Cinco de Mayo was a good day--for many reasons! One of the reasons is that I received notification from FDA that a 510(k) we submitted for our startup medical device client received clearance. Did I mention "5" is my number? 510(k) clearance on 5/5--pretty sweet!
The project has been rewarding and challenging, as with most medical device product development projects.
I especially found the FDA 510(k) review process to be a bit more challenging than I had expected. A few rounds of "refuse to accept" followed by a reviewer who seemed to challenge just about everything we provided as supporting evidence. Having gone through this experience with a tough and difficult reviewer is something I do appreciate. Working with him actually made the second submission much more complete and smoother (so far) with FDA.
Medical device perfection is a matter of perspective. And ensuring your product development team has similar point of view and perspective for your medical device is very important. I think it starts with the vision of the device. It also pertains to what you are trying to achieve and when you are trying to achieve it.
Perfection. Probably not a good choice of words. I'll try to explain through a short story based on a current medical device product development project.
We are in the midst of a electronic medical device. Without getting into too many specifics, the device is class II. It has a custom designed PCB with embedded firmware (along with a few other electronic components). The electronics are contained within a custom designed enclosure. The device mates with single-use disposable components....