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BiocompCHATibilityA podcast dedicated to medical device biocompatibility Author: BiocompCHATibility
BiocompCHATibility Podcast, Presented by NAMSA Unforeseen challenges and roadblocks are often present when managing and conducting medical device biological safety programs. Join NAMSA for a first-of-its-type podcast series, BiocompCHATibility, as each episode features leading industry experts and discussion on how to proactively address specific medical device evaluation scenarios, regulatory expectations and new testing methodologies. Language: en Genres: Health & Fitness, Medicine, Science Contact email: Get it Feed URL: Get it iTunes ID: Get it |
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Navigating Biocompatibility in Early Feasibility Studies
Episode 38
Monday, 22 July, 2024
In this episode of NAMSA’s BiocompCHATibility Podcast, our hosts discuss early feasibility studies and the scope of biocompatibility necessary to get started. They highlight the importance of controlling device response in a small patient group and how this approach shapes biocompatibility considerations within the framework of risk management.“The control measure of just having a few patients is definitely used as a reason why, in part Biocompatibility doesn't need to be as extensive as it needs to be for a pivotal where you have hundreds of people and commercialization where you lose practically all control.” – Don Pohl“I want to make sure I'm choosing materials that I can support in my plan that I know have a general knowledge of safety.” – Sheri Krajewski“There's no specific guidance that tells you what you have to do in terms of testing and what you don't, but the concept is you're going to creep up on everything you'll do. You'll do some biocomp for early feasibility.” – Don PohlKey Discussion Points:Crafting a dynamic biological safety plan that evolves over timeEstablishing a robust evaluation strategy from the beginning to prevent missing important tests laterDesigning studies for high-risk cardiovascular implants and the importance of addressing biocompatibility and safety concerns
