I’m an advocate and support use of Design Controls during medical device product development. Of course, it is the law. However, I’ve seen several cases of poor execution or abuse of Design Controls. People also struggle with application. Design Controls regulations are intended to be straightforward and are in place to help ensure that medical devices are as safe as possible. Design Controls should not stifle innovation or progress. Many, though, cringe when the topic is brought up. Why is this?
David Vogel has a good article that tauts the benefits of Design Controls at MD&DI. Give it a read.