SDT Orthopedic Innovations

by Dr. Grant Garcia | 1 year ago

How do orthopedic surgeons take a napkin idea into a full-blown product? In business, there are well-validated step processes to get this done. In this show, Dr. Grant Garcia discusses taking an idea through to full approval from the FDA: the BEAR Implant. We also discuss how innovation is manufactured and marketed, and the concerns surgeons and hospitals may have especially when they are hesitant to adopt new tech due to concerns about safety, effectiveness, and costs. We touch upon how using the 501(k) pathway is a faster and less expensive way to gain FDA approval for a new use of an existing device or implant.