In this episode, Etienne Nichols hosts regulatory expert Mike Drues to discuss the evolving landscape of home use medical devices. The conversation covers critical topics such as regulatory definitions, safety challenges, and compliance hurdles for devices intended for use outside traditional clinical settings.
They explore how home use devices, such as CPAP machines and infusion pumps, can differ significantly from hospital-based devices in terms of design, post-market surveillance, and user interaction.
The discussion is grounded in real-world examples, most notably the Philips Respironics recall, which became the largest medical device recall in history due to design oversights and failure in post-market surveillance.
This episode sets the stage for a deeper dive into technical, regulatory, and user-related challenges in the next installment.
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What are home use medical devices?
Home use medical devices are defined as devices intended for use in environments outside of traditional clinical settings, such as homes, schools, and offices. These devices must be designed to accommodate non-professional users, accounting for factors like usability, environmental conditions, and ease of maintenance. Understanding these nuances is essential for developing safe and effective devices for a growing market.
FDA Guidance on Home Use Devices: Design Considerations for Devices Intended for Home Use – This guidance provides detailed recommendations on how to design and label home use medical devices.
ECRI’s Top 10 Health Technology Hazards for 2023 and 2024: An annual report highlighting the safety concerns for home use medical devices.
Philips Respironics Recall Case Study: The recall case, which affected over 5.5 million devices, serves as a key example of post-market surveillance failure and design oversight.
Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.
The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...