Let's Talk Risk! with Dr. Naveen Agarwal

Summary “For years, clinical evaluations were mostly a story. What was missing were clearly defined outcome parameters, something measurable that connects the state of the art to benefit–risk conclusions.” In this Let’s Talk Risk! conversation, host Naveen Agarwal welcomes back Florian Tolkmitt, Managing Director of Pro-Liance Global Solutions, for a timely and highly practical discussion on clinical evaluation for medical devices. The conversation centers on the newly released draft ISO standard for clinical evaluation (ISO/DIS 18969), why it was developed, and what problem it is trying to solve. Florian shares first-hand insight from his role in the ISO working group, highlighting common industry misunderstandings, especially around outcome parameters, state of the art, and the linkage between clinical evaluation and ISO 14971 risk management. Together, Naveen and Florian unpack new terminology such as clinical risk, clinical outcome parameters, and available knowledge, clarifying how these concepts are meant to sharpen focus on patient-relevant benefit–risk decisions without overloading clinical evaluation with non-clinical risk data. The episode closes with practical reflections on how manufacturers, especially those struggling with EU MDR expectations, can use this process standard to strengthen their clinical evaluation approach. Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters 00:00 Welcome and introduction to the topic of clinical evaluation 01:25 What companies still get wrong about clinical evaluation 03:10 Overview of the new ISO/DIS 18969 draft standard 05:30 Why the standard is process-focused, not regulatory 06:20 ISO 14971 as a normative reference and the idea of “clinical risk” 10:20 State of the art vs. “available knowledge” 17:40 Clinical outcome parameters and measurable benefit–risk 25:00 Why this standard matters and who will benefit most If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter. Suggested links: LTR: Clinical Evaluation Now More Important Than Ever Under EU-MDR. LTR: Smart Use of AI for Clinical Evaluation. LTR: Clinical Evaluation a Lifecycle Process Not a One Time Activity. Key Takeaways * Clinical evaluation is not a narrative exercise, it must be outcome-driven. * Not all risks belong in clinical evaluation; patient-relevant risks do. * Outcome parameters should be derived from state of the art, not after the fact. * The new ISO draft aims to harmonize global practice without reinventing regulations. * A strong clinical evaluation process improves both regulatory confidence and decision quality. Keywords Clinical Evaluation, ISO/DIS 18969, Risk Management, ISO 14971, EU MDR, Clinical Risk, Benefit–Risk Assessment, State of the Art, Post-Market Surveillance, Medical Device Regulation About Florian Tolkmitt Florian Tolkmitt is the founder and owner of PRO-LIANCE GLOBAL SOLUTIONS GmbH providing consulting services in all aspects of clinical evaluation, regulatory affairs, risk and quality management. He is an expert in clinical evaluation, post-market clinical follow up and post-market reporting compliance. As a co-founder and board member of RAPS Deutschland e.V., he is very active in the regulatory community sharing his expertise and mentoring industry colleagues. Let’s Talk Risk! with Dr. Naveen Agarwal is a bi-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. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe