Episode Thumbnail
Episode 81  |  43:45 min

What's New With PMAs

Episode 81  |  43:45 min  |  11.07.2019

What's New With PMAs

00:00
00:00
This is a podcast episode titled, What's New With PMAs. The summary for this episode is: How do you feel about pre-market approval (PMA) for Class III medical devices? Most businesses are not excited about products that require a PMA. But don’t look at it as the Kiss of Death. Embrace the PMA concept as a way to bring novel and unique devices to the market. Mike Drues of Vascular Sciences and I explore the topic of PMA. Lives depend on it! Some of the highlights of the show include: ● Efforts are being made to entice acceptance of PMAs by requiring less clinical data and testing to get devices on the market sooner for customers. ● Class III medical devices are often those that are life-sustaining, and making them safe is critical. ● Questions to consider: What is safety? How safe is safe? How much testing is enough? ● FDA has an initiative to promote innovation and for companies to bring products to market in the United States. ● Industry statistics show that reporting issues may not be done or delayed when there are problems and malfunctions with devices; deadlines may be extended. ● When you learn of problems with a device, you have a professional and ethical obligation to investigate and resolve them. Don’t just put a Band-Aid on it! ● Finding a new PMA pathway: One way for novel devices and one way for me-too devices ● Take a risk-based approach to regulations and value predicates.
How do you feel about pre-market approval (PMA) for Class III medical devices? Most businesses are not excited about products that require a PMA. But don’t look at it as the Kiss of Death. Embrace the PMA concept as a way to bring novel and unique devices to the market. Mike Drues of Vascular Sciences and I explore the topic of PMA. Lives depend on it! Some of the highlights of the show include: ● Efforts are being made to entice acceptance of PMAs by requiring less clinical data and testing to get devices on the market sooner for customers. ● Class III medical devices are often those that are life-sustaining, and making them safe is critical. ● Questions to consider: What is safety? How safe is safe? How much testing is enough? ● FDA has an initiative to promote innovation and for companies to bring products to market in the United States. ● Industry statistics show that reporting issues may not be done or delayed when there are problems and malfunctions with devices; deadlines may be extended. ● When you learn of problems with a device, you have a professional and ethical obligation to investigate and resolve them. Don’t just put a Band-Aid on it! ● Finding a new PMA pathway: One way for novel devices and one way for me-too devices ● Take a risk-based approach to regulations and value predicates.

More Episodes

Past, Present, Future State (and World) of Quality in the Medical Device Industry

Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

Addressing the 'Who, What, When' of Quality in the Medical Device Industry

Meet a Guru: Maryann Mitchell

Why Storytelling Matters for Medical Device Companies

A Breakthrough Device that Aims to Prevent Osteoporosis