LTR 80: Building safety by design into medical devices

“There is a clear case to put the money into the design of the product, and control that, than relying on the human factor.”In this Let’s Talk Risk! conversation, Alex Saegert highlights the importance of focusing on risk reduction through safety by design, rather than relying on information for safety to users. He recommends risk practitioners to apply best practices from systems safety to build a clear understanding of system-level hazards that lead to harm in a hazardous situation through a sequence of events. Understanding the sequence of events can help create a more robust design to minimize the probability of occurrence of one or more elements involved. He reminds us that there are tools available that can be applied without significantly increasing complexity of the design. Additionally, he recommends linking hazard analysis to design controls (DFMEA) and process controls (PFMEA) to reduce and control probabilities of occurrence of the events that contribute to hazardous situations, while maintaining traceability between hazards and control actions.Listen to this Let’s Talk Risk! conversation with Alex Saegert, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps. 00:01:30 Introduction00:02:30 Connecting risk analysis with design requirements for a balloon catheter00:07:10 Estimating probability of occurrence for sequence of events00:10:03 Connecting design with process FMEA for improved reliability00:14:00 Applying functional safety to medical device design/development00:19:10 Improving cross-functional collaboration00:20:42 Open discussion and audience Q&A00:31:20 Closing comments and key takeawaysIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Tips for integrating risk analysis with design controlsLTR: Design your medical device to be robust to use conditionsLTR: Overcoming challenges in linking risk management with design controlsAbout Alex SaegertAlex Saegert is currently the President of Saegert Solutions Inc., an engineering consultancy focused on new technology commercialization, ensuring safety, reliability and usability. His professional experience includes developing ISO14971 compliant risk management programs for manufacturers of advanced class III medical devices. With over 25 years' experience in reliability engineering, product development and failure analysis across a variety of industries, Alex is a professional engineer, an ASQ-Certified Reliability Engineer (CRE), and IEC61508 Functional Safety Engineer.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. Views expressed by all speakers are their own and do not reflect those of their respective organizations. 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