The White House.
And Design Controls.
Probably not a combo of topics you see grouped together very often.
But we have them all for you on today’s Global Medical Device Podcast.
This is the 2nd edition in our series focused on Design Controls and related topics within the Medical Device Industry.
During this episode, we’ll surface some interesting and potentially controversial views on the subject with our three industry thought leaders.
If you’re like many, you may very well have already heard about the high profile superbug outbreak connected to reprocessing.
You may also have already seen some of the industry’s reactions with lawsuits being filed, FDA alerts being issued...and even the White House getting involved.
That’s where we kickoff today’s conversation with our amazing guests Mike Drues, Jon Speer and Jason McKibbin along with moderator Bill Loss.
You’re going to want to listen closely because these guys really dive deep on some important and controversial topics.
Some Questions Asked:
1. What’s the background behind this reprocessing tragedy anyway?
2. How do our experts see the responsibility panning out at the manufacture’s level as well as those ultimately handling the reprocessing?
3. Could better orchestrated design controls have potentially prevented this tragedy?
4. Do existing design controls apply to problems like this, and if they don’t, should they?
5. Was this problem a design control failure or possibly different steps that should have been handled during the design review process?
6. How do you feel the Design Verification and Design Validation process should fall into place?
About Our Guests:
Michael Drues, Ph.D., is a prolific speaker and consultant to the medical device industry as well as being the President of Vascular Sciences.
Jon Speer is co-founder and resident “Guru” at Greenlight Guru, making waves with his innovative approach to QMS software being built exclusively for the medical device community.
Jason McKibbin’s medtech experiences spans more than 15+ years and in his more recent past played an integral role as COO of MEDISISS which was acquired by Medline Inc. Jason’s currently COO at Greenlight Guru.
Bill Loss has spent the last 20 years in the startup world and actively invests and advises in the medtech space.
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.