Your Software Has a Regulatory Pathway. Build It That Way.

Depends on intended use. Software that treats, mitigates, prevents, or diagnoses a condition is a medical device under FDA law. General wellness software may not be. Regulatory classification is the first question in any DTx engagement — it has a specific answer based on your intended-use statement, and we work through it during discovery.

A focused single-indication behavioral DTx typically runs eight to fourteen months. A complex product with multiple modules, prescription pathway requirements, and full regulatory documentation runs fourteen to twenty-four. These include regulatory prep running concurrently. FDA review after submission is separate.

We're software builders, not clinicians. Ten years in clinical environments means we understand therapeutic protocols, outcome measurement, and regulatory requirements without needing them explained from scratch. The clinical expertise — protocol, advisory, study design — comes from your team or academic partners. We work alongside clinical experts; we don't replace them.

Crisis detection and escalation is non-negotiable in behavioral health or chronic disease DTx. We build PHQ-9 item 9 monitoring, crisis protocol flows, clinical team notification, and emergency services routing into every behavioral health product. Safety risk analysis is conducted during design, documented formally, and adverse event reporting meets FDA post-market surveillance requirements.

You do. Full IP transfer at project close — source code, protocol documentation, regulatory materials, everything. No licensing fees, no ongoing dependency.