How I think about this work

In medical device development, science, product, and regulatory are usually treated as sequential workstreams. First you build, then you validate, then you navigate regulatory. In practice, that sequence is expensive fiction.

Decisions made in product development have direct consequences for your regulatory pathway. Your clinical evidence strategy should be shaping your device design, not chasing it. Your QMS needs to exist before your product does, but it shouldn't be so elaborate that it buries a pre-prototype team in paperwork.

I've seen both failure modes up close. Teams that built a full product and then tried to retrofit a quality system around it; and teams that spent six months architecting compliance infrastructure before they had a prototype worth protecting. Both are a waste of time and runway that early-stage companies can't afford.

My job is to help you move forward: toward real milestones, in the right sequence, without cutting corners that will cost you later or over-engineering systems you don't need yet. That means holding science, product, and regulatory together, not as three separate workstreams that meet at the end.