|
I'm Rick Bollinger, a management consultant with decades of project management experience. A number of those years I was privileged to work in the medical device manufacturing industry. Now I’m trying to help…
|
|
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.
Like LinkedIn®, or Slack® but will support risk management and enforce QMS procedures for FDA regulatory compliance.
|
❶ Give me your email address and I'll send you an Aggressive Risk Management Method PDF for FREE. It combines FMEA and Fault Tree Analysis (FTA) to iteratively and incrementally lower failure mode probabilities. That will find and control more faults.
❷ Let me interview you and I'll help you implement the method for FREE (plus expenses).
❸ In addition, you get a peek into the future at automatic FDA regulatory compliance. ❹ The interview also entitles you to VOTE on new and deferred requirements. Don't miss getting your needs addressed in the new software. Then ➄ come to the cast party.
|
That's what we're building.
Social network technology software for the manufacture of safe, effective, and secure medical devices.
Like LinkedIn®, or Slack®, except it turns collaboration into FDA regulatory compliance evidence, and supports aggressive risk management.
|
|
What do FDA statistics teach us?
1. 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 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 483 citations, but still need to sleep. Get the Aggressive Risk Management method white-paper PDF below. |
Sleep without worry when you've done all within your power.
2. Own your tomorrow. Starting today.
Never zero, you can always make recall probabilities as tiny as you want. Just try something new. The best day to start is TODAY. All in your power will soon include software that collaborates like LinkedIn® or Slack®. But will integrate risk management to fight recalls, and enforce QMS procedures. Then, automatically track and document work with collaboration to prove FDA regulatory compliance.
Click the Interview/DEMO button below now.
Click the Interview/DEMO button below now.
A good percentage of QMS software vendors claim to be designed specifically for the medical device industry. That's not believable, given the thousands of device manufacturers. Will all their QMS's be identical? Will one generic QMS cover them all? Of course not.
The software we are building is being designed to accept your current QMS, store it, execute it, track it and document it. Boom! Then, if a close friend (or paying customer!) wants a copy of yours, you can give it to them, and maybe help them tailor it to accomodate their differences. Then they can buy this software and use something that matches their needs exactly.
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. |
3. Apply a new method of risk management.
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).
Doing all within your power includes practices in the PDF that turbo-charge your risk management with Detection, and meetings designed to find and mitigate faults at common design interface, connection and other problem points.
Human lives are in the balance. Get the Aggressive Risk Management pdf below. |
4. Interview/DEMO with me.
|
Learn about the method and the role it can play in your organization. Learn to turbo-charge risk management practices and facilitate them with software like LinkedIn® or Slack® that also prevents errors of omission and commission to improve FDA compliance.
|
DSOP's
QMS and 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. This feature is PATENT PENDING. |
The choices you have at this point are to:
- adopt software that you had no hand in defining and may not satisfy all your needs. Or,
- help define new software that meets your needs exactly. You can only do that at this time with an interview. One-half hour each to ask questions and see a demo. (30:30)
Counter-rotating processes
Interview with me and I will support 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.
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 choose to come. We'd love to have you.
See below how many tokens/tickets are still available.
See below how many tokens/tickets are still available.
5. Champion new solutions to recalls and citations.
Do all within your power.
|
Learning about new methods and software is interesting. But, the software is not finished yet. It needs final requirements. It needs people in your position to help define it. People with imagination. Not a lot of your time is needed. Just a dash of vision to broaden all of what is in your power to save and improve lives.
Be a champion and help bring solutions into the world. Take a few minutes out of a day to help stop the 2% from producing recalls.
Help stop the 16% from producing citations. Get the Aggressive Risk Management pdf below. |
A Fair Deal for the 1st 100: software meeting your exact needs.
|
Be among the 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 how many tokens/tickets are still available now.
|
TOKENS
LEFT |
Check the deferred requirements list below to see if anything looks interesting to you after you interview. Contact me for clarification. There's lots that can be done when everything's connected.
|
Complaint Handling Sub-system
Corrective and Preventive Actions Integrated Medical Device Reporting Digital QMS and SOP Procedures Add Digital Procedure to Project Google Language Translation Online Speech Recognition Task and Issue Email Update |
Internal FMEA & FTA Analysis
Issue and Task Acceptance Recursive issues, risks and tasks Complaint Predictive AI Medical Device Report AI Risk Management AI Lesson Learned Generation AI Close Issues In Meetings |
Agenda SQL
Risk Vault User Types Permissions Issue Escalation Preferred Devices Complex organizations Zero Minute 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?
Don't worry, be happy, when you've done all within your power.
6. Traction for funding and development.
|
Building the software needs funding from angel investors and venture capitalists. Your power is to express your desire for such a solution as this. Also, grant us your vision of tomorrow. When a critical mass of volunteers like you have indicated their demand, we will have evidence of traction. This we can take to investors in the medical device space to convince them to invest in our future.
|
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.
Price and Scale
The software was designed for medium-sized medical device manufacturers. However, it has features, like communities, procedures and sub-projects that scale up for larger organizations. It will be priced at much less than the $200 per month per seat charged by many big QMS vendors. The software will be priced for companies to help them grow without too much pain. Interview to get into the discussion about price.
Click the interview/DEMO button just below now.
Click the interview/DEMO button just below now.
