MENTORING
Pro-bono mentoring
A small number of early founders mentored at no cost each year.
More →Software that heals, safely.
A boutique advisory for founders carrying medical software from prototype to certified, regulated product.
STRATEGY
Regulatory & SaMD strategy
Classification, QMS structure, and certification pathway design from first prototype onward.
More →MARKET
Digital therapeutics go-to-market
Positioning and evidence strategy for regulated products entering the market.
More →WHO IT'S FOR
We advise founders crossing into regulated healthcare — engineering leaders coming from consumer technology, and scientists, clinicians, and research spinouts moving a discovery from the lab into the world. The stakes shift for both: a software bug is no longer an inconvenience, it's a patient safety risk. We provide the architectural blueprints and strategic oversight required to build software that heals, safely.
Regulated products don't forgive retrofits. Design controls, risk management, and traceability have to be built into the architecture from the first decision, not layered on before a submission. Get this right early and every audit becomes confirmation instead of discovery — not a scramble to reconstruct what should have been there from the start.
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.
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