2020-03-11 update: In response to the recent Wuhan virus, all Interview/DEMOs will be done over the Internet until further notice. People working at home are welcome to use this time to invest an hour into their future, while in their pajamas and slippers.
Better Collaboration
Better Compliance
Better Risk Control
Better Project Performance
What can we do now?
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We are all under stress and trying to cope with our current situations. That has to have our immediate priority right now. All I can do is observe and listen and make myself available if time and opportunity become open, and I can be of service.
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Below you will find a few software features already implemented that would have helped if our current situation was repeated in a year's time. I can show them in a DEMO. But, it would be crass to ask this of anyone at this time.
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I can't ask. But, you can volunteer.
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In return for your email address you'll be sent an Aggressive Risk Management Method PDF for FREE. It combines FMEA and Fault Tree Analysis (FTA) to iteratively and incrementally lower failure mode probabilities. It will find and control more faults. You might learn something interesting at home.
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We can prepare for the next emergency.
The Wuhan virus (COVID-19) is not just making people sick. Is it not also making companies sick? Some of them fatally? Perhaps they need to try out new remedies, like new methods. And, use new tools, like software. Maybe, also find and finish new solutions in the pipeline? What chance is there we can, together, help defend against the next pandemic, resurgence or wave?
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You might enjoy the special deal at the very bottom.
It's already one-half built!
You can help finish what we will need for the next national emergency.
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1. 21 CFR Part 11 compliant
2. Designed to enforce your QMS 3. Supports FMEA and FTA 4. Eliminates Form 483 citations |
Social internet technology software for the manufacture of safe, effective, and secure medical devices.
A project management platform that supports aggressive risk management, captures collaboration like LinkedIn® or Slack®, and turns it into evidence of FDA regulatory compliance.
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Your choices at this point:
- adopt software that you had no hand in defining and may never satisfy all your needs. Or,
- do nothing, take your chances and roll the dice on recalls and Form 483's, or
- help define new software that meets your unique needs exactly.
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Hi, I'm Rick Bollinger, a management consultant with decades of project management experience. As I traveled and in my spare time I have been building a project management platform to make project work better, easier and project teams more productive. I was privileged to manage projects in the medical device manufacturing industry. It was my day job for a number of years.
Semi-retired after those years, I still get the magazines. Medical device manufacturers got unfairly hammered for their poor risk management and inadequate compliance.
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The real fixes are...
- a new method of risk management that chips away at failure probabilities, and
- software that turns collaboration into evidence of FDA regulatory compliance.
My solutions will, at least, help you sleep at night. You won't worry about device defects sitting on your loading dock, or compliance errors waiting for your next inspection. You'll be doing all within your power to prevent them. I have four deals for you. Plus one extra if you can claim it. See below.
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What do FDA statistics teach us?
1. Chances of an FDA recall never go to zero. But don't stay a victim of statistics.
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2% of device manufacturers have been hit with FDA recalls. Meaning the other 98% may be just one defect away from their first recall.
16% of all companies have no recalls but have received citations. Does this predispose them to recalls? Does smoke mean there's a fire? 82% have no history of recalls or FDA citations, and would like to keep it that way. Get the Aggressive Risk Management method white-paper PDF below. |
2. Own your tomorrow. Starting today.
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Never zero, you can always make recall probabilities as tiny as you want. Just try something new. The best day to start is TODAY. The new software collaborates like LinkedIn® or Slack®. And, will integrate risk management to fight recalls, and enforce QMS procedures for FDA regulatory compliance.
What don't you believe? What chances are you taking by not acting? Click the Interview/DEMO button below now. |
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3. Apply a new method of risk management.
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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.
You will look like a genius. And, a hero saving lives. Get the Aggressive Risk Management pdf below. |
4. Interview/DEMO.
Learn about the method and the role it can play in your organization. Learn to turbo-charge risk management practices. Interview and get support for your implementation of the method into your processes for free (+ expenses).
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In addition to ❶ the DEMO, ❷ the free consulting help to implement the method, ❸ the peek into the future at automatic FDA regulatory compliance. ❹ the right to define and vote on requirements, the interview also ➄ gets you a token which is your ticket to the cast party, time and place TBD. This is your EXTRA gift if you can come. You are very welcome.
See below how many tokens/tickets are still available.
See below how many tokens/tickets are still available.
A Real Deal for the first 100: software meeting your unique needs.
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Be among the first 100 to Interview/DEMO. Then help define, design or develop the software. See the DEMO. With a little imagination and vision you can realize the power it will bring to your everyday work. This offer to VOTE on and prescribe requirements is limited to the first 100 who interview. See at right / below how many tokens/tickets are still available now.
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TOKENS
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Check the requirements list below to see if anything looks interesting to you after you interview. Contact us for clarification. There's lots that can be done when everything's connected.
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Complaint Handling Sub-system
Corrective and Preventive Actions Integrated Medical Device Reporting Digital QMS and SOP Procedures Add Digital Procedure to Project Subscriptions For Change Notifications Color Changes For Overdue Items Color Changes For Nearly Due Items Internal FMEA & FTA Analysis Google Language Translation |
Issue and Task Acceptance
Lab Notebook Integration Recursive issues, risks and tasks Complaint Predictive AI Medical Device Report AI Risk Management AI Lesson Learned Generation AI LiveAgenda™ Meeting Dialog Online Speech Recognition |
Agenda SQL
Risk Vault User Types Permissions Issue Escalation Preferred Devices Complex organizations Zero Minute Meetings Close Issues In Meetings |
VOTE to make sure that your specific needs are addressed.
What would you add to the list?
What would you add to the list?
Click here to download a PDF with which to vote and comment.
Familiarity and Ease of Introduction
The software was also designed to be familiar to users. They will see, and manage, projects, team members, issues, risks and tasks. And, these would show up in status reports and meeting documents. All these objects would have discussion threads. Changes and team member comments would be captured in thread logs and made into compliance evidence for saving into history records and files. Automatically. Don't believe it? Click the interview/DEMO button below now.
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Recovery Details
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What is needed to continue medical device manufacture in a pandemic?
Better Collaboration
The new software does not organize messages by person, like LinkedIn®, or by channel or thread, like Slack® and everything else. Channels, #hashtags and @names are not natural. They are artificial. The new software organizes conversations by the work being done. That's how team members would do it, when left to their own devices.
The new software has team members create and share issues like problems, CAPA’s, goals, risks, faults, failure modes and tasks, using meetings and reports. These issues each have a chat 'channel' that team members use for their conversations. These conversations end up in meeting documents and reports. Notice that the granularity and assignment of discussions is accomplished and seen naturally without artificial #hashtags, searching or @names.
Team members have access to all issues they own. Based on permissions they can see, update, converse about, and recieve messages on changes and due dates. Project managers and admins, for example, can see and update all issues and tasks, etc., belonging to a project.
Better Compliance
Team members add all these issues and tasks etc. to their projects ad hoc to define and share their work activities and items.
These items can also be added to Procedures. Later, all can be inserted at once into projects whenever and wherever they are needed to accomplish necessary work. Reports and meeting documents capture team member activities, conversations and changes. When generated and, automatically, saved in history records and files they demonstrate procedures are being followed and FDA regulatory compliance.
Activities assigned to team members and stakeholders can be tracked wherever they are displayed by being highlighted in RED or YELLOW. This eliminates errors of omission. And, adds to the evidence for FDA compliance.
With the subscription of stakeholders, progress can be tracked by interested team members and alerted to changes. This gives reviewers and stakeholders opportunities to eliminate errors of commission.
Better Risk Control
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The new software enables the method mentioned above. It calls for meetings and groups that are supported by team member and stakeholder invitations, and meeting agendas and topics for discussion.
Meeting minutes, and reports, document risk control activities, targets and results. This permits risk stakeholder review that coverage was deep and complete.
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Better Project Performance
Subscriptions to changes in issues, risk and tasks, etc., send messages to interested team members and stakeholders. This eliminates delays in starting subsequent activities like reviews. Which gives more time to check results, and eliminate errors of commission. Which all improves downstream outcomes.
Change messages are built as a user makes changes to text fields, drop-down lists, and check boxes, etc. representing data items. A string "<field> changed from <X> to <Y>" is added. And, "by <name>" is added when the SAVE button is clicked, along with any ad hoc user comments. Then, the resulting message is scheduled to be sent and added to the log with the time and date. During a meeting, and using the LiveAgenda™ dialog, the comment "in <meeting name>" is added instead of a name.
[Re-]typing and summarizing is not required.
All meeting documents and reports are generated.
The new software is a project management platform. The objects with dialogs and logs are almost all found in the PMBOK (Project Management Institute Body of Knowledge).
Performance is not burdened by documenting collaboration, maintaining FDA compliance, or being aggressive on risk management. Instead many of the documents needed are generated and ready for history records and files required as evidence of FDA compliance. They also function as operational guidance, communication, and records.
Converting to the almost plug complatible new software.
If you are using Microsoft Office to produce paper reports or PDF files ad hoc, then start by creating your next new project infrastructure using the new software platform. The result should allow reports to be generated ad hoc.
Converting a project already in progress requires judging the extra effort to maintain two sets of "books". Also, separating historical documents and entering data to take over current documents.
This looks like we will need procedures in a new conversion project. Extra points and gratitude for helping build that reusable asset.
The Interview
The interview is one hour. You ask your questions. You get asked questions. You get shown a demo. You see 21st Century QMS and collaboration software in action and say what you think. It's over in the time it takes to change a tire. And definitely more pleasant. What do you have to lose?
Counter-rotating processes
Interview and you will get support for your implementation of the method into your processes for free (+ expenses). It includes a presentation on the method and how it can be integrated into your existing processes. The interview/DEMO and consulting can be done over the Internet or on-site and in-person. Let's choose how much of each to match your needs.
The DEMO
The Future of Medical Device Manufacturing
03/04/2020
03/25/2020
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03/11/2020
Peeks at the future of our industry
Look at these requirements of the new software. Some are implemented, others designed, planned, or maybe even just dreamed.
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03/18/2020
04/01/2020
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Menlo Park Software
Solving big information problems with the Internet
Menlo Park Software was created by its parent company, Menlo Park Associates, to solve big problems in a big way using the Internet, software and other technologies of today.
Your humble founder has been a medical device company project manager. An FDA Recall Epidemic was discovered by the Medical Device and Diagnostic Institute (MD+DI) magazine. I found the solution to be a method of risk management and software.
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While doing my own research with FDA data I also found a Compliance Crisis. So now the software can play an even larger role in a larger problem.
But, that will not be the end of it. There will always be big problems to be solved with technology. The company will find them, market test solutions and then build them. That is its charge.
Richard Bollinger, Founder and CEOI wanted to retire semi-early as a management consultant. Recent events in the medical device industry have kept me out of retirement and caused me to take a new trajectory.
As an IT project manager, I worked for pharmaceutical and medical device companies. Also in the automotive, aerospace, DOD, and other industries. For a number of years I supervised all American Red Cross First Responder volunteers delivering first aid and emergency care at University of Michigan football games. So I know how to put together a competent program and guide it to success.
While working and traveling, I found time to write a business plan (Winning $1,000 in 2012 for my New Business Idea in the Phase I GLEQ [MiQuest] Business Plan Competition, Third Place).
Recent events have made it clear that new and urgent problems are at hand for the medical device industry. Now I could really use your help. The problems need to be characterized in a way that can suggest exact solutions. That means many voices need to be heard.
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I would like to appreciate and acknowledge help from the following:
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Thanks for reading this far.
Please. Please. Please help move us further along the solution pipeline.
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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. |
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