Prevent FDA recalls.

2017 was the worst year ever for device recalls. There was never any epidemic. Only just economics. More devices mean more recalls.
New device company risk management is not any better. Old companies still struggle. The blame is unfair. But the problem still exists. And, we need a fix.
The trouble lies in risk management, but information problems are the root causes.
Über and AirBnB recognized information problems between buyers and sellers in their targeted industries and invented solutions to fill these gaps. Information problems between risk management participants exist in the medical device industry. I recognize them and I'm trying to define solutions to fill our gaps. The ones that cause FDA recalls and FDA inspections with bad outcomes.
If I am right, you can help with an interview a half-hour or so long to acknowledge your current troubles and priorities. With enough interviews the solutions get built, the pressure is off and you are a hero. If I am wrong, your life stays the same, minus a half-hour or so. A precious little to gamble.  So much to gain in the balance. There are benefits to be in the few that influence and design those solutions.

The larger a company the greater the reason to influence solutions to match exact needs.
I recently developed a new world-class method of risk management for medical device companies that combines Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA). Use it to prevent FDA recalls.

    World-class risk management paper.
    Just send your name and work email.

    Your email will never be shared or sold.
I am building a vehicle to solve problems in the medical device industry. So, I am looking for experts who understand the industry and many of its problems that they also experience.
I am researching current methods and tools. What works, what doesn’t, and what’s wrong? What's your biggest problem? All data collected will be treated as confidential. Use will be only analytical and statistical.
Ask in the interview to see what software could do to eliminate your biggest problems. I would enjoy sharing with you the information technology behind solutions. Tools and methods need to be developed so they support each other and make their solutions much more powerful.
Join your peers. Preview the survey. It contains boilerplate questions, some of  which require offline lookup. These are the beginning questions in the interview. They can be printed to guide and record answers so as to not steal time from the interview.
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GOT QUESTIONS ABOUT THE CHART?
   SAFE THINGS YOU CAN DO NOW:
  • Implement Detection ranking to protect your Risk Priority Number calculations. They are dangerous without it and could let a failure mode evade mitigation.
  • Create synergy from component knowledge and risk expertise by integrating team members with risk experts.
  • Bring them all together to share cross-component failure modes and discoveries.
  • Find risks and mitigations in component interfaces and interactions.
  • Find analogs of risks and mitigations in other risks and components.
  • Learn to reach higher proprietary standards with which to enrich the enterprise. (a.k.a. 'Quality')
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BREAK OUT OF THE  STATUS  QUO.
   A WORLD-CLASS RISK MANAGEMENT METHOD FOR THE FUTURE:
  • Bring together the safety and reliability of FTA and FMEA.
  • Anchor risk management to absolute safety and reliability goals using benefit-risk assessment.
  • Prevent the fade of safety-related behaviors over time.
  • Don't plant the seeds of new errors and troubles.
  • Fine tune your FTA and FMEA processes.
  • Learn to find deep failure modes and innovative mitigations.
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World-Class Risk Management Method
Read about the original FDA Recall Epidemic[1].
Michelangelo said "The greatest danger for most of us is not that our aim is too high and we miss it, but that our aim is too low and we reach it."

What are you willing to risk to prevent just one recall?

How high are you willing to aim?
The world-class risk management method combines FTA, FMEA, and Benefit-Risk Assessment (BRA) to manage the risks and mitigations and maximize the safety and reliability of medical devices.
Their combination is a miracle because they each contribute a part needed for safety and reliability that fits with the others.
Weekend Hours
Official Correspondents like many of you are busy folks. Like me, you might work weekends. Especially on those less urgent tasks that pay off in the future. Like those journals and industry magazines you need to keep current.
New Sessions
Those of you deciding to invest a half-hour or so will find Saturday hours in my internet schedule.
Not every Saturday, and not every hour. But, enough opportunity so you can contribute and not feel guilty of taking time from fire fighting and other urgent issues.
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ABOUT THE WORLD-CLASS METHOD.

PLEASE URGE YOUR PEERS TO JOIN YOU IN THIS RESEARCH.

I was in the medical device industry some years ago. The world has changed. The interview's purpose is to characterize your current  troubles and priorities. And, devise solutions in the industry from your point of view.
For this, I am  gifting the method I have developed that should be helpful today. The 1st 100 absolutely get the FREE pdf. Your views are important. A diversity of views is needed. They will form the basis of needs in new methods and tools.

"You'll always miss 100% of the shots you don't take."
-- Wayne Gretzky, famous hockey player

Use the world-class method to jump start your efforts to make a very large improvement in your risk management practices. Take your shot. Then, if you want, donate your time and views in a one half-hour or more interview. 
You will also get to influence the design of new methods and tools. Make sure your needs are addressed exactly. Ensure your enterprise profits from the close match to features and practices. Share with your friends and peers.

2016

I was supposed to have retired. I built my dream cabin on 400 wooded acres next to a small pond. I thought I could take it easy and just relax. Then I read an article about an FDA Recall Epidemic[1].
Let's you and I solve your biggest problem and then fix it for everybody else, too.

IT'S FREE. NO EMAIL REQUIRED. JUST CLICK AND SAVE THE PDF FILE.

Now I'm back.

In my spare time, I supervised American Red Cross First Aid volunteers for twenty years at University of Michigan sporting events.  GO BLUE!

Menlo Park Associates has a subsidiary:
[1] Medtech Recall Epidemic
File Size: 1370 kb
File Type: pdf
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CONTACT ME
618 Fifth Street
Ann Arbor, MI 48103
+1 734-662-7752
USA 888-828-8107
rick@menloparkassociates.com

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