Richard L. Bollinger, MSE, PMP (retired), Six Sigma Green Belt, CSM, CSPO

MANAGEMENT CONSULTANT

Rick Bollinger

In 2005 I moved from running high-profile projects up to management consulting. I retired my PMP, but not my curiosity or involvement. A year or so ago I caught an article in the Medical Device and Diagnostics Industry magazine: “The Recall Epidemic“.  It portrayed an explosive increase in FDA medical device recalls.

The topic faded into history. But, I kept up with the data and estimated FY2017 would be the worst year ever. It seems risk management might be the problem. But, more research is needed. That’s OK, other problems might be hiding in the FDA publicly available data that are fixable in the short term.

Percent Action RequiredKnowing where to look from my medical device experience, I quickly found clues of a crisis in compliance in a recent file of FDA inspection results. Since 2009, it seems, over one third (1/3) of inspections ended poorly. With a voluntary, or worse, official action. With no signs of improvement, this ratio stayed steady between 35% and 40%, even though the number of inspections went up and down.  To a management consultant that points to a systemic problem. Something is wrong with the status quo. This compliance crisis also requires research. Not seeing any other acknowledgement of the problem by the FDA or in the press, I guess it is up to me.

A CALL TO ACTION

I will be calling you.

So, my plan is to interview 100 or so medical device quality managers and/or CEO’s and get individual opinions on the situation. 1/3 of all inspections going sour means a lot of citations and 483’s. This is an industry-wide problem. But, more importantly, I recognize it’s painful for individual medical device companies and leaders. You bear the burden of acknowledging and answering the citations and following through on your voluntary or official actions.

telephone-ringingThe FDA citations give clues to the infractions. But, the ‘why’ is missing. I know because I have read them. Lots of them. So, I will be calling you and your peers in the industry. I want to understand, from your point of view, about your compliance troubles and their causes. And, if you have any ideas how they can be addressed. If I find anything relevant and coherent I will write an article for MDDI or something. And send you a copy if you give me your email. Or, since I am a consultant, work to craft a solution you might want to hear about.

INTERVIEW

There is some chance that you may not be in the 100 expert medical device practitioners I call. So, if you don’t want to be left out you can try to CONTACT ME using the information at the top of this page. If you want to accelerate the process, just click BOOK AN INTERVIEW NOW and grab a time slot. You will get an email reminder and so will I.

SURVEY

Instead, if your time is tight, click TAKE A SHORT SURVEY, which optionally will also accept your email address. It should only take a few minutes. Much less than the 1/2 hour phone/Skype interview would take. I look forward to talking or corresponding with you soon.

PERSONAL
I am proud to have been an American Red Cross volunteer and leader for 20 years.

Certified as a Project Management Professional, Six Sigma Green Belt, Scrum Master and Scrum Product Owner, I am active in process improvement and risk management, and speak and deliver papers at various seminars and conferences of the PMI and the Dr. W. Edwards Deming Institute.

I have two degrees from the University of Michigan: a Bachelor’s degree in industrial engineering (cum laude) and a Master’s degree in computer engineering. I belong to Mensa, the IEEE, and the Project Management Institute, and serve as a Director on the Board of the Tau Beta Pi Ann Arbor Area Alumni Chapter.

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