EpidemicX vs Economic$ > 5 Ways To Stop FDA Recalls

FDA recalls were down 22% in FY2019. That was in 2019 and before CVD-19. That’s good. But don’t open the champagne just yet. The drop was from basic economics, not poor risk management.

More medical device introductions mean many more opportunities for FDA recalls each year.  With a 96% correlation. And, you can choose to escape it.

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There never was a recall epidemic. It’s just economics. More devices mean more recalls. Medical device manufacturers got a bad rap. It was unfair to give them all the blame.

My MD+DI article tells the story of the complacency that has gripped the industry. Manufacturers are given bad advice. And, hard-coded software solutions require being force-fit to existing procedures.

Take your risk management from C- to A+.

I am an independent management consultant called out of semi-retirement to help save the industry from despair. After a little research, I invented a method that combines Fault Tree Analysis with Failure Modes and Effects Analysis and Benefit-Risk Assessment.

SEE THE FULL MDDI ARTICLE

Prevent recalls and anchor risk management to absolute safety and reliability goals.

I want to make a trade. I send you a FREE paper that describes this method. You return the favor by giving me an hour of your time for an interview. I'm counting on your gratitude.

How many hours would it be worth to stop just one recall? All of them?

My website (www.MenloParkAssociates.com) has information about, and links to start, this process:

1. Click to send your request. Be in the first 100 to get the FREE pdf.
   
2. I reply with the PDF attached and links for the survey / interview.
   
3. You click to start the survey and/or schedule the interview.
   
4. We meet over the phone or Skype or Zoom.
   
5. You implement the method and start preventing recalls.

REFERENCES
[i] “What’s Behind MetTech’s Recall Epidemic?” by Joshua R. Dix, Suraj Ramachandran, and Darin S. Oppenheimer.