# Why Usability Matters

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-11-24
- Length: 25m
- Episode: 237
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-24-why-usability-matters
- Listen: https://podcast.greenlight.guru/episode/why-usability-matters

## Summary

Michaela Kauer-Franz, CEO of Custom Medical, joins host Jon Speer to discuss the critical role of usability engineering in medical device development. They define the distinction between formative evaluations, which guide design direction, and summative evaluations, which prove safety with production units. Kauer-Franz highlights common industry mistakes, such as starting usability testing too late or relying solely on key opinion leaders rather than the broader user base.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-24-why-usability-matters#t=0) Introduction and Guest Background
- [2:41](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-24-why-usability-matters#t=161) The Impact of Usability on Patient Safety
- [7:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-24-why-usability-matters#t=430) Defining Usability and Its Role in Design
- [11:26](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-24-why-usability-matters#t=686) Custom Medical's Services and Formative vs. Summative Testing
- [15:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-24-why-usability-matters#t=904) Common Usability Mistakes and Early Engagement
- [20:50](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-24-why-usability-matters#t=1250) Advice on User Feedback and Key Opinion Leaders

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Industrial & consumer product design](https://hardwarepodcasts.com/topic/industrial-design)

## Most relevant to

established companies

## Mentioned

- Custom Medical (company)
- Greenlight Guru (company)

## Related episodes from other shows

- [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)
- [S6E33 Bryant Foster | Design for Human Factors & User Experience](https://hardwarepodcasts.com/podcast/being-an-engineer/2025-08-15-s6e33-bryant-foster-design-for-human-factors-user-experience) (Being an Engineer)
- [Requirements Engineering, part 2:  A Practical Process for Safety-Critical Development](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-05-27-requirements-engineering-part-2-a-practical-process-for-safety-critical-developm) (The Pragmatic Embedded Podcast)
- [176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski](https://hardwarepodcasts.com/podcast/lets-combinate/2025-02-19-176-the-fastest-way-to-ruin-drug-device-development-and-how-to-avoid-it-with-eri) (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)

## 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/2021-11-24-why-usability-matters. 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.