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

Global Medical Device Podcast · 4 Oct 2024 · 36m · Episode 385

What this episode covers

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.

Most relevant to

large enterprises

Topics

Mentioned

Companies: Philips Respironics
Also: ECRI, FDA, CDRH

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

What this episode covers

Most relevant to

Topics

Mentioned

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

Medical Kits, They're The Future

156 - Combination Product Governance, Big Pharma to Medical Device Startups, Risk Management, Scale Up Challenges, Drug Delivery Innovations, and Home Administration with Laxman Halleppanavar

117 - Post Market Surveillance, Safety Reporting, Databases, Platforms Health Hazards Assessments and Product Responsibilities with Khaudeja Bano

058 - PMSR Globally, Different Clinical Roles and Risk Management with Khaudeja Bano