What happens when the people closest to the technical work can't make the final design decisions- but also can't get the feedback they need to make good recommendations?

In this episode Ken Wilkins takes us inside the world of FDA-regulated medical device development, where design decisions involve life-or-death stakes, regulatory gatekeepers, and technical constraints most of us never think about. Working on a wearable defibrillator, Ken's team faced the challenge of designing for not just their users- but also a faceless regulatory agency that is not exactly speedy in providing feedback.

Part 1 explores how design actually happens when you're operating in a highly regulated space: the tension of needing to make decisions without timely feedback, the complexity of coordinating teams on completely different development cycles, and wha ...