Software With a Treatment Claim Is Held to Treatment Evidence.
Regulatory strategy for prescription and OTC digital therapeutics — clearance, clinical evidence, and the payment path that decides whether the product survives.
The Pioneers Proved the Science. They Didn’t Prove the Business.
The first prescription digital therapeutic was authorized in 2017 — a De Novo that built a device class and seemed to open an industry. What followed was the hard lesson: the company behind the most-cited products cleared FDA, published outcomes, and still collapsed in 2023, because prescriptions without reimbursement are marketing expenses.
The category is now recovering on better foundations — Medicare’s digital mental health treatment codes pay for FDA-cleared products, remote-monitoring codes reach digital interventions, and payers have dossier expectations instead of blank stares. We design DTx programs for both approvals at once, because the second one is where the first generation died.
A DTx is judged against real therapy — sham apps, waitlists, and standard of care, chosen deliberately.
One Product, Two Files. Clearance Is Not Coverage.
Every serious DTx program is running two evidence programs that share data but answer different judges.
The Regulatory File
What the agency needs to authorize a treatment delivered as software.
- Pathway: De Novo where the class doesn’t exist, 510(k) onto the precedents the pioneers built
- Clinical evidence: randomized data against a credible control — sham app or standard of care, endpoints a reviewer recognizes
- Human factors: validation that patients can self-administer therapy without a clinician in the room
- Lifecycle: software change control that tolerates app-store reality
The Economic File
What CMS and commercial payers need to put money behind the prescription.
- Coding: a coverage route — Medicare’s DMHT codes for cleared mental-health devices, RTM codes where monitoring is the mechanism
- Endpoints payers value: utilization, adherence, downstream cost — not just symptom scales
- Engagement durability: real-world retention data, because a therapy nobody finishes has no budget impact
- The dossier: value evidence assembled for P&T review, not press releases
Engagement is the DTx dose. If usage collapses at week three, so does the treatment effect — and the payer knows it.
Design the Trial for the Product You’ll Actually Ship.
DTx trials have their own failure modes: a no-treatment control that flatters the app but persuades nobody, an engagement protocol supervised so heavily it doesn’t resemble the real world, endpoints that move but don’t matter. The sham-app question alone — what does placebo software look like? — deserves more design attention than most programs give the whole protocol.
Positioning decisions ripple through everything: prescription or OTC, standalone therapy or adjunct, and — when the software rides alongside a drug — whether you’re a device at all or the drug sponsor’s labeling problem. We settle claim, comparator, and positioning before the protocol locks, because those three choices are the trial.
What a DTx Program Plans Around.
The history, the payment turn, and the endpoint nobody escapes.
The first prescription DTx authorization — the De Novo that created the class every 510(k) since has stood on.
Medicare’s digital mental health treatment codes — the first durable federal payment lane for FDA-cleared therapeutic software.
The dose-response variable payers audit. Retention curves are economic evidence, not product analytics.
Six Failure Modes We Are Brought In to Prevent.
The pattern across the first generation is legible — and avoidable.
Wellness positioning, treatment claims
An app marketed to “manage depression” while filed as general wellness — the claim decides the category, and screenshots are claims.
A control arm built to lose
Waitlist controls that inflate effect sizes the payer dossier then can’t defend — the trial convinced FDA and nobody else.
Launch before the payment lane
Clearance celebrated, sales hired, and no code, no coverage policy, no billing route — the pioneer’s epitaph.
App-store cadence vs change control
Weekly releases pushed by platform requirements, with no procedure deciding which ones touched the therapeutic algorithm.
Engagement collapse post-launch
Trial retention achieved with coordinator phone calls; real-world retention a fraction of it — and the outcomes contract underwater.
Drug-adjacent software, unanalyzed
Software supporting a specific drug without the drug-and-device analysis — discovering late that the sponsor’s label owns your roadmap.
DTx Regulatory Leadership That Prices the Whole Journey.
Our leads have run software clearances, designed digital-therapy evidence, and built the payer story alongside the regulatory one.
“A digital therapeutic has two approval processes — FDA’s and the payer’s. Companies that treat the second as a marketing problem die with a cleared product.”
The discipline we bring to prescription and OTC therapeutic software.
Building a Digital Therapeutic? Design the Evidence for Both Files.
Bring senior DTx leadership in before the protocol locks — the payer gets a vote, or the product gets a eulogy.
Senior-led. Embedded in your team. No junior hand-offs.