STRATEGY
Regulatory & SaMD strategy
Classification, QMS structure, and certification pathway design from first prototype onward.
Software that heals, safely.
A boutique advisory for founders carrying medical software from prototype to certified, regulated product.
MARKET
Digital therapeutics go-to-market
Positioning and evidence strategy for regulated products entering the market.
MENTORING
Pro-bono mentoring
A small number of early founders mentored at no cost each year.
WHO IT'S FOR
We advise founders and engineering leaders transitioning from consumer technology to regulated healthcare. The stakes are profoundly different — a software bug is no longer an inconvenience, it is a patient safety risk. We provide the architectural blueprints and strategic oversight required to build software that heals, safely.
We work with early founders building software as a medical device — usually pre-certification, pre-seed to Series A — who need a strategy that holds up to scrutiny, not just a pitch deck.
A limited number of advisory conversations are taken on at any time.
Get in touch →EXPERIMENTS
An independent side project — a quiet habit-tracking app for people managing chronic health routines.