In most organizations, you plan first, then build, but what if we plan to build first and design later?

Welcome back to Part 2 of the conversation with Ken Wilkins. In Part 1, we heard how Ken's software team navigated FDA regulations and the tension of needing approval without getting timely feedback. But Part 2 digs into something even more fundamental: what makes a design process actually work?

Ken explains how software's quick prototyping cycles create a unique advantage: you can build something, see how it works, and then loop that learning back to improve your original design. His team transformed a narrow fix-this-one-thing directive into a sustainable framework that would make future work easier. Instead of creating one-off patches, they built a general solution the FDA could approve once and apply to similar ...