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 Pohl

Key Discussion Points:

• Crafting a dynamic biological safety plan that evolves over time
• Establishing a robust evaluation strategy from the beginning to prevent missing important tests later
• Designing studies for high-risk cardiovascular implants and the importance of addressing biocompatibility and safety concerns