LTR 81: 4 key themes in risk management and an upcoming conference

Summary“We are all at some point, either patients or loved ones of patients. So, one way or another, we are all touched by the medical technology we create ourselves. In this episode of the Let's Talk Risk Podcast, Bijan Elahi helps us appreciate the most important aspect of our work as risk practitioners, engineers and quality/regulatory affairs professionals in the medical device industry. That our work makes a direct impact on health and wellness of our loved ones and patients across the world. We focus on 4 big themes in risk management that will continue to demand our attention in 2025 and beyond - AI/ML, cybersecurity, post-market surveillance and usability engineering. QA/RA professionals will need to stay updated as they help their organizations navigate through challenges in these areas. We also talk about an upcoming Conference in April 2025 that will focus exclusively on safety risk management of medical devices. Register now - early bird discounted pricing available until 28 February 2025. Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:00 Introduction and Keynote Insights06:13 AI and Machine Learning in Medical Devices09:08 Cybersecurity Challenges in Medical Devices12:19 Post-Market Safety Surveillance16:07 Usability Engineering and Human Factors18:33 Upcoming Conference Details and TakeawaysSuggested links:* International conference on medical device safety risk management. * LTR: AI/ML in MedTech. * LTR: Medical device cybersecurity now more critical than ever. * LTR: Best practices for applying usability engineering to medical devices. Key Takeaways* We are all at some point either patients or loved ones.* The impact of biomedical engineers on MedTech safety is huge.* AI/ML devices evolve and their performance is not static.* Cybersecurity is increasingly critical for medical devices.* Post-market surveillance is essential for ongoing safety.* Usability engineering can prevent misuse of medical devices.* Collaboration across functions is vital for effective risk management.* The FDA emphasizes explainability in AI ML devices.* Learning from post-market data can improve future designs.* Conferences provide valuable opportunities for knowledge sharing.KeywordsRisk management, AI, machine learning, cybersecurity, medical devices, usability engineering, post-market surveillance, safety conference, safety, healthcareAbout Bijan ElahiBijan Elahi is the founder of MedTech Safety and a globally recognized expert on safety risk management of medical devices. Bijan is a technical fellow, and an affiliate professor at Drexel University, USA. Bijan is also a lecturer at Eindhoven University of Technology in the Netherlands, where he teaches risk management to doctoral students in engineering. He is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. He has trained over 10,000 people worldwide and his book Safety Risk Management of Medical Devices, now in its second edition, is a bestseller.DisclaimerInformation and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. 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