How I learned to Innovate (a bit more) in Regulated Industries

Here's a short story about how I learned to innovate (a bit more) in regulated industries.

In the summer of 2020, Yves Prevoo had got easee in the first Techleap batch. Pretty cool! I was invited to join one of the sessions for the CTOs in which Ali Niknam talked about his adventures. I didn't know anything about him then but I liked him right away as he also wore a black t-shirt and a Casio F91w, my standard outfit.

I had been struggling with innovating in a highly regulated industry. I dreaded the yearly ISO 13485 audits and always had the feeling we were doing everything wrong or breaking some law that we didn't know about yet. It didn't help we didn't have anyone with Medical Device experience and it didn't help that we had a very strict auditor. To be frank, I really had no idea how to develop anything new and get it certified without going bankrupt from the clinical trials. I didn't know what to do or how to lead my team in an inspiring way because of all the regulations.

Hearing Ali speaking about Bunq in such an optimistic sense was surprising. Wasn't banking also highly regulated? How did he keep the can-do attitude that I lost? So I decided to ask him about this during the Q&A. As I stood up he complimented my Casio and I made some stupid joke that didn't land, but then I asked "How do you keep innovation and fun alive in a highly regulated industry?"

I think he understood the pain where my question was coming from and his answer was short and spot on. This is how I remember it:

"Auditors are not omniscient, they are typically pretty boring and their job is to go through checklists. This is how the system works and it's a necessary evil. Now, it's your job to figure out what's on their checklists and how to give an answer to each item on the list. But don't start by focusing on doing everything right, first focus on what you want to achieve, and then figure out the checklists. After all, auditors are not leading industry advances, we need you to do that."

What a fantastic call to action! I felt very empowered and my whole way of thinking about auditors made a 180 in that moment.

In the next year I felt better, was able to file two innovative patents and ship a lot of improvements with my team. There was still quite some residual fear, and the EU really put a hard break on innovation with the "no significant changes" clause in the MDR.

But now, in every new project I take on in a regulated industry, I see my role vs the auditor's role crystal clear. My job is to innovate, their job is to make sure the necessary checklists are checked.

Thanks Ali!

(this is a cross-post from LinkedIn )


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