Working with FDA through the EUA
My company is presently working with company making ventilators for FDA approval. This is a learning experience. Does anyone have any inputs?
7 Replies
Hi William,
How exciting for you and your organization! The realm of mechanical ventilation is fascinating!
Today, more than ever!
Would you be able to provide more detail as to what kind of 'input' you're seeking so that ASQ members can present more specific information to assist you?
I look forward to hearing more and happy to help if I can!

Best wishes,

Melanie Galloway
If this, FDA trials, is something that you will continue on with, learn everything you can about the process. Document everything, even if just for your personal notes. 
Understand how they differentiate data and what paper trails are required for their certifications. 
Hello William,

I have many inputs and would welcome a conversation.  I've spent a good amount of time in the industry and set up FDA-compliant systems.  I am a bit passionate about this because I see people approach this type of challenge two ways.  They either focus on compliance - or they don't.  :-)

I'm in the latter camp. GMPs are called that for a reason - Good Manufacturing Practices.  Focus on developing, documenting and  adhering to Good Practices and you will - by default - be compliant

If your normal work is not in the Medical Device field, then you will also need to drive a shift in Quality Mindset.  I went from making Medical Devices to making Printers (HP).  HP thought it had a good Quality and Reliability focus, but compared to where I came from HP looked like a company making toy trucks.  You are now making LIFE SUSTAINING EQUIPMENT!  Literally LIVES DEPEND UPON IT.

The FDA allows companies to veer from their own procedures using "Deviations" - and many companies used Deviations far too much.  If you deviating, it means you messed up on the front end of your process design.

FYI for those not familiar, Medical Device / FDA systems revolve around "Operating Procedures" and "History Records".  Procedures need to be bullet-proof and Records need to be thorough.  Design a robust Traceability system - you NEED to be able to trace back from the final customer to the sources of all parts of the equipment and then back from the sources to EVERY customer who MIGHT have a suspect component.  Car manufacturers will do "recalls" covering several months of production.  That is not good enough - if you use "normal" lot tracking you are setting yourself up for disaster.  You DO NOT want to pull back equipment from the field that is being used to SAVE LIVES.

Okay - enough rant for now.  The FDA are good people and want your success, but their charter is to prevent you from killing people, over helping you to save people.  It is a pain in the ass, but they will prevent you from saving a thousand to prevent you killing ten.  > sigh <

My background is in Industrial Engineering.  Use the tools of that profession weel and you should be okay. for my contact details.

Personal History
Thanks Dan, I work in the manufacturing field, many years in automotive, now in off-road equipment.  Just read these forums out of general interest being in the quality field all my life.

I just have to say that your post was the best post ("rant" lol) I read on any of these myASQ forums!!!
Thanks, somehow it brightened my day!

Interesting article.  I was not sure what camp you are in when you stated " I'm in the latter camp".  Could you explain?
I noticed your extensive background.  Please refer to year 1-2.
Thank you for your extensive work and guidance in manufacturing medical devices in this pandemic.

Lin Cheng
1 Posts

What a great write up! Thank you for sharing the insights with us. I'm preparing to take my CQE exam in June (registered and scheduled). One of the first thing I want to do after getting certified is to get my foot in the door of medical field. I came from Mechanical Engineering background with working experience in Aerospace.

Currently I work at a company produce ASME pressure relief valves for hospital beds and oxygen equipment. I'm frustrated that quality is not the no. 1 at this company and we don't have much leverage over our overseas suppliers due to the size of our orders. 

My goal is to find a company that sees quality as the No. 1 driving force and I want to meet that challenge by learning new things everyday. I will be sure to visit your website and learn as much as I can. 

My back ground is in the manufacturing world I have manged quality for the creation of products like class 8 trucks, light and heavy military vehicles, body armor including frag vests and chemical warfare suits.  The  quality of the components is the most important thing you need to manage.  Hopefully the components have been tested beforehand and you will need to be ensured with adequate documentation that these components met the specifications. If they haven't been  they will have to be tested.  The concern is that they would be manufactured to commercial quality level which might not be acceptable considering the risk in manufacturing a life saving device like a ventilator.. Develop standards for assembly and testing . A high degree of documentation is important make sure you get accurate feed back from everyone involved  in the processes so you can make the changes necessary. Good luck and thank you for your effort to help people affected by this virus.