154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell

On this episode, I was joined by Devon Campbell, Founder and Managing Director of Prodct. Devon covers the differences between IVDs, companion diagnostics, and precision medicine, the risk management aspects specific to IVDs, and the design, verification, and validation processes involved. Devin shares his extensive experience in both big pharma environments and startups, shedding light on the significant time and resource investments required for successful IVD development. ---------------------------------- Chapters: Exploring In Vitro Diagnostics with Devin Campbell In this episode of the Combinate Podcast, host Subhi Siddek welcomes back Devin Campbell, founder and managing director of Product Know You, to discuss in vitro diagnostics (IVDs). They delve into various aspects of IVD development, including the clinical implications, risk management, and distinctions between companion diagnostics and precision medicine. They also cover regulatory pathways, lab-developed tests, and the rigorous validation processes involved. The conversation aims to demystify the complexities of IVDs for professionals in pharma and medical devices. -------------------------------------- 00:00 Introduction 01:58 Understanding In Vitro Diagnostics (IVDs) 05:26 Companion Diagnostics and Precision Medicine 08:49 Lab Developed Tests (LDTs) 12:39 IVD Development Process 15:27 Risk Management in IVDs 20:17 Clinical Testing and Validation 29:12 Challenges and Considerations in IVDs 37:04 Conclusion and Contact Information Devon Campbell is the Founder, Prodct LLC and Chief Product Officer(CPO), myBiometry. He's launched and exited several MedTech ventures and has worked in large Pharma and large IVD companies in executive roles focusing on engineering and product development. https://www.devonccampbell.com/