Pear Therapeutics — Prescription Digitals
Pear Therapeutics was building what would become the first FDA-approved prescription digital therapeutics (PDT) — software prescribed by doctors to treat addiction disorders, with the same regulatory rigor as a pharmaceutical drug. Nobody had successfully navigated this space before.
Build a software platform that could pass FDA review — not once, but multiple times across different indications. This meant automated compliance pipelines, rigorous quality systems, and development practices designed around regulatory evidence generation rather than just feature delivery.
We built the engineering infrastructure for regulatory compliance alongside the product itself. Automated testing pipelines generated the audit trails FDA reviewers needed. We worked closely with Pear's clinical and regulatory teams to translate medical evidence standards into software engineering requirements — a translation problem that had no existing playbook.
- — Three FDA clearances between 2016 and 2018 — reSET, reSET-O, and Somryst
- — Built automated compliance pipelines that became core IP for Pear's regulatory strategy
- — Established engineering practices for prescription-grade software development
- — Key insight: in regulated software, adoption and behavior change are as important as clinical efficacy