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.


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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:

Greenlight Guru 

Mike on LinkedIn

Vascular Sciences

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

General Wellness Guidance

Use of Real-World Evidence

Technical Considerations for Additive Manufactured Devices

Strategic Priorities 2016-2017

Case for Quality


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.

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