Medical Design & Outsourcing — SEPTEMBER 2018 by WTWH Media LLC

www.medicaldesignandoutsourcing.com SEPTEMBER 2018

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Medical Design & OUTSOURCING medicaldesignandoutsourcing.com ∞ September 2018 ∞ Vol4 No5

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

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HERE’S WHAT WE SEE

Consolidation is still the name of the game The pace of consolidation only increased during 2017, as evidenced by our annual look at the world’s 100 largest medical device makers. The first thing that struck us about this year’s Big 100 list is how much lower the bar was to get in. Last year, the 100thranked firm, Alphatec, eked its way on the list with revenues of $120.2 million. This year, the bar was set at $40.4 million by EDAP. The driver, as ever, was consolidation. Although it hardly seems possible, if anything medtech’s fervor for M&A – as documented in our Big 100 issues from the past few years – only increased last year. In fact, dating back to March 2012 and Fujifilm’s $1 billion buyout of Sonosite, former residents of the Big 100 drew a collective $241.4 billion from acquirers:

COMPANY

DATE

ACQUIRER

DEAL VALUE

Sonosite Arthrocare Medical Action Industries Nobel Biocare Covidien CareFusion Allergan Biomet Hospira Welch Allyn Merge Healthcare Thoratec Volcano Sirona Dental Systems Mindray Medical Toshiba Medical Symmetry Surgical HeartWare St. Jude Medical Vascular Solutions CynoSure Syneron Candela Spectranetics C.R. Bard Exactech Esaote Analogic

March 2012 May 2014 October 2014 January 2015 January 2015 March 2015 March 2015 June 2015 September 2015 September 2015 October 2015 October 2015 February 2016 February 2016 March 2016 June 2016 July 2016 August 2016 January 2017 February 2017 March 2017 July 2017 August 2017 December 2017 February 2018 April 2018 June 2018

Fujifilm Smith & Nephew Owens & Minor Danaher Medtronic Becton Dickinson Actavis (merger) Zimmer (merger) Pfizer Hill-Rom IBM St. Jude Medical Royal Philips Dentsply (merger) management buyout Canon RoundTable Healthcare Medtronic Abbott Teleflex Hologic Apax Partners Royal Philips BD TPG Capital Wandong and co. Altaris Capital

$1,000,000,000 $1,700,000,000 $207,000,000 $2,100,000,000 $50,000,000,000 $12,000,000,000 $66,000,000,000 $14,000,000,000 $15,000,000,000 $2,000,000,000 $1,000,000,000 $3,000,000,000 $1,200,000,000 $5,600,000,000 $3,000,000,000 $6,500,000,000 $140,000,000 $1,100,000,000 $25,000,000,000 $1,000,000,000 $1,700,000,000 $400,000,000 $2,000,000,000 $24,000,000,000 $737,000,000 $0 $1,000,000,000

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

Medical Design & Outsourcing

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| | | |

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Of course, this only reflects a small portion of medtech’s M&A deal volume (albeit a large portion of its M&A spend). As always, there was a plethora of smalland mid-sized transactions; as of this writing in mid-September, our team had reported on nearly 170 acquisitions and divestitures this year alone. Finally, a note on our methodology. We begin the process early each year as companies’ annual results begin to arrive. Once late summer rolls around and the companies with non-calendar fiscal years have reported in and the list begins to shape up, we attempt to contact each company to confirm the information. We then compile the listings, ranking the companies first according to annual revenues, then by R&D spend and number of employees.

We use data from the most recently concluded fiscal year for each company, plus information from our own archives, corporate documents and public regulatory filings, and the companies’ websites. For diversified companies with businesses in non-medical device areas, we exclude those results from our tabulations. For foreign currency conversions, we use the prior year’s average exchange rates as set by the U.S. Federal Reserve. M

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CONTRIBUTORS

DYKEMAN

LAURIA

NAPPI

WEST

DAVID J. DYKEMAN is a registered patent attorney with more than 20 years of experience in patent and intellectual property law, and co-chair of Greenberg Traurigâ&#x20AC;&#x2122;s global Life Sciences & Medical Technology Group. Dykeman's practice focuses on securing worldwide intellectual property protection and related business strategy for medical device clients, with particular experience in medical devices, wearables, robotics, life sciences and information technology. MAURIZIO LAURIA has more than 18 years of application engineering and product management experience with Schmersal and Steute Meditech. He holds a B.E. in electrical engineering and B.S. in applied mathematics from Stony Brook University and an MBA from Marist College.

MARTIN NAPPI, a 30-year veteran of the embedded systems industry, is VP of business development, medical devices and systems for Green Hills Software. PATRICK WEST is a partner and leads the healthcare technology practice at Mirus Capital Advisors, where he focuses on helping companies maximize enterprise and exit value. As a former medtech executive, business founder and company director, he brings the perspective of having sat on all sides of the negotiating table, allowing unique insights and an informed ability to navigate the deal process. Patrick also provides angel investment and strategic direction to a portfolio of companies.

CONNECT WITH US! CHECK US OUT ON ISSUU! 8

Medical Design & Outsourcing

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CONTENTS

medicaldesignandoutsourcing.com ∞ September 2018 ∞ Vol4 No5

DEPARTMENTS 6

HERE’S WHAT WE SEE: Consolidation is still the name of the game

8 CONTRIBUTORS

1OO

ON THE COVER:

BIG 100 BREAKDOWN

104

IP ISSUES: Strong patent portfolios attract strategic investments and deals

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

110 CYBERSECURITY: Medical IoT and the challenges for healthcare 116 DESIGN: Smithwise helps XPrizewinning startup find its focus

14 Big 100 Breakdown

120

Lessons from 20 years of making wireless

94 Top R&D Spenders

ENGINEERING 911:

footswitches

Who’s putting the most into the pipeline?

98 Top Medical Device Employers

124 PACKAGING: Packaging facts you need to know

100 Another big year for medtech M&A

128

management simpler with

132

forefront of innovation 136

Medical Design & Outsourcing

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DEVICE TALKS: How Jeff Karp stays at the

cash-laden companies scooped up smaller firms.

Making diabetes a tubeless pump

The breakneck pace of consolidation continued in 2017, significantly reducing the pool of Big 100 companies, as

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S S S

COMPANIES RANKED BY REVENUE

“THE OPPORTUNITY IS TO GET EVERYBODY ENGAGED. EVERYBODY SHOULD HAVE THIS GENERAL ATTITUDE THAT THEY CAN INNOVATE, THAT THEY CAN BRING NEW IDEAS TO THE TABLE.” – VP OF R&D, BOSTON SCIENTIFIC

RANDY SCHIESTL

Medical Design & Outsourcing

Revenue Rank_9-18_Vs3-CN-FINAL.indd 14

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RANK

COMPANY

REVENUES ($USD)

Medtronic $29,953,000,000

Johnson & Johnson (medical device segment) $26,592,000,000

Fresenius (medical care segment) $20,095,920,000

Royal Philips $20,091,400,000

GE Healthcare (General Electric) $19,116,000,000

Cardinal Health (medical segment) $16,000,000,000

Siemens Healthineers $15,581,570,000

Danaher (life sciences, diagnostics & dental segment) $14,360,900,000

Henry Schein $12,461,543,000

Stryker $12,444,000,000

Baxter $10,561,000,000

Owens & Minor $9,318,275,000

Boston Scientific $9,048,000,000

Abbott (Cardiovascular and Neuromodulation) $8,911,000,000

Essilor $8,475,000,000

Becton, Dickinson (medical segment) $8,105,000,000

Zimmer Biomet $7,824,100,000

B. Braun Melsungen $7,671,457,000

Novartis (Alcon segment) $6,024,000,000

3M Co. (healthcare segment) $5,813,000,000

Olympus (medical business) $5,498,046,387

Smith & Nephew $4,765,000,000

Terumo $4,586,654,773

Dentsply Sirona $3,993,400,000

Fujifilm Holdings (healthcare only) $3,951,828,724

Edwards Lifesciences $3,435,300,000

Hoya (life care segment) $3,147,832,293

Intuitive Surgical $3,128,900,000

Hologic $3,058,800,000

Hill-Rom $2,743,700,000

Getinge $2,720,763,434

Sonova $2,688t,376,346

Nipro (medical segment) $2,677,225,691

Varian Medical Systems $2,668,200,000

Steris $2,619,996,000

BioMerieux $2,585,666,000

Coloplast $2,354,261,110

ResMed $2,340,196,000

Paul Hartmann $2,326,218,000

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S S S

COMPANIES RANKED BY REVENUE RANK

COMPANY

REVENUES ($USD)

Teleflex $2,146,303,000

Cooper Cos. $2,139,000,000

William Demant (hearing segments) $1,999,636,127

44 Drägerwerk (medical business) $1,884,840,000

“WE NEED TO ADD VALUE TO THE EQUATION SO THAT PHYSICIANS, HOSPITALS AND PAYERS CAN CAPITALIZE ON THE BENEFIT OF THESE THERAPIES. WE’RE STILL IN THE EARLY INNINGS IN TERMS OF APPLYING INFORMATION TO DRIVE EFFICIENCY.” – SVP OF CARDIAC ARRHYTHMIAS AND HEART FAILURE, ABBOTT

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9 • 2018

Bruker $1,765,900,000

ConvaTec $1,764,600,000

Miraca $1,743,086,530

Nihon Kohden $1,554,406,780

Align Technology $1,473,413,000

Amplifon $1,430,580,000

Fisher & Paykel Healthcare $1,379,271,551

Elekta $1,370,722,916

Cochlear $1,351,400,000

Carl Zeiss Meditec $1,344,587,000

ICU Medical $1,292,613,000

Smiths Medical (Smiths Group) $1,225,839,000

Fukuda Denshi $1,212,660,147

Agfa-Gevaert (healthcare segment) $1,188,760,000

Integra Lifesciences $1,188,236,000

DJO Global* $1,186,206,000

Integer (formerly Greatbatch) $1,136,000,000

Straumann $1,114,335,200

NuVasive $1,029,520,000

LivaNova (formerly Sorin/Cyberonics) $1,012,277,000

Kawanishi Holdings $968,967,000

Omron (healthcare segment) $967,885,816

Invacare $966,497,000

Haemonetics $903,923,000

Konica Minolta (healthcare segment) $860,838,537

GN Hearing $851,312,219

Masimo $798,108,000

Conmed $796,392,000

Wright Medical $744,989,000

Merit Medical Systems $727,852,000

Dexcom $718,500,000

Avanos Medical (formerly Halyard Health) $611,600,000

Abiomed $593,749,000

Össur $569,000,000

JMS Co. $531,797,000

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S S S

COMPANIES RANKED BY REVENUE RANK

COMPANY

REVENUES ($USD)

Nikkiso (medical segment) $485,789,474

Insulet $463,768,000

Orthofix $433,823,000

Topcon (eye care segment) $414,942,016

Accuray $404,897,000

Asahi Intecc (medical field segment) $397,885,816

NxStage Medical $393,941,000

BTG (Interventional Medicine business) $313,098,100

RTI Surgical $279,563,000

Barco (healthcare division) $274,883,800

K2M Group Holdings $258,031,000

Cardiovascular Systems $217,043,000

CryoLife $189,702,000

AtriCure $174,716,000

SeaSpine $131,814,000

Sectra (Imaging IT division) $124,861,331

Alphatec $101,739,000

ConforMIS $78,115,000

Utah Medical Products $41,414,000

100

EDAP $40,392,980

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THE TOP 1OO MEDTECH COMPANIES

1OO

MEDTRONIC Fridley, Minn.

2017 revenues: $29,953,000,000 2017 R&D spend: $2,253,000,000

Fiscal year ending: April 27, 2018 Employees: 86,000

KEY PERSONNEL:

OMAR ISHRAK, chairman & CEO; MICHAEL COYLE, EVP & president, cardiac & vascular; MIKE GENAU, SVP & president, Americas Region; ALEX GU, SVP & President, Greater China; HOOMAN HAKAMI, EVP & president, diabetes; DR. RICHARD KUNTZ, SVP, chief medical & scientific officer; CHRIS LEE, SVP & president, Asia Pacific; BRAD LERMAN, SVP, general counsel & corporate secretary; GEOFFREY MARTHA, EVP & president, restorative therapies; KAREN PARKHILL, EVP & CFO; LUANN PENDY, SVP, chief quality & regulatory affairs officer; MARK PLOOF, SVP, global operations & business services; CAROL SURFACE, SVP & chief human resources officer; ROB TEN HOEDT, EVP & president, Europe, Middle East & Africa region; BOB WHITE, EVP & president, minimally invasive therapies

he world’s largest medical device business ended the calendar year by weathering a wildfire that savaged Santa Rose, Calif., leaving its two facilities there untouched by the flames but unreachable for a spell. The company began 2018 by announcing a restructuring plan that aims to save $3 billion annually by the end of its 2022 fiscal year. Although Medtronic said its overall headcount would remain largely unchanged, there will be some churn as positions are eliminated and other new roles created. The company is also looking to refinance its debt with a $1.2 billion plan to buy back some of its senior notes. On the M&A front Medtronic had a relatively quiet year; late in 2017 it picked up gastrointestinal disorder diagnostic company Crospon for $45 million including milestones

and the next month closed the $28 million buyout of QT Vascular’s Chocolate PTA balloon. In May Medtronic dealt its stake in China’s LifeTech Scientific to China Everbright and another unnamed investor. This year also saw the company restart its bid for U.S. approval of its renal denervation treatment for hypertension with the launch of a pivotal study of its of its Symplicity Spyral device. And after FDA approved its SynchroMed II implantable drug infusion pump for use with Remodulin to treat pulmonary arterial hypertension, the device was nominated for the prestigious Prix Galien USA award for the best medical technology of the year. And after reporting fiscal 2018 numbers that beat the consensus forecast in May, Medtronic targeted organic revenue growth of 4% or above and adjusted earnings per share growth of 8% over the next few years. M

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THE TOP 1OO MEDTECH COMPANIES

1OO

JOHNSON & JOHNSON New Brunswick, N.J. * Revenues from Johnson & Johnson’s medical device segment.

2017 revenues: $26,592,000,000 2017 R&D spend: $1,610,000,000

Fiscal year ending: December 31, 2017 Employees: 60,000

KEY PERSONNEL:

ALEX GORSKY, chairman & CEO; JOAQUIN DUATO, vice chairman of executive committee; PETER FASOLO, EVP, chief human resources officer; ASHLEY MCEVOY, EVP, worldwide chairman, medical devices; SANDRA PETERSON, worldwide chair; MICHAEL SNEED, EVP, global corporate affairs & chief communication officer; DR. PAUL STOFFELS, vice chair of executive committee & chief scientific officer; JORGE MESQUITA, EVP, worldwide chairman, consumer; JENNIFER TAUBERT, EVP, worldwide chairman, pharmaceuticals; MICHAEL ULLMANN, EVP, general counsel; KATHY WENGEL, EVP & chief global supply chain officer; JOSEPH WOLK, EVP & CFO

ohnson & Johnson continued the transformation of its medtech business last year, after a flurry of M&A deals in 2016 culminated with the $4.3 billion acquisition of Abbott Medical Optics early in 2017. That bet on the vision care market (including the buyouts of picked up TearScience and Sightbox) roughly coincided with a wager on the diabetes market the other way, when J&J announced that it would seek to sell off its LifeScan, Animas and Calibra

Medical brands. The company later decided just to shutter the Animas insulin pump business, dealing the LifeScan blood glucose monitoring unit to Platinum Equity for more than $2 billion and selling Calibra to CeQur in July 2018 for an undisclosed amount. J&J further pared the medtech business with a $1.05 billion deal for its Codman Neurosurgery business to Integra LifeSciences. Also last year, longtime finance chief Dominic Caruso retired and was replaced by Joseph Wolk. M

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THE TOP 1OO MEDTECH COMPANIES

1OO

FRESENIUS Bad Homburg, Germany * Revenues from Fresenius’ medical care segment.

2017 revenues: $20,095,920,000 (€17,784,000,000)

2017 R&D spend: $148,030,000 Fiscal year ending: December 31, 2017

KEY PERSONNEL:

RICE POWELL, chairman; MICHAEL BROSNAN, CFO; DR. OLAF SCHERMEIER, CEO for global R&D; KENT WANZEK, CEO for global manufacturing & quality; BILL VALLE, CEO for Fresenius Medical Care North America; HARRY DE WIT, CEO for Fresenius Medical Care Asia-Pacific

he big news from Fresenius Medical Care this year was the same as last year’s: the $2 billion pickup of NxStage Medical that, as of this writing in mid-September 2018, had yet to close. (It’s on track to meet its Nov. 5 deadline, the German hemodialysis giant said in July). Also that month, Fresenius dealt its Sound Inpatient Physicians business for $2.2 billion to an

investment consortium led by Summit Partners. But another deal, the $4.3 billion merger with U.S. generic drugmaker Akorn, foundered after Fresenius said its due diligence process uncovered material breaches of FDA data integrity requirements. (The companies later exchanged lawsuits over the spiked deal that are still under way). Fresenius also inked a $150 million deal with Humacyte for the exclusive rights to commercialize the Humacyl bioengineered blood vessel. M

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THE TOP 1OO MEDTECH COMPANIES

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ROYAL PHILIPS Amsterdam, the Netherlands

2017 revenues: $20,091,400,000 (€17,780,000,000)

2017 R&D spend: $1,993,320,000 Fiscal year ending: December 31, 2017 Employees: 73,951

KEY PERSONNEL:

FRANS VAN HOUTEN, CEO; EGBERT VAN ACHT, EVP, chief business leader, personal health; SOPHIE BECHU, EVP, chief of operations; ABHIJIT BHATTACHARYA, EVP & CFO; ROB CASCELLA, EVP, chief business leader, diagnosis & treatment; MARNIX VAN GINNEKEN, EVP & chief legal officer; ANDY HO, EVP & CEO of Philips Greater China; HENK SIEBREN DE JONG, EVP, chief of international markets; RONALD DE JONG, EVP, chief human resources officer & chairman of the Philips Foundation; CARLA KRIWET, EVP, chief business leader of connected care & health informatics; VITOR ROCHA, EVP, CEO of Philips North America; JEROEN TAS, EVP, chief innovation & strategy officer

hilips continued a major pivot away from its legacy lighting business to focus on the healthcare market, with a special emphasis on the value-based segment. The Dutch company also continued its series of agreements with healthcare providers, including an 11-year deal in June 2018 with Jackson Health to provide patient monitoring services on a per-patient fee basis and the addition of 10 providers to its Wellcentive population health management program in October 2017. And the company announced plans in January this year to shift its North American headquarters to biotech hotspot Cambridge, Mass. The transformation also involved a slew of acquisitions; here are just a few:

• • • • • •

Remote Diagnostic Technologies (undisclosed, June 2018) EPD Solutions ($293 million, June 2018) Digirad’s sales & service business ($8 million, February 2018) VitalHealth (undisclosed, December 2017) Forcare (undisclosed, December 2017) Analytical Informatics (undisclosed, November 2017)

Philips also said it plans to shutter manufacturing operations at a Cleveland plant that makes computed tomography scanners as part of a $600 million R&D initiative. M

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THE TOP 1OO MEDTECH COMPANIES

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GE HEALTHCARE Chicago, Ill.

2017 revenues: $19,116,000,000 2017 R&D spend: $1,016,000,000

Fiscal year ending: December 31, 2017 Employees: 52,000

KEY PERSONNEL:

KIERAN MURPHY, president & CEO; EMMANUEL LIGNER, president & CEO of GE Healthcare Life Sciences; MAHER ABOUZEID, president & CEO of GE Healthcare, Eastern Growth Markets; TOM MCGUINNESS, president & CEO, GE Healthcare Imaging; TERRI BRESENHAM, chief innovation officer, GE Healthcare; LEE COOPER, president & CEO, U.S. & Canada; RACHEL DUAN, president & CEO, GE Healthcare China; LAURENT DUBOIS, CEO, GE Healthcare Partners; CATHERINE ESTRAMPES, president & CEO, GE Healthcare Europe; THOMAS MITCHELL, acting VP, global supply chain; LAURA O’DONNELL, VP & general counsel; MONISH PATOLAWALA, VP, CFO & chief digital officer; SOICHIRO TADA, president & CEO, GE Healthcare Japan; LUIZ VERZEGNASSI, president & CEO, GE Healthcare Latin America; THOMAS WESTRICK, VP & chief quality officer; ANDERS WOLD, president & CEO, clinical care solutions; WILL SPIERS, chief communications officer; JAN MAKELA, president & CEO, GE Healthcare Global Services; KATYA KRUGLOVA, VP, human resources; MYRA ESKES, president & CEO, GE Healthcare ASEAN, Korea & ANZ; NALINIKANTH (NAL) GOLLAGUNTA, president & CEO, GE Healthcare India & South Asia; FARID FEZOUA, president & CEO, GE Healthcare Africa

arent company General Electric is looking to transform itself under new CEO John Flannery (the former healthcare chief who succeeded Jeff Immelt last year), announcing plans to shift its worldwide headquarters to Boston and spin out its GE Healthcare subsidiary as a stand-alone, publicly traded entity. GE is also planning

an “orderly separation” from its 62.5% stake in the BHGE oil and gas servicing and equipment unit over the next two to three years. Chicago-based GE Healthcare has long been a bright spot for GE, consistently posting sales and profit gains despite overall declines at GE. In April 2018 the division agreed to sell its value-based healthcare division to Veritas Capital for $1.05 billion in cash. M

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1OO

THE TOP 1OO MEDTECH COMPANIES

CARDINAL HEALTH Dublin, Ohio * Revenues from Cardinal Health’s medical segment.

2017 revenues:

$16,000,000,000

Fiscal year ending: June 30, 2018

KEY PERSONNEL:

MIKE KAUFMANN, CEO; JON GIACOMIN, CEO, medical segment; CRAIG COWMAN, EVP, global sourcing; JOSEPH DEPINTO, president; Cardinal Health specialty solutions; MICHELE HOLCOMB, EVP, strategy and corporate development; JORGE GOMEZ, CFO; PAMELA KIMMET, chief human resources officer; STEVE MASON, president, Cardinal Health at Home; CRAIG MORFORD, chief legal & compliance officer; TIFFANY OLSON, president, nuclear pharmacy services; BILL OWAD, SVP, operational excellence; PATRICK HOLT, president, Cordis

ardinal Health this year continued the evolution begun in 2017 with the $6.1 billion acquisition of Medtronic’s patient care, deep vein thrombosis and nutritional insufficiency businesses. The company sold its majority stake in post-acute care provider NaviHealth to private equity firm Clayton, Dubilier & Rice (Cardinal held on to a 45% share in NaviHealth and kept the call right to

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re-aquire the business) and dealt its Cardinal Health China business to Shanghai Pharmaceuticals for $1.2 billion. In a planned succession, chairman & CEO George Barrett retired and was replaced by CFO Mike Kaufmann (Medical segment finance chief Jorge Gomez was named to succeed Kaufmann). In June 2018 the FDA’s Circulatory System Devices advisory panel recommended approval for the Incraft abdominal aortic aneurysm stent graft made by its Cordis subsidiary. M

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1OO

THE TOP 1OO MEDTECH COMPANIES

SIEMENS HEALTHINEERS Erlangen, Germany 2017 revenues: $15,581,570,000 (€13,789,000,000)

Fiscal year ending: September 30, 2017

KEY PERSONNEL:

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

T 32

he big news came last March, when Siemens raised more than $5 billion in an initial public offering for its healthcare business. Investors paid €28.00 per share for 150 million shares, for a collective 15% stake in Siemens Healthineers, raising €4.2 billion ($5.18 billion).

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The stock, which debuted up 3.9% at €29.10 apiece, was trading at €37.89, up 30.2% as of this writing in late August. The IPO put Siemens Healthineers’ market cap at €28 billion, or about $34.52 billion, at the lower end of the expected €26 billion to €31 billion range ($32.05 billion to $38.21 billion). M

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THE TOP 1OO MEDTECH COMPANIES

DANAHER Washington, D.C. * Revenues from Danaher’s life sciences, diagnostics & dental segments.

2017 revenues: $14,360,900,000 2017 R&D spend: $939,100,000

Fiscal year ending: December 31, 2017

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

anaher refined its shift toward the life sciences with the July 2018 news that it’s planning to spin out its $3 billion dental business. The new entity, DentalCo, is slated to go through during the second half of 2019. It’s expected to be led by Amir Aghdaei as president & CEO, who runs the dental unit as group executive; the dental segment employs about 12,000 workers from the Nobel Biocare, Ormco and KaVo Kerr businesses. M

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1OO

THE TOP 1OO MEDTECH COMPANIES

HENRY SCHEIN Melville, N.Y. 2017 revenues:

$12,461,543,000

Fiscal year ending: December 30, 2017 Employees: 22,000

KEY PERSONNEL:

STANLEY BERGMAN, chairman & CEO; GERALD BENJAMIN, EVP, chief administrative officer, member of board of directors; JAMES BRESLAWSKI, vice chairman of the board & president; MICHAEL ETTINGER, SVP, corporate & legal affairs & chief of staff, secretary; JAMES HARDING, JR., CEO, Henry Schein One; JONATHAN KOCH, SVP & CEO, global dental; PETER MCCARTHY, president, global animal health; LORELEI MCGLYNN, SVP, chief human resources officer; DAVE MCKINLEY, chief commercial officer, Henry Schein, & president, corporate commercial development; BOB MINOWITZ, SVP, global dental merchandising & business operations; MARK MLOTEK, EVP, chief strategic officer; STEVEN PALADINO, EVP, CFO; CHRISTOPHER PENDERGAST, SVP, CTO; MICHAEL PACIOPPI, SVP, chief merchandising officer; PAUL ROSE, SVP, global supply chain; WALTER SIEGEL, SVP & general counsel

enry Schein in April said it plans to spin off its animal health business and merge it with Vets First Choice, combining Henry Schein Animal Health’s approximate 4,300 employees with Vets First Choice’s 750 U.S. employees. The newly formed business will have pro forma 2017 sales of approximately $3.6 billion; Schein expects to receive between $1 billion and $1.3 billion in cash on a tax-free basis as part of the transaction, which is expected to close by the end of the year. The company

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also inked a joint-venture deal with Internet Brands, forming the Henry Schein One practice management business. It’s an amalgamation of Schein’s Practice Solutions and international dental practice management operations and the dental business at Internet Brands that posted pro-forma 2017 sales of approximately $400 million. Unfortunately, the reshaping also includes layoffs and plant closures, although the company has stayed mum on the details, saying only that it expects to log a $45 million to $55 million restructuring charge this year. M

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1OO

THE TOP 1OO MEDTECH COMPANIES

STRYKER Kalamazoo, Mich. 2017 revenues: $12,444,000,000 2017 R&D spend: $787,000,000

Fiscal year ending: December 31, 2017 Employees: 33,000

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

lthough it’s a perennial name when the subject of M&A comes up as a potential acquiree, Stryker was active itself as an acquirer after closing the $700 million buyout of Novadaq a year ago. It bought French spinal implant maker Vexim for about $216 million, paid $664 million for minimally invasive sinus balloon maker Entellus Medical, picked up singleuse-device reprocessor Hygia Health Services and acquired Swiss surgical smoke evacuation firm SafeAir. But it was

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the deal that never was that generated the most buzz: the rumor that it would acquire Boston Scientific in a move one analyst said could have formed a “higher-growth Medtronic.” The company’s Performance Solutions division got into the value-based healthcare game with the launch of the Practice Excellence program for orthopedic practices and readied a nearly $110 million facility in its home base of Michigan that’s slated to add as many as 260 jobs. On the personnel front, orthopedics president David Floyd is slated to retire next year, with Timothy Scannell as his replacement. M

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1OO

THE TOP 1OO MEDTECH COMPANIES

BAXTER Deerfield, Ill. 2017 revenues: $10,561,000,000 2017 R&D spend: $617,000,000

Fiscal year ending: December 31, 2017 Employees: 47,000

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; DENNIS CROWLEY senior vice president, business development & licensing; STACEY EISEN, senior vice president, global communications & president and executive director, Baxter International Foundation; CRISTIANO FRANZI, senior vice president and president, EMEA; JACQUELINE (JACKIE) KUNZLER, senior vice president, chief quality officer; DR. SUMANT RAMACHANDRA, senior vice president, chief science and technology officer

B 40

axter continued its buying spree since closing the $625 million pickup of Claris Lifescience’s injectable drug business last year: in March, the company paid $153 million to acquire hemostat and surgical sealant assets from Mallinckrodt Pharmaceuticals. Baxter reeled in

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a number of regulatory wins this year, including the August 2018 CE Mark clearance and regulatory approval in Australia for its Evo IQ infusion system. Earlier this year, Baxter landed FDA approval for its Spectrum IQ infusion system with Dose IQ safety software, touting the system as the first to include bi-directional electronic medical records integration. M

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THE TOP 1OO MEDTECH COMPANIES

OWENS & MINOR Mechanicsville, Va. 2017 revenues:

$9,318,275,000

Fiscal year ending: December 31, 2017 Employees: 8,600

KEY PERSONNEL:

CODY PHIPPS, chairman, president & CEO; RICHARD MEIER, EVP, CFO & president-international; CHRISTOPHER LOWERY, president, global products; RONY KORDAHI, EVP, North American operations; STUART MORRISHIPKINS, EVP, global manufacturer services; CHARLES COLPO, SVP, Europe operations; ERIKA DAVIS, SVP, chief administrative officer; GEOFFREY MARLATT, SVP, manufacturer services, STEPHEN OLIVE, SVP, CIO; NICHOLAS PACE, SVP, general counsel, corporate secretary & chief HR officer

wens & Minor set out to reshape its business last year, inking the $380 million buyout of direct-to-consumer medical supplies distributor Byram Healthcare, and continued the transformation in May when it closed the $710 million sale of its infections business to Halyard Health. The deal added $1 billion in revenues and $80 million in earning before interest, taxes, depreciation and amortization to Owen & Minor’s books. M

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THE TOP 1OO MEDTECH COMPANIES

BOSTON SCIENTIFIC Marlborough, Mass. 2017 revenues: $9,048,000,000 2017 R&D spend: $997,000,000

Fiscal year ending: December 31, 2017 Employees: 29,000

KEY PERSONNEL:

MICHAEL MAHONEY, president and CEO; KEVIN BALLINGER, SVP and president, interventional cardiology; DANIEL BRENNAN, EVP & CFO; DESIREE RALLS-MORRISON, SVP, general counsel and corporate secretary; WENDY CARRUTHERS, SVP, HR; ART BUTCHER, SVP and president, endoscopy; JOSEPH FITZGERALD, EVP and president, rhythm management; EDWARD MACKEY, EVP, operations; JEFF MIRVISS, SVP and president, peripheral interventions; MAULIK NANAVATY, SVP and president, neuromodulation; IAN MEREDITH, EVP and global chief medical officer; DAVID PIERCE, EVP and president, MedSurg; BRAD SORENSON, SVP, manufacturing and supply Chain; ERIC THÉPAUT, SVP and president, Europe; WARREN WANG, SVP and president, Asia Pacific

urnaround complete, Boston Scientific focused its eye to streamlining its operations via a clutch of acquisitions aimed at rounding out its portfolio: stent developer Veniti (August, $160 million); Claret Medical and its Sentinel anti-stroke TAVR device (August, $270 million); Cryterion Medical and its single-shot cryoablation device for atrial fibrillation (July, $202 million); 400m NxThera and its Rezūm benign prostatic hyperplasia device (April, $275 million); women’s health-focused NVision Medical (April, undisclosed); a stake in thermal body mapping device maker Securus Medical (April, $40 million); endoscope maker EMcision (March, undisclosed); a position in Millepede with an option to buy (January, $90 million); and Apama Medical and its radiofrequency balloon

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catheter (October 2017, $300 million). The M&A news didn’t stop there: a false rumor that posited the company as a buyout target for Stryker roiled the markets in June. Boston Scientific was also nominated for two Prix Galien awards for its SpyGlass DS direct visualization system used for cholangiopancreatoscopy and Watchman left atrial appendage closure device. And although CEO Mike Mahoney punted Boston’s entry into the transcatheter aortic valve market, Lotus, into next year, the news wasn’t all bad: Mahoney was named Employee’s Choice number two in Glassdoor.com’s survey of the top CEOs of 2018. M

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ABBOTT Abbott Park, Ill. * Revenues from Abbott’s cardiovascular & neuromodulation segments.

2017 revenues:

$8,911,000,000

Fiscal year ending: December 31, 2017

KEY PERSONNEL:

MILES WHITE, chairman & CEO; HUBERY ALLEN, EVP, general counsel & secretary; BRAIN BLASER, EVP, diagnostic products; JOHN CAPEK, EVP, ventures; ROBERT FORD, EVP, medical devices; STEPHEN FUSSELL, EVP, human resources; ANDREW LANE, EVP, established pharmaceuticals; DANIEL SALVADORI, EVP, nutritional products; BRIAN YOUR, CFO & EVP, finance; ROGER BIRD, SVP, U.S. nutrition; SHARON BRACKEN, SVP, rapid diagnostics; CHUCK BRYNELSEN, SVP, Abbott Vascular; JAIME CONTRERAS, SVP, core laboratory diagnostics, commercial operations; ROBERT FUNCK, SVP, finance & controller; ELAINE LEAVENWORTH, SVP & chief marketing & external affairs officer; JOSEPH MANNING, SVP, international nutrition; CORLIS MURRAY, SVP, quality assurance, regulatory & engineering services; MICHAEL PETERSON, SVP, cardiac arrhythmias & heart failure; SEAN SHRIMPTON, SVP, established pharmaceuticals, emerging markets; JARED WATKIN, SVP, diabetes care; ALEJANDRO WELLISCH, SVP, established pharmaceuticals, Latin America

bbott followed the blockbuster, $25 billion St. Jude Medical buy with the $5 billion buyout of diagnostics company Alere in early October 2017, but otherwise trod quietly along the M&A trail. Although it took its first-generation Absorb bioresorbable stent off the market, Abbott won FDA approval for its Xience Sierra everolimus-eluting stent. And the bets it placed in the diabetes market proved out as that business grew at a healthy double-digit clip. M

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ESSILOR Charenton-le-Pont, France 2017 revenues: $8,475,000,000 (€7,500,000,000)

2017 R&D spend: $245,210,000 Fiscal year ending: December 31, 2017 Employees: 67,000

KEY PERSONNEL:

HUBERT SAGNIÈRES, chairman & CEO; LAURENT VACHEROT, president & COO; JAYANTH BHUVARAGHAN, chief mission officer; JEAN CARRIERGUILLOMET,COO; Frédéric Mathieu, SVP, HR; BERNHARD NUESSER, president, online; HILARY HALPER, CFO; PAUL DU SAILLANT, COO; JEREMY TEO, chief strategy officer; ÉRIC THOREUX president, sun, readers & China

ssilor, an ophthalmic and optics company that manufactures contact lenses including the Varilux, Crizal, Transitions, Eyezen, Xperio, Foster Grant, Bolon and Costa brands, saw the $55.2 billion merger it had under way with Italian eyewear maker Luxottica fall victim to antitrust regulators in the European Union. M

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BECTON, DICKINSON Franklin Lakes, N.J. * Revenues from Becton, Dickinson’s medical segment.

2017 revenues:

$8,105,000,000

Fiscal year ending: September 30, 2017

KEY PERSONNEL:

VINCENT FORLENZA, chairman & CEO; THOMAS POLEN, president; JAMES BORZI, EVP, global operations, chief supply chain office; ALEXANDRE CONROY, EVP & president, Europe, EMA & Americas; ROLAND GOETTE, EVP, president, EMEA; 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; ELLEN STRAHLMAN, EVP, R&D & CMO; LINDA THARBY, EVP & chief HR officer

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following February). BD in March sold its minority stake in respiratory solutions joint venture Vyaire Medical to Apax Partners for $435 million and bought TVA Medical in July 2018 for an undisclosed amount, hard on the heels of that company’s FDA clearance for its EverlinQ EndoAVF hemodialysis device. M

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ZIMMER BIOMET Warsaw, Ind. 2017 revenues: $7,824,100,000 2017 R&D spend: $367,400,000

Fiscal year ending: December 31, 2017 Employees: 18,200

KEY PERSONNEL:

BRYAN HANSON, president, CEO; DANIEL FLORIN, EVP, CFO; AURE BRUNEAU, group president, spine, CMF, thoracic and surgery assisting technology; TONY COLLINS, VP, controller & chief accounting officer; DEREK DAVIS, VP, global integration; ROBERT DELP, president, Americas; DIDIER DELTORT, president, EMEA; RACHEL ELLINGSON, SVP, strategy; WILLIAM (BILL) FISHER, SVP, global HR; MONICA KENDRICK, VP, corporate communications; DAVID KUNZ, SVP, global quality & regulatory affairs; COLEMAN (COLE) LANNUM, SVP, investor relations; ANGELA MAIN, VP, global chief ethics & compliance officer, associate GP; PEDRO MALHA, group VP, global dental division; DAVID NOLAN JR., president, biologics, extremities, sports medicine, surgical, trauma, foot & ankle, office-based technologies & Zimmer Biomet signature solutions; CHAD PHIPPS, SVP, GC, secretary; ZEESHAN TARIQ, VP, CIO; KENNETH TRIPP, SVP global operations and logistics; DANIEL WILLIAMSON, group president, joint reconstruction; SANG YI, president, Asia Pacific

ew CEO Bryan Hanson – hired last year from Medtronic to effect a turnaround for the ailing orthopedics giant – saw the first fruit of his efforts in 2018 when Zimmer Biomet posted first- and secondquarter earnings that beat Wall Street’s expectations. To maintain that trend Hanson has to keep executing on the financial side while overcoming FDA red flags at a plant in Warsaw, Ind., and ongoing supply chain issues affecting its inventory. M

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B. BRAUN MELSUNGEN Melsungen, Germany 2017 revenues: $7,671,457,000 (€6,788,900,000)

2017 R&D spend: $356,967,000 Fiscal year ending: December 31, 2017 Employees: 61,583

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HEINZ-WALTER GROßE, Chairman, Chief HR Officer; ANNETTE BELLER, director, Finance, Taxes & Controlling, Central Service; ANNA MARIA BRAUN, director, President, Asia Pacific; MEINRAD LUGAN, director, Hospital Care , OutPatient; CAROLL NEUBAUER, director, North America; JOACHIM SCHULZ, director, Aesculap; MARKUS STROTMANN, director, Avitum

. Braun’s Aesculap closed a $17.3 million deal in February to buy Dextera out of Chapter 11 bankruptcy. Braun itself inked a deal in early July to acquire NxStage Medical’s Medisystems bloodlines business, as part of the latter’s bid to mollify anti-trust regulators about its pending, $2 billion acquisition by Fresenius. M

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NOVARTIS Fort Worth, Texas * Revenues from Novartis’ Alcon segment.

2017 revenues: $6,024,000,000 2017 R&D spend: $490,000,000

Fiscal year ending: December 31, 2017 Employees: 20,000

KEY PERSONNEL:

MIKE BALL, chairman; DAVID ENDICOTT, CEO; Kim Adler, VP, global communications head; LARENT ATTIAS, SVP, corporate development strategy; ROYCE EDWARD, SVP, GC; IAN BELL, president, EMEA; SERGIO DUPLAN, president, NA; CAMILIA FINZI, president, Latin America & the Caribbean; FRANCK LEVEILLER, head, global R&D; SUE-JEAN LIN, SVP, CIO; 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; ANDY PAWSON, president & GM, global vision care franchise; DAVE SCHOENING, SVP quality; ERIC VAN OPPENS, head, global strategic initiatives

ovartis said in June that it’s planning to spin the device portions of its Alcon ophthalmology subsidiary into a publicly traded company after years of underperformance, retaining Alcon’s $4.6 billion ophthalmic pharmaceuticals business. The spinoff, expected to close during the first half of 2019, is projected to create a $7 billion enterprise with more than 20,000 employees. M

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3M CO. Maplewood, Minn. * Revenues from 3M Co.’s healthcare segment.

2017 revenues:

$5,813,000,000

Fiscal year ending: December 31, 2017

KEY PERSONNEL:

INGE THULIN, executive chairman; MICHAEL ROMAN, 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, business development and marketing-sales; ASHISH KHANDPUR, EVP, electronics & energy; JON LINDEKUGEL, SVP, supply chain; MOJDEH POUL, EVP, safety & graphics; KRISTEN LUDGATE, SVP, HR; HAK CHEOL SHIN, vice chairman & EVP; MICHAEL VALE, EVP, health care; KAREN CARROLL, VP & general auditor; MICHAEL DAI, assistant secretary; SARAH GRAUZE, assistant treasurer; VEENA LAKKUNDI, VP, chief compliance officer, compliance & business conduct; GREGG LARSON, VP, deputy general counsel & secretary; TED RINGSRED, assistant secretary; IPPOCRATIS VROHIDIS, VP, controller & chief accounting officer

M’s Health Care segment makes products for medical and surgical supplies, skin health and infection prevention, inhalation and transdermal drug delivery systems, oral care solutions (dental and orthodontic products), health information systems and more. Some of its medical surgical products include tapes, dressings, wound closure products, orthopedic casting materials, electrodes and stethoscopes. M

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OLYMPUS Tokyo, Japan

* Revenues from Olympus’ medical business.

2017 revenues: $5,498,046,387 (¥616,331,000,000) KEY PERSONNEL:

Fiscal year ending: March 31, 2018

HIROYUKI SASA, president; Yasuo Takeuchi, VP; AKIHIRO TAGUCHI, CFO, senior executive managing office; SHIGEO HAYASHI, head of sales business management office, medical business senior executive managing officer; HARUO OGAWA, head of manufacturing, senior executive managing officer; YASUSHI SAKAI, CTO, head of R&D, executive managing officer; NACHO ABIA, president & CEO, Olympus Corporation of the Americas; FABRICE CANCRE, president, Olympus scientific solutions, Americas; CARYN DASHUKEWICH, corporate VP, HR, Olympus Corporation of the Americas; JOE DOHERTY, president, Olympus surgical technologies, America; THOMAS GLAVIN, chief compliance officer, Olympus Corporation of the Americas; TETSUO KOBAYASHI, corporate EVP, Olympus Corporation of the Americas; PIERRE LACROIX, COO & CFO, Olympus Corporation of the Americas; DONNA MILLER, global GC, Olympus Corporation; JULIEN SAUVAGNARGUES, president, scientific solutions & consumer products, Olympus America Inc.; TODD USEN, president, medical systems, Olympus Corporation of the Americas.

SMITH & NEPHEW London, U.K.

2017 revenues: 2017 R&D spend:

$4,765,000,000 $223,000,000

Fiscal year ending: December 31, 2017 Employees: 15,000

KEY PERSONNEL:

NAMAL NAWANA, CEO; GRAHAM BAKER, CFO; RODRIGO BIANCHI, president, Asia Pacific and Latin America; BRAD CANNON, chief marketing officer; ELGA LOHLER, chief HR officer; CATHERYN O’ROURKE, chief legal & compliance officer; VASANT PADMANABHAN, president, R&D; GLENN WARNER, president, US; MELISSA GUERDAN, chief quality & regulatory affairs officer; SUSAN SWABEY, company secretary; PHIL COWDEY, EVP, business development & corporate affairs; MASSIMILIANO COLELLA, president, Europe, Middle East, Africa & Canada; MARK GLADWELL, president, global operations.

TERUMO Tokyo, Japan

2017 revenues: $4,586,654,773 (¥514,164,000,000)

2017 R&D spend: $14,272,971 Fiscal year ending: March 31, 2018 Employees: 23,319

KEY PERSONNEL:

TAKAYOSHI MIMURA, chairman; SHINJIRO SATO, president & CEO; TOSHIAKI TAKAGI, director & senior managing executive officer, chief quality officer, quality assurance dept., post-market surveillance & vigilance dept., environmental management dept., production dept., procurement dept., IP dept., Teurmo Medical Pranex; SHOJI HATANO, director & managing executive officer, president, general hospital company; DAVID PEREZ, director & senior executive officer, president, blood management company, president & CEO, Terumo BCT.

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DENTSPLY SIRONA York, Pa.

2017 revenues: 2017 R&D spend: Fiscal year ending: Employees:

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* Revenues from Fujifilm Holdings’ healthcare segment.

2017 revenues: $3,951,828,724 (¥443,000,000,000) Fiscal year ending: March 31, 2018 KEY PERSONNEL:

KEY PERSONNEL:

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

SHIGETAKA KOMORI, chairman & CEO; KENJI SUKENO, president & COO; KOUICHI TAMAI, director, senior EVP; TAKATOSHI ISHIKAWA, SVP; TEIICHI GOTO, SVP; TAKASHI IWASAKI, CTO, SVP; SHIGENOBU INENAGA, SVP; JUNJI OKADA, corporate VP; MASAHIRO FUKUOKA, corporate VP; NAOKI HAMA, corporate VP; MASAHIRO OTA, coporate VP; SHIGERU SANO, corporate VP; KAORU TERASHIMA, corporate VP; AIICHIRO HIRUMA, corporate VP; NAOTO YANAGIHARA, corporate VP; AKIRA YODA, CDO, corporate VP; CHISATO YOSHIZAWA, corporate VP; MASATO YAMAMOTO, coporate VP; TOSHIKAZU BAN, corporate VP; SHOEI IMAI, corporate VP; KAZUHISA HORIKIRI, corporate VP.

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EDWARDS LIFESCIENCES Irvine, Calif.

2017 revenues: 2017 R&D spend:

Fiscal year ending: December 31, 2017 Employees: 12,200

$3,435,300,000 $552,600,000

KEY PERSONNEL:

MICHAEL MUSSALLEM, chairman & CEO; DIRKSEN LEHMAN, corporate VP, public affairs; JOHN MCGRATH, corporate VP, quality, regulatory, clinical; CATHERINE SZYMAN, corporate VP, critical care; JEAN-LUC LEMERCIER, corporate VP, EMEA, Canada & Latin America; AIMEE WEISNER, corporate VP, general counsel; BERNARD ZOVIGHIAN, corporate VP, transcatheter mitral & tricuspid therapies; DONALD BOBO JR., corporate VP, strategy & corporate development; CHRISTINE MCCAULEY, corporate VP, human resources; STANTON ROWE, corporate VP, advanced technology & chief scientific officer; SCOTT ULLEM, corporate VP, CFO; DR. HUIMIN WANG, corporate VP, Japan, Asia & Pacific; LARRY WOOD, corporate VP, transcatheter heart valves; JOSEPH NUZZOLESE, corporate VP, global supply chain; DAVEEN CHOPRA, corporate VP, surgical heart valve therapies.

HOYA Tokyo, Japan * Revenues from Hoya’s life care segment.

2017 revenues: $3,147,832,293 (¥352,872,000,000)

Fiscal year ending: March 31, 2018

KEY PERSONNEL:

HIROSHI SUZUKI, representative executive officer president & CEO; RYO HIROOKA representative executive officer & CFO; EIICHIRO IKEDA, executive officer & COO, IT & CTO; AUGUSTINE YEE, executive officer, chief legal officer & head of corporate development & affairs.

INTUITIVE SURGICAL Sunnyvale, Calif.

2017 revenues: 2017 R&D spend:

$3,128,900,000 $328,600,000

Fiscal year ending: December 31, 2017 Employees: 4,444

KEY PERSONNEL:

GARY GUTHART, president, CEO; SALVATORE BROGNA, EVP, CCO; DR. MYRIAM CURET, EVP, CMO; MARSHALL MOHR, EVP, CFO; DAVE ROSA, EVP, CCO; BOB DESANTIS, SVP, instruments & accessories; MARK JOHNSON, SVP, regulatory & quality; CHUCK JONES, SVP, design, brand & user experience; BRIAN MILLER, SVP, systems & vision; COLIN MORALES, SVP, secondary market equipment & service; KARA ANDERSEN REITER, SVP, GC, chief compliance officer; CRAIG CHILD, VP, HR; HENRY CHARLTON, SVP, GM, U.S.; JEROEN VAN HEESEWIJK, SVP, global distribution; GLENN VAVOSO, SVP, global commerical operations, Asia Pacific Direct; DIRK BARTEN, VP, GM, central & eastern Europe; PHIL BRADSHAW, VP, GM, United Kingdom, Eire; DAMIEN DESMEDT, VP, GM, western Europe; MANDEEP SINGH KUMAR, VP, GM, India; KAZUHIRO TAKIZAWA, president & director, Japan

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STEPHEN MACMILLAN, chairman, president & CEO;MONICA AGUIRRE BERTHELOT, senior assistant to CEO; ALLISON BEBO, SVP, HR; SEAN DAUGHERTY, president, GYN surgical solutions; JOHN GRIFFIN, GC; MIKE KELLY, chief supply chain officer & corporate VP of quality assurance & regulatory affairs; KARLEEN OBERTON, CFO; SANJAY PRABHAKARAN, regional president, Asia Pacific; JAY STEIN, cofounder, chairman emeritus, SVP & CTO; KEVIN THORNAL, president, Cynosure; PETER VALENTI III, president, breast & skeletal health solutions; JAY VERSTREKEN, regional president, EMEA & Canada; MICHAEL WATTS, VP, investor relations & corporate communications; THOMAS WEST, president, diagnostics solutions.

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GETINGE Gothenburg, Sweden

2017 revenues: $2,720,763,434 (kr22,495,000,000)

2017 R&D spend: $71,844,120 Fiscal year ending: December 31, 2017 Employees: 10,684

KEY PERSONNEL:

MATTIAS PERJOS, president & CEO; LARS SANDSTROM, CFO; PAUL MARCUN, president, surgical workflows; JENS VIEBKE, president, acute care therapies; CARSTEN BLECKER, CCO; LENA HAGMAN, EVP, quality regulatory compliance; JEANETTE HEDEN CARLSSON, EVP, communications & brand management; HARALD CASTLER, president, life science; MAGNUS LUNDBACK, EVP, HR & sustainability

SONOVA Stäfa, Switzerland

2017 revenues:

$2,688,376,346 (CHF 2,645,900,000)

2017 R&D spend: $145,193,050 Fiscal year ending: March 31, 2018 Employees: 14,242

KEY PERSONNEL:

ARND KALDOWSKI, 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; CLAUDIO BARTESAGHI, GVP corporate HRM & communications; HANS MEHL, GVP operations; ANDI VONLANTHEN, GVP R&D.

NIPRO Osaka, Japan; Bridgewater, N.J. * Revenues from Nipro’s medical segment.

2017 revenues: $2,677,225,691 (¥300,117,000,000)

Fiscal year ending: March 31, 2018

KEY PERSONNEL:

YOSHIHIKO SANO, president; Managing directors: KIYOTAKA YOSHIOKA; KAZUO WAKATSUKI; TOSHIAKI MASUDA; KYOETSU KOBAYASHI; KIMIHITO MINOURA; TSUYOSHI YAMAZAKI; KAZUHIKO SANO; KENICHI NISHIDA; YASUSHI OHYAMA; TAKEHITO YOGO

SolenoidSolutionsInc.com 888.825.8405 66

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9 • 2018

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CONNECTORS FOR MEDICAL DEVICES

Reliability in every detail StĂ¤ubli Electrical Connectors meets your needs Modern critical surgery rooms are designed on a

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04.2017_GI_medical-design-technology-outsourcing_fullpage_en.indd 1 Staubli 9-17.indd 56

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THE TOP 1OO MEDTECH COMPANIES

VARIAN MEDICAL SYSTEMS Stäfa, Switzerland

2017 revenues: 2017 R&D spend: Fiscal year ending: Employees:

35 2017 revenues: 2017 R&D spend: Fiscal year ending: Employees:

$2,668,200,000 $210,000,000 September 29, 2017 6,600

KEY PERSONNEL:

DOW WILSON, president & CEO; KOLLEEN KENNEDY, president, oncology systems & corporate EVP; GARY BISCHOPING, JR., CFO, SVP, finance; PATRICK JODA, SVP, global operations; MOATAZ KARMALAWY, VP & GM, worldwide particle therapy; DEEPAK ‘DEE’ KHUNTIA, SVP & CMO; JOHN KUO, SVP, GC & corporate secretary; MAGNUS MOMSEN, SVP & corporate controller; TERILYN JUAREZ MONROE, chief people officer, SVP, HR; TOM RODDEN, SVP, IT operations; RAFAEL TORRES, SVP, business development & strategy; CHRIS TOTH, president, global commercial & field operations; VY TRAN, SVP, regulatory affairs & quality assurance; ANDREW WHITMAN, SVP, government affairs; COREY ZANKOWSKI, SVP, chief technology innovation officer

Spray It, Dunk It or Dust It,

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For complete Vert-X 13E information visit www.novotechik.com/v13

STERIS Derby, U.K. $2,619,996,000 $60,782,000 March 31, 2018 12,000

KEY PERSONNEL:

KATHLEEN BARDWELL, SVP, chief compliance officer; KAREN BURTON, VP, controller & chief accounting officer; DANIEL CARESTIO, COO; ADRIAN COWARD, SVP, healthcare services; MICHIEL DE ZWAAN, VP & chief human resources officer; GULAM KHAN, SVP, procedural solutions; SUDHIR PAHWA, SVP, infection prevention technologies; WALTER M ROSEBROUGH JR., president & CEO; RENATO TAMARO, VP & corporate treasurer; MICHAEL TOKICH, SVP & CFO; ADAM ZANGERLE, VP, GC & secretary

BIOMERIEUX

Marcy-l’Étoile, France

2017 revenues: $2,585,666,000 (€2,288,200,000) 2017 R&D spend: $343,972,000 Fiscal year ending: December 31, 2017 Employees: 10,400

KEY PERSONNEL:

ALEXANDRE MERIEUX, chairman & CEO; MICHEL BAGUENAULT, company secretary, EVP, HR & communications; GUILLAUME BOUHOURS, EVP, CFO; PIERRE BOULUD, EVP, Asia Pacific region, portfolio & strategic planning; NICOLAS CARTIER, EVP, industrial microbiology unit; PIERRE CHARBONNIER, EVP, global quality, manufacturing & supply chain; FRANCOIS LACOSTE, EVP, clinical unit; MARK MILLER, EVP, CMO; YASHA MITROTTI, EVP, Europe, Middle East, Africa Region & global commercial performance; ALAIN PLUQUET, EVP, chief data officer; RANDY RASMUSSEN, EVP, molecular biology; KIRK RIRIE, EVP, chief innovation officer; STEFAN WILLEMSEN, EVP, Americas region

Novotechnik U.S., Inc. • Telephone: 508-485-2244 • Email: info@novotechnik.com 68

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THE TOP 1OO MEDTECH COMPANIES

COLOPLAST Humlebæk, Denmark

2017 revenues: $2,354,261,110 (kr15,528,000,000) 2017 R&D spend: $87,026,396 Fiscal year ending: September 30, 2017 Employees: 10,420 KEY PERSONNEL:

LARS RASMUSSEN, president & CEO; ANDERS LONNING-SKOVGAARD, EVP, CFO; KRISTIAN VILLUMSEN, EVP, chronic care; ALLAN RASMUSSEN, EVP, global operations; ALAIN MORVAN SVP, sales Europe; CAROLINE VAGNER ROSENSTAND, 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; PETER VOLKERS, SVP, corporate legal & IP; STEFFEN HOVARD, SVP, urology care; THOMAS ALSBJERG, VP, corporate HR

38 2017 revenues: 2017 R&D spend: Fiscal year ending: Employees:

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$2,340,196,000 $39,657,000 June 30, 2018 6,000

KEY PERSONNEL:

MICHAEL 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; KATRIN PUCKNAT, CEO, ResMed Healthcare, Germany; JUSTIN LEONG, SVP, Asia growth markets; NUPUR BHUSHAN, chief HR officer; HEMANTH REDDY, chief strategy officer; CARLOS NUNES, chief medical officer; BOBBY GHOSHAL, CTO; ANDREW PRICE, president, global operations

9 • 2018

Medical Design & Outsourcing 69

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1OO

THE TOP 1OO MEDTECH COMPANIES

PAUL HARTMANN Heidenheim, Germany; Rock Hill, S.C.

2017 revenues: $2,326,218,000 (€2,058,600,000)

Fiscal year ending: December 31, 2017 Employees: 10,764

KEY PERSONNEL:

ANDREAS JOEHLE, CEO & chairman; RAYMUND HEINEN, chief process officer; MICHEL KUEHN, CCO, hygiene; STEPHAN SCHULZ, CFO & labor director

BIO-RAD Hercules, Calif.

2017 revenues: 2017 R&D spend:

$2,160,153,000 $250,301,000

Fiscal year ending: December 31, 2017 Employees: 8,150

KEY PERSONNEL:

NORMAN SCHWARTZ, president & CEO; GIOVANNI MAGNI, EVP & chief strategy officer; CHRISTINE TSINGOS, EVP & CFO; TIMOTHY ERNST, EVP, general counsel & secretary; MIKE CROWLEY, EVP, global commercial operations; ANNETTE TUMOLO, EVP, president, life science; JOHN HERTIA, EVP, president, clinical diagnostics; RONALD HUTTON, VP, treasurer; JAMES STARK, VP, corporate controller

TELEFLEX Wayne, Pa.

2017 revenues: 2017 R&D spend:

$2,146,303,000 $84,800,000

Fiscal year ending: December 31, 2017 Employees: 14,400

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KEY PERSONNEL:

LIAM KELLY, president & CEO; THOMAS KENNEDY, SVP, global operations; THOMAS POWELL, CFO & EVP; MICHELLE FOX, VP, clinical & medical affairs; TIMOTHY DUFFY, chief information officer & VP; JEAN-LUC DIANDA, president, EMEA; SUNNY GOH, president, APAC; GWEN WATANABE, VP, business development & technical resources; JAKE ELGUICZE, treasurer; JOHN DEREN, chief accounting officer & VP; GREGG WINTER, VP, taxes; CAMERON HICKS, VP, global human resources; JAMES LEYDEN, secretary, VP & general counsel; KAREN BOYLAN, VP, global regulatory affairs & quality assurance; ANDREW KRAKAUER, independent director.

Medical Design & Outsourcing

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THE TOP 1OO MEDTECH COMPANIES

COOPER COS. Pleasanton, Calif.

2017 revenues: 2017 R&D spend: Fiscal year ending: Employees:

1OO

WILLIAM DEMANT Smørum, Denmark

* Revenues from William Demant’s hearing segments.

2017 revenues: $1,999,636,127 (DKK kr13,189,000,000) 2017 R&D spend: $8,198,037 Fiscal year ending: December 31, 2017 Employees: 13,280

$2,139,000,000 $69,200,000 October 31, 2017 11,800

KEY PERSONNEL:

ALBERT WHITE III, president & CEO; DANIEL MCBRIDE, EVP, COO & president; HOLLY SHEFFIELD, EVP & chief strategy officer; BRIAN ANDREWS, SVP, CFO & treasurer; AGOSTINO RICUPATI, chief accounting officer & SVP, finance & tax; RANDAL GOLDEN, VP, GC & secretary; ROBERT AUERBACH, president, CooperSurgical.

Capacitive Circuit

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

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1OO

THE TOP 1OO MEDTECH COMPANIES

DRÄGERWERK Lübeck, Germany

* Revenues from Drägerwerk’s medical business. 2017 revenues: $1,884,840,000 (€1,668,000,000) 2017 R&D spend: $182,156,000 Fiscal year ending: December 31, 2017

YOUR IDEA

realized Comprehensive and scalable medical device solutions from development through manufacturing Complete product development services Contract assembly, packaging, and distribution Single-use disposable and reusable products ISO 13485 Certified FDA Registered

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STEFAN DRÄGER, chairman; GERT-HARTWIG LESCOW, CFO & executive board member; RAINER KLUG, executive board member, production, logistics, purchasing; REINER PISKE, executive board member, human resources; ANTON SCHROFNER, executive board member, innovation

BRUKER

Billerica, Mass.

2017 revenues: 2017 R&D spend: Fiscal year ending: Employees:

$1,765,900,000 $162,700,000 December 31, 2017 6,200

KEY PERSONNEL:

FRANK LAUKIEN, chairman, president & CEO; GERALD HERMAN, CFO; MARK MUNCH, president, Bruker Nano; JUERGEN SREGA, president, Bruker CALID; FALKO BUSSE, president, Bruker BioSpin; BURKHARD PRAUSE, president, Bruker Energy & Supercon Technologies

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THE TOP 1OO MEDTECH COMPANIES

46 2017 revenues: 2017 R&D spend:

1OO

Lead Screws New Technology Motion roll over for Control Ball Screws

CONVATEC Reading, U.K.; Bridgewater, N.J. $1,764,600,000 $41,200,000

Fiscal year ending: December 31, 2017 Employees: 9,500

KEY PERSONNEL:

PAUL MORAVIEC, CEO; FRANK SCHULKES, CFO; FIONA ADAM, interim president, advanced wound care; STEPHAN BONNELYCKE, president, ostomy care; FRANK GEHRES, president, continence & critical care; JOHN LINDSKOG, president, infusion devices; KJERSTI GRIMSRUD, president, EMEA; TIM MORAN, president, Americas; GEORGE POOLE, president, APAC; DONAL BALFE, EVP, global operations; SEAN MCGRATH, EVP, global HR; ROBERT STEELE, EVP, quality, regulatory & clinical affairs; ADAM DEUTSCH, EVP, GC, corporate development.

Better Lead Time Better Cost

MIRACA Tokyo, Japan

2017 revenues: $1,743,086,530 (¥195,400,000,000)

• Loads up to 500 pounds with standard product and larger with Kerkite® engineered polymers

Fiscal year ending: March 31, 2018

• Lead accuracies to 0.0001in / in

KEY PERSONNEL:

SHIGEKAZU TAKEUCHI, director, president & CEO; Executive officers: YOSHIHIRO ASHIHARA, IVD; SHUNICHI HIGASHI, CFO, investor & shareholder relations & legal affairs; SHIGETO OHTSUKI, human resources & CSR; HIROAKI KIMURA, general affairs, public relations & information technology; KAZUYUKI HANYU, business development; TADASHI HASEGAWA, corporate planning & management

• Full-line of anti-backlash nuts for zero-backlash operation over product life • Efficiencies over 80% without grease (lead dependent)

NIHON KOHDEN

• Leads from 0.012in to 3.6in (linear travel per revolution)

Tokyo, Japan

2017 revenues: $1,554,406,780 (¥174,249,000,000)

• Online ordering & quick ship

Fiscal year ending: March 31, 2018

KEY PERSONNEL:

HIROKAZU OGINO, president and CEO; TAKASHI TAMURA, executive operating officer, customer service, GM, sales operations; TADASHI HASEGAWA, senior operating officer, chief compliance officer, accounting, legal affairs, human resources & information systems; KAZUTERU YANAGIHARA, sernior operating officer, GM, strategic technology operations; FUMIO HIROSE, senior operating officer, marketing strategy, GM, ventilator & anesthesia device business operations, GM, IVD business operations; MASATO SEMBA, senior operating officer, GM, IT solutions business operations; EIICHI TANAKA, operating officer, GM, import business operations; YASUHIRO YOSHITAKE, operating officer, GM, international operations; SHIGERU HIRATA, operating officer, GM, finance department; TOSHIHIKO HIRAOKA, operating officer, deputy GM, sales operations; YOSHIAKI UEMATSU, operating officer, GM, general affairs department; MAKOTO MAGARA, operating officer, president, Nihon Kohden Tomioka; SHUHEI MORINAGA, operating officer, GM, monitoring business operations; KAZUOMI SHIMODA, operating officer, deputy GM, sales operations; MASATO SEMBA, operating officer, GM, IT solutions business operations; TAKASHI SEO, operating officer, GM, corporate strategy department; MASAHIKO KUMAKURA, operating officer, regional manager, Kansai regional office; NAOYUKI MURAKI, operating officer, GM, operations management; SYUUICHI KURITA, operating officer, GM, international sales operations; SHINICHI IWASAKI, operating officer, GM, customer service operations; NAOKI KOBAYASHI, operating officer, GM, Ogino Memorial Laboratory; HIROYUKI SATAKE, operating officer, GM, biomedical instrument business operations, deputy GM, IVD business operations; KENJI KURUKAWA, operating officer, GM, human resources department

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9 • 2018

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1OO

THE TOP 1OO MEDTECH COMPANIES

ALIGN TECHNOLOGY San Jose, Calif.

2017 revenues: 2017 R&D spend:

$1,473,413,000 $97,600,000

Fiscal year ending: December 31, 2017 Employees: 8,715

KEY PERSONNEL:

JOSEPH HOGAN, president & CEO; YUVAL SHAKED, SVP & managing director, iTero scanner & services; JOHN MORICI, CFO & SVP, global finance; SIMON BEARD, SVP & managing director, EMEA; STUART HOCKRIDGE, SVP, global human resources; ROGER GEORGE, SVP, chief legal & regulatory officer; SREELAKSHMI KOLLI, SVP, global information technology; JENNIFER OLSON, SVP & managing director, doctordirected consumer channel; RAPHAEL PASCAUD, chief marketing officer and SVP, product portfolio & business development; CHRIS PUCO, SVP & managing director, Americas; ZELKO RELIC, CTO & SVP, global research & development; JULIE TAY, SVP & managing director, Asia Pacific; EMORY WRIGHT, SVP, global operations

AMPLIFON Milan

2017 revenues: $1,430,580,000 (€1,266,000,000)

Fiscal year ending: December 31, 2017 Employees: 8,132

KEY PERSONNEL:

ENRICO VITA, CEO; ALESSANDRO BONACINA, chief marketing officer; CRISTIAN FINOTTI, chief procurement officer; GABRIELE GALLI, CFO; GABRIELE CHIESA, CIO; MARC LUNDEBERG, EVP, Americas; FRANCESCA MORICHINI, chief HR officer; IACOPO LORENZO PAZZI, EVP, EMEA; GIULIO PIZZINI, chief strategic development officer; CRAIG STEVENS, EVP, APAC.

FISHER & PAYKEL HEALTHCARE Auckland, New Zealand

2017 revenues:

$1,379,271,551 (NZ $980,800,000)

2017 R&D spend: $133,173,956 Fiscal year ending: March 31, 2018 Employees: 4,174

KEY PERSONNEL:

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

Medical Design & Outsourcing

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THE TOP 1OO MEDTECH COMPANIES

ELEKTA

Precision Components

Stockholm, Sweden 2017 revenues: $1,370,722,916 (kr11,333,000,000) 2017 R&D spend: $132,439,918 Fiscal year ending: April 30, 2018 Employees: 3,702 KEY PERSONNEL:

RICHARD HAUSMANN, president & CEO; GUSTAF SALFORD, CFO; KARIN SVENSKE NYBERG, EVP, human resources; MAURITS WOLLESWINKEL, head of portfolio & chief strategy officer; IOANNIS PANAGIOTELIS, chief marketing & sales officer; STEVEN WORT, COO; JOHN LAPRÉ, CTO; OSKAR BOSSON, EVP, corporate communications & investor relations; PAUL BERGSTRÖM, EVP, global services; PETER GACCIONE, EVP, North America; ANMING GONG, EVP, China; RENATO LEITE, EVP, Europe; JONAS BOLANDER, general counsel & EVP; CAROLINE MOFORS, SVP, chief complaince & integrity officer

COCHLEAR LTD.

New South Wales, Australia 2017 revenues: 2017 R&D spend: Fiscal year ending: Employees:

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EMI/RFI Shielding $1,351,400,000 $167,700,000 June 30, 2018 3,500

KEY PERSONNEL:

DIG HOWITT CEO & President; JAN JANSSEN CTO; RICHARD BROOK President, EMEA & Latin American Region; BRENT CUBIS CFO; TONY MANNA President, Americas Region; ANTHONY BISHOP President, Asia Pacific Region; ROM MENDEL President, Acoustics; STU SAYERS President, Services; DEAN PHIZACKLEA SVP, Global Marketing; DAVID CADE Chief Medical Officer; DAVID HACKSHALL Chief Information Officer; GREG BODKIN SVP, Supply Chain & Operational Excellence; JENNIFER HORNERY SVP, People & Culture

9 • 2018

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• Global supplier standard and custom products • Commercial and military markets • Over 100 finger stock gasket profiles • Shielded vents and filters • Conductive foam and elastomer gaskets • Board level shielding Download Shielding Catalog

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1OO

THE TOP 1OO MEDTECH COMPANIES

CARL ZEISS MEDITEC Jena, Germany

ICU MEDICAL

San Clemente, Calif.

2017 revenues: $1,344,587,000 (€1,189,900,000) 2017 R&D spend: $164,754,000 Fiscal year ending: September 30, 2017 Employees: 2,958

2017 revenues: 2017 R&D spend: Fiscal year ending: Employees:

$1,292,613,000 $51,253,000 December 31, 2017 6,802

KEY PERSONNEL:

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; ROBERTO DEGER, CFO, Carl Zeiss Meditec; STEVEN SCHALLHORN, chief medical officer, ophthalmics, Carl Zeiss Meditec; ANDREW CHANG, global sales head, ophthalmics, Carl Zeiss Meditec.

KEY PERSONNEL:

VIVEK JAIN, chairman & CEO; ALISON BURCAR, CVP & GM, infusion consumables; SCOTT LAMB, CFO; TOM MCCALL, CVP, marketing & communications & GM, critical care; CHRISTIAN VOIGTLANDER, COO

SMITHS MEDICAL

St. Paul, Minn.

2017 revenues: $1,225,839,000 (£951,000,000) Fiscal year ending: July 31, 2017 Employees: 7,700 KEY PERSONNEL:

CHRIS HOLMES, president & CEO; CARL STAMP, SVP, global marketing; JEFFREY BROWN, SVP, global sales; MICHAEL BLUM, acting GC; STEPHEN REMPE, SVP, global human resources; MICHAEL ARMSTRONG, SVP, global regulatory affairs & quality assurance; BRETT LANDRUM, CTO & SVP, research & development; BRENDA MCCORMICK, CFO & SVP, finance

Medical Design & Outsourcing

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Medical Design & Outsourcing

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THE TOP 1OO MEDTECH COMPANIES

FUKUDA DENSHI Tokyo, Japan

2017 revenues: $1,212,660,147 (¥128,883,000,000) Fiscal year ending: March 31, 2018

1OO

AGFA-GEVAERT Mortsel, Belgium

* Revenues from Agfa-Gevart’s healthcare segment.

2017 revenues: $1,188,760,000 (€1,052,000,000) Fiscal year ending: December 31, 2017

KEY PERSONNEL:

KOTARO FUKUDA, chairman & CEO; DAIJIRO SHIRAI, president & COO; KATSUHITO HOSOKI, executive officer, deputy chief director of sales; YOSHINOBU ISHIBASHI, executive officer, director of life technology sales; MASAKI TSUKUDA, executive officer, deputy chief director of sales, senior manager of product planning office; YUZO NISHIOKA, executive officer, director of human resources and general affairs, manager of ERP product; YUSUKE NAKAMURA, executive officer, chief director of quality assurance

2017_UR_Tegra_Medical_PRINT.indd 1

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KEY PERSONNEL:

CHRISTIAN REINAUDO, president & CEO; LUC DELAGAYE, president, Agfa Materials; DIRK DE MAN, CFO; LUC THIJS, president, Agfa Healthcare; STEFAAN VANHOOREN, president, Agfa Graphics

www.medicaldesignandoutsourcing.com

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THE TOP 1OO MEDTECH COMPANIES

INTEGRA LIFESCIENCES Plainsboro, N.J.

2017 revenues: 2017 R&D spend:

$1,188,236,000 $63,500,000

Fiscal year ending: December 31, 2017 Employees: 4,400

KEY PERSONNEL:

PETER ARDUINI, president & CEO; KENNETH BURHOP, CVP & chief scientific officer; GLENN COLEMAN, CFO & CVP, international; WILLIAM COMPTON, SVP, chief information officer; ROBERT DAVIS, CVP & president, orthopedics & tissue technologies; SRAVAN EMANY, VP, treasurer & investor relations; LISA EVOLI, CVP, chief human resources officer; PAUL GONSALVES, SVP, chief commercial officer; RICHARD GORELICK, CVP, GC, administration and secretary; MICHAEL MCBREEN, SVP & president, international; JOHN MOORADIAN, CVP, global operations & supply chain; JUDITH O’GRADY, CVP, global regulatory affairs; MARIA PLATSIS, SVP, corporate development; DAN REUVERS, CVP & president, Codman Specialty Surgical; JOSEPH VINHAIS, CVP, global quality assurance.

DJO GLOBAL* Vista, Calif.

2017 revenues: 2017 R&D spend:

$1,186,206,000 $35,429,000

Fiscal year ending: December 31, 2017 Employees: 4,420

KEY PERSONNEL:

BRADY SHIRLEY, president, CEO & director; MIKE EKLUND, COO & CFO; TOBY BOST, president, DJO global consumer business; W. MARK DORRIS, president, bracing & supports; JEFFERY MCCAULLEY, global president, DJO Surgical; STEVEN INGEL, EVP, healthcare solutions; JEANINE KESTLER, EVP, chief human resources officer; BRYAN MCMILLAN, president, regeneration & reimbursement; STEPHEN MURPHY, president, sales & marketing, international commercial business; RAJ SUBRAMONIAN, SVP & GM, FootCare Solutions; BRADLEY TANDY, EVP, GC & secretary.

INTEGER Frisco, Texas

2017 revenues: 2017 R&D spend:

$1,136,000,000 $49,000,000

Fiscal year ending: December 29, 2017 Employees: 8,000

KEY PERSONNEL:

JOSEPH DZIEDZIC, president & CEO; JEREMY FRIEDMAN, EVP, COO & interim CFO; JOSEPH FLANAGAN, EVP, quality & regulatory affairs; KIRK THOR, EVP, chief HR officer; TONY GONZALEZ, president, cardiac rhythm management & neuromodulation; PAYMAN KHALES, president, cardio & vascular; JENNIFER BOLT, president, electrochem & power solutions; TIMOTHY MCEVOY, SVP, GC, secretary; MICHAEL SPENCER, SVP, chief ethics & compliance officer; TONY BOROWICZ, VP, strategy, business development & investor relations.

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THE TOP 1OO MEDTECH COMPANIES

1OO

STRAUMANN Basel, Switzerland

2017 revenues: Fiscal year ending: Employees:

$1,114,335,200 (CHF 1,112,000,000) December 21, 2017 4,881

KEY PERSONNEL:

MARCO GADOLA, CEO; PETER HACKEL, CFO; GERHARD BAUER, head of R&D & operations; WOLFGANG BECKER, head distributor & emerging markets EMEA; GUILLAUME DANIELLOT, head of sales, North America; JENS DEXHEIMER, head of sales, Europe; FRANK HEMM, head of customer solutions & education; PATRICK KOK-KIEN LOH, head of sales, Asia & Pacific; ALEXANDER OCHSNER, Global People Management & Development; PETRA RUMPF, head of dental service organizations; MIKE RYNERSON, head of digital business; MATTHIAS SCHUPP, head of sales, Latin America, CEO, Neodent.

63 2017 revenues: 2017 R&D spend: Fiscal year ending: Employees:

NUVASIVE San Diego, Calif.

$1,029,520,000 $50,425,000 December 31, 2017 2,600

KEY PERSONNEL:

GREG LUCIER, chairman/CEO; RAJESH ASARPOTA, EVP & CFO; SKIP KILL, EVP, global commercial; PETE LEDDY, EVP people & culture; MATT LINK, EVP, strategy, technology & corporate development; STEVE ROZOW, EVP, global process transformation; NATHAN SISITSKY, SVP/general counsel/corporate secretary

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THE TOP 1OO MEDTECH COMPANIES

LIVANOVA London, U.K.

2017 revenues: 2017 R&D spend:

Fiscal year ending: December 31, 2017 Employees: 4,000

$1,012,277,000 $109,662,000

KEY PERSONNEL:

DAMIEN MCDONALD, CEO; EDWARD ANDRLE, GM, neuromodulation; THAD HUSTON, CFO; BRYAN OLIN, SVP, clinical/quality assurance/regulatory affairs; KEYNA SKEFFINGTON, SVP/general counsel; DAVID WISE, chief administrative officer

KAWANISHI HOLDINGS Okayama City, Japan

2017 revenues: $968,967,000 (¥107,663,000,000)

Fiscal year ending: June 30, 2018

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KEY PERSONNEL:

TOSHIYUKI MAESHIMA, CEO; YOHEI MAESHIMA, president; TAIRA TAKAI, vice chairman; YASUTOSHI OHATA, managing director; NOBUHARU MURATA, managing director

OMRON Kyoto, Japan * Revenues from Omron’s healthcare segment.

2017 revenues: $967,885,816 (¥108,500,000,000)

Fiscal year ending: March 31, 2018 Employees: 4,389

KEY PERSONNEL:

ISAO OGINO, president & CEO, Omron Healthcare; KENJI SUGAWA, director & EVP, Global Sales & Marketing Group HQ; TORU OZEKI, managing officer, international Sales and Marketing HQ; TAKAHIDE TANAKA, managing officer, R&D, & production officer, technology development HQ; KENJI EDA, executive officer, new business development global center HQ & global human resources; ANDRE VAN GILS, executive officer, president & CEO, Omron Healthcare Europe B.V.; AKIRA NODA, executive officer & chairman, Omron Dalian Co,. Ltd.; HIROTO IWASA, executive officer, global human resources & administration HQ, OMRON Corporation; YOSHIHIDE ONISHI, executive officer, production and SCM Strategy HQ

Medical Design & Outsourcing

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Introtek

THE TOP 1OO MEDTECH COMPANIES

INVACARE Elyria, Ohio

2017 revenues: 2017 R&D spend: Fiscal year ending: Employees:

$966,497,000 $17,796,000 December 31, 2017 4,200

KEY PERSONNEL:

MATTHEW MONAGHAN, chairman, president & CEO; DEAN CHILDERS, SVP & GM, North America; DARCIE KAROL, SVP, human resources; ANTHONY LAPLACA, SVP, general counsel & secretary; RALF LEDDA, SVP & GM, Europe; KATHLEEN LENEGHAN, SVP & CFO

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Hemodialysis Drug Delivery Infusion Pumps Heart/Lung Machines Blood Processing

1OO

HAEMONETICS Braintree, Mass

2017 revenues: 2017 R&D spend: Fiscal year ending: Employees:

$903,923,000 $39,228,000 March 31, 2018 3,136

KEY PERSONNEL:

CHRISTOPHER SIMON, president & CEO; MICHELLE BASIL, EVP & general counsel; SAID BOLORFOROSH, EVP, CTO; WILLIAM BURKE, EVP & CFO; DAVID GUENDJIAN, president, international; CARTER HOUGHTON, president, hospital business unit; CHAD NIKEL, president, global blood center; KEVIN O’KELLY-LYNCH, SVP, global business services; IAN PURDY, EVP, global quality & regulatory affairs; JACQUELINE SCANLAN, SVP, human resources; FRANCIS TAN, SVP, corporate development & planning; DAVID WILSON, president, global plasma.

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1OO

THE TOP 1OO MEDTECH COMPANIES

KONICA MINOLTA Tokyo, Japan * Revenues from Konica Minolta’s healthcare segment.

2017 revenues: $860,838,537 (¥96,500,000,000) Fiscal year ending: March 31, 2018

KEY PERSONNEL:

President & CEO, Representative Executive Officer SHOEI YAMANA; Senior Managing Executive Officer: KIYOTAKA FUJII GM, Healthcare Business Headquarters, & Chairman Ambry Genetics Corporation Senior Executive Officer TSUKASA WAKASHIMA Responsible for Human Resources & General Affairs KUNIHIRO KOSHIZUKA Responsible for Technologies KEN OSUGA Responsible for Special Projects SEIJI HATANO Responsible for Business Management, Accounting, Finance & Risk Management SHINGO ASAI GM, Manufacturing Headquarters NORIYASU KUZUHARA GM, Material & Component Business Headquarters & Corporate R&D Headquaters YUJI ICHIMURA GM, Industrial Optical System Business Headquarters & Responsible for BIC (Business Innovation Center) & Public Relations MASAFUMI UCHIDA GM, Quality Headquarters & Responsible for Corporate Sustainability TOSHIMITSU TAIKO Lead officer responsible for Business Technologies Business & GM, Office Business Headquarters IKUO NAKAGAWA Responsible for Digital Workplace Business & IT KAZUYOSHI HATA GM, Corporate Planning & Kansai Regional Director & Responsible for Investor Relations, Corporate Branding, One KM Business Promotion Executive Officer HIROYUKI SUZUKI GM, Corporate Audit ATSUO TAKEMOTO Deputy GM, Manufacturing Headquarters HAJIME TAKEI GM, R&D Headquarters, Business Technologies RICHARD TAYLOR President & CEO, Konica Minolta Business Solutions U.S.A., Inc. TAKAJI ITO GM, Corporate Business Management TOSHIYA EGUCHI GM, IoT Service Platform Development Operations KOJI SUGIE GM, Professional Print Business Headquarters TETSUYA MATSUEDA GM, Corporate Legal & Responsible for Intellectual Property, Compliance & Crisis Management KAZUMI ATAGO GM, Corporate Secretarial & Company Secretary HITOSHI KAMEZAWA GM, Sensing Business Unit, Industrial Optical System Business Headquarters TORU HASEGAWA Deputy GM, Healthcare Business Headquarters & GM, Healthcare Business Unit JEAN-CLAUDE CORNILLET President, Konica Minolta Business Solutions France S.A.S.

GN STORE NORD Ballerup, Denmark

* Revenues from GN Store Nord’s GN hearing unit.

2017 revenues: $851,312,219 (DKK615,000,000)

2017 R&D spend: $68,104,978 Fiscal year ending: December 31, 2017 Employees: 4,500

KEY PERSONNEL:

ANDERS HEDEGAARD, CEO, GN Store Nord, GN Hearing; MARCUS DESIMONI, CFO, GN Store Nord, GN Hearing

MASIMO Irvine, Calif.

2017 revenues: 2017 R&D spend:

$798,108,000 $61,953,000

Fiscal year ending: December 30, 2017 Employees: 1,400

KEY PERSONNEL:

JOE KIANI, CEO & chairman; JON COLEMAN, president, worldwide sales & professional services & medical affairs; MICAH YOUNG, EVP & CFO; YONGSAM LEE, EVP & CIO; ANAND SAMPATH, COO; TOM MCCLENAHAN, EVP, general counsel

Medical Design & Outsourcing

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THE TOP 1OO MEDTECH COMPANIES

72 2017 revenues: 2017 R&D spend: Fiscal year ending: Employees:

CONMED Utica, N.Y.

$796,392,000 $32,307,000 December 31, 2017 3,100

Your EMS Partner Dedicated to Medical Devices

KEY PERSONNEL:

CURT HARTMAN, pesident, CEO & director; PATRICK BEYER, president, international; TERENCE BERGÉ, VP, corporate controller; HEATHER COHEN, EVP, human resources; DANIEL JONAS, EVP, legal affairs, general counsel & secretary; JOHN KENNEDY, VP & GM, CET; VP & GM CET; JOHONNA PELLETIER, treasurer & VP, tax; STANLEY PETERS VP & GM, advanced surgical; WILFREDO RUIZ-CABAN, EVP, regulatory affairs/ quality assurance & operations; PETER SHAGORY, EVP, strategy & corporate development; TODD GARNER, EVP & CFO; SARAH OLIKER, assistant general counsel, assistant secretary

WRIGHT MEDICAL

Memphis, Tenn.

2017 revenues: 2017 R&D spend: Fiscal year ending: Employees:

$744,989,000 $50,115,000 December 31, 2017 2,675

KEY PERSONNEL:

ROBERT PALMISANO, president & CEO; LANCE BERRY, SVP & CFO; PETER COOKE, president, international; KEVIN CORDELL, president, U.S.; JAMES LIGHTMAN, SVP, general counsel & secretary; WESLEY PORTER, SVP & chief compliance officer; JULIE DEWEY, SVP, chief communications officer; JENNIFER WALKER, SVP, process improvement; JULIE ANDREWS, VP & chief accounting officer; TIMOTHY LANIER, president, upper extremities; PATRICK FISHER, president, lower extremities; JASON ASPER, SVP, strategy & corporate development; ANDREW MORTON, SVP & chief human resources officer; KEVIN SMITH, SVP, quality & regulatory; BARRY REGAN, SVP, operations

9 • 2018

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Medical Design & Outsourcing 83

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1OO

THE TOP 1OO MEDTECH COMPANIES

MERIT MEDICAL SYSTEMS South Jordan, Utah

2017 revenues: 2017 R&D spend:

$727,852,000 $51,403,000

Fiscal year ending: December 31, 2017 Employees: 5,400

KEY PERSONNEL:

FRED LAMPROPOULOS, chairman & CEO; JOE WRIGHT, president, international; RONALD FROST, COO; RAUL PARRA, CFO; BRIAN LLOYD, chief legal officer & corporate secretary; JUSTIN LAMPROPOULOS, EVP, commercial; JOHN KNORPP, chief regulatory affairs officer; JOSEPH PIERCE, CIO; LOUISE BOTT, VP, global human resources; JASON TREFT, CTO

DEXCOM San Diego, Calif.

2017 revenues: 2017 R&D spend:

$718,500,000 $185,400,000

Fiscal year ending: Employees:

December 31, 2017 2,290

KEY PERSONNEL:

KEVIN SAYER, CEO & president; ANDREW BALO, EVP, clinical affairs, regulatory strategies & global access; RICK DOUBLEDAY, EVP, chief commercial officer; JAKE LEACH, SVP, R&D; JOHN LISTER, GM, Europe, Middle East & Africa; JEFFREY MOY, SVP, operations; STEVEN PACELLI, EVP, strategy & corporate development; ANNIKA JIMENEZ, SVP, data; CLAUDIA GRAHAM, SVP, global access; DON ABBEY, EVP, quality & regulatory affairs; HEATHER ACE, SVP, human resources; QUENTIN BLACKFORD, CFO; PATRICK MURPHY, general counsel & chief compliance officer

AVANOS MEDICAL (FORMERLY HAYLARD HEALTH) Alpharetta, Ga.

2017 revenues: 2017 R&D spend:

$611,600,000 $38,200,000

Fiscal year ending: December 31, 2017 Employees: 13,000

KEY PERSONNEL:

JOSEPH WOODY, CEO; RHONDA GIBBY, SVP & chief human resources officer; WARREN MACHAN, SVP, business strategy; STEVEN VOSKUIL, SVP & CFO; JOHN WESLEY, SVP & general counsel

Medical Design & Outsourcing

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THE TOP 1OO MEDTECH COMPANIES

ABIOMED Danvers, Mass.

2017 revenues: 2017 R&D spend: Fiscal year ending: Employees: KEY PERSONNEL:

ÖSSUR Reykjavík, Iceland

2017 revenues: $569,000,000 Fiscal year ending: December 31, 2017 Employees: 2,290

$593,749,000 $75,297,000 March 31, 2018 1,143

MICHAEL MINOGUE, CEO, president & chairman; SETH BILAZARIAN, MD, chief medical officer; KELLEY BOUCHER, VP, human resources; WILLIAM BOLT, SVP, global quality, regulatory & clinical operations; ANDREW GREENFIELD, VP & GM; MICHAEL HOWLEY, VP & GM, global sales; DANIEL RAESS, MD, VP, senior medical director; THORSTEN SIESS, CTO; TODD TRAPP, VP & CFO; DAVID WEBER, COO

KEY PERSONNEL:

JON SIGURDSSON, president & CEO; EGILL JÓNSSON, EVP, manufacturing & operations; GUDJON KARASON, EVP, clinics; MARGRÉT LÁRA FRIÐRIKSDÓTTIR, EVP, human resources & corporate strategy; KIM DE ROY, EVP, research & development; ÓLAFUR GYLFASON, EVP, sales & marketing; SVEINN SÖLVASON, CFO

www.medicaldesignandoutsourcing.com

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1OO

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THE TOP 1OO MEDTECH COMPANIES

JMS CO. Hiroshima, Japan

2017 revenues: $531,797,000 (¥56,520,000,000)

2017 R&D spend: $13,853,702 Fiscal year ending: March 31, 2018

KEY PERSONNEL:

HIROAKI OKUKUBO, president & representative director; YASUHIRO AWANE, executive eirector, sales & marketing; JUN KUNITOMI, director, production; SHIGEMI MORIKAWA, director, international business; MASAFUMI SATO, director, R&D; RYUJI KATSURA, director, corporate planning; SHOGO YANAGIDA, director, production

NATUS MEDICAL Pleasanton, Calif.

2017 revenues: 2017 R&D spend:

Fiscal year ending: December 31, 2017 Employees: 1,726

$500,970,000 $51,822,000

KEY PERSONNEL:

JONATHAN KENNEDY, president, CEO & director; AUSTIN NOLL III, VP & GM, neurology; CHRISTOPHER CHUNG, VP, medical affairs, quality & regulatory; CARSTEN BUHL, president & CEO, Otometrics SBU; LESLIE MCDONNELL, VP & GM, newborn care

NIKKISO Tokyo, Japan * Revenues from Nikkiso’s medical segment.

2017 revenues: $485,789,474 (¥54,457,000,000)

Fiscal year ending: December 31, 2017

KEY PERSONNEL:

TOSHIHIKO KAI, president & CEO; HIROSHI NAKAMURA, director, EVP, administration & corporate planning & UV-LED; SHOTARO FUJII, director, senior executive officer, quality control; NAOTA SHIKANO, director, executive officer, industrial businesses; HISAKAZU NAKAHIGASHI, director, executive officer, production & engineering, GM, research & engineering institute, GM, biomedical engineering center; YOSHIHIKO KINOSHITA, director, executive officer, medical business, GM, medical

Medical Design & Outsourcing

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THE TOP 1OO MEDTECH COMPANIES

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INSULET

Billerica, Mass.

2017 revenues: 2017 R&D spend: Fiscal year ending: Employees:

$463,768,000 $74,452,000 December 31, 2017 857

KEY PERSONNEL:

PATRICK SULLIVAN, chairman & CEO; AIMAN ABDEL-MALEK, EVP & CTO; CHARLES ALPUCHE, EVP & chief operations officer; ERIC BENJAMIN, SVP, research & development; BRET CHRISTENSEN, SVP & chief commercial officer; DAVID COLLERAN, SVP, secretary & general counsel; DEBORAH GORDON, VP, investor relations & corporate communications; MICHAEL LEVITZ, SVP, CFO & treasurer; TRANG LY, SVP & medical director; SHACEY PETROVIC, president & COO; MICHAEL SPEARS, SVP, quality & regulatory affairs

ORTHOFIX

Lewisville, Texas

2017 revenues: 2017 R&D spend: Fiscal year ending: Employees:

$433,823,000 $29,700,000 December 31, 2017 858

KEY PERSONNEL:

BRAD MASON, president & CEO; DOUG RICE, CFO; MIKE FINEGAN, chief strategy officer; KIMBERLEY ELTING, chief legal & administrative officer; JILL MASON, chief ethics & compliance officer; JAMES RYABY, chief scientific officer; TIM MCGUIRE, chief information officer; BRAD NIEMANN, president, global Orthofix spine; BOB GOODWIN, president, biologics; DAVIDE BIANCHI, president, global Orthofix Extremities; RAY FUJIKAWA, president, Orthofix Spine Implants

9 • 2018

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THE TOP 1OO MEDTECH COMPANIES

TOPCON Tokyo, Japan * Revenues from Topcon’s eye care segment.

2017 revenues: $414,942,016 (¥46,515,000,000) Fiscal year ending: March 31, 2018

KEY PERSONNEL:

SATOSHI HIRANO, Director, President & CEO; MAKOTO IWASAKI, Director, Senior Managing Executive Officer, GM of Manufacturing Div., GM of General Administration & Legal Div., GM of Custom Products Business Promotion Div.; TAKASHI ETO, Director, Managing Executive Officer, GM of Smart Infrastructure Business Div., GM of Corporate Planning Div.; YASUFUMI FUKUMA, Director, Managing Executive Officer, GM of R&D Div.; HARUHIKO AKIYAMA, Director, Executive Officer, GM of Accounting & Finance Div.; TAKAYUKI YAMAZAKI, Director, Executive Officer, GM of Product Development Div.; RAYMOND O’CONNOR, Senior Managing Executive Officer, GM of Positioning Company, President & CEO of Topcon Positioning Systems Inc.; FUMIO OHUE, Managing Executive Officer, GM of Eye Care Business Div.; MASAMI TSUKADA, Executive Officer, Vice GM of Manufacturing Div., President of Topcon Yamagata Co., Ltd.; KAORU KUMAGAI, Executive Officer, Vice GM of Product Development Div.; SHIGEHIRO OGINO, Executive Officer, Vice GM of Eye Care Business Div.; TAKAAKI HIRAYAMA, Executive Officer, GM of Corporate Communication Div.; NOBUYUKI RYU, Executive Officer, Vice GM of Smart Infrastructure Business Div.; DAVID MUDRICK, Executive Officer, President & CEO of Topcon America Corporation; IVAN DI FEDERICO, Executive Officer, Chief Strategy Officer of Topcon Positioning Systems, Inc.; ERIC FRANKEN, Executive Officer, Managing Director, of Topcon Europe Medical B.V.; HITOSHI SADACHIKA, Executive Officer, Vice GM of Product Development Div. In charge of Development & Production Management; HIROYUKI NISHIZAWA, Executive Officer, GM of Quality Assurance Div.; KINPUI CHAN, Executive Officer, GM of Topcon Advanced Biomedical Imaging Laboratory, Topcon Medical Systems, Inc.; SHOKYU NAKAMURA, Executive Officer, Managing Director, of Topcon Singapore Holdings Pte. Ltd. Managing Director, of Topcon Sokkia India, Pvt. Ltd.; NOBUO ICHIKI, Executive Officer, GM of Corporate Audit Div.; REIKO WATANABE, Executive Officer, Vice GM of General Administration & Legal Div. In charge of Human Resources

ACCURAY Sunnyvale, Calif.

2017 revenues: 2017 R&D spend:

Fiscal year ending: June 30, 2018 Employees: 998

$404,897,000 $57,251,000

KEY PERSONNEL:

JOSHUA LEVINE, president & CEO; LIONEL HADJADJEBA, SVP, chief commercial officer; ROBERT HILL, SVP, corporate development; ANDY KIRKPATRICK, SVP, global operations & R&D; DARL MORELAND, SVP, regulatory, quality and compliance; PATRICK SPINE, SVP, chief HR officer; KEVIN WATERS, SVP, CFO

ASAHI INTECC

Nagoya, Japan

* Revenues from Asahi Intecc’s medical field segment.

2017 revenues: $397,885,816 (¥44,603,000,000)

CMY

Fiscal year ending: June 30, 2018 Employees: 6,220

KEY PERSONNEL:

MASAHIKO MIYATA, president & CEO; KENJI MIYATA, EVP & COO; TADAKAZU KATO, senior member of board; Board members: IPPEI YUGAWA, YOSHINORI TERAI, MUNECHIKA MATSUMOTO, MIZUHO ITO

Medical Design & Outsourcing

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THE TOP 1OO MEDTECH COMPANIES

NXSTAGE MEDICAL Lawrence, Mass.

2017 revenues: 2017 R&D spend: Fiscal year ending: Employees:

1OO

BTG London, U.K.

* Revenues from BTG’s Interventional Medicine business.

2017 revenues: $313,098,100 (£242,900,000) Fiscal year ending: March 31, 2018

$393,941,000 $39,608,000 December 31, 2017 3,800

KEY PERSONNEL:

JEFF BURBANK, CEO; Matthew Towse, CFO; JOSEPH TURK, JR., president; LISA CURTIS, SVP, international; TODD SNELL, SVP of quality assurance, regulatory & clinical affairs; TOM SHEA, SVP, chief operations officer; WINIFRED SWAN, SVP & general counsel; JEFFREY RAINS, SVP, sales & marketing; DARREN SCANDONE, SVP, human resources; DENNY TREU, SVP, research & development

KEY PERSONNEL:

LOUISE MAKIN, CEO; DUNCAN KENNEDY, CFO; MELANIE LEE, chief scientific officer; JAMIE HEATH, chief development officer; JOHN SYLVESTER, chief commercial officer; PETER PATTISON, head of interventional oncology; ANTHONY HIGHAM, head of manufacturing & supply, head of pharmaceuticals & U.S. commercial operations; YVONNE ROGERS, head of human resources; PAUL MUSSENDEN, general counsel, head of strategic affairs, company secretary, head of PnuemRx; PAUL MCCUBBIN, head of strategy; PETER STRATFORD, head of innovation

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Multi-Layered Tube for BALLON CATHETERS

Ultra-thin, High Performance forPTFE Liner CATHETER MANUFACTURING

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• Chemical etching available for adhesion to outer jacket • In-house manufacturing allows tightly controlled wall tolerence [+/- 0.000079" (2um)] and thickness (10 micron)

• Excellent R&D support works closely with your team

• OD monitoring and pin hole check on entire length

Polymers OD Wall OD Tolerance Number of Layers Delivery

General purpose resin (e.g., HDPE, PA, PA elastomer, TPU, etc.) 0.016" to 0.039" (0.4mm to 1.0mm) 0.0020" to 0.0047" (0.05mm to 0.12mm) +/- 0.0008" (0.02mm) 2 layers, 3 layers, all different polymers possible Cut piece, L= 72" max (1,500mm)

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Frequency

25 20 15 10 5 0

Competitor Wall Thickness Varies widely（2% to 15%） STD = 2.7% Average = 5.1%

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Frequency

The smaller the percentage, the more uniform in wall thickness: 25 20 15 10 5 0

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Uneven Wall Thickness (%)

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1OO

THE TOP 1OO MEDTECH COMPANIES

RTI SURGICAL Alachua, Fla.

2017 revenues: 2017 R&D spend:

Fiscal year ending: December 31, 2017 Employees: 942

$279,563,000 $13,375,000

KEY PERSONNEL:

CAMILLE FARHAT, president & CEO; JONATHON SINGER, chief financial & administrative officer, corporate secretary; LENNOX ARCHIBALD, medical director; JULIUS AVIZA, VP, global quality & assurance; PAUL MONTAGUE, VP, human resources; ENRICO SANGIORGIO, VP & GM, international markets; JOHN VARELA, EVP, global operations; OLIVIER VISA, VP, OEM, sports & donor services

BARCO Kortrijk, Belgium

* Revenues from Barco’s healthcare division.

2017 revenues: $274,883,800 (€243,260,000)

Fiscal year ending: December 31, 2017

KEY PERSONNEL:

JAN DE WITTE, CEO; ANN DESENDER, SVP, CFO; AN DEWAELE, SVP, chief HR officer; FILIP PINTELON, SVP, GM, healthcare; WIM BUYENS, CEO, Cinionic; GEORGE STROMEYER, SVP, GM, Enterprise; PIET CANDEEL, SVP, EMEA; NEY CORSINO, SVP, Americas; JOHAN HEYMAN, SVP, operations; XAVIER BOURGOIS, SVP, information technologies; KURT VERHEGGEN, SVP, general counsel; CHANG TET JONG, SVP, managing director, Barco China; OLIVIER CROLY, SVP, APAC; NICOLAS VANDEN ABEELIE, SVP, GM, entertainment

K2M GROUP HOLDINGS Leesburg, Va.

2017 revenues: 2017 R&D spend:

$258,031,000 $22,247,000

Fiscal year ending: December 31, 2017 Employees: 484

KEY PERSONNEL:

ERIC MAJOR, chairman, CEO, president, cofounder; JOHN KOSTUIK, chief medical officer cofounder; GREGORY COLE, CFO; GIANLUCA IASCI, chief commercialization officer; DAVE MACDONALD, SVP, operations; LANE MAJOR, COO; LUKE MILLER, SVP, general counsel & secretary; GEORGE MORATIS, global accounting officer; LAURA SUGDEN, SVP, human resources

Medical Design & Outsourcing

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THE TOP 1OO MEDTECH COMPANIES

CARDIOVASCULAR SYSTEMS St. Paul, Minn.

2017 revenues: 2017 R&D spend: Fiscal year ending: Employees: KEY PERSONNEL:

$217,043,000 $26,756,000 June 30, 2018 652

SCOTT WARD, chairman, president & CEO; JEFFREY POINTS, CFO; RHONDA ROBB, COO; LAURA GILLUND, chief talent officer; ALEXANDER ROSENSTEIN, GC & secretary; SANDRA SEDO, chief compliance officer

TOP 21-100 100 List_9-18_Vs6.indd 91

1OO

CRYOLIFE Kennesaw, Ga.

2017 revenues: 2017 R&D spend: Fiscal year ending: Employees:

$189,702,000 $19,500,000 December 31, 2017 1,000

KEY PERSONNEL:

PATRICK MACKIN, chairman, president & CEO; THOMAS BOGENSCHÃ&#x153;TZ, VP, EMEA & GM, JOTEC; SCOTT CAPPS, VP, clinical research; JOHN DAVIS, SVP, global sales & marketing; JEAN HOLLOWAY, SVP, general counsel, chief compliance officer & corporate secretary; AMY HORTON, VP, chief accounting officer; ASHLEY LEE, EVP, COO & CFO; DENNIS MAIER, VP, Kennesaw operations; JIM MCDERMID, SVP, chief human resources officer; WILLIAM NORTHRUP III, VP, physician relations & education; SHERRY SAURINI, VP, quality; MIKE TUCKERMAN, VP, sales North America

9/18/18 5:49 PM

1OO

THE TOP 1OO MEDTECH COMPANIES

ATRICURE Mason, Ohio

2017 revenues: 2017 R&D spend:

Fiscal year ending: December 31, 2017 Employees: 570

$174,716,000 $34,144,000

KEY PERSONNEL:

MICHAEL CARREL, president & CEO; ANDREW WADE, SVP & CFO; DOUGLAS SEITH, COO; JUSTIN NOZNESKY, SVP, marketing & business development; TONYA AUSTIN, VP, human resources; KARL DAHLQUIST, VP, legal & chief compliance officer; VINI DORAISWAMY, SVP, clinical, regulatory & scientific affairs; SAM PRIVITERA, CTO

SEASPINE Carlsbad, Calif.

2017 revenues: 2017 R&D spend:

Fiscal year ending: December 31, 2017 Employees: 327

$131,814,000 $12,180,000

KEY PERSONNEL:

KEITH VALENTINE, president, CEO & director; JOHN BOSTJANCIC, SVP, CFO; DENNIS CIRINO, SVP, spinal systems; TYLER LIPSCHULTZ, SVP, orthobiologics & business development; LAETITIA COUSIN, VP, regulatory & quality assurance; PATRICK KERAN, general counsel & corporate secretary; BILL RHODA, GM, process innovation & development; CHRIS SHEN, VP, customer experience & information technology; JOHN WINGE, VP, sales; TROY WOOLLEY, VP, marketing

SECTRA Linköping, Sweden

* Revenues from Sectra’s imaging IT division.

2017 revenues: $124,861,331 (kr1,032,341,000)

2017 R&D spend: $19,110,052 Fiscal year ending: April 30, 2018 Employees: 479

KEY PERSONNEL:

TORBJÖRN KRONANDER, CEO & president; MATS FRANZÉN, CFO; MARIE EKSTRÖM, EVP & president, imaging IT solutions; SIMO PYKÄLISTÖ, EVP & president, secure communications; SOFIA BERLING, GM, medical education; GUSTAF SCHWANG, GM, orthopedics; LISA EVERHILL, market communication & investor relations manager; CLAES LUNDSTRÖM, research director, medical systems; PER ANDERSNÄS, VP, operational excellence & IT; STAFFAN BERGSTRÖM, senior EVP, imaging IT solutions

Medical Design & Outsourcing

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THE TOP 1OO MEDTECH COMPANIES

ALPHATEC Carlsbad, Calif.

2017 revenues: 2017 R&D spend: Fiscal year ending: Employees: KEY PERSONNEL:

PATRICK MILES, chairman & CEO; TERRY RICH, president & COO; CRAIG HUNSAKER, EVP, people & culture & general counsel; JEFF BLACK, EVP & CFO; BRIAN SNIDER, EVP, strategic marketing & product development; KELLI HOWELL, EVP, clinical strategies

CONFORMIS Billerica, Mass.

2017 revenues: 2017 R&D spend: Fiscal year ending: Employees:

$101,739,000 $4,920,000 December 31, 2017 138

1OO

$78,115,000 $17,136,000 December 31, 2017 350

KEY PERSONNEL:

MARK AUGUSTI, CEO & president; PAUL WEINER, CFO; DANIEL STEINES, CTO; PATRICIA DAVIS, chief legal officer & general counsel; LISA DONNELLY, SVP, global marketing; DAN KRUPP, SVP, U.S. sales; EMMANUEL NYAKAKO, SVP, quality & regulatory affairs; JOHN SLAMIN, SVP, product engineering; MARC QUARTULLI, VP, clinical affairs; ED KILGALLEN, VP, operations

UTAH MEDICAL PRODUCTS Midvale, Utah

2017 revenues: 2017 R&D spend: Fiscal year ending: Employees:

$41,414,000 $447,000 December 31, 2017 172

KEY PERSONNEL:

KEVIN CORNWELL, chairman, president, CEO & secretary; MARCENA CLAWSON, VP corporate sales; PAUL RICHINS, principal financial officer, chief administrative officer; BEN SHIRLEY, VP product development & quality assurance

100

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EDAP Vaulx-en-Velin, France

2017 revenues: $40,392,980 (€35,746,000.00) 2017 R&D spend: $4,385,530 Fiscal year ending: December 31, 2017 Employees: 200

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

KEY PERSONNEL:

MARC OCZACHOWSKI, CEO; FRANÇOIS DIETSCH, CFO

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Medical Design & Outsourcing 93

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TOP R&D SPENDERS

R&D ranking by total spend:*

RANK COMPANY

R&D SPEND

R&D ranking by percentage of revenues:*

RANK COMPANY

R&D SPEND

1 Dexcom

$185,400,000

$718,500,000

25.8%

2 ConforMIS

$17,136,000

$78,115,000

21.9%

$34,144,000

$174,716,000

19.5%

Medtronic $2,253,000,000

Royal Philips $1,993,320,000

(medical device Johnson & Johnson $1,610,000,000 segment)

3 AtriCure

GE Healthcare (General Electric) $1,016,000,000

Boston Scientific $997,000,000

(life sciences, diagnostics Danaher $939,100,000 & dental segment)

Stryker $787,000,000

Baxter $617,000,000

Edwards Lifesciences $552,600,000

Novartis (Alcon segment) $490,000,000

Zimmer Biomet $367,400,000

12 B. Braun Melsungen $356,967,000 13 BioMerieux $343,972,000

Edwards Lifesciences

REVENUES ($USD) % OF REVENUES

$552,600,000 $3,435,300,000

16.1%

5 Insulet

$74,452,000

$463,768,000

16.1%

6 Sectra (Imaging IT division)

$19,110,052

$124,861,331

15.3%

7 Accuray

$57,251,000

$404,897,000

14.1%

8 BioMerieux

$343,972,000 $2,585,666,000

13.3%

9 Abiomed

$75,297,000

12.7%

10 Cochlear

$167,700,000 $1,351,400,000

12.4%

11 Cardiovascular Systems

$26,756,000

12.3%

12 Carl Zeiss Meditec

$164,754,000 $1,344,587,000

12.3%

13 Bio-Rad

$250,301,000 $2,160,153,000

11.6%

$593,749,000 $217,043,000

Boston Scientific

$997,000,000 $9,048,000,000

11.0%

15 LivaNova (formerly Sorin/Cyberonics)

$109,662,000 $1,012,277,000

10.8%

16 Essilor $245,210,000

16 Intuitive Surgical

$328,600,000 $3,128,900,000

10.5%

17 Hologic $232,800,000

$51,822,000

$500,970,000

10.3%

18 CryoLife

$19,500,000

$189,702,000

10.3%

19 NxStage Medical

$39,608,000

$393,941,000

10.1%

14 Intuitive Surgical $328,600,000 15 Bio-Rad $250,301,000

18 Smith & Nephew $223,000,000 19 Varian Medical Systems $210,000,000 20 Dexcom $185,400,000 21 Drägerwerk (medical business)

$182,156,000

22 Cochlear $167,700,000 23 Carl Zeiss Meditec $164,754,000 24 Bruker $162,700,000 25 Dentsply Sirona $151,700,000 26 Fresenius (medical care segment) $148,030,000 27 Sonova $145,193,050 28 Hill-Rom $133,700,000 29 Fisher & Paykel Healthcare $133,173,956 30 Elekta $132,439,918 31 LivaNova (formerly Sorin/Cyberonics) $109,662,000 32 Align Technology $97,600,000 33 Coloplast $87,026,396 34 Teleflex $84,800,000 35 Abiomed $75,297,000 The color codes correspond to the top 10 R&D spenders.

Medical Design & Outsourcing

R&D breakout_9-18_Vs4.indd 94

9 • 2018

Natus Medical

Royal Philips

$1,993,320,000 $20,091,400,000

9.9%

21 Drägerwerk (medical business)

$182,156,000 $1,884,840,000

9.7%

22 Elekta

$132,439,918 $1,370,722,916

9.7%

23 Fisher & Paykel Healthcare

$133,173,956 $1,379,271,551

9.7% 9.2%

24 SeaSpine

$12,180,000

25 Bruker

$162,700,000 $1,765,900,000

9.2%

26 K2M Group Holdings

$22,247,000

8.6%

Novartis (Alcon segment)

$131,814,000 $258,031,000

$490,000,000 $6,024,000,000

8.1%

28 GN Hearing

$68,104,978

8.0%

29 Varian Medical Systems

$210,000,000 $2,668,200,000

7.9%

30 Masimo

$61,953,000

7.8%

31 Hologic 32

Medtronic

$851,312,219 $798,108,000

$232,800,000 $3,058,800,000

7.6%

$2,253,000,000 $29,953,000,000

7.5%

33 Merit Medical Systems

$51,403,000

$727,852,000

7.1%

34 Orthofix

$29,700,000

$433,823,000

6.8%

35 Wright Medical

$50,115,000

$744,989,000

6.7%

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

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TOP R&D SPENDERS

R&D ranking by total spend:*

RANK COMPANY

R&D SPEND

36 Insulet $74,452,000 37 Getinge $71,844,120 38 Cooper Cos. $69,200,000 39 GN Hearing $68,104,978 40

Integra Lifesciences $63,500,000

41 Masimo $61,953,000 42 Steris $60,782,000 43 Accuray $57,251,000 44 Natus Medical $51,822,000 45 Merit Medical Systems $51,403,000 46 ICU Medical $51,253,000 47 NuVasive $50,425,000 48 Wright Medical $50,115,000 49 Integer (formerly Greatbatch) $49,000,000 50 ConvaTec $41,200,000 51 ResMed $39,657,000 52 NxStage Medical $39,608,000 53 Haemonetics $39,228,000 Halyard Health) 54 Avanos Medical (formerly

$38,200,000

55 DJO Global* $35,429,000 56 AtriCure $34,144,000 57 Conmed $32,307,000 58 Orthofix $29,700,000 59 Cardiovascular Systems $26,756,000 60 K2M Group Holdings $22,247,000 61 CryoLife $19,500,000 62 Sectra (Imaging IT division) $19,110,052 63 Invacare $17,796,000 64 ConforMIS $17,136,000 65 Terumo $14,272,971 66 JMS Co. $13,853,702 67 RTI Surgical $13,375,000 68 SeaSpine $12,180,000 69 William Demant (hearing segments)

$8,198,037

70 Alphatec $4,920,000 71 Utah Medical Products $447,000 The color codes correspond to the top 10 R&D spenders.

Medical Design & Outsourcing

R&D breakout_9-18_Vs4.indd 96

9 â&#x20AC;˘ 2018

R&D ranking by percentage of revenues:*

RANK COMPANY

R&D SPEND

REVENUES ($USD) % OF REVENUES

36 Align Technology

$97,600,000

$1,473,413,000

6.6%

sciences, diagnostics & dental segment) Danaher (life

$939,100,000 $14,360,900,000

6.5%

Stryker

$787,000,000 $12,444,000,000

6.3%

$38,200,000

6.2%

39 Avanos

Medical (formerly Halyard Health)

Johnson &

Baxter

device segment) Johnson (medical

$1,610,000,000 $26,592,000,000

6.1%

$617,000,000 $10,561,000,000

5.8%

$145,193,050 $2,688,376,346

5.4%

42 Sonova 43 Integra Lifesciences 44

GE Healthcare (General Electric)

$611,600,000

$1,188,236,000

5.3%

$1,016,000,000 $19,116,000,000

$63,500,000

5.3%

45 NuVasive

$50,425,000

46 Hill-Rom

$133,700,000 $2,743,700,000

$1,029,520,000

4.9% 4.9%

47 Alphatec

$4,920,000

$101,739,000

4.8%

48 RTI Surgical

$13,375,000

$279,563,000

4.8%

49 Zimmer Biomet

$367,400,000 $7,824,100,000

4.7%

50 Smith & Nephew

$223,000,000 $4,765,000,000

4.7%

51 B. Braun Melsungen

$356,967,000 $7,671,457,000

4.7%

52 Haemonetics

$39,228,000

$903,923,000

4.3%

53 Integer (formerly Greatbatch)

$49,000,000

$1,136,000,000

4.3%

54 Conmed

$32,307,000

$796,392,000

4.1%

55 ICU Medical

$51,253,000

$1,292,613,000

4.0%

56 Teleflex

$84,800,000

$2,146,303,000

4.0%

57 Dentsply Sirona

$151,700,000 $3,993,400,000

3.8%

58 Coloplast

$87,026,396

$2,354,261,110

3.7%

59 Cooper Cos.

$69,200,000

$2,139,000,000

3.2%

60 DJO Global*

$35,429,000

$1,186,206,000

3.0%

61 Essilor

$245,210,000 $8,475,000,000

2.9%

62 Getinge

$71,844,120

$2,720,763,434

2.6%

63 JMS Co.

$13,853,702

$531,797,000

2.6%

64 ConvaTec

$41,200,000

$1,764,600,000

2.3%

65 Steris

$60,782,000

$2,619,996,000

2.3%

66 Invacare

$17,796,000

$966,497,000

1.8%

67 ResMed

$39,657,000

$2,340,196,000

1.7%

$447,000

$41,414,000

1.1%

68 Utah Medical Products 69 Fresenius (medical care segment)

$148,030,000 $20,095,920,000

0.7%

70 William Demant (hearing segments)

$8,198,037

$1,999,636,127

0.4%

71 Terumo

$14,272,971

$4,586,654,773

0.3%

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

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COMPANIES RANKED BY EMPLOYMENT

Company ranking by employee totals

RANK

COMPANY

EMPLOYEES

RANK

COMPANY

EMPLOYEES

Varian Medical Systems 6,600

Hologic 6,233

Bruker 6,200

ResMed 6,000

Merit Medical Systems 5,400

Medtronic 86,000

Straumann 4,881

Royal Philips 73,951

GN Hearing 4,500

Essilor 67,000

Intuitive Surgical 4,444

B. Braun Melsungen 61,583

DJO Global* 4,420

Johnson & Johnson (medical device segment) 60,000

Integra Lifesciences 4,400

GE Healthcare (General Electric) 52,000

Omron (healthcare segment) 4,389

Baxter 47,000

Invacare 4,200

Stryker 33,000

Fisher & Paykel Healthcare 4,174

Boston Scientific 29,000

LivaNova (formerly Sorin/Cyberonics)

Terumo 23,319

NxStage Medical 3,800

Henry Schein 22,000

Elekta 3,702

Novartis (Alcon segment) 20,000

Cochlear 3,500

Zimmer Biomet 18,200

Haemonetics 3,136

Dentsply Sirona 16,100

Conmed 3,100

Smith & Nephew 15,000

Carl Zeiss Meditec 2,958

Teleflex 14,400

Wright Medical 2,675

Sonova 14,242

NuVasive 2,600

William Demant (hearing segments) 13,280

Dexcom 2,290

4,000

Avanos Medical (formerly Halyard Health) 13,000

Össur 2,290

Edwards Lifesciences 12,200

Natus Medical 1,726

Steris 12,000

Masimo 1,400

Cooper Cos. 11,800

Abiomed 1,143

Paul Hartmann 10,764

CryoLife 1,000

Getinge 10,684

Accuray 998

Coloplast 10,420

RTI Surgical 942

BioMerieux 10,400

Orthofix 858

Hill-Rom 10,000

Insulet 857

ConvaTec 9,500

Cardiovascular Systems 652

Align Technology 8,715

AtriCure 570

Owens & Minor 8,600

K2M Group Holdings 484

Bio-Rad 8,150

Sectra (Imaging IT division) 479

Amplifon 8,132

ConforMIS 350

Integer (formerly Greatbatch) 8,000

SeaSpine 327

Smiths Medical (Smiths Group) 7,700

Utah Medical Products 172

ICU Medical 6,802

Alphatec 138

Medical Design & Outsourcing

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Medical Design & Outsourcing

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MERGERS & ACQUISITIONS

THE MEDICAL DEVICE INDUSTRY may not be keeping pace with initial public offerings in biotech, but medtech is holding its own when comes to mergers and acquisitions, according to industry watchers. Boston Scientific alone bought seven companies as of mid-August, by when 11 venturebacked deals had also occurred; Johnson & Johnson bought French robot-assisted surgery company Orthotaxy in February. "The biotech industry has been in a resurgence over the last few years with many high-value IPOs. The medical device industry hasn’t garnered the same IPO headlines, but there have been a number of megamergers between the medtech giants and many meaningful acquisitions of early-stage companies by the big players,” patent attorney

NAN

CY C ROTT I|S ENIO R ED ITOR

David Dykeman, a shareholder with the Greenberg Traurig law firm in Boston, told Medical Design & Outsourcing. The medtech megamergers of the past few years have created huge medtech companies that are looking for early-stage acquisitions providing innovative solutions that treat a large unmet medical need in a cost-effective and reimbursable manner, Dykeman said. These smaller companies can bring new disruptive technologies to market quickly, and if the innovative technologies have been de-risked via regulatory strategy, intellectual property and patient adoption, the big players are often willing to pay a premium for them, he added. They can certainly afford it, according to Matt Arens, CEO and senior portfolio manager of First Light Asset Management, a healthcare investment firm based in Edina, Minn.

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MERGERS & ACQUISITIONS

"The large buyers have unprecedented levels of cash," Arens said. "We're still in a low-interest-rate environment, so that cash is largely a nonperforming asset. Finding durable growth assets, we think, is critically important to the large companies' future growth." Companies seeking pre-market approvals or de novo clearances from the FDA continue to attract more interest from suitors than 510(k) clearance holders, and they make quicker exits, according to Jonathan Norris, managing director of the healthcare investment practice at Silicon Valley Bank in Santa Clara, Calif. PMA and de novo seekers also tend to represent bigger market opportunities to acquirers and may already hold the CE Mark in Europe – with data from that market to boot. Products that hold a 510(k) clearance "are typically a nice piece to add to your grouping of products," but don't generate the excitement of a game-changing device in a high-need area of healthcare, Norris told us. Prospective acquirers want the companies that make these devices to prove their salability, build up their sales force, win reimbursement and ramp up revenue before being considered for acquisition. "They have to prove that the dogs are eating the dog food," Norris explained. "Acquirers out there are so [earnings-pershare]-focused, these public companies, that they don't want to acquire companies that they have to put a lot of money into unless they're game-changers." "The bigger guys want growth. They want something that's growing faster than their core business," agreed Mike Matson, senior equity research analyst at Needham & Co. in Boston. "If they're growing at 5%, they probably want something to grow at 10%-plus." Venture-backed M&A has been roaring ahead, with five deals announced from July to midAugust and 11 year-to-date, including four undisclosed agreements, according to Norris. Deals that have been made public include bids for TVA Medical by Becton Dickinson; ReCor Medical by Otsuka Holdings; and Claret Medical, Cryterion Medical and Veniti, all three by Boston Scientific.

THE LARGE BUYERS HAVE UNPRECEDENTED LEVELS OF CASH. WE’RE STILL IN A LOWINTEREST-RATE ENVIRONMENT, SO THAT CASH IS LARGELY A NONPERFORMING ASSET.

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MERGERS & ACQUISITIONS

"It seems like it's second half of the year loaded for venture-backed M&A," Norris said. "We're already at 11 and that bodes well for them hitting the mid-teens mark, which would make it a very solid year and put them in the middle of where we've seen activity over the last five years." Larger players are willing to place an earlier bet on early-stage companies with very promising technologies, but if the targets are willing to wait longer for an acquisition, they can fetch a much higher price. Among public companies, the wait-forit trend has become a drag on medtech M&A, according to Matson. He sees some smaller public companies' sky-high valuations giving would-be acquirers pause and expects the number of M&A deals in 2018 and their dollar volume to decline compared with 2017 because of it. Counting veterinary devices, two deals of more than $1 billion have been announced for 2018, Zoetis' pending acquisition of Abaxis for $1.7B and ICU Medical's $2.7 billion bid for Smiths Medical. As of June 30, there were 102 deals totaling $9.5 billion; at that pace, Matson estimated a total of 207 deals worth $19.3 billion in 2018, compared with 242 deals worth a collective $45.5 billion last year – which would make this year the one with the lowest number of deals since 2002 and the lowest dollar volume of deals since 2011. Public companies' multiples influence private companies' valuations, even if they're not exactly in sync, Matson has found. "That may become a more fertile ground for M&A, because they're not as expensive and there are a lot of private things out there that can get acquired," he said. Medtech market-watchers are wondering when Medtronic and Abbott, quiet since their major acquisitions in 2015 and 2017, will jump back in the game. "When one of the big acquirers is quiet, that gives them more of an opportunity to look for what they want to add to their portfolio and maybe at a price that fits with what they see as value at this point," Norris said. "If you have less potential acquirers, it's harder for companies to get bids to bump up the price." M

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IP ISSUES

Strong patent portfolios attract strategic investments and deals Amassing a strong patent portfolio helps medical device companies attract interest from strategic investors and potential acquirers. David J. Dykeman | G r e e n b e r g Tr a u r i g |

Patrick West | Mirus Capital Advisors |

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The medical device industry has demonstrated strong and sustainable growth in recent years. Given the aging population, increasing incidence of chronic and lifestyle diseases, emergence of artificial intelligence (AI) and big data, and significant investments in R&D and M&A, the medtech sector appears to be in prime health. According to KPMG, the medical device industry’s global annual sales are forecast to rise more than 5% a year to reach nearly $800 billion by 2030. As the industry evolves, medtech companies are making strategic moves to stay ahead in their respective markets. Strategic investments on the rise The last decade has seen a dramatic rise in large life science companies creating venture funds to invest in promising early stage medical technologies that align with the larger giants. In the last few years, large medtech companies have been competing in the race to acquire private medical device companies with a particular focus on neurosurgery, orthopedics and cardiology. 9 • 2018

Industry analysts note that large medtech players – including Johnson & Johnson, Medtronic, Boston Scientific and HMO Kaiser Permanente – made major investments in medical device startups in 2017. As of August 2017, there were more than 50 corporate deals channeling more than $833 million of investment to private medical device companies. This trend is continuing in 2018. Some recent examples of strategic investments by major players in early stage companies include: •

•

In August 2018, Boston Scientific signed an agreement to acquire Veniti, which developed the Vici Venous Stent System for treating venous obstructive disease. In 2016, Boston Scientific invested in Veniti for 25% ownership of the company. The transaction price for the remaining ownership stake included $108 million up-front cash, and up to $52 million in payments contingent upon FDA approval. In February 2018, global orthobiologics company Bioventus invested $2.5

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IP ISSUES

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million in Israeli-based CartiHeal, which is developing an implant for treating joint surface lesions in traumatized and osteoarthritic knees. Johnson & Johnson also participated in the $21 million financing round. In two transactions in early 2018 in the personalized medicine/CRO space, Precision Therapeutics (f/k/a Skyline Medical), a company focused on applying AI to personalized medicine and drug discovery, converted a previous $500,000 loan to Helomics into a 5% equity stake, and purchased preferred stock convertible to 20% of outstanding common stock of Helomics.

Big pharma players are also involved with venture investing in medtech startups including Merck, Roche, Novartis, Eli Lilly, AstraZeneca and GlaxoSmithKline. In addition to traditional sectors such as cardiovascular and orthopedics, medtech investments are being driven by new technologies in high demand, such as mobile health, big data, robotics and artificial intelligence. As mobile health continues to become more ubiquitous, digital and mobile health solutions are becoming increasingly important to traditional medical device companies as investment, partnership and acquisition targets. M&A remains robust On the M&A front, various reports suggest that strategic acquisitions of emerging medtech companies and start-up innovations have been a key catalyst driving the U.S. healthcare space, with some experts stating that medtech M&A activity surged 50% in 2017, increasing the value of aggregate M&A to more than $200 billion. The strong M&A trend in earlier stage companies is continuing in 2018, including the following examples. •

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Boston Scientific has been very active this year, announcing seven acquisitions worth up to $1.4 billion through August 2018. In March 2018, Johnson & Johnson enhanced its surgical robotics Medical Design & Outsourcing

9 • 2018

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capabilities by purchasing French software-enabled surgery technology developer Orthotaxy. The acquisition aims to help J&J create a more wide-ranging robot-assisted platform for total and partial knee replacement procedures. In April 2018, Medtronic acquired Israeli minimally invasive surgery provider Visionsense. The deal has been valued at $75 million with $4050 million in cash and the remainder in milestone payments. In May 2018, Orthofix paid $105 million for Spinal Kinetics’ M6 cervical disc implant. The deal calls for $45 million in up-front cash, plus another $60 million in milestones related to U.S. FDA approval of the M6 cervical device and trailing 12-month sales targets.

Patents help drive deals with both strategics and private equity An interesting emerging dynamic is the competition among strategic buyers and private equity funds for earlierstage assets in all sectors of medtech. While the strategic giants are seeking to broaden their portfolios and/or invest in emerging technologies and areas they already serve, clever private equity investors such as Audax Private Equity and Graham Partners recognize the value smaller companies with strong protected technology and brand positions offer as platform investments. The May 2018 acquisition of NightBalance by Philips is a perfect example of strategic positioning. NightBalance is a Netherlands-based digital health startup that has developed a sleep apnea wearable that is used to

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treat positional obstructive sleep apnea and positional snoring. NightBalance offered a complementary technology and a strong patent portfolio that helped Philips to expand its growing sleep and respiratory care offerings. It would seem that with Audax’s acquisition of blood and fluid infusion provider Belmont Instrument Co. in December 2017, Audax is seeking to reproduce the significant success it had with Laborie Medical Technologies, which was sold to Patricia Industries in August 2016. Acquired in 2012, Laborie is an industry-leading manufacturer and supplier of novel patented pelvic health and gastrointestinal medical equipment and consumables. Audax completed 14 complementary acquisitions and significantly grew Laborie off of its solid foundation prior to exit.

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IP ISSUES

Tips to attract strategics Emerging medtech companies that have developed value-driven patent portfolios can maximize opportunities for potential M&A, investment and partnering deals. Below are some considerations for early stage companies to become attractive targets. 1. Be an innovator: Although large medical device companies continue to have significant R&D budgets, early-stage companies can sometimes act as outsourced R&D laboratories on the leading edge of innovation. These smaller companies can bring new technologies to market quickly and often create disruptive technologies with high market potential that are appealing to traditional medical device

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players. Acquirers are willing to pay a premium for next-generation products that can disrupt the medtech market. If the story is compelling, acquirers will pay for the promise of what the product can deliver in the market, even if regulatory approval is still years away. 2. Plan ahead and be creative: Strategic investments and acquisitions, particularly with early-stage companies, often take much longer than anyone anticipates, so companies need to plan for deals years in advance. The deal lifecycle is lengthening because the larger medical device companies are concerned about limiting unnecessary risk. Interest is often developed over years of watching a technology develop and getting comfortable with the product and management team.

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Investment and deal structures are often heavily dependent on meeting performance milestones. 3. De-risk your technology and company: Deals at all stages are getting done, but the higher valuations tend to be companies that have less risk and are further down the patent, regulatory and commercialization paths. As an early-stage company develops its investment and exit strategies, it should take a hard look in the mirror and conduct a thorough self-assessment. No matter how promising the technology, a company needs to assess where it is now and what the hurdles are to reach the finish line. Medtech startups need to address their IP, regulatory pathway and reimbursement from the day the company is formed.

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4. Build a strong patent portfolio: An early-stage company’s patent portfolio is one of its strongest assets. Companies need to think strategically about their patent portfolio from the start and supplement early patent filings to cover the latest innovations and improvements. Creating a “picket fence” of patent protection around the core technology by filing additional patent applications covering incremental improvements and new innovations can lead to greater market share and higher valuations in deals. 5. Show strong initial adoption: More established medtech companies need to focus on adoption and sales. Large medical device companies are looking to acquire promising companies that can benefit from a stronger sales force to accelerate the commercialization curve. Thus, showing strong initial sales and adoption in hospitals and clinics is important even if in a limited or focused market. Adoption and re-use rates within specific institutions are key to demonstrating that a new technology has real commercial potential. The convergence of new technologies and innovations including connected health, AI and big data informatics, robotics, biologics and gene therapies are disrupting healthcare. As medtech innovations continue to enhance and shape healthcare and the way we live, early-stage medtech companies must think strategically to position themselves for strategic investments, partnerships and M&A deals. With careful planning that includes a strategic patent portfolio with worldwide patent protection, innovators can thrive in the dynamic medtech market. M

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CYBERSECURITY

Medical IoT and the challenges for healthcare What do healthcare providers want from medical device manufacturers concerning network and device security?

The advent of the Internet of Things (IoT) has created enormous opportunity and profound challenges for any business looking to take on the digital transformation. But no industry faces more of a test to make this change than healthcare. Organizations that want to embrace IoT can struggle for many years in the pursuit of “going digital” and still fail. Hospitals and other healthcare providers have all the operational complexities of other businesses with the added responsibilities of keeping their patients safe, ensuring patient health records are secure and

Martin Nappi | Green Hills Software |

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keeping their facilities operational 24/7. Plus, the healthcare industry is a primary target of increasingly sophisticated cybercriminals looking to install ransomware, to steal patient health records or harm patients with connected medical devices such as insulin pumps or pacemakers. A healthcare facility could follow the National Institute of Standards Technology’s Cybersecurity Framework to the letter, but its network will only be as secure as the weakest entry point. Increasingly, unsecured medical devices are used as beachheads to gain access to a hospital network.

www.medicaldesignandoutsourcing.com

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CYBERSECURITY

Every type of connected medical device has its own set of complexities that need to be secured at the time of product design. Each device has an application programming interface (API), a user interface, a URL, and often interfaces for HDMI, Bluetooth or WiFi, all of which may be exploited if not properly secured by the device manufacturer. Unfortunately, the major burden of responsibility for securing these devices ultimately falls on the healthcare provider. Cybercriminals usually focus on stealing electronic health records (EHRs) due to their black market value of $300 to $500 per record. They may also install malware or ransomware on the hospital network, encrypting and disabling the connected servers and systems and causing total disruption to the provision of care. The systems

remain dysfunctional until the hospital pays the ransom, finds a way to subvert the encryption algorithm – rarely a trivial task – or restores systems from backups, which could take several days or longer. A large hospital’s real cost of recovering from a ransomware attack generally runs in the millions of dollars. The cost to a smaller medical practice is usually less, but this does not include the disruption of care and access to patient health information. Healthcare providers might also incur heavy fines under HIPAA and General Data Protection Regulation requirements for the theft of EHRs and the breach of personal health information (PHI). Medical device manufacturers that build products that handle, store or transmit PHI may also be subject to substantial monetary penalties if proven negligent in a hospital

breach in which PHI was compromised. Healthcare organizations are bearing the brunt of these crippling attacks. In the first quarter of 2018, several hospitals were attacked and infected with ransomware and, in most cases, paid the ransom. As cybercriminals become more technically sophisticated, medical device manufacturers need to be at least equally as responsive and sophisticated in their efforts to shore up their device security. Healthcare organizations, hospitals, clinics and other providers are the major customers and primary source of revenue for medical device manufacturers. We contacted about three dozen physicians, executives and other organizations that support, or work on behalf of, healthcare providers. Here are their thoughts about cybersecurity:

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Are you aware that unsecured medical devices on healthcare networks can be used as beachheads to infiltrate the organization’s network and servers, allowing a cybercriminal to install malware or steal Electronic Health Records (EHR)? A solid 95% of the interviewees were aware of this issue. Everyone agreed that “medical device safety and security” must be top of the priority list for all medical devices connected to healthcare networks.

•

Do you think the FDA is doing enough to encourage manufacturers to provide safe and secure medical devices? The responses were mixed. Fifty-five percent of respondents were not satisfied with the current FDA guidance. Their reasons for this dissatisfaction included: o The FDA guidance needs to require device manufacturers to provide detailed information to make it easier for healthcare providers to compare the levels of security and safety built into a medical device. The hope is that the requirement for a software bill of materials (SBOM) will help in this regard. o The FDA should require medical device manufacturers to adhere to a clearly specified standard that is escalated by the criticality of the device’s application. Thirty percent of respondents were satisfied with the FDA guidance and the remaining 15% chose not to answer or didn’t know enough about the subject to comment.

SMALL ORGANIZATIONS CANNOT AFFORD TO RETAIN THE IN-HOUSE STAFF TO DETERMINE THE CYBERSECURITY CAPABILITIES OF THE PRODUCTS WE PROCURE. MOST OFTEN, WE ARE FORCED TO DEPEND UPON THE WORD OR REPUTATION OF THE MANUFACTURER OR, IN OUR CASE, DISTRIBUTOR. THE PROBLEM IS THAT THEY ARE ALL GETTING HACKED. •

If you are a healthcare provider, does your organization have a program that specifies rigorous testing of medical device safety and security as part of the procurement process? Almost all IT executives and physicians interviewed were investing substantially in protecting their internal networks. However, only larger healthcare providers had the resources and the staff to institute official policies and procedures to ensure that procured medical devices are manufactured using industry best practices for safe coding and cybersecurity.

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“I think the FDA guidance has come a long way, and it is continuing to improve,” said Courtney Young, a senior risk management attorney for Medmarc, which insures and provides risk management services to medical device manufacturers. “I advise medical device manufacturers how to mitigate risk, and I try to help them understand that the FDA guidance should be looked at as a floor. It’s not a ceiling. It’s a starting point to be improved upon.” •

9 • 2018

Should life-critical medical devices and systems be subject to mathematically proven and secured system requirements, as with the Medical Design & Outsourcing 113

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CYBERSECURITY

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aerospace industry? The physicians and security executives we spoke with agreed that life-critical medical devices must be safer and more secure than non-life-critical medical devices. They also thought that other industries’ security measures should immediately be examined and evaluated for their applicability for medical devices. Finally, the respondents agreed that an independent accrediting body should certify the safety and security of life-supporting or life-saving medical systems. It should be made up of medical industry stakeholders without government oversight, they said. “Small organizations cannot afford to retain the in-house staff

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to determine the cybersecurity capabilities of the products we procure,” one physician explained. “Most often, we are forced to depend upon the word or reputation of the manufacturer or, in our case, distributor. The problem is that they are all getting hacked.” Medical device manufacturers should ease the burden on healthcare, improve the medical device ecosystem, and provide a much higher level of patient safety. From the initial product design, they must use rigorously tested software within their devices to avoid product malfunction and vulnerabilities. Network-connected medical devices must build upon FDA guidance and employ cybersecurity techniques capable of defending against sophisticated, well-funded cybercriminals. Newly proposed SBOM guidance must clearly inform the healthcare industry of the risks and capabilities of connected medical devices. Lastly, there should be a more equitable distribution of responsibility for securing medical IoT. The medical device manufacturers that embrace safety and security as their top priority will succeed at medical IoT and most importantly, keep patients safe from cyber-harm. M

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DESIGN

Smithwise helps XPrize-winning startup find its focus Basil Leaf Technologies may have won the $2 million XPrize, but getting to market was another story.

Nancy Crotti | Senior Editor |

After Basil Leaf Technologies won the Qualcomm Tricorder XPrize in 2017, founder Dr. Basil Harris needed help figuring out how to bring this almost-allin-one diagnostic tool to market. Basil Leaf’s mobile platform DxtER includes a group of non-invasive sensors that can wirelessly communicate with a smart device as they collect data on vital signs, body chemistry and biological functions. An artificially intelligent engine at the heart of DxtER learned to diagnose by integrating ER practices and data from actual patients with a variety of medical conditions and outcomes. A Philadelphia-area emergency room doctor with a PhD in engineering, Harris worked with his brother, network engineer George Harris, and their Final Frontier Medical Device team to invent their version of the tricorder of Star Trek fame.

the device development company Harris tapped for help with engineering and regulatory issues. “You need to focus in on a specific patient population and figure out what problem you’re trying to solve in that patient population,” Sugalski told Medical Design & Outsourcing. Harris settled on heart failure as the first use for DxtER because it would best show the capabilities of its sensors. Heart failure is also a major malady among Harris’ ER patients and a leading cause of hospital readmittance. Rather than marketing DxtER as diagnostic, the first iteration is designed to help physicians manage heart failure patients to keep them healthy and out of the hospital, he told us. Patients would use it at home to measure their vital signs and notify their doctor if something seems amiss. “We’re using some unique measurements to really predict whether this patient is heading toward a decompensation event, when their heart failure really gets out of control,” Harris explained. “We can predict when they’re headed toward this before they’re even feeling major symptoms. Then we can intervene with the same medications, but we’re catching it early enough that we can keep them out of the hospital. “If the patient’s picking up the phone and calling 911, we’ve already lost the battle,” he said. After Harris identified the target patient population, Smithwise started designing the clinical strategy, then the regulatory and payer aspects of that population. Now the product is in the

WE’RE USING SOME UNIQUE MEASUREMENTS TO REALLY PREDICT WHETHER THIS PATIENT IS HEADING TOWARD A DECOMPENSATION EVENT, WHEN THEIR HEART FAILURE REALLY GETS OUT OF CONTROL. But DxtER had a problem. The platform had too many potential uses to become a single product. “That’s a little bit like trying to boil the ocean in medical device,” said Eric Sugalski, founder & president of Smithwise, 116

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DESIGN

design phase. All of this had to happen before the company could launch its first clinical trial, something Harris had hoped to begin months before. Basil Leaf is like many other medtech startups whose leaders are focused on obtaining initial clinical data to prove their value proposition, Sugalski noted. That especially applies to companies developing a diagnostic device that has no significant risk associated with it, such as DxtER. Other startups want to dive into manufacturing without considering some of the big questions surrounding payers and economics, he added. The first clinical trial of DxtER is set to begin next year at Harris’ base, Wynnewood, Pa.’s Lankenau Medical Center, and at the University

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of California at San Diego. He hopes to enroll 150 patients and expects the trial to last a year. DxtER has been through a few institutional review board reviews

The company also needs to build trust among cardiologists in the AI it demonstrated in the XPrize competition, according to Harris.

IF THE PATIENT’S PICKING UP THE PHONE AND CALLING 911, WE’VE ALREADY LOST THE BATTLE. at Lankenau and will have two or three more there and at UCSD, according to Harris. He expects that the device will need 510(k) clearance for basic functions and then either pre-market approval for the overall device or more 510(k)s for other advanced functions.

“It’s been great with Eric and Smithwise because they’ve been able to really get us focused and get us on track in a very logical trajectory and streamlined what we were thinking of,” he said. “I was trying to go all the directions at the same time and it was really not sustainable.” M

9/18/18 7:11 PM

ENGINEERING 911

Hereâ&#x20AC;&#x2122;s what Steute Meditech learned from 20 years of making wireless footswitches Steute Meditech pioneered the wireless foot switch in 1998. Here are some lessons learned along the way.

Maurizio Lauria | Brand Manager | Steute Meditech Inc. |

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Historically, medical device manufacturers who needed a foot control as a human interface used a cabled unit that plugged into the system console of the device. Until the late 1990s, a cabled unit was the only available option. Although these cabled solutions proved acceptable, many OEMs recognized that the cable presented some limitations. For example, the cable made it difficult to store and/or clean the foot switch. It was also typically the single most frequent point of failure, and it posed a tripping hazard, especially in busy operating rooms. These issues, combined with field experience and the proliferation of wireless equipment, led many medical device OEMs to wonder whether it was possible to eliminate the cable. Wireless operation became the most frequently requested feature on a Steute foot switch.

9 â&#x20AC;˘ 2018

Even with all the initial interest, few of our OEM customers wanted to be the first to offer a wireless foot switch, due to concerns about the unknown including worldwide acceptability, the robustness of the wireless signal and interference with other wireless signals commonly found within an OR environment (i.e. WLAN, wireless computer accessories, etc.). In 1998, Steute used its first wireless foot switch to control a medical imaging device. This switch used an infrared interface, the only suitable option at that time. Just two years later, Steute created a radio-frequency-based wireless foot switch to control an MRI system.

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9/18/18 7:16 PM

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ENGINEERING 911

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Among the first lessons we learned was understanding the risk classification of the medical application and how to select a suitable wireless protocol to meet it and the functional system requirements. We also had to keep in mind the acceptable wireless protocol used in a specific geographic area. Since these early days of wireless foot switches, Steute has evaluated several technologies, including ENOCEAN, DECT, WLAN, ZIGBEE and Bluetooth. They all had pros and cons; ultimately, Steute decided to create its own wireless protocol specifically for medical device applications. This proprietary protocol, called SW2.4(LE), is based on spread spectrum technology. By creating our own protocol, we were able to customize the software to carry enough data packets, and customize the best broadcasting algorithm to improve coexistence characteristics. It allowed us the freedom to meet the customer’s functional requirements. Battery management was also a careful consideration. Various medical applications require different battery capacities. Some applications require a simple “on/off” function. The pedal is pressed or released, sending an “on” or “off” data packet signal. In this case, a simple primary battery may suffice. Other applications, such as for ophthalmology, require a battery that can power an electronic breaking system. These magnet-based breaks, which are often actuated, consume substantial battery power. In this case, a rechargeable Li-ion battery is better suited.

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Other battery management considerations include the use of a sleep mode, which completely cuts off the foot switch communication to preserve battery life. Once the user presses the pedal or any other type of actuator, the foot switch “wakes up” and sends the command signal within 50-70 ms. This rapid response time is seamless to the user. Lastly, one of the most important lessons we learned over the years was the need to work as partners with our customers, rather than having a typical supplier-customer relationship. It’s not realistic to build a one-sizefits-all wireless foot switch, because every medical device manufacturer has different interface requirements and receiver mounting locations. For example, one medical OEM may require serial communication from the

receiver to the medical device; another may request relay outputs. Some may wish to install the foot switch receiver inside the host medical device, while some may request an externally-mounted solution. It was important for Steute to learn about the medical application and how the system was being used in order to design and offer a safe and robust system that could easily interface with the host medical device. In addition, Steute needed to offer supporting documentation to its customer base to allow them to comply with the numerous medical regulations. These included test certificates, test reports, component testing, etc. Working in a partnership was the only way to ensure a smooth development cycle and make life easier for the medical device manufacturer. M

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PACKAGING

Packaging facts you need to know The wrong packaging can literally break a medical device or render it useless due to sterility issues.

Nancy Crotti | Senior Editor |

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A recent study about recalls of foot and ankle implants had a portion that likely drew less attention: A number of these implants were recalled because they arrived at the hospital in an unsterile condition – and faulty packaging may have been the cause. A lot can go wrong as a result of poor packaging. A package that holds a sterile medical device not only has to arrive at the hospital or clinic free of holes, tears and broken seals, it also has to withstand sitting on a shelf, possibly for years, without breaking down. A couple of medical device packaging experts shared their insights into what device-makers should know about packaging. Manufacturers like to use the smallest possible containers for shipping, which can compromise package integrity, according to David Furchak, launch architect with Keystone Solutions Group, a packaging design and manufacturing company in Kalamazoo, Mich. “Specifically, it’s a concern with sterile, which is what we almost exclusively deal with,” Furchak told Medical Design & Outsourcing. Keystone works closely with Packaging Compliance Labs (Grand Rapids, Mich.), which validates sterile medical device packaging according to FDA-recognized standard, ISO 11607. 9 • 2018

The standard has three main pillars, according to Ryan Erickson, a packaging engineer at PCL: 1.

A manufacturer must be able to consistently form and seal a package, meeting requirements for the strength and seal of the bond after heat-sealing, the visual aesthetics of the seal and the ability to open the package. If the end user in an ambulance, hospital or clinic has trouble opening a package, it may rip or tear, exposing the device inside to contamination and rendering it unusable. 2. The package design must be sufficiently robust to withstand shipping to a hospital or clinic through all types of climates and a variety of physical hazards. PCL simulates different types of hazards that packages might encounter, exposing them to sub-zero, desert and tropical conditions, dropping, compression, vibration, impacts and altitude simulations. 3. A package must also be able to maintain its integrity over time. For a sterile, disposable device package, that’s usually two years, Furchak noted. PCL uses real-time aging in a controlled environment and accelerated aging, which requires baking the package.

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DESIGN

Our intelligently designed mobility solutions have been honored with renowned design awards and satisfy the highest demands when it comes to esthetics. They can be adapted seamlessly to the individual design of our customers and allow for easy brand differentiation. We provide entire product ranges for medical and institutional market applications to compliment your design and requirements. Our broad selection of casters, wheels and accessories offer the right features for every need, while maintaining a uniform appearance. TENTE solutions never fail to impress when the design needs to fulfill a specific function for the user. This is because they open up a wide range of customization options that allow the casters to communicate information, such as assigning codes, color coordination, or improving your brand presence by including your logo and corporate colors.

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PACKAGING

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“Forty days in the oven is equivalent to one year sitting on the shelf,” Erickson said. If the material hasn’t weakened too much and the heat seals remain secure, a company can officially market the device with the validated expiration date claim. Many other considerations come into play. A package can neither be too small nor too large. Labeling must be clear and well-placed. Package manufacturers such as Keystone have numerous responsibilities. Raw materials must be traceable, safe and effective in creating a microbial barrier. Machinery must be set up and maintained in a validated state and produce a result that can be measured and monitored over time for performance to specification. The packages must pass different quality assurance checks. “A lot goes into making a good package,” Erickson said. “It’s not easy, certainly.” PCL likes to receive two to five prototypes of package designs to compare the relative defect rates, understand the modes of failure and make a plan to fix them, he added. The company performed its own study of packaging systems that came through its lab. The OEMs and contract manufacturers sent packages that were saleable goods, representing the product as it would otherwise be presented to a hospital or clinic. One of three failed validation. “If companies were more focused on doing engineering feasibility trials prior to undertaking a validation study, a lot of these issues could have been worked out,” Erickson explained. “The very first time you test something, there’s a very good chance of something going wrong.” Improperly designed and validated packaging “can derail a whole product launch in the 11th hour,” Erickson said. “We’ve been in that group of 30%,” Furchak said. “Last year we had a project that was a little bit delayed given a packaging failure that was unexpected.” Keystone worked with PCL to resolve the problem while achieving the look, feel and utility that its customer needed and

IF COMPANIES WERE MORE FOCUSED ON DOING ENGINEERING FEASIBILITY TRIALS PRIOR TO UNDERTAKING A VALIDATION STUDY, A LOT OF THESE ISSUES COULD HAVE BEEN WORKED OUT.

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AGENCY: INTERCROSS (952-935-2994)

Medical Design & Outsourcing

9 • 2018

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meeting all of the sterile barrier requirements, he added. Packaging problems can be averted if the customer gives contract manufacturers such as Keystone the ability to change the design after validation testing, Erickson said. Sending prototype devices that are the same size and weight of the proposed finished product can also avert disaster. PCL once received a 3D-printed hip replacement implant prototype in packaging that passed all the tests. When testing the same packaging containing the actual, much heavier implant months later, packages were cracking, lids were popping off and the implant’s rough coating was rubbing off and shredding, Erickson said. “I’m glad we caught it in development,” he added. M

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TUBING TALKS

Making diabetes management simpler with a tubeless pump People using traditional insulin pumps to manage their diabetes often have to adjust their daily lives to live comfortably with a tubed pump. Insulet wants to change that.

Insulet’s Omnipod Dash system

Sarah Faulkner | Associate Editor |

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For nearly three decades, hundreds of thousands of people with diabetes have relied on insulin pumps to titrate the drug that keeps their blood sugar in check. Insulin pumps have remained largely unchanged over the years, leaving the device ripe for innovation. So when Insulet’s founder, John Brooks III, set out to find a better way to deliver insulin to his diabetic son, he looked for technologies that would make his son’s life simpler. He founded Insulet in 2000 and just five years later hit the market with the first tubeless insulin delivery system. The Omnipod consists of a lightweight, disposable pod that attaches anywhere on the user’s body and carries up to three days of nonstop 9 • 2018

insulin. The pod automatically inserts a small, flexible cannula to delivers the user’s insulin. The tubeless device communicates with a remote controller, called the personal diabetes manager, to determine when to deliver insulin. “Our customers tell us that they prefer the Omnipod because it gives them consistent, round the clock, uninterrupted insulin delivery without the need for either four to five insulin injections per day or the need to be tethered to a tubed pump,” president & COO Shacey Petrovic told Medical Design & Outsourcing. Today, nearly 150,000 people living with diabetes use Insulet’s Omnipod system to control their insulin therapy. Roughly 75% of those customers,

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TUBING TALKS

according to Petrovic, switch to the Omnipod system from multiple daily injections of insulin. “The reason is that more than half of those users tell us that they wouldn’t go on pump therapy if not for Omnipod.

They know that they could probably get better outcomes with pump therapy, but they’re turned off by the complexity of those devices and by the fact that they have to be attached to tubing and wear something on their waist that advertises their disease,” said Petrovic, who was recently named to succeed Patrick Sullivan as CEO. “We help people get access to the benefits of continuous subcutaneous insulin infusion - people who might not otherwise have ever moved to pump therapy.” For young kids, the tubeless, waterproof device

OUR CUSTOMERS TELL US THAT THEY PREFER THE OMNIPOD BECAUSE IT GIVES THEM CONSISTENT, ROUND THE CLOCK, UNINTERRUPTED INSULIN DELIVERY WITHOUT THE NEED FOR EITHER FOUR TO FIVE INSULIN INJECTIONS PER DAY OR THE NEED TO BE TETHERED TO A TUBED PUMP.

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Shacey Petrovic

www.medicaldesignandoutsourcing.com

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allows them to simply be kids, she added, while their parents are nearby, adjusting insulin delivery using the remote control. There are a number of everyday activities that can be challenging to accomplish with a tubed insulin pump. From sleeping to showering, people with diabetes have to adjust their daily lives to live comfortably with traditional pumps. “My father told me that for most of the last seven years, he had horrible shoulder problems. He always slept on one side because his insulin pump was on the other side and he was fearful of disrupting it,” Petrovic said. “But when you’re moving your Pod around, you no longer have those limitations. And after just a few months on the Pod, his shoulder pain went away.” Petrovic also recalled meeting a woman who hadn’t worn a dress in two decades because there was nowhere to clip her pump.

“Coming at it with the view of a patient as opposed to a medical device manufacturer, I think that’s what helped to design such a novel technology,” she said. The company relies on its 150,000 “Podders” to help create the next generation of tubeless insulin delivery technologies. Insulet’s User Experience Group, which includes Podders and people who are managing their diabetes with injections and traditional pumps, is regularly charged with describing their ideal diabetes management system. “That uncovers features and functions and needs that we might not otherwise know existed,” Petrovic explained. “The Omnipod is what happens when a user, an end user, designs a device.” M

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DEVICE TALKS

Lessons learned: How Jeff Karp stays at the forefront of innovation Serial entrepreneur Jeff Karp has a philosophy for his laboratory: find important problems and get solutions to people quickly.

Sarah Faulkner | Associate Editor |

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After Jeff finished his PhD in chemical and biomedical engineering at the University of Toronto, he knew he wanted to work with Robert Langer. “He’s the intergalactic translational superstar,” Karp said. Langer, a professor at the Massachusetts Institute of Technology and one of the most cited engineers of all time, receives thousands of applications per year from people looking to join his lab, Karp said. So when Langer wrote back to Karp telling him that his lab didn’t have enough funding to take him, Karp took matters into his own hands. “So I wrote him back and said, ‘Well, if I brought my own funding, would you take me?’ and he wrote back immediately and said, ‘Yes,’” Karp told us. “And then I said, ‘Would you put that in writing?’” He applied for a fellowship with the Canadian government, attaching Langer’s promise to his application which led to a two-year fellowship. He was soon on his way to Massachusetts, where he trained under one of the world’s most prolific innovators. The lessons Karp gleaned from his time with Langer have stuck with him throughout his career. Now that he runs his own lab at Boston’s Brigham & Women’s Hospital, he tries to embody some of the things he learned from Langer. “He is an incredible role model – he’s very supportive of the people in his lab. He’s showing you what’s possible by creating these new technologies and starting companies, and when you’re in his lab, he commits to being your perpetual mentor,” Karp said. “So anybody who joins my lab, I tell them, ‘I commit to being your mentor for life,’ whether it’s a high school student, undergraduate, post-doc – I commit to helping them whenever needed.” 9 • 2018

Maximizing potential A slew of companies have been founded thanks to research from Karp and Langer. Most recently, Woburn, Mass.-based Frequency Therapeutics launched a clinical trial of a first-in-class drug designed to restore a person’s hearing. The drug, which is delivered directly to the ear by injecting a drug-eluting gel, is based on work conducted by Karp at Harvard Medical School and Langer at MIT. Langer and Karp discovered that a cocktail of small molecules could trigger the proliferation

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9/18/18 7:34 PM

Cords Your Way

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DEVICE TALKS

ANYBODY WHO JOINS MY LAB, I TELL THEM, ‘I COMMIT TO BEING YOUR MENTOR FOR LIFE,’ WHETHER IT’S A HIGH SCHOOL STUDENT, UNDERGRADUATE, POST-DOC – I COMMIT TO HELPING THEM WHENEVER NEEDED.

of progenitor cells, activating the body’s ability to regenerate itself. Frequency Therapeutics began with hearing loss, hypothesizing that triggering progenitor cells in a person’s ear will help them regrow the tiny hairs that are found in the inner ear and are essential for hearing. But Langer, Karp and the Frequency Therapeutics team sees its ‘Progenitor Cell Activation’ method as a platform that could be used across an array of therapeutic areas. Choosing to work on important problems and finding a way to maximize the potential of the work is just another lesson from his days in Langer’s lab, Karp said. “Bob will often say that it takes just as much time to work on something important as it does to work on something that’s not important. So the onus is on us to do the most impactful work we possibly can with the time we have,” he said. In Karp’s lab, researchers are taught to find solutions that could quickly help people, while still relying on rigorous science. Karp’s lab also comprises people with diverse academic backgrounds, which he said was entirely intentional.

“If you have good relationships with people, it can lead to so many other things. It can be hard to see that when you’re in so deep, but it really can,” he said. “It just becomes a huge win for everybody.” M TO LEARN ABOUT THE EXCITING TECHNOLOGIES EMERGING FROM KARP’S LAB, JOIN US AT DEVICETALKS BOSTON ON OCT. 8-10.

“We’ve had people from over 30 countries in our lab and we have very minimal overlap in expertise. We’ll have chemists, chemical engineers, mechanical engineers, clinicians, biologists, immunologists, surgeons, dentists, etc.,” he explained. “The idea is when you have people around a table and we’re brainstorming solutions, everyone can provide a unique perspective and contribute value, which is very fulfilling.” The other part of Karp’s scientific philosophy? Leave your ego at the door. “I think ego, which is linked to insecurities, can lead to a lot of bad decisions and create a nonconducive environment, because then things can become competitive. By developing an awareness of when ego takes over, one can focus on good decisions that are in the best interests of everyone involved – this maximizes people’s likelihood to go ‘all-in,’ as everyone benefits” he said. The process of innovating within academia and industry is deeply rooted in relationships, Karp added. www.medicaldesignandoutsourcing.com

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AD INDEX

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