Hardware Podcasts

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

Let's Combinate · 18 Sept 2024 · 37m

What this episode covers

Devon Campbell, Founder of Prodct LLC and CPO of myBiometry, explains the regulatory and engineering distinctions between In Vitro Diagnostics (IVDs), Lab Developed Tests (LDTs), and companion diagnostics. He details how IVD development mirrors medical device design control but adds critical layers of risk management regarding false positives and negatives, particularly for home-use devices like COVID tests. Campbell emphasizes that clinical validation requires proving statistical validity across diverse populations to establish Limit of Detection (LOD) and sensitivity, noting that clinical studies are often the most time-consuming and expensive part of the process for startups.

Most relevant to

early-stage companies and large enterprises

Topics

Mentioned

Companies
Prodct LLC, myBiometry, Roche, Novartis
Also
FDA, CLIA, ISO 13485, QMSR, 510(k), PMA

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