Episode 445

#445: ISO 10993-1:2025: What Risk-Based Biocompatibility Means for MedTech

In this episode, Etienne Nichols sits down with Thor Rollins, a leader at Nelson Labs and the convener of the committee revising ISO 10993-1. The conversation centers on the newest 2025 version of the standard, which represents a massive philosophical shift from a "checkbox" testing mentality to a rigorous, risk-based approach aligned with ISO 14971.

Rollins explains that modern medical devices are far more complex than the metal and hard plastics of the past. With the rise of degradable materials, coatings, and nanomaterials, traditional animal testing often fails to provide the best science. The new standard introduces critical concepts such as biological risk estimation, foreseeable misuse, and a comprehensive lifecycle evaluation that looks beyond "time zero" safety.

The duo also discusses the practical implications for manufacturers, including the controversial requirement to evaluate biocompatibility at the end of a product’s lifecycle—a particular challenge for reprocessed devices. Rollins provides insider knowledge on the US’s stance on the revision, the timeline for FDA recognition, and how companies can leverage biological equivalence to potentially reduce their testing burden.

Key Timestamps

1. 01:45 – The shift from "checkboxing" to a risk-based approach.
2. 03:10 – The rapid timeline of the 2025 revision and the influence of ISO 14971.
3. 04:22 – Lifecycle Evaluation: Assessing safety beyond the "brand new" state.
4. 06:50 – Chronic toxicity vs. acute reactions: Why front-end evaluation matters.
5. 08:15 – Foreseeable Misuse: When doctors use scopes outside their intended anatomy.
6. 12:10 – The concept of Bioequivalence: Using existing data to justify reduced testing.
7. 13:45 – Breakthrough: The removal of material-mediated pyrogenicity testing for known materials.
8. 15:30 – Why the US voted "No" on the current draft: A call for better guidance.
9. 18:50 – Notified Bodies and MDR: The 2025 version as "State of the Art."
10. 21:15 – Practical chemistry tests for aging polymers (DSC, GPC, FTIR).
11. 25:40 – Advice for small vs. large companies on building material databases.

Quotes

"The testing that we developed back in the 50s and 60s actually doesn’t really work the best with some of these complex devices... we’ve been moving the standard away from what we call checkboxing." - Thor Rollins

"I only say that expensive tests always impact innovation. We don’t want to over-test, but we want to do the right tests." - Thor Rollins

Takeaways

1. Lifecycle is the New Frontier: You must now evaluate biocompatibility throughout the product’s life, especially for reprocessed devices that may degrade after hundreds of cleaning cycles.
2. Foreseeable Misuse is a Regulatory Reality: If it is likely a clinician will use your device off-label (e.g., a pulmonary scope used in vascular applications), you must account for that biological risk in your assessment.
3. Leverage Bioequivalence: Stop testing the same stainless steel or titanium repeatedly. Use existing data and internal databases to justify "no testing" for known materials and processes.
4. Partner with Expertise: Because the standard is less prescriptive and more risk-based, the quality of your Biological Evaluation Plan (BEP) depends entirely on the expertise of the person writing it.
5. Chemistry over Animals: Whenever possible, use chemistry (Extractables & Leachables) and in vitro methods to replace legacy animal tests, as the 2025 revision officially begins to phase out certain animal-based requirements.

References

1. ISO 10993-1:2025: The primary global standard for the biological evaluation of medical devices.
2. ISO 14971: The standard for the application of risk management to medical devices, now heavily integrated into 10993-1.
3. Nelson Labs: The laboratory where Thor Rollins leads biocompatibility strategy.
4. Etienne Nichols: Connect with Etienne on LinkedIn.

MedTech 101: Bioequivalence

Think of bioequivalence like buying a generic medication versus a brand-name one. If you know the ingredients (materials) and the way they are manufactured (processes) are identical to a device that has already been proven safe on the market, you shouldn’t have to re-run expensive, time-consuming tests. In MedTech, this means showing that your "New Device B" is biologically the same as your "Proven Device A" because they use the same grade of titanium and the same sterilization method.

Sponsors

This episode is brought to you by Greenlight Guru. As the industry shifts toward a risk-based approach as seen in ISO 10993-1:2025, having a centralized source of truth is vital. Greenlight Guru’s QMS (Quality Management System) allows you to integrate risk management directly into your design process, while their EDC (Electronic Data Capture) solution helps you gather the clinical evidence needed to prove long-term safety. When your risk assessments and clinical data live in the same ecosystem, "state of the art" compliance becomes a standard, not a struggle.

Feedback Call-to-Action

We want to hear from you! How is your team preparing for the 2025 revision of ISO 10993-1? Are you concerned about the lifecycle evaluation requirements? Send your thoughts, questions, or topic suggestions to podcast@greenlight.guru. We read every email and love providing personalized responses to our community.