Global Medical Device Podcast powered by Greenlight Guru

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

Quotes
"This is a starting point. This is not a stopping point... Use your own good judgment." — Mike Drues"The goal is not really to build a museum of SOPs; the goal is a quality management system that teams will actually use." — Etienne NicholsTakeaways
Prioritize the Big Four: During the development phase, focus your limited resources on Design Controls, Risk Management, Document Control, and Supplier Quality Management.
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.
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.
Key Timestamps
01:45 - Introduction to MD&M West and the "AI Guy for SaMD," Ashkon Rasooli.
04:12 - Defining Generative AI: How it differs from traditional machine learning and image recognition.
06:30 - Hallucinations: Exploring failure modes where AI creates plausible but false data.
08:50 - The Autonomy Scale: Applying standard 34971 to determine the level of human supervision required.
12:15 - Regulatory Gaps: Why no generative AI medical devices have been cleared by the FDA yet.
15:40 - Safety by Design: Using "independent verification agents" to monitor AI outputs in real-time.
19:00 - The Shift to Post-Market Validation: Why 90% validation at launch requires 10% continuous monitoring.
22:15 - Comparing AI to Laboratory Developed Tests (LDTs) and the role of the expert user.

Quotes
"Hallucinations are just a very familiar form of failure modes... where the product creates sample data that doesn't actually align with reality." - Ashkon Rasooli"Your validation plan isn't just going to be a number of activities you do that gate release to market; it is actually going to be those plus a number of activities you do after market release." - Ashkon RasooliTakeaways
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.
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.

Dr. Jenny Hoffmann, MedTech executive and author of Open Up: Step Into the Leader You Are Meant to Be, joins host Etienne Nichols to discuss the evolution of leadership in the medical device industry. Drawing from her experience as a bioengineer and CEO, Dr. Hoffmann explains why the traditional model of the "rigid, perfect leader" is no longer sustainable. She shares her personal journey—from being one of the first IVF babies in the U.S. to navigating life-threatening health complications—and how these experiences shaped her mission to help others lead with authenticity.
The conversation centers on the concept of "SOS moments," which Dr. Hoffmann defines as those critical points of distress or crisis that occur in both personal lives and product development. By applying her CEC framework—Curiosity, Empathy, and Connection—leaders can transform these high-pressure moments into stories of strength. This approach is particularly vital in MedTech, where the ultimate goal is to serve patients during their own most vulnerable SOS moments.
Etienne and Jenny also explore the intersection of human leadership and emerging technology. While AI continues to streamline technical workflows, Dr. Hoffmann argues that human empathy and curiosity remain irreplaceable assets for innovation. The episode concludes with a practical look at the return on investment (ROI) for "opening up," demonstrating how personal connection leads to higher quality products, better team retention, and the resilience needed to survive the "messy middle" of product development.
Key Timestamps
00:00 - Introduction of Dr. Jenny Hoffmann and her background in MedTech and innovation.
01:28 - Motivation for writing Open Up: Scaling impact through vulnerable storytelling.
04:23 - The shift from the "perfectly composed" leader to the vulnerable leader.
05:45 - Dr. Hoffmann’s personal origin story: Being one of the first IVF babies in the U.S.
08:30 - Listening to the "whisper" and the courage required to respond to inner intuition.
10:14 - The ROI of Vulnerability: How personal connection drives higher quality and team motivation.
14:39 - Defining SOS moments: Turning distress signals into leadership strengths.
18:42 - The CEC Method: Breaking down Curiosity, Empathy, and Connection.
20:25 - AI in MedTech: Why human empathy is the one thing machines cannot replace.
25:57 - Strategic Sharing vs. Oversharing: How to lead by example without losing professional boundaries.
28:52 - The power of storytelling for engineers and data-driven professionals.

Quotes
"The leader is the first one to step out on the bridge that no one’s sure if they want to cross. You paint that vision of the bridge, and then you’re the first one to step out on it." - Dr. Hoffman"If we can put empathy first and think about how we are each a patient first... then we can uncover the real needs to

In this episode, Etienne Nichols and guest Ashkon Rasooli explore the transformative impact of AI in the medical device industry. From AI-driven diagnostics and wearable health monitors to the future of surgical robots, they delve into how these technologies are reshaping healthcare.
The discussion also touches on the challenges and opportunities in validating and regulating AI within MedTech, highlighting real-world applications and predicting future trends.
"Validation of AI tools in MedTech requires a staged adoption to build confidence due to the inherent uncertainty in AI outcomes." - Ashkon Rasooli
00:00 - Introduction to AI in MedTech
05:15 - Discussing AI's deterministic vs. statistical nature
12:30 - AI in diagnostics: Radiology, Cardiology, and Neurology
20:45 - Wearable health monitors and patient-driven health data
28:10 - The role of AI in medical device operations and manufacturing
35:00 - AI at the point of care: Enhancing patient and clinician experience
42:15 - Regulatory challenges and the future of AI in healthcare

Key Takeaways:
1. Latest MedTech Trends:
The integration of AI in diagnostics is growing, particularly in radiology, cardiology, and neurology, aiding in more accurate and quicker diagnoses.
Wearable health monitors are empowering patients to take control of their health data, leading to personalized healthcare solutions.

2. Practical Tips for MedTech Enthusiasts:
Stay informed about the latest AI advancements and regulatory guidelines to leverage AI effectively in MedTech.
Consider the ethical implications and ensure bias mitigation in AI model training and deployment.

3. Predictions for the Future:
Increased adoption of AI across various healthcare sectors, including surgery and patient care management.
Evolution of regulatory frameworks to better accommodate and oversee AI-driven medical devices.

References:
Ashkon Rasooli on LinkedIn
[email protected]
Engenius Solutions
AFDO/RAPS Working Group
Etienne Nichols on LinkedIn

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