LTR 78: New challenges in managing risks of software in IVDs

“Software more than any other type of device, has integrations with other systems and devices. You have to consider a complex network of dependencies and infrastructure when analyzing risks.”In this Let’s Talk Risk! conversation, Megan Kane highlights the growing role of software, including artificial intelligence, in in-vitro diagnostic devices, including in next generation sequencing applications. We are now living at at time where technology is rapidly enabling precision medicine solutions for an individual patient. In this high-tech environment, increasingly driven by software, new risks are also emerging. Cybersecurity, patient data privacy, service availability are common concerns. But when it comes to IVDs, it becomes challenging to connect the dots to find a direct link to the patient. Inaccurate or delayed results are common risks related to IVDs, but their potential impact on a patient is difficult to figure out with sufficient confidence. It often results in underestimating the severity of potential harm as reflected by a recent FDA warning letter. Another key development in this area is the new FDA regulation for Lab Developed Tests (LDT), which is expected to add new requirements for pre-market reviews, risk management and quality system. Listen to this Let’s Talk Risk! conversation with Megan Kane, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps. 00:01:10 Introduction00:01:50 How software is increasingly driving IVD applications00:03:30 Emerging risks with software in IVDs00:06:15 Evolving regulatory approach to IVDs affecting LDTs00:09:13 Increasing focus on risk management for LDTs00:12:50 Risk considerations when software is a component of an IVD00:15:30 Open discussion and audience Q&A00:28:01 Closing comments and key takeawaysIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: 3 pillars for defining your IVD risk management strategyLTR: Focus on intended use for risk management of IVDsFDA: Laboratory developed testsAbout Megan KaneMegan Kane is currently Director of Regulatory Operations at Velsera, where she supports the mission of radically improving healthcare globally through multi-omics to fuel growth of precision medicine. She is primarily involved in developing advanced software, including AI applications for end-to-end Next Gen Sequencing analysis. Previously she held various roles in Quality and Regulatory functions at both large and small medical device and in-vitro diagnostic companies. She holds a Bachelor’s degree in Molecular and Cell Biology, and Internal Auditor certifications from BSI in ISO 13485:2016 and ISO 9001:2015. 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