How the advisory works

A small number of early founders are mentored at no cost each year. It is meant for people at the very beginning — before funding, before a regulatory plan, sometimes before a prototype — where one well-aimed conversation can change the direction of the next year of work. No fee, no equity, no obligation.

Regulatory strategy for software as a medical device is the work of deciding early what your product legally is, and building the quality system and evidence that follow from that answer. It covers qualification, classification, the certification route, and the QMS structure needed to survive an audit — while those decisions are still cheap to change.

Go-to-market for a digital therapeutic is the work of turning a certified product into a purchased one. It covers the clinical and economic evidence a payer or health system will actually accept, positioning and claims that stay inside your certified intended purpose, and the partnership routes — pharma, insurer, provider — that carry regulated software to patients.