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October 5 - 7, 2015<br />
San Diego Convention Center<br />
San Diego, CA<br />
advamed2015.com<br />
@AdvaMedConf<br />
FINAL PROGRAM<br />
*as of 9/11/15<br />
Host Sponsors<br />
<strong>Access</strong>.<br />
Insight.<br />
Opportunity.<br />
www.advamed2015.com | @AdvaMedConf
2 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
Letter from the Chairman & CEO of AdvaMed<br />
Dear Colleague:<br />
Welcome to AdvaMed 2015: The MedTech Conference!<br />
While we are celebrating our ninth conference, AdvaMed<br />
is commemorating its 40th anniversary, and what better<br />
place to celebrate than in San Diego! We are so glad you<br />
could join us for our first-ever meeting on the west coast.<br />
While Southern California is a place known for pristine<br />
beaches and beautiful sunsets, it is also a major economic<br />
center; home to diversified medical technology companies<br />
as well as a multitude of prestigious, world-renowned<br />
research universities, including UCSD, Scripps, Salk<br />
and Burnham. With more than 80 research institutions<br />
throughout Southern California, San Diego is the perfect<br />
place to host this year’s conference.<br />
In the midst of this expanding high-tech sector, AdvaMed<br />
2015 will bring together more than 2,500 MedTech<br />
representatives in a uniquely multifaceted environment<br />
for business development, capital formation, innovative<br />
technology showcasing, world-class educational<br />
opportunities and networking. In honor of AdvaMed’s<br />
anniversary and the incredible progress in the realm of<br />
medical technology over the past four decades, the theme<br />
for this year’s conference is Advocating For Innovation: 40<br />
Years & Beyond.<br />
Giving us a glimpse of the future of innovation, during<br />
our Wednesday Plenary Breakfast, for the first time we<br />
will host the MedTech Innovator Finals, during which<br />
four emerging companies will present their products and<br />
compete for more than $300,000 in prizes. As a member of<br />
the audience, you will have a hand in who wins by casting<br />
your vote for the most innovative company.<br />
Over the course of the conference, leading thinkers from<br />
government, industry and academia will discuss the key<br />
regulatory, reimbursement, legal, compliance and business<br />
opportunities and issues affecting the medical technology<br />
industry. Of particular interest will be our plenary sessions:<br />
in addition to having the honor of presenting Dr. Thomas<br />
J. Fogarty with our industry’s Lifetime Achievement Award,<br />
we will hear from Dr. Eric J. Topol and FDA Center for<br />
Devices and Radiological Health Director Jeffrey Shuren,<br />
among other notable speakers.<br />
AdvaMed 2015 will welcome back our Scientist Mentoring<br />
& Diversity Program for MedTech, a year-long program<br />
aimed at benefitting minority graduate students and postdoctoral<br />
researchers interested in careers in MedTech. We<br />
will also host a group of local veterans hoping to transition<br />
into careers in the medical technology space. These vets<br />
recently participated in a daylong “re-careering” program<br />
organized by the MedTech and Biotech Veterans Program.<br />
For the second year in a row, AdvaMed is offering a Women’s<br />
Executive Network event; bringing together women in<br />
the MedTech and diagnostics industries for networking,<br />
professional development and relationship building.<br />
We cannot thank you enough for attending AdvaMed 2015,<br />
and we hope that you will have time over the next few days<br />
to reflect on the impact of our industry for the past 40 years<br />
and beyond. Our continued success would not be possible<br />
without your support, commitment and participation. We<br />
hope you have an enjoyable and rewarding experience,<br />
and be sure to make plans to join us in Minneapolis on<br />
October 17-19, 2016, for AdvaMed 2016!<br />
The conference is the perfect venue to advance our<br />
industry and the value that our innovations bring to<br />
patients worldwide, so they can lead longer, more<br />
productive lives. We improve the efficiency of health care<br />
systems through earlier detection and more effective<br />
treatment options. And, we spur economies by creating<br />
the kind of high-paying, high-tech jobs that local, state and<br />
national governments want to attract.<br />
Vincent A. Forlenza<br />
AdvaMed Chairman<br />
Chairman, Chief<br />
Executive Officer<br />
and President<br />
BD<br />
Stephen J. Ubl<br />
President and CEO<br />
AdvaMed<br />
FINAL PROGRAM | 1
Michael A. Mussallem (Co-Chair)<br />
Chairman & Chief Executive Officer<br />
Edwards Lifesciences<br />
Gregory T. Lucier (Co-Chair)<br />
Chairman of the Board & Chief<br />
Executive Officer<br />
NuVasive, Inc.<br />
Letter from the Chairmen<br />
As Chairmen of AdvaMed 2015: The MedTech Conference,<br />
we are excited to welcome you to San Diego, a city<br />
known for its blue skies, 70 miles of beaches, and<br />
70-degree weather. In addition to being synonymous<br />
with sunshine, San Diego also means business.<br />
Thanks to its ideal location on the Pacific Rim, San<br />
Diego is a gateway to international trade, business<br />
and commerce, particularly for the MedTech<br />
industry. San Diego is the hub of one of the world’s<br />
largest and most diverse collection of medical<br />
technology companies, making it an ideal location to<br />
host AdvaMed 2015.<br />
This year is also special in that we are celebrating<br />
AdvaMed’s 40th anniversary. Over the past four<br />
decades, AdvaMed’s membership has reached nearly<br />
300 members with a global presence in Europe,<br />
India, China, Brazil and Japan. AdvaMed 2015 will<br />
celebrate the rich legacy AdvaMed has created<br />
by advocating for policies that help ensure timely<br />
patient access for the latest innovations.<br />
Our conference is a global event – open to all<br />
industry stakeholders – and the largest gathering of<br />
MedTech professionals in North America. AdvaMed<br />
2015 promises to bring together more than 2,500<br />
of the brightest minds in the industry. We aspire to<br />
share with participants insights on the regulatory,<br />
reimbursement, legal, compliance and business<br />
issues driving our industry. AdvaMed 2015 provides<br />
access to key industry leaders and gives attendees<br />
an unparalleled opportunity to connect and network<br />
with colleagues.<br />
We thank you for joining us in San Diego at AdvaMed<br />
2015 to take advantage of this experience and<br />
ensure we continue to advance our collective goals<br />
of improving the lives of patients and the medical<br />
technology industry that supports them.<br />
Michael A. Mussallem<br />
Chairman and Chief Executive Officer<br />
Edwards Lifesciences<br />
Co-Chairman, AdvaMed 2015<br />
Gregory T. Lucier<br />
Chairman of the Board and<br />
Chief Executive Officer<br />
NuVasive, Inc.<br />
Co-Chairman, AdvaMed 2015<br />
2 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
FINAL PROGRAM | 3
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Corporation 4 | ADVAMED and/or Systagenix 2015Wound Management, Limited, their affiliates and/or licensors. DSL#15-0487.US CONNECT (Rev. 8/15) WITH US ON TWITTER: #AdvaMed15
We sincerely thank<br />
Michael A. Mussallem<br />
We sincerely thank our AdvaMed 2015 Chairmen,<br />
Michael A. Mussallem and Gregory T. Lucier, for<br />
their dedication, enthusiasm and leadership over this<br />
past year. Their unwavering support and guidance has<br />
helped us to pull together one of the biggest and best<br />
conferences in our history.<br />
We sincerely thank<br />
Michael “Mick” Farrell<br />
We sincerely thank our<br />
AdvaMed 2015 Host<br />
and Local Committee<br />
Chairman, Michael “Mick”<br />
Farrell, for his diligence,<br />
enthusiasm and guidance<br />
over this past year.<br />
Honoring a Legend<br />
Dr. Thomas J. Fogarty<br />
Gregory T. Lucier<br />
AdvaMed is thrilled to<br />
welcome and honor<br />
Dr. Thomas J. Fogarty<br />
with the Lifetime<br />
Achievement Award. As<br />
a leader, innovator and<br />
entrepreneur, Fogarty’s<br />
dedication to improving<br />
patient care through<br />
medical technology is<br />
unrivaled in the industry.<br />
Table of<br />
Contents<br />
1 Letter from the Chairman and<br />
CEO of AdvaMed<br />
2 Letter from the Chairmen of<br />
AdvaMed 2015<br />
6 Sponsors<br />
8 About AdvaMed & The MedTech<br />
Conference<br />
10 AdvaMed 2015 Steering<br />
Committee<br />
12 AdvaMed 2015 Planning<br />
Committees<br />
19 Agenda-at-a-Glance<br />
24 Floor Map<br />
26 Networking Receptions<br />
30 Plenary Sessions<br />
35 Panel Sessions<br />
63 CEOs Unplugged Series<br />
68 Business Development and<br />
Investor Programming<br />
71 Innovation Showcase<br />
76 MedTech Partnering<br />
79 Special Programming<br />
79 International Seminar<br />
79 Women’s Executive Network<br />
80 Entrepreneurship Boot Camp<br />
85 Scientist Mentoring & Diversity<br />
Program<br />
86 MedDevice Development Course<br />
90 Exhibit Hall<br />
91 Schedule<br />
92 Floorplan<br />
94 Exhibitors<br />
96 Supporting Partner Organizations<br />
97 International Delegation Partners<br />
97 Media Partners<br />
FINAL PROGRAM | 5
AdvaMed 2015 would like to<br />
thank our Sponsors<br />
(as of September 11, 2015)<br />
Host<br />
Platinum<br />
®<br />
Gold<br />
6 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
Silver<br />
medical devices<br />
Bronze<br />
Special Thanks to Our California Partners!<br />
San Diego Host Organization<br />
California-based Sponsors<br />
FINAL PROGRAM | 7
About AdvaMed 2015<br />
AdvaMed 2015 is the leading MedTech conference in North America, bringing more than 1,000 companies<br />
together in a unique, multifaceted environment for business development, capital formation, innovative<br />
technology showcasing, world-class educational opportunities and networking. An event rich in international<br />
flavor and featuring a deep, diverse attendee list that includes influential policy makers, business executives<br />
and media, AdvaMed 2015 seeks to advance industry discussion from key perspectives through detailed<br />
panel sessions, executive forums and more. It is a must-attend event for any MedTech company. Whatever<br />
your goals may be, you are sure to accomplish, and even surpass them, at AdvaMed 2015.<br />
Who Attends<br />
The MedTech Conference attracts the industry’s most important and influential stakeholders year after year.<br />
Here’s a snapshot of whom you’ll meet this year at AdvaMed 2015.<br />
AdvaMed 2014<br />
Attendee by<br />
Title:<br />
About AdvaMed<br />
The Advanced Medical Technology Association (AdvaMed) is a trade<br />
association that leads the effort to advance medical technology in<br />
order to achieve healthier lives and healthier economies around the<br />
world. AdvaMed’s member companies range from the largest to the<br />
smallest medical technology innovators and companies throughout<br />
the U.S. and the world. AdvaMed acts as the common voice for<br />
companies producing medical devices, diagnostic products and<br />
health information systems.<br />
This year, AdvaMed is celebrating its 40th anniversary. AdvaMed began operations<br />
in 1975 with just 90 members and four employees. Four decades later, AdvaMed’s<br />
membership has reached nearly 300 members and more than 70 employees with<br />
a global presence in Europe, India, China, Brazil and Japan.<br />
8 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
Minnesota is #1 in FDA pre-market approvals — 6.5 months faster on average<br />
Minnesota ranks #2 in med device patents<br />
Highest concentration of medical technology workers in the US<br />
Register to win two tickets to the 2016 Ryder Cup<br />
at Hazeltine National Golf Course in Chaska, Minnesota<br />
®<br />
@mndeed<br />
@LifeSciAlley<br />
Minneapolis Saint Paul Regional Economic Development Partnership<br />
@GreaterMSP<br />
Cover photos: Restore Sensor provided courtesy of Medtronic; Protégé MRI provided courtesy of St. Jude Medical; Incepta ICD provided courtesy of Boston Scientific<br />
FINAL PROGRAM | 9
Steering Committee Members<br />
Peter Arduini<br />
President & Chief<br />
Executive Officer<br />
Integra LifeSciences Corporation<br />
Tony Davis<br />
Managing Partner<br />
Linden Capital Partners<br />
Vincent A. Forlenza<br />
Chairman, Chief Executive<br />
Officer and President<br />
BD<br />
John Kilcoyne<br />
President and CEO<br />
ReVision Optics, Inc.<br />
John Babitt<br />
Partner, Transaction Advisory<br />
Services, Life Sciences<br />
Ernst & Young<br />
Joseph DeVivo<br />
President & Chief<br />
Executive Officer<br />
AngioDynamics<br />
Sean Freeman<br />
Vice President & Head of<br />
Corporate Development<br />
NuVasive, Inc.<br />
Lester B. Knight<br />
Founding Partner<br />
RoundTable Healthcare Partners<br />
Non-Executive Chairman, Aon<br />
Doug Bryant<br />
President & CEO<br />
Quidel Corporation<br />
Tim Dugan<br />
Managing Partner<br />
Water Street Healthcare<br />
Partners, LLC<br />
Kieran Gallahue<br />
Former CEO and & Chairman<br />
CareFusion Corporation<br />
Joan Koerber-Walker<br />
President and CEO<br />
Arizona BioIndustry<br />
Association (AZBio)<br />
Donald M. Casey<br />
Chief Executive Officer,<br />
Medical Segment<br />
Cardinal Health<br />
Camille Farhat<br />
Group President & CEO<br />
AMS<br />
John Greisch<br />
President & CEO<br />
Hill-Rom<br />
Gregory T. Lucier, (Co-Chair),<br />
Chairman of the Board &<br />
Chief Executive Officer<br />
NuVasive, Inc.<br />
Patrick Daly<br />
President and Chief<br />
Executive Officer<br />
Cohera Medical, Inc.<br />
Michael “Mick” Farrell<br />
CEO<br />
ResMed<br />
Brian K. Hutchison<br />
President & CEO<br />
RTI Surgical, Inc.<br />
Dr. Kavita Mehrotra<br />
Global Strategic Alliances<br />
Manager<br />
UL<br />
10 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
Brian C. Miller<br />
Managing Partner<br />
Linden Capital Partners<br />
Joe Panetta<br />
President & CEO<br />
Biocom<br />
Joseph M. Smith, MD, PhD<br />
Chief Medical and<br />
Science Officer<br />
West Health<br />
Thomas A. West<br />
Division President,<br />
Diagnostic Solutions<br />
Hologic, Inc.<br />
Michael R. Minogue<br />
Chairman, President &<br />
Chief Executive Officer<br />
ABIOMED, Inc.<br />
Todd M. Pope<br />
President and Chief<br />
Executive Officer<br />
TransEnterix, Inc.<br />
James D. Southwick<br />
Vice President, Global<br />
Government Affairs<br />
Medtronic plc<br />
Joseph Woody<br />
President and CEO<br />
Acelity L.P. Inc.<br />
Mike Mogul<br />
President & CEO<br />
DJO Global<br />
Sara Radcliffe<br />
President & Chief Executive Officer<br />
California Life Sciences<br />
Association (CLSA)<br />
Mark Stevenson<br />
EVP & President, Life<br />
Sciences Solutions<br />
Thermo Fisher Scientific<br />
Erik J. Wordelman<br />
Global Medtech Leader<br />
Spencer Stuart<br />
Michael A. Mussallem<br />
(Co-chair), Chairman &<br />
Chief Executive Officer<br />
Edwards Lifesciences<br />
Timothy M. Ring<br />
Chairman & Chief<br />
Executive Officer<br />
C. R. Bard, Inc.<br />
Sandy Thompson<br />
Senior Partner<br />
RoundTable Healthcare<br />
Partners<br />
Caroll H. Neubauer<br />
Chairman & Chief<br />
Executive Officer<br />
B. Braun Medical Inc.<br />
Kevin R. Sayer<br />
President & CEO<br />
Dexcom, Inc.<br />
Stephen J. Ubl<br />
President & Chief<br />
Executive Officer<br />
AdvaMed<br />
FINAL PROGRAM | 11
AdvaMed 2015 Business Development Committee<br />
Co-Chair:<br />
Sandy Thompson<br />
Senior Partner<br />
RoundTable Healthcare<br />
Partners<br />
Co-Chair:<br />
Sean Freeman<br />
Vice President & Head of<br />
Corporate Development<br />
NuVasive<br />
Milena Adamian<br />
Managing Partner / Founder<br />
Azimuth Ventures / Life Science<br />
Angel Network<br />
Vicki Anastasi<br />
Vice President and Global Head,<br />
Medical Device and Diagnostics<br />
Research<br />
ICON<br />
David Anderson<br />
Managing Director - Medical<br />
Technology<br />
GE Capital<br />
Shabbir Bambot<br />
Co-founder & Chief Technology<br />
Officer<br />
LumaMed LLC<br />
Randall Barko<br />
President & CEO<br />
Ximedica<br />
Isabelle Billet<br />
Principal<br />
IBHC Advisors<br />
Dennis Crowley<br />
Vice President, Corporate<br />
Development<br />
Medtronic plc<br />
Allan Daisley<br />
President<br />
ZeroTo510 Medical Device<br />
Accelerator<br />
Matt Dolan<br />
Director, Business Development<br />
Volcano<br />
Jackie Gonzalez<br />
CEO<br />
J29 Associates<br />
Barbara Goodman<br />
Senior Vice President, PROPEL<br />
iBIO Institute<br />
Paul Grand<br />
Managing Director<br />
RCT Ventures<br />
Thomas Harper<br />
Senior Consulting Manager<br />
Plante Moran<br />
Jason Hillenbach<br />
Knowledge Leader - Life Sciences<br />
Ernst & Young LLP<br />
Hope Hopkins<br />
VP, Communications<br />
Ximedica<br />
Justin Klein<br />
Partner<br />
NEA<br />
Christine Lindgren<br />
Vice President, Marketing<br />
Evaluate Ltd<br />
Nick Manusos<br />
VP, Business Development<br />
Baxter Healthcare<br />
Caren Mason<br />
President and CEO<br />
STAAR Surgical Company<br />
John Meduri<br />
Global Director, Business<br />
Development<br />
BD Diagnostics<br />
Teri Melese<br />
Associate Professor Medicine &<br />
Rady School of Management<br />
University of California, San Diego<br />
Faviola Michelot<br />
Principal Project Manager<br />
Edwards Lifesciences<br />
Susan Morano<br />
VP, New Business<br />
Development<br />
Johnson & Johnson<br />
Susan Posner<br />
Partner<br />
Health Advances<br />
Israel Raz<br />
Vice President<br />
Extera Partners<br />
Susan Rockwell<br />
Senior Director, Global Medical<br />
Device Business Development<br />
ICON<br />
Kevin Schimelfenig<br />
President<br />
SalesForce4Hire<br />
Aileen Stockburger<br />
Vice President Worldwide<br />
Business Development<br />
Johnson & Johnson<br />
Nicole Walker<br />
Director, Venture Capital<br />
Baird Capital<br />
Brian Williams<br />
Global Healthcare Clients and<br />
Markets<br />
PwC Consulting<br />
Andrew Williamson<br />
Head of Corporate Development<br />
Heraues Medical<br />
Ashley Wittorf<br />
Executive Director<br />
AdvaMed Accel<br />
Bryant Zanko<br />
Vice President, Business<br />
Development<br />
Stryker<br />
12 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
YOUR PARTNER IN ACHIEVING<br />
GLOBAL REGULATORY COMPLIANCE<br />
• Exclusive Online Compliance Learning Partner<br />
• Medical Technology Quality, Compliance & Clinical Training<br />
• Global Health Care Content<br />
• Educational Collaboration with AdvaMed<br />
• We work with you to meet your project timeline<br />
• Full time employees to interact with directly versus subcontractor<br />
• We look for conformance and work with you to get there<br />
• We provide easy transfers – ISO and NB Friendly<br />
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Find out more about UL’s services<br />
ul.com/medical<br />
FINAL PROGRAM | 13
Events &<br />
Education<br />
Join the thousands of professionals who have<br />
elevated their careers with our workshops,<br />
webinars, certification program & other events.<br />
2015 Schedule<br />
Event<br />
Date<br />
510(k) Submissions Oct. 19 - 20<br />
IDE Submissions Oct. 21<br />
PMA Submissions Oct. 22 - 23<br />
Recalls From A to Z Oct. 27 - 28<br />
EU MDR Readiness Oct. 28<br />
Japan’s Pharmaceutical and Medical Device Law Oct. 29 - 30<br />
MedTech Compliance Boot Camp Nov. 4 - 5<br />
Managing Risk and Compliance with ISO 14971 Nov. 10 - 11<br />
Working with Private Payers Nov. 12<br />
Advertising and Promotion of Medical Devices Nov. 17 - 18<br />
Cybersecurity in a Connected Health Care System Dec. 1<br />
Medical Device Clinical Trials Dec. 2 - 3<br />
www.advamedmtli.org<br />
14 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
AdvaMed 2015 International Committee<br />
Chairman:<br />
James D. Southwick<br />
Vice President, Global<br />
Government Affairs<br />
Medtronic plc<br />
Vicki Anastasi<br />
Vice President and Global Head,<br />
Medical Device and Diagnostics<br />
Research<br />
ICON plc<br />
Martina Beverly<br />
Managing Partner<br />
Beverly & Associates<br />
Shahira Bhimani<br />
Project Manager<br />
HTX<br />
Isabelle Billet<br />
Owner, Principal<br />
IBHC Advisors LLC<br />
Leif Bowman<br />
Senior Director, Marketing<br />
Dexcom, Inc.<br />
Elizabeth Brooks<br />
President<br />
Decision Driver Analytics, Inc.<br />
Patricia Cosgrove<br />
Area Director, USA Health<br />
Industries<br />
Ontario Ministry of Economic<br />
Development, Trade and<br />
Employment and Ministry of<br />
Research and Innovation<br />
Jane Fischer<br />
President and CEO<br />
Trygve, LLC<br />
Susan Garfield<br />
Principal, Advisory Services<br />
Ernst & Young LLP<br />
Elisabeth George<br />
Vice President of Global<br />
Regulations & Standards<br />
Philips, Inc.<br />
Claudia Graeve<br />
Vice President<br />
Health Advances, LLC<br />
Christian Haller<br />
President<br />
RavenOye Group<br />
Dave Hood<br />
President & CEO<br />
DH3 & Associates<br />
Ralph Ives<br />
Executive Vice President, Global<br />
Strategy and Analysis<br />
AdvaMed<br />
Alan Kholos<br />
Director, International<br />
Distribution Management Group<br />
CareFusion<br />
Ulrike Knies-Bamforth<br />
Strategic Lead - Medical<br />
Technologies<br />
Scottish Enterprise<br />
Sue Lapp<br />
President/Owner<br />
Lapp Medical Consulting<br />
Kate Liebelt<br />
Chief of Staff, US Health Care<br />
Provider Consulting<br />
Deloitte Consulting, LLP<br />
Gemma Moore<br />
Vice President of International<br />
Regulatory Affairs<br />
Edwards Lifesciences<br />
Rigel Navarro<br />
CEO<br />
Tijuana Economic Development<br />
Corporation<br />
Omar Oweiss<br />
Director, Investment Promotion<br />
Germany Trade and Invest<br />
Jeffrey Rainey<br />
Business Investment<br />
GREATER MSP<br />
Stephane Richard<br />
President & Founder<br />
French BioBeach<br />
Cheryl Rogers<br />
Trade Commissioner<br />
Consulate of Canada, San Diego<br />
John Schueler<br />
Chief Operating Officer<br />
Fujirebio<br />
Harrison Shapira<br />
Vice Consul<br />
UK Trade & Investment<br />
Naomi Soffa<br />
Business Development Manager<br />
New Zealand Trade and Enterprise<br />
Dallas Thomas<br />
Senior International Regulatory<br />
Affairs Specialist<br />
Biomet 3i<br />
Jan Wauters<br />
Technology Attache<br />
Flanders Investment and Trade -<br />
Consulate General of Belgium<br />
Pamela Weagraff<br />
Director, Medical Device &<br />
Diagnostics Regulatory Consulting<br />
Quintiles - Advisory Services<br />
Diane Weaver<br />
Health Economics & Policy<br />
Dexcom, Inc.<br />
Andrew Williamson<br />
Head of Corporate Development<br />
Heraues Medical<br />
Zita Yurko<br />
Director, Global Regulations &<br />
Standards<br />
Philips, Inc.<br />
FINAL PROGRAM | 15
AdvaMed 2015 Host & Local Committee<br />
Committee Chair:<br />
Michael “Mick” Farrell<br />
CEO<br />
ResMed<br />
Meghan Alonso<br />
San Diego Chair<br />
DeviceAlliance<br />
Roseann E. Burhenne<br />
Senior Director, Marketing<br />
Strategy - Medical<br />
Flextronics<br />
Heather Chambers<br />
Senior Manager, Global<br />
Communications<br />
Edwards Lifesciences<br />
Larissa D’Andrea<br />
Director, Government &<br />
Regulatory Affairs<br />
ResMed Corp.<br />
Rick Fultz<br />
VP of Business Development for<br />
Biocom and Managing Director of<br />
the Biocom Purchasing Group<br />
Biocom<br />
Todd Gillenwater<br />
Executive Vice President –<br />
Advocacy & External Relations<br />
California Life Sciences Association<br />
Tim Gleeson<br />
Chief Executive Officer<br />
Novasyte<br />
Alison Graves<br />
Director, Corporate Communications<br />
ResMed Corp.<br />
Cristina Hermosillo<br />
President<br />
Tijuana Economic Development<br />
Corporation (DEITAC)<br />
Chelsea Hewitt<br />
Head of Marketing<br />
Johnson & Johnson Innovation,<br />
JLABS San Diego<br />
Barbara Hunter<br />
Brand Marketing and Creative<br />
Services Leadership<br />
Tim Ingersoll<br />
Director of Communications<br />
West Health<br />
Daniel Kleeburg<br />
Partner | Assurance and Advisory<br />
Business Services<br />
Ernst & Young LLP<br />
Jennifer Landress, CMP<br />
Senior VP and Chief Operating<br />
Officer<br />
Biocom<br />
Sally L. Maher<br />
V.P. Regulatory & Clinical, Global<br />
Critical Care<br />
Edwards Lifesciences<br />
Jack Maniko<br />
Director, Federal Legislative Affairs<br />
Baxter Healthcare Corporation<br />
Meloudy O’Reilly<br />
Business Development Manager<br />
and Global Lead Healthcare and<br />
Life Sciences<br />
Latham & Watkins LLP<br />
Joseph D. Panetta<br />
President & CEO and Member,<br />
BIOCOM Board of Directors<br />
Biocom<br />
Frank Pokrop<br />
Director - Quality and Regulatory<br />
Affairs<br />
CareFusion/BD<br />
Sara Radcliffe<br />
President & Chief Executive Officer<br />
California Life Sciences Association<br />
Marisa Reinoso<br />
Associate Director - Marketing &<br />
Programs<br />
California Life Sciences Association<br />
Stacy Roughan<br />
Director, Investor Relations &<br />
Corporate Communications<br />
NuVasive<br />
Joleen Schultz<br />
Director, Marketing &<br />
Communications<br />
University of California, San Diego -<br />
Rady School of Management<br />
Joseph M. Smith, MD, PhD, FACC<br />
Chief Medical Officer, Chief<br />
Science Officer<br />
West Health<br />
Misha Tsirulnikov, CMP<br />
Senior Vice President of Program<br />
Strategy and Marketing<br />
California Life Sciences Association<br />
Victoria Tucker<br />
CEO<br />
ZBGlobal<br />
AdvaMed 2015 Program Committee<br />
Chairman:<br />
Timothy Dugan<br />
Managing Partner<br />
Water Street Healthcare Partners<br />
Milena Adamian<br />
Managing Partner / Founder<br />
Azimuth Ventures / Life Science<br />
Angel Network<br />
Vicki Anastasi<br />
Vice President and Global Head,<br />
Medical Device and Diagnostics<br />
Research<br />
ICON<br />
David Anderson<br />
Managing Director - Medical<br />
Technology<br />
GE Capital<br />
Shabbir Bambot, Ph.D.<br />
Co-founder & Chief Technology<br />
Officer<br />
LumaMed LLC<br />
Henry Beverly<br />
Division Sales and Operation<br />
Planning<br />
Abbott Laboratories<br />
Martina Beverly<br />
Managing Partner<br />
Beverly & Associates<br />
Isabelle Billet<br />
Principal<br />
IBHC Advisors<br />
Leif Bowman<br />
Senior Director, Marketing<br />
Dexcom, Inc.<br />
Ann S. Brandt, Ph.D.<br />
Partner<br />
HealthCare Appraisers<br />
Elizabeth (Beth) A. Brooks, Ph.D.<br />
President<br />
Decision Driver Analytics, Inc.<br />
Roseann E. Burhenne<br />
Senior Director, Marketing<br />
Strategy - Medical<br />
Flextronics<br />
Allan Daisley<br />
President<br />
ZeroTo510 Medical Device<br />
Accelerator<br />
Matt Dolan<br />
Director, Business Development<br />
Volcano<br />
16 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
AdvaMed 2015 Program Committee<br />
Sara Dyson<br />
Assistant Vice President<br />
Medmarc Insurance Group<br />
Shamiram Feinglass<br />
Vice President, Medical and<br />
Regulatory Affairs<br />
Danaher Corporation<br />
Jane Fischer<br />
President and CEO<br />
Trygve, LLC<br />
Susan Garfield, DrPH<br />
Principal, Advisory Services<br />
EY<br />
Elisabeth George<br />
Vice President of Global<br />
Regulations & Standards<br />
Philips, Inc.<br />
Christopher R. Gingras<br />
Compliance Officer<br />
RTI Surgical, Inc.<br />
Jackie Gonzalez<br />
CEO<br />
J29 Associates<br />
Barbara Goodman<br />
Senior Vice President, PROPEL<br />
iBIO Institute<br />
Claudia Graeve<br />
Vice President<br />
Health Advances, LLC<br />
Sonali Gunawardhana<br />
Of Counsel<br />
Wiley Rein LLP<br />
Christian Haller<br />
President<br />
RavenOye Group<br />
Thomas A. Harper<br />
Senior Consulting Manager<br />
Plante Moran<br />
Jason Hillenbach<br />
Knowledge Leader - Life Sciences<br />
EY<br />
Dave Hood<br />
President & CEO<br />
DH3 & Associates<br />
Ulrike Knies-Bamforth<br />
Scottish Enterprise<br />
Sue Lapp<br />
President/Owner<br />
Lapp Medical Consulting<br />
Kate Liebelt<br />
Chief of Staff, US Health Care<br />
Provider Consulting<br />
Deloitte Consulting, LLP<br />
Christine Lindgren<br />
Vice President, Marketing<br />
Evaluate Ltd<br />
Brian J. Malkin<br />
McGuireWoodsLLP<br />
Caren Mason<br />
University of California, San Diego -<br />
Rady School of Management<br />
Dave Mauro<br />
Director, North American Sales<br />
Sparta Systems, Inc.<br />
Robert B. McCray<br />
President & CEO<br />
Wireless-Life Sciences Alliance<br />
John Meduri<br />
Global Director, Business Development<br />
BD Diagnostics<br />
Teri Melese<br />
Associate Professor Medicine &<br />
Rady School of Management<br />
University of California, San Diego<br />
Faviola Michelot<br />
Principal Project Manager<br />
Edwards Lifesciences<br />
Gregory Montalbano<br />
Principal Owner<br />
MIDI Medical Product Development<br />
Gemma Moore<br />
Vice President of International<br />
Regulatory Affairs<br />
Edwards Lifesciences<br />
Susan Morano<br />
VP, New Business Development<br />
Johnson & Johnson<br />
Jeffrey Rainey<br />
Business Investment<br />
GREATER MSP<br />
Lakshman Ramamurthy<br />
Vice President<br />
Avalere Health LLC<br />
Israel Raz<br />
Vice President<br />
Extera Partners<br />
Tabitha Reed<br />
Senior Manager, Post Market<br />
Surveillance<br />
Intuitive Surgical<br />
Stephane Richard<br />
President & Founder<br />
French BioBeach<br />
Kevin J. Schimelfenig<br />
President<br />
SalesForce4Hire<br />
John Schueler<br />
Chief Operating Officer<br />
Fujirebio<br />
Joseph P. Sener, PE<br />
Vice President, Quality, Device<br />
Engineering<br />
Hospira, Inc.<br />
Harrison Shapira<br />
Vice Consul<br />
UK Trade & Investment<br />
Joseph M. Smith, MD, PhD<br />
Chief Science and Medical Officer<br />
West Health and West Health Institute<br />
Naomi Soffa<br />
Business Development Manager<br />
New Zealand Trade and Enterprise<br />
Jim Southwick<br />
Vice President, Global<br />
Government Affairs<br />
Medtronic plc<br />
Larry Stambaugh<br />
Principal<br />
Apercu Partners<br />
Aileen Stockburger<br />
Vice President, Worldwide<br />
Business Development<br />
Johnson & Johnson<br />
Dallas Thomas<br />
Senior International Regulatory<br />
Affairs Specialist<br />
Biomet 3i<br />
Nicole Walker<br />
Director, Venture Capital<br />
Baird Capital<br />
Jan Wauters<br />
Technology Attache<br />
Flanders Investment and Trade -<br />
Consulate General of Belgium<br />
Pamela J Weagraff, MBA<br />
Director, Medical Device &<br />
Diagnostics Regulatory Consulting<br />
Quintiles - Advisory Services<br />
Diane Weaver<br />
Health Economics & Policy<br />
Dexcom, Inc.<br />
Veronique (Nikki) Willett<br />
Global Life Sciences, Quality and<br />
Compliance<br />
Accenture<br />
Andrew Williamson<br />
Head of Corporate Development<br />
Heraues Medical<br />
Kelly Zitlow<br />
Corporate Communications<br />
Water Street Healthcare Partners<br />
FINAL PROGRAM | 17
18 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
Agenda-at-a-Glance<br />
Unless otherwise noted, all events are located in the San Diego Convention Center.<br />
SUNDAY, OCTOBER 4<br />
Start End Event Title Location<br />
1:00 pm 5:30 pm Seminar International Seminar<br />
5:30 pm 6:30 pm Reception International Reception<br />
MONDAY, OCTOBER 5<br />
Marriott Marquis<br />
San Diego Marina<br />
Marina Ballroom D<br />
Marriott Marquis<br />
San Diego Marina<br />
South Pool Deck<br />
Start End Event Title Location<br />
8:00 am 3:00 pm Boot Camp Entrepreneurship Boot Camp (Separate Registration Required)<br />
9:00 am 4:30 pm Workshop<br />
12:00 pm<br />
6:00 pm<br />
7:00 pm<br />
Concierge<br />
Desk<br />
Speaker<br />
Ready Room<br />
MedDevice Development Course (Separate, Paid Registration<br />
Required)<br />
MedTech Partnering Concierge Desk Open<br />
Speaker Ready Room Open<br />
Ballrooms 6C, 6E<br />
and 6F Upper<br />
Marriott Marquis<br />
San Diego Marina<br />
Coronado<br />
Info Booth, Lobby A<br />
Room 12<br />
Mezzanine<br />
7:30 pm Registration Registration Lobby A<br />
1:00 pm 2:15 pm Panel<br />
Medical Technology Needs of our Active Warriors and Veterans<br />
Scientific Exchange: Interpreting the Available Guidance Regarding the<br />
Dissemination of Data Regarding Off-Label Uses of Medical Devices<br />
Integrating Wearable Technology into Medical Devices: Promise or<br />
Pipedream?<br />
EU Medical Device Directives Update<br />
1:30 pm 2:30 pm Forum Business Development - Investor Forum (Invitation Only)<br />
Room 11B Upper<br />
Room 9 Upper<br />
Room 10 Upper<br />
Room 11A Upper<br />
Room 16A<br />
Mezzanine<br />
Business Development<br />
& Finance<br />
Compliance Best Practices<br />
Digital Medical<br />
Technologies<br />
Emerging & Early<br />
Growth Company Issues<br />
In Vitro Diagnostics<br />
International<br />
Key Health Policies<br />
Legal<br />
MedTech & the<br />
Economy<br />
Payment & Health Care<br />
Delivery<br />
Quality<br />
Technology & Regulation<br />
CEOs Unplugged Stage is located in<br />
the Exhibit Hall, Hall B.<br />
*All locations are subject to change<br />
FINAL PROGRAM | 19
MONDAY, OCTOBER 5<br />
Start End Event Title Location<br />
2:30 pm 3:45 pm Panel<br />
3:00 pm 4:30 pm<br />
Speed<br />
Dating<br />
4:00 pm 5:15 pm Panel<br />
4:30 pm 5:30 pm Reception<br />
TUESDAY, OCTOBER 6<br />
Anti-Corruption in the Life Sciences - Trends in Emerging Markets<br />
Tendering: Best Practices<br />
The New Frontier of FDA & FCC Oversight and Innovative Medical<br />
Devices<br />
CMS Data: What it Says and What You Should Do<br />
Strategic Investor Speed Dating (Invitation Only)<br />
Why Compliance is an Integral Part of Mergers & Acquisitions<br />
The Hidden Life of Devices: Cybersecurity and Embedded<br />
Medical Devices<br />
Global Health Economics: Trends in Health Technology<br />
Assessments and Reimbursement<br />
The Role of Medical Devices in Pediatrics and Rare Diseases<br />
AdvaMed Accel Business Development - Investor Reception<br />
(Invitation Only)<br />
Room 9 Upper<br />
Room 11A Upper<br />
Room 10 Upper<br />
Room 11B Upper<br />
Room 15B<br />
Mezzanine<br />
Room 11B Upper<br />
Room 10 Upper<br />
Room 11A Upper<br />
Room 9 Upper<br />
West Mezzanine<br />
Terrace<br />
5:00 pm 6:30 pm Workshop Women's Executive Network Ballroom 6F Upper<br />
5:30 pm 7:00 pm Reception SoCal Welcome Reception<br />
7:30 pm 9:30 pm Reception AdvaMed Board of Directors Dinner (Invitation Only)<br />
9:30 pm 11:00 pm Reception Post-Board Dinner Reception (Invitation Only)<br />
7:00 am<br />
6:00 pm<br />
Speaker<br />
Ready Room<br />
Speaker Ready Room Open<br />
West Upper<br />
Terrace<br />
Marriott Marquis<br />
San Diego Marina,<br />
Marina Ballroom DE<br />
Marriott Marquis<br />
San Diego Marina,<br />
Marina Kitchen<br />
Start End Event Title Location<br />
7:00 pm<br />
Concierge<br />
Desk<br />
7:30 am 9:00 am Plenary<br />
9:00 am<br />
9:10 am 9:50 am<br />
MedTech Partnering Concierge Desk Open<br />
Room 12<br />
Mezzanine<br />
Exhibit Hall<br />
Registration Registration Open Lobby A<br />
Plenary Breakfast: General Stanley McChrystal (Ret.) on<br />
Leadership, Team Building and Geopolitics<br />
Plenary Stage, Hall B<br />
5:30 pm Partnering MedTech Partnering Open Exhibit Hall<br />
7:00 pm Exhibit Hall Exhibit Hall Open Exhibit Hall<br />
CEOs<br />
Unplugged<br />
CEOs Unplugged - Understanding the Needs of Hospital CEOs & Payers<br />
Exhibit Hall<br />
Business Development<br />
& Finance<br />
Compliance Best Practices<br />
Digital Medical<br />
Technologies<br />
Emerging & Early<br />
Growth Company Issues<br />
In Vitro Diagnostics<br />
International<br />
Key Health Policies<br />
Legal<br />
MedTech & the<br />
Economy<br />
Payment & Health Care<br />
Delivery<br />
Quality<br />
Technology & Regulation<br />
CEOs Unplugged Stage is located in<br />
the Exhibit Hall, Hall B.<br />
*All locations are subject to change<br />
20 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
TUESDAY, OCTOBER 6<br />
Start End Event Title Location<br />
9:15 am<br />
9:50 am<br />
9:55 am 10:30 am<br />
10:00 am 10:30 am<br />
10:30 am 11:00 am<br />
11:00 am<br />
Innovation<br />
Showcase<br />
10:30 am Panel<br />
11:35 am<br />
11:40 am<br />
11:40 am 12:15 pm<br />
11:45 am 12:15 pm<br />
Innovation<br />
Showcase<br />
CEOs<br />
Unplugged<br />
Innovation Showcase: Big Data and Analytics<br />
Quality of Life Products in the Value-Based Care Landscape<br />
Leadership Views on the Future of Diagnostics<br />
Case for Quality 2015 – CDRH Industry Update<br />
Pulse of the Industry: Capital Allocation: Moving Beyond Face Value<br />
Innovation Showcase: Technology for Ambulatory and Home<br />
Settings<br />
CEOs Unplugged - Legislative and Policy Issues Facing the<br />
MedTech Industry<br />
Exhibit Hall<br />
Room 11B Upper<br />
Room 11A Upper<br />
Room 9 Upper<br />
Room 10 Upper<br />
Exhibit Hall<br />
Exhibit Hall<br />
Networking Refreshment Break Exhibit Hall<br />
Innovation<br />
Demo<br />
Innovation<br />
Showcase<br />
CEOs<br />
Unplugged<br />
12:15 pm Panel<br />
Innovation<br />
Showcase<br />
CEOs<br />
Unplugged<br />
Innovation Pavilion Company Demos<br />
Innovation Showcase: Chronic Disease Management<br />
CEOs Unplugged - Company Culture and Other Leadership Issues<br />
The Future is Now: Harnessing Innovation and Public Health<br />
Through Risk Based Oversight of Diagnostics<br />
The Role of M&A in Building Value<br />
Improving <strong>Access</strong> to Innovation Under Health Reform<br />
Single Audit Program<br />
Innovation Showcase: Patient Safety and Satisfaction<br />
CEOs Unplugged - Digital Health<br />
Exhibit Hall<br />
Exhibit Hall<br />
Exhibit Hall<br />
Room 11A Upper<br />
Room 10 Upper<br />
Room 11B Upper<br />
Room 9 Upper<br />
Exhibit Hall<br />
Exhibit Hall<br />
12:30 pm 2:00 pm Plenary Plenary Lunch: Eric J. Topol, MD on the Future of Health Care Plenary Stage, Hall B<br />
2:00 pm 2:20 pm Book Signing<br />
2:10 pm 2:50 pm<br />
2:15 pm<br />
2:50 pm<br />
CEOs<br />
Unplugged<br />
Innovation<br />
Showcase<br />
3:30 pm Panel<br />
The Patient Will See You Now: The Future of Medicine is in Your<br />
Hands by Eric J. Topol, MD<br />
CEOs Unplugged - Commercialization Outsourcing Options – What<br />
Are Investors and Top Management Looking For Today?<br />
Innovation Showcase: Shifting to Less-invasive Therapies and Site<br />
of Care<br />
New Drivers in MedTech Investing<br />
Evolution of U.S. Hospital Landscape and Implications for MedTechs<br />
Integrating Patient Perspectives into the Medical Device Regulatory<br />
Process<br />
How Novel Diagnostics Are Changing the Health Care Value<br />
Proposition<br />
MeetUp Zone<br />
(Exhibit Hall)<br />
Exhibit Hall<br />
Exhibit Hall<br />
Room 10 Upper<br />
Room 11B Upper<br />
Room 9 Upper<br />
Room 11A Upper<br />
Business Development<br />
& Finance<br />
Compliance Best Practices<br />
Digital Medical<br />
Technologies<br />
Emerging & Early<br />
Growth Company Issues<br />
In Vitro Diagnostics<br />
International<br />
Key Health Policies<br />
Legal<br />
MedTech & the<br />
Economy<br />
Payment & Health Care<br />
Delivery<br />
Quality<br />
Technology & Regulation<br />
CEOs Unplugged Stage is located in<br />
the Exhibit Hall, Hall B.<br />
*All locations are subject to change<br />
FINAL PROGRAM | 21
TUESDAY, OCTOBER 6<br />
Start End Event Title Location<br />
2:55 pm<br />
3:30 pm<br />
3:35 pm<br />
3:30 pm 4:00 pm<br />
4:00 pm<br />
4:35 pm<br />
4:45 pm<br />
4:40 pm 5:15 pm<br />
4:45 pm 5:15 pm<br />
5:15 pm<br />
Innovation<br />
Showcase<br />
CEOs<br />
Unplugged<br />
Innovation Showcase: Personalized MedTech<br />
CEOs Unplugged - Emerging Markets<br />
Exhibit Hall<br />
Exhibit Hall<br />
Networking Refreshment Break Exhibit Hall<br />
Innovation<br />
Demo<br />
Innovation<br />
Showcase<br />
CEOs<br />
Unplugged<br />
5:15 pm Panel<br />
Innovation<br />
Showcase<br />
AdvaMed<br />
Membership<br />
Meeting<br />
Innovation Pavilion Company Demos<br />
Innovation Showcase: Point of Care Diagnostics<br />
CEOs Unplugged - The Innovation Ecosystem in Crisis and What to<br />
Do About It<br />
Conducting Global IVD Clinical Trials to Support US and<br />
International Markets<br />
Improving Adoption Utilizing Human-Centered Design for<br />
Commercialization & Innovation<br />
Super Session: Walking the Tightrope – Titrating Evidentiary<br />
Requirements for Regulatory and Reimbursement for Medical<br />
Devices<br />
Innovation Showcase: Digital Health Meets Medical Device<br />
AdvaMed Annual Membership Meeting *members only*<br />
Exhibit Hall<br />
Exhibit Hall<br />
Exhibit Hall<br />
Room 11A Upper<br />
Room 10 Upper<br />
Ballroom 6F Upper<br />
Exhibit Hall<br />
San Diego<br />
Convention Center<br />
Room 15 A<br />
Mezzanine<br />
6:30 pm Panel Promoting Innovation in the U.S.: FDA's Early Feasibility Studies Room 9 Upper<br />
7:00 pm Reception Chairmen's Networking Reception - An Irish Pub Night Exhibit Hall<br />
9:30 pm 11:00 pm Reception MedTech After Party - Rock on the Rooftop!<br />
WEDNESDAY, OCTOBER 7<br />
Petco Park Western<br />
Metal Rooftop<br />
Start End Event Title Location<br />
7:00 am<br />
12:00 pm<br />
4:00 pm<br />
Speaker<br />
Ready Room<br />
Speaker Ready Room Open<br />
Room 12<br />
Mezzanine<br />
Registration Registration Open Lobby A<br />
Concierge<br />
Desk<br />
MedTech Partnering Concierge Desk Open<br />
Exhibit Hall<br />
7:30 am 9:00 am Plenary Plenary Breakfast: MedTech Innovator Finals Plenary Stage, Hall B<br />
Business Development<br />
& Finance<br />
Compliance Best Practices<br />
Digital Medical<br />
Technologies<br />
Emerging & Early<br />
Growth Company Issues<br />
In Vitro Diagnostics<br />
International<br />
Key Health Policies<br />
Legal<br />
MedTech & the<br />
Economy<br />
Payment & Health Care<br />
Delivery<br />
Quality<br />
Technology & Regulation<br />
CEOs Unplugged Stage is located in<br />
the Exhibit Hall, Hall B.<br />
*All locations are subject to change<br />
22 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
WEDNESDAY, OCTOBER 7<br />
Start End Event Title Location<br />
9:00 am<br />
4:00 pm Partnering MedTech Partnering Exhibit Hall<br />
5:00 pm Exhibit Hall Exhibit Hall Open Exhibit Hall<br />
9:10 am 9:45 am<br />
9:15 am<br />
9:50 am<br />
CEOs<br />
Unplugged<br />
Innovation<br />
Showcase<br />
10:30 am Panel<br />
CEOs Unplugged - Wearables – From Fashion Runway to<br />
Medical Diagnostic<br />
Innovation Showcase: Chronic Disease Management<br />
Best Practices Developed by Leading Medical Technology<br />
Companies in the CaliBaja Region<br />
Combination Products<br />
New Advances in Managing Chronic Disease<br />
Exhibit Hall<br />
Exhibit Hall<br />
Room 11B Upper<br />
Room 9 Upper<br />
Room 11A Upper<br />
The Role of Local Innovation Ecosystems in Bringing Complex<br />
Medical Devices to Market<br />
Room 10 Upper<br />
9:55 am<br />
10:30 am<br />
10:35 am<br />
Innovation<br />
Showcase<br />
CEOs<br />
Unplugged<br />
Innovation Showcase: Point of Care Diagnostics<br />
CEOs Unplugged - Understanding the Power and Challenges of<br />
Today’s Patient<br />
Exhibit Hall<br />
Exhibit Hall<br />
10:30 am 11:00 am<br />
10:55 am 11:35 am<br />
11:35 am<br />
Networking Refreshment Break Exhibit Hall<br />
Innovation<br />
Demo<br />
CEOs<br />
Unplugged<br />
Innovation<br />
Showcase<br />
Innovation Pavilion Company Demos<br />
CEOs Unplugged - Advocating for Medical Innovation: 40 Years &<br />
Beyond: Insights from Industry Innovators and Icons<br />
Innovation Showcase: Patient Safety and Satisfaction<br />
Exhibit Hall<br />
Exhibit Hall<br />
Exhibit Hall<br />
11:00 am<br />
12:15 pm Panel<br />
Leadership Dynamics That Drive Better Business Results 2.0<br />
MDEpiNet PASSION Program: Achieving Predictability and<br />
Sustainability<br />
Room 10 Upper<br />
Room 9 Upper<br />
Bedside Connections: Interoperability Advances in Washington, D.C.<br />
Room 11A Upper<br />
11:40 am 12:15 pm<br />
11:45 am 12:15 pm<br />
Innovation<br />
Showcase<br />
CEOs<br />
Unplugged<br />
12:30 pm 2:00 pm Plenary<br />
2:15 pm 4:00 pm<br />
Plenary/<br />
Town Hall<br />
Innovation Showcase: Point of Care Diagnostics<br />
CEOs Unplugged - Current Investment Flow, M&A and Deal<br />
Structures<br />
Plenary Lunch: AdvaMed's Lifetime Achievement Award and Michael<br />
Eisner on Creativity, Innovation & the Value of Great Partnerships<br />
Closing Plenary: CDRH Town Hall with Dr. Jeffrey Shuren<br />
Exhibit Hall<br />
Exhibit Hall<br />
Plenary Stage, Hall B<br />
Ballroom 6F Upper<br />
4:15 pm 5:00 pm Reception Closing Reception Exhibit Hall<br />
Business Development<br />
& Finance<br />
Compliance Best Practices<br />
Digital Medical<br />
Technologies<br />
Emerging & Early<br />
Growth Company Issues<br />
In Vitro Diagnostics<br />
International<br />
Key Health Policies<br />
Legal<br />
MedTech & the<br />
Economy<br />
Payment & Health Care<br />
Delivery<br />
Quality<br />
Technology & Regulation<br />
CEOs Unplugged Stage is located in<br />
the Exhibit Hall, Hall B.<br />
*All locations are subject to change<br />
FINAL PROGRAM | 23
Floor Maps<br />
San Diego Convention Center<br />
Exhibit Halls<br />
Ground Level<br />
ELEVATOR<br />
[<br />
MedTech Partnering<br />
(Hall B2)<br />
[<br />
Exhibit Hall<br />
(Hall B1)<br />
Plenary Entrance<br />
ESCALATOR/ELEVATOR/STAIRS<br />
BAYSIDE LOBBY<br />
TIDES<br />
RESTAURANT<br />
Registration<br />
24 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
San Diego<br />
Convention Center<br />
Mezzanine Level<br />
Various<br />
Programming<br />
Media<br />
Oce<br />
Speaker<br />
Ready Room<br />
Press<br />
Conference Room<br />
To access the Mezzanine Level,<br />
please proceed to the Upper<br />
Level, walk past Ballroom 6 and<br />
the Sails Pavilion and at the end<br />
of the corridor, head down to the<br />
Mezzanine Level.<br />
Welcome<br />
Reception<br />
Panel Sessions<br />
Entrepreneurship Boot Camp<br />
Women’s Executive Network<br />
Super Session<br />
CDRH Town Hall<br />
San Diego<br />
Convention Center<br />
Upper Level<br />
San Diego Convention Center<br />
FINAL PROGRAM | 25
Networking Receptions<br />
SoCal Welcome Reception<br />
Sponsored by<br />
Monday, October 5<br />
5:30 pm – 7:00 pm<br />
West Upper Terrace<br />
Welcome to sunny California! Reconnect with clients, colleagues and friends at the SoCal Welcome<br />
Reception on an outside terrace overlooking the iconic San Diego Bay. Scheduled to take place after<br />
workshops, panels and Exhibit Hall move-in, this lively reception is a great way to network while enjoying<br />
California cuisine and soaking up the sunshine.<br />
Chairmen’s Networking Reception<br />
An Irish Pub Night<br />
Sponsored by<br />
Tuesday, October 6<br />
5:15 pm – 7:00 pm<br />
Exhibit Hall<br />
We’re putting a California spin on our annual Irish tradition! Whether you’re enjoying a pint of Guinness or a<br />
locally brewed craft beer, be sure to join us in the Exhibit Hall to check out the latest and greatest from our<br />
MedTech exhibitors. Take advantage of this excellent networking opportunity with all of your colleagues,<br />
including members of the AdvaMed, AdvaMedDx and Accel Boards of Directors.<br />
26 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
PLEASE VISIT US AT<br />
BOOTH 400<br />
Nypro, a Jabil company, provides the<br />
world’s best design, manufacturing, and supply<br />
chain solutions to leading brands of medical<br />
devices, diagnostics and pharmaceutical<br />
delivery systems.<br />
We execute with certainty from inspiration into<br />
package, from launch through lifecycles. Nypro<br />
helps customers evolve to uniquely solve the<br />
rapidly changing needs of payers and providers to<br />
cost-effectively sustain and improve patient lives<br />
worldwide. We bring confidence to customers,<br />
value to payers and peace-of-mind to patients.<br />
EXECUTION WITH CERTAINTY.<br />
CONFIDENCE FOR PATIENT CARE.<br />
FINAL PROGRAM | 27
28 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
MedTech After Party<br />
Rock on the Rooftop!<br />
Sponsored by<br />
® &<br />
Tuesday, October 6<br />
9:30 pm – 11:00 pm<br />
Petco Park Western Metal Rooftop<br />
Gaslamp Gate (located at 7th Avenue and K Street)<br />
After a long day of conference sessions, it’s time to join your MedTech colleagues for a night under the<br />
stars! Taking full advantage of the Southern California climate, AdvaMed 2015 will host this year’s MedTech<br />
After Party at Petco Park’s Western Metal Rooftop, home of the Major League Baseball team the San Diego<br />
Padres. Enjoy free drinks, live music and San Diego’s beautiful weather while catching up with old friends.<br />
Closing Reception<br />
Wednesday, October 7<br />
4:15 pm – 5:00 pm<br />
Exhibit Hall<br />
Take advantage of one last opportunity to network with colleagues as we close out a successful AdvaMed<br />
2015 and look ahead to next year. This fun-filled Closing Reception will offer attendees their final<br />
opportunity for invaluable networking as they look forward to next year’s conference.<br />
FINAL PROGRAM | 29
Plenary Sessions<br />
Plenary Breakfast: General Stanley McChrystal (Retired) on<br />
Leadership, Team Building and Geopolitics<br />
Tuesday, October 6<br />
7:30 am - 9:00 am<br />
Former commander of U.S. and International Forces in Afghanistan, author of best-sellers<br />
Team of Teams and My Share of the Task, and co-founder of the McChrystal Group<br />
General Stanley McChrystal is a four-star general, the former commander of U.S. and<br />
international forces in Afghanistan and the former leader of Joint Special Operations<br />
Command, which oversees the most sensitive counter-terrorism units. He is widely praised for revolutionizing<br />
warfare by fusing intelligence and operations and is credited with the capture of Saddam Hussein and the<br />
killing of al-Qaeda’s leader in Iraq. Secretary of Defense Robert Gates called McChrystal “one of America’s<br />
greatest warriors.” McChrystal will address leadership, teambuilding and geopolitics.<br />
Plenary Lunch: Eric J. Topol, M.D., on the Future of Health Care<br />
Tuesday, October 6<br />
12:30 pm - 2:00 pm<br />
Scripps Health Chief Academic Officer, Eric J. Topol, M.D., is a practicing cardiologist with<br />
Scripps Clinic and a pioneer in the field of cardiovascular medicine. A physician-scientist, he<br />
has built an international reputation for his ground-breaking research and expertise.<br />
Of special interest to Dr. Topol are genomics, wireless sensors, preventive cardiology,<br />
coronary artery disease and preventive medicine. The research that Dr. Topol has<br />
done on genomic and wireless digital technologies continues to reshape the future of<br />
medicine. Despite his in-depth research focus, he continues to see patients at Scripps Clinic, as he believes<br />
that research is only as good as what it can do to help others. Dr. Topol’s philosophy of care is based on the<br />
belief that patients should be fully empowered.<br />
In a 2012 poll conducted by Modern Healthcare, Dr. Topol was voted as the number one Most Influential<br />
Physician Executive in the United States. An avid educator, he founded a medical school, with the goal of training<br />
future generations of physician-scientists. In addition, he ran the Cleveland Clinic heart program for 14 years,<br />
and brought it to the number one ranking by U.S. News and World Report for more than 10 years consecutively.<br />
Today, he plays a critical role in the physician-scientist track within the Scripps Clinic and Scripps Green Hospital<br />
Internal Medicine Residency and Fellowship Program. Dr. Topol is an elected member of the Institute of Medicine<br />
of the National Academy of Sciences and is one of the top 10 most cited researchers in medicine.<br />
30 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
Plenary Breakfast: MedTech Innovator Finals<br />
Wednesday, October 7<br />
7:30 am - 9:00 am<br />
The final round of the MedTech Innovator 2015 Competition takes place LIVE during this AdvaMed 2015<br />
Plenary Breakfast. MedTech Innovator is a venture competition and accelerator, designed to foster<br />
transformative innovation that benefits patients and delivers improved value to the health care system.<br />
MedTech Innovator is a strategic partnership with industry leaders and AdvaMed to identify and accelerate<br />
early-stage MedTech companies, including medical device, diagnostic and digital health. Nearly 300<br />
companies from around the globe applied to the 2015 competition and four finalists will compete on the<br />
plenary stage for over $300,000 in awards and prizes.<br />
Don’t miss this exciting, interactive program,<br />
where the audience vote will determine the<br />
winners of MedTech Innovator 2015.<br />
Host: Paul Grand<br />
Albert Lauritano<br />
Josh Makower<br />
Alan Russell<br />
Renee Ryan<br />
Host: Paul Grand, Producer and Emcee, MedTech Innovator; Managing Director, RCT Ventures<br />
Judges:<br />
Albert Lauritano, Director, Strategic Technology Partnerships, BD<br />
Josh Makower, General Partner, New Enterprise Associates<br />
Alan Russell, Chief Innovation Officer & Executive Vice President, Allegheny Health Network<br />
Renee Ryan, Vice President, Johnson & Johnson Innovation – JJDC<br />
MedTech Innovator Finalists:<br />
TM<br />
FINAL PROGRAM | 31
Plenary Lunch: Michael Eisner on Creativity, Innovation and<br />
the Value of Great Partnerships<br />
Wednesday, October 7<br />
12:30 pm - 2:00 pm<br />
Michael Eisner teaches audiences how to develop corporate creativity and strategically<br />
invest in innovation, based on his experiences as CEO of Disney and as Founder of<br />
The Tornante Company, a fund to invest in and develop companies in the media<br />
and entertainment sector. Both a Fortune 500 CEO and entrepreneur, Mr. Eisner<br />
knows that even large global companies can innovate and adapt to new markets, new economies and new<br />
technologies. Through his remarks, he not only inspires corporate innovation, he gives parameters for<br />
successful execution such as brand building, establishing strategic partnerships and employee work teams.<br />
Under the leadership of Michael Eisner, Walt Disney Company revenues grew from $1.7 billion to more than<br />
$30 billion by focusing on the power of ideas, pursuing the innovative vision and taking creative risks. As a<br />
leader in the media industry for four decades, Mr. Eisner has overseen organizations recognized for their<br />
inventiveness and innovation, experienced an explosion of technological advances that have impacted his<br />
business and led his companies through the advent of the next big ideas. In his presentations on leadership,<br />
he shares his insights on what it takes to run a company that must always grow and change.<br />
Lifetime Achievement Award<br />
For the third year in a row, AdvaMed will honor a legend within the medical technology<br />
industry through presentation of its 2015 Lifetime Achievement Award. This year,<br />
the honor is bestowed upon Dr. Thomas J. Fogarty, a world-renowned cardiovascular<br />
surgeon, entrepreneur and prolific inventor.<br />
For more than a half century, Dr. Fogarty has been dedicated to improving the health<br />
of people around the world. From his development of the balloon catheter more than<br />
50 years ago, to his work today mentoring young innovators in their quest to develop<br />
the treatments of tomorrow, Dr. Fogarty has had a transformative effect on the<br />
medical technology community and patients worldwide.<br />
We will honor Dr. Fogarty alongside several other MedTech Legends and former top industry executives<br />
during this plenary session.<br />
Closing Plenary: CDRH Town Hall<br />
Wednesday, October 7<br />
2:15 pm - 4:00 pm<br />
Ballroom 6F<br />
Join us for an exclusive peek into FDA’s Center for Devices and Radiological Health (CDRH) during our<br />
Wednesday afternoon CDRH Town Hall. This is a rare opportunity to interact directly with Dr. Jeff Shuren<br />
and other senior office leaders from CDRH. After Dr. Shuren provides an update on CDRH priorities,<br />
panelists will answer specific questions from the audience. Take advantage of this session and get answers<br />
to all of your burning questions directly from CDRH.<br />
Jeff Shuren, M.D., Director, Center for Devices and Radiological Health, FDA<br />
Owen Faris, Ph.D., Clinical Trials Director (acting), Office of Device Evaluation, CDRH, FDA<br />
Alberto Gutierrez, Ph.D., Director, Office of In Vitro Diagnostics and Radiological Health, CDRH, FDA<br />
William (Bill) MacFarland, Director, Division of Enforcement B, Office of Compliance, CDRH, FDA<br />
Tahseen Mirza, Ph.D., M.B.A., Deputy Director, Policy and Administration, CDRH Office of Surveillance and Biometrics, FDA<br />
32 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
Something<br />
for<br />
Everyone<br />
Save the Date!<br />
Oct 17-19, 2016<br />
Minneapolis, MN<br />
We’ll see you there!<br />
FINAL PROGRAM | 33
© 2015 EYGM Limited. All Rights Reserved. ED0617<br />
As health care moves<br />
from treatment to<br />
prevention, how will<br />
medtechs remain<br />
relevant?<br />
Find out how we’re working with medical<br />
technology companies to plan for tomorrow.<br />
ey.com/lifesciences #BetterQuestions<br />
34 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
Panel Sessions<br />
Business Development & Finance Track<br />
Sponsored by<br />
Pulse of the Industry - Capital Allocation: Moving Beyond Face Value<br />
Tuesday, October 6<br />
9:15 am - 10:30 am<br />
Room: 10 Upper<br />
MedTech market valuations and deal premiums have skyrocketed, while the hot IPO market has created exit options<br />
for early-stage companies and their investors. Don’t let the good times fool you. Global reimbursement challenges<br />
in the U.S. and Europe, plus a slowdown in emerging markets, continue to thwart the growth ambitions of most<br />
MedTechs, even as shareholder activism becomes a more potent force. In such a climate, MedTechs must embrace<br />
the notion that “good enough” capital management is irrelevant if shareholders believe more could be done to<br />
create long-term value. As Yogi Berra might have said, your company’s nickel ain’t worth an investor’s dime anymore.<br />
Indeed, there has never been a more important time to reexamine whether your capital allocation decisions are<br />
aligned with your corporate strategy. While it may sound obvious, the way a MedTech deploys its capital has a<br />
profound impact on its strategic direction ― and vice versa. In this panel, moderated by EY and The MedTech Strategist,<br />
industry executives will discuss which capital allocation levers are most consistent with long-term value creation in an<br />
industry experiencing rapid consolidation and a changing customer base. Among the topics to be addressed:<br />
• Balancing investments in future growth with the need to meet near-term shareholder expectations<br />
• Extracting full value from high-priced acquisition targets at a time when investors are rewarding deal activity<br />
• The importance of portfolio optimization as a path to long-term value creation<br />
• The business implications of payer and provider consolidation<br />
• How smaller companies can create value in an environment where scale is the organizing principle<br />
To provide context to the discussion, EY will present data from its 2015 Pulse of the Industry report, including<br />
an analysis of M&A and financial performance trends.<br />
Moderators:<br />
David Cassak, Managing Partner and Co-Founder, Innovation in Medtech, publisher of The Medtech Strategist<br />
Jeffrey Greene, Global Life Sciences Transactions Advisory Services Leader, EY<br />
Panelists:<br />
Andre-Michel Ballester, Chief Executive Officer, Sorin Group<br />
Ronald Kuerbitz, Chief Executive Officer, Fresenius Medical Care North America<br />
Gary Pruden, Worldwide Chairman, Johnson & Johnson Medical Devices<br />
Mark Secrest, Managing Director – Healthcare, Stifel<br />
Presenter:<br />
John Babitt, Americas Medical Technology Leader, EY<br />
FINAL PROGRAM | 35
The Role of M&A in Building Value<br />
Tuesday, October 6<br />
11:00 am - 12:15 pm<br />
Room: 10 Upper<br />
M&A is at the core of value creation in medical technology, but the nature of these transactions and associated<br />
drivers of value are evolving and becoming more complex in response to market trends. Device M&A has mostly<br />
centered on the accretion of small venture-backed companies that offer novel therapies to larger ones; that build<br />
scale, access and next-generation offerings. Disruptive forces in the industry have altered the M&A strategy for<br />
large and small firms. Factors affecting investment and risk include consolidation across providers, payers and<br />
manufacturers; low R&D productivity; tax, regulatory, time-to-market and pricing pressures. Novel technology<br />
acquisition is a priority, but associated deal pricing and structuring (e.g., earnouts) are compensating for these<br />
shared risks. Larger device companies are looking at sizable transactions to capture more of the value chain,<br />
establish new business models, create competitive barriers, gain supplier power and ultimately make up for low<br />
organic growth. It is no surprise to see the acquisition of Covidien by Medtronic, CareFusion by BD and Biomet by<br />
Zimmer. The panel will discuss how the value-adding logic and financial drivers have become more strategic, and<br />
achieving synergy and ROI targets require more comprehensive deal structuring and integration.<br />
Moderator:<br />
Tim Durst, Partner, A.T. Kearney<br />
Panelists:<br />
Peter Arduini, CEO, Integra Lifesciences<br />
David Dvorak, President and CEO, Zimmer Biomet<br />
Camille Farhat, President & CEO, AMS<br />
New Drivers in MedTech Investing<br />
Tuesday, October 6<br />
2:15 pm - 3:30 pm<br />
Room: 10 Upper<br />
The investment landscape for medical devices and digital health technologies is shifting. Traditional<br />
corporate business development and private equity are important drivers of funding with corporations<br />
leading earlier stage deals and joined by private equity operators in later stage transactions. However,<br />
corporate funding for early-stage medical devices is scarce relative to other industries and lags behind<br />
new money deals supported by venture capital. There is also a greater emphasis on partnered deals that<br />
share commercialization risk, and stand-alone corporate venture funds are establishing their position in the<br />
current market. Venture capital for medical devices and diagnostics continues to be uncertain, as indicated<br />
by an overall rise in medical device investments in 2014, followed by a significant decrease in Q1 2015.<br />
Yet, the launch of sizable new venture funds in 2015 could present opportunities for emerging medical<br />
technology. Meanwhile, non-traditional players, such as technology giants Samsung and Google, are making<br />
significant investments in transformational technologies and pushing the boundaries of digital health.<br />
This panel of industry leaders and investors will discuss how these dynamics are impacting the market for<br />
MedTech investing and creating opportunities for early-stage medical device and digital health companies.<br />
Moderator:<br />
Brian Williams, Director, Global Healthcare Strategy, PricewaterhouseCoopers LLP<br />
Panelists:<br />
Rick Anderson, Managing Director, PTV Healthcare Capital<br />
Leslie Bottorff, Managing Director, Healthcare, GE Ventures<br />
Nick Manusos, Vice President, Global Head Business Development, Baxter International Inc<br />
36 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
Compliance Best Practices<br />
Sponsored by<br />
CMS Data: What it Says and What You Should Do<br />
Monday, October 5<br />
2:30 pm - 3:45 pm<br />
Room: 11B Upper<br />
Over the past few years, the Centers for Medicare and Medicaid Services (CMS) have provided the general<br />
public with increased transparency of information about business activities, which has created some unique,<br />
new compliance opportunities and challenges. While just a speculation over the last year, we are now<br />
hearing directly from enforcement agencies that this data is currently being used in active enforcement<br />
actions, as well as for identification of new actions. The key theme is that companies need to know their data<br />
better than anyone else and use the available data to identify issues before someone else does. Our panel<br />
of chief compliance officers will discuss their perspectives on how CMS data is impacting their companies,<br />
what they are doing to understand what the data says about company practices, and how they are using<br />
this information to strengthen their compliance efforts. Panelists will also share their views on how this data<br />
has impacted government investigation and their advice on what companies should be doing to prepare for<br />
increased public scrutiny.<br />
Moderator:<br />
Eileen Erdos, Principal, Life Sciences Fraud Investigation and Dispute Services, EY<br />
Panelists:<br />
Compliance Executive, Medtronic<br />
Compliance Executive, GE Healthcare<br />
Compliance Executive, Zimmer Biomet<br />
FINAL PROGRAM | 37
Why Compliance is an Integral part of Mergers & Acquisitions<br />
Monday, October 5<br />
4:00 pm - 5:15 pm<br />
Room: 11B Upper<br />
While closed transactions have declined, a robust M&A activity is expected to continue into 2016. Thorough<br />
analysis regarding the impact of compliance on global business activities with customers, distributors and agents<br />
is imperative to the success of an organization. Interactions with health care professionals (HCP) are becoming<br />
more complex in our global activities. Considering all aspects of the deal and having compliance as a seat at the<br />
table is crucial when looking at the deal lifecycle. This is especially true when completing due-diligence activities,<br />
pre-close activities planning for day one and implementation considerations. Actions involving the life sciences<br />
industry continue to serve as one of the largest sources of recoveries for the U.S. Department of Justice.<br />
• 2014 Justice Department Recoveries from False Claims Act Cases amounts to $5.69 billion;<br />
• $20 billion in recoveries are expected in the next five years;<br />
• Over the past five years, the U.S. government recovered over $14 billion related to Corporate Integrity<br />
Agreement settlements with the life sciences industry, including $124.1 million with small to large<br />
medical device companies;<br />
• There has been continual enforcement of the industry through investigations, settlements, and in some<br />
instances, prosecution; and<br />
• Of the 16 FCPA-related settlements reported across all industries in 2013 and 2014, 25 percent were<br />
with medical device companies.<br />
Let us take you through HCP and third-party management considerations as a part of this panel, including<br />
complexities of cross border interactions that come into play with global mergers and acquisitions.<br />
Moderator:<br />
Jean McKiernan, Director, Pharmaceutical and Life Sciences Advisory, PwC<br />
Panelists:<br />
Wes Porter, Senior Vice President & Chief Compliance Officer, Wright Medical Technology, Inc.<br />
Jessica Puathasnanon, Chief Compliance Officer, Medtronic Diabetes Group<br />
Kristian A. Werling, Partner, McDermott Will & Emery<br />
38 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
Digital Medical Technologies<br />
Sponsored by<br />
Integrating Wearable Technology into Medical Devices: Promise or Pipedream?<br />
Monday, October 5<br />
1:00 pm - 2:15 pm<br />
Room: 10 Upper<br />
This panel will explore the application of wearables in the medical ecosystem. Topics will include: 1)<br />
wearables defined; 2) how they can be integrated into medical devices; 3) how the technology can improve<br />
outcomes and lower costs; and 4) how to overcome clinical, regulatory and reimbursement hurdles.<br />
Wearable medical devices are defined as devices with sensors attached to the body that detect and monitor<br />
changes in body signatures of various areas, systems and organs.<br />
Moderator:<br />
Mark Kemp, President, Flex<br />
Panelists:<br />
Christian Stemmel, Founder and CEO, Wearables Technologies<br />
Nathan A. Brown, Partner, Akin Gump Strauss Hauer & Feld LLP<br />
Other Industry Experts<br />
The New Frontier of FDA & FCC Oversight and Innovative Medical Devices<br />
Monday, October 5<br />
2:30 pm - 3:45 pm<br />
Room: 10 Upper<br />
As the U.S. embraces the possibilities of innovative medical devices, the need to ensure wireless and mobile<br />
communications also must be addressed. The FCC and FDA have been working together to come up with an<br />
appropriate regulatory framework that addresses the needs of both regulated industry as well as the U.S.<br />
consumer. Mobile health is tremendously important wherever direct access to health care is limited. Some<br />
factors affecting rural areas include limited access to health care facilities because of location, not to mention the<br />
inability to secure adequate means of transportation to traditional health care areas. Devices that use wireless<br />
and mobile communication require a level of regulatory oversight to ensure that these secure mobile health<br />
devices protect individual privacy, civil liberties and security of personal information. At the same time, FDA<br />
has a public health responsibility to oversee the safety and effectiveness of medical devices. It is evident that<br />
FDA (through its recent publication of various guidance documents) encourages the development of innovative<br />
products, while also trying to balance where the regulatory line lies in order to safeguard public health.<br />
Moderator:<br />
Sonali Gunawardhana, Of Counsel, Wiley Rein LLP<br />
Panelists:<br />
Scott Delacourt, Partner, Wiley Rein LLP<br />
Michael Gibbons, Federal Communications Commission<br />
Robert Jarrin, Senior Director, Qualcomm Inc.<br />
Bakul Patel, Associate Director for Digital Health, FDA<br />
FINAL PROGRAM | 39
The Hidden Life of Devices: Cybersecurity and Embedded Medical Devices<br />
Monday, October 5<br />
4:00 pm - 5:15 pm<br />
Room: 10 Upper<br />
This panel will dive into the hidden life of modern and connected medical devices that include an increasing<br />
array of features that can be intentionally or unintentionally misused. It will then explore the impacts of<br />
cybersecurity risks in medical devices and ways that companies may more effectively assess, manage and<br />
mitigate such risks to systems, data and devices. The panel will address:<br />
Recognizing traditional and non-traditional vulnerabilities and risks in embedded medical devices;<br />
• Understanding direct and indirect impacts of poor security in a medical device;<br />
• Applying a cybersecurity risk framework to help with risk management; and,<br />
• Building an effective cybersecurity team with participation from device developers, product designers<br />
and Quality Assurance.<br />
Moderator:<br />
Melissa Masters, Director, DeviceSecure Services and Manager, Electrical Software and Systems Engineering, Battelle<br />
Panelists:<br />
Debra Breummer, Manager, Clinical Information Security, Mayo Clinic<br />
Mike Seeberger, Principal Systems Engineer, Boston Scientific<br />
Bakul Patel, Associate Director for Digital Health, FDA<br />
Billy Rios, Founder, Laconicly LLC<br />
Emerging & Early-Growth Company Issues Track<br />
Sponsored by<br />
Improving Adoption Utilizing Human-Centered Design for Commercialization<br />
& Innovation<br />
Tuesday, October 6<br />
4:00 pm - 5:15 pm<br />
Room: 10 Upper<br />
Learn new tools and perspectives on how companies, such as GE Healthcare and Merck, have successfully<br />
achieved product adoption, growth, market acceleration and ROI with solutions that resonate with users through<br />
a human-centered design approach. Employing design thinking, early and throughout the strategic planning<br />
process, encourages cross-departmental innovation and fosters development of value–added solutions and market<br />
opportunities based on unmet user needs. It mitigates risk by developing hypotheses from a user/ patient-centric view<br />
in which concepts are then tested and validated through an iterative process. A positive user experience offers a key<br />
competitive advantage and increased brand value. We will discuss how to take human-centered design to a new level,<br />
along with opportunities to increase ROI through the introduction of emotion and empathy into medical products.<br />
We’ll also explore case studies of global health care products that have effectively employed such methods.<br />
Moderator:<br />
Gunnar Trommer, Ph.D., Principal, BCG Digital Ventures<br />
Panelists:<br />
Andrew P. Miller, Ph.D., Founder and Chief Executive Officer, NAT Diagnostics, Inc<br />
Chuck Pelly, Chief Creative Officer, Intersection-Inc.<br />
Robert (Bob) T. Schwartz, General Manager, Global Design & User Experience, GE Healthcare<br />
40 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
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PROGRAM | 41
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AdvaMed goal to<br />
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through earlier disease<br />
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effective treatments.<br />
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42 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
The Role of Local Innovation Ecosystems in Bringing Complex Medical<br />
Devices to Market<br />
Wednesday, October 7<br />
9:15 am - 10:30 am<br />
Room: 10 Upper<br />
Technology advancements in clinical research can deliver needed enhancements and significant medical<br />
device innovation. The translation to practical treatments that can be replicated and delivered in hospitals,<br />
at medical centers and in the home require significant know-how and collaboration between the engineers<br />
and/or scientists and the funding entity/emerging company. But the analytical validation, clinical validation<br />
and clinical utility of any device requires design, development, manufacturing, service and operational<br />
procedures of the highest standards. In addition, fledgling companies must balance financing and business<br />
requirements. This panel will explore more successful innovation processes and roles an effective local<br />
ecosystem can play in bringing complex medical devices to market, while adhering to proven product<br />
lifecycle processes and quality requirements. Case studies from across the U.S. will be highlighted as we<br />
explore best practices in the current early stages of the MedTech ecosystem – and regional cultures of<br />
innovation that have evolved.<br />
Moderator:<br />
Caren Mason, President and CEO, STAAR Surgical Company<br />
Panelists:<br />
Dottie Clower, Chief Scientific Officer, Cohera Medical<br />
Erol Erturk, Director, Research and Development, D & K Engineering<br />
John Watson, Emeritus Professor, Bioengineering & Director Advanced Study Program in Medical Device<br />
Engineering, UC San Diego<br />
Tiffany Wilson Karp, Executive Director, Global Center for Medical Innovation<br />
Leadership Dynamics That Drive Better Business Results 2.0<br />
Wednesday, October 7<br />
11:00 am - 12:15 pm<br />
Room: 10 Upper<br />
Building on the success of last year’s panel, we are bringing it back for a more in-depth look with a brand<br />
new, all-star CEO panel. This session will focus on leadership challenges in the MedTech industry for<br />
emerging and early-growth companies, including: 1) Building and sustaining relevant boards – creating<br />
the right balance with experienced board members, scientific advisors, investors and business leaders; 2)<br />
Executive leadership – juggling scientific, regulatory and business demands; 3) Leadership requirements<br />
through each phase of the company’s product lifecycle; and, 4) Human resources dynamics – the need to<br />
build scientific leaders sooner rather than later to minimize personnel issues. This expert panel will impart<br />
inspiring anecdotes from their personal experiences in leading top companies, as well as key takeaways that<br />
can be implemented immediately. You don’t want to miss it!<br />
Moderator:<br />
Gaylene Xanthopoulos, President, The Leadership Edge<br />
Panelists:<br />
Darrel Drinan, President and CEO, PhiloMetron, Inc<br />
John Kilcoyne, President & CEO, ReVision Optics ® , Inc.<br />
Mike Oliver, President and CEO, Spectra Science<br />
Cary Vance, President & CEO, Hansen Medical, Inc.<br />
FINAL PROGRAM | 43
In Vitro Diagnostics Track<br />
Leadership Views on the Future of Diagnostics<br />
Tuesday, October 6<br />
9:15 am - 10:30 am<br />
Room: 11A Upper<br />
This panel will convene leaders in the diagnostics field to discuss how advances in technology and business<br />
models are transforming the role of diagnostics in health care. Panelists will address the business and<br />
health care implications of such topics as technology convergence and wearable and implantable sensors,<br />
the expansion of rapid point of care testing, patient-directed testing, big data and the rise of genomics and<br />
precision medicine.<br />
Moderator:<br />
Andrew Fish, Executive Director, AdvaMedDx<br />
Panelists:<br />
Grant Campany, Senior Director, Qualcomm Tricorder XPRIZE and Nokia Sensing XCHALLENGE<br />
Drew Hall, Ph.D., Asst. Professor, Electrical and Computer Engineering, Jacobs School of Engineering, UC San Diego<br />
Brad Kittredge, Vice President, Product Development, 23andMe<br />
Thomas McClain, CEO, Exosome Diagnostics<br />
The Future is Now: Harnessing Innovation and Public Health Through Risk-Based<br />
Oversight of Diagnostics<br />
Tuesday, October 6<br />
11:00 am - 12:15 pm<br />
Room: 11A Upper<br />
Diagnostics are a cornerstone of modern health care and critical to a personalized and effective health<br />
care system. FDA took a critical step in moving to implement risk-based oversight of laboratory developed<br />
tests. What does risk-based regulation of all diagnostics mean? Are additional changes being considered<br />
to support timely access to high quality diagnostic innovations for patients and health care professionals?<br />
This panel will discuss perspectives on the latest hot topics in the diagnostic regulatory landscape,<br />
including companion diagnostics, precision medicine and next generation sequencing and Congressional<br />
developments. We will also discuss opportunities and challenges unique to diagnostic technologies.<br />
Moderator:<br />
Shamiram Feinglass, Vice President, Medical and Regulatory Affairs, Danaher Corporation<br />
Panelists:<br />
Jeff Allen, Executive Director, Friends of Cancer Research<br />
Alberto Gutierrez, Director, Office of In Vitro Diagnostics and Radiological Health, FDA<br />
Debra Rasmussen, Senior Director, Regulatory Affairs, Johnson & Johnson<br />
44 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
How Novel Diagnostics Are Changing the Health Care Value Proposition<br />
Tuesday, October 6<br />
2:15 pm - 3:30 pm<br />
Room: 11A Upper<br />
In today’s fast-paced and ever-evolving health care environment, multiple forces are converging that<br />
impact coverage and payment policy. Driven by health care reform, movement toward alternative care and<br />
payment models and value-driven payments, these changing forces point toward the need for more rational<br />
use of resources and targeted application of interventions. The role of diagnostics can fall squarely in the<br />
center of health care delivery. As interest in precision medicine grows, stakeholders must rethink existing<br />
health care delivery and payment models and consider systems of care rather than individual therapies or<br />
tests on their own. Clear evidence of clinical and economic value is needed in order for all stakeholders,<br />
including diagnostics manufacturers, payers, clinicians and others, to overcome barriers to innovative tests<br />
that can delay modern diagnostic and treatment pathways. This panel will bring together payers, diagnostic<br />
innovators and policy experts to discuss specific examples of diagnostic-driven health care and to tackle the<br />
barriers that currently stand in the way of widespread adoption. Panelists will also discuss who should pay<br />
for the evidence needed to support the value proposition for innovative diagnostic technologies and how<br />
new partnerships can benefit all stakeholders by improving health care delivery as well as quality of care.<br />
Moderator:<br />
Susan Garfield, Principal, Advisory Services, EY<br />
Panelists:<br />
Eric Faulkner, Practice Lead, Quintiles<br />
Nick Poulios, Ph.D., PhM, Head of MORE - Medical Outcomes - Reimbursement & Economics, Roche<br />
Molecular Systems, Inc<br />
Tamara Syrek Jensen, Director, Coverage and Analysis Group, Center for Medicare & Medicaid Services<br />
Conducting Global IVD Clinical Trials to Support U.S. and International Markets<br />
Tuesday, October 6<br />
4:00 pm - 5:15 pm<br />
Room: 11A Upper<br />
Conducting global IVD clinical trials to support U.S. and international markets can be very challenging from a<br />
regulatory and clinical perspective. The experts on this panel will discuss:<br />
• Best practices in managing IVD clinical studies;<br />
• How to find good quality clinical sites and testing labs;<br />
• New developments in the U.S., E.U. and beyond;<br />
• Managing expectations through conversations with regulators; and<br />
• Discussion of mechanisms to obtain reimbursement for IVD in OUS markets.<br />
Moderator:<br />
Susan Rockwell, M.Ed., Senior Director, Global Medical Device Business Development, Medical Device &<br />
Diagnostics Research, ICON plc<br />
Panelists:<br />
Deborah Kurtock, CRO Manager, Roche Diagnostics<br />
Robin Newman, MSN, CPNP, CCRA, RAC, Vice President, Quality Management, Siemens Healthcare<br />
Diagnostics, Inc.<br />
Paula Wittels, Programme Director, Translucency Ltd<br />
FINAL PROGRAM | 45
International Track<br />
Sponsored by<br />
E.U. Medical Device Directives Update<br />
Monday, October 5<br />
1:00 pm - 2:15 pm<br />
Room: 11A Upper<br />
The E.U. is in the process of revising its regulations for medical devices and diagnostics, with early 2016<br />
expected to be a pivotal period for the E.U.’s three governmental entities (the Commission, Parliament and<br />
Council) to establish provisions of these regulations. The MedTech Conference offers a robust panel ripe<br />
with the latest information on the legislative process and changes likely to occur. This panel will include<br />
experts from the Commission, industry and notified bodies.<br />
Moderator:<br />
Erik Vollebregt, Partner, Axon Lawyers<br />
Panelists:<br />
Andre-Michel Ballester, Chief Executive Officer, Sorin SpA<br />
Gert Bos, Head of Regulatory and Clinical Affairs, BSI<br />
Niall MacAleenan, The Health Products Regulatory Authority (invited)<br />
Tendering: Best Practices<br />
Monday, October 5<br />
2:30 pm - 3:45 pm<br />
Room: 11A Upper<br />
AdvaMed 2015: The MedTech Conference will be the culmination in a series of conferences (Toronto,<br />
Barcelona, Beijing) where AdvaMed Global is addressing the issue of tending with international experts<br />
and developing a set of best practices for publication. This panel will explore many of the key current<br />
global issues being faced in tendering, including those in both mature and emerging markets. It will inform<br />
regarding solutions that are the result of recent trends toward a more progressive and comprehensive<br />
discussion on MedTech value. The panel will discuss mechanisms for ensuring that value and innovation<br />
are maintained and balanced in public tenders for medical technology. Case studies will illustrate how this<br />
approach can be successfully implemented to enhance value.<br />
Moderator:<br />
Jim Southwick, Vice President, Global Government Affairs, Medtronic plc<br />
Panelists:<br />
Diomedes Berroa, SR Procurement Specialist, World Bank<br />
Joao Costa, Legal Counsel, Medtronic, Portugal<br />
Paul Davis, Program Director for the MSc in Strategic Procurement and the MSc in International<br />
Management, Dublin City University (invited)<br />
Iris Ko, Director, Strategic Policy and Innovation, Ministry of Government Services, Ontario, Canada (invited)<br />
Giuseppe Turchetti, Full Professor of Economics, Institute of Management, Scuola Superiore Sant’Anna, Pisa<br />
46 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
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FINAL PROGRAM | 47
Making connections<br />
in health care transformation<br />
The health care system is transforming, opening the door for MedTech organizations to<br />
innovate and create meaningful solutions along the patient journey. In this time of<br />
change, MedTech executives may face complex questions:<br />
• How should we adapt our business model to focus on exponential technologies?<br />
• How do we define innovation in a new way that captures value for our patients and<br />
shareholders?<br />
• Should we build capabilities, or partner or buy?<br />
Deloitte brings insights and experience from across the health care ecosystem to help<br />
MedTech organizations stay ahead of the health care transformation, innovate, and<br />
make new connections.<br />
Learn more at: www.deloitte.com/lifesciences<br />
Join our discussion: @DeloitteHealth<br />
Contact: Glenn Snyder<br />
Medical Technology Segment Lead, Deloitte Consulting LLP<br />
+1 415 699 4469 or gsnyder@deloitte.com<br />
As used in this document, “Deloitte” means Deloitte Consulting LLP, a subsidiary of Deloitte LLP. Please see www.deloitte.<br />
com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries. Certain services may not be<br />
available to attest clients under the rules and regulations of public accounting.<br />
Copyright © 2015 Deloitte Development LLC. All rights reserved.<br />
Member of Deloitte Touche Tohmatsu Limited.<br />
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48 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
Global Health Economics: Trends in Health Technology Assessments and<br />
Reimbursement<br />
Monday, October 5<br />
4:00 pm - 5:15 pm<br />
Room: 11A Upper<br />
Medical technology companies are under growing pressure to provide health economic evaluations of<br />
their products, particularly in developed markets in Europe and Asia. With varying criteria by country and<br />
the payer demands for larger bodies of evidence to demonstrate value, health technology assessment can<br />
be a significant barrier to reimbursement and market entry in countries outside of the U.S. Understanding<br />
core market reimbursement archetypes and how decision-makers evaluate and pay for novel technologies<br />
is critical for evidence development and commercial planning, especially for small companies. A panel of<br />
global health economics and outcomes research experts and a successful small company executives will<br />
present their experiences of reimbursement through health technology, discuss the best way of undertaking<br />
cost-effectiveness analysis and how to prepare for reimbursement negotiations, including practical advice<br />
on when to start and the minimum requirements for successful reimbursement submissions.<br />
Moderator:<br />
Betsy Lahue, Worldwide Vice President Health Economics and Outcomes Research, Becton Dickinson<br />
Panelists:<br />
Mark Cook, Director Reimbursement & Government Affairs, Medtronic<br />
Mirella Marlow, Programme Director - Devices and Diagnostics Systems, National Institute for Health and<br />
Care Excellence<br />
Iain McDougall, CEO, Taragenyx ltd.<br />
Key Health Policies Track<br />
New Advances in Managing Chronic Disease<br />
Wednesday, October 7<br />
9:15 am - 10:30 am<br />
Room: 11A Upper<br />
The data behind the impact of chronic disease is staggering and proof of an epidemic that desperately<br />
needs to be addressed. Chronic disease costs the U.S. more than $1 trillion annually and accounts for<br />
every $3 of $4 spent on health care. Chronic diseases such as heart disease, diabetes and cancer are the<br />
leading causes of disability and death. New advances in managing chronic disease are critical to combat the<br />
alarming financial and human costs. Panelists representing industry, academic, public health and provider<br />
perspectives will explore how innovation and technological advances can change the future outlook of<br />
chronic illness through existing technologies and real-world scenarios from the community.<br />
Moderator:<br />
Jay Keese, Legislative Director, Partnership to Fight Chronic Disease<br />
Panelists:<br />
Phillip B. Adamson, M.D., Director and Vice President for Medical Affairs, St. Jude Medical<br />
Christopher R. Burrow, M.D., EVP Medical Affairs, Humetrix<br />
Bernadette Mazurek Melnyk, Ph.D., RN, CPNP/PMHNP, FAANP, FNAP, FAAN, Associate Vice President for<br />
Health Promotion, University Chief Wellness Officer, Dean and Professor, College of Nursing, Professor of<br />
Pediatrics and Psychiatry, College of Medicine, The Ohio State University<br />
FINAL PROGRAM | 49
Bedside Connections: Interoperability Advances in Washington, D.C.<br />
Wednesday, October 7<br />
11:00 am - 12:15 pm<br />
Room: 11A Upper<br />
As electronic health record interoperability takes center stage in health IT policy circles, where do connected<br />
medical devices fit in the regulatory landscape? Join leaders from the U.S. Food and Drug Administration,<br />
the Office of the National Coordinator for Health IT and the West Health Institute as they discuss the future<br />
of interoperable, connected care at the bedside. Will FDA issue guidance on medical device interoperability?<br />
Will medical device interoperability be federally mandated? What do hospitals want to see in the new<br />
systems and devices they will be purchasing, and how is the industry responding? Hear answers to these<br />
questions and more in this informative panel of industry and regulatory leadership about the future of highquality,<br />
low-cost, connected health care.<br />
Moderator:<br />
Joe Smith, M.D., Ph.D., Chief Science and Medical Officer, West Health and West Health Institute<br />
Panelists:<br />
Joe Kiani, Founder, Chairman and CEO, Masimo Corporation<br />
Kerry McDermott, Vice President, Public Policy & Communications, Center for Medical Interoperability<br />
Bakul Patel, Associate Director for Digital Health, FDA<br />
Legal<br />
Scientific Exchange: Interpreting the Available Guidance Regarding<br />
Dissemination of Data Regarding Off-Label Uses of Medical Devices<br />
Monday, October 5<br />
1:00 pm - 2:15 pm<br />
Room: 9 Upper<br />
This panel will explore FDA’s Draft Guidance on the dissemination of information regarding off-label uses<br />
and discuss the specific challenges faced by medical device companies, recent device-specific enforcement<br />
activities focused on alleged off-label promotion and provide practical guidance to manage field sales and<br />
medical activities to reduce potential exposure in this area.<br />
Moderator:<br />
Jaime Jones, Partner, Sidley Austin LLP<br />
Panelists:<br />
Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom<br />
Sandra Cohen Kalter, Vice President and Chief Regulatory Counsel, Medtronic<br />
Eve Ross, J.D., Public Policy + Strategy, W.L. Gore and Assoc., Inc<br />
Lauren R. Silvis, Deputy Center Director for Policy, Office of the Center Director, CDRH, FDA<br />
50 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
Anti-Corruption in the Life Sciences - Trends in Emerging Markets<br />
Monday, October 5<br />
2:30 pm - 3:45 pm<br />
Room: 9 Upper<br />
The United States and foreign enforcement authorities continue to aggressively pursue life sciences<br />
companies for violations of anti-corruption laws, including the FCPA, UK Bribery Act and other local bribery<br />
laws. The emerging markets (e.g., Russia, China, India and Latin America) provide unique bribery and anticorruption<br />
challenges in an industry already facing specific risks based on the extensive use of third parties<br />
and regular contact with government officials. This panel will address:<br />
• Anti-corruption and bribery enforcement trends in the life sciences industry;<br />
• Risks specific to the life sciences industry;<br />
• Unique challenges faced in emerging markets; and<br />
• Compliance best practices for minimizing risk when operating in emerging markets.<br />
Panelists:<br />
Colleen A. Conry, Partner, Ropes & Gray LLP<br />
John Kelly, Member, Bass Berry & Sims PLC<br />
Adam Morris, Sr. Legal Counsel, Global Investigations, Medtronic<br />
Leo Tsao, Assistant Chief, Fraud Section, Department of Justice, Criminal Division<br />
MedTech & the Economy: Spotlight on San Diego<br />
Medical Technology Needs of our Active Warriors and Veterans<br />
Monday, October 5<br />
1:00 pm - 2:15 pm<br />
Room: 11B Upper<br />
This panel will explore how the Medical Technology industry can best meet the needs of health care<br />
customers within the Department of Veterans Affairs and the Department of Defense. The discussion will<br />
explore how the unique needs of military and veteran patients can be met through innovation in industry,<br />
how MedTech companies can meet and overcome challenges to best serve the VA/DOD health care space,<br />
and how the MedTech industry can benefit by bringing veterans into the corporate workforce.<br />
Moderator:<br />
Mike Grice, LtCol USMC (Retired), Chief Operating Officer, MedTech and BioTech Veterans Program<br />
Panelists:<br />
Jeff Bruno, Vice President Strategic Accounts - Federal Government, CareFusion Corporation<br />
Jeffrey T. Gering, FACHE, Director, VA San Diego Healthcare System<br />
William Howell, Former Deputy Commander for Acquisition, Senior Executive Service, US Army Medical<br />
Research and Materiel Command<br />
Michael Minogue, Chairman, President and Chief Executive Officer, ABIOMED, Inc.<br />
FINAL PROGRAM | 51
Best Practices Developed by Leading Medical Technology Companies in the<br />
CaliBaja Region<br />
Wednesday, October 7<br />
9:15 am - 10:30 am<br />
Room: 11B Upper<br />
Welcome to San Diego, one of the world’s leading innovation and life science clusters. Welcome also to the<br />
CaliBaja Bi-National Mega-Region, a region that combines the benefits of world-class Southern Californiabased<br />
research with globally competitive Mexico-based manufacturing in a concentrated two nation area<br />
at the crossroads to North and South America and the Pacific Rim markets. The Calibaja region is home to<br />
significant U.S. and foreign medical device, diagnostic, digital, genomic discovery as well as manufacturing<br />
companies and facilities. Many companies operate facilities on both sides of the border, yet many others<br />
are found exclusively in San Diego or Mexico. What lessons have we learned from dealing with, cross border<br />
management and logistics? Join us for a lively discussion as this panel that includes executives from several<br />
successful companies operating in the region will discuss manufacturing process adaptations, FDA and<br />
COFERIS compliance, quality assurance, U.S. Customs clearance, regulatory issues and other critical topics to<br />
our industry.<br />
Moderator:<br />
Riccardo Butta, General Manager and Global VP, Flex (invited)<br />
Panelists:<br />
Mario Cervantes, VP North American Infusion Disposables Manufacturing, CareFusion<br />
Gerardo de la Concha, VP Mexico Operations, Medtronic<br />
Antonio Gonzalez, VP of Operations, Greatbatch<br />
Hector Marquez, DJO Global<br />
Payment & Health Care Delivery Track<br />
Quality of Life Products in the Value-Based Care Landscape<br />
Tuesday, October 6<br />
9:15 am - 10:30 am<br />
Room: 11B Upper<br />
Quality of life products are designed to enable patients to live healthier, safer and more functional lives<br />
despite otherwise life-altering effects from medical conditions or treatments. These products play a critical<br />
role in returning patients to vibrant and active lives and allow them to resume their place as contributing<br />
members of society. Despite this, payment models typically do not treat coverage and reimbursement for<br />
these products as essential. This panel will explore challenges impacting coverage and payment for quality<br />
of life technologies and their place in the new value and evidence-focused payment hierarchy.<br />
Moderator:<br />
Bruce Japsen, Reporter, Forbes<br />
Panelists:<br />
Joseph Chin, Acting Deputy Director, Coverage and Analysis Group, Centers for Medicare & Medicaid Services<br />
Camille Farhat, President & CEO, AMS<br />
Jo Carol Hiatt, MD, MBA, FACS, Chair of the National Product Council, Kaiser Permanente<br />
Joseph Rolley, Vice President, Global Market <strong>Access</strong>, ConvaTec Inc.<br />
52 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
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Improving <strong>Access</strong> to Innovation Under Health Reform<br />
Tuesday, October 6<br />
11:00 am - 12:15 pm<br />
Room: 11B Upper<br />
The triple aim of health reform is well understood and widely entrenched: to reduce costs, optimize individual<br />
patient care and improve the population’s health. Striking the appropriate balance among these three goals<br />
remains a challenge for policymakers, payers, providers and industry. One particular concern is ensuring<br />
access to innovative technologies to all who may benefit from them, while keeping health care spending in<br />
check. This session will explore deficiencies under current reimbursement systems in ensuring patient access<br />
to new technologies and generate discussion around potential solutions to the following issues:<br />
• Traditional fee-for-service payment systems provide a fixed payment per stay and incentivize hospitals<br />
to reduce costs per encounter, without regard to long-term value of a technology. Additionally,<br />
Medicare’s New Technology Add-On Payment fails to facilitate access as intended;<br />
• New payment and delivery reform models, such as ACOs, shift providers’ focus to improving patient care<br />
and controlling costs more longitudinally. However, use of historical spending benchmarks that do not<br />
account for innovation over time creates barriers to providers adopting promising new technologies; and<br />
• Risk-sharing arrangements between manufacturers and payers hold theoretical promise to ensure<br />
access for new products in order for their value to be demonstrated on a long-term basis, but<br />
challenges persist in their operationalization.<br />
Moderator:<br />
Nancy McGee, Executive Vice President, Avalere Health<br />
Panelists:<br />
Sheila Fifer, Ph.D., Senior Advisor, The Network for Excellence in Health Innovation<br />
John Hernandez, Vice President, Health Economics and Outcomes Research, Abbott Vascular<br />
Jo Carol Hiatt, MD, MBA, FACS, Chair of the National Product Council, Kaiser Permanente<br />
FINAL PROGRAM | 53
Evolution of U.S. Hospital Landscape and Implications for MedTechs<br />
Tuesday, October 6<br />
2:15 pm - 3:30 pm<br />
Room: 11B Upper<br />
Hospital systems are under cost and margin pressures and are taking on several measures to survive. They are<br />
consolidating with other hospitals to improve leverage on payers and suppliers, integrating with non-acute facilities to<br />
access referrals and enable improved coordination of care, taking on greater accountability in order to benefit from<br />
and showcase improved outcomes and centralizing/coordinating their supply chains to become more standardized<br />
and efficient. These measures have major implications for suppliers. Firstly, consolidation and integration is leading to<br />
fewer large customers for MedTechs. This means that suppliers will need to retool their commercial infrastructures<br />
to increase focus on key decision makers (i.e., increasingly economic buyers) among the largest systems. In addition,<br />
as many of the leading hospital systems are trying to strategically integrate across the care continuum (e.g., physician<br />
offices, ASCs, long-term care facilities) and take on greater levels of accountability, suppliers need to develop and offer<br />
solutions and approaches to support these efforts. This includes providing broader portfolios and service lines. Finally,<br />
suppliers will need to offer more robust value propositions with greater emphasis on economic costs/benefits, not just<br />
clinical benefits, to win the right to be chosen as preferred partners to leading systems.<br />
Moderator:<br />
Jonas Funk, Managing Director, L.E.K. Consulting<br />
Panelists:<br />
Jamie Condie, President, US Region, Becton Dickinson<br />
John Kuzmishin, Chief Financial Officer, University of Pittsburgh Medical Center<br />
Super Session<br />
(EEGC, Payment & Health Care Delivery and Technology & Regulation Tracks)<br />
Walking the Tightrope – Titrating Evidentiary Requirements for Regulatory &<br />
Reimbursement for Medical Devices<br />
Tuesday, October 6<br />
4:00 pm - 5:15 pm<br />
Room: Ballroom 6F<br />
The recent FDA announcement on the Expedited <strong>Access</strong> PMA Approval process for medical devices was received<br />
with mixed feedback. Manufacturers, particularly smaller companies, welcomed that FDA was considering moving<br />
the burden of clinical data collection to post-market registries and studies, thus reducing the extent of required preapproval<br />
studies. Unlike manufacturers, payers demonstrated a less enthusiastic response. They have raised questions<br />
on the clinical usefulness of devices that are yet to obtain data post-market. More recently, Center for Medicare and<br />
Medicaid Services (CMS) has increasingly hinted at using coverage with evidence development (CED) as a measure<br />
to cover devices when the data may not be complete and if burden shifts to post-market. During this session, we will<br />
also explore general coverage challenges companies are currently encountering and the importance of considering<br />
evidentiary requirements for both regulatory and reimbursement purposes early in new technology development.<br />
Moderator:<br />
Lakshman Ramamurthy, Vice President, Avalere Health<br />
Panelists:<br />
Perry Bridger, Vice President, Reimbursement & Public Policy, Edwards Lifesciences<br />
Harith Rajagopalan, M.D., Ph.D., CEO, Fractyl Inc.<br />
Jeff Shuren, Director, Center for Devices and Radiological Health, FDA<br />
Tamara Syrek-Jensen, Director, Coverage & Analysis Group, Centers for Medicare & Medicaid Services<br />
54 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
For us, every<br />
innovation<br />
starts with<br />
a human<br />
inspiration<br />
At Edwards Lifesciences, everything we do comes from a<br />
very human place. We’re driven by a passion to help restore<br />
patients’ lives. And empower the caring clinicians who treat<br />
them. Together, they inspire us to create medical technologies<br />
that transform care in structural heart disease and<br />
critical care monitoring.<br />
Innovation is what we do. Humanity is why we do it.<br />
To learn more about Edwards Lifesciences visit us at www.edwards.com<br />
Edwards, Edwards Lifesciences, and the stylized E logo are trademarks of Edwards Lifesciences Corporation.<br />
© 2013 Edwards Lifesciences Corporation.<br />
All rights reserved. AR10345<br />
Edwards Lifesciences | edwards.com<br />
One Edwards Way | Irvine, California 92614 USA<br />
Switzerland | Japan | China | Brazil | Australia | India<br />
FINAL PROGRAM | 55
13 of the top 15 medical<br />
device manufacturers *<br />
use TrackWise ® for their<br />
quality and compliance needs.<br />
Visit us at booth #412 to learn more.<br />
*2014 Internet Medicine Digital Healthcare’s top 40 Medical Device Companies.<br />
Enterprise Quality Management Solutions<br />
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©2015 Sparta Systems, Inc. All Rights Reserved.<br />
Advancing Care.<br />
Reducing Complications.<br />
Minimizing Costs.<br />
Improving patient outcomes. Reducing healthcare costs. Learn how at angiodynamics.com<br />
AngioDynamics and the AngioDynamics logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or a subsidiary. © 2015 AngioDynamics, Inc. MLC 676 US Rev A<br />
PROUD SPONSOR<br />
AdvaMed 2015<br />
The MedTech Conference<br />
56 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
Quality Track<br />
Sponsored by<br />
Case for Quality 2015 – CDRH-Industry Update<br />
Tuesday, October 6<br />
9:15 am - 10:30 am<br />
Room: 9 Upper<br />
This panel will provide up-to-the-minute presentations from both the CDRH Office of Compliance head and<br />
ORA division head, as well as industry leaders as to how FDA will implement this crucial Case for Quality<br />
initiative. Great strides have been made over the past year, including the improvement and expansion of the<br />
Library of Successful Quality Practices posted on the AdvaMed website. This interactive panel will include<br />
FDA slide presentations and industry/audience dialog.<br />
Moderator:<br />
Judith K. Meritz, Associate General Counsel, Covidien<br />
Panelists:<br />
Jeff Fecho, VP Global Quality, St. Jude Medical<br />
Kim Lewandowski-Walker, ORA National Expert Investigator, FDA<br />
Bill MacFarland, Director, Division of Enforcement B, Office of Compliance, FDA<br />
Marla A. Phillips, Ph.D., Director, Xavier Health, Xavier University<br />
Joe Sapiente, V.P. Quality Operations, Covidien<br />
Single Audit Program<br />
Tuesday, October 6<br />
11:00 am - 12:15 pm<br />
Room: 9 Upper<br />
This panel will focus on global manufacturing site inspections, the Medical Device Single Audit program<br />
(MDSAP) and how this program is being implemented in participating countries, with particular focus on<br />
the U.S. and Japan. Learn how the MDSAP can help you streamline external quality system audits (also<br />
accepted by Australia, Brazil, and Canada). Gain insights around how FDA and MHLW will accept MDSAP<br />
Audits as routine inspections. Panelists will discuss how MDSAP is working to assist in achieving regulatory<br />
convergence, what is going well and areas needing improvement.<br />
Moderator:<br />
Pamela J. Weagraff, MBA, RAC, Director and Group Lead, Quintiles Advisory Services<br />
Panelists:<br />
Hideyuki Kondo, Deputy Director, Ministry of Health, Labour and Welfare, Japan<br />
Kimberly A Trautman, Associate Director, International Affairs, FDA<br />
FINAL PROGRAM | 57
Technology & Regulation Track<br />
Sponsored by<br />
The Role of Medical Devices in Pediatrics and Rare Diseases<br />
Monday, October 5<br />
4:00 pm - 5:15 pm<br />
Room: 9 Upper<br />
Innovation in medicine is driven by market forces. The demand for medical devices in pediatric patients and<br />
those with rare diseases does not cover expensive R&D investments necessary for medical device companies<br />
to develop these technologies. The result is a treatment gap for patients who need medical devices, such as<br />
heart valves. In 2007, Congress passed the Pediatric Medical Device Safety and Improvement Act, allowing<br />
FDA to offer grants to stimulate the development of pediatric devices. While the agency has provided more<br />
than $11 million in grants, and continues to do so, the development of medical devices for children lags<br />
behind device development for adults. Using off-label devices for children presents a bevy of challenges,<br />
but is practiced in many specialties, particularly in interventional cardiology and orthopedics with stents,<br />
defibrillators and metal implants. This panel will explore the unique challenges of developing, evaluating and<br />
bringing to market devices intended for patients with rare diseases and pediatric use so that improvements<br />
barriers can be eradicated and more health conditions can be properly addressed.<br />
Moderator:<br />
Jodi Lemacks, National Program Director, Mended Little Hearts<br />
Panelists:<br />
Charles I. Berul, M.D., Chief, Division of Cardiology, Children’s National Medical Center<br />
Mark D. Carlson, M.D., M.A., Chief Medical Officer & Vice President, St. Jude Medical<br />
Eric Chen, Director, Humanitarian Use Device Program, FDA/Office of Orphan Products Development<br />
Integrating Patient Perspectives into the Medical Device Regulatory Process<br />
Tuesday, October 6<br />
2:15 pm - 3:30 pm<br />
Room: 9 Upper<br />
Since 2012, CDRH Benefit-Risk Guidance recommended that sponsors interact with FDA staff regarding<br />
the development of patient-centered risk-benefit information. There has been increased interest in<br />
understanding validated methods and tools for collecting patient preference information and how sponsors<br />
should collect and present that information to CDRH. As sponsors seek to include patient preference<br />
information in regulatory submissions there is a clear need to improve the methods to collect and present<br />
validated patient-centered benefit-risk information. This panel will discuss a framework developed by a<br />
government/industry/patient public-private partnership to help regulators consider the patient perspective<br />
on the benefits and risks of medical devices. In order to properly take patient preferences into account,<br />
regulators must have reliable and accurate methods, tools and approaches to capture and analyze the<br />
information. The framework includes factors to consider when incorporating patient preferences into<br />
regulatory submissions, a catalog of patient preference assessment methods and considerations for<br />
incorporating patient preference across the product lifecycle. This may prove to be an important new tool<br />
promoting robust patient-centered benefit-risk assessment in regulatory submissions.<br />
58 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
Moderator:<br />
Michelle McMurry-Heath, M.D., Ph.D., WW Vice President, Regulatory Affairs Medical Devices &<br />
Diagnostics, Johnson & Johnson<br />
Panelists:<br />
Ross A. Jaffe, M.D., Managing Director, Versant Ventures, Director, National Venture Capital Association<br />
(NVCA), MDIC Board Member<br />
Kathryn M. O’Callaghan, Associate Center Director for Science and Strategic Partnerships (Acting), FDA<br />
Center for Devices & Radiological Health (CDRH)<br />
Bray Patrick-Lake, MFS, Director of Stakeholder Engagement, Clinical Trials Transformation Initiative<br />
Promoting Innovation in the U.S.: FDA’s Early Feasibility Studies<br />
Tuesday, October 6<br />
5:15 pm - 6:30 pm<br />
Room: 9 Upper<br />
Historically, many companies have gone off-shore for First in Human (FIH) Studies and have gone after<br />
approval in the E.U. before coming to the U.S. The U.S. FDA is looking to promote more innovation in the<br />
United States and has launched the Early Feasibility Studies (EFS) Program to allow for FIH studies in the U.S.<br />
and potentially fast-tracking the time to market for U.S. companies. This panel would provide experiences<br />
on this pathway from FDA perspective as well as from large and small medical device companies about how<br />
to use this pathway for success in accelerating products to the U.S. market.<br />
Moderator:<br />
Seth Goldenberg, Ph.D., Director, Product Development Strategy, NAMSA<br />
Panelists:<br />
Owen Faris, Ph.D., Clinical Trials Director (acting), Office of Device Evaluation, CDRH, FDA<br />
Sean C. Morris, Chief Executive Officer, Pulse Therapeutics<br />
Michael Morton, VP, Corporate Regulatory Affairs, Medtronic<br />
Combination Products<br />
Wednesday, October 7<br />
9:15 am - 10:30 am<br />
Room: 9 Upper<br />
Promoting the public health and expanding patient access to beneficial health care products by enhancing<br />
clarity, predictability and efficiency in the regulatory review process for combination products will be<br />
discussed. Some possible solutions could include:<br />
• First, make combination product designations more purposeful. For example, no devices are classified and<br />
regulated as drugs because of minor chemical action. Also, a process for developing limited clinical or non-clinical<br />
data to resolve conflicts about the significance of a combination product’s chemical action should be considered;<br />
• Second, focus combination product development and review on only the incremental risks of the<br />
combination product over any previously approved constituent parts (i.e., a risk-based review for<br />
combination products and reliance on prior findings of safety and effectiveness for drugs);<br />
• Third, in order to provide combination product sponsors with clarity about their regulatory pathway<br />
and requirements, there should be a mechanism to seek from FDA an up-front binding agreement with<br />
timeframes for combination product review and regulation through a pre-submission review plan (akin<br />
to device “presub” submissions and review plans); and<br />
• Finally, ensure timely and better coordinated feedback from FDA to combination product sponsors and<br />
improve dispute resolution for combination products.<br />
FINAL PROGRAM | 59
Moderator:<br />
Michelle McMurry-Heath, M.D., Ph.D., WW Vice President, Regulatory Affairs Medical Devices &<br />
Diagnostics, Johnson & Johnson<br />
Panelists:<br />
Mark Heller, Partner and Chair, FDA Group, Goodwin Proctor<br />
Diana Salditt, Regulatory Advocacy Program Director, Medtronic<br />
MDEpiNet PASSION Program: Achieving Predictability and Sustainability<br />
Wednesday, October 7<br />
11:00 am - 12:15 pm<br />
Room: 9 Upper<br />
Medical Device Epidemiology Network (MDEpiNet) Public Private Partnership has recently launched the<br />
PASSION (Predictable and Sustainable Implementation of National Registries) Program. This vast partnering<br />
between multiple stakeholders in the cardiovascular devices space, including three professional societies<br />
(ACC NCDR, HRS and STS), three Federal agencies (FDA, CMS and NIH), at least four universities (Harvard,<br />
Cornell, Yale and Duke University) and medical device manufacturers will illustrate the value of NCDR<br />
registry-based randomized and single-arm IDE studies as uniquely efficient and less expensive means of<br />
developing new labeling for cardiovascular devices. The panel will discuss these novel efforts with specific<br />
emphasis on (1) coronary; (2) valve; (3) electrophysiology; and (4) vascular PASSION developments.<br />
Moderator:<br />
Eve Ross, J.D., Public Policy + Strategy, W.L. Gore and Assoc., Inc<br />
Panelists:<br />
Ralph Brindis, MD, MPH, Professor of Medicine, U.C.S.F<br />
Mitchell W. Krucoff, M.D.<br />
Danica Marinac-Dabic, Director, Division of Epidemiology, FDA/CDRH<br />
60 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
Wherever you face challenges.<br />
We have answers<br />
Informa helps you make<br />
the right choices.<br />
Visit the Informa booth<br />
#510 in the exhibit hall.<br />
FINAL PROGRAM | 61
62 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
CEOs Unplugged Series<br />
Sponsored by<br />
TUESDAY, OCTOBER 6<br />
Start End Event<br />
9:10 am 9:50 am Understanding the Needs of Hospital CEOs & Payers<br />
10:00 am 10:30 am Legislative and Policy Issues Facing the MedTech Industry<br />
11:00 am 11:40 am Company Culture and Other Leadership Issues<br />
11:45 am 12:15 pm Digital Health<br />
2:10 pm 2:50 pm<br />
Commercialization Outsourcing Options – What Are Investors and<br />
Top Management Looking For Today?<br />
2:55 pm 3:35 pm Emerging Markets<br />
4:00 pm 4:45 pm The Innovation Ecosystem in Crisis and What to Do About It<br />
WEDNESDAY, OCTOBER 7<br />
Start End Event<br />
9:10 am 9:45 am Wearables – From Fashion Runway to Medical Diagnostic<br />
9:55 am 10:35 am Understanding the Power and Challenges of Today’s Patient<br />
10:55 am 11:35 am<br />
Advocating for Medical Innovation: 40 Years & Beyond: Insights from<br />
Industry Innovators and Icons<br />
11:45 am 12:15 pm Current Investment Flow, M&A and Deal Structures<br />
Tweeting about CEOs Unplugged sessions? Use #CEOsUnplugged to join in<br />
on the conversation!<br />
FINAL PROGRAM | 63
Understanding the Needs of Hospital CEOs & Payers<br />
Tuesday, October 6<br />
9:10 am – 9:50 am<br />
The landscape of purchaser company relationships is undergoing tectonic shifts. This up close and personal<br />
discussion with top executives of leading health providers and insurers will help you understand what<br />
they are looking for, what your company needs to know to be successful in this changing market, what<br />
opportunities exist for creative partnerships and what these CEOs value from providers that goes beyond<br />
simple price competition.<br />
Moderator:<br />
Michael “Mick” Farrell, CEO, ResMed<br />
Gail Boudreaux, CEO & Founder, GKB Global Health, LLC and Former CEO, United Healthcare<br />
Michael W. Murphy, CEO, Sharp HealthCare<br />
Glenn Steele, Chairman, xG Health Solutions and Immediate Past President and CEO, Geisinger Health System<br />
Legislative and Policy Issues Facing the MedTech Industry<br />
Tuesday, October 6<br />
10:00 am – 10:30 am<br />
The Chairs of AdvaMed’s three governing bodies, the AdvaMed Board of Directors, AdvaMedDx and<br />
AdvaMed Accel, will share the podium to review and address today’s most pressing legislative and policy<br />
issues facing our industry. Join us for a discussion about the key issues – both domestic and foreign,<br />
supporting and challenging the commercialization of innovative medical technology companies.<br />
Moderator:<br />
Ipsita Smolinski, Managing Director, Capitol Street<br />
John L. Bishop, Chairman and Chief Executive Officer, Cepheid, and Chair, AdvaMedDx<br />
Vincent A. Forlenza, Chairman, President and CEO, BD, and Chair, AdvaMed<br />
Nadim Yared, President & CEO, CVRx, and Chair, AdvaMed Accel<br />
Stephen J. Ubl, President & CEO, AdvaMed<br />
Company Culture and Other Leadership Issues<br />
Tuesday, October 6<br />
11:00 am – 11:40 am<br />
Respected and seasoned chief executive officers discuss leadership issues, including the importance of<br />
establishing a company culture and developing an environment that fosters quality, innovation, teamwork<br />
and success.<br />
Moderator:<br />
Lauren O’Donnell, Global General Manager and Vice President, Life Sciences Industry, IBM<br />
Robert Abernathy, CEO, Halyard Health<br />
Connie Ryan, President/CEO, Streck, Inc.<br />
Benson Smith, Chairman, President & CEO, Teleflex Incorporated<br />
64 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
Digital Health<br />
Tuesday, October 6<br />
11:45 am – 12:15 pm<br />
Digital Health covers a wide and growing area including, but not limited to Mobile, Wireless and eHealth,<br />
Health IT, Big Data, Cloud Computing, Gamification, Telehealth, Telemedicine, Wearables and much more.<br />
It’s a fast growing field and attracting a larger and growing percentage of investment and attention from<br />
both new digital health companies and from the traditional device and diagnostic makers. Join us for some<br />
lively dialogue with leaders from the digital health space.<br />
Moderator:<br />
Glenn H. Snyder, Principal, Life Sciences/Strategy, Med Tech Practice Leader, Deloitte Consulting LLP<br />
Sheri Dodd, Vice President & General Manager, Patient Management Services, Medtronic<br />
Deborah Kilpatrick, Chief Executive Officer, Evidation Health<br />
Raj Sodhi, President, Healthcare Informatics GBU, ResMed<br />
Rick Valencia, Senior Vice President and General Manager, Qualcomm Life<br />
Commercialization Outsourcing Options – What Are Investors and Top<br />
Management Looking For Today?<br />
Tuesday, October 6<br />
2:10 pm – 2:50 pm<br />
Outsourcing is extensively used in medical technology with widespread applications within R&D,<br />
Manufacturing, Regulatory and Clinical. Is outsourced commercialization next? Perfecting a sales process,<br />
brand positioning and value proposition development are major challenges for early companies with limited<br />
resources. Even global market leaders may ask themselves why not test the theories and processes before<br />
making a full-scale investment.<br />
This panel will discuss the pros, cons and trends of outsourcing sales and commercialization activities,<br />
including direct hiring, training and implementation of in-house sales forces, temporary and long-term<br />
uses of specialized sales personnel, broad-based 1099 sales representatives and small targeted outsource<br />
models. Furthermore, this panel will explore outsourcing for real-time, in-field testing, proof of concept,<br />
benchmarking and product and value positioning.<br />
Moderator:<br />
Kevin Schimelfenig, President, SalesForce4Hire<br />
Don Casey, CEO, Medical Segment, Cardinal Health<br />
Patrick Daly, President & CEO, Cohera Medical, Inc.<br />
Christopher Dunn, MD, Founding Member, Life Science Angels<br />
Doug Lawrence, Chief Executive Officer, CeQur<br />
FINAL PROGRAM | 65
Emerging Markets<br />
Tuesday, October 6<br />
2:55 pm – 3:35 pm<br />
Markets outside of the U.S. and Europe continue to grow and expand at attractive rates, but with these<br />
opportunities come both known and unknown challenges. Join us for a discussion about operating business<br />
units and selling medical technology in emerging markets.<br />
Moderator:<br />
Rupam Chaudhury, Global Industry Vertical Head (EIS – Life Sciences), Tata Consultancy Services<br />
Kevin Lobo, Chairman and Chief Executive Officer, Stryker Corporation<br />
David Perez, President & CEO, Terumo BCT | Chairman, Blood Management Business, Terumo Corporation,<br />
Terumo BCT, Inc.<br />
Timothy M. Ring, Chairman and Chief Executive Officer, C.R. Bard, Inc.<br />
The Innovation Ecosystem in Crisis and What to Do About It<br />
Tuesday, October 7<br />
4:00 pm – 4:45 pm<br />
Research and development is the key to creating the next breakthrough in medical progress. With an aging<br />
population, people with disabilities living longer, and chronic disease growing at faster rates, now is the time<br />
for more—not less—resources to advance cures and treatments that help people live healthier, longer and<br />
more independent lives. This panel would feature an array of speakers that will dissect the challenges facing<br />
the innovation ecosystem and put forth solutions to maintain U.S. global leadership.<br />
Moderator:<br />
Ashley Wittorf, Executive Director, AdvaMed Accel<br />
Cathy Burzik, General Partner, Targeted Technology, and former President, CEO and Director, Kinetic Concepts, Inc.<br />
Caroll Neubauer, President and CEO, B. Braun Medical Inc.<br />
Nadim Yared, President & CEO, CVRx and Chair, AdvaMed Accel<br />
Wearables – From Fashion Runway to Medical Diagnostics<br />
Wednesday, October 7<br />
9:10 am – 9:45 am<br />
Major consumer electronics companies such as Apple, Samsung, Microsoft and Google are joining<br />
established and emerging medical device companies in launching wearable technologies from wristwatches,<br />
to smart clothing, activity trackers, patches, ingestibles and smart implants. These “New Entrants” are<br />
attacking the health and wellness market integrating basic vital signs and consumer generated health data<br />
into patient specific and cohort data sets, enabling holistic views of health and health care. MedTech has<br />
traditionally competed only at or during the episode of care. Providers are looking to connect and integrate<br />
data from wearables into care solutions, allowing them to leverage constrained practitioner assets to<br />
serve broader populations more effectively and at a lower cost. MedTech companies will need to define<br />
commercial models that focus on integrated solutions to capture value in the “New Health Economy.”<br />
Moderator:<br />
Brian S. Williams, Director, Global Healthcare Strategy, PricewaterhouseCoopers LLP<br />
Ranndy Kellogg, Chief Operating Officer, Omron Healthcare, Inc.<br />
James R. Mault, M.D., F.A.C.S., Vice President and Chief Medical Officer, Qualcomm Life<br />
Nersi Nazari, CEO, Vital Connect<br />
66 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
Understanding the Power and Challenges of Today’s Patient<br />
Wednesday, October 7<br />
9:55 am – 10:35 am<br />
Never before has the health care industry seen such a great shift toward patient centricity. Patients are<br />
more involved and more educated than ever before; yet at the same time, there is a great need to increase<br />
patient satisfaction, reduce hospital readmissions and improve outcomes. We will discuss the importance of<br />
managing and engaging patients as well as building patient-centric brands that differentiate themselves in<br />
the medical device marketplace.<br />
Moderator:<br />
Rolf Benirschke, Chief Patient Officer, Legacy Health Strategies and former NFL placekicker with the San<br />
Diego Chargers<br />
Kevin Sayer, President and Chief Executive Officer, Dexcom<br />
Bill Walton, NBA Hall of Famer and back surgery patient<br />
Advocating for Medical Innovation: 40 Years & Beyond: Insights from Industry<br />
Innovators and Icons<br />
Wednesday, October 7<br />
10:55 am – 11:35 am<br />
This year marks AdvaMed’s 40th anniversary. The past four decades have seen tremendous growth in the<br />
medical technology industry and in the development of life-changing innovations that help patients worldwide<br />
live longer, healthier, more productive lives. Join us for an engaging discussion with some innovators and icons<br />
of the medical technology industry as they discuss the past, present and future challenges and opportunities<br />
for the association, the industry and the next generation of medical advancements.<br />
Moderator:<br />
Dr. Kavita Mehrotra, Global Strategic Relationships Head, Life & Health, UL EduNeering<br />
John W. Brown, Chairman Emeritus, Stryker Corporation<br />
Cathy Burzik, General Partner, Targeted Technology, and former President, CEO and Director, Kinetic<br />
Concepts, Inc.<br />
Martin Fitchet, M.D., Global Head, Research & Development, Johnson & Johnson Medical Devices<br />
Current Investment Flow, M&A and Deal Structures<br />
Wednesday, October 7<br />
11:45 am – 12:15 pm<br />
It’s been a very busy year for consolidation, investment, reorganization and growth in the medical<br />
technology space. Join us for a lively and frank discussion about why and what it all means for the industry<br />
and health care delivery. The session will be led by a seasoned independent investment banker as the panel<br />
discusses mergers and acquisitions, financial restructuring, valuation, company capital structures with<br />
buyers, sellers and top industry executives.<br />
Moderator:<br />
Keith A. Paganani, Partner, Sullivan & Cromwell<br />
Joseph DeVivo, President and Chief Executive Officer, AngioDynamics, Inc.<br />
Kieran Gallahue, former CEO and Chairman, CareFusion Corporation<br />
Lester Knight, Founding Partner, RoundTable Healthcare Partners<br />
Michael Robinson, Managing Director, Jefferies<br />
FINAL PROGRAM | 67
Business Development and<br />
Investor Programming<br />
AdvaMed 2015 presents unique programming for business development executives and investors to connect<br />
with peers and explore investment and strategic partnership opportunities with the emerging-growth<br />
MedTech companies in the Innovation Showcase.<br />
AdvaMed 2015 will host leading corporate business development teams, corporate venture, VCs and active<br />
angels investors for the following invitation-only events on Monday, October 5:<br />
• Business Development - Investor Forum – Corporate business development executives and investors<br />
will gather for networking and open discussion on the opportunities and expectations for engaging<br />
with accelerator and incubators programs to discover and advance MedTech innovations.<br />
• Strategic Investor Speed Dating – Active health care investors and corporate business development<br />
teams will be paired for 1-1 meetings with the 48 promising early-stage MedTech companies<br />
represented in the Innovation Showcase.<br />
• AdvaMed Accel Business Development - Investor Reception – MedTech investors, strategic business<br />
development executives and small innovators will gather for networking immediately preceding the<br />
AdvaMed 2015 Welcome Reception.<br />
Sponsored by<br />
68 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
Observe. Adapt. Advance. (Repeat.)<br />
To better serve clients, McGuireWoods LLP explores and navigates the latest<br />
issues in constantly evolving industries like medical technology. We proudly<br />
support the efforts of AdvaMed 2015 to promote the exchange of information<br />
and advance the industry.<br />
Timothy H. Kratz, Partner | 404 443 5730 | tkratz@mcguirewoods.com<br />
Kathleen H. Dooley, Partner | 704.343.2347 | kdooley@mcguirewoods.com<br />
Raj Natarajan, Partner | 704.343.2330 | rnatarajan@mcguirewoods.com<br />
1,000 lawyers | 21 offices | www.mcguirewoods.com<br />
FINAL PROGRAM | 69
Where healthcare companies thrive.<br />
Linden Capital Partners devotes world-class resources to developing<br />
exceptional healthcare companies. Dedicated focus and expertise,<br />
collaborative partnerships, and a diligent value creation program<br />
differentiate our rm. ur companies not onl grow, the prosper. or<br />
more information please visit us at www.lindenllc.com.<br />
Proud to sponsor<br />
AdvaMed 2015<br />
Supporting healthcare<br />
professionals for over<br />
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70 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15<br />
©2015 Smith & Nephew. All rights reserved. Printed in USA. 04348 V1 08/15
Sponsored by & &<br />
Innovation Showcase<br />
See the latest innovations and leading early-stage MedTech companies during the Innovation Showcase.<br />
Formerly known as Company Presentations, and building on the successful track record of this program,<br />
AdvaMed 2015 presents Innovation Showcase, a new and unique program featuring the most promising,<br />
emerging-growth MedTech companies from across the country and around the world.<br />
In partnership with MedTech Innovator, the AdvaMed 2015 Business Development Committee selected 48<br />
medial technology companies to participate in 12 Innovation Showcases on a special stage in the Exhibit<br />
Hall. Each showcase features 4 companies representing a specific theme of MedTech innovation. Following<br />
video introductions, a moderator will lead an interactive discussion with the CEOs and founders of these<br />
innovative, early-stage MedTech companies.<br />
TUESDAY, OCTOBER 6<br />
9:15 AM – 9:50 AM<br />
Big Data and Analytics<br />
Moderator: Paul Grand, Producer and Emcee, MedTech Innovator and Managing Director, RCT Ventures<br />
AMP3D<br />
MedTech Innovator Semi-finalist<br />
Medaware<br />
MedTech Innovator Finalist<br />
uBiome<br />
MedTech Innovator Finalist<br />
Vynca<br />
MedTech Innovator Semi-finalist<br />
9:55 AM – 10:30 AM<br />
Technology for Ambulatory and Home Settings<br />
Moderator: Bryant Zanko, Vice President, Corporate Business Development, Stryker<br />
CytoChip, Inc.<br />
MedTech Innovator Semi-finalist<br />
Fosmo Med<br />
MedTech Innovator Semi-finalist<br />
InvisionHeart, Inc.<br />
SEMDA Scholar<br />
SPR Therapeutics<br />
NIH/NINDS Scholar<br />
FINAL PROGRAM | 71
TUESDAY, OCTOBER 6<br />
11:00 AM – 11:35 AM<br />
Chronic Disease Management<br />
Moderator: Susan E. Morano, Vice President, New Business Development, Johnson & Johnson Medical Devices<br />
Companion Medical<br />
San Diego Regional EDC Scholar<br />
Endotronix<br />
iBIO/PROPEL Scholar<br />
Spinal Singularity<br />
MedTech Innovator Semi-finalist<br />
Vixiar Medical<br />
MedTech Innovator Semi-finalist<br />
11:40 AM – 12:15 PM<br />
Patient Safety and Satisfaction<br />
Moderator: Kristin Havranek, Associate, Wilson Sonsini Goodrich & Rosati<br />
Aperture Biomedical<br />
MedTech Innovator Semi-finalist<br />
Cognition Medical<br />
MedTech Innovator Semi-finalist<br />
Emmetrope<br />
MedTech Innovator Semi-finalist<br />
Lightpoint Medical<br />
MedTech Innovator Semi-finalist<br />
2:15 PM – 2:50 PM<br />
Shifting to Less-invasive Therapies and Site of Care<br />
Moderator: Bruce Rosengard, M.D., Chief Technology Officer, Johnson & Johnson Medical Devices<br />
Briteseed, LLC<br />
MedTech Innovator Finalist<br />
Harpoon Medical, Inc.<br />
BioMaryland Scholar<br />
MiNDERA<br />
MedTech Innovator Semi-finalist<br />
PixelEXX Systems, Inc.<br />
MedTech Innovator Semi-finalist<br />
2:55 PM – 3:30 PM<br />
Personalized MedTech<br />
Moderator: Randall S. Barko, President and Chief Executive Officer, Ximedica<br />
Cyfuse Biomedical<br />
UTEC Scholar<br />
InBrace<br />
MedTech Innovator Semi-finalist<br />
OmniCyte<br />
NIH/NCI Scholar<br />
Repertoire Genesis, Inc.<br />
Chubu TLO Scholar<br />
4:00 PM – 4:35 PM<br />
Point of Care Diagnostics<br />
Moderator: John F. Somers, President and CEO, Harmac Medical Products<br />
Admetsys<br />
MedTech Innovator Semi-finalist<br />
Cell IDx<br />
Biocom Scholar<br />
Disease Diagnostic Group<br />
MedTech Innovator Semi-finalist<br />
Nesher Technologies, Inc.<br />
NIH/NINDS Scholar<br />
72 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
TUESDAY, OCTOBER 6<br />
4:40 PM – 5:15 PM<br />
Digital Health Meets Medical Device<br />
Moderator: Albert Lauritano, Director, Strategic Technology Partnerships, BD<br />
Biolinq, Inc.<br />
NIH/NIDDK Scholar<br />
Bloom Technologies<br />
MedTech Innovator Semi-finalist<br />
Mobile ODT<br />
MedTech Innovator Finalist<br />
Prediktor Medical<br />
Oslo MedTech Scholar<br />
WEDNESDAY, OCTOBER 7<br />
9:15 AM – 9:50 AM<br />
Chronic Disease Management<br />
Moderator: John F. Somers, President and CEO, Harmac Medical Products<br />
Eyenuk<br />
NIH/NIBIB Scholar<br />
MSDx, Inc.<br />
Arizona BIO Scholar<br />
Pax Neuroscience, Inc.<br />
iBIO/PROPEL Scholar<br />
Rebiotix<br />
LifeScience Alley Scholar<br />
9:55 AM – 10:30 AM<br />
Point of Care Diagnostics<br />
Moderator: John J. Meduri, Global Director, Business Development, Diagnostic Systems, BD<br />
Aldatu Biosciences<br />
NIH/NIAID Scholar<br />
ApoCell, Inc.<br />
NIH/NIC Scholar<br />
QT Medical, Inc.<br />
NIH/NHLBI Scholar<br />
WinProbe Corporation<br />
NIH/NIBIB Scholar<br />
11:00 AM - 11:35 AM<br />
Patient Safety and Satisfaction<br />
Moderator: Dennis Crowley, Vice President, Business Development, Medtronic<br />
Adient Medical<br />
NIH/NHLBI Scholar<br />
Advanced Cooling Therapy, Inc<br />
iBIO/PROPEL Scholar<br />
ClearSight, LLC<br />
NIH/NIDDK Scholar<br />
Sonavex, Inc.<br />
BioMaryland Scholar<br />
11:40 AM – 12:15 PM<br />
Point of Care Diagnostics<br />
Moderator: Randall S. Barko, President and Chief Executive Officer, Ximedica<br />
3PrimeDX<br />
iBIO/PROPEL Scholar<br />
HelixBind, Inc<br />
NIH/NIAID Scholar<br />
Kestrel Labs, Inc.<br />
Colorado Biosciences Scholar<br />
Preora Diagnostics<br />
iBIO/PROPEL Scholar<br />
FINAL PROGRAM | 73
Innovation Showcase Scholarships<br />
All 48 companies received a scholarship from a supporting organization to participate in the Innovation<br />
Showcase at AdvaMed 2015. Scholarships include full access registration, invitations to an exclusive<br />
Strategic Investor Speed Dating event and networking reception, as well as dedicated meeting space and<br />
an enhanced profile in MedTech Partnering.<br />
Thanks to all of the organizations<br />
that provided Innovation<br />
Showcase Scholarships!<br />
Innovation Showcase Scholarship Sponsors<br />
®<br />
74 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
Save the<br />
Date!<br />
Oct 17-19, 2016<br />
Minneapolis, MN<br />
Photo Courtesy of Meet Minneapolis<br />
Proud Sponsor<br />
Advamed<br />
At Smiths Medical, we are<br />
passionate about sustaining and<br />
improving the lives of patients.<br />
Specializing in infusion systems,<br />
vital care, and vascular access...<br />
our innovative products serve<br />
hospital, emergency, home<br />
and specialty care facilities<br />
around the globe.<br />
2015<br />
www.smiths-medical.com<br />
©2015 Smiths Medical. All rights reserved.<br />
FINAL PROGRAM | 75
MedTech Partnering<br />
AdvaMed 2015 is pleased to offer MedTech Partnering – a one-on-one meeting solution designed to<br />
AdvaMed 2014 is pleased to offer MedTech Partnering—a one-on-one meeting solution designed to<br />
maximize networking opportunities for MedTech companies and other industry stakeholders. In addition to<br />
maximize networking opportunities for MedTech companies and other industry stakeholders. In addition to<br />
connecting with your peers and scheduling private meetings, use our state-of-the-art MedTech Partnering<br />
connecting with your peers and scheduling private meetings, use our state-of-the-art MedTech Partnering<br />
system to:<br />
system to:<br />
• See who else is attending;<br />
• View the conference agenda and build an individual schedule that integrates one-on-one meetings,<br />
panel sessions and personal calendar items;<br />
• View a list of sponsors and exhibitors, as well as an interactive exhibit hall floor plan;<br />
• Download the conference mobile application (for Android and iOS),<br />
• And more!<br />
The AdvaMed 2015 mobile application is available for Android through Google Play and for iOS through<br />
iTunes – search “AdvaMed 2015” and get ready to partner!<br />
MEDTECH PARTNERING<br />
Date<br />
Location<br />
Start<br />
End<br />
Tuesday, October 6 Exhibit Hall - MedTech Partnering Zone 9:00 am 5:30 pm<br />
Wednesday, October 7 Exhibit Hall - MedTech Partnering Zone 9:00 am 4:00 pm<br />
MEDTECH PARTNERING CONCIERGE DESK<br />
Date<br />
Location<br />
Start<br />
End<br />
Monday, October 5 Info Booth, Lobby A 12:00 pm 6:00 pm<br />
Tuesday, October 6 Exhibit Hall - MedTech Partnering Zone 7:00 am 7:00 pm<br />
Wednesday, October 7 Exhibit Hall - MedTech Partnering Zone 7:00 am 4:00 pm<br />
76 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
Imaging solutions, powered by people.<br />
The logical choice for today and tomorrow.<br />
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Bayer in Radiology leads with investment<br />
in innovation—from our roots in Medrad<br />
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equipment service and radiology informatics.<br />
We believe success comes from systems that<br />
are smarter by design, powered by people<br />
committed to making a difference.<br />
That’s Radiological<br />
Bayer, and the Bayer Cross are trademarks of the Bayer group of companies.<br />
© 2015 Bayer, 100 Bayer Boulevard, P.O. Box 915, Whippany, NJ 07981. PP-CP-US-0049 March 2015<br />
FINAL PROGRAM | 77
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At Cognizant, we help medtech companies run better<br />
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For more information, visit us at cognizant.com/life-sciences<br />
78 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
Special Programming<br />
International Seminar & Reception<br />
Sunday, October 4<br />
1:00 pm – 6:30 pm<br />
Marriott Marquis San Diego Marina<br />
Marina Ballroom D<br />
The International Seminar at AdvaMed 2015 will address key issues for MedTech companies outside the U.S.<br />
seeking to launch products in the U.S. market. A series of presentations and interactive discussions with<br />
subject matter experts will assist international companies as they navigate regulatory pathways, plan for<br />
reimbursement, protect their IP, understand operational compliance and develop strategic partnerships<br />
with industry and government in the U.S. An International Reception held on the South Pool Deck of the<br />
Marriott Marquis San Diego Marina will follow the International Seminar.<br />
The program is complimentary for full-access attendees from outside the U.S. Priority will be given to<br />
International Delegation Partners and their delegate companies.<br />
Women’s Executive Network<br />
Monday, October 5, 2015<br />
5:00 pm - 6:30 pm<br />
5:00 pm - Welcoming Remarks<br />
5:15 pm - 6:00 pm - Panel Discussion<br />
6:00 pm - 6:30 pm - Networking Reception<br />
In its second year, AdvaMed will bring together women in the MedTech and diagnostics industries for<br />
networking, professional development and relationship building during the Women’s Executive Network<br />
event. This event is open to all women in the industry and will include a panel discussion by noted industry<br />
leaders to be followed by a networking reception.<br />
Throughout the year, WEN works to address key issues facing female medical device industry executives,<br />
pathways for success at senior leadership levels and effective career management strategies, including<br />
elevating women executives to leadership positions within the association.<br />
Moderator:<br />
Gail Boudreaux, CEO & Founder, GKB Global Health, LLC and Former CEO, United Healthcare<br />
Panelists:<br />
Lisa Earnhardt, President and CEO, Intersect ENT<br />
Deborah Kilpatrick, PhD, CEO, Evidation Health<br />
Valerie Palmieri, President and CEO, Vermillion<br />
Erica Rogers, President and CEO, Silk Road Medical Inc<br />
FINAL PROGRAM | 79
Entrepreneurship Boot<br />
Camp at AdvaMed 2015<br />
Sponsored by<br />
&<br />
medical devices<br />
Monday, October 5<br />
8:00 am – 3:00 pm<br />
Ballroom 6F Upper (unless otherwise noted)<br />
The Entrepreneurship Boot Camp at AdvaMed 2015 provides leadership insights to emerging and earlygrowth<br />
medical technology companies as they bring their innovations to market. Successful CEOs share<br />
their experiences and best practices, and three innovative start-up companies put their strategic plans to<br />
the test in the AdvaMed Accel Business Plan Competition. The Virginia Shimer Rybski Memorial Award will<br />
be presented during the networking lunch, and a series of afternoon workshops offer in-depth discussion<br />
and analysis of key issues facing small companies.<br />
8:00 am – 8:15 am - Welcome Remarks<br />
Dan Sterling, President, Sterling Medical Devices<br />
Rick Geoffrion, President and CEO, Mitralign<br />
8:15 am – 9:05 am - Leadership Lessons in Managing Risk and Growth<br />
Experienced MedTech CEOs share strategies for advancing concepts from start-up phase to full<br />
commercialization, and how they navigate options and challenges in removing risks through economic and<br />
clinical value proposition validation, technology choices and sales and marketing execution.<br />
Moderator:<br />
Isabelle Billet, Principal, IBHC Advisors LLC<br />
Charles S. Carignan, MD, President and CEO, BionX (formerly iWalk)<br />
Larry Mastrovich, President and Chief Executive Officer, Breathe Technologies, Inc.<br />
James V. Mazzo, Chairman & Chief Executive Officer, AcuFocus and Executive Chairman, Neurotech<br />
9:10 am – 10:00 am - CEO Q&A on Fundraising and Commercialization<br />
A panel of seasoned executives will participate in an open Q&A session and share their experiences in<br />
securing investment capital and executing commercial strategies with the audience.<br />
Moderator:<br />
Ned Scheetz, Founder, Managing Partner, Aphelion Capital<br />
Brian Hutchinson, CEO, RTI Surgical<br />
Ken Reali, CEO, Clinical Innovations<br />
Erica Rogers, CEO, Silk Road Medical<br />
Martha Shadan, President & CEO, Rotation Medical<br />
80 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
10:00 am – 10:15 am - Networking Break<br />
10:15 am - Welcome and Introduction<br />
Michelle Axelrod, Principal, Porzio<br />
10:15 am – 11:45 am - AdvaMed Accel Business Plan Competition<br />
Three MedTech start-ups will present business plans and compete for the Virginia Shimer Rybski Memorial<br />
Award and a $10,000 cash prize. Participating companies will be drawn from Innovation Showcase applicant pool<br />
and selected by the AdvaMed 2015 Business Development Committee. A panel of judges will provide feedback<br />
and analysis (10-minute presentation, 10-minute feedback discussion per spin-out), before selecting the winner.<br />
Moderator:<br />
Martha J. Connolly, Ph.D., Director, Mtech Baltimore<br />
Judging Panel:<br />
Vicki Anastasi, Vice President and Global Head, Medical Device and Diagnostics Research, ICON plc<br />
Jan D’Alvise, Life Science Entrepreneur and CEO, von Liebig Entrepreneurism Center, Jacobs School of<br />
Engineering, UC San Diego<br />
Niall O’Donnell, Managing Director, RiverVest Venture Partners<br />
Three Presenting Companies:<br />
Jet Lasik, Inc.<br />
Sintact Medical Systems<br />
Thermatome Corporation<br />
12:00 pm – 1:00 pm - Networking Lunch and Virginia Shimer Rybski Memorial Award Presentation<br />
Ballroom 6C Upper<br />
Sponsored by<br />
&<br />
Afternoon Workshops<br />
1:15 pm – 2:00 pm - Translating Value to Sales (Ballroom 6F Upper)<br />
MedTech and hospital executives provide advice on how to evaluate a product’s value proposition both clinically and<br />
economically and translate that to sales through payment and reimbursement. We will explore health economic<br />
considerations and product positioning and the evolving buyers’ decision-making drivers in various settings.<br />
Moderator:<br />
Susan Posner, Partner, Health Advances<br />
Dave Amerson, President and CEO, NeoTract, Inc.<br />
Matthew Cantonis, Corporate Director, Orthopedics, Spine, Neuroscience and Rehabilitation Clinical Care<br />
Lines, Scripps Health<br />
1:15 pm – 2:00 pm - When Going Abroad May be the Best First Step (Ballroom 6E Upper)<br />
Seasoned CEOs discuss the opportunities and challenges of going global early in such a way as to facilitate<br />
U.S. market entry. AdvaMed will provide resources for small manufacturers operating in overseas markets.<br />
Moderator:<br />
Christian Haller, CEO, The RavenOye Group<br />
Phil Agress, Senior Vice President for Global Strategy and Analysis, AdvaMed<br />
David Zapol, CEO, Third Pole<br />
FINAL PROGRAM | 81
2:00 pm – 2:15 pm - Networking Break<br />
2:15 pm – 3:00 pm - Regulatory: 510(k) Preparatory Course (Ballroom 6F Upper)<br />
Get the most out of communicating with the FDA and learn best practices for interfacing with FDA by<br />
examining regulator and innovator perspectives on 510(k) submissions.<br />
• How to gather resources to prepare submissions?<br />
• What resources does FDA have online?<br />
• How best to interface with FDA?<br />
• What are reviewers’ expectations of a submission?<br />
Co-Moderators:<br />
Grace Bartoo, Ph.D., RAC, CBA, President and CEO, Decus Biomedical<br />
Kwame Ulmer, Vice President, Regulatory Affairs/Quality Assurance, Implant Direct<br />
2:15 pm – 3:00 pm - Developing, Defending and Leveraging Intellectual Property ( Ballroom 6E Upper)<br />
IP is the foundation of successful technology companies. This workshop will address fundamental questions<br />
for early stage MedTech companies to establish IP portfolios that drive and sustain growth.<br />
• Is your product patentable and what steps are necessary to secure and protect patents?<br />
• How to establish Freedom To Operate? And what are the implications?<br />
• How to mitigate IP risk and demonstrate a strong position to investors?<br />
Moderator:<br />
Bruce Swope, VP of Engineering, Sterling Medical Devices<br />
Benjamin Glenn, Partner, ShayGlenn LLP<br />
Patrick Johnson, President & CEO, BioPhotas, Inc.<br />
82 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
INNOVATING WITH<br />
PATIENTS AND<br />
PROVIDERS<br />
IN MIND<br />
Helping patients get healthy, feel better, live longer is<br />
all in a day’s work at Medtronic. Helping healthcare<br />
systems be more efficient is, too.<br />
Learn about how we’re taking healthcare Further,<br />
Together by visiting Medtronic.com.<br />
UC201602145b EN © 2015 Medtronic All Rights Reserved<br />
FINAL PROGRAM | 83
Aon Risk Solutions<br />
Life Sciences Practice<br />
Data and Information<br />
Empower Results<br />
We use data to help our clients make smart, informed decisions.<br />
Our signifi cant investments in data platforms and expert analysis give<br />
our Life Sciences clients a competitive edge. We deliver the industry’s<br />
most forward-looking tools and expertise to support fact-based<br />
decisions making for insurance and risk management programs.<br />
Aon Risk Solutions’ Life Science Practice is unmatched in its<br />
demonstrated experience in supporting organizations from the initial<br />
discovery phase to fi nal product launch.<br />
To learn more, contact James Walters, Life Sciences Practice Leader<br />
at james.walters@aon.com or +1.215.255.1795.<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
Risk. Reinsurance. Human Resources.<br />
84 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
Scientist Mentoring and Diversity Program<br />
AdvaMed 2015 and AdvaMed member companies will sponsor a training session for the Scientist Mentoring<br />
& Diversity Program for Medical Technology (SMDP MedTech), October 3-7, 2015 in San Diego, CA.<br />
The year-long mentoring program benefits post baccalaureate and graduate students from racial and ethnic<br />
groups underrepresented in the MedTech industry, including Hispanic Americans, Pacific Islanders, African<br />
Americans and Native Americans.<br />
Attending students are interested in careers in the medical technology industry.<br />
Scholars are paired with industry mentors who work at medical device and diagnostic companies. The SMDP<br />
MedTech Scholars will be introduced to their mentors during a five-day career training experience in San<br />
Diego. During the training, Scholars learn about career opportunities in the industry and receive career<br />
development coaching. They also attend AdvaMed 2015: The MedTech Conference.<br />
As part of the program, SMDP MedTech Scholars and their mentors create personalized career development<br />
plans, which the students implement over the course of the year following the training session. The mentormentee<br />
teams communicate and carry out the career plans virtually, aided by ICPD (International Center<br />
for Professional Development) staff and the SMDP Mentoring Portal, an Internet-based tool that supports<br />
mentor-mentee collaboration and communication. For more information about SMDP MedTech, visit www.<br />
smdpmedtech.org.<br />
ICPD is a not-for-profit 501c3 Charitable Organization.<br />
2015 Scientist<br />
Mentoring & Diversity<br />
Program for Medical Technology<br />
Oct 3-7, 2015 | San Diego, CA | www.smdpmedtech.org<br />
Thanks to our sponsors:<br />
LEAD SPONSORS MAJOR SPONSORS PROGRAM SPONSORS PARTNERING SPONSORS<br />
FINAL PROGRAM | 85
MedDevice Development Course<br />
Monday, October 5<br />
9:00 am – 4:30 pm<br />
Marriott Marquis San Diego Marina<br />
Coronado<br />
MedDevice Development Course is a one-day preparatory course offered on Monday, October 5, designed<br />
for new MedTech industry professionals seeking an introductory industry understanding. Instructed by<br />
Jim Macemon, a medical device expert, this course examines all aspects of medical device development,<br />
starting with an overview of the different types of devices and the various industry sectors, then delving into<br />
the changing regulatory environment. This includes a discussion of the different regulatory pathways and<br />
a comparison of FDA vs. EU approval processes. The five phases of medical device development – market<br />
opportunity, evaluation, design, verification and manufacturing – are described in detail. Attendees will<br />
develop a basic understanding of the process required to bring a new medical device to market.<br />
Instructor: Jim Macemon, Medical Device and Diagnostic Expert<br />
Mr. Macemon is a medical device executive with extensive experience in<br />
diagnostics, critical care, patient monitoring, imaging and lab products.<br />
During his 30+ year medical device focused career, he led numerous<br />
Research & Development and manufacturing teams, successfully launching<br />
products to aid laboratory and health care professionals and improve<br />
patient care.<br />
Delivered by: Biotech Primer, Inc.<br />
86 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
MONDAY, OCTOBER 5<br />
9:00 AM - 9:30 AM<br />
MEDICAL DEVICE OVERVIEW<br />
Medical Device Defined<br />
Medical Device Diversity<br />
9:30 AM - 10:30 AM<br />
MEDICAL DEVICE REGULATION<br />
Quality System Regulations (QSRs)<br />
Current Good Manufacturing Practices<br />
Good Laboratory Practices<br />
Good Clinical Practices<br />
Risk Management Plan<br />
Exemptions<br />
Rest Of World Approval Pathways<br />
Special Categories:<br />
Home Brew & Combination Devices<br />
10:30 AM - 10:45 AM | BREAK<br />
10:45 AM - 12:00 PM<br />
MEDICAL DEVICE REGULATIONS<br />
CONT.<br />
Regulatory Challenges<br />
Diagnostics<br />
Predicates<br />
New Technologies<br />
Clinical Trails<br />
Medical Device Reporting<br />
12:00 PM - 1:00 PM<br />
LUNCH PROVIDED<br />
1:00 PM - 3:00 PM<br />
MEDICAL DEVICE DEVELOPMENT<br />
Phase I: Market Opportunity Evaluation<br />
Market Analysis<br />
Risk Management Plan<br />
Phase II: Concept Evaluation<br />
Formulation Steps<br />
Feasibility<br />
Phase III: Engineering Design Process<br />
Design & Development<br />
Software Development<br />
Prototyping<br />
Phase IV: Verification<br />
Phase V: Manufacturing Transfer<br />
Documentation<br />
Equipment IQ/OQ/PQ<br />
Biocompatibility<br />
Sterilization<br />
Shipping & Storage<br />
3:00 PM - 3:15 PM | BREAK<br />
3:15 PM - 4:15 PM<br />
MEDICAL DEVICE APPROVAL<br />
Clinical Trials<br />
Need For A “Gold Standard”<br />
Regulatory Submissions<br />
Coding & Reimbursement<br />
4:15 PM - 4:30 PM | Q&A/REVIEW<br />
FINAL PROGRAM | 87
S<br />
M<br />
MVPVets Special ReCareering Event<br />
Sunday, October 4<br />
8:30 am - 3:30 pm<br />
San Diego Zoo<br />
The MedTech and BioTech Veterans Program (MVPVets) is a 501(c)(3) fiscally sponsored nonprofit organization<br />
that enables and empowers veterans and transitioning military personnel to find compelling careers in life<br />
sciences companies. MVPVets serves as a connector between the veteran community and the life sciences<br />
industry by helping veterans build their knowledge of the industry and improve their job seeking skills while<br />
equipping companies to reach out to veterans as a resource for employment. The mission of MVPVets exists<br />
to reduce veteran unemployment and provide talented and dedicated employees to life sciences companies.<br />
MVPVets program accomplishes its mission of enabling and empowering veterans to find careers in the life<br />
sciences by bringing together three core groups: Veterans, mentors and companies.<br />
Our partners at BEDC are co-hosting a ReCareering event at the San Diego Zoo on Oct. 4, just one day<br />
before AdvaMed 2015.<br />
During this event, veterans will learn about life sciences and meet with industry professionals, all with the<br />
aim of transitioning into a medical device or biotech career.<br />
88 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
Save the Date!<br />
Oct 17-19, 2016<br />
Minneapolis, MN<br />
We’ll see you there!<br />
AVE DATE<br />
THE<br />
INNEAPOLIS<br />
MN<br />
OCTOBER 17-19, 2016<br />
FINAL PROGRAM | 89<br />
Photo Courtesy of Meet Minneapolis
Exhibit Hall<br />
The AdvaMed 2015 Exhibit Hall is a hub for learning, networking and business development. It will feature<br />
120+ exhibitors from every corner of the industry and the world displaying the latest in innovative<br />
MedTech products and services. Exhibitors include medical device manufacturers of every size; economic<br />
development and trade organizations; universities; industry consultants and service providers; media;<br />
non-profits and other important stakeholders. The Exhibit Hall is also home to our CEOs Unplugged<br />
Series, featuring the industry’s top thought leaders, decision-makers and innovators.<br />
Innovation Pavilion<br />
Sponsored by<br />
New for 2015, this area of the Exhibit Hall will feature 10 innovative early-stage companies showcasing<br />
demos of their technology. Visit the Innovation Pavilion for a hands-on experience with the latest and<br />
greatest that the MedTech industry has to offer. Featured companies include:<br />
Advanced Cooling Therapy, Inc.<br />
Briteseed, LLC<br />
Electrical Geodesic, Inc. (EGI)<br />
Entra Health<br />
Fibralign Corporation<br />
InvisionHeart, Inc.<br />
Lightpoint Medical<br />
MiNDERA<br />
Prediktor Medical<br />
Sonavex, Inc.<br />
Stay up to date on the latest developments by following us on Twitter and joining<br />
the AdvaMed 2015 LinkedIn group.<br />
#AdvaMed15<br />
@AdvaMedConf<br />
AdvaMed 2015<br />
90 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
TUESDAY, OCTOBER 6<br />
Start End Event<br />
9:00 am 7:00 pm Exhibit Hall Open<br />
10:30 am 11:00 am Innovation Pavilion Company Demos<br />
3:30 pm 4:00 pm Innovation Pavilion Company Demos<br />
5:15 pm 7:00 pm<br />
WEDNESDAY, OCTOBER 7<br />
Start End Event<br />
Chairmen’s Networking Reception:<br />
An Irish Pub Night<br />
9:00 am 5:00 pm Exhibit Hall Open<br />
10:30 am 11:00 am Innovation Pavilion Company Demos<br />
4:15 pm 5:00 pm Closing Reception<br />
It’s better under the umbrella ®<br />
FINAL PROGRAM | 91
Exhibit Hall Floor Plan<br />
LOUNGE<br />
PARTNERING<br />
CHECK-IN<br />
92 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
HALL B<br />
CEOs Unplugged Stage<br />
MeetUp Zone<br />
Food &<br />
Beverage<br />
Food &<br />
Beverage<br />
PLENARY AREA<br />
PLENARY & EXHIBIT HALL ENTRANCE<br />
FINAL PROGRAM | 93
Find an Exhibitor<br />
by Name…<br />
3D Communications 508<br />
Abiomed 427<br />
Acclarant, Inc. 617<br />
Acelity 617<br />
AdvaMed 401<br />
AdvaMed Life Changing 401<br />
Innovation<br />
AdvaMed MTLI 401<br />
Advanced Cooling Therapy, Inc. 709<br />
Airgas 101<br />
Arizona- PHX East Valley 425<br />
Auriga Inc. 205<br />
AZBio 425<br />
B. Braun Medical 526<br />
Barney & Barney 101<br />
Battelle 131<br />
Baxter Healthcare Corporation 509<br />
BD 608<br />
Big3D.com Worldwide 627<br />
Biocom 423<br />
Biocom Purchasing Group 101<br />
BioMelbourne Network, Australia 117<br />
Biosense Webster, Inc. 700<br />
Boston Biomedical Associates 230<br />
Boston Healthcare 300<br />
Briteseed, LLC 709<br />
BSI Group America Inc. 604<br />
California Life Sciences 208<br />
Association (CLSA)<br />
Cardinal Health 303<br />
Codman Neuro 700<br />
Cognizant Technology Solutions 231<br />
CROMSOURCE 626<br />
Deloitte 416<br />
DePuy Synthes 700<br />
DigiCert 109<br />
DocuSign 302<br />
Dohmen Life Science Services 610<br />
Electrical Geodesics, Inc. (EGI) 709<br />
Entra Health 709<br />
Ethicon 700<br />
Evaluate 501<br />
FedEx HealthCare Solutions 417<br />
Fibralign 709<br />
FIT Agency 513<br />
Flex 435<br />
Foreign Affairs, Trade and 530<br />
Development Canada<br />
GoFed 309<br />
Health Policy Associates 408<br />
(HPA, Inc.)<br />
HealthCare Appraisers 227<br />
Hobson & Motzer 223<br />
ICON plc 600<br />
IDA Ireland 322<br />
Informa 510<br />
Innovation in Medtech 410<br />
Integron, Inc. 330<br />
Intertek 512<br />
InvisionHeart, Inc. 709<br />
Johnson & Johnson 700<br />
Life Science Nation 525<br />
LifeCollaborative 309<br />
LifeScience Alley 217<br />
Lightpoint Medical 709<br />
MEDEC 530<br />
Medmarc | The Hartford 404<br />
MedTech & BioTech Veterans 309<br />
Program<br />
Mentor Worldwide, LLC 700<br />
MiNDERA 709<br />
MPR Associates 505<br />
National Cancer Institute 717<br />
National Heart, Lung, and 717<br />
Blood Institute<br />
National Institute of Allergy 717<br />
and Infectious Diseases<br />
National Institute of Biomedical 717<br />
Imaging and Bioengineering<br />
National Institute of Diabetes and 717<br />
Digestive and Kidney Diseases<br />
National Institute of 717<br />
Neurological Disease and Stroke<br />
National Institutes of Health 717<br />
National Research Council 530<br />
Canada<br />
Northwestern Simulation 225<br />
NSF Health Sciences 113<br />
Nypro, A Jabil Company 400<br />
OCTANe 324<br />
Office Depot 101<br />
Pacific Bridge Medical 622<br />
PHLCVB 724<br />
PHLLife 724<br />
Pilgrim Quality Solutions 212<br />
Poly-Med, Inc. 301<br />
Prediktor Medical 709<br />
Puerto Rico Industrial 517<br />
Development Company (PRIDCO)<br />
RCRI 726<br />
Reed Technology and 201<br />
Information Services<br />
Regulatory Compliance 304<br />
Associates, Inc.<br />
SalesForce4Hire 431<br />
Select Greater Philadelphia 724<br />
Smartbrief 511<br />
Smiths Medical 612<br />
Sonavex, Inc. 709<br />
Sparta Systems 412<br />
STC Australia 117<br />
Sterling Medical Devices 523<br />
Sunrise Labs 326<br />
Tata Consultancy Services 332<br />
Tijuana Economic 522<br />
Development Corporation<br />
TikaMobile 534<br />
Transperfect 101<br />
TriNet 624<br />
UL 409<br />
UPS 527<br />
Veeva Systems 411<br />
VWR 101<br />
Xavier University 413<br />
ZubbaHub 309<br />
94 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
…Or by Booth<br />
Number<br />
Airgas 101<br />
Barney & Barney 101<br />
Biocom Purchasing Group 101<br />
Office Depot 101<br />
Transperfect 101<br />
VWR 101<br />
DigiCert 109<br />
NSF Health Sciences 113<br />
BioMelbourne Network, 117<br />
Australia<br />
STC Australia 117<br />
Battelle 131<br />
Reed Technology and 201<br />
Information Services<br />
Auriga Inc. 205<br />
California Life Sciences 208<br />
Association (CLSA)<br />
Pilgrim Quality Solutions 212<br />
LifeScience Alley 217<br />
Hobson & Motzer 223<br />
Northwestern Simulation 225<br />
HealthCare Appraisers 227<br />
Boston Biomedical Associates 230<br />
Cognizant Technology Solutions 231<br />
Boston Healthcare 300<br />
Poly-Med, Inc. 301<br />
DocuSign 302<br />
Cardinal Health 303<br />
Regulatory Compliance 304<br />
Associates, Inc.<br />
LifeCollaborative 309<br />
MedTech & BioTech Veterans 309<br />
Program<br />
ZubbaHub 309<br />
GoFed 309<br />
IDA Ireland 322<br />
OCTANe 324<br />
Sunrise Labs 326<br />
Integron, Inc. 330<br />
Tata Consultancy Services 332<br />
Nypro, A Jabil Company 400<br />
AdvaMed 401<br />
AdvaMed Life Changing 401<br />
Innovation<br />
AdvaMed MTLI 401<br />
Medmarc | The Hartford 404<br />
Health Policy Associates 408<br />
(HPA, Inc.)<br />
UL 409<br />
Innovation in Medtech 410<br />
Veeva Systems 411<br />
Sparta Systems 412<br />
Xavier University 413<br />
Deloitte 416<br />
FedEx HealthCare Solutions 417<br />
Biocom 423<br />
Arizona- PHX East Valley 425<br />
AZBio 425<br />
Abiomed 427<br />
SalesForce4Hire 431<br />
Flex 435<br />
Evaluate 501<br />
MPR Associates 505<br />
3D Communications 508<br />
Baxter Healthcare Corporation 509<br />
Informa 510<br />
Smartbrief 511<br />
Intertek 512<br />
FIT Agency 513<br />
Puerto Rico Industrial 517<br />
Development Company (PRIDCO)<br />
Tijuana Economic 522<br />
Development Corporation<br />
Sterling Medical Devices 523<br />
Life Science Nation 525<br />
B. Braun Medical 526<br />
UPS 527<br />
Foreign Affairs, Trade and 530<br />
Development Canada<br />
MEDEC 530<br />
National Research Council 530<br />
Canada<br />
TikaMobile 534<br />
ICON plc 600<br />
BSI Group America Inc. 604<br />
BD 608<br />
Dohmen Life Science Services 610<br />
Smiths Medical 612<br />
Acclarant, Inc. 617<br />
Acelity 617<br />
Pacific Bridge Medical 622<br />
TriNet 624<br />
CROMSOURCE 626<br />
Big3D.com Worldwide 627<br />
Biosense Webster, Inc. 700<br />
Codman Neuro 700<br />
DePuy Synthes 700<br />
Ethicon 700<br />
Johnson & Johnson 700<br />
Mentor Worldwide, LLC 700<br />
Advanced Cooling Therapy, Inc. 709<br />
Briteseed, LLC 709<br />
Electrical Geodesics, Inc. (EGI) 709<br />
InvisionHeart, Inc. 709<br />
Lightpoint Medical 709<br />
MiNDERA 709<br />
Prediktor Medical 709<br />
Sonavex, Inc. 709<br />
Entra Health 709<br />
Fibralign 709<br />
National Cancer Institute 717<br />
National Heart, Lung, and 717<br />
Blood Institute<br />
National Institute of Allergy 717<br />
and Infectious Diseases<br />
National Institute of Biomedical 717<br />
Imaging and Bioengineering<br />
National Institute of Diabetes and 717<br />
Digestive and Kidney Diseases<br />
National Institute of 717<br />
Neurological Disease and Stroke<br />
National Institutes of Health 717<br />
PHLCVB 724<br />
PHLLife 724<br />
Select Greater Philadelphia 724<br />
RCRI 726<br />
FINAL PROGRAM | 95
AdvaMed 2015 would like thank our Supporting<br />
Partner Organizations, International Delegation<br />
Partners and Media Partners<br />
Supporting Partner Organizations<br />
(as of September 11 2015)<br />
Premier<br />
wisconsin’s independent voice for bioscience<br />
Florida Medical Manufacturers Consortium<br />
®<br />
Standard<br />
96 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15
International Delegation Partners<br />
Media Partners<br />
From the publishers of Nature<br />
FierceMedicalDevices<br />
FINAL PROGRAM | 97
Solutions for joint pain.<br />
zimmerbiomet.com<br />
For more than 80 years, Zimmer Biomet has been a driving force<br />
in joint replacement technologies and other advancements<br />
in musculoskeletal health. Our success would not be possible<br />
without the personal dedication of our employees worldwide. It is<br />
through their commitment that we are able to make a difference by<br />
developing products that help to ease pain, restore mobility and<br />
improve the quality of life for millions of people around the globe.<br />
©2015 Zimmer Biomet<br />
Make intelligent decisions<br />
faster to solve your toughest<br />
business challenges...<br />
With the trusted source<br />
for life science market<br />
intelligence.<br />
EvaluateMedTech provides superior quality data content, expert<br />
analysis and consensus forecasts to 2020, delivered to save you<br />
time via a single, integrated, standardized platform.<br />
Visit booth 501 to receive a complimentary copy of our annual<br />
sector report: EvaluateMedTech World Preview 2015, Outlook<br />
to 2020 and enter our i-Pad raffle.<br />
Integra LifeSciences is a world leader in medical<br />
technology, dedicated to limiting uncertainty<br />
for caregivers, so they can concentrate on providing<br />
the best patient care. Integra offers innovative<br />
solutions in regenerative technologies,<br />
specialty surgical solutions, and orthopedics<br />
and tissue technologies, saving and sustaining<br />
lives around the world.<br />
integralife.com<br />
Korn Ferry is proud<br />
to support AdvaMed<br />
Korn Ferry is a single source for leadership and talent<br />
consulting services to empower businesses and<br />
leaders to reach their goals. Our solutions range from<br />
executive recruitment and leadership development<br />
programs, to enterprise learning, succession planning<br />
and recruitment process outsourcing (RPO).<br />
www.kornferry.com<br />
www.evaluate.com<br />
98 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15<br />
Korn Ferry<br />
202 Carnegie Center, Suite 105<br />
Princeton, NJ 08540
Unparalleled<br />
Networking<br />
Opportunities<br />
Save the Date!<br />
Oct 17-19, 2016<br />
Minneapolis, MN<br />
We’ll see you there!<br />
FINAL PROGRAM | 99
REACHING MORE PATIENTS, RESTORING MORE LIVES.<br />
100 | ADVAMED 2015 CONNECT WITH US ON TWITTER: #AdvaMed15<br />
© Copyright Johnson & Johnson Services, Inc. 2015. All Rights Reserved.
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