LTR 109: Focus on risk, not just testing, for biocompatibility of medical devices

Summary“Know your device, prepare your biological evaluation plan and apply a risk-based approach.”In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with biocompatibility expert Marina Daineko to discuss the intricacies of biocompatibility assessments for medical devices. They explore the upcoming updates to ISO 10993-1, the importance of a risk-based approach, and the distinction between effects and endpoints in biocompatibility. Marina shares insights on common challenges faced in biological assessments, the implications of cumulative contact exposure, and the role of environmental controls and data analytics in ensuring patient safety. The conversation emphasizes the need for a comprehensive understanding of biocompatibility in the context of evolving materials and regulatory standards.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:15 Introducing Marina Daineko01:16 Quick Update on Proposed Changes in ISO 10993-103:42 Applying a Risk-Based Approach in Biocompatibility05:58 Endpoints vs. Biological Effects in Biocompatibility10:27 Navigating Uncertainty at FDA in Biocompatibility Evaluation13:25 Clarifying Endpoints in Biocompatibility Evaluations15:01 Common Challenges in Biocompatibility Evaluations16:22 Connecting Design and Process FMEA to Ensure Biocompatibility18:19 Understanding Requirements for Cumulative Contact Exposure22:06 Environmental Controls and Data Analytics for Biocompatibility24:49 Future Considerations: Nanomaterials and Patient Safety26:39 Announcement, Closing Comments and Key TakeawaysIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Understanding risk-based thinking.LTR: Tips for a risk-based approach to auditing Quality Systems. ACHIEVE: Post-market surveillance workshop.Key Takeaways* Know your device thoroughly.* Prepare a comprehensive biological evaluation plan.* Apply a risk-based approach and understand its implications.* Stay updated with the latest standards and guidelines.* Consider cumulative contact exposure in assessments.* Connect design and process FMEAs for better traceability.* Utilize data analytics for environmental monitoring.* Engage cross-functional teams in risk management processes.* Understand the systemic toxicity of materials used in devices.* Be proactive in addressing challenges related to advanced materials.KeywordsBiocompatibility, ISO 10993-1, risk-based approach, medical devices, biological assessments, cumulative contact exposure, environmental controls, data analytics, patient safety, advanced materialsAbout Marina DainekoMarina Daineko is a Biocompatibility Consultant at Intrinsic Medical Group (IMG), with an MSc in Analytical Chemistry and over 10 years of experience in the medical device industry. She is a Certified Biological Evaluator and Subject Matter Expert in ISO 10993-1:2018. Marina is the author of 15 scientific papers and holds 2 patents in the field of material science. In recognition of her contributions, she was nominated for the Women in Tech Award in 2023 and was named one of the top 25 MedTech Leading Voices on LinkedIn. Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe