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 325 UNLEASHINGOUR POTENTIAL America’s medical technology industry creates life-saving and life-enhancing treatments and cures that drive efficiencies and cost savings in the health care system, improve the quality of patient care and generate high-quality jobs that contribute to economic growth. In this century of the life sciences, the opportunities for life-changing new treatments and diagnostics are breathtaking. But the innovation ecosystem that supports medical technology development today also faces unprecedented challenges that impede rather than speed our progress. To respond to these challenges, AdvaMed proposed in February a new Innovation Agenda. AdvaMed’s Innovation Agenda – including a streamlined, seamless pathway at FDA and the Centers for Medicare and Medicaid Services (CMS) for significant breakthrough products – is a comprehensive program to unleash the potential of medical technology to extend and improve lives, reduce the cost and burden of disease, and maintain and enhance U.S. scientific and economic leadership. AdvaMed’s Innovation Agenda consists of five “pillars,” each addressing a key component of the American innovation eco­ system. They include: improving FDA’s regulatory processes, restructuring CMS’s coverage and payment processes, reforming the U.S. tax system, improving access ­ to international markets, and supporting the maintenance and growth of America’s R&D infrastructure. Throughout this report are further details of these five pillars, which will guide the Association’s long-term advocacy activities. In 2015, AdvaMed worked with policymakers and other industry stakeholders, and with lawmakers in Congress, to advance our proposals and to help ensure the continued promise of breath- taking medical progress in this century of the life sciences. I N N O VA T I O N A G E N D A Vanessa Ghigliotty was a recent college graduate and single mother working as a nanny when she was diagnosed with stage four colon cancer. Admitted to the hospital for a suspected burst appendix, an x-ray revealed tumors both inside and outside of her colon. One year later, a PET scan detected a recurrence. After eight surgeries and three years of chemotherapy, Vanessa is a cancer-free advocate for life-saving innovations. P R O F I L E I N I N N O VAT I O N