Design in Reverse - Part 1: Design without Feedback
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Design in Reverse - Part 1: Design without Feedback
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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 what it takes to think strategically about trade-offs when you can't build everything.
If you've ever felt stuck waiting for stakeholder input while somehow being expected to deliver the 'right' solution, this episode is for you! The constraints might differ across sectors, but the tension between authority, information, and decision-making is universal.