Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27 Page 28 Page 29 Page 30 Page 31 Page 3224 A D V A M E D 2 0 1 6 A N N U A L R E P O R T ACCELERATING SMALL BUSINESSES AdvaMed Accel is the division within AdvaMed committed to accelerating the growth and success of small medical technology companies. Accel is dedicated to providing advocacy for a policy environment more conducive to capital formation and innovation; insight into ever-changing regulatory, reimbursement, compliance and business environments; and opportunity for member engagement with peers, subject matter experts and policymakers, as well as strategic partners and investors, to help small companies thrive. RESEARCH AdvaMed Accel released a report in October spotlighting key challenges in the medtech innovation ecosystem that impact small companies in particular, and helping to advance effective solutions. Entitled “A Future at Risk: Economic Performance, Entrepreneurship, and Venture Capital in the U.S. Medical Technology Sector,” the research reflected input from multiple industry stakeholder roundtables on capital formation challenges faced by small companies. CONFERENCES & SEMINARS Building on its partnership with MedTech Innovator – the industry’s global competition and accelerator program – AdvaMed Accel facilitated the Innovation Showcase and MedTech Innovator Finals Competition at AdvaMed’s annual medtech conference. Accel also organized a leadership seminar at the conference to focus on solutions to critical management issues facing emerging companies. During the year, Accel supported key events to advance capital formation and strategic partnerships in our industry. For example, Accel leveraged its relation- ships with Silicon Valley Bank, Vivo Ventures and Piper Jaffray to present the Healthcare Capital Connections Summit in Shanghai, China, providing members unique opportunities to explore fundraising and market access in this fast-growing market. POLICY DEVELOPMENT In 2016, Accel and its members contributed to AdvaMed advocacy in favor of key provisions of the landmark 21st Century Cures Act, including regulatory and reimbursement reforms to ease small companies’ path to market. In preparation for reauthorization of the Medical Device User Fee Act (MDUFA), Accel advocacy also helped ensure a pro-innovation agreement with FDA that commits the agency to improved review time goals, with continued reduced fees for small companies. PHYSICIAN-OWNED INNOVATORS In May, Accel’s long-standing advocacy to address fraud and abuse risks posed by physician-owned distributors (PODs) paid off when the Senate Finance Committee released an updated report on the entities reflecting key small-company priorities. Importantly, the report included an unambiguous statement that “hospitals must be able to recognize that certain physician ownership in legitimate innovator companies is allowable, and to differentiate legitimate physician-owned businesses from problematic POD arrangements.” u A C C E L Alexander Schueller, president of Adhesys Medical (center) accepts on behalf of his company two awards in October, including the AdvaMed Accel Virginia Shimer Rybski Memorial Award for medtech entrepreneurship, presented at AdvaMed 2016 by Accel Chairman Patrick Daly of Cohera Medical (at left), and the MedTech Innovator 2016 Execution Award, presented by Paul Grand, CEO of MedTech Innovator (at right). AdvaMed Accel Leadership Seminar panel participants at AdvaMed 2016 include, from left to right: Maria Berkman, director, Broadview Ventures; Nancy Briefs, president, CEO and co-founder, InfoBionic; Mike Black, president, Advanced Circulatory; Philip Faris, MedTech Practice Lead, ProSavant International; and Christian Haller, CEO, The RavenOye Group.