If you believe this title, you have not worked on many medical device product development projects. But interestingly, FDA design control regulations and ISO 13485 design & development requirements convey the process as a linear progression. And most every product development and design control procedures I’ve read (and written) also lay out medical device product development in a very methodical, step-by-step fashion.
The trouble is no project ever follows a nice linear progression. Sometimes it seems as though everything is happening all at once. Sometimes it seems like manufacturing constraints dominate before the user needs are even defined.
And this is just the way it is.
With each medical device product development project I’m involved with, I grow more and more comfortable in the midst of the chaos. I also consider myself in a very auspicious and unique situation on these projects. I have an innate understanding and comprehension of the rules. And despite the muddy mess of a picture I might have just painted, there are several rules that must be followed. Having someone that knows how to navigate and apply the rules is important (if I do say so myself).
Please don’t misunderstand what I’m trying to convey. Yes, I definitely believe defining the process IS critical. Yes, you need to have a procedure that lays out the project phases and deliverables. And yes, this process should lay things out in a simple, linear fashion. Just don’t be so naive to think your medical device product development project is going to follow that process to the letter. If it does, you are not pushing hard enough. You have to figure out a way to get things done as quickly and thoroughly as possible. The process and the deliverables are reminders of what must be done.