Digital Therapeutics Software Development Company

DTx startups and mental health platforms move fast until they hit the evidence wall: clinical outcome data scattered across systems that don't connect, adherence tracking that breaks at scale, and a regulatory architecture that was never designed into the product. When your intervention software needs to prove it works, the data infrastructure underneath it has to be built right.

  • Evidence-based intervention delivery platforms built for CBT, DBT, chronic disease coaching, and behavioural health programs

  • Clinical outcome measurement with validated scales (PHQ-9, GAD-7, HbA1c tracking) and FHIR-compliant data export for EHR integration

  • Patient adherence and engagement systems with personalised nudges, progress tracking, and provider dashboards

  • HIPAA-compliant, SaMD-aware architecture designed for regulatory review from sprint one

Recognition

Sound familiar?

  • Collecting patient outcome data from three separate tools and manually aggregating it before each clinical review?

  • Built adherence tracking into the app but losing 40% of patients by week four because engagement loops weren't designed for the long term?

  • FDA SaMD classification blocking your roadmap because the architecture wasn't designed with regulatory-grade audit trails from day one?

The short answer

RaftLabs builds custom digital therapeutics software for DTx startups, mental health platforms, chronic disease management companies, and prescription digital therapeutics developers. Our work covers evidence-based intervention delivery, patient adherence tracking, clinical outcome measurement, FHIR-compliant data pipelines, and FDA Software as a Medical Device (SaMD) architecture. Most digital therapeutics software development projects deliver in 14 to 24 weeks at a fixed, agreed cost.

What is digital therapeutics software?

Digital therapeutics (DTx) software delivers evidence-based therapeutic interventions directly to patients through software, treating or managing medical conditions the way a drug or device would. Unlike general wellness apps, DTx platforms collect clinical outcome data, track patient adherence, integrate with healthcare workflows via FHIR, and are designed to meet FDA Software as a Medical Device (SaMD) requirements when a regulatory pathway is needed.

01 Diagnosis

Problems we solve in digital therapeutics

  1. 01
    Problem

    Your clinical outcome data lives in three tools and reaches your team days late

    Solution

    When validated assessment scores come from one system, session completion data from another, and provider notes from a third, the data your clinical team needs to make decisions about a patient's care plan takes hours to assemble manually before each review. Gaps appear when a staff member is out, and the picture is always slightly out of date. A unified outcome data pipeline that captures PHQ-9, GAD-7, PROMIS, or disease-specific scores directly within the intervention session, time-stamps them, and surfaces them in a provider dashboard in real time cuts that manual assembly to zero and gives your clinical team a complete view at the moment they need it. "RaftLabs nailed what other agencies couldn't — they started with our business problem and worked backwards to the right product. We were live in 14 weeks.", Daniel Reeves, CEO

  2. 02
    Problem

    Patient drop-off spikes at week four and your engagement data can't tell you why

    Solution

    According to a pilot randomized controlled trial published in PMC (2022), digital therapeutics for chronic disease management achieved statistically significant improvements in adherence only when personalised behavioural nudges and human check-in triggers were built into the software. Passive notification systems alone did not sustain engagement beyond the initial weeks. When your DTx platform sends the same reminder to every patient at the same time regardless of their usage pattern, drop-off is a predictable outcome rather than a surprise. Adherence systems that adjust nudge timing and content based on individual session behaviour, combined with provider alert workflows that trigger when a patient crosses an inactivity threshold, cut four-week drop-off consistently across the DTx programs we've built.

  3. 03
    Problem

    Your FDA SaMD submission is stalled because the audit trail wasn't designed in

    Solution

    Digital therapeutics regulated as Software as a Medical Device require an audit trail that captures every clinical data access and modification event, version control that maps each software update to its clinical evidence base, and cybersecurity risk documentation that covers the full data flow. When none of that was designed into the original system, the work to retrofit it is significant: schema changes, new logging infrastructure, and a re-review of data flows that may have PHI passing through undocumented paths. Designing SaMD-aware architecture from sprint one means the audit trail, data integrity controls, and version documentation are part of the definition of done for every feature, not a separate project at submission time.

  4. 04
    Problem

    Prescribers can't see patient progress in their EHR so they stop prescribing

    Solution

    Prescription digital therapeutics live or die on prescriber adoption. When a physician prescribes a DTx and the patient's progress data doesn't flow back into the EHR they use for every other clinical decision, the prescriber has no visibility into whether the intervention is working. Without that feedback loop, repeat prescriptions drop and the commercial pathway stalls. FHIR-compliant integration that pushes outcome scores, session completion rates, and clinical alerts back into Epic, Cerner, or Athenahealth in the prescriber's existing workflow closes that loop, and prescribers who can see measurable patient progress prescribe again.

02 What we ship

Digital therapeutics software we build

  1. Evidence-based intervention platforms

    We build structured intervention delivery systems for cognitive behavioural therapy (CBT), dialectical behaviour therapy (DBT), acceptance and commitment therapy (ACT), chronic disease coaching, and condition-specific behavioural programs. Each session module is authored in a content management system your clinical team controls, so intervention protocols can be updated without a developer involved. Session sequencing adapts to the patient's progress data, not a rigid weekly schedule.

    Intervention fidelity logging captures exactly which protocol elements were delivered, when, and in what order, giving your clinical research team the data they need to demonstrate evidence of efficacy in a regulatory submission or payer negotiation.

    Built for DTx startups building their first intervention platform, mental health companies moving from therapist-delivered to software-delivered programs, and pharmaceutical partners building a companion DTx alongside a drug product.

  2. Patient adherence and engagement systems

    Adherence architecture covers session reminders with personalised timing based on individual usage patterns, progress milestone celebrations that reinforce early wins, streak tracking, and inactivity alert triggers that notify a coach or provider when a patient crosses a defined non-engagement threshold. Push notifications, SMS via Twilio, and in-app messaging channels are all configurable per patient cohort.

    We instrument every engagement event so your analytics team can see exactly where patients drop out of a session, which content modules have the lowest completion rates, and which nudge strategies retain patients longest. That data feeds directly into product improvement cycles rather than sitting in a raw event log.

    Built for chronic disease management platforms aiming for 70%+ active usage at 12 weeks, mental health apps replacing high-cost one-to-one therapy at scale, and DTx programs entering payer negotiations where adherence data is a reimbursement lever.

  3. Clinical outcome measurement tools

    Validated assessment instruments, PHQ-9, GAD-7, PHQ-15, PROMIS scales, AUDIT-C, HbA1c logging, blood pressure and weight tracking, and disease-specific outcome tools, are embedded directly into the intervention session flow. Scores are calculated in real time, time-stamped to the second, and stored with a full audit trail linking each score to the patient session, device, and software version that produced it.

    FHIR R4 Observation resources carry outcome data to EHR systems and research databases via standard APIs, removing the manual extraction step that currently delays clinical review. Longitudinal outcome dashboards give your clinical team a patient-level and cohort-level view of progress without running a database query.

    Built for DTx platforms seeking FDA SaMD clearance, clinical research teams running real-world evidence studies, and outcome-based reimbursement arrangements where payers require periodic outcome reporting as a condition of coverage.

  4. Provider and care coordinator dashboards

    Provider dashboards surface the patient data a clinician needs before a check-in: most recent outcome scores with a trend line, session completion rate over the past two weeks, inactivity alerts, and any flags the intervention logic triggered. Dashboards are role-based: a prescribing physician sees clinical outcome trends; a health coach sees daily engagement and open tasks; an ops manager sees cohort-level adherence rates and programme completion.

    We build EHR-embedded dashboard views using SMART on FHIR so providers can see patient progress without leaving Epic or Cerner. Standalone web dashboards are available for care teams who manage patients across multiple EHR systems.

    Built for prescription DTx companies whose commercial success depends on prescriber retention, digital health platforms with multidisciplinary care teams, and disease management programmes operating under value-based care contracts.

  5. Regulatory-grade data architecture

    SaMD-aware data architecture covers the full technical safeguard layer the FDA expects in a premarket submission: immutable audit logs that record every clinical data access and modification event, software version control that maps each release to its clinical evidence base, cybersecurity risk documentation covering all data flows, and data integrity controls that confirm records cannot be altered after the fact without detection.

    HIPAA-compliant data handling is built in from sprint one: PHI encryption at rest using AES-256 and in transit via TLS 1.3, role-based access controls scoped to minimum necessary access, and business associate agreement coverage mapped to every infrastructure provider. De-identification pipelines for research use follow Safe Harbor or Expert Determination methods as required.

    Built for DTx companies planning an FDA 510(k) or De Novo submission, prescription digital therapeutics developers navigating the Software as a Medical Device pathway, and any DTx platform handling PHI in a regulated market.

  6. Remote care coordination software

    Care coordination platforms connect patients, health coaches, prescribing physicians, and specialist providers around a shared view of the patient's therapeutic program. Secure messaging built on HIPAA-compliant infrastructure, task assignment with completion tracking, care plan management with protocol versioning, and escalation workflows that notify the right person when a clinical threshold is breached form the operational layer.

    We integrate with telehealth video platforms (Zoom for Healthcare, Doxy.me, AWS Chime) for scheduled check-ins, and with HL7 FHIR APIs to pull patient context from the EHR into the care coordination interface. Appointment scheduling, session recording consent management, and billing data preparation for remote therapeutic monitoring CPT codes (98975, 98976, 98977) are included.

    Built for DTx platforms operating under a hybrid software-plus-human-coaching model, chronic disease management companies coordinating care across primary care and specialist providers, and remote therapeutic monitoring programs billing under CMS RTM codes.

03 How we work

How we build digital therapeutics software

  1. 01

    Discovery and regulatory scoping

    Two to three weeks working with your clinical, product, and regulatory teams to map the intervention protocol, the outcome measurement requirements, the EHR integration landscape, and the FDA classification pathway if applicable. We identify data flows that involve PHI, confirm HIPAA safeguard requirements, and produce a fixed-price specification before development begins. This step prevents the architecture decisions that create rework during a regulatory review.
  2. 02

    Clinical architecture design

    We design the data model around your clinical requirements: the outcome data schema, the intervention session structure, the audit log format, the FHIR resource mapping, and the role-based access control matrix. For SaMD-pathway products, software version documentation and cybersecurity risk mapping are locked before the first line of clinical logic is written. EHR integrations are prototyped in the first sprint because they carry the highest dependency risk.
  3. 03

    Build in two-week sprints

    Working software ships at the end of every two-week sprint. Clinical outcome measurement and adherence tracking come first, because those are the data foundations everything else depends on. Intervention content modules, provider dashboards, and third-party integrations follow in sequence. Your clinical team reviews working software at each sprint checkpoint, not mockups.
  4. 04

    Validation testing and launch

    Internal security testing runs throughout the build. Pre-launch testing covers data integrity, audit trail completeness, PHI handling, and load testing under realistic patient volume. We produce the technical documentation package your regulatory team needs: data flow diagrams, infrastructure architecture with BAA coverage mapped, access control matrix, and audit log specifications. Go-live is phased, starting with a controlled patient cohort before full rollout.

Companies we've built for

Vodafone
Nike
Microsoft
Cisco
T-Mobile
Aldi
Heineken
GE

04 Track record

What digital therapeutics teams get when they work with us

Typical delivery for a DTx intervention platform with outcome tracking
14 wk
Software products shipped across healthcare and digital health
100+
Compliant architecture built into every DTx project from sprint one
HIPAA
Cost delivery agreed before development begins
Fixed

06 Client voices

What our clients say

Three-year average engagement. Founders and operators describing the work in their own words. No marketing varnish.

D
Daniel Reeves
USA flagUSA
CEO

RaftLabs nailed what other agencies couldn't — they started with our business problem and worked backwards to the right product. We were live in 14 weeks.

07 Why us

Why choose us?

  1. 01

    We've seen your problem before

    The industry changes. The broken process usually looks the same. Across 14+ industries and 100+ products, we recognise your problem fast, and we frame the fix around your margin and your operations.

  2. 02

    We own the number, not the ticket

    We measure success the way you do: hours saved, revenue earned, margin recovered. We stay through launch and growth, so the result is ours to own.

  3. 03

    Serious businesses trust us

    Vodafone, T-Mobile, Cisco, Energia, Aldi, Nike. Six years, 100+ products in production, 4.9 on Clutch. Serious businesses keep coming back because we stay accountable long after launch.

08 Questions

Frequently asked questions

Yes. We design DTx platforms with SaMD classification in mind from the architecture phase, covering audit trail requirements, version control for software updates, cybersecurity risk documentation, and data integrity controls that FDA premarket review expects. We don't provide regulatory affairs consulting, but we build the technical foundation your regulatory team needs to complete the submission. The compliance documentation package, data flow diagrams, infrastructure architecture with BAA coverage mapped, and access control matrix, is assembled throughout the build, not produced as a final deliverable.

We build validated assessment instruments, PHQ-9, GAD-7, PROMIS scales, HbA1c logging, and disease-specific outcome tools, directly into the intervention session flow. Scores are calculated in real time, time-stamped to the second, and stored with a full audit trail. FHIR R4 Observation resources carry outcome data to EHR systems and research databases via standard APIs, removing the manual extraction that currently delays your clinical reviews by days.

Yes. FHIR R4 API integration with Epic, Cerner, Athenahealth, and SMART on FHIR-compatible systems is standard on DTx projects. We scope the integration during discovery to confirm what the EHR exposes via its API, then build the data pipeline to sync patient records, prescription events, and outcome data bidirectionally where the EHR supports it. Older HL7 v2 feeds are supported for EHR systems that have not yet moved to FHIR.

We design adherence systems using behavioural science principles: session reminders with personalised timing based on individual usage patterns, progress milestone reinforcement, inactivity alert triggers that notify a coach or provider when a patient crosses a defined non-engagement threshold, and human check-in workflows that activate when passive nudges alone aren't retaining a patient. Research consistently shows that human-in-the-loop models outperform passive notification systems in retention past week four.

A focused DTx platform covering intervention delivery, outcome tracking, and a provider dashboard typically delivers in 14 to 20 weeks. A prescription digital therapeutics platform with SaMD architecture, EHR integration, and regulatory documentation support runs 20 to 32 weeks. Cost depends on scope, integration complexity, and the number of validated assessment instruments embedded. Fixed cost is agreed after a discovery scoping phase of two to three weeks.

Yes. Both are within our scope. Mental health platforms covering CBT, DBT, and teletherapy workflows, and chronic disease platforms covering diabetes, hypertension, cardiovascular disease, and respiratory conditions, are the two most common DTx project types we take on. The intervention delivery architecture, outcome measurement tooling, and adherence system are tailored to the specific condition and care model during discovery.

Ready to build your digital therapeutics software?

Tell us what condition you're treating, who your users are, and where your current system is creating clinical or regulatory friction. We'll tell you how we'd approach it.

  • Scope and cost agreed before work starts. No surprises. No obligation.
  • Working prototype within 3 weeks of kickoff.
  • Pay by milestone. You see progress before each invoice.
  • 60-day post-launch warranty. Bug fixes, UI tweaks, and deployment support. No retainer.
  • All conversations are NDA-protected.