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

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

Lifecycle is the New Frontier: You must now evaluate biocompatibility throughout the product's life, especially for reprocessed devices that

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

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