Institute Collaborates With FDA to Increase the Efficiency of the Medtech Approval Process

by | Sep 5, 2015 | Alliances, Education, Fogarty Innovation, Policy

Dr. Thomas Fogarty has long worked with regulatory bodies in his quest to improve and expedite the approval process for medical devices.

His quest came to fruition when the Food & Drug Administration proposed to work with the Institute to learn more about the challenges that medtech startups face when bringing their products to market.

We are excited to announce that we recently signed an agreement with the FDA to begin a first-of-its-kind educational program. The goal of the program is to help accelerate medical device innovation by improving communication, collaboration and understanding between the FDA and early-stage medical device innovators, thereby improving the overall efficiency of the medical device approval process.

This initial pilot program is a strong step forward. The Institute recently hosted two FDA reviewers from the Office of Device Evaluation in the FDA’s Center for Device and Radiological Health, the governmental body that is responsible for the program areas through which medical devices are evaluated or cleared for clinical trials and marketing. The FDA staff participated in a one-week educational program at the Institute, working closely with our startups to obtain a better understanding of what it takes to bring a device to market in the U.S., and the impact FDA policy and decisions have on startups’ ability to commercialize innovative and potentially life-saving technologies.

“This is a critical step to help develop a safe and effective U.S. medical device ecosystem, with the end goal of supporting medical innovation that benefits patients,” said Ann Fyfe, President and CEO of the Fogarty Institute. “The Institute provided FDA staff with access to a ‘living laboratory’ of medical device start-up companies, providing insight into the challenges faced by these companies; and, in turn, offering our companies-in-residence a better understanding of the positive impact the FDA can have on the development of safer medical devices.”

“Our goal at the FDA is to promote innovation and efficacy in medical devices, to better serve the American public while maintaining the highest level of safety,” said Murray Sheldon, MD, Associate Director for Technology and Innovation in the FDA’s Center for Devices and Radiological Health. “We believe this collaboration will assist the FDA in better understanding the unique considerations of medtech startups; and the costs, time and money incurred during early-stage development to bring their innovation to doctors and patients.”

We are grateful to the FDA for partnering with the Institute to improve the mutual understanding between the startups and the Agency, for the greater good of patients. We look forward to continuing our discussions and building on our pilot program.

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