Requirements Engineering, part 2: A Practical Process for Safety-Critical Development

In this second part of our requirements engineering series, Jeff walks us through his preferred process for developing safety-critical products, particularly medical devices. We explore the crucial distinction between prototyping and design-controlled development, discussing when to start formal requirements work and how to keep your first version minimal yet complete.

Jeff emphasizes the importance of deeply fleshing out requirements before implementation—including error handling, which often comprises 70% of a product. We discuss tracer bullets as a development strategy, the value of writing test cases alongside requirements, and why tracking requirements completion gives you honest project status. Luca and Jeff also debate the finer points of MVPs versus prototypes, and Jeff announces his upcoming requirements management tool for medical device startups.