I'm Rick Bollinger, Founder & CEO of Menlo Park Associates and
Menlo Park Software. Thanks for visiting.
Menlo Park Software. Thanks for visiting.
Experienced Management Consultant
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Menlo Park Associates is a management consulting firm specializing in process improvement. Classic risk management has failed the medical device industry. I researched the real cause of the rise in FDA recalls. And, I developed a new method of risk management to find and mitigate more failure modes.
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This company owns Menlo Park Software. It created a prototype 21st century project management platform using social media software technology. The software can demonstrate the support that can be given to the new risk management method as well as to FDA regulatory compliance.
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Experienced Validation Consultant
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I built and managed a successful Retrospective Validation project for Pfizer (Parke-Davis) when it was in town. The FDA had changed its preclinical software validation policy. Pfizer panicked and I delivered. I developed and documented a minimal process to follow, and hired and trained a team of statistical and IT specialists to follow it. They validated and revalidated preclinical systems to assemble and complete the massive documentation needed for the FDA.
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An FDA Auditor was on site at some point and knew about the project. He asked to see some evidence. The interim review elicited from the auditor "It seems like you know what you're doing." I received a personal letter from Dr. Robert Zerbe, Senior VP of Clinical Research at the time, which closed with "...your contributions to the retrospective validation effort helped us meet our goals for 1996. I appreciate your efforts."
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SEE WHAT THE SOFTWARE TOOL CAN DO.
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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The trouble lies in risk management.
The solution is a new method and a supporting software tool.
The solution is a new method and a supporting software tool.
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The 21st Century solution to FDA medical device recalls is a new World-Class Risk Management Method supported by a project management platform using social media software technology.
Team members with device knowledge will be integrated with risk specialists and their expertise. This will outperform classic risk management that is outsourced and performed remotely.
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If I am right, you can help with a one hour interview 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 an hour. 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.
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What have you got to lose?
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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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My new method is aggressive risk management using Detection that systematically mitigates more faults and drives down failure probabilities. The iterative approach increasingly mitigates known faults and finds new unknown failure modes to incrementally exceed global and proprietary standards of safety and reliability.
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 only risk management, it's also poor information.
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The solution is world-class risk management tools and methods that, together, escape 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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The FTA & FMEA combination is a miracle because they each contribute parts needed for safety and reliability that fit with the other.
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Weekend Hours
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Official Correspondents like you are busy folks. Like me, you might work weekends. Especially on less urgent tasks that pay off in the future. Like those journals and industry magazines.
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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 your current troubles and priorities. And, devise 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 who interview absolutely get the FREE demo and a copy of the new method pdf. Your views are important. A diversity of views is needed.
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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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Claim your FREE world-class method paper and 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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CONTACT ME
618 Fifth Street Ann Arbor, MI 48103 | |||
All rights reserved © 2019 Menlo Park Associates LLC. Owner of Menlo Park Software LLC
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