MEDICAL DESIGN & OUTSOURCING - September 2017 by WTWH Media LLC

www.medicaldesignandoutsourcing.com SEPTEMBER 2017

BIG1OO ALSO INSIDE: The Big 100: Why does it matter? The Top Medical Device Employers R&D: Whoâ&#x20AC;&#x2122;s Spending the Most?

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HERE’S WHAT WE SEE

The Big 100: Why does it matter? It’s a question worth asking: What is the value of listing the largest 100 medical device companies in the world – and doing so every year? Don’t most industry insiders know what the largest companies are? Do they really change each year? In fact, they do. In the process, the list can reveal trends in the medical device industry. Call it an annual checkup on the state of medtech. Here are some observations from this year’s Big 100: 1. The merger frenzy continues Mergers & acquisitions continue to change the medical device landscape, as reflected in our rankings. For example, Medtronic kept its hold on the top spot largely thanks to its $50 billion acquisition of Covidien in 2015, holding Johnson & Johnson’s medical device business to second place on our list. Zimmer Biomet – created through the 2015 merger of the two

Chris Newmarker Managing Editor Medical Design & Outsourcing c newmark er@wtwhmedia.com

Medical Design & Outsourcing

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9 • 2017

Warsaw, Ind.–based orthopedics giants – is now 15th on the list, up from 19th last year. Danaher, which retooled to focus on the life science industry, jumped from 13th to eighth on the Big 100 this year, largely thanks to its purchase of a clinical microbiology business from Siemens Healthcare Diagnostics. Integer – the medical device contract manufacturing giant created through the 2015 merger of Greatbatch and Lake Region Medical – jumped to 50th, up from 74th a year before. Expect to see M&A drive more changes in next year’s Big 100. For example, just days after the end of its 2016 fiscal year, Abbott closed on its $25 billion acquisition of St. Jude Medical. Ditto for BD, which at the time of this writing was in the process of merging with C.R. Bard for $24 billion. Meanwhile, Cardinal Health in July 2017 closed on the $6.1 billion purchase

of Medtronic’s patient care, deep vein thrombosis and nutritional insufficiency businesses. 2. M&A isn’t just the acquisitions Spinouts and divestitures are also part of the M&A churn. For example, take the split at Integra LifeSciences, which spun its spinal business out in 2015. That business, rebranded as Seaspine, makes its debut at 99th this year. 3. The rising tide that lifts all boats Consolidation has another effect when it comes to our list: It allows companies that were on the cusp in recent years to make their first appearances in the Big 100, as players are taken off the board higher in the rankings. In addition to Seaspine, Syneron Candela, Spectranetics, Barco’s healthcare division, Exactech, K2M Group, MiMedx, CryoLife, AtriCure and Alphatec made the list after just missing the cut in 2016. 4. Innovation can fuel growth, too Medical device companies don’t necessarily need to acquire to rise through the ranks. Take NxStage Medical and the home hemodialysis system it developed. NxStage jumped from No. 97th last year to 88th this year, likely its last appearance on our list given its pending acquisition by Fresenius (5th this year). Another example is Abiomed, a proven disruptor in the cardiovascular space. As detailed in this issue’s Big 100 feature story, revenues climbed to nearly $330 million last year, allowing it to rise to 88th from its previous 98th finish. Abiomed’s rise was propelled by its tiny Impella device, billed as the world’s smallest heart pump. Designed to be delivered to the heart via catheter, Impella’s 50,000 rpm pump helps ailing hearts send blood to the rest of the body, giving it a chance to rest and recover from heart failure – and hopefully avoid the need for a heart transplant. M

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Medical Design & OUTSOURCING

medicaldesignandoutsourcing.com ∞ September 2017 ∞ Vol3 No5

E D I T O R I A L EDITORIAL Founding Editor Paul Dvorak pdvorak@wtwhmedia.com @paulonmedical Executive Editor Brad Perriello bperriello@wtwhmedia.com Managing Editor Chris Newmarker cnewmarker@wtwhmedia.com @newmarker Senior Editor Heather Thompson hthompson@wtwhmedia.com Associate Editor Fink Densford fdensford@wtwhmedia.com Associate Editor Sarah Faulkner sfaulkner@wtwhmedia.com Assistant Editor Danielle Kirsh dkirsh@wtwhmedia.com

Publisher Brian Johnson bjohnson@wtwhmedia.com 617.905.6116

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9 • 2017

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CONTENTS

medicaldesignandoutsourcing.com ∞ September 2016 ∞ Vol3 No5

HERE’S WHAT WE SEE: Why does the Big 100 matter?

10 CONTRIBUTORS

1OO

ON THE COVER:

Big 100: Medtech’s 100 Largest Players Here’s our annual roundup of the world’s 100 leading medical device companies, with rankings by revenue, R&D spend and employee headcount

14 Big 100 Breakdown

BIG 100 BREAKDOWN

106

REGULATORY & REIMBURSEMENT FDA’s new programs on combination and digital products

110

TESTING & INSPECTION: Could a new assay reduce the need for animal tests?

114 STERILIZATION: How UVC LEDs are energizing a new generation of portable disinfection devices 118

TUBING TALKS: Six things you need to know about reinforced silicone tubing

124

THE CATH LAB: Navtar expands medical tubing portfolio

126

ENGINEERING 911: Integer’s cutting-edge disposable surgery tools for ortho device companies

130

DEVICE TALKS: GE’s impact on the ranks of medtech CEOs and a thanks to all our 2017 sponsors

136

AD INDEX

90 Top R&D Spenders

Who’s putting the most into the pipeline?

94 Top Medical Device Employers

98 How Abiomed Cracked the Big 100 Abiomed has quickly climbed our Big 100 list, landing this year at 90th, and it has done so without major acquisitions. Fueling the global medtech company’s growth is a device with unique indications and a patient-centered business strategy.

Medical Design & Outsourcing

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CONTRIBUTORS

SANCHEZ

PIZZUTO

VICTOR

SMITH

MARK PIZZUTO is director of global product management–disinfection at Crystal IS. Pizzuto has more than 20 years of experience positioning innovative new technologies – including addition cure liquid silicone resins and UV curable adhesives – into the global healthcare, industrial and consumer marketplace.

MARK E. SMITH has served as chief scientific officer of American Preclinical Services since APS became operational in 2006. Smith has more than 25 years of experience in pre-clinical drug/medical device discovery and development. Smith earned his PhD from the University of Texas Medical Branch, Galveston in 1977, and was a postdoctoral fellow and staff fellow at the National Institutes of Health from 1977 through 1985.

DAN SANCHEZ is an R&D engineering manager, principal engineer at Trelleborg Sealing Solutions. He has a BS degree in mechanical engineering from California Polytechnic University. He presently works at the Trelleborg’s Paso Robles, Calif. facility, overseeing the prototyping department.

GARY VICTOR is senior manager of orthopedics R&D at Integer. Victor has expertise in injection molding processing and product design, tool design, injection molding primary and peripheral equipment, factory design and layout, equipment and tooling procurement, and program management. He has bachelor’s and master’s degrees in mechanical engineering from the University of Buffalo.

Medical Design & Outsourcing

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9/18/17 12:39 PM

TEST YOUR MEDICAL PRODUCTS FOR EXPORT

The Interpower® International Power Source is an AC power source used to verify your product design and for product testing. The unit can be used on a bench top or is rack mountable. Interpower has four models available which have an input of 100–240VAC/50–60Hz. The first two models are supplied with a NEMA 5-20 plug and have an output of 2200VA maximum with a Low Range variable of 10–138VAC at 16A RMS maximum and High Range variable of 10–276VAC at 8A RMS maximum, 47–450Hz. The second two models are supplied with a NEMA 5-15 plug and have an output of 1725VA maximum with a Low Range variable of 10–138VAC at 12.5A RMS maximum and High Range variable of 10–276VAC at 6.25A RMS maximum, 47–450Hz. For each output option we offer a model with a RS232 and USB port and a model with no communication ports. The Interpower International Power Source can also be ordered for international use with a country-specific input power plug. Interpower offers a 1-week U.S. manufacturing lead-time on non-stock Interpower products and same day shipments on in-stock Interpower products. From 1 to 1,000 pieces or more, we have no minimum order or dollar requirements. • Made in Iowa, U.S.A. • 7 worldwide sockets in 1 AC Power Source

• Remote control operation ideal for automated test applications using optional IPS Interface Software

• Interpower carries a variety of North American and international power cords and cord sets

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Medical Design & OUTSOURCING

BIG1OO

A look at the world’s leading medtech companies, with rankings by annual revenues, R&D spend, and employee headcount.

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

Big 100 Breakdown p.14 Top R&D Spenders p.90 Top Medical Device Employers p.94

www.medicaldesignandoutsourcing.com

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S S S

COMPANIES RANKED BY REVENUE 2017 OVERALL COMPANY 2017 REVENUES RANK

ABIOMED IS A GREAT COMPANY BECAUSE WE FAILED. IT’S HARD TO CHANGE THE STANDARD OF CARE. BUT WE PUT THE PATIENT OUTCOMES AS A PRIORITY ABOVE EVERYTHING ELSE - ABOVE REVENUE, ABOVE GROWTH. IF YOU DO THAT, YOU’LL SURVIVE AND YOU’LL DO WELL. – CHAIRMAN, PRESIDENT & CEO, ABIOMED

MICHAEL MINOGUE

Medical Design & Outsourcing

Revenue Rank_9-17_Vs2-BP FINAL.indd 14

9 • 2017

FISCAL YEAR END

Medtronic

$29,710,000,000

4/28/17

Johnson & Johnson (medical device segment)

$25,119,000,000

1/1/17

Royal Philips (HealthTech segment only)

$19,289,638,400

12/31/16

GE Healthcare (General Electric)

$18,291,000,000

12/31/16

Fresenius (medical care segment)

$17,911,000,000

12/31/16

Siemens Healthineers

$14,985,952,000

9/30/16

Cardinal Health (medical segment)

$13,500,000,000

6/30/17

Danaher (life sciences, diagnostics & dental segment)

$13,189,600,000

12/31/16

Stryker

$11,325,000,000

12/31/16

Baxter

$10,163,000,000

12/31/16

Owens & Minor

$9,723,431,000

12/31/16

Becton, Dickinson (medical segment)

$8,654,000,000

9/30/16

Boston Scientific

$8,386,000,000

12/31/16

Essilor

$7,877,728,000

12/31/16

Zimmer-Biomet

$7,683,900,000

12/31/16

B. Braun Melsungen

$7,164,666,842

12/31/16

Novartis (Alcon segment)

$5,812,000,000

12/31/16

3M Co. (healthcare segment)

$5,527,000,000

12/31/16

Olympus (medical business)

$5,294,358,550

3/31/17

Abbott (medical device segment)

$5,233,000,000

12/31/16

Terumo

$4,731,860,850

3/31/17

Smith & Nephew

$4,669,000,000

12/31/16

Dentsply-Sirona

$3,745,300,000

12/31/16

C.R. Bard

$3,714,000,000

12/31/16

Fujifilm Holdings (healthcare only)

$3,533,959,139

3/31/17

Getinge

$3,478,565,834

12/31/16

Varian Medical Systems

$3,217,800,000

9/30/16

Edwards Lifesciences

$2,963,700,000

12/31/16

Hoya (life care segment)

$2,893,815,572

3/31/17

Hologic

$2,832,700,000

9/24/16

Intuitive Surgical

$2,704,400,000

12/31/16

Hill-Rom

$2,655,200,000

9/30/16

Steris

$2,612,756,000

3/31/17

Sonova

$2,432,676,686

3/31/17

Nipro (medical segment)

$2,427,507,823

3/31/17

BioMerieux

$2,328,441,600

12/31/16

Paul Hartmann

$2,199,452,800

12/31/16

Coloplast

$2,182,204,650

9/30/16

Bio-Rad

$2,068,172,000

12/31/16

ResMed

$2,066,737,000

6/30/17

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S S S

COMPANIES RANKED BY REVENUE 2017 OVERALL COMPANY 2017 REVENUES RANK

FISCAL YEAR END

Cooper Cos.

$1,966,814,000

10/31/16

Miraca

$1,879,670,532

3/31/17

Teleflex

$1,868,027,000

12/31/16

Drägerwerk (medical segment)

$1,824,001,280

12/31/16

ConvaTec

$1,688,300,000

12/31/16

William Demant (hearing segments)

$1,622,123,789

12/31/16

Bruker

$1,611,300,000

12/31/16

Halyard Health

$1,592,300,000

12/31/16

Nihon Kohden

$1,530,323,946

3/31/17

Integer (formerly Greatbatch)

$1,386,778,000

1/1/17

Elekta

$1,311,768,626

5/31/17

Amplifon

$1,254,568,320

12/31/16

LivaNova (formerly Sorin/Cyberonics)

$1,213,925,000

4/24/17

Agfa-Gevaert (healthcare segment)

$1,206,848,000

12/31/16

Carl Zeiss Meditec

$1,205,037,728

9/30/16

CULTURE WILL TAKE THE COMPANY TO ITS TOP PERFORMANCE. AND IT CAN TAKE A COMPANY DOWN SO FAST. IT’S ALL ABOUT LEADERSHIP AND THE PEOPLE THAT YOU HAVE AROUND THE TABLE LEADING THE COMPANY. STRATEGIES CAN BE REPLICATED, CULTURES CAN’T. CULTURE IS YOUR VALUE AS A COMPANY” - CEO, BAXTER

JOSÉ “JOE” ALMEIDA

Revenue Rank_9-17_Vs2-BP FINAL.indd 16

Medical Design & Outsourcing

9 • 2017

9/18/17 12:43 PM

STAMPING PROBLEMS? 2017 OVERALL COMPANY 2017 REVENUES RANK

FISCAL YEAR END

Smiths Medical (Smiths Group)

$1,184,707,000

7/31/16

DJO Global*

$1,155,288,000

12/31/16

Cochlear

$1,131,000,000

6/30/17

Fukuda Denshi

$1,120,439,904

3/31/17

Align Technology

$1,079,874,000

12/31/16

Invacare

$1,047,474,000

12/31/16

Integra Lifesciences

$992,075,000

12/31/16

Kawanishi

$973,476,900

6/30/17

NuVasive

$962,072,000

12/31/16

Omron (healthcare segment)

$932,219,768

3/31/17

Straumann

$932,168,968

2/25/17

Haemonetics

$886,116,000

4/1/17

Konica Minolta (healthcare segment)

$833,618,627

3/31/17

GN Store Nord (GN Hearing segment)

$766,395,148

12/31/16

Conmed

$763,520,000

12/31/16

Masimo

$694,625,000

1/2/17

Wright Medical

$690,362,000

12/27/16

Merit Medical Systems

$603,838,000

12/31/16

Grifols

$574,318,168

12/31/16

DexCom

$573,300,000

12/31/16

Fisher & Paykel Healthcare

$568,892,800

3/31/17

Össur

$520,748,000

12/31/16

JMS Co.

$511,448,555

3/31/17

$505,199,706

12/31/16

Nikkiso

Analogic (Medical Imaging and Ultrasound businesses)

$452,400,000

7/31/16

CynoSure

$433,532,000

12/31/16

Orthofix

$409,788,000

12/31/16

Topcon (eye care segment)

$403,405,117

3/31/17

Accuray

$398,800,000

6/30/16

Natus

$381,892,000

12/31/16

(medical segment)

ICU Medical

$379,372,000

12/31/16

Insulet

$366,989,000

12/31/16

WE ARE CONTINUING TO ACTIVELY MANAGE OUR PORTFOLIO, FOCUSING ON TRANSITIONING OUR BUSINESS IN HIGHER GROWTH AREAS WITH LARGE UNMET NEEDS.

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9 • 2017

Revenue Rank_9-17_Vs2-BP FINAL.indd 17

Medical Design & Outsourcing 17

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COMPANIES RANKED BY REVENUE 2017 OVERALL COMPANY 2017 REVENUES RANK

S S S

FISCAL YEAR END

NxStage Medical

$366,378,000

12/31/16

Abiomed

$329,543,000

3/31/17

Syneron Candela

$298,102,000

12/31/16

RTI Surgical

$272,865,000

12/31/16

Spectranetics

$270,823,000

12/31/16

Barco (healthcare division)

$259,785,658

12/31/16

Exactech

$257,573,000

12/31/16

K2M Group Holdings

$236,634,000

12/31/16

MiMedx

$187,296,000

12/31/16

CryoLife

$180,380,000

12/31/16

AtriCure

$155,109,000

12/31/16

SeaSpine

$128,860,000

12/31/16

100

Alphatec

$120,248,000

12/31/16

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THE TOP 1OO MEDTECH COMPANIES

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MEDTRONIC Dublin, Ireland (Operation HQ in Fridley, Minn.)   www.medtronic.com

ometimes it’s not easy being big. The world’s largest medical device operation, created through the $50 billion merger of Medtronic and Covidien in early 2015, hit some operational snags in recent months: An “inadvertent human error” caused an IT systems shutdown in June, and demand is so high for Medtronic’s hybrid closed loop MiniMed 670G insulin pump system that it temporarily outstripped production capacity for the continuous glucose monitoring sensors that are part of the system. The recent problems, though, amounted to a stubbed toe for the medical device giant, which sells everything from cardiac and vascular devices to minimally invasive therapies to restorative therapies to diabetes devices. Profits for the first quarter ended July 28, 2017 were up 9.4% year-over-year, to $1.02 billion, with sales growing 3.1% to $7.39 billion. For the fiscal year ended April 28, 2017, profits grew $13.8% to $4.03 billion, with revenue up 3.0% to $29.71 billion. During his recent first-quarter earnings call with analysts, CEO Omar Ishrak outlined Medtronic’s three growth strategies: innovative new therapies, embrace of globalization and driving economic value for health systems. Besides the MiniMed 670G, which launched in the U.S. in June 2017, other products driving growth include: • The Solitaire stent retriever accesses arteries in the brain through a micro-sized catheter. It restores blood flow and removing blood clots that cause acute ischemic stroke; • The Resolute Onyx drug-eluting stent, recently approved in both the U.S. and Japan, has a metallically dense, radiopaque inner core within its cobalt alloy wire to boost visibility during placement. • The pill-sized Micra leadless pacemaker, already introduced in the U.S. and Europe, is coming to Japan. When it comes to globalization, emerging markets grew 12% in the first quarter, with strong growth in countries ranging from China to Brazil to Saudi Arabia. Medtronic’s Hospital Solutions business also grew double-digits, with the company now managing cath labs and operating rooms for nearly 140 heath provider customers worldwide. Medtronic also further streamlined through the $6 billion sale of its patient care, deep vein thrombosis and nutritional insufficiency business to Cardinal Health; the deal closed in July. M

2016 RANK: 1 Employees: 91,267 Revenue: $29,710,000,000 R&D Spend: $2,193,000,000 Fiscal year ending: April 28, 2017

KEY PERSONNEL: OMAR ISHRAK, chairman & CEO; MICHAEL COYLE, EVP, president, cardiac & vascular; MIKE GENAU SVP, president, Americas; HOOMAN HAKAMI, EVP, president-diabetes; BRYAN HANSON, EVP, president, minimally invasive therapies; DR. RICHARD KUNTZ, SVP, chief scientific, clinical, & regulatory officer; CHRIS LEE, SVP & president, Greater China; BRAD LERMAN, SVP, general counsel & secretary; GEOFFREY MARTHA, therapies; KAREN PARKHILL, EVP & CFO; LUANN PENDY, SVP-global quality; MARK PLOOF, SVP-global operations & business services; CAROL SURFACE, SVP & chief HR officer

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THE TOP 1OO MEDTECH COMPANIES

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JOHNSON & JOHNSON New Brunswick, N.J.   www.jnj.com

edical devices are the fastest-growing business for Johnson & Johnson. The company’s medtech segment enjoyed 4% year-over-year sales growth, to $13.0 billion, during the first six months of 2017, versus 1.8% growth for the entire company. The situation is a change from 2016, when the year’s medtech sales were slightly down even as the company’s revenue overall grew 2.6%. “We are continuing to actively manage our portfolio, focusing on transitioning our business in higher growth areas with large unmet needs,” CEO Alex Gorsky said during a July earnings calls with analysts. J&J has been actively acquiring and forging partnerships to further the growth. Company officials, for example, have said they are on track with their Verb Surgical robotic surgery partnership with Google’s Alphabet parent, which Gorsky has described as “computerized surgery.” Verb Surgical is more than a robotics company; it’s a platform company, Verb Surgical CEO Scott Huennekens said during DeviceTalks West in December 2016. “There will be robotics – which are a key element – but also advanced instrumentation, advanced visualization, data analytics and machine learning,” Huennekens said. Important acquisitions include: • J&J made a major surgical vision care play with its $4.33 billion buyout of Abbott Medical Optics, which closed in February 2017. • The company in July 2017 said it was taking its Pulsar Vascular and Neuravi acquisitions and combining them with its existing Codman Neuro neurological portfolio to create a new neurovascular business called Cerenovus. • Johnson & Johnson subsidiary DePuy Synthes said in January 2017 that it had agreed to buy Interventional Spine’s expandable cages for minimally invasive spinal fusion surgeries. • J&J subsidiary Ethicon Endo-Surgery announced in January 2017 that it had bought electrosurgical tools maker Megadyne Medical Products. • J&J’s Ethicon in March 2017 closed on its purchase of Torax Medical and its Linx acid reflux treatment portfolio. The Linx system is made of interlinked titanium beads with magnetic cores that augment the esophageal sphincter’s barrier function, preventing reflux in patients with gastro-esophageal reflux disease. Torax has a similar device called Fenix that is designed to treat fecal incontinence. M

2016 RANK: 2 Revenue: $25,119,000,000* Fiscal year ending: Jan. 1, 2017 * Revenues from J&J's medical device segment.

KEY PERSONNEL: ALEX GORSKY, chairman & CEO; DOMINIC CARUSO, EVP & CFO; JOAQUIN DUATO, EVP & chairman, pharmaceuticals; PETER FASOLO, EVP & chief HR officer; ASHLEY MCEVOY, chairwoman, consumer medical devices; JORGE MESQUITA, EVP, chairman, consumer; SANDRA PETERSON, worldwide chairwoman; MICHAEL SNEED, worldwide VP, corporate Affairs & chief communication officer; DR. PAUL STOFFELS, EVP & chief scientific officer; JENNIFER TAUBERT, chairwoman, Americas pharmaceuticals; MICHAEL ULLMANN, EVP & general counsel; KATHRYN WENGEL, worldwide VP, supply chain

www.medicaldesignandoutsourcing.com

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THE TOP 1OO MEDTECH COMPANIES

ROYAL PHILIPS Amsterdam

www.philips.com/global The Veradius Unity X-ray system

hilips set about to redefine itself in 2016 even as it celebrated its 125th year, spun out its legacy lighting business as a separately traded concern, and dealt away its combined Lumileds and automotive lighting businesses. Last year also marked Philips’s successful integration of its Volcano acquisition, the Dutch company told us. Philips made another big buy, closing its $2 billion play for Spectranetics in August 2017. The company also made a raft of smaller buys in personal health, diagnosis & treatment and innovation, including Electrical Geodesics, TomTec, RespirTech, Wellcentive, PathXL and the VersaVue and DynaCAD assets from iCad. And Philips sold another business, the Sonalleve MR-HIFU operation, to Profound Medical.

PHILIPS IS DRIVING FUTURE GROWTH AND PROFIT EXPANSION WITH ITS SHIFT TO SOLUTIONS. Looking ahead, the company said it plans to increase its productivity by lowering the cost of goods, non-manufacturing costs and “the cost of non-quality,” all while “embedding the digital transformation in every aspect of its operations.” Philips said it’s also eying its core businesses for growth, “by executing more effectively on customer partnerships, further transforming the business model from ‘transactional’ to one of ‘long-term partnerships’, with shared business goals and recurring revenue streams.” “Philips is driving future growth and profit expansion with its shift to solutions. The company is investing strongly in research and development for value-added, integrated solutions along the health continuum, most notably in the areas of precision diagnostics, cardiology, oncology, respiratory and population health,” the company told us. M

2016 RANK: Employees: Revenue: R&D Spend: Fiscal year ending:

3 70,968 $19,290,000,000* $1,847,916,800 Dec. 31, 2016

* Revenues from Royal Philips HealthTech segment

KEY PERSONNEL: FRANS VAN HOUTEN, CEO; ABHIJIT BHATTACHARYA, EVP & CFO; SOPHIE BECHU, EVP & COO; ROB CASCELLA, EVP, diagnosis & treatment; MARNIX VAN GINNEKEN, EVP, chief legal officer & general secretary; ANDY HO, EVP, Greater China; HENK DE JONG, EVP, international markets; RONALD DE JONG, EVP & chief HR officer; CARLA KRIWET, EVP, connected care & health informatics; PIETER NOTA, EVP, personal health & chief marketing officer; BRENT SHAFER, EVP, North America; JEROEN TAS, EVP, chief innovation & strategy officer

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Medical Design & Outsourcing 25

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THE TOP 1OO MEDTECH COMPANIES

4 J

GE HEALTHCARE

(GENERAL ELECTRIC)

Chicago

www3.gehealthcare.com/en/global_gateway

OEC Elite C-Arm surgical technology and Venue 40 ultrasound. Photo courtesy of GE Healthcare

ohn Flannery, who is slated to assume the corner office at General Electric in 2018, has served as chief executive of the company’s healthcare division since 2014. There, he helped to turn around GE Healthcare, growing organic revenue by 5% and margins by 100 base points last year. Under Flannery’s watch, the healthcare unit inked a number of deals, including a development and manufacturing deal with Check-Cap – a company developing an indigestible capsule designed for colorectal screening. GE Healthcare also partnered with Accuray last year, collaborating on financing options for Accuray’s CyberKnife and TomoTherapy Systems. The deal, which is designed to make it easier for clinicians in Europe to offer the systems, will allow hospitals and healthcare practitioners to lease Accuray equipment and services through a turnkey offering. In regulatory news, the FDA approved label changes for GE Healthcare’s ultrasound contrast agent, Optison. The decision removed contraindications for use in patients with cardiac shunts and for administration by intra-arterial injection – it’s the first contrast agent available in the U.S. to receive this label change, according to GE. The company landed a reimbursement win when Cigna revised its coverage to include 3D mammography for routine breast cancer screening. GE Healthcare is one of only two companies with mammography systems on the market in the U.S. that can perform 3D breast tomosynthesis. M

2016 RANK: 4 Employees: 54,000 Revenue: $18,290,000,000 Fiscal year ending: Dec. 31, 2016 KEY PERSONNEL: KIERAN MURPHY, president & CEO; EMMANUEL LIGNER, president & CEO, life sciences; MAHER ABOUZEID, president & CEO, Eastern growth markets; TERRI BRESENHAM, president & CEO, sustainable healthcare solutions; SEAN BURKE, president & CEO, Asia Pacific; LEE COOPER, president & CEO, U.S. & Canada; JÖRG DEBATIN, VP & CTO; RACHEL DUAN, president & CEO, China; LAURENT DUBOIS, CEO, GE Healthcare Partners; JAMES RICHARDS, CIO; KARIM KARTI, president & CEO, imaging; CHARLES KOONTZ, president & CEO, GE Healthcare IT & chief digital officer; RAGHU KRISHNAMOORTHY, VP, HR; JEANMICHEL MALBRANCQ, president & CEO, Europe; THOMAS MITCHELL, VP, sourcing; CHUCK NUGENT, VP, global supply chain; LAURA O’DONNELL, VP & General Counsel; MONISH PATOLAWALA, VP & CFO; SUE SIEGEL, CEO, GE Ventures & healthymagination; DAURIO SPERANZINI JR., president & CEO, Latin America; THOMAS WESTRICK, VP & chief quality officer; SARAH WILLS, chief communications officer; ANDERS WOLD, president & CEO, clinical care solutions

www.medicaldesignandoutsourcing.com

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THE TOP 1OO MEDTECH COMPANIES

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FRESENIUS Bad Homburg, Germany www.fmcna.com

he big news from Fresenius Medical Care this year was that it inked a deal to pay $2 billion for NxStage Medical (#88 on this year’s list) and its home hemodialysis technology at $30 per share. The deal is slated to close in 2017 and Fresenius said it expects NxStage to add to net income and earnings per share within three years of the deal’s close. Waltham, Mass.-based Fresenius Medical Care also rebranded its dialysis division last year, to Fresenius Kidney Care, launching a new website to provide education about dialysis and treatment options for people in various stages of kidney disease. As the company aims to see revenues climb above $20 billion by 2020, it has spent the last year acquiring several large dialysis providers around the world. In February 2016, it bought Japan’s largest dialysis group with around 6,000 patients. In its biggest takeover yet, Fresenius bought Spain’s biggest private hospital chain Quironsalud for $6.4 billion in September last year. Fresenius continues to deal with the lawsuits that came after the FDA launched a Class I recall of its GranuFlo product in March 2012. The company’s GranuFlo and Naturalyte products were used to lower the acidity of patients’ blood during dialysis treatments, but lawsuits allege that the compounds’ high concentrations of acetone led to abnormally high levels of bicarbonate in the blood, which caused fatal heart problems and strokes. In March 2017, Fresenius Medical Care won the first bellweather trial in a series of product liability lawsuits brought over the dialysis drugs, after a Massachusetts jury found that the plaintiff’s estate failed to prove its case. It was the first case to go trial among a group of plaintiffs who declined to enter a $250 million settlement struck in 2016 in the multi-district litigation proceeding in a Mass.-based federal court. In an internal annual medical report, Fresenius last year touted a 27% reduction in mortality and a 22% cut in hospitalizations amongst its permanent dialysis patients over 10 years. The company accredited the positive patient outcomes to the company’s expansion into care coordination and continued innovation. M

Fresenius Medical Care’s 6008 CAREsystem, which launched in 2016. Photo courtesy of Fresenius Medical Care.

2016 RANK: 5 Employees: 109,319 Revenue: $17,910,000,000* R&D Spend: $162,000,000 Fiscal year ending: Dec. 31, 2016 * Revenues from Fresenius’ medical care segment.

KEY PERSONNEL: RICE POWELL, Chairman & CEO; MICHAEL BROSNAN, CFO; OLAF SCHERMEIER, CEO, global R&D; WILLIAM VALLE, CEO, North America; KENT WANZEK, CEO, global manufacturing & quality; DOMINIK WEHNER, CEO, EMEA; HARRY DE WIT, CEO, Asia Pacific

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THE TOP 1OO MEDTECH COMPANIES

SIEMENS Erlangen, Germany www.healthcare.siemens.com

he biggest news of 2016 for the German industrial conglomerate’s healthcare business came mid-year, with a global rebranding as Siemens Healthineers. Before and after that were a string of clearances and approvals from the FDA. (Notably, the U.S. safety watchdog gave the nod to the Sysmex CS-5100 and Xprecia Stride hemostasis analyzers; the Biograph Horizon PET/ CT scanner; a trio of new mobile C-arms; stand-alone 3D breast screening for the Mammomat Inspiration; and the dual-source CT scanner Somatom Drive.) Siemens Healthineers also inked several deals with a range of partners: a molecular testing pact with lab equipment giant Thermo-Fisher, a global alliance with IBM Watson Health for population health management and an outcomes studies agreement with Northwell Health, to name a few. On the M&A trail, late in 2016 the company acquired open connectivity provider Conworx Technology and, as of the time of this writing, had added workflow management provider Medicalis and announced the intent to acquire the Epocal blood diagnosis business from Alere. M

2016 RANK: 6 Revenue: $14,985,952,000* Fiscal year ending: Sept. 30, 2016 * Revenues from Siemens Healthineers segment.

KEY PERSONNEL: JOE KAESER, president & CEO; DR. ROLAND BUSCH, CTO; LISA DAVIS, CEO, Siemens Corp. USA; RALF THOMAS, CFO; BERND MONTAG, CEO, Siemens Healthineers

The Artis Pheno Robotic C-arm Angiography suite

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Your integrated Nitinol supplier. Because quality saves lives. Fort Wayne Metals is the world’s leading melt to finish source for Nitinol dedicated to the medical device industry. By controlling the entire process, we ensure the high levels of precision and performance you demand for critical applications. If you’re looking for customizable solutions using Nitinol or other advanced materials, give us a call. We’ll put our commitment to excellence to work for you.

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THE TOP 1OO MEDTECH COMPANIES

CARDINAL HEALTH Dublin, Ohio www.cardinalhealth.com

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

2016 RANK: 7 Employees: 30,251** Revenue: $13,500,000,000* Fiscal year ending: June 30, 2017 * Revenues from Cardinal Health’s medical segment. ** MDO accidentally published Cardinal Health’s total employee count, versus medical segment employee count, in last year’s Big 100.

KEY PERSONNEL: GEORGE BARRETT, chairman & CEO; DONALD CASEY JR., CEO, medical segment; CRAIG COWMAN, EVP, global sourcing; JOSEPH DEPINTO, president; Cardinal Health specialty solutions; MIKE DUFFY, president, hospital solutions & global supply chain; JON GIACOMIN CEO, pharmaceutical segment; MICHELE HOLCOMB, EVP, strategy and corporate development; MIKE KAUFMANN, CFO; PAMELA KIMMET, chief human resources officer; STEVE MASON, president, Cardinal Health at Home; CRAIG MORFORD, chief legal & compliance officer; PATRICIA MORRISON, EVP, customer support services & CIO; TIFFANY OLSON, president, nuclear pharmacy services; BILL OWAD, SVP, operational excellence; DAVID WILSON, president, Cordis

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BMPmedical 42 Linus Allain Gardner, MA 01440 Phone: 978-632-2555; Toll Free: 800-253-3684 Fax: 978-632-2524 E-mail: sales@bmpmedical.com Web: www.bmpmedical.com

all areas of the Medical Device and Diagnostics including but not limited to IVD, IV access, Sample preparation devices and lateral flow technologies. With head-quarters based in Gardner, Ma and global manufacturing capabilities BMPmedical can service our partner requirements on a worldwide basis.

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VITAL STATISTICS Year Founded: 1978 Number of Employees: 60 Certifications: ISO 9001:2008; ISO 13485:2003; FDA registration #1220502; ISO Class 8 injection molding; ISO Class 8 packaging and assembly; 21 CFR 820 Quality System Regulation FDA subchapter H-Medical Devices; Veteran Owned –Small Business

WHO WE ARE • • • • • • • • • •

BMPmedical is a ISO13485 certified contract manufacturer of quality plastic medical device and medical diagnostic components. BMPmedical utilizes state-of-the-art all electric injection molding and injection blow molding (IBM) technologies for product realization. Our project team will support your requirements from concept to production. We offer custom cleanroom (ISO Class 8) manufacturing, packaging and assembly. Specializing in mid-tier projects, BMPmedical is a Veteran Owned Small Business (VSOB) and has been incorporated since 1978. We understand what it takes to bring an idea from a concept to a finished product.

Custom Injection Molding Custom Injection Blow Molding (IBM) Clean Room Manufacturing (Class 8) Clean Room Packaging and Assembly (Class8) Product Development Services Sterilization Services Custom Packaging Pad Printing DNase-RNase free manufacturing FDA Registered Facility

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MAJOR MARKETS BMPmedical is global contract manufacturer servicing the Medical Device and Medical Diagnostics markets with manufacturing facilities in Massachusetts and Asia. We service 26

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THE TOP 1OO MEDTECH COMPANIES

DANAHER Washington, D.C. www.danaher.com

anaher jumped from 13th to eighth on the Big 100 this year, largely on its purchase of the clinical microbiology business of Siemens Healthcare Diagnostics. The unit includes clinical lab, acute care and pathology diagnostics businesses. This latest purchase, however, is one in a long line of diagnostics growth through acquisitions for the conglomerate. In 2004 Danaher acquired Radiometer and has shifted steadily toward diagnostics and the life sciences since then, acquiring Leica Microsystems in 2005, Vision Systems in 2006, Genetix in 2009, AB Sciex and Molecular Devices in 2010, Beckman Coulter in 2011, Iris International and Aperio Technologies in 2012, HemoCue in 2013 and Devicor Medical Products in 2014. Most recently, the company completed acquisitions of Cepheid, a molecular diagnostics firm, and Pall Corporation, which provides filtration, separation and purification technologies for a range of industries. Both of those acquisitions contributed significantly to the company’s recent performance. At the same time, the firm has made changes to tighten its focus on life sciences and diagnostics, through divesting both communications and industrial technologies. In July 2015, Danaher sold its communications business to NetScout for $2.3 billion, and in July 2016, completed a spin-off of Fortive, the professional instrumentation and industrial technologies businesses. Despite this activity, analysts have remained tepid on Danaher. The company has taken a lot of criticism because of its lack of organic growth. In its second quarter of 2017, Danaher reported total sales of $4.5 billion, an increase of 6.3% year over year. However, 6% of that growth is from acquisitions. Many industry watchers note that the move to focus on diagnostic and life sciences subsidiaries promises long-term sustainability. The most recent earnings call for Q2, 2017 reported that the life sciences segment rose 4% year over year to about $1.4 billion. The sales growth of this segment is driven by a strong market for traction of mass spectrometers, microscopy, flow cytometry and genomics products. Impressive rise in the operating margin was driven by higher sales volumes and incremental year-over-year cost savings associated with restructuring actions. The diagnostics segment is nearly equally as promising. Revenues at the diagnostics segment increased 14.5% year over year to $1.44 billion. Impressive performance of clinical business in China and robust performance of acute care diagnostic and

Medical Design & Outsourcing

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9 • 2017

2016 RANK: 13 Revenue: $13,189,600,000* R&D Spend: $787,800,000 Fiscal year ending: Dec. 31, 2016 * Revenues from Danaher’s life sciences, diagnostics & dental segments.

KEY PERSONNEL: THOMAS JOYCE JR., president & CEO; DANIEL COMAS, EVP & CFO; RAINER BLAIR, EVP, life sciences; WILLIAM DANIEL II, EVP, diagnostics & dental; BRIAN ELLIS, SVP & general counsel; WILLIAM KING IV, SVP, strategic development; ANGELA LALOR, SVP, HR; ROBERT LUTZ, SVP & chief accounting officer; DANIEL RASKAS, SVP, corporate development

pathology diagnostics business proved conducive to growth of this segment. However, operating margin at the segment contracted 760 basis points year over year, to 10.9%. The fall is attributed to higher costs associated with new product development and higher restructuring and impairment charges. Still as of press time, Danaher is hovering in a low middle ground, having lost another 2.8% in shares in the month following Q2 earnings calls. This is a waiting game for analysts to see whether Danaher can metabolize its acquisitions to fuel energetic growth. M

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THE TOP 1OO MEDTECH COMPANIES

STRYKER Kalamazoo, Mich. www.stryker.com Stryker’s orthopedic-focused robotic-arm assisted platform is now cleared for both total hip and total knee replacement. Acquired from Mako Surgical in 2013, the company touts that the system has been used in over 50,000 hip and knee procedures since its inception.

fter a year filled with acquisitions, Stryker was relatively calm on the M&A trail in 2016 – apart from a $700 million deal for fluorescence imaging technology developer Novadaq and the buyout of substance disposal maker Cactus. The past year was still a busy one for the company, which offers an array of products across orthopedics, general medical and surgical use, spinal and neurotech fields. Business for Stryker has been brisk, and while it has been engaged on a number of legal fronts, including hip implant suits and its own levied employee poaching suits, it has avoided any major pitfalls so far. In March, Stryker launched the robotic-arm assisted total knee arthroplasty application for its Mako system, touting it as the first and only robotic tech for total knee, hip and partial knee replacements. The launch marked a major milestone for the company, which closed its $1.7 billion acquisition of Mako Surgical in 2013 but was met with skepticism from analysts on Wall Street, who questioned the potential uptake for the device. On the vascular front, the company celebrated an unexpected victory, putting an early stop to enrollment in a clinical trial of its Trevo anti-stroke device after a review board decided that the trial had a high probability of success. The device, designed to remove blood clots that cause ischemic stroke, came with the company’s $135 million acquisition of Concentric Medical in 2011. In February, Stryker inked a deal with the U.S. Defense Dept., netting a $486 million fixed-price contract to supply orthopedic products to the military and other federal agencies. In a boost to its production capabilities, Stryker announced a deal with GE Healthcare’s 3D printing arm, GE Additive, looking to build out its own additive design and manufacturing facilities. Through the deal, the company looked to acquire machines, materials and services, adding to the 3D printing machines it acquired from Arcam and Concept Laser. Internally, the company opened a new customer experience center in San Jose, Calif., featuring what it calls the “Operating Room of the Future.” The display includes integration of Microsoft’s alteredreality HoloLens holographic computer system, and gives a glance into how the company’s devices integrate to improve efficiency and safety. Stryker also won a tax break in Portage, Mich., where it plans to begin construction on a new research and development facility estimated to cost as much as $154 million, slated to be completed by 2019. M

Medical Design & Outsourcing

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2016 RANK: Employees: Revenue: R&D Spend:

10 33,000 $11,325,000,000 $715,000,000

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

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THE TOP 1OO MEDTECH COMPANIES

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BAXTER Deerfield, Ill.

www.baxter.com

axter is a company undergoing a major transformation under CEO José “Joe” Almeida, who took the reins from longtime CEO Robert Parkinson Jr. early last year after leading Covidien through its $50 billion merger with Medtronic in 2015. The Deerfield, Ill.–based company, which sells renal and medical products including pharmaceutical devices and acute renal care equipment, has spent the last year-and-a-half under Almeida’s guidance adjusting its corporate culture and its focus on innovation and invention. “Culture will take the company to its top performance. And it can take a company down so fast. It’s all about leadership and the people that you have around the table leading the company. Strategies can be replicated, cultures can’t. Culture is your value as a company,” Almeida said last November at the annual Cleveland Clinic Medical Innovation Summit. Almeida said that he has worked to shift the culture to reduce excessive internal over-analysis and improve employee independence, creating an environment where innovation can flourish. “The part that separates most companies regarding innovation, those that truly get it, is the bridge between the invention and the innovation,” Almeida said. “The ability to create value in healthcare and access is quite significant.” The transformation has been positive for the company, which Almeida said in June is positioned to pull the trigger on a massive acquisition worth up to $7.5 billion – as long as it’s the right company. “We’re open to the tuck-ins, and we’re doing them, and we’re working very hard to get even more opportunities. We have a good pipeline in our pharmaceutical business between partnership and some tuck-ins and even in our advanced surgery, our biosurgery business,” Almeida said during the company’s first-quarter earnings call. Though it hasn’t jumped on any acquisitions that large, the company did close a $625 million acquisition of Claris Lifesciences’ injectable drug business in July, including the company’s portfolio of injectable generics and 3 manufacturing plants. Baxter also announced it inked a deal with Israel’s Tel Aviv University’s Ramot business segment, looking to bring early stage research technologies developed at the University to market. The move is significant for Baxter, which Almeida said previously had no connections in the country. “We did not have any contacts in Israel. You think about it. If

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Baxter’s Sigma Spectrum infusion system is a lightweight, compact device designed to improve clinical workflows by allowing infusions to be programmed in its drug library in a minimal amount of steps.

2016 RANK: 9 Employees: 48,000 Revenue: $10,163,000,000 R&D Spend: $647,000,000 Fiscal year ending: Dec. 31, 2016 KEY PERSONNEL: JOSÉ (JOE) ALMEIDA, chairman, president & CEO; GIUSEPPE ACCOGLI, SVP & president, global businesses; BRIK EYRE, SVP & president, Americas; ANDREW FRYE, SVP & president, APAC; SEAN MARTIN, SVP & general counsel ; JEANNE MASON, SVP, HR; SCOTT PLEAU, SVP, operations; JAMES SACCARO, EVP & CFO; SCOTT BOHABOY, SVP, treasurer & global planning head; CAROLINE KARP, SVP & controller; PAUL MARTIN, SVP & CIO; ELLEN MCINTOSH, SVP & corporate secretary

you were a medtech and you don’t have a foot in Israel, you’re missing a big part of innovation,” Almeida said. The company has strengthened its portfolio pipeline through other contracts as well, inking a collaborative deal with the Mayo Clinic in May with an initial focus on kidney disease. Baxter is continuing to grow, getting leaner and meaner and looking to improve its portfolio, including its management in venture capital and financial returns. M

www.medicaldesignandoutsourcing.com

9/18/17 12:53 PM

Discover Our Core CAPABILITIES EXPERIENCE Merit Medical OEM

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THE TOP 1OO MEDTECH COMPANIES

OWENS & MINOR Mechanicsville, Va. www.owens-minor.com

2016 RANK: 12 Revenue: $9,723,431,000 Fiscal year ending: Dec. 31, 2016

KEY PERSONNEL: CODY PHIPPS, chairman, president & CEO; RICHARD MEIER, EVP, CFO & presidentinternational; RONY KORDAHI, EVP, North American operations; STUART MORRIS-HIPKINS, EVP, global manufacturer services; CHARLES COLPO, SVP, Europe operations; ERIKA DAVIS, SVP, chief administrative officer; JAMES GLASSCOCK, SVP, clinical procedural solutions; GEOFF MARLATT, SVP, manufacturer services, STEPHEN OLIVE, SVP, CIO; NICHOLAS PACE, SVP, general counsel, corporate secretary & chief HR officer; JOSEPH ZALUZNEY, SVP, commercial services

Employees:

OWENS & MINOR struggled in 2016 and may have made missteps in its own consolidation practices while responding to changes in the healthcare field. The firm is in transition to respond to the shifts in the healthcare ecosystem. During its second-quarter earnings call, CEO Cody Phipps noted that the company is still feeling the April 2016 loss of a $525 million contract with Kaiser Permanente. That loss was two-fold, as Kaiser then signed with competitor Cardinal Health. Phipps noted that Owens & Minor is evaluating every aspect of its business to identify improvements in operating efficiency and revenue growth, introducing a four-part strategy for sustained, profitable growth. For example, Owens & Minor recently closed the acquisition of Byram Healthcare, a disposable medical supplies firm that delivers directly to patients. Phipps noted that the $380 million acquisition provides access to the healthcare consumer and furthers the goal of “clinical relevancy along the continuum of care,” with its unique patient access. M

BECTON, DICKINSON Franklin Lakes, N.J. www.bd.com

2016 RANK: 8 Revenue: $8,654,000,000* Fiscal year ending: Sept. 30, 2016

Employees:

KEY PERSONNEL:

BECTON, DICKINSON through its BD Medical business segment produces a wide array of medical technologies for health providers. BD Medical has four major business units: • Diabetes Care makes syringes, pen needles and IV sets; • Medication and Procedural Solutions offers needles, syringes and intravenous catheters for medication delivery – and much more; • Medication Management Solutions makes intravenous medication safety and infusion therapy delivery systems; • Pharmaceutical Systems creates refillable drug delivery systems for pharmaceutical companies. Plans for a $24 billion merger with C. R. Bard, expected to close this year, should make BD even more of a major presence in the medical device industry. M

VINCENT FORLENZA, chairman & CEO; THOMAS POLEN, president; GARY COHEN EVP & president, global health; ALEXANDRE CONROY, EVP & president, Europe, EMA & Americas; JAMES LIM, EVP & president, greater Asia; ALBERTO MAS, EVP & president, life sciences; CHRISTOPHER REIDY, EVP, CFO & chief administrative officer; NABIL SHABSHAB, EVP, strategic planning & chief marketing officer; JEFFREY SHERMAN, EVP & general counsel; STEPHEN SICHAK, EVP, integrated supply chain; ELLEN STRAHLMAN, EVP, R&D & CMO; LINDA THARBY, EVP & chief HR officer; PIERRE BOISIER, EVP & chief quality officer; LINDA PETERS, EVP & chief regulatory officer; RICHARD PIERLE, EVP & CIO 40

7,900

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24,000

* Revenues from Becton, Dickinson’s medical segment.

www.medicaldesignandoutsourcing.com

9/18/17 1:09 PM

Plastic Part Validation Have You Buried? Let PTI Engineered Plastics Dig You Out. In this age of high-tech manufacturing, quality requirements have never been tougher. Thatâ&#x20AC;&#x2122;s why PTI Engineered Plastics has built their operations to support validations throughout their manufacturing and assembly processes. Our team is highly trained to define and implement all facets of IQ, OQ, PQ process validation, including many other quality standards required in the plastic injection molding industry.

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THE TOP 1OO MEDTECH COMPANIES

BOSTON SCIENTIFIC Marlborough, Mass. www.bostonscientific.com

2016 RANK: 16 Revenue: $8,386,000,000 Fiscal year ending: Dec. 31, 2016

KEY PERSONNEL: MICHAEL MAHONEY, chairman & CEO; KEVIN BALLINGER, EVP & president, interventional cardiology; SUPRATIM BOSE, EVP & president, Asia-Pacific, Middle East & Africa; DANIEL BRENNAN, EVP & CFO; ART BUTCHER, SVP & president, endoscopy; WENDY CARRUTHERS, SVP, HR; JOSEPH FITZGERALD, EVP & president, rhythm management; EDWARD MACKEY, EVP, global operations; DR. IAN MEREDITH, EVP & global CMO; JEFF MIRVISS, SVP & president, peripheral interventions; MAULIK NANAVATY, SVP & president, neuromodulation; MICHAEL PHALEN, EVP & president, medsurg; DAVID PIERCE, SVP & health; TIMOTHY PRATT, EVP, chief administrative officer, general counsel & secretary; BRAD SORENSON, SVP, manufacturing & supply chain; ERIC THÉPAUT, SVP & president, Europe

27,000 $920,000,000

BOSTON SCIENTIFIC put its turnaround in the rear view mirror in 2016 and set its sights on accelerating and stabilizing that growth by expanding into high-growth adjacent markets. “Our investment strategy has focused on diversifying our portfolio and shifting the growth profile of the company toward higher-growth markets and focusing on globalization,” a company spokeswoman told us, noting that once-core products likes stents, pacemakers and defibrillators are now only 50% of the total offering. “We expect that to be about a third as we continue to grow with our robust pipeline,” she said, adding that nearly half of Boston Scientific’s sales come from global markets. A June 2016 restructuring meant little net change to total employment numbers, as BSC looked to pare its pre-tax expenses by $115 million to $150 million by the end of 2020. M

ESSILOR Charenton-le-Pont, France www.essilor.com

2016 RANK: 17 Revenue: $7,877,728,000 Fiscal year ending: Dec. 31, 2016

Employees: R&D Spend:

KEY PERSONNEL:

ESSILOR is a major ophthalmic and optics company, manufacturing a wide range of lenses to improve and protect eyesight. Flagship brands include Varilux, Crizal, Transitions, Eyezen, Xperio, Foster Grant, Bolon and Costa. Besides continuing to spend the equivalent of more than $200 million a year on research and development, Essilor also spent a similar amount on media last year to boost brand awareness among consumers. Essilor is in the process of merging with Italian eyewear maker Luxottica in a deal worth €46 billion ($49 billion). M

HUBERT SAGNIÈRES, chairman & CEO; LAURENT VACHEROT, president & COO; JAYANTH BHUVARAGHAN, chief mission officer; JEAN CARRIER-GUILLOMET, COO; FRÉDÉRIC MATHIEU, SVP, HR; BERNHARD NUESSER, president, online; GÉRALDINE PICAUD, CFO; PAUL DU SAILLANT, COO; JEREMY TEO, chief strategy officer; ÉRIC THOREUX president, sun, readers & China

Employees: R&D Spend:

Medical Design & Outsourcing

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64,000 $236,940,800

www.medicaldesignandoutsourcing.com

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THE TOP 1OO MEDTECH COMPANIES

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ZIMMER BIOMET

Warsaw, Ind.

www.zimmerbiomet.com

2016 RANK: 19 Revenue: $7,683,900,000 Fiscal year ending: Dec. 31, 2016 Employees: 18,500 R&D Spend: $365,600,000 KEY PERSONNEL: DANIEL FLORIN, interim CEO, SVP & CFO; TONY COLLINS, VP, controller & chief accounting officer; DEREK DAVIS, VP, global integration; ROBERT DELP, president, Americas; WILLIAM (BILL) FISHER, SVP, global HR; ADRIAN FUREY, SVP, global operations & logistics; ADAM JOHNSON, president, spine, dental, CMF & thoracic; DAVID KUNZ, SVP, global quality & regulatory affairs; DR. KATARZYNA MAZUR-HOFSAESS, president, EMEA; DAVID NOLAN, president, biologics, extremities, sports medicine, surgical, trauma, foot & ankle, office-based technologies & Zimmer Biomet signature solutions; CHAD PHIPPS, SVP, general counsel & secretary; DANIEL WILLIAMSON, president, joint reconstruction; SANG YI, president, Asia Pacific ZIMMER BIOMET has had a hectic year, with 10-year veteran David Dvorak abruptly stepping away from the corner office in July and senior VP and CFO Daniel Florin stepping in until a replacement is found. Dvorak hasn’t been the only employee to exit the company, which said it “cleaned house” at certain Warsaw-based facilities after receiving a number of violations during an FDA inspection. The purge included replacing the company’s senior vice president of global operations and logistics, vice president of quality assurance at all of its Warsaw sites, the quality assurance director for its North Campus facilities, the compliance director for the Biomet network, and the quality assurance director for post-market surveillance and complaint handling. M 9 • 2017

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THE TOP 1OO MEDTECH COMPANIES

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B. BRAUN

Melsungen, Germany www.bbraunusa.com

2016 RANK: 18 Revenue: $7,164,666,842 Fiscal year ending: Dec. 31, 2016 Employees: 58,037 R&D Spend: $322,638,080

KEY PERSONNEL: ANNA MARIA BRAUN, president, Asia Pacific; ANNETTE BELLER, CFO; HEINZ-WALTER GROSSE, chairman, chief HR officer; MEINRAD LUGAN, president, hospital care, OPM; CAROLL NEUBAUER, chairman & CEO, B. Braun Medical; MARKUS STROTMANN, president, Avitum; JOACHIM SCHULZ, chairman, Aesculap; BRUCE HEUGEL, SVP & CFO, B. Braun Medical; ROB ALBERT, SVP & chief marketing officer, B. Braun Medical; JOE GRISPO JR., SVP & chief sales officer, B. Braun Medical; FRANK KATONA, SVP & COO, B. Braun Medical; CATHY CODREA, SVP, general counsel & chief compliance officer, B. Braun Medical; DR. WES CETNAROWSKI, SVP, scientific affairs & CMO, B. Braun Medical

B. BRAUN has seen a flurry of product releases this year, launching its Easypump home infusion app, Diacap Pro Dialyzer, Protosan wound gel, Actreen urological mini catheters, the Docit and HubScrub sterilization devices and its Flow Collector ostomy device. B. Braun also announced the integration of its Outlook large-volume infusion pumps with Iatric Systems Accelero Connect software, clearing the device to communicate with a number of electronic health record systems. The company has also continued its focus on partnership, collaboration and profitability. Braun and Christie Medical said they plan to combine the VeinViewer system with Braun’s line of IV products to enhance the ease and safety of peripheral IV catheters. M 9 • 2017

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THE TOP 1OO MEDTECH COMPANIES

NOVARTIS Fort Worth, Texas www.alcon.com

2016 RANK: 11 Revenue: $5,812,000,000* Fiscal year ending: Dec. 31, 2016

KEY PERSONNEL: MIKE BALL, CEO; Kim Adler, head, global communications; LAURENT ATTIAS, head, strategy, BD&L & market access; ROYCE BEDWARD, SVP & general counsel; IAN BELL, president, EMEA; SERGIO DUPLAN, president, North America; DAVID ENDICOTT, COO; CAMILA FINZI, president, Latin America & the Caribbean; FRANCK LEVEILLER, head, global R&D; MERRICK MCCRACKEN, SVP, HR; ED MCGOUGH, SVP, global manufacturing & technical operations; JIM MURPHY, president, Japan; DAVID MURRAY, CFO; RAJKUMAR NARAYANAN, president, Asia; MICHAEL ONUSCHECK, head, Alcon Surgical; DAVE SCHOENING, SVP quality; ERIC VAN OPPENS, head, global strategic initiatives

ALCON’S surgical and vision care businesses together boast one of the world’s widest selections of eye care devices. Products range from sophisticated eye surgery equipment to advanced contact lenses. Alcon went through a transition year in 2016, according to the annual report of Alcon’s parent company Novartis. There was more of a concentration on eye care devices – as well as R&D investment and new systems and capabilities to boost relationships with customers. Rumors once again swirled last year about a possible private equity spinout or IPO for Alcon; with CEO Joe Jimenez turning the corner office over to Dr. Vasant Narasimhan early next year, those rumors are not likely to go away. M

www.3m.com

INGE THULIN, chairman, president & CEO; JOHN BANOVETZ, SVP, R&D & CTO; JAMES BAUMAN, EVP, industrial; JULIE BUSHMAN, EVP, international operations; JOAQUIN DELGADO, EVP, consumer; IVAN FONG, SVP, legal affairs & general counsel; NICHOLAS GANGESTAD, SVP & CFO; ERIC HAMMES, SVP, business transformation & IT; PAUL KEEL, SVP, supply chain; ASHISH KHANDPUR, EVP, electronics & energy; JON LINDEKUGEL, SVP, business development & marketingsales; FRANK LITTLE, EVP, safety & graphics; MARLENE MCGRATH, SVP, HR; KIMBERLY FOSTER PRICE, SVP, communications & enterprise services; MICHAEL ROMAN, COO & EVP; HAK CHEOL SHIN, vice chairman & EVP; MICHAEL VALE, EVP, health care

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* Revenues from Novartis’ Alcon segment.

Maplewood, Minn.

KEY PERSONNEL:

Medical Design & Outsourcing

19,000 $486,000,000

3M CO.

2016 RANK: 22 Revenue: $5,527,000,000* Fiscal year ending: Dec. 31, 2016

Employees: R&D Spend:

9 • 2017

* Revenues from 3M’s Health Care segment. 3M’S Health Care segment sells products and services including medical and surgical supplies, skin health and infection prevention products, inhalation and transdermal drug delivery systems, oral care solutions (dental and orthodontic products), health information systems and more. Medical and surgical products include tapes, dressings, wound closure products, orthopedic casting materials, electrodes and stethoscopes. When it comes to infection prevention, 3M markets surgical drapes, masks and preps, as well as sterilization assurance equipment and patient warming solutions. Drug delivery systems include metered-dose inhalers, transdermal skin patches and related components. M

www.medicaldesignandoutsourcing.com

9/18/17 1:09 PM

VIONiC™ digital encoder series Designed for the designer

The VIONiC digital incremental encoder series has been specifically designed with the machine builder in mind. Its enhanced ease of use, superior metrology capability and multiple configuration options all ensure optimal machine performance. VIONiC really has been designed for the designer. • The most powerful integrated interpolator chip on the market: The custom-made, Versatile Interpolation ASIC (VIA) chip outputs digital signals and uses advanced signal processing to reduce encoder error • Exceptional point-to-point accuracy: RELM linear spar scale has an accuracy of <±1 µm/m and a low coefficient of thermal expansion, for temperature-sensitive environments where accuracy is paramount • High repeatability: VIONiC series can directly output digital signals at resolutions as fine as 2.5 nanometres, with no need for an interface • Quick and easy to install and calibrate: No need for additional set-up tools • Optional Advanced Diagnostics Tool (ADT): Remotely calibrates the readhead and performs system diagnosis for in-field servicing or fault-finding

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Renishaw 9-17.indd 56

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THE TOP 1OO MEDTECH COMPANIES

OLYMPUS CORP. Tokyo

* Revenues from Olympus’s medical business.

www.olympusamerica.com

2016 RANK: 23 Revenue: $5,294,358,550* Fiscal year ending: March 31, 2017

KEY PERSONNEL: HIROYUKI SASA, CEO & president; YASUO TAKEUCHI, VP & CFO; AKIHIRO TAGUCHI, senior executive managing officer & head, sales, medical; SHIGEO HAYASHI, senior executive managing officer & head, manufacturing; HARUO OGAWA, senior executive managing officer & head, R&D; YASUSHI SAKAI, executive managing officer & chief improvement officer; AKIRA KUBOTA, executive managing officer & head, medical affairs & CSR; NOBUHIRO ABE, executive managing officer & chief regional representative officer, Asia Pacific; KIICHI HIRATA, executive managing officer & CAO

OLYMPUS dominates the endoscopic camera market. It is a global company with about 70% of its medical technology production in Japan and 30% elsewhere. The company has chosen to focus on China as the world’s largest market, which appears to be paying off. Olympus seems to have recovered from a media storm in late 2015 and early 2016, when one of its reusable duodenoscopes was linked to superbug outbreaks in several markets and the company faced accusations of failing to quickly alert the U.S. public to the danger. The results of this issue, however, seem minor since the company reported a 3% increase in its medical business revenue. Even the reported operating profit decline of 9% is due to changes in the product mix, as mainstay systems reach the later stage of their product cycles, and higher SG&A (selling, general and administrative) expenses. Meanwhile, in May, Olympus acquired Image Stream Medical, which develops video equipment and system integration used in operating rooms, for $87 million. It also completed a new building at the Aomori medical manufacturing plant. It also launched several new products including a single-use aspiration needle, a single-use electrosurgical knife with fluid injection function, and an ultra-high definition surgical endoscope, among others. M

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SCHOTT Solidur® LEDs

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THE TOP 1OO MEDTECH COMPANIES

ABBOTT Abbott Park, Ill. www.abbott.com

2016 RANK: 24 Revenue: $5,233,000,000* Fiscal year ending: Dec. 31, 2016

* Revenues from Abbott’s medical device segment.

us.schott.com/led

KEY PERSONNEL: MILES WHITE, chairman & CEO; HUBERT ALLEN, EVP, general counsel & secretary; BRIAN BLASER, EVP, diagnostics; JOHN CAPEK, EVP, ventures; ROBERT FORD, EVP, medical devices; STEPHEN FUSSELL, EVP, HR; ANDREW LANE, EVP, established pharmaceuticals; HEATHER MASON, EVP, nutritional; BRIAN YOOR, EVP, finance & CFO; ROGER BIRD, SVP, U.S. nutrition; JAIME CONTRERAS, SVP, core laboratory diagnostics, commercial operations; DENIS GESTIN, SVP, global commercial integration; ELAINE LEAVENWORTH, SVP, chief marketing & external affairs officer; JOSEPH MANNINg, SVP, international nutrition; CORLIS MURRAY, SVP, quality assurance, regulatory & engineering services; DANIEL SALVADORI, SVP, established pharmaceuticals, Latin America; JARED WATKIN, SVP, diabetes.

ABBOT moved from 24th to 20th in 2016, and there’s every indication that by 2018 it will have risen higher in the ranks, thanks to its $25 billion acquisition of St. Jude Medical in January 2016. In August, the FDA approved HeartMate 3, a bridgeto-transplant cardiac assist device that pumps blood for heart-failure patients using a fully magnetically levitated impeller that simulates the beating of a heart. The HeartMate 3 device is among key products in the St. Jude Medical portfolio, along with the other major launch this year, Tacticath, a contact force enabled catheter. And Abbott is also making moves in the diabetes space, inking a deal with Bigfoot Biomedical, integrating its FreeStyle Libre glucose sensing technology with Bigfoot's insulin delivery solutions. M 52

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Medical Design & Outsourcing

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THE TOP 1OO MEDTECH COMPANIES

TERUMO Tokyo

www.terumo.com

2016 RANK: 28 Revenue: $4,731,860,850 Fiscal year ending: March 31, 2017

Employees:

20,697

KEY PERSONNEL: SHINJIRO SATO, president & CEO; HIKARU SAMEJIMA, president, cardiac & vascular; MASATAKA HARAGUCHI, branch manager, Tokyo; TAKANORI SHIBAZAKI, president & CEO, Terumo (China) Holdings; KAZUHISA SENSHU, chief clinical & regulatory affairs officer; FUMIHISA HIROSE, SVP, cardiac & vascular; PAUL HOLBROOK, president, vascular graft, president & CEO, Vascutek

SMITH & NEPHEW London www.smith-nephew.com

2016 RANK: 25 Revenue: $4,669,000,000 Fiscal year ending: Dec. 31, 2016

Employees: 15,644 R&D Spend: $230,000,000

KEY PERSONNEL: OLIVER BOHUON, CEO; GRAHAM BAKER, CFO; RODRIGO BIANCHI, president, international; BRAD CANNON, president, Europe & Canada; ELGA LOHLER, chief HR officer; CATHERYN O’ROURKE, chief legal officer; VASANT PADMANABHAN, president, R&D; CYRILLE PETIT, chief corporate development officer & president, global business services; MATTHEW STOBER, president, global operations; GLENN WARNER, president, U.S.

DENTSPLY SIRONA York, Pa. www.dentsply.com/en-us

2016 RANK: 34 Revenue: $3,745,300,000 Fiscal year ending: Dec. 31, 2016

Employees: 15,700 R&D Spend: $128,500,000

KEY PERSONNEL: JEFFREY SLOVIN, CEO; ULRICH MICHEL, EVP & CFO; MAUREEN MACINNIS, SVP & chief HR officer; CHRISTOPHER CLARK, president & COO, technologies; RAINER BERTHAN, EVP, manufacturing, supply chain & operational excellence; WALTER PETERSOHN, chief commercial officer

Medical Design & Outsourcing

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QUALITY OF LIFE ENERGY STRENGTH FLEXIBILITY NEW HOPE HEALING HAPPINESS FEELING WHOLE SLEEPING NORMAL AGAIN IMPLANT QUALITY OF LIFE ENERGY STRENGTH FLEXIBILITY NEW HOPE HEALING HAPPINESS FEELING WHOLE SLEEPING NORMAL AGAIN QUALITY OF LIFE ENERGY STRENGTH the Providing

most orthopedic solutions under one roof.

Helping others live a better life.

NORTH AMERICA

Orchid 9-17.indd 56

EUROPE

ASIA

+1 (517) 694-2300 www.orchid-ortho.com

KN-1-1

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ISO 9001

ISO 13485

AS 9100

C.R. BARD

Murray Hill, N.J.

perfection in stainless steel

www.crbard.com/Home.html

2016 RANK: 30 Revenue: $3,714,000,000 Fiscal year ending: Dec. 31 2016 Employees: 16,300 R&D Spend: $292,800,000

KEY PERSONNEL:

CNC machining

TIMOTHY RING, chairman & CEO; JOHN WEILAND, vice chairman, president & COO; CHRISTOPHER HOLLAND, SVP & CFO; JIM BEASLEY, president; TIMOTHY COLLINS, president; SHARON LUBOFF, VP; JOHN GROETELAARS, president; JOHN DEFORD, SVP, science, technology & clinical affairs; SAMRAT KHICHI, SVP, general counsel & secretary; PATRICIA CHRISTIAN, VP, regulatory affairs; TODD GARNER, VP, IR; TONY JOHNSON, VP, global operations; BETTY LARSON, VP, HR; SCOTT LOWRY, VP & Treasurer; FRANK LUPISELLA JR., VP & Controller; GERARD PORRECA III, VP, quality, regulatory & medical affairs; PATRICK ROCHE, VP, IT solutions; RICHARD ROSENZWEIG, VP, law & assistant secretary

Laser machining

Eagle is the supplier of choice for close-tolerance, exotic metal parts in diameters from 0.032" to 2". We have the skills and the technology required to deliver exactly what you want, when you want it. Call us for a quote. You won't get voice mail. You'll get instant responses from real people !

Eagle Stainless Tube & Fabrication, Inc. 10 Discovery Way • Franklin, MA 02038 Phone (800) 528-8650 • www.eagletube.com 56

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FUJIFILM HOLDINGS

Tokyo

www.fujifilmholdings.com/en/index.html

2016 RANK: Revenue: Fiscal year ending:

14 $3,533,959,139 * March 31, 2017

* Revenues from Fujifilm Holdings’ healthcare segment.

Forging Dreams Into Reality Complete Product Development Services Contract Assembly, Packaging and Distribution

KEY PERSONNEL: SHIGETAKA KOMORI, chairman & CEO; KENJI SUKENO, president & COO; KOUICHI TAMAI, VP & chief innovation officer; YUZO TODA, VP & CTO; MASATAKA AKIYAMA, president & CEO, Fujifilm Medical Systems USA; JOHANN FERNANDO, COO, Fujifilm Medical Systems USA; DR. DIKU MANDAVIA, CMO, Fujifilm Medical Systems USA; WILLIAM LACY, VP, medical informatics, Fujifilm Medical Systems USA; EIJI OGAWA, VP, modality solutions, quality, regulatory, clinical affairs, Fujifilm Medical Systems USA; KEIICHI NAGATA, divisional president, endoscopy, Fujifilm Medical Systems USA; JASON HEIM, sales VP, Fujifilm Medical Systems USA; MARTIN SPENCE, VP, services & support, operations, Fujifilm Medical Systems USA; SATOSHI AMANO, VP, finance, Fujifilm Medical Systems USA; JOHN LUCAS, executive director, business operations, Fujifilm Medical Systems USA

Durable Goods and Single Use Disposable Products

From Dream to Distribution

www.keystone-pd.com · ISO13485 Certified · FDA Registered ·

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GETINGE Gothenburg, Sweden

www.getingegroup.com

2016 RANK: 29 Revenue: $3,478,565,834 Fiscal year ending: Dec. 31, 2016

Employees: 15,582 R&D Spend: $147,882,302

KEY PERSONNEL: MATTIAS PERJOS, president & CEO; REINHARD MAYER, CFO; FRÉDÉRIC PETTE, acting president, surgical workflows; JENS VIEBKE president, acute care therapies; JOACIM LINDOFF, president, patient & postacute care; CARSTEN BLECKER, president, EMEA; RAOUL QUINTERO, president, Americas; LENA HAGMAN, EVP, quality, regulatory & compliance; JEANETTE HEDÉN CARLSSON, EVP, communications & brand management; MAGNUS LUNDBÄCK, EVP, HR & sustainability; MARKUS MEDART, acting president, supply chain

VARIAN MEDICAL SYSTEMS Palo Alto, Calif. www.varian.com

2016 RANK: 31 Revenue: $3,217,800,000 Fiscal year ending: Sept. 30, 2016

Employees: 7,800 R&D Spend: $253,500,000

KEY PERSONNEL: DOW WILSON, president & CEO; JESSICA DENECOUR, EVP & CIO; GARY BISCHOPING JR., SVP & CFO; KOLLEEN KENNEDY, EVP, oncology systems; PATRICK JODA, SVP, global operations; MOATAZ KARMALAWY, VP and general manager, worldwide particle therapy; DR. DEEPAK “DEE” KHUNTIA, SVP and CMO; JOHN KUO, SVP, general counsel and corporate secretary; MAGNUS MOMSEN, SVP and corporate controller; FRANCO PALOMBA, SVP, finance and treasurer; WENDY SCOTT, SVP and chief human resources officer; RAFAEL TORRES, SVP, business development and strategy; CHRIS TOTH, chairman, global commercial & field operations; VY H. TRAN, SVP, regulatory affairs and quality assurance; COREY ZANKOWSKI, SVP, CTO; ANDREW WHITMAN, SVP, government affairs

EDWARDS LIFESCIENCES Irvine, Calif. www.edwards.com

2016 RANK: 36 Revenue: $2,963,700,000 Fiscal year ending: Dec. 31, 2016

Employees: 11,100 R&D Spend: $443,300,000

KEY PERSONNEL: MICHAEL MUSSALLEM, chairman & CEO; DIRKSEN LEHMAN, corporate VP, public affairs; JOHN MCGRATH, corporate VP, quality, regulatory, clinical; KATIE SZYMAN, corporate VP, critical care; PATRICK VERGUET, corporate VP, EMEA, Canada and Latin America; AIMEE WEISNER, corporate VP, general counsel, BERNARD ZOVIGHIAN, corporate VP, surgical heart valve therapy; DONALD BOBO JR., corporate VP, strategy & corporate development; CHRISTINE MCCAULEY, corporate VP, human resources; STANTON J. ROWE, corporate VP, advanced technology & chief scientific officer; SCOTT B. ULLEM, corporate VP, CFO; DR. HUIMIN WANG, corporate VP, Japan, Asia and Pacific; LARRY L. WOOD, corporate VP, transcatheter heart valves

Medical Design & Outsourcing

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

2016 RANK: Revenue: Fiscal year ending:

35 $2,893,815,572 * March 31, 2017

* Revenues from Hoya’s life care segment.

KEY PERSONNEL: HIROSHI SUZUKI, representative executive officer, president & CEO; RYO HIROOKA, representative executive officer & CFO; EIICHIRO IKEDA, executive officer & COO, IT & CTO; GIRTS CIMERMANS, executive officer, vision care company president; AUGUSTINE YEE, executive officer, chief legal officer & head of corporate development and affairs

HOLOGIC Marlborough, Mass. www.hologic.com

2016 RANK: 33 Revenue: $2,832,700,000 Fiscal year ending: Sept. 24, 2016

Employees: 5,333 R&D Spend: $232,100,000

KEY PERSONNEL: STEPHEN MACMILLAN, Chairman, President & CEO; ERIC COMPTON, COO; ROBERT MCMAHON, CFO; ALLISON BEBO, SVP & chief HR; JOHN GRIFFIN, general counsel; JAY STEIN, cofounder, chairman emeritus, SVP & CTO; SEAN DAUGHERTY, division president, GYN surgical solutions; KEVIN THORNAL, division president, Cynosure; PETER VALENTI III, division president, breast and skeletal health solutions; THOMAS WEST, division president, diagnostics solutions

INTUITIVE SURGICAL Sunnyvale, Calif. www.intuitivesurgical.com

2016 RANK: 37 Revenue: $2,704,400,000 Fiscal year ending: Dec. 31, 2016

Employees: 3,755 R&D Spend: $239,600,000

KEY PERSONNEL: GARY GUTHART, president and CEO; DAVE ROSA, EVP & chief commercial officer; SALVATORE BROGNA, EVP, product operations; HENRY CHARLTON, SVP, U.S. sales; DR. MYRIAM CURET, SVP, CMO; BOB DESANTIS, SVP, instruments & accessories; MARK JOHNSON, SVP, regulatory & quality; CHARLES JONES, SVP, design & user experience; MARK MELTZER, SVP, general counsel & chief compliance officer; BRIAN MILLER, SVP, systems & vision; MARSHALL MOHR, SVP & CFO; COLIN MORALES, SVP, secondary market equipment & service; GLENN VAVOSO, SVP, global commercial operations & Asia Pacific direct; PAIGE BISCHOFF, VP, global public affairs; CRAIG CHILD, VP, human resources; GILLIAN DUNCAN, VP, da Vinci professional education & program services–worldwide; CATHERINE MOHR, VP, strategy; DR. DAVID STOFFEL, VP, marketing and new business development

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HILL-ROM Chicago

www.hill-rom.com

2016 RANK: 45 Revenue: $2,655,200,000 Fiscal year ending: Sept. 30, 2016

Employees: 10,000 R&D Spend: $133,500,000

KEY PERSONNEL: JOHN GREISCH, president & CEO; CARLOS ALONSO, SVP & president, HillRom International; FRANCISCO CANAL, SVP & president, surgical solutions; ANDREAS FRANK, SVP, corporate development & strategy; DAVID HELSEL, SVP, global supply chain; PAUL JOHNSON, SVP & president, patient support systems; BRIAN LAWRENCE, SVP & CTO; SUEJEAN LIN, SVP & CIO; KEVIN MCCULLOCH, SVP & president, global solutions; KEN MEYERS, SVP & chief human resources officer; MICHAEL MURPHY, SVP, quality assurance & regulatory affairs; DEBORAH RASIN, SVP & chief legal officer & secretary; ALTON SHADER, SVP & president, front line care; ILANA SHULMAN, chief compliance officer; STEVEN STROBEL, SVP, CFO

STERIS Leicester, U.K. www.steris.com

2016 RANK: 38 Revenue: $2,612,756,000 Fiscal year ending: March 31, 2017

Employees: 12,000 R&D Spend: $59,397,000

KEY PERSONNEL: WATER ROSEBROUGH, JR., president & CEO; KATHLEEN BARDWELL, SVP, chief compliance officer; KAREN BURTON, VP, controller & chief accounting officer; DANIEL CARESTIO, SVP, Steris applied sterilization technologies & life sciences; ADRIAN COWARD, SVP, healthcare specialty services; SUZANNE FORSYTHE, VP, HR; GULAM KHAN, SVP, procedural solutions; SUDHIR PAHWA, SVP, infection prevention technologies; MICHAEL TOKICH, SVP, CFO & treasurer; ADAM ZANGERLE, VP, GC & secretary

SONOVA Stäfa, Switzerland www.sonova.com/en

2016 RANK: 44 Revenue: $2,432,676,686 Fiscal year ending: March 31, 2017

Employees: 12,802 R&D Spend: $139,250,609

KEY PERSONNEL: LUKAS BRAUNSCHWEILER, CEO; HARTWIG GREVENER, CFO; CLAUDE DIVERSI, GVP, hearing instruments wholesale; HANSJÜRG EMCH, GVP, cochlear implants; CHRISTOPHE FOND, GVP, retail; MARTIN GRIEDER, GVP, hearing instruments marketing; SARAH KREIENBÜHL, GVP, corporate HRM & communications; HANS MEHL, GVP, operations; ANDI VONLANTHEN, GVP, research & development

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NIPRO Osaka, Japan; Bridgewater, N.J. www.nipro.co

2016 RANK: 46 Revenue: $2,427,507,823* Fiscal year ending: March 31, 2017

* Revenues from Nipro’s medical segment.

KEY PERSONNEL: YOSHIHIKO SANO, president; MAKOTO SATO, KAZUO WAKATSUKI, KIYOTAKA YOSHIOKA, TOSHIAKI MASUDA, & KYOETSU KOBAYASHI, managing directors

BIOMERIEUX L’Étoile, France www.biomerieux-usa.com

2016 RANK: 39 Revenue: $2,328,441,600 Fiscal year ending: Dec. 31, 2016

Employees: 9,800 R&D Spend: $301,047,680

KEY PERSONNEL: JEANLUC BÉLINGARD, chairman; ALEXANDRE MÉRIEUX, CEO; MICHEL BAGUENAULT, general secretary, corporate VP, human resources & communications; PIERRE BOULUD corporate VP, Asia Pacific region; NICOLAS CARTIER, corporate VP, industry unit, group portfolio & strategic planning; PIERRE CHARBONNIER, corporate VP, manufacturing & supply chain; CLAIRE GIRAUT, corporate VP & CFO; FRANÇOIS LACOSTE, corporate VP, clinical unit; MARK MILLER, CMO; YASHA MITROTTI corporate VP, Europe, Middle East, Africa Region & Global commercial performance; ALAIN PLUQUET, corporate VP, CTO & innovation; RANDY RASMUSSEN, corporate VP, molecular biology; STEFAN WILLEMSEN, corporate VP, Americas region, group chief legal officer

PAUL HARTMANN Heidenheim, Germany; Rock Hills, S.C. us.hartmann.info

2016 RANK: 41 Revenue: $2,199,452,800 Fiscal year ending: Dec. 31, 2016

Employees: 10,372 R&D Spend: $65,214,080

KEY PERSONNEL: ANDREAS JOEHLE, CEO & chairman; RAYMUND HEINEN, chief process officer; MICHEL KUEHN, chief commercial officer, incontinence & personal healthcare; STEPHAN SCHULZ, CFO & labor relations director

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COLOPLAST Humlebæk, Denmark www.coloplast.us

2016 RANK: 40 Revenue: $2,182,204,650 Fiscal year ending: Sept. 30, 2016

Employees: 9,817 R&D Spend: $75,658,481

KEY PERSONNEL: LARS RASMUSSEN, president & CEO; ANDERS LONNINGSKOVGAARD, EVP, CFO; KRISTIAN VILLUMSEN, EVP, chronic care; ALLAN RASMUSSEN, EVP, global operations; ALAIN MORVAN SVP, sales Europe; CAROLINE VAGNER ROSENSTAND, director, corporate development & strategy; ED VEOME, SVP, North America; RASMUS HANNEMANN MØLLER, SVP, global marketing; JESPER KALENBERG, VP, corporate procurement; NICOLAI BUHL ANDERSEN, SVP, wound care; OLIVER JOHANSEN, SVP, global R&D; PAUL MARCUN, SVP, emerging markets; PETER VOLKERS, SVP, corporate legal & IP; STEFFEN HOVARD, SVP, urology care; THOMAS ALSBJERG, VP, corporate HR

BIO-RAD Hercules, Calif. www.bio-rad.com

2016 RANK: 43 Revenue: $2,068,172,000 Fiscal year ending: Dec. 31, 2016

Employees: 8,250 R&D Spend: $205,864,000

KEY PERSONNEL: NORMAN SCHWARTZ, president & CEO; JOHN GOETZ, EVP & COO; GIOVANNI MAGNI, EVP & chief strategy officer; CHRISTINE TSINGOS, EVP & CFO; TIMOTHY ERNST, 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

RESMED San Diego www.resmed.com/us/en/consumer.html

2016 RANK: 51 Revenue: $2,066,737,000 Fiscal year ending: June 30, 2017

Employees: 6,080 R&D Spend: $144,467,000

KEY PERSONNEL: MICHAEL “MICK” FARRELL, CEO; ROB DOUGLAS, president & COO; DAVID PENDARVIS, chief administrative officer, global general counsel; BRETT SANDERCOCK, CFO; JIM HOLLINGSHEAD, president, sleep business; RICHIE MCHALE, president, respiratory care business; RAJ SODHI, president, SaaS business & healthcare informatics; KATRIN PUCKNAT, CEO, ResMed Healthcare, Germany; JUSTIN LEONG, SVP, Asia growth markets; NUPUR BHUSHAN, chief human resources officer; HEMANTH REDDY, chief strategy officer; DR. CARLOS NUNEZ, CMO; FRANK LACAGNINA, CIO; ANDREW PRICE, president, global operations

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COOPER COS. Pleasanton, Calif. www.coopercos.com

2016 RANK: 49 Revenue: $1,966,814,000 Fiscal year ending: Oct. 31, 2016

Employees: 10,600 R&D Spend: $65,411,000

KEY PERSONNEL: ROBERT WEISS, president & CEO; DANIEL MCBRIDE, EVP, COO & president; CAROL KAUFMAN, EVP, secretary, chief administrative officer & chief governance officer; ALBERT WHITE III, EVP, CFO & chief strategy officer; PAUL REMMELL, president & CEO, CooperSurgical

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

2016 RANK: 50 Revenue: $1,879,670,532 Fiscal year ending: March 31, 2017 KEY PERSONNEL: SHIGEKAZU TAKEUCHI, director, president & group CEO; NAOKI KITAMURA, CFO, legal affairs and overseas CLT; SHIGETO OHTSUKI, human resources, general affairs and CSR; HIROAKI KIMURA, investor and public relations & IT); HIROMITSU TAZAWA, corporate projects; KAZUYUKI HANYU, corporate strategy

TELEFLEX Wayne, Pa. www.teleflex.com/en/usa/index.html

2016 RANK: 48 Revenue: $1,868,027,000 Fiscal year ending: Dec. 31, 2016

Employees: 12,600 R&D Spend: $58,579,000

KEY PERSONNEL: BENSON SMITH, chairman, president & CEO; LIAM KELLY, EVP & president, Americas; THOMAS POWELL, EVP & CFO; TONY KENNEDY, SVP, global operations; CAMERON HICKS, VP, global human resources & employee communications; JAMES LEYDEN, VP, general counsel & secretary; KAREN BOYLAN, VP, global regulatory affairs & quality assurance

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DRÄGERWERK Lübeck, Germany

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

2016 RANK: Revenue: Fiscal year ending:

47 $1,824,001,280 * Dec. 31, 2016

* Revenues from Drägerwerk’s medical segment.

KEY PERSONNEL: STEFAN DRÄGER, chairman of the executive board; GERTHARTWIG LESCOW, CFO & executive board member for IT; RAINER KLUG, executive board member for production, logistics, purchasing; REINER PISKE, executive board member for human resources; ANTON SCHROFNER, executive board member for innovation

CONVATEC Bridgewater, N.J. www.convatec.com

2016 RANK: 52 Revenue: $1,688,300,000 Fiscal year ending: Dec. 31, 2016

Employees: 8,524 R&D Spend: $38,100,000

KEY PERSONNEL: PAUL MORAVIEC, CEO; NIGEL CLERKIN, CFO; SYMERIA HUDSON, president, global franchises and innovation; TIM MORAN, president, Americas; JOHN LINDSKOG, president, B2B and infusion devices; GEORGE POOLE, president, APAC; MARC REUSS, EVP, human resources; ADAM DEUTSCH, EVP and general counsel; ROBERT STEELE, EVP, quality, regulatory & clinical affairs

WILLIAM DEMANT Smørum, Denmark www.demant.com

2016 RANK: 55 Revenue: $1,622,123,789* Fiscal year ending: Dec. 31, 2016

* Revenues from William Demant’s hearing segments.

KEY PERSONNEL: SØREN NIELSEN, president & CEO & president of Oticon A/S; RENÉ SCHNEIDER, CFO

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BRUKER Billerica, Mass.

www.bruker.com

2016 RANK: 53 Revenue: $1,611,300,000 Fiscal year ending: Dec. 31, 2016

Employees: R&D Spend:

6,000 $149,000,000

KEY PERSONNEL: FRANK LAUKIEN, chairman, president & CEO; ANTHONY MATTACCHIONE, SVP & CFO; MARK MUNCH, president, Nano Group; JUERGEN SREGA, president, CALID Group

INNOVATION ... is in our blood

automatic assembly systems

9 • 2017 Medical Design & Outsourcing www.arthurgrussell.com

www.medicaldesignandoutsourcing.com

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HALYARD HEALTH South Alpharetta, Ga.

www.halyardhealth.com

2016 RANK: 56 Revenue: $1,592,300,000 Fiscal year ending: Dec. 31, 2016

Employees: 12,000 R&D Spend: $41,100,000

KEY PERSONNEL: JOSEPH WOODY, CEO; CHRIS ISENBERG, SVP, global supply chain & procurement; CHRIS LOWERY, SVP & COO; JOHN WESLEY, SVP & general counsel; RHONDA GIBBY, SVP and chief human resources officer; STEVE VOSKUIL, CFO; WARREN MACHAN, SVP of business strategy

NIHON KOHDEN Tokyo www.nihonkohden.com

2016 RANK: 57 Revenue: $1,530,323,946 Fiscal year ending: March 31, 2017 KEY PERSONNEL: HIROKAZU OGINO, president & CEO; TAKASHI TAMURA, executive operating officer, responsible for customer service, general manager, sales operations; YOSHITO TSUKAHARA, senior operating officer, general manager, recurring business promotion division; TADASHI HASEGAWA, senior operating officer, chief compliance officer, responsible for accounting, legal affairs, human resources & information systems; KAZUTERU YANAGIHARA, senior operating officer, general manager, strategic technology operations; FUMIO HIROSE, senior operating officer, responsible for marketing strategy, general manager, ventilator & anesthesia device business operations

INTEGER (FORMERLY GREATBATCH) Frisco, Texas www.greatbatch.com

2016 RANK: 74 Revenue: $1,386,778,000 Fiscal year ending: Jan. 1, 2017

Employees: 9,400 R&D Spend: $55,001,000

KEY PERSONNEL: JOSEPH DZIEDZIC, president & CEO; JEREMY FRIEDMAN, EVP & COO; GARY HAIRE, EVP & CFO; JOSEPH FLANAGAN, EVP, quality & regulatory affairs; DECLAN SMYTH, president, adv. surgical & orthopedics; TONY GONZALEZ, president, CRM & neuromod; JOHN HARRIS, interim president, Cardio & Vascular; JENNIFER BOLT, president, electrochem; TIMOTHY MCEVOY, SVP, GC, secretary; MICHAEL SPENCER, SVP, chief ethics & compliance officer; TONY BOROWICZ, VP, strategy & biz dev; KIRSTEN MICKESH, interim chief HR officer

Medical Design & Outsourcing

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ELEKTA Stockholm, Sweden www.elekta.com

2016 RANK: 58 Revenue: $1,311,768,626 Fiscal year ending: May 31, 2016

Employees: 3,600 R&D Spend: $158,403,572

KEY PERSONNEL: RICHARD HAUSMANN, president & CEO; GUSTAF SALFORD, CFO; IAN ALEXANDER, COO; PETER GACCIONE, EVP, North America; KARIN SVENSKE NYBERG, EVP HR; JOHN LAPRÉ, CTO; MAURITS WOLLESWINKEL, chief strategy officer; JONAS BOLANDER, EVP, general counsel; IOANNIS PANAGIOTELIS, chief marketing officer.

AMPLIFON Milan, Italy www.amplifonusa.com

2016 RANK: 63 Revenue: $1,254,568,320 Fiscal year ending: Dec. 31, 2016 KEY PERSONNEL: ENRICO VITA, CEO; GIOVANNI CARUSO, chief HR officer; ALESSANDRO BONACINA, chief marketing officer; CRISTIAN FINOTTI, chief procurement officer; MASSIMILIANO GERLI, CIO; GABRIELE GALLI, CFO; CRAIG STEVENS, EVP, APAC; IACOPO LORENZO PAZZI, EVP, EMEA; GIULIO PIZZINI, chief strategic development officer; MARC LUNDEBERG, EVP, Americas.

LIVANOVA (FORMERLY SORIN/CYBERONICS) London www.livanova.com

2016 RANK: 80 Revenue: $1,213,925,000 Fiscal year ending: April 24, 2017

Employees: 4,500 R&D Spend: $122,454,000

KEY PERSONNEL: DAMIEN MCDONALD, CEO; MICHEL DARNAUD, president, cardiac surgery; STEFANO DI LULLO, president, cardiac rhythm management; JASON RICHEY, president, neuromodulation; JACQUES GUTEDEL, president, intercontinental; EDWARD ANDRLE, SVP, new ventures & business development; VIVID SEHGAL, CFO; BRIAN SHERIDAN, SVP, GC & secretary; PRITPAL SHINMAR, SVP, market access; DAVID WISE, SVP, HR & IT

www.medicaldesignandoutsourcing.com

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THE TOP 1OO MEDTECH COMPANIES

AGFAGEVAERT Mortsel, Belgium

www.agfa.com/global/en/main/index.jsp

2016 RANK: 60 Revenue: $1,206,848,000* Fiscal year ending: Dec. 31, 2016

* Revenues from AgfaGevaert’s healthcare segment.

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

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

2016 RANK: 62 Revenue: $1,205,037,728 Fiscal year ending: Sept. 30, 2016

Employees: R&D Spend:

2,910 $136,635,123

KEY PERSONNEL: MICHAEL KASCHKE, president & CEO; THOMAS SPITZENPFEIL, CFO; MATTHIAS METZ, president & CEO, Carl Zeiss Vision International; LUDWIN MONZ, president & CEO, Carl Zeiss Meditec; CHRISTIAN MÜLLER, managing director, finance & controlling, investor relations, legal & taxes, service, quality management & regulatory affairs, Carl Zeiss Meditec; JAMES MAZZO, global president, ophthalmics, Carl Zeiss Meditec; ROBERT DEGER, CFO, Carl Zeiss Meditec, DR. STEVEN SCHALLHORN, CMO, ophthalmics, Carl Zeiss Meditec; ANDREW CHANG, global sales head, ophthalmics, Carl Zeiss Meditec.

SMITHS MEDICAL (SMITHS GROUP) St. Paul, Minn. www.smiths.com/media.aspx

2016 RANK: 59 Revenue: $1,184,707,000 Fiscal year ending: July 31, 2016

Employees: 7,600 R&D Spend: $70,486,000

KEY PERSONNEL: SIR GEORGE BUCKLEY, chair, Smiths Group; ANDY REYNOLDS SMITH, chief executive, Smiths Group; BILL SEEGER, interim CFO, Smiths Group; CHRIS HOLMES, president & CEO, Smiths Medical; CARL STAMP, VP, global marketing, Smiths Medical; JEFFREY BROWN, VP, global sales, Smiths Medical; MARK MCDONALD, VP, global operations, Smiths Medical; MICHAEL BLUM, acting general counsel, Smiths Medical; STEPHEN REMPE, VP, global human resources, Smiths Medical; BEN SOMMERNESS, VP, global strategy & transformation; Smiths Medical; MICHAEL ARMSTRONG, VP, global regulatory affairs & quality assurance, Smiths Medical; BRETT LANDRUM, CTO & VP, R&D, Smiths Medical; GEORGE MONTAGUE, CFO & VP, global finance; JEFF WAGAMAN, executive CIO & VP enterprise solutions

Medical Design & Outsourcing

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DJO GLOBAL Vista, Calif.

www.djoglobal.com

2016 RANK: 65 Revenue: $1,155,288,000 Fiscal year ending: Dec. 31, 2016

Employees: 4,980 R&D Spend: $37,710,000

KEY PERSONNEL: BRADY SHIRLEY, president & CEO; TOBY BOST, president, DJO Global Consumer Business; JEANINE KESTLER, EVP, chief HR officer; STEVEN INGEL, president, Global Bracing & Supports; STEPHEN MURPHY, president, sales & marketing, Int’l Commercial Business; MIKE PETERS, EVP, CIO; JEFFERY MCCAULLEY, president, DJO Surgical; BRADLEY TANDY, EVP, GC & secretary; MIKE EKLUND, COO, CFO.

COCHLEAR Macquarie University, NSW, Australia www.cochlear.com/wps/wcm/connect/intl/home

2016 RANK: 70 Revenue: $1,131,000,000 Fiscal year ending: June 30, 2017

Employees: 2,934 R&D Spend: $143,000,000

KEY PERSONNEL: CHRIS SMITH, CEO; DIG HOWITT, president; GREG BODKIN, SVP, manufacturing & logistics; RICHARD BROOK, president, Europe; DAVID HACKSHALL, CIO; JAN JANSSEN, SVP, design & development; TONY MANNA, president, North America; KATHARINE MCLENNAN, SVP, people & culture; BRENT CUBIS, CFO; STUART SAYERS, president, services; DEAN PHIZACKLEA, SVP, global marketing; ANTHONY BISHOP, president, Asia Pacific; XINYU LI, GM, Greater China; ROM MENDEL, GM, cochlear acoustics; LISA EMERSON, SVP, quality.

FUKUDA DENSHI Tokyo www.fukuda.co.jp/english/index.html

2016 RANK: 66 Revenue: $1,120,439,904 Fiscal year ending: March 31, 2017

KEY PERSONNEL: KOTARO FUKUDA, chairman & CEO; DAIJIRO SHIRAI, president & COO

www.medicaldesignandoutsourcing.com

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THE TOP 1OO MEDTECH COMPANIES

ALIGN TECHNOLOGY San Jose, Calif.

www.aligntech.com

2016 RANK: 71 Revenue: $1,079,874,000 Fiscal year ending: Dec. 31, 2016

Employees: R&D Spend:

6,060 $75,720,000

KEY PERSONNEL: JOSEPH HOGAN, president & CEO; JOHN MORICI, CFO; SIMON BEARD, VP & managing director, EMEA; STUART HOCKRIDGE, VP, global HR; ROGER GEORGE, VP, legal affairs & GC; RAPHAEL PASCAUD, chief marketing portfolio & business development officer, VP, iTero scanner & services; CHRISTOPHER PUCO, VP & managing director, North America; ZELKO RELIC, VP, R&D; JULIE TAY, VP & managing director, Asia Pacific; EMORY WRIGHT, VP, operations; SREELAKSHMI KOLLI, VP, IT; JENNIFER OLSON, VP & managing director, doctordirected consumer channel; LYNN PENDERGRASS, VP & managing director, Americas.

INVACARE Elyria, Ohio www.invacare.com/cgi-bin/imhqprd/default.jsp

2016 RANK: 64 Revenue: $1,047,474,000 Fiscal year ending: Dec. 31, 2016

Employees: R&D Spend:

4,600 $17,123,000

KEY PERSONNEL: MATTHEW MONAGHAN, chairman, president & CEO; ROBERT GUDBRANSON, SVP & CFO; DEAN CHILDERS, SVP & GM, North America; ANTHONY LAPLACA, SVP, GC; PATRICIA STUMPP, SVP, HR.

INTEGRA LIFESCIENCES Plainsboro, N.J. www.integralife.com

2016 RANK: 69 Revenue: $992,075,000 Fiscal year ending: Dec. 31, 2016

Employees: 3,700 R&D Spend: $58,155,000

KEY PERSONNEL: PETER ARDUINI, president & CEO; KENNETH BURHOP, CVP, chief scientific officer; GLENN COLEMAN, CVP, CFO & principal accounting officer, CVP, int’l; WILLIAM COMPTON, SVP, CIO; ROBERT DAVIS JR., CVP, president, orthopedics & tissue technologies; LISA EVOLI, CVP, chief HR officer; PAUL GONSALVES, SVP, chief commercial officer; RICHARD GORELICK, VP, GC, administration & secretary; JOHN MOORADIAN, VP, global operations & supply chain; JUDITH O’GRADY, CVP, global regulatory affairs; MARIA PLATSIS, SVP, corporate development; DAN REUVERS, VP, president, specialty surgical solutions; JOSEPH VINHAIS, VP, global quality assurance

Medical Design & Outsourcing

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KAWANISHI Okayama City, Japan

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

2016 RANK: 72 Revenue: $973,476,900 Fiscal year ending: June 30, 2017 KEY PERSONNEL: TOSHIYUKI MAESHIMA, CEO; YOHEI MAESHIMA, president; TAIRA TAKAI, vice chairman; YASUTOSHI OHATA, managing director

NUVASIVE San Diego www.nuvasive.com

2016 RANK: 73 Revenue: $962,072,000 Fiscal year ending: Dec. 31, 2016

Employees: 2,200 R&D Spend: $47,999,000

KEY PERSONNEL: GREGORY LUCIER, chairman & CEO; PATRICK MILES, vice chairman; MATT LINK, EVP, strategy, technology & corporate development; QUENTIN BLACKFORD, EVP & CFO; CAROL COX, EVP, external affairs; PETE LEDDY, EVP, global HR, integrations, global risk & integrity, real estate and internal communications & culture; SKIP KIIL, EVP, global commercial; STEVE ROZOW, EVP, global process transformation; JOAN STAFSLIEN, EVP, GC & corporate secretary

OMRON Kyoto, Japan www.omron.com

2016 RANK: 68 Revenue: $932,219,768* Fiscal year ending: March 31, 2017

* Revenues from Omron’s healthcare segment.

KEY PERSONNEL: FUMIO TATEISHI, chairman; YOSHIHITO YAMADA, president & CEO; KIICHIRO MIYATA, CTO, senior GM, technology & IP; KOJI NITTO, CFO, senior GM, global strategy; ISAO OGINO, president & CEO, Omron Healthcare; MASAHIKO TOMITA, senior GM, global HR & administration; KENJI SUGAWA, EVP, senior GM, global sales & marketing group, Omron Healthcare; TSUTOMU IGAKI, senior GM, global investor relations & corporate communications

www.medicaldesignandoutsourcing.com

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THE TOP 1OO MEDTECH COMPANIES

STRAUMANN Basel, Switzerland www.straumann.us/en/home.html

2016 RANK: 76 Revenue: $932,168,968 Fiscal year ending: Feb. 25, 2017

Employees:

3,797

KEY PERSONNEL: MARCO GADOLA, CEO; PETER HACKEL, CFO; WOLFGANG BECKER, head, distributor & emerging markets EMEA; GUILLAUME DANIELLOT, head, North America sales; ALEXANDER OCHSNER, global people management & development; FRANK HEMM, head, customer solutions & education; GERHARD BAUER, head, R&D & operations; PETRA RUMPF, head, Instradent & strategic alliances; JENS DEXHEIMER, head, Europe Sales; MATTHIAS SCHUPP, head, Latin America sales, CEO, Neodent; PATRICK KOKKIEN LOH, head, APac sales

HAEMONETICS Braintree, Mass. www.haemonetics.com

2016 RANK: 67 Revenue: $886,116,000 Fiscal year ending: April 1, 2017

Employees: R&D Spend:

3,107 $37,556,000

KEY PERSONNEL: CHRIS SIMON, president & CEO; WILLIAM BURKE, EVP, CFO, business development; KEVIN O’KELLYLYNCH, SVP, global business services; IAN PURDY, SVP, global quality & regulatory affairs; NEIL RYDING, EVP, global operations; DAVID GUEUNDJIAN, president, int’l; CARTER HOUGHTON, president, hospital business unit; THOMAS MCCURDY, president, global plasma; DR. JAN HARTMANN, VP, head of strategic programs

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KONICA MINOLTA Tokyo konicaminolta.us

2016 RANK: 78 Revenue: $833,618,627* Fiscal year ending: March 31, 2017

* Revenues from Konica Minolta’s healthcare segment.

KEY PERSONNEL: SHOEI YAMANA, president & CEO; Senior Executive Officers: JUN HARAGUCHI, TSUKASA WAKASHIMA, KUNIHIRO KOSHIZUKA, KEN OSUGA, SEIJI HATANO, SHINGO ASAI, TOYOTSUGU ITOH, NORIYASU KUZUHARA, KIYOTAKA FUJII; EXECUTIVE OFFICERS: KAZUYOSHI HATA, HIROYUKI SUZUKI, AKIRA TAI, IKUO NAKAGAWA, YUJI ICHIMURA, TOSHIMITSU TAIKO, ATSUO TAKEMOTO, MASAFUMI UCHIDA, HAJIME TAKEI, RICHARD TAYLOR, TAKAJI ITO, TOSHIYA EGUCHI, KOJI SUGIE, TETSUYA MATSUEDA

Medical Design & Outsourcing

9 • 2017

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GN STORE NORD Ballerup, Denmark www.gn.com

2016 RANK: 75 Revenue: $766,395,148* Fiscal year ending: Dec. 31, 2016

Employees: 4,275 * Revenues from GN Store Nord’s hearing segment.

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

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THE TOP 1OO MEDTECH COMPANIES

CONMED Utica, N.Y. www.conmed.com

2016 RANK: 79 Revenue: $763,520,000 Fiscal year ending: Dec. 31, 2016

Employees: 3,300 R&D Spend: $32,254,000

KEY PERSONNEL: CURT HARTMAN, CEO; PATRICK BEYER, president, int’l; TERENCE BERGÉ, VP, corporate controller; HEATHER COHEN, EVP, HR & secretary; NATHAN FOLKERT, VP & GM, U.S. orthopedics; DANIEL JONAS, EVP, legal affairs & GC; JOHN KENNEDY, VP & GM, CET; JOHONNA PELLETIER, VP & treasurer, tax; STANLEY PETERS, VP & GM, advanced surgical; LUKE POMILIO, CFO & EVP, finance; WILFREDO RUIZCABAN, EVP, regulatory affairs, quality assurance & operations; PETER SHAGORY, EVP, strategy & corporate development

MASIMO Irvine, Calif. www.masimo.com

2016 RANK: 81 Revenue: $694,625,000 Fiscal year ending: Jan. 2, 2017

Employees: R&D Spend:

1,243 $59,362,000

KEY PERSONNEL: JOE KIANI, CEO & chairman; JON COLEMAN, president, worldwide sales, professional services & medical affairs; MARK DE RAAD, EVP & CFO; RICK FISHEL, president, worldwide OEM business & strategic development; YONGSAM LEE, EVP & CIO; ANAND SAMPATH, COO; TOM MCCLENAHAM, EVP & GC

WRIGHT MEDICAL Memphis, Tenn. www.wmt.com

2016 RANK: 88 Revenue: $690,362,000 Fiscal year ending: Dec. 27, 2016

Employees: 2,394 R&D Spend: $50,514,000

KEY PERSONNEL: ROBERT PALMISANO, president & CEO; LANCE BERRY, SVP & CFO; ROBERT BURROWS, SVP, supply chain; PETER COOKE, president, int’l; KEVIN CORDELL, President, U.S.; JAMES LIGHTMAN, SVP, GC & secretary; GREGORY MORRISON, SVP, HR; WESLEY PORTER, SVP, chief compliance officer; JULIE TRACY, SVP, chief communications officer; JENNIFER WALKER, SVP, process improvement; JULIE ANDREWS, VP & chief accounting officer; TIMOTHY LANIER, president, upper extremities; PATRICK FISHER, president, lower extremities

Medical Design & Outsourcing

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THE TOP 1OO MEDTECH COMPANIES

MERIT MEDICAL SYSTEMS South Jordan, Utah www.merit.com

2016 RANK: 84 Revenue: $603,838,000 Fiscal year ending: Dec. 31, 2016

Employees: 4,150 R&D Spend: $45,229,000

KEY PERSONNEL: FRED LAMPROPOULOS, chairman & CEO; BERNARD BIRKETT,CFO; JOE WRIGHT, president, int’l sales; DARLA GILL, president, Merit Endotek; RONALD FROST, COO; BRIAN LLOYD, chief legal officer & corporate secretary; JUSTIN LAMPROPOULOS, EVP, U.S., EMEA, global marketing & strategy; JOHN KNORPP, chief regulatory affairs officer; JOSEPH PIERCE, CIO; LOUISE BOTT, VP, global HR; JASON TREFT, CTO

GRIFOLS Barcelona, Spain www.grifols.com/en/web/international/home

2016 RANK: 27 Revenue: $574,318,168 Fiscal year ending: Dec. 31, 2016 KEY PERSONNEL: VÍCTOR GRIFOLS ROURA, coCEO; VICTOR GRIFOLS DEU, coCEO; RAMÓN RIERA ROCA, EVP, president, global commercial division; ALFREDO ARROYO GUERRA, corporate VP, CFO; CARLOS ROURA FERNANDEZ, chief industrial officer; MONTSERRAT LLOVERAS CALVO, corporate VP, director, corporate accounting & reporting; VICENTE BLANQUER TORRE, corporate VP, quality & R&D; MATEO FLORENCIO BORRAS HUMBERT, corporate VP, director, global HR; FRANCISCO JAVIER JORBA RIBES, corporate VP, president, biological industrial group; GREGORY GENE RICH, corporate VP, president & CEO Grifols Shared Services North America; DAVID IAN BELL, corporate VP, GC, Grifols Shared Services North America; NURIA PASCUAL LAPENA, corporate VP, treasury, risk management & IRO; SHINJI WADA, corporate VP, president, plasma operations, Grifols Shared Services North America; LAFMIN MORGAN, president, bioscience & hospital division, CARSTEN SCHROEDER, president, diagnostics

DEXCOM San Diego www.dexcom.com

2016 RANK: 89 Revenue: $573,300,000 Fiscal year ending: Dec. 31, 2016

Employees: 2,300 R&D Spend: $156,100,000

KEY PERSONNEL: TERRANCE GREGG, chairman; KEVIN SAYER, CEO & president; ANDREW BALO, EVP, clinical, regulatory & global access; RICK DOUBLEDAY, EVP & CCO; JACOB LEACH, SVP, R&D; JOHN LISTER, GM, Europe, Middle East & Africa; JEFFREY MOY, SVP, operations; STEVEN PACELLI, SVP, strategy & corporate development; ANNIKA JIMENEZ, SVP, data; CLAUDIA GRAHAM, SVP, global access; DON ABBEY, EVP, quality & IT; HEATHER ACE, SVP, HR; KEVIN SUN, VP & interim CFO

Medical Design & Outsourcing

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THE TOP 1OO MEDTECH COMPANIES

FISHER & PAYKEL HEALTHCARE Auckland, New Zealand www.fphcare.com

2016 RANK: 82 Revenue: $568,892,800 Fiscal year ending: March 31, 2017

Employees: 3,623 R&D Spend: $50,924,800

KEY PERSONNEL: LEWIS GRADON, managing director & CEO; PAUL SHEARER, SVP, sales & marketing; TONY BARCLAY, CFO; WINSTON FONG, VP, surgical technologies; JONTI RHODES, GM, supply chain; BRIAN SCHULTZ, VP, quality & regulatory affairs; DEBRA LUMSDEN, VP, HR & privacy officer; ANDREW SOMERVELL, VP, products & technology; NICHOLAS FOURIE, VP, information & communication technology

ÖSSUR Reykjavík, Iceland www.ossur.com

2016 RANK: 85 Revenue: $520,748,000 Fiscal year ending: Dec. 31, 2016

Employees: R&D Spend:

2,795 $23,166,000

KEY PERSONNEL: JÓN SIGURÐSSON, president & CEO; EGILL JÓNSSON, EVP, manufacturing & operations; JOS VAN POORTEN, managing director, EMEA; MARGRÉT LÁRA FRIÐRIKSDÓTTIR, EVP, HR & strategy; ÓLAFUR GYLFASON, EVP, sales & marketing; SVEINN SÖLVASON, CFO; ÞORVALDUR INGVARSSON, EVP, R&D

JMS CO. Hiroshima, Japan www.jms.cc/english/index.html

2016 RANK: 87 Revenue: $511,448,555 Fiscal year ending: March 31, 2017 KEY PERSONNEL: HIROAKI OKUKUBO, president & representative director; YASUHIRO AWANE, executive director, sales & marketing; JUN KUNITOMI, director, production; SHIGEMI MORIKAWA, director, international; MASAFUMI SATO, director, R&D; RYUJI KATSURA, director, planning; SHOGO YANAGIDA, director, production division

Medical Design & Outsourcing

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Come explore the possibilities with our medical and implant grade silicones. Same company, same personal service, same products...new name! Elkem Silicones offers a full range of Silbione® and Silbione® Biomedical brand products that you can count on the for the highest quality healthcare silicone solutions, produced and packaged in ISO 7 & 8 certified clean rooms , and backed by biocompatibility testing to meet your application needs. From technical support to customized formulations and regulatory support, Elkem Silicones has the people in place when and where you need them, committed to help you deliver your potential with a personal touch. LSR ● HCR ● RTV ● Gels ● Skin Adhesives ● Specialty Silicones For more information call us at 1-866-474-6342

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THE TOP 1OO MEDTECH COMPANIES

NIKKISO Tokyo www.nikkiso.com/index.html

2016 RANK: 94 Revenue: $505,199,706 Fiscal year ending: Dec. 31, 2016

* Revenues from Nikkiso’s medical segment.

KEY PERSONNEL: TOSHIHIKO KAI, president & CEO; HIROSHI NAKAMURA, EVP, administration & corporate planning; NAOTA SHIKANO, EVP, industrial business; SHOTARO FUJII, senior executive officer, R&D, engineering & quality control; HISAKAZU NAKAHIGASHI, executive officer, production; YOSHIHIKO KINOSHITA, executive officer, medical division

ANALOGIC Peabody, Mass. www.analogic.com

Revenue: $452,400,000* Fiscal year ending: July 31, 2016

Employees: 1,577 R&D Spend: $67,100,000 * Revenues from Analogic’s medical imaging and ultrasound businesses.

KEY PERSONNEL: FRED PARKS, president and CEO; KATIA BEJAN, global human resources VP; MICHAEL BOURQUE, CFO, treasurer, senior VP; ALBERT CEFALO, quality assurance, compliance and regulatory affairs VP; MERVAT FALTAS, medical imaging business GM, senior VP; JOHN FRY, general counsel, secretary, senior VP; JIM RYAN, security detection and power technologies GM, senior VP; YASH SINGH, Power and Motion GM, senior VP; BROOKS WEST, global ultrasound business GM, senior VP

CYNOSURE Westford, Mass. www.cynosure.com

2016 RANK: 96 Revenue: $433,532,000 Fiscal year ending: Dec. 31, 2016

Employees: 982 R&D Spend: $28,973,000

KEY PERSONNEL: MICHAEL DAVIN, chairman, president & CEO; TIMOTHY BAKER, COO & CFO; DOUGLAS DELANEY, EVP, sales

Medical Design & Outsourcing

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Design Standards Corporation We design, develop & manufacture complex components and complete, finished medical devices.

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THE TOP 1OO MEDTECH COMPANIES

ORTHOFIX Lewisville, Texas www.orthofix.com

2016 RANK: 90 Revenue: $409,788,000 Fiscal year ending: Dec. 31, 2016

Employees: 938 R&D Spend: $28,803,000

KEY PERSONNEL: BRAD MASON, president & CEO; DOUG RICE, CFO; MIKE FINEGAN, chief strategy officer; KIMBERLY ELTING, chief legal officer; JILL MASON, chief ethics & compliance officer; JIM RYABY, chief scientific officer; TIM MCGUIRE, chief information officer; BRAD NIEMANN, president, biostim; BOB GOODWIN, president, biologics; DAVIDE BIANCHI, president, extremity fixation; RAY FUJIKAWA, president, spine fixation; STEVE MARTIN, SVP, operations

TOPCON Tokyo global.topcon.com

2016 RANK: 93 Revenue: $403,405,117 Fiscal year ending: March 31, 2017

* Revenues from Topcon’s eye care segment.

KEY PERSONNEL: SATOSHI HIRANO, president & CEO; MAKOTO IWASAKI, director, senior managing executive officer, GM, production, general administration & legal; TAKASHI ETO, director & managing executive officer, GM, sales & marketing; YASUFUMI FUKUMA, director & executive officer, GM, R&D; HARUHIKO AKIYAMA, director & executive officer, GM, accounting & finance; TAKAYUKI YAMAZAKI, director & executive officer, corporate planning div GM; TAKAYUKI YAMAZAKI, director & executive officer, GM, planning

ACCURAY Sunnyvale, Calif. www.accuray.com

2016 RANK: 91 Revenue: $398,800,000 Fiscal year ending: June 30, 2016

Employees: 959 R&D Spend: $56,700,000

KEY PERSONNEL: JOSHUA LEVINE, president & CEO; LIONEL HADJADJEBA, SVP & CCO; KEVIN WATERS, SVP & CFO; DARL MORELAND, SVP, quality management; ALALEH NOURI, SVP, general counsel; ANDY KIRKPATRICK, SVP, global operations & R&D

Medical Design & Outsourcing

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MS1048

THE TOP 1OO MEDTECH COMPANIES

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NATUS Pleasanton, Calif.

www.natus.com

2016 RANK: 92 Revenue: $381,892,000 Fiscal year ending: Dec. 31, 2016

Employees: 1,160 R&D Spend: $33,443,000

KEY PERSONNEL: JAMES HAWKINS, president & CEO; JONATHAN KENNEDY, SVP & CFO; AUSTIN NOLL III, VP & GM, neurology; KENNETH TRAVERSO, VP & GM, newborn care; DR. CHRISTOPHER CHUNG, VP, medical affairs, quality & regulatory

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1OO

THE TOP 1OO MEDTECH COMPANIES

ICU MEDICAL San Clemente, Calif. www.icumed.com

2016 RANK: 95 Revenue: $379,372,000 Fiscal year ending: Dec. 31, 2016

Employees: 2,803 R&D Spend: $12,955,000

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

INSULET Billerica, Mass. www.myomnipod.com

2016 RANK: 99 Revenue: $366,989,000 Fiscal year ending: Dec. 31, 2016

Employees: R&D Spend:

640 $55,710,000

KEY PERSONNEL: PATRICK SULLIVAN, president & CEO; AIMAN ABDELMALEK, SVP, IT; CHARLES ALPUCHE, SVP & COO; BRET CHRISTENSEN, SVP & chief commercial officer; DAVID COLLERAN, SVP, general counsel; DEBORAH GORDON, SVP, communications; MICHAEL LEVITZ , SVP & CFO; DR. TRANG LY, VP & medical director; SHACEY PETROVIC, EVP, diabetes products; MICHAEL SPEARS, SVP, quality management; BRAD THOMAS, EVP, HR

NXSTAGE MEDICAL Lawrence, Mass. www.nxstage.com

2016 RANK: 97 Revenue: $366,378,000 Fiscal year ending: Dec. 31, 2016

Employees: 3,400 R&D Spend: $31,032,000

KEY PERSONNEL: JEFF BURBANK, CEO; MATTHEW TOWSE, CFO; JOSEPH TURK JR, president; LISA CURTIS, SVP, international; TODD SNELL, SVP of QA, regulatory & clinical affairs; TOM SHEA, SVP & COO; WINIFRED SWAN, SVP, general counsel; JEFFREY RAINS, SVP, sales and marketing; DARREN SCANDONE, SVP, HR; MARK WYETH, SVP, product development

Medical Design & Outsourcing

TOP 21-100 100 List_9-17_Vs3.indd 84

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9/18/17 2:34 PM

THE TOP 1OO MEDTECH COMPANIES

1OO

ABIOMED Danvers, Mass. www.abiomed.com

2016 RANK: 98 Revenue: $329,543,000 Fiscal year ending: March 31, 2017

Employees: 747 R&D Spend: $49,759,000

KEY PERSONNEL: MICHAEL MINOGUE, CEO, president & chairman; DR. SETH BILAZARIAN, chief medical officer; KELLY BOUCHER, VP, HR; WILLIAM BOLT, SVP, global product operations; ANDREW GREENFIELD, VP & GM, marketing; MICHAEL HOWLEY, VP & GM, global sales; STEVE MCEVOY, VP, general counsel; DR. THORSTEN SIESS, CTO; MICHAEL TOMSICEK, CFO; DR. DAVID WEBER, COO

SYNERON Yokneam Illit, Israel syneron-candela.com/na

2016 RANK: 101 Revenue: $298,102,000 Fiscal year ending: Dec. 31, 2016

Employees: 817 R&D Spend: $23,043,000

KEY PERSONNEL: AMIT MERIDOR, CEO; HUGO GOLDMAN, CFO; PAUL LITTLE, COO; JEFF NARDOCI, CCO; PHILIPPE SCHAISON, EVP, strategy & business development, Syneron Candela NA CEO; SARIT SOCCARY, VP strategy & business development; YARIV MATZLIACH, EVP, distribution channels; ROBERT FIELETZ, VP & managing director, EMEA; ROBERT RUCK, EVP, Asia Pacific

RTI SURGICAL Alachua, Fla. www.rtix.com/en_us

2016 RANK: 100 Revenue: $272,865,000 Fiscal year ending: Dec. 31, 2016

Employees: 1,140 R&D Spend: $16,090,000

KEY PERSONNEL: CAMILLE FARHAT, president & CEO; ROBERT JORDHEIM, EVP & CFO; KEVIN BRANDT, EVP, chief commercial officer; JOHN VARELA, EVP, global operations; PAUL MONTAGUE, VP, HR; ROGER ROSE, EVP, Pres, RTI donor services; ENRICO SANGIORGIO, VP & GM, international markets; KEITH KOFORD, VP, legal, regulatory & clinical affairs; BRYAN MARTIN, VP, global QA; DR. LENNOX ARCHIBALD, medical director; THOMAS ROSE, secretary

www.medicaldesignandoutsourcing.com

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Medical Design & Outsourcing 85

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1OO

THE TOP 1OO MEDTECH COMPANIES

SPECTRANETICS Colorado Springs, Colo. www.spectranetics.com

2016 RANK: 103 Revenue: $270,823,000 Fiscal year ending: Dec. 31, 2016

Employees: 960 R&D Spend: $67,480,000

KEY PERSONNEL: SCOTT DRAKE, director, president and CEO; STACY MCMAHAN, CFO; SHAHRIAR MATIN, COO; DONNA FORDSERBU, SVP, sales & marketing lead management; ROBERT FUCHS, SVP, global HR; PAUL GARDON, SVP, GC

BARCO Kortrijk, Belgium www.barco.com

2016 RANK: 105 Revenue: $259,785,658* Fiscal year ending: Dec. 31, 2016

Employees: 3,500 * Revenues from Topcon’s eye care segment.

KEY PERSONNEL: JAN DE WITTE, CEO; ANN DEZENTER, SVP, CFO; AN DEWAELE, SVP, chief HR officer; FILIP PINTELON, SVP, GM, healthcare; WIM BUYENS, SVP, GM, entertainment; GEORGE STROMEYER, SVP, GM, enterprise; PIET CANCEL, SVP, EMEA; NEY CORSINO, SVP, Americas; JOHAN HEYMAN, SVP, operations; XAVIER BOURGOIS, SVP, IT; KURT VERHEGGEN, SVP, GC

EXACTECH Gainesville, Fla. www.exac.com

2016 RANK: 104 Revenue: $257,573,000 Fiscal year ending: Dec. 31, 2016

Employees: 733 R&D Spend: $21,377,000

KEY PERSONNEL: DAVID PETTY, CEO and president; WILLIAM PETTY, executive chairman and chairman of the board; GARY MILLER, EVP, R&D; BETTY PETTY, VP, administration, corporate secretary; JOEL PHILIPS, CFO; DONNA EDWARDS, VP, legal; BRUCE THOMPSON, SVP, GM, biologics

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9 • 2017

9/18/17 2:35 PM

THE TOP 1OO MEDTECH COMPANIES

1OO

K2M GROUP HOLDINGS Leesburg, Va.

www.k2m.com

2016 RANK: 106 Revenue: $236,634,000 Fiscal year ending: Dec. 31, 2016

Employees: 457 R&D Spend: $21,547,000

KEY PERSONNEL: ERIC MAJOR, president, CEO; DR. JOHN KOSTUIK, chief medical officer; GREGORY COLE, CFO; LARRY DOOLEY, VP, national accounts; SANDRA GILBERT, VP, global regulatory & quality; GIANLUCA IASCI, chief commercialization officer; DAVE MACDONALD, SVP, operations; LANE MAJOR, chief strategy officer; LUKE MILLER, SVP, GC, secretary; GEORGE MORATIS, global accounting officer; RICH PELLEGRINO, VP, R&D; LAURA SUGDEN, SVP, HR

MIMEDX Marietta, Ga. www.mimedx.com

2016 RANK: 108 Revenue: $187,296,000 Fiscal year ending: Dec. 31, 2016

Employees: 690 R&D Spend: $8,413,000

KEY PERSONNEL: PARKER PETIT, CEO and chairman; WILLIAM TAYLOR, president, COO; MICHAEL J. SENKEN, CFO; ALEXANDRA HADEN, GC, secretary; CHRISTOPHER CASHMAN, EVP, chief commercialization officer; DEBORAH DEAN, EVP; BRENT MILLER, EVP; THORNTON KUNTZ, SVP, administration; MICHAEL CARLTON, SVP, global sales; MARLENE DESIMONE, SVP, corporate strategic development; DR. DONALD FETTEROLF, chief medical officer; THOMAS KOOB, chief scientific officer; FRANK BURROWS, VP, clinical and scientific liaison; REBECCAH BROWN, VP, product development, regulatory affairs, QA; RANDALL SPENCER, VP, clinical innovation; DR. DAVID MASON JR., VP, medical affairs for clinical practice; DR. I. LANDY, VP, strategic initiatives

CRYOLIFE Kennesaw, Ga. www.cryolife.com

2016 RANK: 112 Revenue: $180,380,000 Fiscal year ending: Dec. 31, 2016

Employees: 665 R&D Spend: $13,446,000

KEY PERSONNEL: J. PATRICK MACKIN, president, CEO, board chair; SCOTT CAPPS, VP, clinical research; JOHN DAVIS, SVP, global sales & marketing; DAVID GALE, VP, R&D; RICHARD GRIDLEY II, VP, Asia Pacific & the Americas, CryoLife Asia Pacific PTE GM; DAVID HOLLINWORTH, VP, CryoLife Europa GM; JEAN HOLLOWAY, SVP, GC, chief compliance officer, corporate secretary; AMY HORTON, VP, chief accounting officer; D. ASHLEY LEE, EVP, COO, CFO; WILLIAM MATTHEWS, SVP, operations, QA, regulatory; JIM MCDERMID, SVP, chief HR officer; DR. WILLIAM NORTHRUP III, VP, physician relations & education; SHERRY SAURINI, VP, quality; DEREK SOUTHARD, VP, operations & CryoLife GM; MIKE TUCKERMAN, VP, NA sales

www.medicaldesignandoutsourcing.com

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Medical Design & Outsourcing 87

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1OO

THE TOP 1OO MEDTECH COMPANIES

ATRICURE Mason, Ohio

www.atricure.com

2016 RANK: 114 Revenue: $155,109,000 Fiscal year ending: Dec. 31, 2016

Employees: 500 R&D Spend: $35,824,000

KEY PERSONNEL: MICHAEL CARREL, president, CEO; M. ANDREW WADE, SVP, CFO; DOUGLAS SEITH, COO; TONYA AUSTIN, VP, HR; DAVID FRANCISCHELLI, VP, R&D; ANDREW LUX, SVP, operations and quality; JUSTIN NOZNESKY, SVP, marketing and business development; VINI DORAISWAMY, SVP, clinical, regulatory and scientific affairs; KARL DAHLQUIST, VP, legal and chief compliance officer; SHANA SINK, VP, clinical affairs; MICHAEL J. ROGGE, VP, professional education; SAM PRIVITERA, CTO

SEASPINE Carlsbad, Calif. www.seaspine.com

2016 RANK: 113 Revenue: $128,860,000 Fiscal year ending: Dec. 31, 2016

Employees: R&D Spend:

310 $11,442,000

KEY PERSONNEL: KEITH VALENTINE, president, CEO; JOHN BOSTJANCIC, CFO, treasurer; JOHN WINGE, VP, sales; BRIAN BAKER, VP, global operations; COLIN SMITH, VP, spinal implant systems, international; TROY WOOLLEY, VP, marketing; LAETITIA COUSIN, VP, regulatory clinical and quality assurance; TYLER LIPSCHULTZ, VP, orthobiologics, business development; PATRICK KERAN, GC, corporate secretary

100

ALPHATEC Carlsbad, Calif. alphatecspine.com

2016 RANK: 109 Revenue: $120,248,000 Fiscal year ending: Dec. 31, 2016

Employees: 162 R&D Spend: $9,248,000

KEY PERSONNEL: TERRY RICH, CEO; JON ALLEN; EVP, commercial operations; MIKE PLUNKETT, president, COO; CRAIG HUNSAKER, EVP, people & culture, GC; JEFF BLACK, EVP, CFO; BRIAN SNIDER, EVP, strategic marketing & product development

Medical Design & Outsourcing

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9/18/17 2:35 PM

VERIFY AND OPTIMIZE YOUR DESIGNS with COMSOL Multiphysics

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COMSOL 9-17.indd 56

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TOP R&D SPENDERS

R&D ranking by total spend:*

2017 OVERALL COMPANY RANK

R&D SPEND

2017 OVERALL COMPANY RANK

% REVENUES

R&D SPEND

75 DexCom

27.2% $156,100,000

(HealthTech segment only) 3 Royal Philips $1,847,916,800

92 Spectranetics

24.9% $67,480,000

13 Boston Scientific $920,000,000

98 AtriCure

23.1% $35,824,000

87 Insulet

15.2% $55,710,000

9 Stryker $715,000,000

89 Abiomed

15.1% $49,759,000

10 Baxter $647,000,000

28 Edwards Lifesciences

15.0% $443,300,000

Medtronic $2,193,000,000

R&D ranking by percentage of revenues:*

(life sciences, diagnostics & dental segment) Danaher $787,800,000

17 Novartis (Alcon segment) $486,000,000

28 Edwards Lifesciences $443,300,000

84 Accuray

14.2% $56,700,000

15 Zimmer-Biomet $365,600,000

36 BioMerieux

12.9% $301,047,680

16 B. Braun Melsungen $322,638,080

58 Cochlear

12.6% $143,000,000

36 BioMerieux $301,047,680

51 Elekta

12.1% $158,403,572

55 Carl Zeiss Meditec

11.3% $136,635,123

27 Varian Medical Systems $253,500,000

13 Boston Scientific

11.0% $920,000,000

31 Intuitive Surgical $239,600,000

53 LivaNova (formerly Sorin/Cyberonics)

10.1% $122,454,000

14 Essilor $236,940,800

39 Bio-Rad

10.0% $205,864,000

30 Hologic $232,100,000

3 Royal Philips (HealthTech segment only) 9.6% $1,847,916,800

22 Smith & Nephew $230,000,000

47 Bruker

9.2% $149,000,000

39 Bio-Rad $205,864,000

95 K2M Group Holdings

9.1% $21,547,000

5 Fresenius (medical care segment)

76 Fisher & Paykel Healthcare

9.0% $50,924,800

99 SeaSpine

8.9% $11,442,000

C.R. Bard $292,800,000

$162,000,000

51 Elekta $158,403,572

Imaging and Ultrasound businesses) Analogic (Medical

14.8% $67,100,000

75 DexCom $156,100,000

31 Intuitive Surgical

8.9% $239,600,000

47 Bruker $149,000,000

85 Natus

8.8% $33,443,000

26 Getinge $147,882,302

71 Masimo

8.5% $59,362,000

40 ResMed $144,467,000

88 NxStage Medical

8.5% $31,032,000

58 Cochlear $143,000,000

17 Novartis (Alcon segment)

8.4% $486,000,000

34 Sonova $139,250,609

94 Exactech

8.3% $21,377,000

55 Carl Zeiss Meditec $136,635,123

30 Hologic

8.2% $232,100,000

32 Hill-Rom $133,500,000

24 C.R. Bard

7.9% $292,800,000

23 Dentsply-Sirona $128,500,000

27 Varian Medical Systems

7.9% $253,500,000

53 LivaNova (formerly Sorin/Cyberonics)

90 Syneron

7.7% $23,043,000

60 Align Technology $75,720,000

100 Alphatec

7.7% $9,248,000

38 Coloplast $75,658,481

73 Merit Medical Systems

7.5% $45,229,000

56 Smiths Medical (Smiths Group)

97 Cryolife

7.5% $13,446,000

92 Spectranetics $67,480,000

1 Medtronic

7.4% $2,193,000,000

(Medical Imaging and 80 Analogic $67,100,000 Ultrasound businesses)

72 Wright Medical

7.3% $50,514,000

$122,454,000

$70,486,000

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

Medical Design & Outsourcing

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

www.medicaldesignandoutsourcing.com

9/18/17 2:38 PM

Get To Know Your Options. s Achieve squareness under load (SUL) s Integrated attachments s Assembly time reduction s Higher geometric precision s Increased life span s Multi-start helix configurations

M ac hi nedSprin g s.c o m Helical 9-17.indd 56

9/18/17 11:53 AM

TOP R&D SPENDERS

R&D ranking by total spend:*

2017 OVERALL COMPANY RANK

R&D SPEND

R&D ranking by percentage of revenues:*

2017 OVERALL COMPANY RANK

% REVENUES

R&D SPEND

41 Cooper Cos. $65,411,000

82 Orthofix

7.0% $28,803,000

37 Paul Hartmann $65,214,080

60 Align Technology

7.0% $75,720,000

33 Steris $59,397,000

40 ResMed

7.0% $144,467,000

71 Masimo $59,362,000

81 CynoSure

6.7% $28,973,000

43 Teleflex $58,579,000

10 Baxter

6.4% $647,000,000

62 Integra Lifesciences $58,155,000

9 Stryker

6.3% $715,000,000

(life sciences, diagnostics & dental segment) Danaher

84 Accuray $56,700,000

87 Insulet $55,710,000

56 Smiths Medical (Smiths Group)

5.9% $70,486,000

50 Integer (formerly Greatbatch) $55,001,000

91 RTI Surgical

5.9% $16,090,000

76 Fisher & Paykel Healthcare $50,924,800

62 Integra Lifesciences

5.9% $58,155,000

72 Wright Medical $50,514,000

34 Sonova

5.7% $139,250,609

89 Abiomed $49,759,000

32 Hill-Rom

5.0% $133,500,000

64 NuVasive $47,999,000

64 NuVasive

5.0% $47,999,000

73 Merit Medical Systems $45,229,000

22 Smith & Nephew

4.9% $230,000,000

48 Halyard Health $41,100,000

15 Zimmer-Biomet

4.8% $365,600,000

45 ConvaTec $38,100,000

16 B. Braun Melsungen

4.5% $322,638,080

57 DJO Global* $37,710,000

96 MiMedx

4.5% $8,413,000

67 Haemonetics $37,556,000

77 Össur

4.4% $23,166,000

98 AtriCure $35,824,000

26 Getinge

4.3% $147,882,302

85 Natus $33,443,000

67 Haemonetics

4.2% $37,556,000

6.0% $787,800,000

70 Conmed $32,254,000

70 Conmed

4.2% $32,254,000

88 NxStage Medical $31,032,000

50 Integer (formerly Greatbatch)

4.0% $55,001,000

81 CynoSure $28,973,000

38 Coloplast

3.5% $75,658,481

82 Orthofix $28,803,000

23 Dentsply-Sirona

3.4% $128,500,000

77 Össur $23,166,000

86 ICU Medical

3.4% $12,955,000

90 Syneron $23,043,000

41 Cooper Cos.

3.3% $65,411,000

95 K2M Group Holdings $21,547,000

57 DJO Global*

3.3% $37,710,000

94 Exactech $21,377,000

43 Teleflex

3.1% $58,579,000

61 Invacare $17,123,000

14 Essilor

3.0% $236,940,800

91 RTI Surgical $16,090,000

37 Paul Hartmann

3.0% $65,214,080

97 Cryolife $13,446,000

48 Halyard Health

2.6% $41,100,000

86 ICU Medical $12,955,000

33 Steris

2.3% $59,397,000

99 SeaSpine $11,442,000

45 ConvaTec

2.3% $38,100,000

100 Alphatec $9,248,000

61 Invacare

1.6% $17,123,000

96 MiMedx $8,413,000

5 Fresenius (medical care segment)

0.9% $162,000,000

11 Owens & Minor

0.0% $0

11 Owens & Minor $0 The color codes correspond to the top 10 R&D spenders.

Medical Design & Outsourcing

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

www.medicaldesignandoutsourcing.com

9/18/17 2:38 PM

Space Tight?

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Company ranking by employee totals

COMPANIES RANKED BY EMPLOYMENT

Medical Design & Outsourcing

Employer Rank_9-17_Vs2-BP FINAL.indd 94

2017 RANK OVERALL COMPANY EMPLOYEES RANK

FISCAL YEAR END

Fresenius (medical care segment)

109,319 12/31/16

Medtronic

91,267 4/28/17

Royal Philips (HealthTech segment only)

70,968 12/31/16

Essilor

64,000 12/31/16

B. Braun Melsungen

58,037 12/31/16

GE Healthcare (General Electric)

54,000 12/31/16

Baxter

48,000 12/31/16

Stryker

33,000 12/31/16

Cardinal Health (medical segment)

30,251 6/30/17

Boston Scientific

27,000 12/31/16

Becton, Dickinson (medical segment)

24,000 9/30/16

Terumo

20,697 3/31/17

Novartis (Alcon segment)

19,000 12/31/16

Zimmer-Biomet

18,500 12/31/16

C.R. Bard

16,300 12/31/16

Dentsply-Sirona

15,700 12/31/16

Smith & Nephew

15,644 12/31/16

Getinge

15,582 12/31/16

Sonova

12,802 3/31/17

Teleflex

12,600 12/31/16

Halyard Health

12,000 12/31/16

Steris

12,000 3/31/17

Edwards Lifesciences

11,100

Cooper Cos.

10,600 10/31/16

Paul Hartmann

10,372 12/31/16

Hill-Rom

10,000 9/30/16

Coloplast

9,817 9/30/16

BioMerieux

9,800 12/31/16

Integer (formerly Greatbatch)

9,400 1/1/17

12/31/16

ConvaTec

8,524 12/31/16

Bio-Rad

8,250 12/31/16

Owens & Minor

7,900 12/31/16

Varian Medical Systems

7,800 9/30/16

Smiths Medical (Smiths Group)

7,600 7/31/16

ResMed

6,080 6/30/17

Align Technology

6,060 12/31/16

Bruker

6,000 12/31/16

Hologic

5,333 9/24/16

DJO Global*

4,980 12/31/16

Invacare

4,600 12/31/16

9 â&#x20AC;¢ 2017

www.medicaldesignandoutsourcing.com

9/18/17 2:39 PM

Revoxs 9-17.indd 56

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Company ranking by employee totals

COMPANIES RANKED BY EMPLOYMENT

Medical Design & Outsourcing

Employer Rank_9-17_Vs2-BP FINAL.indd 96

2017 RANK OVERALL COMPANY EMPLOYEES RANK

FISCAL YEAR END

LivaNova (formerly Sorin/Cyberonics)

4,500 4/24/17

GN Store Nord (GN Hearing segment)

4,275 12/31/16

Merit Medical Systems

4,150 12/31/16

Straumann

3,797 2/25/17

Intuitive Surgical

3,755 12/31/16

Integra Lifesciences

3,700 12/31/16

Fisher & Paykel Healthcare

3,623 3/31/17

Elekta

3,600 5/31/17

Barco (healthcare division)

3,500 12/31/16

NxStage Medical

3,400 12/31/16

Conmed

3,300 12/31/16

Haemonetics

3,107 3/28/16

Cochlear

2,934 6/30/17

Carl Zeiss Meditec

2,910 9/30/16

ICU Medical

2,803 12/31/16

Össur

2,795 12/31/16

Wright Medical

2,394 12/27/16

DexCom

2,300 12/31/16

NuVasive

2,200 12/31/16

Analogic (Medical Imaging and Ultrasound businesses) 1,577

Masimo

1,243 1/2/17

Natus

1,160 12/31/16

RTI Surgical

1,140 12/31/16

CynoSure

982 12/31/16

Spectranetics

960 12/31/16

Accuray

959 6/30/16

Orthofix

938 12/31/16

Syneron

817 12/31/16

Abiomed

747 3/31/17

Exactech

733 12/31/16

MiMedx

690 12/31/16

Cryolife

665 12/31/16

Insulet

640 12/31/16

AtriCure

500 12/31/16

K2M Group Holdings

457 12/31/16

SeaSpine

310 12/31/16

100

Alphatec

162 12/31/16

9 • 2017

7/31/16

www.medicaldesignandoutsourcing.com

9/18/17 2:39 PM

First sterilizable encoder

The first sterilizable drive system. maxon launches a sterilizable encoder, offering its customers a complete system with high speed BLDC motor, gearhead and encoder that withstands more than 1000 autoclave cycles. Advantages of a sterilizable drive system maxon ECX motor

Up to 120,000 rpm, smooth-running.

maxon GPX gearhead

Transmission of high torques and speeds. Up to 90% efficiency.

maxon ENX encoder

Integrated incremental (1024 impulses) or absolute (4096 steps) encoder.

Short delivery time

Configurable online and ready for delivery within 11 days.

maxon precision motors, inc., www.maxonmotorusa.com, phone 508 677 0520 sterilizable.maxonmotorusa.com

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ABIOMED

How

abiomed cracked the

big 100 Abiomed has quickly climbed our Big 100 list, landing this year at 90th, and it has done so without major acquisitions. Fueling the global medtech companyâ&#x20AC;&#x2122;s growth is a device with unique indications and a patient-centered business strategy.

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More than 60,000 patients have been treated using Abiomed’s Impella heart pumps – and every time the world’s smallest heart pump is given to someone, CEO Michael Minogue and his management team get an email. The email, which contains case information and notes from the physician, is just one way that the company seeks to put patients at the center of their business. The company’s newly-expanded headquarters doubles as a shrine to their patients. Hanging along the walls of nearly every room and hallway are pictures of people who are alive thanks to Abiomed’s devices. Walking through the facility, Minogue stops at each one and recalls their name and story. He says that despite any obstacles Abiomed has faced in the past, it’s the company’s passion for patients that has propelled them to success. “Abiomed is a great company because we failed,” Minogue said, referring to a December 2012 FDA decision that forced the firm to take to the more-stringent pre-market approval path after initially marketing the device under a 510(k) clearance. “It’s hard to change the standard of care. But we put the patient outcomes as a priority above everything else - above revenue, above growth. If you do that, you’ll survive and you’ll do well.” Based in Danvers, Mass., Abiomed is a disruptive player in the cardiovascular space. In 2016, the company’s headcount rose to 1,000, its revenue climbed to $330 million and they more than doubled the space of their headquarters with a massive expansion project. A little over a decade ago, the company wasn’t making heart pumps. Instead, they were focused on developing the world’s first artificial heart – a feat that they accomplished in 2001. After Abiomed acquired the Impella technology in 2005, the company evolved from heart replacement to heart recovery – a concept Minogue says is entirely unique to Abiomed. Recovery for a patient’s own heart When a person suffers an event like a heart attack, the heart muscle stuns itself into hibernation and slows the flow of blood to the rest of the body. This triggers the brain, which is receiving less blood than usual, to try to stimulate the heart to do more work. The kidneys begin to shut down in an attempt to reserve blood flow back to the extremities. It’s a cascade of organ failures. The purpose of Abiomed’s Impella device is to help restore blood flow and allow the heart to rest. The device, snaked through the femoral or ¬¬¬axillary artery, sits in the heart and spins at 50,000 revolutions per minute, sending blood away from the heart and to the rest of the body. It’s a minimally invasive procedure that differs dramatically from the standard of care. Traditionally, surgeons have used a procedure called a sternotomy to access the heart. It involves opening the sternum with a saw, spreading the ribs and taking out a chunk of the heart muscle to insert a device. The patients that Abiomed’s pumps are designed for have had very few options for treatment in the past. They are usually too sick or too high-risk for most procedures and their next step is often a heart transplant.

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ABIOMED

Abiomed’s pumps are the only products approved by the FDA as safe and effective for high-risk percutaneous coronary intervention and acute myocardial infarction cardiogenic shock. The Impella device is also the only product on the market cleared for heart recovery – a point of immense pride for the company. Keeping a patient’s native heart is critical, Minogue says, from a clinical perspective and from a financial perspective. “The reason this technology is growing so much is because maintaining your own heart is the greatest outcome. God is the best engineer and if you can keep your native heart, that’s going to be the best quality of life, that’s going to be the most cost effective,” he explained. “Because these are million-dollar patients if they don’t recover.” The device can be used for patients undergoing a variety of heart-related conditions. Minogue said Impella has saved

the lives of people who have had a massive heart attack and have gone into cardiogenic shock. But it’s also been used to treat kids with viruses that attack the heart. The pump has helped women with post-partum cardiomyopathy or spontaneous coronary artery dissection. Among the thousands of patients treated with an Impella device since it first launched, there is one thing that binds them all together – most of them still have their own heart. Changing a decades-long standard One of the challenges still facing Abiomed is that there are a lot of patients that should be using their devices, but don’t have access to them, according to Minogue. The company is constantly working on ways to improve the device to make it easier to use. “The ease-of-use is important because we’re asking physicians that have been treating patients for the last 40 years in a certain way, we’re asking

GE HEALTHCARE’S MEDTECH LEGACY

Before he assumed the corner office at Abiomed, Mike Minogue spent 11 years at GE Healthcare working under two well-known leaders: first Jack Welch and then Jeffrey Immelt. “What I took away from GE were the processes and the culture. I came to a company like Abiomed, which was focused around innovation and the patients, and I merged the two together,” Minogue said. Welch served as GE’s CEO for two decades, between 1981 and 2001, before passing the business over to Immelt. The company recently announced that John Flannery, head of GE Healthcare, will become GE’s chief executive at the start of 2018. “He is a great leader and really

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brought a certain level of leadership into medical, creating medical as a premiere organization inside of GE,” Minogue said of Immelt. Both Immelt and Welch have an immense network of leaders across medtech that they helped to foster, many of them heads of industryleading companies. Michael Mahoney, chairman & CEO of Boston Scientific; Omar Ishrak, chairman & CEO of Medtronic; Greg Lucier, chairman & CEO of Nuvasive; Mark Augusti, president & CEO of ConforMIS, among many others, all have roots at GE. “There’s a great alumni in medtech,” Minogue said. “Folks joke that there’s a secret GE handshake.”

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ABIOMED

them to do something new on one of the sickest patients in the hospital,” he said. In one room in the company’s Heart Recovery Institute, there is a model used to simulate Impella’s set-up and administration process. Two months ago, Minogue set up the pump in one minute and twenty seconds – and he is quick to say that he isn’t the fastest at the company Speed and comfort are extremely important, as Minogue pointed out – some patients get Impella while doctors are still performing CPR on them. “It’s got to work, it’s got to be quick, easy, reliable and [healthcare workers] have got to feel confident,” he said. One of the ways that they work to improve their devices is by thumbing through the emails they get every time a patient receives an Impella device. Each

Monday, the staff gathers to look at the cases that offer opportunities to improve – whether it involves changes to training protocols or fixing something in the software that controls the pump. The company also spends a “tremendous amount of money” on a registry of data. In the U.S. database, they have information from more than 60,000 patients that they use to identify best practices and ways to boost outcomes. The company will even set up live cases to stream into a large auditorium at Abiomed’s headquarters, so that engineers and scientists can chat with doctors about what works and what doesn’t work. “Adoption is a function of training, data and time,” Minogue said, adding that the company is deliberate in its pace. “There’s a lot of regulation, there’s a lot of scrutiny on

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ABIOMED

physicians. They have to make sure that, as a company, you get great outcomes for patients. You don’t try to go at a pace that eliminates the ability to control that.” Moving forward, Abiomed is developing new pumps for different patient populations – such as the Impella 5.5 and the Impella BTR, which are designed to support patients with heart failure. Minogue envisions that the Impella family of devices will be used with other adjunctive therapies, such as stem cells or immunosuppressants. The company is also prototyping devices that could be used to calculate cardiac power and help heal the heart just as you would any other muscle. Using realtime information in what Minogue referred to as “smart pumping,” an algorithm could be used to wean the heart back from its hibernation state as it grows stronger. Ultimately, Minogue said he sees a future without sternotomies and without heart-and-lung machines. Growing a successful medtech company Abiomed is aiming to be the fastestgrowing, GAAP-profitable medtech company that improves the standard of care, Minogue said. To accomplish this, the company has to strike a balance between financial stability and growth. “Financially, our discipline has allowed us to be profitable in an earlier stage, have no debt and have a very strong cash position,” Minogue said. “But that happens when you focus on those things. It’s a lot of work and it means that you defer investing in things like [building an expansion] until you get to a certain level.” Hanging outside of Minogue’s office is an excerpt from the book, Blueprint to a Billion by David Thomson, which he said helps to reinforce their business strategy. “The bottom line is not about the coolness of the brand, the positioning of the business or the pedigree of the CEO. Those can be important inputs; however, it is exponential revenue growth that makes a great company — so long as the management team ethically seizes the opportunity that it creates to achieve profitability, maintain positive cash flow, and produce high return on capital,” the quote reads. 9 • 2017

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ABIOMED

Lining the walls of the main hall in Abiomed’s headquarters are the company’s values – recovering hearts and saving lives; leading in technology and innovation; growing shareholder value; and sustaining a winning culture. Under the plaques that describe each value sit conference rooms, each named after a patient whose life has been saved with an Impella device. One room is named after the first patient in the U.S. to be treated with Abiomed’s Impella 2.5 heart pump. “Without any exaggeration, he went from being couch-bound to playing golf with me in Puerto Rico at one of our national meetings – and he beat me,” Minogue said. If you ask Minogue what has fueled the growth of his company over the years, he will say it is a relentless focus on patients and their hearts. “We’re not talking about one less day or half a day in the ICU. We’re talking about someone being able to stay alive and potentially go home with their own heart.” M MassDevice_MDOAd2017.pdf

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REGULATORY

FDA’s new programs on combination and digital products are something to cheer about. An FDA insider offers insights into FDA’s promising moves in managing combination and digital product submissions.

Karen Corallo believes there are a lot of positive moves going on at the FDA – and she should know. Corallo, of counsel at global law firm Greenberg Traurig, is the former director of the FDA’s Division of Drug Imports, Exports, Recalls, & Shortages at the Center for Drug Evaluation & Research. Before that, Corallo was associate chief counsel in FDA’s chief counsel office. Today, she represents pharmaceutical and medical device industry clients in administrative, regulatory and enforcement matters. Corallo spoke with MDO on the energy coming out of FDA, noting the effects of the 21st Century Cures Act as well as new commissioner Dr. Scott Gottleib’s industry-friendly tone. She discussed how FDA’s new pilot program on digital health products and improved transparency with combination product decisions are a step in the right direction. Heather Thompson | Senior Editor |

MDO: You went from private practice to the FDA, where you spent the last six years before returning to private practice. What did you observe and how can medtech take an active role it the regulatory process? KC: After spending 27 years in private practice working on the side of industry, I had a unique perspective going to the FDA and putting on the regulator’s hat. During my time at the agency, I found there is more that unites than divides. Although industry and regulators have different motivations and interests, there is sufficient overlap: Innovators

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want to see good, safe devices get to patients as quickly as possible, and so does the FDA. “Partnering with industry” was a phrase I heard often at the FDA from the highest levels of leadership. That has real meaning for sponsors during product development and review, where industry can engage their reviewers by educating them on the technology in a collaborative way. It builds trust and commitment on both sides and helps to ensure a smooth review process. Most importantly, it goes a long way in avoiding late-cycle surprises. Demonstrate your expertise in

I SAW ONE STATISTIC THAT THE MARKET FOR COMBINATION PRODUCTS IS EXPECTED TO REACH $144 BILLION THIS YEAR. your product design and performance and bring the reviewers along so they thoroughly understand the technology, and there are no surprises on either side.

And communicate as often as necessary so there is a shared understanding about the technology and the issues. MDO: What trends are you seeing for combination products? Has the FDA been able to respond to criticisms about lack of transparency and deadlines for decisions? KC: I saw one statistic that the market for combination products is expected to reach $144 billion this year. That number provides context for the attention combination products received in the 21st Century Cures Act. The device provisions of the Cures Act provide more clarity and transparency around the process of assigning the product to a lead center and streamlining the review, clearance or approval of combination products. It fits nicely into commissioner Gottlieb’s larger focus on facilitating development of innovative and effective therapies as key to lowering healthcare costs over the long run, including clarifying R&D requirements to limit unnecessary regulatory costs. The review of combination products also drives the agency toward finding better ways to collaborate between and among product centers and with stakeholders.

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REGULATORY

Another point worth mentioning given to us by the Cures Act is the “clarity and certainty” meeting. After a product has been assigned to a center, you can request this meeting to address approval/clearance standards, good manufacturing practices, post market changes, among other things. Most importantly, as a result of this meeting, FDA and the sponsor will agree on these elements and incorporate them into a plan, known as the Combination Product Review Plan. Anyone who’s been through the review process knows how valuable this tool is to mitigate regulatory risk. It keeps something like a change of personnel from derailing things. MDO: FDA has issued guidance related to mobile medical devices and digital health. What are your thoughts on the pre-certification program? KC: Guidances – one of my favorite subjects. They are pure gold when trying to understand the agency’s thinking on a given topic. The number of guidances from FDA in the last six to 18 months on the topic of digital health speaks to the importance of the topic. I predict that the FDA will continue to segment the market and allocate its limited resources on products that pose the greatest risk to patients and away from the lowest-risk devices. The pilot pre-certification program is a great example of a new approach to regulatory oversight for digital health technology. This program aims to pre-certify software developers with a track record in developing, testing, and maintaining software products – and work in a culture that honors quality and organizational excellence. The FDA’s assessment will be based on objective criteria. It shifts the regulatory focus from the product to the software developer because the FDA’s traditional approach, used to monitor hardwarebased devices, doesn’t work for the faster, iterative approach to software products. To borrow a phrase, this is a giant leap for the FDA and a welcome one.

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MDO: What trends generally do you see at the FDA that could be helpful to medical device companies? KC: At the risk of repeating myself, the FDA will continue its hands-off approach to lower-risk digital health technology, like we’ve already seen with medical device data systems, general wellness products and clinical decision support software. Because the FDA can’t be expert in everything as quickly as technology is evolving, I think you’ll see more collaboration between regulators and sponsors and, I hope, a true partnership. I saw it personally during my time with the agency and have been heartened by what I’ve heard commissioner Gottlieb talk about. We’re in this together to get good, safe, high quality and effective products to patients as quickly as possible. This is a shared goal that should drive behavior on both sides of the regulatory fence, and I think we’re seeing that now. M www.medicaldesignandoutsourcing.com

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TESTING & INSPECTION

Could a new assay reduce the need for animal tests? American Preclinical Services developed a novel assay that its creators think could replace the thromboresistance animal tests for medical devices using dogs, sheep and pigs. The replacement assay – the In-vitro Blood Loop Assay – utilizes blood from donor sheep pumped through a closed tubing loop, which simulates the circulation in the animal. Image courtesy of American Preclinical Services.

Mark E. Smith | American Preclinical Services |

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Blood-contacting medical devices and the materials from which they are constructed must meet stringent safety criteria prior to regulatory approval for sale and distribution. Key among these requirements is the need for hemocompatibility testing, governed by the international standard ISO-10993-4 – recently updated to reflect some of the most recent advances in the science of blood compatibility. One of the primary requirements for blood-contacting medical devices such as catheters, sheaths, introducers, wires and the whole family of implantables such as stents and valves is the ability of the intact device or the material from which it is constructed to offer

resistance to platelet adhesion, activation and eventual blood clot formation. In other words, blood-contacting devices need to demonstrate materials-mediated thromboresistance. There is a conventional test that has been around for many years, called the NonAnticoagulated Venous Implant (NAVI) assay, which FDA often requires for final approval of blood-contacting medical devices. This test uses at minimum two large animals – typically dogs, sheep or pigs. During this evaluation, the animals are anesthetized and the devices to be tested are placed in the animals’ veins or arteries for about four hours. The animals are then humanely euthanized; the

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devices are removed and evaluated for blood clot formation on the surface and at the implant site in the blood vessel. Overall, the reproducibility of the NAVI test is poor, the number of tested devices is insufficient to allow statistical analysis (typically only two test articles and two comparator devices) and the test often yields ambiguous results. It is widely accepted that the animal test presently used does a poor job in assuring adequate thromboresistance evaluation of new devices; such evaluation is need to show the devices will be safe when placed in a patient’s bloodstream. Also, the regulatory direction when a test fails is to add additional animals – which can result in an unclear outcome, a definite waste of experimental animals. At American Preclinical Services, we developed a novel assay which we hope will eventually replace the commonly used animal-based NAVI test. Our replacement assay – the In-vitro Blood Loop Assay – utilizes blood from donor sheep pumped through a closed tubing loop, which simulates the circulation in the animal. The test and comparator devices (up to nine of each, allowing statistical assessment of endpoints) are deployed in the flowing blood for a similar duration of about four hours, after which the devices are removed and quantitatively evaluated for the presence of blood clots in a manner similar to that used in the NAVI model. American Preclinical Services in May published a paper about the assay in The American Society of Mechanical Engineers’s Journal of Medical Devices. Our research demonstrated a high confidence in similarity between the NAVI animal model and the circulating bloodloop model, and we are continuing to collect data supporting the validation of the test and its ability to accurately predict device safety. The goal of FDA regulators, who are responsible for approving medical devices, is to be able to guarantee safety of new products.

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TESTING & INSPECTION

This new in vitro test utilizes reproducible positive and negative controls, allows a robust assessment of individual animal variability, provides a larger number of replicates for device assessment and will eventually lead to a more accurate comparison of new devices with legallymarketed comparators to assure that they will be safe during clinical use. APS is presently collaborating with researchers at the FDA to ensure that this assay, if ultimately deemed acceptable by the FDA, has the potential to significantly improve testing accuracy and to dramatically reduce the number of animals used for routine testing of this class of devices.

American Preclinical Services won the AAALAC’s 2017 Global 3Rs Award for North America – a significant acknowledgement from a well-respected external organization that APS’s ongoing efforts to redesign thrombogenicity testing can have a global impact. The goal is to significantly enhance the accuracy and performance of thrombogenicity testing and substantially reduce the number of research animals used to accomplish these goals. Within the past few months, several large and small medical device manufacturers have successfully used this new in vitro test in lieu of the

current NAVI test in routine submission packages for blood-contacting medical devices. We eagerly await expanded use of the assay among our colleagues in other U.S. medical device testing laboratories and are submitting our findings to the FDA so that the test can be recognized as a suitable replacement for the in NAVI thrombogenicity tests. At the very least, the approval of this test method by the FDA will provide medical device manufacturers and other contract research organizations a superior alternative method for testing that is acceptable for use in manufacturers’ submissions to regulatory bodies for approval. M

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STERILIZATION SERVICES

UVC LEDs: Energizing a new generation of portable, healthcare disinfection devices

Mark Pizzuto | Crystal IS |

Figure 1: Log reduction as a function of time for various microbes at 2 in. distance.

According to the Centers for Disease Control & Prevention (CDC), one in every 25 hospital patients in the U.S. will contract a hospital-acquired infection (HAI) during their visit. Often expensive and sometimes fatal, HAIs are adding billions to the country’s already bourgeoning healthcare costs. For decades, hospitals and other healthcare facilities have employed ultraviolet germicidal irradiation systems (more recently referred to as germicidal UV or GUV), equipped with low-pressure mercury vapor lamps as an added layer of disinfection for a variety of applications ranging from operating rooms to the air circulating in the building’s ductwork. Although effective, these lamps are inherently cumbersome and too fragile to address the growing need for smaller, lightweight, portable disinfection devices. As an alternative medical device manufacturers are turning to deep-ultraviolet (UVC) light-emitting diodes (LEDs), which offer a substantially smaller footprint and directional UV light in the optimal 250 nm to 280 nm wavelength range for disinfection. Whether part of a large, comprehensive system or a portable device, UVC LEDs represent a major upgrade: They deliver UVC light in optimal wavelengths for improved disinfection; have a much smaller footprint; and consume far less energy due to their instant on/off capability. However, it should be noted that LEDs are not simple plug-andplay replacements for existing applications using mercury lamps. For maximum design flexibility and disinfection efficacy, it’s important to understand the target microbe’s spectral response curve, UV dosage requirement, distance to the source and residence time available within the system. Examining UV susceptibility by microbe When developing a UVC disinfection device, the two most critical parameters for calculating dosage are the intensity of the light source (expressed as mW/ cm²) and the exposure or residence time/duration the microbe is exposed to UVC energy. By understanding

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STERILIZATION SERVICES

the dosage requirements, an LED sterilization device can be created to match even the smallest disinfection target. Crystal IS recently contracted with a thirdparty microbiological testing facility to measure the level of UVC LED disinfection achieved on common target microbes. The log reduction (the number of microbes eliminated from a surface by disinfection) for each microbe was measured after UVC exposures of 30, 60 and 120 seconds at a distance of 2 in. from the light source (Figure 1). The data shows that after 120 seconds the log reduction varied from just over 1 log reduction to up to a 6-log reduction for MRSA. If the distance between the light source and the surface is increased while holding the time and UVC power constant, the log reduction will be lower. However, the decrease is not linear and can be unpredictable, suggesting dosage calculations should be validated through microbiology studies to confirm the actual results. Achieving uniform disinfection with design flexibility Complete exposure of a surface, regardless of shape, will allow for optimal dosage. The compact footprint of UVC LEDs enables better disinfection of small or irregular objects. By leveraging the much smaller, solid-state LED footprint, new disinfection devices can be created to emulate the shape of the intended target.

Understanding UV disinfection is line-of-sight irradiation; Figures 2 and 3 illustrate how the LEDs can be configured to deliver uniform light dispersion across two very different surfaces – a cylindrical vial and a small workstation. In Figure 2, a cylindrical vial requires a dosage of 5mJ/cm2. First, the designer considers the power and time required to achieve that dosage at the furthest point from the LED array – the base of the vial, which is 81 mm from the light source. While the irradiation will be higher near the top of the vial, delivering the minimum dosage to the base ensures the entire vial is disinfected. Therefore, this arrangement will achieve the required dosage after 10 seconds. Figure 3 illustrates the disinfection of a workspace surface 100mm wide (4 in.), requiring a dosage of 12mJ/cm2. The LEDs are in a 100mm-wide strip of 4 UVC LEDs approximately 25mm above the surface. To achieve a uniform dispersion with the 100° viewing angle, the LEDs are placed 25 mm apart. The target dosage can be achieved by irradiating the surface for 60 seconds. Being able to arrange LEDs to accommodate a specific surface enables medical device engineers to create a whole new generation of reliable devices that deliver uniform and highly efficient UV disinfection. As a result, manufacturers can develop innovative and, when necessary, customized solutions for specific high-contact surfaces.

Figure 2: Arrangement of LEDs for disinfection of vials (A), the optical modeling of the irradiation of the vial (B), and the irradiation pattern at the bottom of the vial (C).

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Summary According to the CDC, microorganisms and viruses have developed numerous resistance mechanisms that enable them to evade the effects of antimicrobials, antivirals and chemical treatment. With medical care being now administered in a range of settings – including the home – the need for portable disinfection equipment to protect patients and clinicians from drug-resistant pathogens and lifethreatening infections has never been greater. In fact, considering the professional/nonprofessional cross section of potential users – the FDA’s usability standards for new product development suggest that ease-of-use will be a key ingredient in future medical device designs. As such, all indications are that UVC LEDs will play a major role in the development of next generation disinfection devices. M

Figure 3: Arrangement for surface disinfecting bar that can move along the axis (A) and radiation pattern from the LED on to a surface in stationary mode (B).

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TUBING TALKS

Reinforced silicone tubing: Six things you need to know Biocompatibility, flexibility and durability make extruded silicone a top medical device tubing choice. Keep these six things in mind when reinforcing it.

Dan Sanchez | Tr e l l e b o r g S e a l i n g S o l u t i o n s |

When it comes to their use in medical devices, silicone tubes are getting even better â&#x20AC;&#x201C; enhanced with a variety of reinforcements and coatings that help manufacturers meet the marketâ&#x20AC;&#x2122;s escalating demand for smaller, more durable devices. Here are six things to keep in mind about reinforced silicone tubing:

1. Spiral design adds kink resistance Silicone is a soft material, and extrudable silicones are in the Shore-A durometer scale. This makes them prone to kinking, especially in small dimensions. As designs call for smaller device footprints and tubes as a result become smaller, tube diameters reach the point where, without reinforcement, they easily bend or collapse, halting the flow of fluid. The solution is to embed monofilaments, either in a spiral or braided design, within the wall of the tube to add radial strength, making extruded silicone tubes highly resistant to kinking and compression. Today, small silicone tubes (1/8 in. to 3/16 in.) are available with a variety of reinforcements. Monofilaments in a tight spiral design are ideal for adding kink resistance to small-diameter tubes. The reinforcement adds enough radial strength so that tubing can be bent almost in half without affecting fluid flow. Because the monofilaments are embedded in the tube wall, they do not affect the inner diameter of the tube. This configuration is ideal for creating a small, highly flexible tube that will not kink or collapse, even when required to conform around anatomical features. Kink-resistant tubing provides a pathway for fluids to enter into and from the body. It must meet mechanical requirements such as adequate hoop strength and flexibility to conform to anatomical features. Image courtesy of Trelleborg Sealing Solutions.

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TUBING TALKS

However, plastic reinforcements are sensitive to heat, so they cannot be used in devices that will be subjected to high temperatures, such as those seen in autoclave sterilization. The silicone itself is highly heatresistant, but the autoclaveâ&#x20AC;&#x2122;s high temperature would degrade the mechanical performance of the plastic embedded in the wall. In addition to plastic, spiral reinforcements can be manufactured from nylon and stainless steel, both of which are more heat-resistant than plastic. Braided monofilament provides flexibility yet is less susceptible to collapse under pressure.

Image courtesy of Trelleborg Sealing Solutions.

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2. Braids prevent burst tubes Some medical applications require tubes that are slightly less flexible but stronger than those that can be produced by spiral. Rather than kink resistance, the aim is to produce a tube that wonâ&#x20AC;&#x2122;t expand, burst or collapse under pressure. The solution is a braided monofilament, which can be constructed from a variety of plastics and metals including polyethylene, nylon and stainless steel. The flexibility of a braided monofilament depends on the number of crossed pieces in a given area. This is typically measured in per-inch crosses, or PICs. The higher the PICs, the tighter the braid; the tighter the braid, the less flexible but stronger it will be. 3. Reinforcers extend durability Reinforced tubing can also be designed to increase wear resistance. Materials such as polyester and polyethylene can be placed inside the silicone wall in a spiral or braid configuration for tubes to be used inside the body.

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An application example is where excess tubing is coiled up and placed behind a pacemaker in the chest cavity. This may rub against the pacemaker due to arm/shoulder movement and, over time, cause the outer layer of silicone to break down. A smooth, durable reinforcement placed inside the silicone makes the tube considerably more wear-resistant, extending the length of time the device can function inside the body before surgical replacement. 4. Designing with mandrels in mind Unlike thermoplastics, which must be melted to an exact point before extrusion and then cooled quickly to set their shape, highconsistency “rubbers”/elastomer (HCR/Es) silicones are thermoset materials that rely on a chemical crosslinking process. HCEs have considerable green strength, making them an ideal material for extrusion, but once crosslinked they will not re-melt. However, the reinforcement process adds a layer of complexity to tubing manufacture. The tube wall must be built on a mandrel while the spiral or braid is being created. The mandrel is removed once the reinforcement is complete.

THE FLEXIBILITY OF A BRAIDED MONOFILAMENT DEPENDS ON THE NUMBER OF CROSSED PIECES IN A GIVEN AREA.

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TUBING TALKS

Reinforced tubing can also be designed to increase wear resistance.

Image courtesy of Trelleborg Sealing Solutions.

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Removing the mandrel can be difficult for long tubes, limiting the length of certain types of reinforced tubing. When long lengths are specified, one solution is to deliver the tube with the mandrel still inside. The customer cuts the tube to length, then removes the mandrel. The size of the inner diameter (ID) is also a factor: Larger-tube IDs require a larger mandrel. As the mandrel increases in size, the surface area’s contact with the silicone enlarges significantly, increasing friction and making Silicone tubing, because of its unique the mandrel more difficult biocompatibility and physical durability, plays a to remove. Thus, the use of fundamental role in medical device applications. reinforcement in silicone tubes Image courtesy of Trelleborg Sealing Solutions. is currently limited to less than 1/8 in. in diameter. Thicker walls can also have a negative impact on removing tube, it’s wise to choose one that is clear, the mandrel because they may have a translucent or has a translucent color. This tighter grip on the mandrel, increasing the ensures the reinforcement can be easily friction coefficient between the silicone inspected to ascertain whether or not the wall and the mandrel. correct number of coils in a spiral (or PICs in a braid) are present in the reinforcement. 5. Keeping an eye on loose ends A variety of silicone coatings is also Because silicone doesn’t easily available. Other than the heat necessary to bond to other materials, the cure the coating, there are no additional reinforcements described above are obstacles to coating a reinforced tube. encapsulated in the silicone walls Because uncoated silicone tubes tend but not chemically bonded to them. to have a slightly tacky surface, frictionThis is not a concern for reducing surface coatings are often added. applications in which both ends of In summary, silicone’s natural flexibility the reinforced tube are attached to lends itself to tubing, with extrusions from another part of the device. However, 20 durometers to 80 durometers possible if the tube were to be unattached at one on the Shore-A scale. (20-A durometer is end, it might need to be sealed through not recommended due to increased lot a secondary process to ensure that nonvariability, gel presence and difficulty in biocompatible (and possibly sharp) processing.) As long as you understand monofilaments don’t come into contact the advantages and limitations, there are a with the body or bodily fluids. variety of reinforcements and coatings that can enhance silicone tubing even more. M 6. Considering colors and coatings Although silicone is naturally clear or translucent, it can be pigmented in a Dan Sanchez is an R&D engineering variety of opaque or translucent colors. manager, principal engineer at Trelleborg However, when specifying a reinforced Sealing Solutions. 5 • 2017

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THE CATH LAB

Navtar expands medical tubing portolio The companyâ&#x20AC;&#x2122;s new thermoplastic microextrusion tubing offering could help drive innovation in surgical applications.

Heather Thompson Senior Editor |

Natvar, a Tekni-Plex company, has launched thermoplastic microextrusion tubing for surgical applications such as neurovascular interventional therapies. Microextrusion tubing offers a replacement for glass and fluoropolymers, and the company promises short development lead time. The new tubing option could help drive innovation in these therapeutic spaces. Microextruded options include monolayer, coextruded, multilumen tubing or profiles in a variety of thermoplastic (PVC, urethanes, TPEs) materials at CPK values above 2.0. Note: The CPK value indicates how close a process is running to its specification limits, relative to the natural variability of the process. The higher the index, the less likely it is that any item will be outside the specs. As a frame 124

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medical tubing product portfolio by making silicone extrusion tubing available to customers around the world. The company’s manufacturing facility in China, and its U.S.-based engineering and technical support offer options for pump applications in the global marketplace. The company says it offers improved economics over North American supply options. Silicone is an inert, biocompatible material that can hold tight-tolerances for demanding applications. Silicone extrusions are typically used for items such as catheters, feeding tubes, drug delivery and peristaltic pump applications. Donohue said he believes the supplier’s ability to keep tight control over the raw material supply chain in essential in ensuring that Navtar is a differentiator. M

of reference, a CPK of 1.33 or better is what medical device companies typically require. Thermoplastics keep costs down, particularly compared with fluoropolymers and glass, said Bob Donohue, general manager, Natvar. Natvar’s microextrusion tubing comes in wall thicknesses ranging from .003 in. to .005 in. and can be coextruded in up to four layers. The manufacturing line can also run fluoropolymers to deliver specific attributes or in instances when the company wants to avoid validating costs associated with a different material. Target applications for the microextrusion tubing line include IV cannulas, pediatric devices, infant microcatheters, guidewires, catheter leads and any others where diameter and tight tolerances are necessary to achieve product objectives. The company also recently expanded its

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ENGINEERING 911

Here’s how Integer is creating cutting-edge disposable surgical tools for orthopedics With health providers increasingly demanding single-use devices, Integer successfully created disposable bonecutting tools for its orthopedic device customers.

Gary Victor | Integer |

Conceptual images of Integer single-procedure orthopedic surgical instruments in development.

Image courtesy of Integer.

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Within healthcare today, there is a heightened focus on “value” – on the episode of care and the need to deliver improved patient care outcomes and lower overall costs. A related trend in the orthopedic segment involves the role instruments can play and how they can ensure optimal clinical outcomes while mitigating expenses associated with postoperative infections. Hundreds of thousands of hospital acquired infections (HAIs) occur in U.S. hospitals annually, requiring treatment costing tens of billions of dollars, according to U.S. Centers for Disease Control & Prevention. This, coupled with a growing requirement for instrument traceability, has led the orthopedic device industry toward disposable devices. These single-use solutions must live up to the promises of their original reusable versions to gain market acceptance. They must deliver on ever-critical performance, durability and value vectors. As a leading medical device outsource manufacturing company, Integer has an important role to play. We’ve been stepping beyond traditional roles and proactively presenting unique solutions to our partners. Ultimately, we bring these products and technologies to market by engaging with programs through all phases of the development and production life cycle. Our goal is to work through our customers to bring viable solutions to the medical device industry that enhance patients’ lives. To help our orthopedic device company customers, Integer identified three clinical focus areas for organic product development: product traceability, consistent cutting www.medicaldesignandoutsourcing.com

9/18/17 4:12 PM

Make everything except compromise. HP Jet Fusion 3D Printing is up to 10x1 faster at half the cost2.

1 Based on internal testing and simulation, HP Jet Fusion 3D printing solution average printing time is up to 10x faster than average printing time of comparable FDM & SLS printer solutions from $100,000 USD to $300,000 USD on market as of April 2016. Testing variables: Part Quantity -1 full bucket of parts from HP Jet Fusion 3D at 20% of packing density vs same number of parts on above-mentioned competitive devices; Part size: 30g; Layer thickness: 0.1mm/0.004 inches. Fast Cooling is enabled by HP Jet Fusion 3D Processing Station with Fast Cooling, available in 2017. HP Jet Fusion 3D Processing Station with Fast Cooling accelerates parts cooling time vs recommended manufacturer time of SLS printer solutions from $100,000 USD to $300,000 USD, as tested in April 2016. FDM not applicable. 2 Based on internal testing and public data, HP Jet Fusion 3D printing solution average printing cost-per-part is half the average cost of comparable FDM & SLS printer solutions from $100,000 USD to $300,000 USD on market as of April 2016. Cost analysis based on: standard solution configuration price, supplies price, and maintenance costs recommended by manufacturer. Cost criteria: printing 1build chambers per day/ 5 days per week over 1 year of 30-gram parts at 10% packing density using HP 3D High Reusability PA 12 material, and the powder reusability ratio recommended by manufacturer.

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ENGINEERING 911

use of a metal injection molding (MIM) manufacturing process. We used rapid prototyping in multiple design-build-test iterations to optimize cutting performance. Using DMLS to optimize performance, we began using MIM to produce parts. Through creative mold tooling design, we produced low-cost, single-use cutting heads that require no additional post-manufacturing processes and have proven to perform as well as re-usable machined metal systems currently on the market yet at a lower cost.

Conceptual images of Integer single-procedure orthopedic surgical instruments in development. Image courtesy of Integer.

tool sharpness and repetitive cleanliness. Based on the design team’s expertise in design control, unique manufacturing methods, material science knowledge and the state of the art mechanical testing labs, the obvious entry point was disposable bone-cutting tools. These highuse instruments are difficult to clean, require consistent sharpness and experience supply chain challenges in some markets such as rural settings and ambulatory surgery centers (ASC). The trauma market was also a natural fit due in part to the inability to forecast emergencies, which exacerbates supply chain issues. Our engineers carefully evaluated our customers’ portfolios to identify gaps and launched research and development programs to meet those needs. We now have several programs underway in various phases of the development cycle and recently collaborated on a new product introduction by one of our partners. Products in development include a single-procedure intramedullary reamer, single-procedure patella reamer, single-procedure acetabular reamer and more. Here are three important ways we’ve helped create single-use bonecutting tools that perform as well as the reusable kind: 1. Innovative design Utilizing innovative design techniques, we changed the paradigm of cutting tools production without compromising performance. Each step of our approach required ingenuity. First we compared the performance of existing, reusable cutting heads to cutting heads of the same design manufactured with direct metal laser sintering (DMLS). Through extensive testing and analysis, we identified specific improvements that could be anticipated through the 128

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2. Using lower-cost materials without compromising performance The durability of a cost-effective shaft represented the next challenge for the design team. Using predicate wirewound and nitinol reusable shafts to set performance requirements, the team tested several lower-price options against established standards used by the reusable systems already on the market – and selected a carbon fiber cannulated shaft. To mitigate torque related performance when using the carbon fiber shaft intraoperatively, the team included two additional features. The first was a proximal torque slip mechanism that would control and limit amounts of torque that could be applied to the shaft. The second feature was an outer sleeve to provide a material barrier and fully encapsulate the shaft. These features ensure the product can be used safely and withstand aggressive use –without causing harm to the patient.

This chart shows how a predicate reusable device requires more torque to advance when cutting samples than Integer’s disposable cutting head. Image courtesy of Integer.

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3. Testing systems to prove we got it right Equally important in designing and manufacturing our products is testing. When pursuing new technologies, we feel it is critical to characterize and compare performance and safety against currently used products. We used our deep knowledge and experience in material sciences and orthopedic cutting to design and produce custom test equipment and fixtures. Our rigor and focus around mechanical testing included the development of a truly unique powered delivery system that utilizes analytical and computer based simulations. These systems were leveraged to not only analyze current design performance, but also to help predict and evaluate alternative design performance. This allows us to demonstrate with absolute certainty that our single-use instruments are substantially equivalent to predicate re-usable devices, thus ensuring performance and patient safety is never compromised. (See the two charts with this article for examples.) The result Stepping out of a traditional outsourcer role to get closer to our customers and better understand their needs and constraints has enabled us to proactively provide innovative solutions that address some of the most pressing challenges in the orthopedic surgery market today. In this case, we took an existing reusable product and re-engineered it for disposable use, which led to a new fully designed system. The comprehensive solution has received high praise from our market leading customer base and proven successful in numerous settings, including Integer and customer testing labs as well as co-sponsored cadaver labs. While it is difficult to predict exactly where the market is trending in the coming five to 10 years, Integer is proving that by finding gaps in the instrument space, while also remaining aware of current market dynamics, it is possible to identify customer-enabling solutions. M 9 â&#x20AC;˘ 2017

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JOHNSON: One of the things that we are always remarking on is the impact that GE chairman and former CEO Jeff Immelt has had on the medtech industry, when you consider all the people that have worked for him and who have gone on to lead medtech companies. In fact, DeviceTalks could be called the Jeff Immelt Alumni Assn. Boston Scientific CEO Mike Mahoney, Abiomed CEO Mike Minogue, Medtronic CEO Omar Ishrak, yourself – the list goes on and on and on. What do you think is the reason that so many CEOs have come out of this world? WOLD: I think GE has been a very good breeding ground for innovation. And in GE, you have a few things that other companies wouldn't have. There are some resources … everything from supply chain globalization. You get the distribution arm, you get the branding, all these different things. And on top of that, you have very, very strong management skills and experienced people involved. Jeff Immelt was very true to specialization, domain knowledge, to staying close to market versus other companies that prioritize general management and commodities and things like that. So I think those are the drivers behind this. Now, you could also argue, why isn't everybody staying? I think there's also a very good breeding ground for managers to do this, and consequently there are other options on the table, frequently. So, others try to venture out. I think that's a natural kind of evolution of that. Hear from Wold and many more of medtech's best minds at DeviceTalks Boston on Oct. 2. http://www.devicetalks.com/devicetalks-boston-2017/ www.medicaldesignandoutsourcing.com

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PRODUCT WORLD

RENCO encoder for blood pumps The RENCO RCML 15 rotary encoder from Heidenhain, often used for preferred feedback in automated medical devices, is now featured in motors for blood pumps. With its slim and lightweight design, the encoder gives motion and speed feedback in blood pump motors that are usually in hematology analyzers. The motor designers are more flexible when using the RCML 15 rotary encoder, freeing up space and weight. It also uses brushless motor communication pulses and incremental position feedback while simultaneously improving performance and reliability of the brushless motor/encoder package. The encoder has an installation length of 49mm, an operation length of 42.4mm, a width of 38.9mm and a height of 8.9mm. Heidenhain heidenhain.com

Sepac’s spring-engaged tooth brakes

Plastisol Y connectors from Qosina Qosina recently released a variety of Y connectors made of plastisol, which is used to make flexible components. The plastisol material, also known as liquid polyvinyl chloride (PVC) is Class VI approved and BPA- and latexfree. Qosina’s Y connectors are made using dip molding and not injection molding. The use of dipping dies during production makes for easily scalable production in a costeffective manner. The company’s Y connectors come in standard and universal. Customers can choose from a variety of connectors that are horseshoe-shaped, three-way connectors or reinforced Y connectors. Qosina qosina.com

Sepac’s new SETB electromagnetic spring-engaged tooth brakes are designed to be used in medical applications. Its power-off brake has large bore sizes, low backlash, high torque-to-size ratio, high number of index positions, positive engagement and a reliable coil to provide custom voltage options. It also has a less than 0.5° of backlash within the brake if properly installed, high-temperature Class H insulation with fully potted coil rated for 180°C, 2:1 size reduction and lead wires can be fed through the bore or rear of the magnet body. Sepac sepac.com

www.medicaldesignandoutsourcing.com

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PRODUCT WORLD

Titanium coatings for PEEK substrates from Orchid Orthopedics Orchid Orthopedics is touting its HeniaPore titanium orthopedic coatings for PEEK materials. Porous titanium coatings help protect the mechanical properties of the PEEK substrates it covers. It is also porous in nature and offers no deterioration of mechanical properties. Because it is a VPS coating, it also exceeds the ASTM requirements and eliminates cracking of an implant. The coating is also capable of keeping the implant under 200ยบC in the event that the implant is exposed to high temperatures. The pure titanium coating is made in a two-step process. First, the surface is prepared. Then, microporous titanium plasma is sprayed on the implant. The entire process helps create strong adhesion to the titanium VPS coating. Orchid Orthopedics orchid-ortho.com

Hydrophilic coating technology from Teleflex Medical Teleflex Medical recently released a hydrophilic surface coating for polymer-based devices that are usually navigated through the vascular system. The coating has shown to be efficient in lubricity and extended durability. It is also biocompatible and has shelf-life stability with low particulate count in testing and adhesion to substrate materials. The coating is customizable for any performance characteristics needed for specific tasks. The company suggests that its hydrophilic coating could be used for introducers, diagnostic catheters, balloon catheters and components while reducing insertion force. The maximum device length it can be used on it 2m. The maximum coated length is 1.3m. Teleflex Medical teleflexmedicaloem.com

Dymax needlebonding adhesive Dymax is touting its new 1406-M needle-bonding adhesive for manufacturers who want to switch to LED curing in small-gauge needle applications. The 1406-M bonding adhesive is designed to be used on smaller surface areas of cannulas and is able to withstand aging and sterilization to reduce cannula substrate failure. The adhesive can be cured with 385nm or 406nm UV wavelength light sources to bond multiple substrates typically used in the manufacturing of needle assemblies and syringes or other medical devices. It also fluoresces blue of in-line inspection under a lowintensity black light. It can be bonded to stainless steel, PP, PE, ABS, PC, PEI, PETG, PMMA, PS, and PVC. Dymax dymax.com

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Zeus Industrial’s extremely thin-walled extrusions Zeus Industrial Products announced that it has launched its new PTFE Sub-Lite-Wall Streamliner extrusion series. Zeus’ Sub-Lite-Wall StreamLiner XT tubing offers maximum wall thickness of 0.00075 in. and features the company’s LoPro technology. The StreamLiner series also offers a stronger and more robust catheter liner with reduced deployment force and are available for purchase through Zeus’ website. The Sub-LiteWall adds to Zeus’ line of extremely thin-walled extrusions and represents the latest breakthrough in the company’s catheter line. The product line further advances the company’s catheter design that improves patient care and clinical outcomes. Zeus zeusinc.com

ABM’s new traction drive system solutions ABM recently released new traction drive system solutions for medical machine travel motion control and electric vehicles. The solutions are available as bevel gearboxes, helical gearboxes and hub wheel drives. The drives are efficient and quiet, according to the company, and can be used in forklifts, pallet trucks and sweeper/scrubbers. ABM motors and drive systems have a long life with no unexpected downtimes, compact design, low maintenance and can be easily integrated into any vehicle. Traction motors are available in up to 16 kW outputs with a duty cycle of 52-60 minutes. Induction and Sinochron motors have high-power density and are reliable. Gearbox designs can be easily adapted to the requirement of any vehicle and motors come with sensor bearings or coils. ABM abm-drives.com

Stainless Steel. Standard Parts. Winco.

Explore our full line at www.jwwinco.com or contact us with your application requirements. Sales@jwwinco.com Phone: 800-877-8351 Fax: 800-472-0670

JWWinco.com www.medicaldesignandoutsourcing.com

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JW Winco offers stainless steel parts for industry with very high corrosion resistance, hygienic properties, and the ultimate in material quality.

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AD INDEX

SALES Mike Caruso mcaruso@wtwhmedia.com 469.855.7344 Michael Ference mference@wtwhmedia.com 408.769.1188 @mrference David Geltman dgeltman@wtwhmedia.com 516.510.6514 @wtwh_david Jim Powers jpowers@wtwhmedia.com 312.925.7793 @jpowers_media Tom Lazar tlazar@wtwhmedia.com 408.701.7944 @wtwh_Tom Courtney Seel cseel@wtwhmedia.com 440.523.1685 @wtwh_CSeel Neel Gleason ngleason@wtwhmedia.com 312.882.9867 @wtwh_ngleason Jessica East jeast@wtwhmedia.com 330.319.1253 @wtwh_MsMedia Mary Ann Cooke mcooke@wtwhmedia.com 781.710.4659 Mike Francesconi mfrancesconi@wtwhmedia.com 630.488.9029 Michelle Flando mflando@wtwhmedia.com 440.670.4772 @mflando Garrett Cona gcona@wtwhmedia.com 213.219.5663 @wtwh_gcona

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Accumold............................................................ 37 Acorn Product Development........................... 119 AdvaMed........................................................... 132 AIM Plastics......................................................... 35 Arthur G. Russell Co., Inc................................... 65 Asahi Intecc....................................................... 125 ASCO..................................................................... 1 B.Braun............................................................... BC Bal Seal Engineering, Inc................................. 102 Binder USA.......................................................... 75 Biomedical Polymers.......................................... 33 Bluestar Silicone................................................. 79 Bodine Electric Company.................................... 3 Cadence Inc........................................................ 17 CGI....................................................................... 26 Chieftek Precision USA.......................... 59, 61, 63 Cicoil.................................................................... 93 Clippard Instrument Laboratory, Inc................... 9 COMSOL, Inc...................................................... 89 CPC-Colder Products......................................... 19 Design Standards Corporation.......................... 81 Donatelle............................................................. 46 Dunkermotoren................................................ 107 Eagle Stainless Tube........................................... 56 Fischer Connectors............................................. 53 Fotofab.............................................................. 111 Ft. Wayne Metals................................................ 31 Helical Products Company................................ 91 HP 3D Printing.................................................. 127 ICON.................................................................. 113 Integer Holdings................................................... 6 Interpower........................................................... 11 Introtek International.......................................... 73 IXYS.................................................................... 112 J.W. Winco, Inc................................................. 135 Jordi Labs.......................................................... 108 Keystone Solutions Group................................. 57 Lin Engineering................................................... 24 Magnet Applications........................................ 103

Master Bond.......................................................... 7 maxon precision motors.............cover/corner, 97 Medbio.............................................................. 109 MEDEFAB............................................................ 22 Memory Protection Devices, Inc....................... 20 Merit Medical OEM............................................ 39 MicroLumen.............................................. 120, 121 MICROMO.......................................................... 16 Model Solution................................................... 83 MTD Micro Molding........................................... 86 MW Industries Aerospace Solutions............... 101 NB Corporation.................................................. 12 Nelson Laboratories, LLC................................ 115 New England Catheter....................................... 45 New England Wire............................................. 47 Nitto Kohki............................................................ 7 ODU-USA, Inc..................................................... 44 Okay Industries..................................................... 5 Orchid Orthopedic Solutions............................ 55 Proto Labs........................................................... 51 PTI Engineered Plastics...................................... 41 Renishaw.............................................................. 49 Resonetics......................................................... IFC REVOX Sterilization Solutions........................... 95 SCHOTT Electronic Packaging.......................... 52 Smalley Steel Rings............................................ 43 SMC Ltd............................................................. 104 Solenoid Solutions, Inc..................................... 100 Spectrum Plastics................................................ 18 Stäubli Electrical Connectors, Inc...................... 28 STEUTE Meditech, Inc........................................ 15 Tech-Etch, Inc.................................................... 123 Tegra Medical................................................... IBC THK TOS................................................................ 2 Toxikon Corporation........................................... 77 TUV Rheinland.................................................. 105 Universal Robots............................................... 117 Valtronic............................................................. 129 Wabash MPI........................................................ 50

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MEDICAL DESIGN & OUTSOURCING does not pass judgment on subjects of controversy nor enter into disputes with or between any individuals or organizations. MEDICAL DESIGN & OUTSOURCING is also an independent forum for the expression of opinions relevant to industry issues. Letters to the editor and by-lined articles express the views of the author and not necessarily of the publisher or publication. Every effort is made to provide accurate information. However, the publisher assumes no responsibility for accuracy of submitted advertising and editorial information. Non-commissioned articles and news releases cannot be acknowledged. Unsolicited materials cannot be returned nor will this organization assume responsibility for their care. MEDICAL DESIGN & OUTSOURCING does not endorse any products, programs, or services of advertisers or editorial contributors. Copyright©2017 by WTWH Media, LLC. No part of this publication may be reproduced in any form or by any means, electronic or mechanical, or by recording, or by any information storage or retrieval systems, without written permission from the publisher. SUBSCRIPTION RATES: Free and controlled circulation to qualified subscribers. Non-qualified persons may subscribe at the following rates: U.S. and possessions, 1 year: $125; 2 years: $200; 3 years $275; Canadian and foreign, 1 year: $195; only U.S. funds are accepted. Single copies $15. Subscriptions are prepaid by check or money orders only. SUBSCRIBER SERVICES: To order a subscription or change your address, please visit our web site at www.medicaldesignandoutsourcing.com MEDICAL DESIGN & OUTSOURCING (ISSN 2164-7135) is published six times per year: January, March, May, July, September and November by WTWH Media, LLC. 6555 Carnegie Ave., Suite 300, Cleveland, Ohio 44103. APPLICATION TO MAIL AT PERIODICALS POSTAGE PRICES AND ADDITIONAL OFFICES IS PENDING AT CLEVELAND, OH. POSTMASTER: Send address changes to WTWH Media LLC, 6555 Carnegie Ave., Suite 300, Cleveland, Ohio 44103

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CMY

When it comes to medical devices, Tegra Medical offers the whole hog. With our wide range of manufacturing capabilities, Tegra Medical is an expert at creating your entire medical device. We’ll help refine your design and ensure it can be manufactured efficiently, prototype and pilot-produce it, and handle full-scale production. From the “business end” to the handle and everything in between, we’ll manufacture the whole device, then finish, assemble and package. With a single vendor you get your devices to market quickly and cost-effectively, with consistently high quality. Tegra Medical is your end-to-end solutions provider from head-to-tail. Count on Tegra Medical to be your end-to-end solutions provider, from DFM and prototyping to finished devices and assembly and packaging.

tegramedical.com  508.541.4200

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Where medical devices come to life.SM

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BOSTON MEMPHIS COSTA RICA

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If you’re looking for a single-source supplier, how about one that has a full range of parenteral

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& there’s more. Besides a line containing hundreds of products, we offer a full range of capabilities. Project management puts your product on a fast track to market without compromising quality. Our engineering and quality systems maintain exacting standards of excellence. Other services under our roof include full sterilization capabilities and regulatory expertise to ensure compliance in this country and around the world. It all adds up to a single-source supplier that goes far beyond being a vendor to being a true partner. Visit BBraunOEM.com.

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