Hi, I'm Rick Bollinger, a management consultant with decades of project management experience. I have solved process problems for companies in many industries. My resume can be found on my About page.

As I traveled and worked, I was building my dream project management platform based on my experiences. I managed projects in the medical device manufacturing and pharmaceutical industries. It was my day job for a good number of years.

In 2017 I read an article: "What's Behind the Recall Epidemic?" The authors identified a real problem. But, their criticism of the entire medical device industry was wrong. You can request a white-paper on the correct solution below. It's titled Aggressive Risk Management Combining FMEA and FTA. A method is described that will find and mitigate more failure modes and lower the probabilty of FDA recalls. And, it's FREE. Just request the PDF.

I also found an industry problem with compliance that my project management platform can solve. The black line on the chart at right shows the percentage of inspection outcomes with voluntary or official actions required, (CAPAs). They have been stuck between 30% to 40% for a decade. They should be between 0% and 10% with my solutions.

The solution for this Compliance Crisis is software. That won't be FREE for everybody. Only the first 100 who interview.

As a consultant, my solutions are my work. And, it's being impacted by the Wuhan Virus (COVID-19), too. Just like you. My solutions need the help of experts in the medical device industry like you. But, I don't need your blood. I don't need your plasma. I need something more valuable. I need an hour of your time.

I need to know I'm on the right track.

One-half hour if you just want to take an internet survey. Same questions. No demo. Click the button at right.

Chances of an FDA recall never go to zero.

2% of device manufacturers have been hit with FDA recalls. Meaning the other 98% may be just one defect away from their first recall.

My guess is that large companies have their own own software. And, that they have learned to tolerate the costs involved. Small companies likely get by with Microsoft Office using Word, Excel. [That's how I did it.]

16% of all companies have no recalls but have received citations.
Does this predispose them to recalls? Does smoke mean there's a fire?

Own your tomorrow. Starting today.

The good news is that your company would most likely be found in the first two groups. But, what's not known for others are the effort and costs incurred to avoid FDA recalls and citations. Who knows when lightning will strike? And how bad the damage will be?

I believe there are a number that use QMS software, home grown or off the shelf. Some of it very expensive. But, to be honest, I really don't know the percentages, yet.

That's why I would like to interview you.

I would like you and others in the industry to volunteer for interviews. And, do a demo using Zoom, or whatever. Don't decide now. I haven't shown what my method and prototype can do. Or, what designs I have on them to do.

The only QMS and

collaboration tool for

collabora-tion tool for

Safety-Critical projects

in regulated industries.

Aggressive Risk Management™

Menlo Park Project™

Reduce device failure mode probabilities and FDA recalls.

Loops

The secret to the new method of risk management is loops. FMEA looks at all faults individually. Then they go to FTA to look for the tallest pole in the tent. New configurations get probabilities to use in BRA and decide if the device benefits now outweigh the risks or another loop is required.

I have developed an Aggressive Risk Management method that will iteratively and incrementally reduce failure mode probabilities. Get the PDF for FREE. It combines FMEA and Fault Tree Analysis (FTA).

Turbo-charge your risk management with Detection. Leverage meetings designed to find and mitigate faults at common design interface, connection and other problem points. Instead of being considered a waste of time, meetings will become engines of performance.
Get the Aggressive Risk Management pdf below.

Reduce Form 483 Citations, CAPAs, Non-Conformances, Device Reports and Complaints.

Issues, risks and tasks turn RED when overdue in dialogs, meetings and reports. That will eliminate very many errors of omission. Interested team members and stakeholders may subcribe to alerts and reminders of status and progress. Resulting follow up and review will eliminate many errors of commission that would spoil FDA compliance.

Digital SOP's

QMS and regular SOP procedures will be stored by the new software and dropped into projects to define work for team members. Procedures can be used in all stages of device manufacture. Everybody gets to look good. Especially you.

Improve project performance by alerting stakeholders to issue, risk and task status changes and reminders. Save time by generating status reports and meeting agenda and minutes documents. These serve as traditional operational documents, as well as evidence of FDA regulatory compliance.

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