“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 Introduction
00:03:03 Strategic questions to ask for IVD risk management
00:05:10 3 pillars of IVD risk management strategy
00:06:45 Example of a strategy for a simple point-of-care assay IVD
00:08:31 Special considerations for home-based IVDs
00:09:20 Leadership opportunity for QA/RA professionals in setting strategy
00:10:15 Practical tips for assigning severity and probability for IVD risks
00:12:51 Latest update on LDTs
00:14:50 Audience Q&A and open discussion
00:35:50 Closing comments and key takeaways
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Suggested links:
LTR podcast: Focus on intended use in the clinical environment for IVD risk management
LTR podcast: Risk management of IVDs requires a different approach
About Claudia Campbell-Matland
Claudia 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.
Disclaimer
Information 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.
LTR 67: 3 pillars for defining your IVD risk management strategy