachi’s Healthcare Business segment only.

* Revenues from Bayer’s Medical Care division only.



MCKESSON

VARIAN MEDICAL SYSTEMS

DENTSPLY INTERNATIONAL

One Post Street, San Francisco, California 94104

3100 HANSEN WAY PALO ALTO CA 94304-1000

Susquehanna Commerce Center 221 W. Philadelphia St. York, PA 17405



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

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

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

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

(415) 983-8300 www.mckesson.com/

(650) 424-5834 www.varian.com

(717) 845-7511 www.dentsply.com/en-us

MARKETS: Healthcare IT

MARKETS: Dental

29

30

31




HOYA

SHIP HEALTHCARE HOLDINGS INC.

HOLOGIC

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

3-20-8 Kasuga Suita Osaka, 565-0853 Japan

35 CROSBY DRIVE BEDFORD MA 01730


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

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

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

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

KEY PERSONNEL:

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

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

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

www.hologic.com

MARKETS: Vision, Endoscopic/arthroscopic

MARKETS: Hospital Supplies

MARKETS: Wound Care, Diagnostics, Women’s Health

32

33

34

* Revenues from Hoya’s Life Care segment only.



PAUL HARTMANN GROUP

EDWARDS LIFESCIENCES

BECTON, DICKINSON & CO.

PAUL HARTMANN AG Paul-Hartmann-Straße 12 89522 Heidenheim

One Edwards Way Irvine, CA 92614

1 Becton Drive Franklin Lakes, New Jersey 07417-1880

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

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

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

KEY PERSONNEL:

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

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

KEY PERSONNEL:

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

+49-7321 36-0 us.hartmann.info

www.edwards.com/Pages/Default.aspx

www.bd.com

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

MARKETS: Surgical, Structural Heart

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

35

36

37

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




BIOMERIEUX

NIPRO

COLOPLAST

69280 Marcy l’Etoile, France

3-9-3 HONJO-NISHI KITA-KU OSAKA 531-8510 JAPAN

200 Crossing Blvd. Bridgewater, NJ 08807

Holtedam 1 3050 Humlebæk Denmark

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



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

KEY PERSONNEL:

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

KEY PERSONNEL:

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

33 04 78 87 20 00 www.biomerieux-usa.com/

(908) 393-7030 www.nipro.com

www.coloplast.us

MARKETS: Diagnostics

MARKETS: Dialysis, Hospital Supplies

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

38

39

40




BIO-RAD

INTUITIVE SURGICAL

DRAEGERWERK

1000 Alfred Nobel Drive, Hercules, California 94547

1020 KIFER ROAD SUNNYVALE CA 94086

Thomas Fischler Moislinger Allee 53-55 23558 Lübeck

Draeger Medical Inc. 3135 Quarry Road Telford, PA 18969




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

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

KEY PERSONNEL:

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

(510) 724-7000 www.bio-rad.com/

(408) 523-2100 www.intuitivesurgical.com

1-800-437-2437 www.draeger.com/sites/enus_us/Pages/default.aspx

MARKETS: Robot-assisted Surgery

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

41

42

43* Revenues from Draegerwerk’s Medical segment only.




WATERS

ABBOTT LABORATORIES

MIRACA HOLDINGS

34 Maple Street, Milford, Massachusetts 01757

100 ABBOTT PARK ROAD D-322 AP6D ABBOTT PARK IL 60064-3500

Shinjuku Mitsui Building 8th floor, 2-1-1 Nishishinjuku, Shinjuku-ku, Tokyo 163-0408


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


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

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

KEY PERSONNEL:

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)

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

(847) 937-6100 www.abbott.com

+81-3-5909-3335 www.miraca-holdings.co.jp/eng/

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

MARKETS: Diagnostics, Laboratory, Sterilization

44

45

46

MARKETS: Laboratory



ACELITY

SONOVA HOLDING

STERIS

12930 West Interstate 10 San Antonio, Texas 78249

Laubisrütistrasse 28 8712 Stäfa Switzerland

5960 HEISLEY ROAD MENTOR OH 44060 US




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 & CFOGAURAV AGARWAL, President, Businesses & Innovation

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

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.acelity.com/

+41 58 928 33 33 www.sonova.com/en

www.steris.com

MARKETS: Hearing

MARKETS: Sterilization, Laboratory

47

48

49




TELEFLEX

CONVATEC

THE COOPER COS.

550 E Swedesford Rd Suite 400 Wayne Pa 19087 US

200 Headquarters Park Drive Skillman, NJ 08558

Mühlentalstrasse 36 8200 Schaffhausen Switzerland

Åholmvej 1-3, Osted 4320 Lejre Denmark

6140 Stoneridge Mall Road, Suite 590 Pleasanton, CA 94588



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

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

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

KEY PERSONNEL:

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

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

1-800-422-8811; +0041 52 630 54 00; +45 4816 7000 www.convatec.com/

(925) 460-3600 www.coopercos.com

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

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

MARKETS: Women’s Health, Vision

50

51

52



HILL-ROM HOLDINGS

RESMED

HALYARD HEALTH

1069 State Route 46 East Batesville, Indiana

9001 Spectrum Center Blvd. San Diego, CA 92123

5405 Windward Parkway Suite 100 South Alpharetta, Georgia 30004


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


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

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

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

(812) 934-7777 www.hill-rom.com/usa/

(858) 836-5000 www.resmed.com/us/en/consumer.html

www.halyardhealth.com/

MARKETS: Respiratory

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

53

54

55


BRUKER40 MANNING RD BILLERICA MA 01821


KEY PERSONNEL:

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

(978) 663-3660 www.bruker.com

MARKETS: Laboratory

56THE TOP 1OO MEDTECH COMPANIES1OO



ELEKTA

NIHON KOHDEN

BOX 7593 10393 STOCKHOLM SWEDEN V7 00000

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

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


KEY PERSONNEL:

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

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

(858) 836-5000 www.elekta.com

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

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

MARKETS: Patient Monitoring, Surgical, Veterinary

58

57

WILLIAM DEMANT HOLDINGKongebakken 9 DK-2765 Smørum Denmark


KEY PERSONNEL:

NIELS JACOBSEN, President & CEO SVEND THOMSEN, Head of Finance

+45 3917 7300 www.demant.com

MARKETS: Hearing

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




IDEXX LABS

AGFA-GEVAERT

1 Idexx Drive, Westbrook, Maine 04092

Setestraat 27, B-2640 Mortsel, Belgium



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

KEY PERSONNEL:

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

(207) 556-0300 www.idexx.com/corporate/home.html

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

MARKETS: Veterinary


61

60

* Revenues from AGFA Healthcare segment only.

SMITHS MEDICAL1265 Grey Fox Road, St Paul, MN 55112

1500 Eureka Park, Lower Pemberton,

Ashford, Kent, TN25 4BF 600 Cordwainer Drive,

3rd Fl, Norwell, MA 02061

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

KEY PERSONNEL:

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

(651) 633-2556; +44 (0)845 850 0445; (781) 792-2500 [email protected]; www.smiths.com/media.aspx

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

62



MINDRAY MEDICAL

INVACARE

Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen 518057 The People’s Republic of China

ONE INVACARE WAY P O BOX 4028 ELYRIA OH 44036



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

KEY PERSONNEL:

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

www.mindray.com/en/homepage/index.html

www.invacare.com/cgi-bin/imhqprd/default.jsp

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

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

64

63

DJO GLOBAL1430 Decision Street Vista, California


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

(800) 336-5690 www.djoglobal.com

MARKETS: Orthopedics, Prosthetic

65




NIKKISO

CARL ZEISS MEDITEC

Yebisu Garden Place Tower 22nd Floor, 20-3, Ebisu 4-Chome, Shibuya-ku, Tokyo 150-6022, Japan

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

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

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

KEY PERSONNEL:

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

www.nikkiso.com/index.html

www.zeiss.com/meditec/en_us/home.html

MARKETS: Dialysis, Diabetes

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

67

66

* Revenues from Nikkiso’s Medical division only.

SIRONA DENTAL SYSTEMS30-30 47Th Ave Suite 500 Long Island City Ny 11101


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

www.sironausa.com/us/

MARKETS: Dental

68



Goeschwitzer Strasse 51-52 D-07745 Jena Germany

OTTOBOCK Max-Näder-Straße 15 D-37115 Duderstadt Germany

11501 Alterra Parkway Suite 600 Austin, TX 78758 USA

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

KEY PERSONNEL:

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

+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

69

* Revenues from Ottobock’s healthcare business only.

2815 S. Calhoun RoadNew Berlin, WI 53151Phone: 800-877-8351Fax: [email protected]

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.




FUKUDA DENSHI39-4, Hongo 3-chome, Bunkyo-ku,Tokyo 113-8483


KEY PERSONNEL:

KOTARO FUKUDA, Chairman & CEO DAIJIRO SHIRAI, President & COO

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

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

70

SORINVia Benigno Crespi 17 20159 Milan, Italy

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

KEY PERSONNEL:

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

www.sorin.com/home.action

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

71

OMRON53, Kunotsubo, Terado-cho, Muko, Kyoto 617-0002 Japan

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

KEY PERSONNEL:

ISAO OGINO, President & CEO, Omron Healthcare

www.omron.com

MARKETS: Patient Monitoring, Respiratory, Neuromodulation/neurostimulation

72* Revenues from Omron’s healthcare segment only.



INTEGRA LIFESCIENCES311 Enterprise Drive Plainsboro NJ 08536 US


KEY PERSONNEL:

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

www.integralife.com

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

73

COCHLEAR LTD.1 University Avenue, Macquarie University NSW 2109 Australia

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

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

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

MARKETS: Hearing

74

HAEMONETICS400 Wood Road Braintree Ma 02184 US

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

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.haemonetics.com

MARKETS: Blood Management

75




KAWANISHI HOLDINGS8th Floor, Nihon-Seimei Okayama BuildingII 1-1-3 Shimoishii, Kita-ku, Okayama City, Okayama Japan 700-0907

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

KEY PERSONNEL:

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

www.kawanishi-md.co.jp/english/index.asp

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

76

GN STORE NORD

NUVASIVE

Lautrupbjerg 7 2750 Ballerup Denmark

7475 Lusk Blvd. San Diego CA 92121

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


KEY PERSONNEL:

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

KEY PERSONNEL:

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

+45 45 75 00 00 www.gn.com

www.nuvasive.com

MARKETS: Hearing

MARKETS: Neuromodulation/neurostimulation, Orthopedics, Spinal

78

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



ALIGN TECHNOLOGY

KONICA MINOLTA HOLDINGS

CONMED

2560 Orchard Parkway San Jose CA 95131

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

525 French Road Utica NY 13502




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

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

KEY PERSONNEL:

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.aligntech.com

(81) 3-6250-2111 konicaminolta.us

www.conmed.com

MARKETS: Imaging/radiology, Healthcare IT

MARKETS: Dental

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

79

81

80* Revenues from Konica Minolta Holdings’ healthcare division only.




GREATBATCH

WELCH ALLYN*

AMPLIFON

2591 Dallas Parkway, Suite 101 Frisco Tx 75034

4341 State Street Road Skaneateles Falls, NY 13153

Via Ripamonti, 133 20141 Milano

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


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

KEY PERSONNEL:

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

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

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

www.greatbatch.com

1.800.535.6663 www.welchallyn.com/

+39 02.574721 www.amplifon.com/English/Pages/default.aspx

MARKETS: Diagnostics, Patient Monitoring, Hospital Supplies, Veterinary

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

MARKETS: Hearing

82

84

83



STRAUMANN60 Minuteman Road Andover, MA 01810


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

(800) 448-8168; (978) 747-2500 www.straumann.us

MARKETS: Dental

85

Precision Injection Molds

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small part molds and repairs

3D Design - Machining - Wire EDM - Sinker EDM

Micro Laser Welding - Laser Marking/Engraving

Assembly fixturing/automation

34 Tower Street - Hudson, MA 01749

www.maynardtool.com978-568-1900

.025”pins

63 xWhen power is critical to your equipment aswell as your patients, you can rely on MEGAElectronics to deliver. Produced in ISO9000facilities, our line of hospital grade powercords,related components and DC to DC convertersall conform to the highest standards.

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MASIMO

JMS CO.

52 Discovery Irvine CA 92618 United States

2-38-9 Kawauchi, Asaminami-ku, Hiroshima 731-0102

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


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

KEY PERSONNEL:

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

www.masimo.com

+81-82-962-0532 www.jms.cc/ENGLISH/INDEX.HTML

MARKETS: Patient Monitoring

MARKETS: Drug Delivery, Dialysis cardiovascular, Hospital Supplies

88

86

FISHER AND PAYKEL15 Maurice Paykel Place East Tamaki, Auckland

2013 PO Box 14 348 Panmure, Auckland 1741 New Zealand


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

www.fphcare.com

MARKETS: Respiratory, Intensive Care

87



ANALOGIC

MERIT MEDICAL SYSTEMS

ÖSSUR

8 CENTENNIAL DRIVE PEABODY MA 01960

1600 West Merit Parkway South Jordan UT 84095 USA

Grjothals 1-5 110 Reykjavik Iceland

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



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 JACQUES 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

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

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.analogic.com

www.merit.com

www.ossur.com/americas

MARKETS: Cardiovascular, Surgical, Hospital Supplies, Drug Delivery


MARKETS: Prosthetic, Orthopedics

89

91

90




CANTEL MEDICAL

THORATEC

ORTHOFIX INTERNATIONAL

OVERLOOK AT GREAT NOTCH 150 CLOVE ROAD LITTLE FALLS NJ 07424

6035 Stoneridge Dr Pleasanton Ca 94588 US

7 ABRAHAM DE VEERSTRAAT CURACAO NETHERLANDS ANTILLES P8 00000

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

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

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

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

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

KEY PERSONNEL:

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

www.cantelmedical.com

www.thoratec.com

www.orthofix.com

MARKETS: Cardiac Assist Devices

MARKETS: Sterilization, Infection Prevention

MARKETS: Prosthetic, Orthopedics, Neuromodulation/neurostimulation

92

94

93



SYMMETRY MEDICAL/TECOMET

TOPCON

ACCURAY

3724 N STATE ROAD 15 WARSAW IN 46582

75-1,Hasunuma-cho, Itabashi-ku, Tokyo 174-8580

1310 Chesapeake Terrace Sunnyvale CA 94089



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

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

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.symmetrymedical.com

+81-3-3966-3141 global.topcon.com/

www.accuray.com

MARKETS: Vision

MARKETS: Orthopedics, Surgical, Sterilization


95

97

96

* Revenues from Topcon’s eye care division only.




NATUS6701 KOLL CENTER PARKWAY, SUITE 120 PLEASANTON CA 94566

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

KEY PERSONNEL:

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

www.natus.com

MARKETS: Pediatrics, Women’s Health, Intensive Care

98

DW-MDO-HPAD-PC Valves - Sept 2015.indd 1 7/13/15 4:53 PM



ICU MEDICAL

NXSTAGE MEDICAL

951 CALLE AMANECER SAN CLEMENTE CA 92763-6212

350 MERRIMACK STREET LAWRENCE MA 01843



KEY PERSONNEL:

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

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, COOJEFFREY 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

www.icumed.com

www.nxstage.com

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

MARKETS: Dialysis

100

99


BIG1OOTO MEDTECH'S 100 LARGEST PLAYERS

CONGRATULATIONS



TOP R&D SPENDERS

RANK COMPANY R&D SPEND REVENUES % OF REVENUESRANK COMPANY R&D SPEND

1 Thoratec $105,475,000 $477,560,000 22.1% 2 Edwards Lifesciences $346,500,000 $2,322,900,000 14.9% 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 McKesson $392,000,000 $3,069,000,000 12.8% (Technology Solutions segment)

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 Boston Scientific $817,000,000 $7,380,000,000 11.1% 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% (AGFA Healthcare segment)

19 Natus $31,788,000 $355,834,000 8.9% 20 Intuitive Surgical $178,000,000 $2,131,700,000 8.4% 21 Elekta $126,283,248 $1,559,437,704 8.1% 22 Medtronic $1,640,000,000 $20,261,000,000 8.1% 23 Hologic $203,200,000 $2,530,700,000 8.0% 24 Hospira $344,300,000 $4,463,700,000 7.7% 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%

1 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

R&D ranking by percentage of revenues:*R&D ranking by total spend:*

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R&D breakout_9-15_Vs5.indd 74 9/19/15 3:15 PM

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CGI 9-15.indd 15 9/17/15 11:16 AM


TOP R&D SPENDERS

RANK COMPANY R&D SPEND REVENUES % OF REVENUESRANK 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

34 Stryker Corp $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 $1,652,000,000 $27,522,000,000 6.0% (MDDI segment only)

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%

R&D ranking by percentage of revenues:*R&D ranking by total spend:*

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R&D breakout_9-15_Vs5.indd 76 9/18/15 10:37 AM

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

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

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

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234.95x282.57.indd 1 31.08.2015 10:08:19Maxon Motors 9-15.indd 15 9/15/15 3:35 PM


COMPANIES RANKED BY EMPLOYMENT

RANK COMPANY OVERALL EMPLOYEES RANK

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

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

Employee Count By Color

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

Employer Rank_9-15_Vs3.indd 78 9/19/15 3:16 PM

Building a better future means innovation and finding new ways tosolve product design challenges. Extruded aluminum is already a partof many of the most exciting advances in healthcare. Aluminum givestoday’s design engineers the ability to develop parts and productswhich are strong, lightweight, and easier to produce and machine.

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

SAPA 6-15.indd 56 9/15/15 3:39 PM


RANK COMPANY OVERALL EMPLOYEES RANK

COMPANIES RANKED BY EMPLOYMENT

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

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

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

Employee Count By Color

Employer Rank_9-15_Vs3.indd 80 9/18/15 4:42 PM

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.

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

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

Moving medical technology.

NOO-014_3.indd 1 5/8/15 9:57 AMNOOK 9-15.indd 15 9/15/15 3:36 PM


GEOGRAPHIC HEATMAP - UNITED STATES

RANK STATE COMPANIES PER STATE

1 California 142 Massachusetts 93 New Jersey 74 Minnesota 45 Illinois 35 Indiana 35 New York 35 Ohio 35 Pennsylvania 35 Texas 311 District of Columbia 111 Maine 111 Michigan 111 Missouri 111 Tennessee 111 Utah 1

Alaska

Hawaii

Washington

Oregon

California

Nevada

Idaho

Montana

Arizona

Utah

New Mexico

Colorado

North Dakota

Wyoming

US heatmap_9-15_Vs3.indd 82 9/19/15 3:17 PM


Colorado

North Dakota

Minnesota

Iowa

Missouri

Arkansas

MississippiAlabama

Tennessee

Kentucky

Florida

Georgia

South Carolina

North Carolina

VirginiaWest

Virginia

Illinois

Wisconsin

Michigan

Indiana

Ohio

Pennsylvania

Maryland

Delaware

New Jersey

Connecticut

Rhode Island

Massachusetts

VermontNew Hampshire

Maine

New York

Louisiana

South Dakota

Nebraska

Kansas

Oklahoma

Texas


US heatmap_9-15_Vs3.indd 83 10/23/15 4:50 PM


GEOGRAPHIC HEATMAP - GLOBAL

RANK COUNTRY COMPANIES PER COUNTRY

1 United States 582 Japan 163 Germany 64 Denmark 35 France 25 Great Britain 25 Italy 25 Netherlands 25 Sweden 25 Switzerland 211 Australia 111 Belgium 111 China 111 Iceland 111 New Zealand 1

United States

Iceland

World heatmap_9-15_Vs2.indd 84 9/19/15 3:18 PM

www.medicaldesignandoutsourcing.com 9 • 2015 Medical Design & Outsourcing 85www.medicaldesignandoutsourcing.com 9 • 2015 Medical Design & Outsourcing 85

Japan

Germany

NetherlandsBelgium

Sweden

Italy

China

New Zealand

Australia

Switzerland

Great Britain

France

Denmark

World heatmap_9-15_Vs2.indd 85 9/19/15 3:18 PM


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

ONES TO WATCH

MARKET 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 all- in-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.

Ones to Watch_9-15_Vs3.indd 86 9/19/15 3:18 PM

Compact, Hollow Shaft DesignThe 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

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

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

High-Precision GearsHarmonic Drive® CSD

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Component Sets are offered in fi ve different component

sizes with peak output torques ranging from 1.8 Nm to

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your application requirements.

Lightweight Precision GearheadsIdeally suited for robotic and

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the new CSG-LW and

CSF-LW gearheads are

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designs without reducing

the torque rating or signifi cantly

changing interface dimensions.

The CSG high-torque gearhead delivers 30% more

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

A high capacity cross roller bearing and output fl ange is

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SHA-20A_V2_FP_DW.indd 1 4/15/15 10:17 AMHarmonic Drive 9-15.indd 15 9/15/15 4:19 PM



ONES TO WATCH

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-portorificeplatform for use in minimally invasive surgery.

24 Robotics: Hansen Medical Makes the Magellan

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.

WHAT WE’RE DOING IS ADDRESSING THE BIOLOGY OF THE TENDON. OUR BIO-

INDUCTIVE IMPLANT ACTUALLY HELPS INDUCE NEW TISSUE GROWTH, CREATING A THICKER [ROTATOR CUFF] TENDON AND

THEREBY HEALING THE TISSUE.

- CEO, ROTATION MEDICALMARTHA SHADAN

Ones to Watch_9-15_Vs2.indd 88 9/18/15 11:15 AM



34 Urology: Profound Medical Makes the Tulsa MRI- guided 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 Afinityintraocularlenses.

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.

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.

- SECOND SIGHT MEDICAL CEO DR. ROBERT GREENBERG

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

- CEO, GLOOKORICK ALTINGER

Ones to Watch_9-15_Vs3.indd 89 9/19/15 3:19 PM


CEO SHUFFLE

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,

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:

1 432

Thomas Prescot retires

Tim McCarthy is replaced by

Charles Carignan

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

David Pyott retires after $70.5 billion

Actavis buyout(March 2015)

replaced by Joseph Hogan (March 2015)

who leaves the corner office at

NinePoint Medical to former NeuroTherm chief Chris von Jako

(July 2014)

Who’s In & Out of the Corner Office

CEO Shuffle_9-15_Vs2-BP.indd 90 9/18/15 12:01 PM

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

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NEW UNIQUE DEVICE IDENTIFICATION SYSTEMDue 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.

Interpower 9-15.indd 15 9/15/15 4:19 PM


CEO SHUFFLE 5

8 9 10 11

6 7

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)

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

January 2015.

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)

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.

The elder Corasanti passes away in

March 2015.

replaces Steven Anderson, who

stays as chairman (July 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 Carr-Brendel in June 2014.

Andre Michel Ballester is tapped to lead

LivaNova, the new entity resulting from Sorin’s $1.4 billion merger with Cyberonics, with ex-Cyberonics CEO Dan

Moore as chairman (planned September 2015)

Duane DeSisto is replaced by ex-Cytyc CEO

Patrick Sullivan (September 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)

14

1815 16 17

1312

Alexander Lukianov is fired after violating

reimbursement & personnel policies, replaced by former Life Technologies

chief Gregory Lucier (March 2015)

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)


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19

20

Scott Huennekens is named chairman

at EndoChoice after Volcano’s $1

billion acquisition by Philips Healthcare cloese in February 2015 (April 2015)

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)

CEO SHUFFLE

9 • 2015 Medical Design & Outsourcing 95

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MANUFACTURING & MACHINING

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.

Improved lasersLasers 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.

Using lasers to build a better medical device

D a v e H u d s o n | P r e s i d e n t a n d C E O |

J o i n i n g Te c h n o l o g i e s |

Manufac-Machine_SEPT 2015_Vs7.indd 96 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.


98 Medical Design & Outsourcing 9 • 2015

MANUFACTURING & MACHINING

The Apollo Endosurgery Overstich System has 12-laser weld points,

seven of which are visible here.

Cheaper and enhancedWhen 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 high-value 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



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.

Brazilian regulators may ease quality system audit requirementsBrazil’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 enigmaticMedical 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

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.

S t e w a r t E i s e n h a r t | S e n i o r R e g u l a t o r y A n a l y s t |

E m e r g o |

Regulatory_SEPT 2015_Vs4.indd 99 9/18/15 12:20 PM


REGULATORY

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.

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.


Medical Design & Outsourcing 101

Higher costs for Chinese market entryAlthough 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 leapingGiven 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

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© 2015 Web Industries, Inc. All rights reserved.

It’s Not Magic.

ISO 9001:2008 & 13485



TUBING TALKS

Positioning peristaltic rollers allows more precise dispensing

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

D a v i d B a c h | 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 |

A Lexium MDrive series 23 motor drives a Watson-Marlow 313 pump with

the red cover.

Accurate dispensing affects a great deal of drug development and delivery. For instance, leading-edge pharmaceuticals, bio-tech “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.

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.

Tubing_SEPT 2015_Vs6.indd 102 9/18/15 12:46 PM


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

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 Watson-Marlow 520 peristaltic pump with and without roller positioning.

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

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 three-roller 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”

Wiring - Roller Positioning

3 Roller Dispense

Half Revolution Indexes - 3 Roller



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.

Four-roller configuration – Watson-Marlow 313 pumpA 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 pumpThe 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.

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

RollerPositioningValve

RollerPositioningValve

Dispense ValveDispense Valve

Peristaltic Pump

Roller InlinePeristaltic Pump

Waste Waste

Supply Supply Supply

Offset RollerPeristaltic Pump

A

A few pump and valve setups

B C

A F E W P U M P A N DVA LV E S E T U P S



SummaryVarious 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

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.

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.

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Volume versus Dispense cycle for a 520 pump with 1.6-mm silicon tubing



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 off-the-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 off-the-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

CONNECTOR & CABLES CORNER

A brief guide to selecting plastic circular medical connectors

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.

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 connector-contact 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

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Cable_Corner_SEPT 2015_Vs4-BP.indd 106 9/18/15 12:56 PM


Circular (MPC) connectors and cable assemblies meet stringent industry standards and provide exceptional performance at a fraction of the cost of machined-contact 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

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

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

A checklist of specs for a medical connector

Cable_Corner_SEPT 2015_Vs4-BP.indd 107 9/18/15 12:56 PM


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 mechanismsIntegrating 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 complianceWhen 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

SECURITY

Securing mobile medical equipment with electronic access

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.

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Security_SEPT 2015_Vs5.indd 108 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 record-keeping – 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:

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EACH TIME A CABINET EQUIPPED WITH A SELF-CONTAINED SOLUTION IS OPENED USING AN RFID BADGE, IT STORES A SIGNAL THAT CONFIRMS AND LOGS ACCESS.

SECURITY

Intelligent electronic locks offer a unique and efficient way to control access and maintain security of valuable information and medical supplies.

• 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 controlA 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 self-contained 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

port. This digital record of information can then be used to demonstrate compliance with regulatory requirements.

Consider electronic accessInstalling 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 access-control challenges. M



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

Validating sterilization processes by ethylene oxide

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.

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 processEO 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 sub-atmospheric 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.

P a u l D v o r a k | F o u n d i n g E d i t o r | M e d i c a l D e s i g n

& O u t s o u r c i n g |

VALIDATION

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112 Medical Design & Outsourcing 9 • 2015 www.medicaldesignandoutsourcing.com 9 • 2015 Medical Design & Outsourcing 113

THE HALF CYCLE’S LETHALITY MUST BE DEMONSTRATED AT LEAST THREE

TIMES BEFORE CONSIDERING IT ADEQUATE OR VALIDATED.

VALIDATION

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.

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.

Validation_SEPT 2015_Vs4-BP.indd 112 9/18/15 1:28 PM


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-to-handle, inexpensive PCD, like a coupon, is

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 non-vented 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

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Validation_SEPT 2015_Vs5.indd 113 9/18/15 4:31 PM


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.

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

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 fiber-optic 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.

MOTION CONTOL

Motors make spectrophotometer foolproof

The DS-11 spectrophotometer delivers high-dynamic-range

measurements with the touch of the screen. (All photos from DeNovix)

M i k e L e B l a n c | A p p l i c a t i o n s E n g i n e e r |

M I C R O M O |

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THE BRUSHED MOTOR RADICALLY SIMPLIFIED THE DESIGN AND INTEGRATION PROCESS.

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 motorThe 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

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.

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

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.



MOTION CONTROL

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 modulesOnce 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

Inside the solutionThe 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

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



Raising the bar on FDA guidelines

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.

For example, recent deaths resulted from infections transmitted during medical procedures through bacterially-contaminated 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

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

The Langford “LIC” machine is an example of how device engineering

and FDA standards evolve in tandem.

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.

FDA

K e n n e t h A . F i n e | P r e s i d e n t a n d C o - F o u n d e r |

P r o v e n P r o c e s s M e d i c a l D e v i c e s |

FDA_SEPT 2015_Vs6.indd 117 9/18/15 2:07 PM


FDA NEW PRODUCTS

Medtech approvals: FDA releases June 2015 PMAs

PMA Original Approvals

Summary of PMA Originals & Supplements ApprovedOriginals: 5Supplements: 80

Summary of PMA Originals Under ReviewTotal Under Review: 53Total Active: 22Total On Hold: 31

Summary of PMA Supplements Under ReviewTotal Under Review: 575Total Active: 418Total On Hold: 157

Summary of All PMA SubmissionsOriginals: 4Supplements: 72

Summary of PMA Supplement PMA Approval/Denial Decision TimesNumber of Approvals: 80Number of Denials: 0Average Days Fr Receipt to Decision (Total Time): 115.2FDA Time: 97.1 DaysMFR Time: 18.1 Days

APPLICATION NUMBER / DATE OF APPROVAL

DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP

DEVICE DESCRIPTION / INDICATIONS

P1200246/11/15

activL® Artificial Disc Aesculap Implant Systems, LLCCenter 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.

P1400096/12/15

Brio Neurostimulation System St. Jude MedicalPlano, 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.

P1400216/11/15

Elecsys® Anti-HCV II Immunoassay and Elecsys® PreciControl Anti-HCV

Roche DiagnosticsIndianapolis, 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, LLCIrvine, 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).

The FDA today released its list of the pre-market approvals it granted for medical devices in June 2015:

For a detailed look at the products granted pre-market approval by the FDA in June, please visit dwo.me/1gmQVNG.

FDA_SEPT 2015_Vs6.indd 118 9/18/15 2:07 PM


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 non-provisional 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. First and foremost, all employees, including the founders, should sign invention assignment agreements. The company should

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

Five questions for early-stage companies looking to protect their IP

TO ENSURE THAT YOUR COMPANY OWNS ITS INTELLECTUAL PROPERTY, THERE ARE FEW BASIC STEPS TO FOLLOW.

PATENT PROTECTION

J e d G o r d o n | P a r t n e r a n d I P l a w y e r |

F o l e y & L a r d n e r L L P |

Patent_SEPT 2015_Vs5.indd 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.

4. ShouldIfileaProvisionalPatentApplication? 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

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.


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


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INFORMAL PROVISIONALS CAN ALSO LEAD TO BUDGET WOES.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



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.

DEVICE TALKS

DeviceTalks: Boston Scientific CEO Mike Mahoney

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,

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.

Device_Talks_Sept 2015_Vs3.indd 122 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

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 decision-making, 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



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

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.



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 thirty-year 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 thirty-year 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.


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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.



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.

DEVICE TALKS

TO THIS DAY I STILL SAY THIS IS THE DREAM JOB FOR ME, AND I REALLY WANT TO BE HERE FOR

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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

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

Read the full interview online!devicetalks.com




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

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& there’s more. Besides a line containing hundreds of products, we offer a full range of capabilities.

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