About Jae Yoon Lee

I am building regulatory intelligence software for early-stage medical device teams navigating 510(k) strategy.

I've spent my career in medtech at the intersection of product, operations, data, and regulatory execution — across R&D, Operations, Commercial, and Post-Market Surveillance for products commercialized through EUA, De Novo, and 510(k) pathways.

One of the most formative experiences of my career was scaling through a year in which revenue grew from $23M to $618M (27x). We secured FDA clearances, built strong market traction, launched a live GTM motion, and completed a successful IPO. The company still filed for Chapter 7.

That experience made one thing clear: in regulated product companies, regulatory should not be a last-mile documentation function. It should be treated as core product infrastructure.

Too often, teams wait to formalize regulatory strategy until after the product is working. By then, evidence is scattered, predicate logic is weak, technical decisions are already embedded, and traceability has to be rebuilt after the fact.

What should be an execution plan becomes a reconstruction effort.