If you ask me this question, my answer will always be “absolutely critical”. Why? Design Controls are the FDA regulations pertaining to medical device design and development activities (the FDA Design Control Guidance is pretty decent). Design control documentation is your objective evidence demonstrating you designed the right product and that it is safe.
Interestingly, though, this week, I’ve had conversations with two different medical device startups who have decided to push forward with their design and product development resources without worrying about complying with FDA Design Controls. Okay, neither stated it exactly this way. But when I challenged each on how they plan to ensure design and development documentation and records comply with FDA Design Control regulations, I got blank stares and a long pause. Neither realized or really appreciated the gravity of my question (just for fun, you should should FDA warning letters and find out how many times “failure to comply with Design Controls” is stated).
In the first case, the startup CEO tried to skip over my inquiries. I think he thought I was trying to make a pitch for hiring CQ throughout the project. I left this conversation stating something along the lines of “. . . Please make sure you address Design Controls and have appropriate documentation and records to comply with FDA regulations. It’s like insurance. And I’m not suggesting you use CQ. Just make sure to meet the regulations.”
In the second case, one of the other service providers assisting with product development efforts realized the criticality of ensuring Design Controls are properly documented. They contacted me and asked if I could consult with their firm to make sure everything is documented appropriately.
Okay, I realize having resources to write quality system procedures and design control documents isn’t sexy. I realize that these resources are probably in the category of overhead. But nothing could be more deflating to a company than launching a product without good, complete documentation in place. Sure, a company could easily launch a product, ignore FDA regulations, and may never get caught. But what if they do?