Bradley Merrill Thompson Quoted in “FDA to Hire Entrepreneurs-in-Residence to Help Develop PreCert Software Program”

Inside Health Policy

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Inside Health Policy, in “FDA to Hire Entrepreneurs-in-Residence to Help Develop PreCert Software Program,” by David Lim. (Read the full version – subscription required.)

Following is an excerpt:

FDA announced Wednesday (Sept. 6) it is hiring Entrepreneurs-In-Residence with backgrounds in software design, business process modeling, clinical trial design and investment to help develop the agency's Software Precertification (PreCert) Pilot Program -- including identifying reliable predictors of product quality, and developing data collection models. …

Brad Thompson of Epstein, Becker & Green praised the move, noting that FDA's device center has made “ample use” of EIR programs over the years. “It tends to be used when FDA is confronting a new technology, and they want to bolster their expertise for some duration while they create a new approach for new program. In addition to expertise in technology and the innovation process, personally I think FDA uses the program whenever they are struggling and want fresh ideas. It's a great way to get outside thinking, and typically thinking well outside of the box. So it can help the agency breakthrough the existing paradigm. I think that's exactly what's going on here. Certainly FDA will benefit from additional technical expertise, but I think they also quite simply want fresh thinking,” Thompson told IHP.