Prescription-grade patient apps
Native iOS and Android plus web. Prescription unlock workflows, clinician-prescribed protocols, adherence tracking, in-app therapy delivery. WCAG 2.2 accessibility.
Custom Software
AI Engineering for Digital Therapeutics
Prescription-grade DTx platforms with AI personalization, FDA SaMD pathway support, payer-grade evidence infrastructure, and EHR integration. Built by the team that’s been integrating with hospital systems since 2013.
$45K Discovery · $95K Production-Ready · $145K FDA-pathway Pilot-Ready
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📌 Definition
Digital Therapeutics (DTx) are evidence-based, software-driven therapies that prevent, manage, or treat a medical disorder or disease — delivered to patients via mobile or web apps, often prescription-only, often FDA-cleared. AI-augmented DTx in 2026 includes personalized therapy adjustment, AI-driven engagement, predictive adherence modeling, and clinical decision support for the prescribing clinician. Production DTx engineering requires FDA SaMD pathway compliance, randomized clinical trial infrastructure, payer-grade evidence generation, EHR integration via FHIR, and HIPAA-compliant BAA-covered cloud. Productized fixed-price tiers: $45K (4-week Discovery), $95K (8-week Production-Ready), $145K (12-week FDA-pathway Pilot-Ready).
What we build for DTx companies
AI personalization engine
Adaptive therapy adjustment based on patient response. Reinforcement learning for engagement optimization. RAG-grounded clinical content. Override-and-audit-logged.
Clinician portal
Prescriber dashboard for protocol management, patient progress monitoring, intervention queues, and clinical decision support. Role-based access.
Clinical trial infrastructure
RCT-grade data collection, randomization engines, blinding workflows, eCRF integration, ePRO/eCOA collection, 21 CFR Part 11 compliance.
Real-world evidence (RWE) generation
Production data pipelines feeding RWE studies. De-identification, cohort matching, outcome tracking, payer-grade evidence packaging.
FDA SaMD pathway support
$30K productized FDA SaMD pathway assessment. Predicate device research, risk classification, design history file structure, 510(k) or De Novo submission support.
Payer integration infrastructure
Eligibility verification, prior authorization workflows, prescription validation, claims-grade outcomes reporting for value-based contracts.
EHR integration
FHIR R4 integration via SMART on FHIR. Prescription writes via CDS Hooks. Outcomes write-back to clinician inbox. Epic, Cerner-Oracle, Athena, Allscripts.
DTx engineering pricing · 2026
What’s included in every DTx engagement
- HIPAA-compliant architecture from day 1 — encryption at rest and in transit, role-based access, audit logging
- BAA-covered AI providers (OpenAI, Anthropic, AWS Bedrock, Google)
- IEC 62304 software life cycle documentation
- ISO 14971 risk management documentation
- 21 CFR Part 11 compliance for clinical trial data
- FHIR R4 integration with hospital EHR systems
- SMART on FHIR launch app patterns
- CDS Hooks for in-EHR prescription workflows
- Native iOS and Android plus responsive web
- ePRO/eCOA collection infrastructure
- De-identification pipelines for RWE generation
- Pre-signed BAA templates with major cloud and AI providers
- SOC 2 Type II and HITRUST audit-ready documentation
Common DTx use cases
Use case 1 · Behavioral health DTx
Cognitive behavioral therapy (CBT) for depression, anxiety, insomnia, substance use disorder. AI-personalized exercise sequencing, adherence prediction, therapist escalation.
Use case 2 · Chronic disease management DTx
Diabetes, hypertension, cardiovascular disease management. Behavioral coaching plus medication adherence plus lifestyle modification. Outcomes-tied payer contracts.
Use case 3 · Pediatric DTx
ADHD, autism spectrum, pediatric anxiety. Age-appropriate engagement mechanics. Caregiver-mediated workflows. Stricter FDA pathway requirements.
Use case 4 · Oncology-supportive DTx
Symptom management during chemotherapy, mental health support, adherence to oral oncolytics. Integration with oncology EHR workflows.
Use case 5 · Post-surgical DTx
Rehab adherence after orthopedic, cardiac, or neurological surgery. AI-paced rehab protocols. Outcomes write-back to surgeon.
Production reality
Ship a DTx that survives FDA, payers, and clinicians
Free 30-min architecture call. We’ll scope your AI personalization approach, FDA pathway requirements, and the right tier for your therapeutic area.
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FAQs
FAQ
It depends on whether the DTx is prescription-only (Rx-DTx) or non-prescription wellness. Rx-DTx that diagnoses, treats, or prevents disease usually requires FDA SaMD pathway — 510(k), De Novo, or PMA. Non-prescription wellness apps with AI features usually don’t. We provide a productized $30K FDA SaMD pathway assessment on every engagement where this is a question.
Adaptive personalization in an FDA-regulated DTx requires a Predetermined Change Control Plan (PCCP) filed with FDA. The PCCP defines what the model is allowed to adjust (engagement sequencing, content selection) versus what requires a new 510(k) (the underlying therapy protocol). We build PCCP-aligned model architectures from day 1.
Yes. SMART on FHIR launch from inside Epic, Cerner-Oracle, Athena, or Allscripts. CDS Hooks for in-workflow prescription. Outcomes write-back to clinician inbox or care plan. This is what separates production DTx from wellness apps — the clinician can prescribe, monitor, and adjust without leaving the EHR.
Three dominant patterns in 2026: (1) prescription-grade benefit covered like a pharmaceutical, (2) value-based contracts paid on outcomes (adherence, A1C reduction, ED visits avoided), (3) per-member-per-month (PMPM) employer contracts. The evidence infrastructure required for each is different; we scope per engagement.
Randomized controlled trial-grade data collection — randomization engines, blinding workflows, eCRF integration, ePRO/eCOA collection, 21 CFR Part 11-compliant audit trails. Most DTx companies need this infrastructure for their pivotal trial and for ongoing RWE generation post-launch.
Yes. MDR/IVDR-compatible documentation patterns are included on every engagement. We can ship US-first and add EU expansion later, or build for both markets from day 1. The 510(k) and MDR pathways have overlapping documentation but non-identical requirements.
4-week Discovery, 8-week Production-Ready, 12-week Pilot-Ready. Full production with FDA SaMD pathway adds 16–32 weeks. Pivotal RCT infrastructure adds 8–16 weeks depending on protocol complexity.