The Starting Line: Turning the Corner with a Device Concept (by John Gagliardi written for OrthoPreneur)
Surgeons approach me with new product ideas on a near-weekly basis. I consider myself lucky to see these in the “wishes and dreams” stages of development. Orthopaedic surgeons have many great thoughts for innovative medical devices in a field where bringing a new medical device to market can be a long and arduous journey, with unexpected challenges—everything from funding to FDA approvals.The conversations usually start at a height of about 40,000 feet before the realities of a regulated industry are presented by yours truly. The discussion’s outcome is commonly aligned with a smattering of disbelief (that this device is regulated), a hard dose of “We had better go back to the drawing board,” a spoonful of “I can’t believe that we have to comply with the Quality System Regulation for Design Controls,” and the realization that a Premarket Notification has an FDA user fee attached to it and (later on) a registration/listing fee, as well. I find myself laying out the regulations and costs involved rather swiftly because the early-on, 40,000-foot drop to the runway should include a ...
