Fogarty Institute, FDA Partner on Education Program for Startups

The Fogarty Institute for Innovation, a nonprofit that provides intellectual, physical and financial resources to medtech startups, has signed an agreement with the U.S. Food & Drug Administration (FDA) to help educate early-stage companies on the device approval process.

The educational program is designed to help accelerate medical device innovation by improving communication, collaboration and understanding between the FDA and early-stage medical device innovators, and thereby improve the overall efficiency of the medical device approval process, Fogarty executives said.

Initial FDA participants include representatives of the Office of Device Evaluation in the FDA’s Center for Device and Radiological Health (CDRH), the governmental body that is responsible for the program areas through which medical devices are evaluated or cleared for clinical trials and marketing. FDA staff recently participated in a one-week educational program at the Institute, working closely with its startups to obtain a better understanding of what it takes to bring a device to market in the United States, 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 for Innovation. “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, M.D., associate director for Technology and Innovation at the CDRH. “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.”

The Fogarty Institute for Innovation is a 501(c)(3) non-profit that helps early-stage medical companies transform their ideas into medical products that improve patient care. Medical innovators are offered workspace, research and development resources, financial aid, and mentoring by physicians and industry experts to bring their products to market. Based in Mountain View, Calif., the Institute was founded in 2007 by internationally renowned cardiovascular surgeon Thomas J. Fogarty, M.D.