MedTech Recall Epidemic Still Rages?
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There was never any FDA recall epidemic. Only just economics. More devices mean more recalls.
New device company risk management is just not any better. Older companies are still struggling, too. And, the blame is unfair.
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I am researching a paper on industry problems with current methods and tools. What works, what doesn’t. What’s wrong. All data collected will be treated as confidential. Use will be only analytical and statistical.
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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.
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The solution is A+ risk management method that escapes the status quo.
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THERE ARE SAFE THINGS YOU CAN DO NOW:
- Implement Detection ranking to protect your Risk Priority Number calculations. They are dangerous with out 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')
LEARN THE A+ RISK MANAGEMENT METHOD FOR THE FUTURE:
- 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.
I am researching a paper on industry problems with current methods and tools. What works, what doesn’t. What’s wrong. All data collected will be treated as confidential. Use will be only analytical and statistical.
THE GOOD NEWS IS THAT I AM GIVING THE A+ METHOD AWAY FOR FREE.
The A+ 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 A+ risk management method combines and iterates Fault Tree Analysis (FTA), Failure Mode and Effects Analysis (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.
FEMA focuses on each and every fault individually to minimize its risk. FTA looks at the whole system. Its purposes include finding configurations and weak points to minimize the overall risk and then calculating quantitative risk probabilities. These are just what are needed for BRA to apply and see real world dangers in human terms of safety and reliability.
Before tool support there will be assistance available to help configure your quality system to get FEMA, FTA and BRA working together as they should.
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I want to give you my new method in trade. I don't want your money. I want a little of your time. I am interviewing medical device leaders like yourself to diagnose the state of the industry and define more solutions for today's problems. Here is how the deal works:
The method is straightforward and you should be capable of the combination on your own. There are no tools that currently automate the process.
It is possible you might discover the method on your own. But, you need a couple of hours of research to see all the connections. And, another couple of hours to get the iterations just right so the overall operation is competent and effective.
The method description I will send you has all of this figured out for your first iteration. So, your one hour interview would jump start your efforts to make a quantum improvement in your risk management processes.
The A+ method got its name because risk management is so very hard. Doing it right should be given a high grade.
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NO EMAIL REQUIRED. JUST CLICK AND SAVE THE PDFs!
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 willing to give you a 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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Trade your time and views in a one hour interview.
Then use the A+ method to jump start your efforts to make a very large improvement in your risk management processes. Take your shot. |
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.
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I am researching a paper on industry problems with current methods and tools. What works, what doesn’t. What’s wrong. All data collected will be treated as confidential. Use will be only analytical and statistical.
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I have been a management consultant for over fifteen years. Before that time, I managed projects in the pharmaceutical, medical device, aerospace, DoD, and other tech industries. I taught the section on risk management in the PMP certification exam prep classes many times.
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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 bring everyone up to an A+ .
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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 | |||
