{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F46d21a18-e85f-485a-b0c4-3be090091891","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Biocompatibility Nuances and its Impact on Medical Devices","description":"Biocompatibility can be challenging and frustrating when developing a medical device. Why do you have to spend time and money to do the same testing, if the materials used in your device have already been tested, approved, and put in medical devices on the market? Biocompatibility impacts the majority of medical devices. \n\nToday\u2019s guest is Josh Crist, a biocompatibility expert who used to work for the FDA and is now with Biologics Consulting and he and Jon discuss the nuances of biocompatibility.\n\nSome of the highlights of the show include:\n \n\u25cf\tBest practices for biocompatibility include using the ISO 10993 test matrix for evaluating tissue, duration, and other factors. \n\u25cf\tA common misconception about the test matrix is how the FDA determines and considers cumulative contact. \n\u25cf\tAre all tests absolutely necessary? Are there other ways to reduce testing requirements? Consider chemical characterization and risk assessments.\n\u25cf\tJosh describes challenges he experienced as both a biocompatibility consultant and FDA reviewer. \n\u25cf\tWhat the FDA expects with chemical characterization: Master file, testing on final finished device, and more. \n\u25cf\tStart with FDA\u2019s biocompatibility guidance documents, interact early on with FDA during pre-submission process, and conduct quantitative and qualitative tests. \n\u25cf\t\u201cI promise\u2026\u201d days are gone. Other options for 510(k) to avoid getting additional information (AI) letter or not substantially equivalent (NSE) decision.\n\u25cf\tMost common mistake made by companies when it comes to biocompatibility is not testing.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/dafd1f38-b434-40bd-8e16-a7e06b42758e/9cb396d8-4115-473b-809f-9646179907e2.jpg"}