LTR 67: 3 pillars for defining your IVD risk management strategy

“There are 3 pillars I consider essential to defining a strategy for IVD risk management. What is the system definition, who are the user groups, and what is the level of novelty?”In this Let’s Talk Risk! conversation, Claudia Campbell-Matland highlights the broad range of in-vitro diagnostic devices (IVD), which requires a strategic approach to their development and risk management. Claudia advises IVD manufacturers to consider their risk management strategy and scope under 3 pillars - the system definition, the target user groups and the level of complexity. A simple, home-based IVD requires a very different approach than a highly complex analytical system used as a companion diagnostics for highly sophisticated immunotherapies. She recommends taking some time to develop a business strategy first before jumping into product development and risk management activities. Listen to this Let’s Talk Risk! conversation with Claudia Campbell-Matland, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.00:01:33 Introduction00:03:03 Strategic questions to ask for IVD risk management00:05:10 3 pillars of IVD risk management strategy00:06:45 Example of a strategy for a simple point-of-care assay IVD00:08:31 Special considerations for home-based IVDs00:09:20 Leadership opportunity for QA/RA professionals in setting strategy00:10:15 Practical tips for assigning severity and probability for IVD risks00:12:51 Latest update on LDTs00:14:50 Audience Q&A and open discussion00:35:50 Closing comments and key takeawaysIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR podcast: Focus on intended use in the clinical environment for IVD risk managementLTR podcast: Risk management of IVDs requires a different approachAbout Claudia Campbell-MatlandClaudia Campbell-Matland is a consultant and managing member at CNCM Consulting LLC providing services to medical device and IVD manufacturers in product development, risk management, project management and strategy development. She has nearly 30 years of experience in the clinical space at various global organizations. She holds a Masters degree in Microbiology and Bachelors in Biology, as well as multiple certifications in auditing and project management. 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