The medical device industry is in trouble.
I'm Rick Bollinger, Founder and CEO of Menlo Park Software. Thanks for visiting.
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Weekend Hours
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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.
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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.
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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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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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Weekend Hours
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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.
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New Sessions
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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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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 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.
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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 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.
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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 | |||