# How to Integrate Usability into your Medical Device

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-04-01
- Length: 30m
- Episode: 139
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-01-how-to-integrate-usability-into-your-medical-device
- Listen: https://podcast.greenlight.guru/episode/how-to-integrate-usability-into-your-medical-device

## Summary

Isabella Schmitt, a regulatory affairs consultant with Proxima Clinical Research, joins host Jon Speer to discuss integrating usability into medical device development. They emphasize that usability must be integrated early with design controls and risk management to avoid costly redesigns and ensure patient safety. Key topics include identifying user groups, conducting simulated usability testing with representative users, and avoiding the trap of treating usability as a late-stage checkbox activity.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-01-how-to-integrate-usability-into-your-medical-device#t=0) Introduction and Usability Definition
- [3:05](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-01-how-to-integrate-usability-into-your-medical-device#t=185) Usability and Design Controls Alignment
- [10:22](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-01-how-to-integrate-usability-into-your-medical-device#t=622) Risk Management and User Error Mitigation
- [15:24](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-01-how-to-integrate-usability-into-your-medical-device#t=924) Defining User Groups and Testing Requirements
- [19:42](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-01-how-to-integrate-usability-into-your-medical-device#t=1182) Simulated Usability Testing and FDA Expectations
- [25:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-01-how-to-integrate-usability-into-your-medical-device#t=1556) Challenges of Late-Stage Usability and Conclusion

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Industrial & consumer product design](https://hardwarepodcasts.com/topic/industrial-design)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- Proxima Clinical Research (company)
- EpiPen (product)
- FDA (other)

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- [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)
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## 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/2020-04-01-how-to-integrate-usability-into-your-medical-device. 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.