LTR 128: Edward Ball on AI, Vigilance and Future of MedTech Regulation

Summary“Risk management is nothing without asking questions. And just as important, we need to create a culture where people aren’t afraid to ask them, because without that, everything grinds to a halt.”In this Let’s Talk Risk! conversation, host Naveen Agarwal welcomes Edward Ball, Manager of Intelligence and Strategic Execution at RQM+. Ed shares insights from his 20+ years in medical devices, including his unique perspective gained through roles at MHRA, ConvaTec, Fresenius Kabi, and now RQM+. The conversation dives into his role in monitoring regulatory intelligence, supporting clients in navigating evolving global requirements, and making sense of the shifting landscape of risk and compliance.Ed and Naveen explore key themes from the recent RAPS Euroconvergence Conference, including the growing influence of AI in regulatory processes, the importance of standardized IMDRF coding for vigilance and trending, and the need to bridge gaps between post-market surveillance, risk management, and complaints handling. They also reflect on how language and interpretation such as “indicators,” “benefit-risk ratio,” and “state of the art” are shaping our understanding and regulatory expectations. Ed closes with a reminder that asking the right questions, building systems that deliver actionable answers, and fostering a culture of curiosity are essential to effective risk management.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters* 00:10 – Introducing Edward Ball* 02:41 – Insights from the RAPS Euroconvergence Conference* 04:41 – AI in MedTech regulation and FDA’s use of AI tools* 07:00 – AI for vigilance reporting and trending of adverse events* 09:00 – Importance of IMDRF coding and challenges with standardization* 12:00 – Disconnect between vigilance, complaints, and risk management files* 16:20 – Indicators vs. thresholds in post-market surveillance* 18:30 – Misinterpretations of “benefit-risk ratio” and “state of the art”* 22:00 – Regulatory expectations vs. manufacturer practices* 23:47 – Announcements, Key takeaways and Closing CommentsIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Defining state of the art can be challenging - here are a few tips.LTR: AI use cases in MedTech regulatory applications.ACHIEVE: PMS Workshop.Key Takeaways* AI is increasingly used by regulators for trending and vigilance, but its outputs are only as reliable as the inputs.* Standardized IMDRF coding is critical for consistent vigilance reporting and meaningful trend analysis.* Many companies still struggle to align internal complaints data with standardized codes, creating disconnects in risk management.* Post-market surveillance (PMS) is not new, but it must be integrated into the quality and risk management system, not treated as a silo.* “Indicators” in PMS are not always numeric; a single new signal or case can be just as important as statistical thresholds.* Misinterpretation of terms like “benefit-risk ratio” or “state of the art” can cause regulatory confusion and misaligned expectations.* Regulators, notified bodies, and manufacturers often use different definitions, underscoring the need for clearer common language.* Building PMS systems around the questions you need to answer ensures data is actionable for patients, regulators, and companies.* A culture of curiosity where people feel safe asking questions is essential for effective risk management.* Continuous learning and diverse perspectives strengthen both regulatory understanding and organizational decision-making.KeywordsAI in MedTech, Vigilance reporting, IMDRF coding, Post-market surveillance (PMS), Risk management, Regulatory intelligence, Benefit-risk ratio, State of the art, Trend reporting, Complaints handling, Patient safetyAbout Edward BallEdward Ball is a seasoned medical device specialist with over 20 years of experience spanning regulatory compliance, risk management, product safety, quality systems, and post-market surveillance. He has held leadership roles at RQM+, Fresenius Kabi, ConvaTec, and the UK’s MHRA, where he led complex investigations, vigilance reporting, and technical reviews of medical devices.With a strong foundation in medical engineering (MSc, University of Liverpool), Edward brings deep expertise in design controls, incident investigation, and CAPA systems, helping organizations navigate evolving global regulatory frameworks and ensure patient safety.Let’s Talk Risk! with Dr. Naveen Agarwal is a 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.DisclaimerInformation 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