We’re in the last days of 2016, and it’s a good time to look back as we plan for the future. On today’s episode, Mike Drues and Jon go over the many happenings in the medical device industry over the past year. Mike is a frequent guest on our show, and today we will be talking about the year in review.
Listen Now:
Like this episode? Subscribe today on iTunes or SoundCloud.
Some of the topics you’ll hear discussed include:
- Some of the significant guidance documents that were new in 2016, including one on medical device reporting for manufacturers.
- Two guidances on when to submit a 510K and why these in particular are important.
- General wellness devices: What they are and what makes them different from regulated devices.
- Thoughts on the Use of Real-World Evidence guidance document.
- Why the guidance on 3D printing is so impactful.
- What might happen from a regulatory perspective in 2017, including more specific guidances and focusing on usability.
- Thoughts on whether the FDA should be in the business of putting out guidance documents.
Links and Resources:
Deciding When to Submit a 510(k) for a Change to an Existing Device
Deciding When to Submit a 510(k) for a Software Change to an Existing Device
Medical Reporting for Manufacturers
Technical Considerations for Additive Manufactured Devices
Strategic Priorities 2016-2017
Quotes:
“Medical devices are constantly changing and constantly evolving.” - Mike Drues
“It’s not the technology or how it works: It’s what we say about it.” - Mike Drues
“The general trend is all about re-emphasizing product safety and the efficacy of technology and devices.” - Jon Speer
About The Global Medical Device Podcast:
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.
Like this episode? Subscribe today on iTunes or SoundCloud.
