Digital Therapeutics (DTx) & Prescription Software Development
Transform clinical evidence into scalable prescription software applications (PDTx). We engineer gamified behavioral therapies, rigorous ePRO trial pipelines, and FDA SaMD clearance architectures for mental health, chronic pain, oncology, and metabolic care.
Prescription DTx Engine
Clinically Validated InterventionsDigital Therapeutics Software Modules
We combine behavioral science, medical regulatory engineering, and gamified user experiences to maximize treatment efficacy and regulatory clearance.
Gamified Adherence & Micro-Interventions
Keep patients engaged with streak tracking, motivational interviewing bots, dynamic goal setting, and personalized push notifications calibrated to prevent app abandonment.
Validated ePRO / eCOA Clinical Scales
Digitize standardized medical survey instruments (PHQ-9, GAD-7, PROMIS, BPI) with strict 21 CFR Part 11 compliance, tamper-proof electronic signatures, and audit trails.
Physician Prescription & Access Controls
Implement secure single-use prescription access codes, provider prescribing portals, and automated integration with pharmacy benefit managers (PBMs).
Remote Therapeutic Monitoring (RTM) Billing
Automate compliance documentation for Medicare RTM reimbursement codes (CPT 98975 for initial setup, 98976/98977 for device monitoring, 98980/98981 for clinical management time).
Real-World Evidence (RWE) Analytics
High-throughput data pipelines aggregating de-identified patient telemetry, symptom progression, and clinical endpoints for post-market surveillance and peer-reviewed journals.
FDA 510(k) & De Novo Clearance Pathways
Full software development lifecycle (SDLC) documentation adhering to IEC 62304 Class B/C controls, human factors usability (IEC 62366), and ISO 13485 quality systems.
Frequently Asked Questions About Digital Therapeutics Development
A general wellness app provides generic tracking without medical claims. A Prescription Digital Therapeutic (PDTx) is an FDA-cleared Software as a Medical Device (SaMD) clinically proven in randomized controlled trials to treat a specific disease, requiring a doctor's prescription and eligible for health insurance reimbursement.
We build FDA 21 CFR Part 11 compliant eSource and ePRO trial software with double-blind randomized assignment modules, cryptographic data timestamping, patient consent e-signatures, and instant EDC (Electronic Data Capture) exports.