Waterfall vs. Agile: Battle of the Product Development Methodologies
Jon Speer, host of the Global Medical Device Podcast, interviews Devon Campbell, founder and CEO of Prodct, to debunk myths surrounding waterfall and agile methodologies in medical device development. They argue that the FDA's Design Control Guidance is often misinterpreted as mandating a rigid waterfall process, when it merely illustrates one possible approach. Campbell and Speer emphasize that successful product development relies on defined processes, traceability, and hybrid models rather than adherence to a specific named methodology. They advocate for 'documenting early and revising often' to manage the high costs of late-stage changes in electromechanical hardware.