FDA Staff to Gain Insight On Challenges Facing Startups

For years, medical device companies have complained of their frustration with inconsistency in decisions by different FDA reviewers. A new program is aiming to change that — at least for startups.

The Fogarty Institute for Innovation, a Mountain View, Calif.-based nonprofit, has inked an agreement with the agency with the goal of improving communication, collaboration and understanding between the FDA and early stage medical device innovators.

As part of the arguement, representatives from the CDRH’s Office of Device Evaluation will be part of an initial group to take part in a one-week program working with startups to gain insight into why it takes devices so long to come to market in the U.S.

Ann Fyfe, Fogarty’s president and CEO, says the program will give the FDA access to a ‘living laboratory’ of startups, while innovators will have a chance to see how the agency can have a positive impact on the development of novel 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,” adds Murray Sheldon, MD, associate director for technology and innovation at 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.”— Elizabeth Hollis