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

- Show: [The Pragmatic Embedded Podcast](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast)
- Published: 2026-05-27
- Length: 50m
- Page: https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-05-27-requirements-engineering-part-2-a-practical-process-for-safety-critical-developm
- Listen: https://agileembeddedpodcast.com/episodes/requirements-engineering-part-2-a-practical-process-for-safety-critical-development-9BL5n3Fl

## Summary

Jeff Gable and Luca engineer discuss a rigorous process for requirements engineering in safety-critical development, particularly for medical devices. They distinguish between prototyping (technical feasibility) and MVPs (market viability), emphasizing that design-controlled requirements must be minimal yet comprehensive, including extensive error handling. The hosts advocate for writing test cases alongside requirements, tracking requirements completion for honest project status, and using 'tracer bullets' to reduce uncertainty early in implementation.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-05-27-requirements-engineering-part-2-a-practical-process-for-safety-critical-developm#t=0) Introduction and Prototyping vs. Design Controls
- [4:57](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-05-27-requirements-engineering-part-2-a-practical-process-for-safety-critical-developm#t=297) The MVP vs. Prototype Debate
- [11:57](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-05-27-requirements-engineering-part-2-a-practical-process-for-safety-critical-developm#t=717) Minimal but Deep Requirements and Error Handling
- [21:18](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-05-27-requirements-engineering-part-2-a-practical-process-for-safety-critical-developm#t=1278) Writing Test Cases Early and Verification
- [31:12](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-05-27-requirements-engineering-part-2-a-practical-process-for-safety-critical-developm#t=1872) Project Management and Tracking Requirements
- [37:29](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-05-27-requirements-engineering-part-2-a-practical-process-for-safety-critical-developm#t=2249) Tracer Bullets and Implementation Strategy
- [44:09](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-05-27-requirements-engineering-part-2-a-practical-process-for-safety-critical-developm#t=2649) Jeff's Upcoming Requirements Management Tool

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Embedded firmware](https://hardwarepodcasts.com/topic/embedded-firmware)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Hiring & workforce](https://hardwarepodcasts.com/topic/hiring-and-workforce)

## Most relevant to

early-stage companies

## Mentioned

- FDA (other)
- Jira (tool)
- Linear (tool)
- Agile Embedded Slack Channel (other)
- Matt Pocock (other)
- The Pragmatic Programmer (other)
- The Art of Unix Programming (other)
- Embedded.fm (other)
- Elecia White (other)
- Christopher White (other)
- Intertek (other)
- STM32 HAL (chip)

## Related episodes from other shows

- [#392: Verification and Validation in MedTech: A Practical Guide with Devon Campbell](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-11-22-392-verification-and-validation-in-medtech-a-practical-guide-with-devon-campbell) (Global Medical Device Podcast)
- [Are you Spending Enough Time Defining and Managing Requirements for your Medical Device?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-11-18-are-you-spending-enough-time-defining-and-managing-requirements-for-your-medical) (Global Medical Device Podcast)
- [Project Management for Product Development of Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-27-project-management-for-product-development-of-medical-devices) (Global Medical Device Podcast)
- [67: Software for Things That Can Kill People](https://hardwarepodcasts.com/podcast/embedded-fm/2014-09-11-67-software-for-things-that-can-kill-people) (Embedded.fm)
- [#393: Engineering MedTech Success: Simplifying Prototypes, Pivoting Strategy, and Creating Complex Designs with Justin Bushko](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-11-29-393-engineering-medtech-success-simplifying-prototypes-pivoting-strategy-and-cre) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-05-27-requirements-engineering-part-2-a-practical-process-for-safety-critical-developm. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to The Pragmatic Embedded Podcast.