# #386: The Danger of In-Home Use Medical Devices, Pt. 2

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-10-10
- Length: 52m
- Episode: 386
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-10-386-the-danger-of-in-home-use-medical-devices-pt-2
- Listen: https://podcast.greenlight.guru/episode/386-the-danger-of-in-home-use-medical-devices-pt-2

## Summary

Regulatory expert Mike Drues joins host Etienne Nichols to discuss the unique challenges of in-home medical devices, focusing on labeling, usability, and cybersecurity. They argue that manufacturers must explicitly define the 'intended user' and 'intended use environment' in high-level labeling to limit unnecessary testing and ensure safety for non-clinicians. Drues highlights critical risks such as environmental variability, improper cleaning of reusable devices like CPAPs, and the need for robust post-market surveillance to track devices used outside controlled clinical settings.

## Outline

1. Introduction and Recap of Home Use Devices
2. Defining Intended User and Use Environment in Labeling
3. Technological and Environmental Challenges in the Home
4. Reprocessing and Cleaning Risks for Reusable Devices
5. Usability Testing and Human Factors for Non-Clinicians
6. Cybersecurity and Data Security in Connected Devices
7. Calibration, Maintenance, and Post-Market Surveillance

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)

## Most relevant to

established companies

## Mentioned

- Greenlight Guru (company)
- Rook Quality Systems (company)
- Philips Respironics (company)
- CPAP (product)
- EpiPen (product)
- Da Vinci surgical robot (product)
- FDA (other)

## Related episodes from other shows

- [127 - "If we do our job, no one will know" with LeRonda Perry](https://hardwarepodcasts.com/podcast/people-of-packaging/2022-04-27-127-if-we-do-our-job-no-one-will-know-with-leronda-perry) (People of Packaging)
- [021 - "Options" with Karandeep Singh Badwal](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal) (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)
- [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)
- [074: Medical Device Product Development Best Practices](https://hardwarepodcasts.com/podcast/product-startup/2021-05-05-074-medical-device-product-development-best-practices) (Product Startup)

## 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/2024-10-10-386-the-danger-of-in-home-use-medical-devices-pt-2. 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.