In this episode, host Brandon Miller is joined by Dr. Matthew Jorgensen and Audrey Turley to delve into the critical aspects of irritation and sensitization in medical device biocompatibility. Dr. Jorgensen, a board-certified toxicologist with a Ph.D. in chemistry, serves as Nelson Laboratory’s Chemistry and Materials Scientist. Audrey Turley is a Senior Biocompatibility Expert at Nelson Labs.
Brandon, Matt, and Audrey take listeners on an educational journey through the processes and importance of irritation and sensitization testing for medical devices. These tests are vital to ensure that medical devices do not cause adverse reactions when in contact with human tissues. The episode provides detailed explanations of the methodologies used to assess these biocompatibility endpoints, helping listeners understand how to properly evaluate their products before launching them into the market.
Listeners will learn about the various standards and protocols that guide irritation and sensitization testing, including in vivo and in vitro methods. Matt and Audrey discuss the significance of these tests in the broader context of product safety and regulatory compliance. They highlight the challenges faced during testing and offer practical advice on how to overcome them to ensure accurate and reliable results.
The discussion also covers real-world examples and case studies, illustrating the potential pitfalls and best practices in irritation and sensitization testing. By understanding these principles, manufacturers can better prepare their medical devices for regulatory approval and successful market entry.
This episode is part of the Intro into Biocompatibility podcast series and is essential for professionals involved in the development, testing, and regulatory compliance of medical devices. Tune in to gain valuable insights into irritation and sensitization testing and learn how to ensure the safety and effectiveness of your medical devices.