# Challenges related to Home Use Devices

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-09-10
- Length: 30m
- Episode: 163
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-10-challenges-related-to-home-use-devices
- Listen: https://podcast.greenlight.guru/episode/challenges-related-to-home-use-devices

## Summary

Mike Drues, founder of Vascular Sciences, discusses the unique safety, risk, and usability challenges of medical devices used in non-traditional, home-like environments by laypeople rather than trained professionals. He highlights the difficulty of defining user subgroups for human factors testing, noting that engineers often fail to represent patients with physical or cognitive limitations. Drues argues that risk mitigation should rely on intelligent design rather than labeling, as users rarely read manuals, and emphasizes the need to decouple regulated and consumer functions when assessing combined system risks.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-10-challenges-related-to-home-use-devices#t=0) Introduction: Defining Home and Non-Traditional Environments
- [3:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-10-challenges-related-to-home-use-devices#t=205) The Shift from Trained Professionals to Lay Users
- [6:44](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-10-challenges-related-to-home-use-devices#t=404) Human Factors Testing and User Subgroups
- [13:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-10-challenges-related-to-home-use-devices#t=814) Risk Mitigation: Design vs. Labeling
- [18:37](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-10-challenges-related-to-home-use-devices#t=1117) Blending Regulated and Consumer Products
- [23:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-10-challenges-related-to-home-use-devices#t=1435) Final Takeaways and Lessons Learned

## Topics

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

## Most relevant to

early-stage companies

## Mentioned

- Vascular Sciences (company)
- Green Light Guru (company)
- FDA (other)
- ISO (other)
- NASA (other)

## Related episodes from other shows

- [072 - OXO PFS, Drug/Device Usability, Toothbrushes for Children, Epicurious Series and Baseball with Dan Formosa](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-15-072-oxo-pfs-drug-device-usability-toothbrushes-for-children-epicurious-series-an) (Let's Combinate)
- [012 - "Asking then Seeing" with Sara Waxberg Mcnew](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew) (Let's Combinate)
- [049 - "What Does the Data Say?" with Shannon Hoste](https://hardwarepodcasts.com/podcast/lets-combinate/2022-09-07-049-what-does-the-data-say-with-shannon-hoste) (Let's Combinate)
- [055 - "Critical Tasks and Knowledge Tasks" with Alexandra Benbadis](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-19-055-critical-tasks-and-knowledge-tasks-with-alexandra-benbadis) (Let's Combinate)
- [S2E33 Custom Medical Device Manufacturing, Durability, & the Future of Med Device Tech | Mark A. Farber, MD](https://hardwarepodcasts.com/podcast/being-an-engineer/2021-07-30-s2e33-custom-medical-device-manufacturing-durability-the-future-of-med-device-te) (Being an Engineer)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-10-challenges-related-to-home-use-devices. 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 Global Medical Device Podcast.