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.
Dr. Garcia discusses how he and other surgeons utilize Biomechanical labs for innovation in orthopedic implants. In these labs, extensive testing is done to validate the performance of orthopedic implants before they are used in patients. They must provide the necessary data and effectiveness before meeting FDA approval. Last, but not least we discuss Arthrex, the industry leader. Arthrex is a hub for all levels of design, engineering, marketing, teaching, learning videos, and more. Dr. Garcia mentioned he had utilized the SwiveLock anchor numerous times and how suture tape was a staple in his surgeries just like so many other doctors. I joked that I had seen one of their videos online utilizing the nano-SwiveLock on a patient's finger as they did a finger repair using an internal brace. I told him I was ready to perform surgery. Maybe not just yet.
Check out Sports Doc Talk with Will Sanchez and Dr. Grant Garcia on all major podcast platforms and also on our YouTube channel. Please reach out to us for any questions or show ideas at sportsdoctalkpodcast@gmail. You can also reach Dr. Grant Garcia at grantgarciamd.com for great orthopedic information and content.
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