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.
Chapters
00:15 Introducing Marina Daineko
01:16 Quick Update on Proposed Changes in ISO 10993-1
03:42 Applying a Risk-Based Approach in Biocompatibility
05:58 Endpoints vs. Biological Effects in Biocompatibility
10:27 Navigating Uncertainty at FDA in Biocompatibility Evaluation
13:25 Clarifying Endpoints in Biocompatibility Evaluations
15:01 Common Challenges in Biocompatibility Evaluations
16:22 Connecting Design and Process FMEA to Ensure Biocompatibility
18:19 Understanding Requirements for Cumulative Contact Exposure
22:06 Environmental Controls and Data Analytics for Biocompatibility
24:49 Future Considerations: Nanomaterials and Patient Safety
26:39 Announcement, Closing Comments and Key Takeaways
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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.
Keywords
Biocompatibility, ISO 10993-1, risk-based approach, medical devices, biological assessments, cumulative contact exposure, environmental controls, data analytics, patient safety, advanced materials
About Marina Daineko
Marina 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.
Disclaimer
Information 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.
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