Agile Embedded Podcast E95: Requirements Engineering Part 2: Medical Device Process

Jeff shares his requirements process for medical devices from FDA-regulated startups. Step zero: prototype first. Before design controls, answer via iteration: Can we build this? Will someone buy it? Start formal process when uncertainty is acceptable. Define minimal V1, then fully specify. Common trap: teams rush requirements with TBDs, skip error handling, sprint to code. Reality: error handling is 70% of product. Specifying only happy path is self-deception. Paper beats code for details. Prototypes vs MVPs (different terms, same principles): reduce uncertainty before formal development. Write test cases early with requirements. Add verification fields for test hooks and CLIs - trivial early, painful later. Get test engineers reviewing requirements to catch holes. Luca's satellite test with five-year delay proves this. Track completion with clear definition: code written, docs updated, verification done, scripts ready. Track functionality, not task counts, avoiding "90% done" trap. Implementation: tracer bullets - vertical slices through all layers. Get one command end-to-end before horizontal building. Validates architecture early. Jeff's building requirements tool for medical device startups - bridging dev and enterprise solutions. Design controls don't mean waterfall. Iterate with documentation and traceability while maintaining rigor. 0:00 Welcome to Requirements Engineering Part Two 1:03 Medical Device Development Landscape 3:08 Prototyping Before Design Control Phase 6:27 The Prototypes Versus MVPs Debate 11:52 Starting the Design Controlled Process 15:29 Minimal but Comprehensive First Requirements 22:17 Writing Test Cases Early On 27:01 Test Engineers Catching Issues Early 31:43 Project Management and Progress Tracking 39:01 Tracer Bullets Implementation Approach 46:53 Requirements and Test Management Tools 49:04 Wrapping Up and Contact Information