YOU ARE NOT TO BLAME FOR RECALLS.
BUT WHAT WOULD YOU GIVE TO
MAKE YOUR RISK MANAGEMENT
WORLD-CLASS?
Prevent FDA recalls.
There was never any FDA recall 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.
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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.
I am also researching a paper on industry problems with current methods and tools. What works, what doesn’t, and what’s wrong. All data collected will be treated as confidential. Use will be only analytical and statistical.
Join your peers. Preview the survey which is just preliminary interview questions. They can be printed to guide and record answers that need to be looked up.
This will save time in the interview, make it more productive, and leave more time to cover your story.
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My recent MD+DI article about recalls shows 2017 is now the worst year ever. It's not all your fault.
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The problem isn't risk management, it's complacency. |
One solution is a world-class risk management method that escapes the status quo.
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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')
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.
World-Class Risk Management Method
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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?
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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.
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Their combination is a miracle because they each contribute a part needed for safety and reliability that fits with the others.
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PLEASE URGE YOUR PEERS TO JOIN YOU IN THIS RESEARCH.
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I was in the medical device industry some years ago. The world has changed. The interview's purpose is to characterize the current problems and solutions in the industry from your point of view.
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For this, I am gifting you the method I have developed that should be helpful today. Your views are important. I need a diversity of views. They will form the basis of needs in new methods and tools.
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"You'll always miss 100% of the shots you don't take."
-- Wayne Gretzky, famous hockey player
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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 hour interview.
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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.
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2016I 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 raise the current standard of risk management and make it all world-class.
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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!
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CONTACT ME
618 Fifth Street Ann Arbor, MI 48103 | |||