#392: Verification and Validation in MedTech: A Practical Guide with Devon Campbell
Devon Campbell, a medical device consultant, explains the critical distinctions between verification (did we build the product right?) and validation (did we build the right product?) for early-stage medtech companies. He emphasizes that strong, testable user needs and design inputs are prerequisites for successful V&V, warning that weak requirements lead to validation failures. Campbell advocates for pre-verification testing to refine protocols and manage sample sizes, ensuring that design reviews and traceability are robust before formal regulatory submission.