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.

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.

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

This episode explores the transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) and the foundational elements required for medical device compliance. Host Etienne Nichols and guest Mike Drues discuss the philosophy of building a usable system rather than a "museum of SOPs," emphasizing that the standard list of QMS sections should be viewed as a starting point rather than an exhaustive checklist.

The conversation examines the critical differences between 510(k), De Novo, and PMA pathways regarding manufacturing requirements. While a 510(k) submission may not strictly require detailed manufacturing information at the time of filing, Mike explains why companies must remain audit-ready from the moment they register their establishment with the FDA. The discussion clarifies the timing of registration and the "radar" companies enter once they become commercially active.

Finally, the dialogue focuses on a "triage" approach for resource-constrained startups. By prioritizing Design Controls and Risk Management during early development, teams can remain compliant and ethical without over-investing in post-market systems, such as complaint handling, before they have a product on the market. Mike warns against the dangers of "copy-and-paste" quality systems, urging manufacturers to use professional judgment to tailor their processes to their specific technology.

1. 00:00 - Introduction to QMS requirements and guest Mike Drues.
2. 03:45 - The core sections of a QMS according to the Quality System Regulation.
3. 05:12 - Why the QSR list is a starting point, not a stopping point.
4. 08:20 - Regulatory vs. Ethical vs. Economical: The three legs of the medical device stool.
5. 10:30 - Do you need a full QMS for 510(k) vs. PMA submissions?
6. 13:15 - Understanding the timing and strategy for FDA Establishment Registration.
7. 15:40 - The Triage Approach: Which QMS sections matter most during early development?
8. 19:00 - The dangers of boilerplate SOPs and non-specific quality manuals.

1. Prioritize the Big Four: During the development phase, focus your limited resources on Design Controls, Risk Management, Document Control, and Supplier Quality Management.
2. Understand Pathway Nuances: While 510(k) submissions don't require manufacturing details, you must be fully compliant and ready for inspection once your establishment is registered and the product is launched.
3. Avoid Boilerplate SOPs: Quality systems must be specific to your organization. Including irrelevant device types or procedures in...

In this episode, host Etienne Nichols sits down with Ashkon Rasooli, founder of Ingenious Solutions and a specialist in Software as a Medical Device (SaMD). The conversation previews their upcoming session at MD&M West, focusing on the critical intersection of generative AI (GenAI) and quality assurance. While many AI applications exist in MedTech, GenAI presents unique challenges because it creates new data—text, code, or images—rather than simply classifying existing information.

Ashkon breaks down the specific failure modes unique to generative models, most notably "hallucinations." He explains how these outputs can appear legitimate while being factually incorrect, and explores the cascading levels of risk this poses. The discussion moves from simple credibility issues to severe safety concerns when AI-generated data is used in critical clinical decision-making without proper guardrails.

The episode concludes with a forward-looking perspective on how validation is shifting. Ashkon argues that because GenAI behavior is statistical rather than deterministic, traditional pre-market validation is no longer sufficient. Instead, a robust quality framework must include continuous post-market surveillance and real-time independent monitoring to ensure device safety and effectiveness over time.

1. 01:45 - Introduction to MD&M West and the "AI Guy for SaMD," Ashkon Rasooli.
2. 04:12 - Defining Generative AI: How it differs from traditional machine learning and image recognition.
3. 06:30 - Hallucinations: Exploring failure modes where AI creates plausible but false data.
4. 08:50 - The Autonomy Scale: Applying standard 34971 to determine the level of human supervision required.
5. 12:15 - Regulatory Gaps: Why no generative AI medical devices have been cleared by the FDA yet.
6. 15:40 - Safety by Design: Using "independent verification agents" to monitor AI outputs in real-time.
7. 19:00 - The Shift to Post-Market Validation: Why 90% validation at launch requires 10% continuous monitoring.
8. 22:15 - Comparing AI to Laboratory Developed Tests (LDTs) and the role of the expert user.

1. Right-Size Autonomy: Match the AI’s level of independence to the risk of the application. High-risk diagnostic tools should have lower autonomy (Level 1-2), while administrative tools can operate more freely.
2. Implement Redundancy: Use a "two is one" approach by employing an independent AI verification agent to check the primary model’s output against safety guidelines before it reaches the user.