What’s Up with the FDA? Part 6 – Medical Devices

October 28th, 2011 by MorganDowney Leave a reply »

In mid-October, the Food and Drug Administration Center for Devices and Radiological Health and Massachusetts General Hospital conducted a workshop on device development in obesity and metabolic disease. The two-day program covered clinical trial design, inclusion criteria, outcome targets, device development strategies and regulatory considerations. Perspectives were vigorously offered from the clinical, industry, payer and FDA perspectives.

 A couple of important issues emerged. First, device developers are as frustrated with the FDA as are drug developers. The reasons for the frustration are similar as well: uncertainty over what is clinically meaningful weight loss and the need for a new guidance for device developers which eschew the ‘one size fits all’ approach in favor of a new system which takes into account the invasiveness of the procedure and the expected amount of weight loss and its durability. The FDA is also grappling with the decision to lower the BMI threshold for gastric banding in terms of understanding the benefits of weight loss at lower BMIs.

 An extensive discussion, led by Dr. Lee Kaplan of the Harvard Medical School, focused on why developers were conducting so much research outside of the United States. The answer from the companies and venture capital investors was clear: the delays and uncertainty in the FDA process (“regulatory purgatory” was the term of one participant) cost too much time and money for a small company compared to going to Europe or South America for research and for obtaining the “CE” mark to allow marketing in Europe. The bottom line was that the device industry was looking to move its research and development base (and jobs) outside the US.