# #385: The Trouble with Home-Use Devices, Pt. 1

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-10-04
- Length: 36m
- Episode: 385
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-04-385-the-trouble-with-home-use-devices-pt-1
- Listen: https://podcast.greenlight.guru/episode/385-the-trouble-with-home-use-devices-pt-1

## Summary

Regulatory expert Mike Drues joins host Etienne Nichols to discuss the unique challenges of home-use medical devices, defining them by their intended use environment rather than just location. They analyze the Philips Respironics recall, the largest in industry history, highlighting how foam degradation and failures in post-market surveillance led to a $13 billion settlement. Drues argues that while technical failures might occur in hospitals, the lack of professional oversight in homes exacerbates safety risks and complaint handling difficulties.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-04-385-the-trouble-with-home-use-devices-pt-1#t=0) Introduction and Sponsor Reads
- [2:13](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-04-385-the-trouble-with-home-use-devices-pt-1#t=133) Defining Home Use Devices and Regulatory Scope
- [5:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-04-385-the-trouble-with-home-use-devices-pt-1#t=325) Strategic Priority and ECRI Safety Hazards
- [11:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-04-385-the-trouble-with-home-use-devices-pt-1#t=691) Philips Respironics Case Study and Recall Details
- [24:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-04-385-the-trouble-with-home-use-devices-pt-1#t=1461) Post-Market Surveillance and Complaint Handling Challenges
- [35:26](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-04-385-the-trouble-with-home-use-devices-pt-1#t=2126) Teaser for Part 2: Labeling and Usability

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)

## Most relevant to

large enterprises

## Mentioned

- Philips Respironics (company)
- ECRI (other)
- FDA (other)
- CDRH (other)

## Related episodes from other shows

- [129 - Combination Products, Infusion Pumps and Recalls, Responding to Health Disasters with Public Health Service, and FDA Rule-making Process with Captain Alan Stevens](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-27-129-combination-products-infusion-pumps-and-recalls-responding-to-health-disaste) (Let's Combinate)
- [Medical Kits, They're The Future](https://hardwarepodcasts.com/podcast/the-amp-hour/2020-03-30-medical-kits-theyre-the-future) (The Amp Hour)
- [156 - Combination Product Governance, Big Pharma to Medical Device Startups, Risk Management, Scale Up Challenges, Drug Delivery Innovations, and Home Administration with Laxman Halleppanavar](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-02-156-combination-product-governance-big-pharma-to-medical-device-startups-risk-ma) (Let's Combinate)
- [117 - Post Market Surveillance, Safety Reporting, Databases, Platforms Health Hazards Assessments and Product Responsibilities with Khaudeja Bano](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-03-117-post-market-surveillance-safety-reporting-databases-platforms-health-hazards) (Let's Combinate)
- [058 - PMSR Globally, Different Clinical Roles and Risk Management with Khaudeja Bano](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-09-058-pmsr-globally-different-clinical-roles-and-risk-management-with-khaudeja-ban) (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/2024-10-04-385-the-trouble-with-home-use-devices-pt-1. 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.