Go-to-market for a digital therapeutic is the work of turning a certified product into a purchased one. It covers the clinical and economic evidence a payer or health system will actually accept, positioning and claims that stay inside your certified intended purpose, and the partnership routes — pharma, insurer, provider — that carry regulated software to patients.
Certification proves safety and performance to a regulator. It does not demonstrate clinical or economic benefit to a payer, and those are different evidentiary bars judged by different audiences. Most digital therapeutics that stall commercially have satisfied the regulator and never built the case the buyer needed.
More than the regulator, usually. Outcomes that map to their cost base, in a population that resembles theirs, over a time horizon they care about. The expensive mistake is treating this as a phase that begins after certification — the same study, planned earlier, often serves both purposes.
Direct-to-consumer avoids long procurement cycles but caps price and can change your regulatory and data-protection footing — a consumer app is usually its own controller under GDPR, with the full weight of consent and rights handling. Partner routes are slower to sign and far more durable once signed.
Germany’s fast-track for digital health applications is the most developed reimbursement route in Europe, and its evidence requirements shape product decisions well before you apply. Worth deciding early whether you are building for it, because retrofitting a study design to fit it is considerably harder than planning for it.
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