Jon_solo podcast

It’s time to recap what happened in the medical device industry this year and start to think about what’s expected to happen in 2019.



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Some of the highlights of the show include:

  • 2018 Prediction #1: It’s going to be harder for medical devices to get to market and stay in the market in EU. Still confusing; clarity to come in 2019?
  • 2018 Prediction #2: Mad dash to update ISO 13485 certification before deadline. Resources were constrained, some came late to the party, progress was made.
  • 2018 Prediction #3: ISO 14971 will be revised for industry comment. Draft was released in September/October to receive comments. Be on the lookout for a revision around mid-year.
  • 2018 Prediction #4: Health Canada will back off on MDSAP deadline. Would have provided constraints for many companies, but Canada didn’t back down.
  • 2018 Prediction #5: Medical device companies shift from compliance-focused to quality-focused. FDA’s been proactive, some movement, but a long way to go.
  • 2019 Prediction #6: Wearable medical devices will become more common. A trend with more consumer good companies entering medical device market.
  • 2019 Prediction #7: EU MDR challenges. Will still be more difficult and unclear on how to get products to market.
  • 2019 Prediction #8: Expect FDA to continue to shake up regulatory submission processes. Modernizing 510(k) process into Safety and Performance-based Pathway. 
  • 2019 Prediction #9: FDA QSR harmonizing with ISO 13485:2016. FDA is interested in moving away from 21 CFR Part 820 for ISO 13485. Prepare for it!
  • 2019 Prediction #10: The FDA’s Case for Quality. It’ll continue and gain momentum. Initiatives include Medical Device Discovery Appraisal Program.



Medical Device Industry in 2018 (And How You Can Prepare)

Medical Device Industry in 2019 (and how you can prepare)

Case for Quality Program

Apple Watch


Bose Hearing Aid

Webinar - Final Guidance on “General Wellness: Policy for Low-Risk Devices”

ISO 14971

ISO 13485:2016

Yes it’s true – the US FDA is shifting toward ISO 13485. But how much and how soon?

21 CFR Part 820 - Quality System Regulation (QSR)


ISO/TC 210 Working Group

Medical Device Discovery Appraisal Program

Medical Device Innovation Consortium

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices

Greenlight Guru


Quotes by jon speer:

The last half of 2018 has been pretty exciting - a lot of news on the regulatory front.

(Wearable medical devices) This is the beginning of a trend, I think.

EU is going to be probably one of the most, if not the most challenging markets for medical device companies in 2019.

Part of (FDA) their mission is certainly to ensure and promote the health of patients. But they’re also very interested in innovation. They’re trying to be progressive.



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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