LTR 110: Focusing on reliability to build safe medical devices

Summary“If your device fails 1 out of 100 times, you might think it is good. But if that one time is in the middle of surgery, or when the parent is using it for their children, you are bringing harm.” In this episode of the Let's Talk Risk Podcast, Naveen Agarwal and Mitra Soltani delve into the critical relationship between reliability and safety in medical devices. They discuss the importance of effective communication and leadership in engineering, the challenges faced by startups in balancing speed and reliability, and the significance of assumption registers in the design process. Mitra shares her career journey, pivotal moments, and offers valuable advice for aspiring professionals in the QA/RA field.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:25 Introducing Mitra Soltani04:14 Link Between Safety and Reliability05:52 Understanding the Connection With Design Inputs07:07 How Using an Assumption Register Can Help With Reliability10:31 Challenges in Startups: Balancing Speed and Reliability14:00 Training for Success: Preparing Teams for Reliability15:33 An Example of Testing for Reliability Before Launch20:41 Career Reflections: Pivotal Moments and Lessons Learned23:20 Career Tips for QA/RA Professionals25:17 Closing Comments and Key TakeawaysSuggested links:* LTR - Fidelis lead recall, probability and statistics, and career tips with Eric Maas.* LTR: It’s time to start applying system safety to medical devices.* Mitra Soltani: Superstars of Tomorrow.Key Takeaways* Reliability and safety are interconnected in medical devices.* Effective communication is essential for engineers.* Assumption registers help clarify design expectations.* Startups often overlook reliability in their rush to market.* Training early can enhance team effectiveness.* Decisions made early in a career can shape future opportunities.* Understanding user environments is crucial for design success.* Designing for worst-case scenarios is necessary for reliability.* Learning from decisions is key to professional growth.* Leadership must prioritize reliability in product development.KeywordsMedical devices, risk management, reliability, safety, engineering, startups, communication, leadership, career development, assumption registerAbout Mitra SoltaniMitra Soltani is a reliability engineer, innovator and consultant in the medical device industry. In a career spanning over 15 years, she has worked on a variety of complex electromechanical medical devices, including the VERITAS vision system, a next-generation cataract surgery platform that enhances patient outcomes and surgeon efficiency. Specializing in embedded hardware design, she has delivered over 7 medical and commercial devices, from concept to market, while driving strategic decisions that boost efficiency and deliver cost savings. She has a Bachelor’s degree in Electrical, Electronics and Communications Engineering, and numerous continuing education certifications. 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.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.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