Arlen Meyers, MD, is president and CEO of the Society of Physician Entrepreneurs (SoPE). He also is professor of otolaryngology, dentistry and engineering at the University of Colorado Denver. The founder or co-founder of several companies, he is a consultant to life science, IT and investment firms.

I've attended more FDA advisory committee hearings than most and believe I have a decent grasp of how those hearings should go. It's true I'm no expert, but recent hearings for medical devices have gone in a direction that strikes me as odd. For instance, at the Jan. 11 meeting of the gastroenterology/urology devices committee, FDA's Herb Lerner, MD, addressed post-market study requirements for an application filed by Torax Medical of St. Paul, Minnesota. Among the items of discussion that day were quality-of-life scores for gastroesophageal reflux and measures of esophageal pH. Lerner said: “This is a very interesting...