The FDA Compliance Crisis

Rick Bollinger, Founder and CEO of Menlo Park Software.

That black line is the industry "FDA Compliance Crisis".

See the flat black line on the chart?

That flat BLACK LINE on the chart in the picture above shows the problem. The percentage of inspection outcomes with voluntary or official actions required has been stuck at 40% or more for 10 years.

Just click the chart to expand it.

I managed projects in medical device and pharmaceutical manufacturing. My travel, work, and experience allowed me to diagnose important and hidden problems using statistical analysis, and design process improvement solutions.
I may be calling you.

Are you the FDA Official Correspondent (OC) of your company?  Then I may be calling you. A great deal of trust and responsibility has likely been placed upon you in this role. I have managed projects for a number of medical device and pharmaceutical manufacturers.
The OC was almost always held in high esteem. And, I am sure they understood the paperwork burden I was always under for project operations and regulatory compliance.

The FDA defines the Official Correspondent as the person designated by the owner/operator of an establishment who is responsible for the annual registration of the establishment and the device listing. The OC also receives correspondence from the FDA involving the owner/operator and any of the firm's establishments.

After I retired I decided to make the job of project manager easier and better. I would create a system that supported operations, enforced the QMS, captured the collaboration and then generated the paperwork to demonstrate regulatory compliance.
Hi, I'm Rick Bollinger, Founder and CEO of Menlo Park Software. I'm a management consultant with decades of project management experience. Seeing and solving process problems was my day job for many of those years. Now, retired, I'm an entrepreneur.

Don't take my word for it.
You can see the solution in action
with an interview and DEMO!

The solution eliminates errors of omission and commission. And the demo displays how this is done.
What real proof can I give you?
Note the frequency of 'lack of procedures' which is the citation there is no formal documentation of the requirement. People are doing the best they can. A smart solution is one that amplifies efforts, facilitates and captures collabortion and turns it into FDA evidence of regulatory compliance and risk analysis.
How can I convince you that the interview and demonstration are worth someone's time? Perhaps you know the person who would be most most interrested in what I am  offering. Or, would really want to see the technology. Maybe it's you. I really don't want to waste anyone's time. Including mine, as much as I enjoy seeing my prototype in action.
Let me point out the rewards you get from an interview and DEMO. First off, you will get a token of appreciation that also serves as a ticket to the cast party in Ann Arbor. Can't make it? We can set up a Zoom session and get you some champagne. See below how many token/tickets are left. Take pride in your contribution and get some swag to display in your office for co-workers and peers to see. I wouldn't be doing this if I couldn't create some way for us all to have fun doing it.

My Purpose

I'm collecting evidence of demand for my software that helps stop FDA recalls and citations. This body of information is meant for investors to get their support and funding for further development of requirements: the very requirements I invite from you and your peers, along with design features and look and feel. When was the last time you were part of an epic and exciting project? Your knowledge and experience would make a great contribution. Who else do you know would have a tremendous impact on the industry. And, enjoy doing it.

Crazy / Courage

I must admit that it takes a bit courage to interview/DEMO. Or, maybe a dash of crazy. I'm an entrepreneur. So, I have crazy in good supply. It often masquerades as courage. But, I suspect you will have to conjure up the genuine article. And, that is what I am asking you to do. Sorry.

Michigan

I would like to believe that a good many medical device manufacturers in Michigan would be be predisposed to help industry startups in our great State. I would hate to think our industry interviews and demonstrations can't keep up with California if we just try. I have put thousands of hours into planning, prototype development and interview preparation. I am only asking for maybe one or so. That seems hardly fair.
I'm an entrepreneur. For just one interview, get to see how to eliminate FDA Citations at their  source.
What do you really have to lose?
How can I finish the product without the knowledge and experience of current industry experts like you?
Can we have a conversation?
What do you really worry about?
You're not alone. The trend of FDA failed inspections with objectionable conditions or practices has been stuck over 40% for a decade.
For growing medical device manufacturers, this company's first product, Menlo Park Project™, will be the software to improve FDA recalls, citations, inspections, and quality because it will:
  • eliminate errors of omission and commission,
  • turn project collaboration content into evidence of FDA regulatory compliance and risk analysis,
  • reduce form 483's, Non-comformances, CAPAs, etc.
  • store, track and enforce QMS procedures and tasks,
  • manage and document FMEA and FTA parameters, changes, and calculations.
Menlo Park Project™ will be the only 21st Century, Internet Technology, Patent Pending, 21 CFR Part 11 compliant, project management, QMS, collaboration and risk analysis platform for Safety-Critical projects in regulated industries. Like yours, perhaps.

"Everything is impossible until someone does it." - Arnold Schwarzenegger

Click above to Interview and get a DEMO.
By appointment only.

Let's fix this problem once and for all by turning it inside-out.

See what's coming for the medical device industry.
Just click here to peek at THE FUTURE and mold its features to match your precise purposes.

Menlo Park Project QMS/Collaboration Software

The core prototype has been developed. See how the new software will give smaller and growing firms an edge on compliance and risk management over your larger brothers. Follow the same regulations with much less manual effort.
For example, automatically turning your teams collaboration into evidence of FDA regulatory compliance and risk analysis. We just need to agree on QMS features to accept, store and use to track procedures.  See a DEMO before committing to anything.
The hardest part is done. The core platform already tracks work with alerts and reports. We can design the few missing QMS parts to meet your exact needs. You'll want a DEMO before deciding.
Solutions of this scale need the help of medical device industry experts like you. An hour of your time is needed. That's very valuable. Grab your time slot. Their number is limited.

HOW TO IMPROVE INSPECTIONS AND CITATIONS

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1. Eliminate errors of omission and commission, which will...
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2. Reduce Form 483's, Non-Conformance's, CAPA's, Device Reports and Complaints, and...
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3. Capture collaboration content as evidence of FDA regulatory compliance and risk analysis.

Eliminate Errors

In the core system prototype, issues, risks and tasks turn RED when overdue in dialogs, meetings and reports. And YELLOW when nearly due. This eliminates errors of omission.
The core system now also allows interested team members and stakeholders to subscribe to alerts and reminders of status and progress. Resulting follow up and review eliminates errors of commission that can spoil FDA compliance.

Fix FDA Regulatory Compliance

QMS and regular SOP procedures will be stored by the new software and dropped into projects to define work for team members.
Procedures will be used in all stages of device manufacture. Use them for more than compliance. They will give you a performance edge.
Execution related to issues, tasks, and risks will be tracked and enforced. They show up in alerts, status reports, meeting agendas and minutes. All of that is now generated automatically, including collaboration content, for history records and files to provide evidence of FDA regulatory compliance. This existing feature is now PATENT PENDING.

HOW TO IMPROVE PROJECT PERFORMANCE

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Alert stakeholders to issue, risk and task status changes and reminders. Advance your performance edge by generating status reports and meeting agenda and minutes documents instead of creating them manually. These serve as traditional operational documents, as well as evidence of FDA regulatory compliance and risk analysis.
Already implemented in core system prototype.
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Organize work topics, issues, faults, tasks and risks. Use the resulting structure to collaborate at appropriate levels and locations without searching. Generate status reports and meeting documents to capture collaboration content as evidence of FDA regulatory evidence and risk analysis without manual creation.
Already implemented in core system prototype.
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Magnify the value of outsourcing and working remotely. Integrate external teams with in-house teams despite the pandemic. Merge their collaboration by topic, issue, risk and task. Using email would require copying and pasting all over.
Already implemented in core system prototype.

HOW TO IMPROVE RISK MANAGEMENT

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Define issues, tasks, risks, faults, failure modes and procedures for management in the platform. Use them to keep track of risk parameters. Facilitate Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA).
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Use issues, tasks, risks, faults, amd failure modes in meeting agendas to organize their content to bring the right people together and follow a method that iteratively and incrementally reduces risk probabilities. Request your copy of the the method below. Or, see more about the RECALL EPIDEMIC.

See how Menlo Park Project™ by Menlo Park Software helps the Menlo Park Associates
5 Ways Risk Management Method

  • Stores, tracks and enforces, (turns red and generates reminder messages), execution related to procedures, issues, tasks, risks, faults and failure modes.
  • Manages and documents the parameters and calculations of Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA) and Benefit-Risk Assessment (BRA).
  • Captures and documents all team-member collaboration related to risk analysis and safety-related procedures.

    Request 5 Ways to Stop FDA Recalls method PDF

    Request Problems and Solutions at your own pace presentation.
Interview
Tokens
Left

Tokens are good for free consulting. Until they are gone.

Get the compliance solution you need. The one you deserve.

(It will also help you with the Recall Epidemic)

How may I give you hope?

There are 18 easy questions about how you do things. #19 and #20 are wide open.
Review and save your answers. Some might take time to look up. You could print the questions out and annotate with your answers (and your questions) and spend less time on the survey.

What proof may I give you?

The survey questions are the first 20 in the interview.
If you answer a question in the survey here, we won't have to spend time on it during the interview. That means more time for the DEMO.

What do you have to lose?

In the interview we check the first 20 questions. The process tries to leave the most time for the DEMO.
The interview earns you a TOKEN. It's your ticket to the after cast party. For the first 100, it's also your coupon for free consulting.
Management consulting to help implement the 5 Ways method of risk management and reduce recalls. See diagram at left.

Click for the FDA 'Recall Epidemic' cure.
Medical device company investors: what is your vision for the industry?

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In 2017 the I read an article: "What's Behind the Recall Epidemic?" The authors did identify 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 5 Ways to Stop FDA Recalls. 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.
What's in Your History Files?™
Contact: rick@menloparksoftware.com
+1 734-662-7752 Office
All rights reserved © 2020 Menlo Park Software LLC
A subsidiary of Menlo Park Associates LLC.