An Investigational Device Exemption (IDE) approval is necessary before conducting FDA sanctioned medical device clinical trials. Companies often (around 200 times per year) utilize an informal pre-IDE process as a pre-cursor to the IDE application for the purpose of gaining insight from their FDA review team and presenting their product and testing or clinical plan. But, what seems like a no-brainer is not right for all projects, and a company needs to know to drop the informal interaction when it no longer serves its purpose. Read More
Many, if not most, medical device companies perform pilot clinical studies outside of the U.S. Cost reductions, avoiding a protracted FDA Investigational Device Exemption (IDE) approval process, and the ability to make design changes during the study without continual IDE amendments are the leading reasons to perform early studies outside the U.S (OUS). Read More
Incorporating clinical studies prior to design “freeze” into a medical device product development plan is foreign to some organizations, including supposedly nimble start-ups. Changing a company’s clinical research philosophy requires well-defined goals, proactive collaboration between functional areas and discipline. Read More
The current state of medical device product development has relegated clinical trials to achieving two goals: 1.) reaching a milestone for funding or exit, or 2.) supporting regulatory submissions. Unfortunately, what has been lost is the pursuit of learning that drives refinement of the device.