The founder of a promising bedside respiration technology was
worried about controlling development costs. He called me with a specific aim: he wanted to determine whether investing in expensive encryption technology would be a net positive. He asked whether the FDA required encryption in a very specific use context.

His device had little chance of getting through FDA clearance without encryption. Going beyond saying “Yes, this is required” I challenged his thinking and broadened the question, while also providing the answer. Instead of thinking about whether the technology was required, I asked him about the impact on his future customers. I showed him that the underlying function of encryption would also allow him to increase the velocity and value of his technology.

Instead of asking about compliance with FDA rules, the founder is now approaching regulatory requirements as an opportunity to create market differentiation and customer value. The co-founder left the call with a lot of relief. He said: “You have completely changed how I am thinking about this. It’s actually a strategic advantage.”