# 67: Software for Things That Can Kill People

- Show: [Embedded.fm](https://hardwarepodcasts.com/podcast/embedded-fm)
- Published: 2014-09-11
- Length: 1h 09m
- Page: https://hardwarepodcasts.com/podcast/embedded-fm/2014-09-11-67-software-for-things-that-can-kill-people
- Listen: https://makingembeddedsystems.libsyn.com/embedded-ep67mp3

## Summary

Hosts Chris White and Elecia White discuss the rigorous regulatory processes for safety-critical software, drawing on their experiences with the FAA (DO-178B) and FDA (510k, PMA) for medical devices and avionics. They explain how hazard analysis determines certification levels, the necessity of extensive documentation and traceability, and the tension between agile development and waterfall compliance. The conversation highlights the ethical responsibility of engineers to push back against unsafe deadlines, the use of hardware compartmentalization (FPGAs, voting systems) to ensure safety, and the legal liabilities associated with product failures.

## Chapters

- [0:06](https://hardwarepodcasts.com/podcast/embedded-fm/2014-09-11-67-software-for-things-that-can-kill-people#t=6) Introduction: Chris White and Elecia White on Safety-Critical Software
- [5:43](https://hardwarepodcasts.com/podcast/embedded-fm/2014-09-11-67-software-for-things-that-can-kill-people#t=343) FDA Software Process: Levels of Concern and Documentation
- [15:03](https://hardwarepodcasts.com/podcast/embedded-fm/2014-09-11-67-software-for-things-that-can-kill-people#t=903) 510k vs. PMA: Predicate Devices and Clinical Trials
- [25:53](https://hardwarepodcasts.com/podcast/embedded-fm/2014-09-11-67-software-for-things-that-can-kill-people#t=1553) Agile vs. Waterfall: Managing Auditors and Prototypes
- [30:30](https://hardwarepodcasts.com/podcast/embedded-fm/2014-09-11-67-software-for-things-that-can-kill-people#t=1830) Hardware Safety: Voting Systems, FPGAs, and Compartmentalization
- [43:37](https://hardwarepodcasts.com/podcast/embedded-fm/2014-09-11-67-software-for-things-that-can-kill-people#t=2617) Test-Driven Development in Startup Environments
- [51:16](https://hardwarepodcasts.com/podcast/embedded-fm/2014-09-11-67-software-for-things-that-can-kill-people#t=3076) Ethics, Liability, and the Role of Engineers
- [1:04:31](https://hardwarepodcasts.com/podcast/embedded-fm/2014-09-11-67-software-for-things-that-can-kill-people#t=3871) Machine Learning, Autonomous Systems, and Legal Standards

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Mechanical engineering](https://hardwarepodcasts.com/topic/mechanical-engineering)
- [Embedded firmware](https://hardwarepodcasts.com/topic/embedded-firmware)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

early-stage companies

## Mentioned

- FAA (other)
- FDA (other)
- DO-178B (other)
- 510k (other)
- PMA (other)
- ISO-26262 (other)
- DO-26262 (other)
- FPGA (chip)
- PC Lint (tool)
- Toyota (company)
- Kleiner Perkins (company)
- Hacker Dojo (other)
- San Jose State University (other)

## Related episodes from other shows

- [Agile Manifesto Pt. 1](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2022-03-08-agile-manifesto-pt-1) (The Pragmatic Embedded Podcast)
- [How to Speed Up Safety Critical Processes](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-07-27-how-to-speed-up-safety-critical-processes) (The Pragmatic Embedded Podcast)
- [The Future of Cybersecurity](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-30-the-future-of-cybersecurity) (Global Medical Device Podcast)
- [E94 Requirements Engineering, part 1: Fundamentals](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-04-15-e94-requirements-engineering-part-1-fundamentals) (The Pragmatic Embedded Podcast)
- [Does DevOps Make Sense for Embedded Systems?](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-01-06-does-devops-make-sense-for-embedded-systems) (The Pragmatic Embedded Podcast)

## Citing this page

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