Problem
CBT is one of the most effective treatments for these conditions, but access is severely limited by therapist availability and cost. NHS waiting times for therapy could stretch to 12+ months. Private therapy was unaffordable for the majority. The business problem was demonstrating clinical equivalence to traditional therapy at a fraction of the cost — the evidence base required for NHS contracts, FDA submission, and investor confidence.
My role
I owned the product end-to-end: market research, clinical concept validation, product definition, roadmap, UX design, agile development, and coordination with the MGH and Harvard research teams. Managing the relationship between product development culture (fast, iterative, tolerant of uncertainty) and clinical research culture (rigorous, protocol-driven, documented) was a significant part of the role. Regulatory strategy (FDA Class II de novo, CE Class I) was shaped in collaboration with a regulatory consultant, but every design decision had to account for regulatory documentation requirements.
Approach
The product assessed users for early symptoms using validated clinical instruments, then initiated a personalised CBT programme based on their symptom profile. Therapist involvement was integrated — clinicians monitored progress via a dashboard, stepped in at key moments, and were available when the system flagged elevated risk. The hybrid model kept human oversight central while dramatically reducing per-user therapist time. Clinical protocols were designed and validated by MGH; my team's job was to make them work as a consumer digital product without compromising therapeutic integrity.
Outcome
- 90% of participants responded to treatment
- Average symptom reduction of 55%, on par with results from the best MGH therapists
- 95% reduction in cost compared to traditional therapy
- Results contributed directly to Koa Health's €66M investment round
- Product pending FDA Class II de novo approval and CE Class I mark at time of publication
