Defined Therapeutic Mechanism
A specific intervention — CBT for insomnia, ACT for chronic pain, neurocognitive training for ADHD — with a clinical rationale tying it to the outcome. Not a general condition-management tool.
Trusted by startups and global leaders
The Numbers Behind Software That Earns the DTx Label
Measured outcomes from evidence-based therapeutic products we've designed, validated, and shipped.
Delivered
30+
Digital Therapeutic & Evidence-Based Software Products Built
Experience
10+ Years
Building Regulated & Clinical-Grade Software for Healthcare
Engagement
3x Patient Engagement vs. Standard Health Apps
Adherence designed in from sprint one — because therapeutic outcomes are dose-dependent.
Adherence
85% Average Patient Adherence at 90 Days
In products we've built — the variable that decides whether the evidence base delivers real-world benefit.
Regulatory
FDA SaMD
Regulatory Pathway Experience Across Multiple Product Categories
Validation
Zero
Products Shipped Without Clinical Validation & Regulatory Review
Digital Health Has a Credibility Problem
Most health apps make therapeutic claims with no evidence. DTx sits on the evidence side — treating clinical validation as a design requirement, not a marketing afterthought.
Talk to Us About Your DTx BuildWhat Makes Something a Digital Therapeutic
The term gets used loosely — and building to the wrong definition wastes time, money, and clinical credibility. A genuine DTx has four components, each mattering independently.
Target Clinical Population
Built for patients with specific clinical characteristics — not anyone who downloads the app. This shapes study design, regulatory strategy, and prescribing pathway.
Measurable Clinical Outcome
HbA1c reduction, PHQ-9 improvement, ISI score change — not engagement or satisfaction metrics. Outcomes meaningful to clinicians and payers, measurable in a clinical study.
Clinical Evidence
The line separating DTx from digital health. Evidence needn\'t be an RCT for every category, but it must exist, be methodologically sound, and support the product\'s clinical claims.
What We Build
Eight DTx product categories, each with its own regulatory profile, evidence requirements, and clinical design challenge.
Prescription Digital Therapeutics (PDT)
The pharmaceutical pathway, applied to software. FDA-regulated, prescription-required.
SaMD — Software as a Medical Device
Not every product needs the prescription pathway. Lower-risk functions may qualify for 510(k).
Payer-Covered DTx Programs
Coverage is separate from regulation — and decides whether a DTx reaches patients. We build the payer evidence in early.
Behavioral Health DTx
Strongest evidence base, widest access gap. CBT, DBT, ACT, ERP protocols delivered digitally.
Chronic Disease DTx
Not a tracker with a coaching module. Structured interventions for diabetes, obesity, hypertension, COPD, chronic pain.
Substance Use Disorder & Recovery
Relapse prevention, MAT adherence, craving tools. 42 CFR Part 2 compliant, trauma-informed.
Neurological & Cognitive DTx
Neuroplasticity as the mechanism. Cognitive rehab for TBI, stroke, neurodegeneration, ADHD.
Pediatric DTx
Children are not small adults. Developmental fit, parental workflows, school integration.
The Evidence Generation Problem
Evidence built in from the first design conversation — not after.
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Clinical Study Design Consultation
Clinical Study Design Consultation
We work with your clinical advisors before development begins — conversations that change product design decisions.
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Outcome Measure Integration
Outcome Measure Integration
Validated outcome measures — PHQ-9, GAD-7, ISI, HbA1c and more — built in as clinical infrastructure, with automated administration, data export, and longitudinal tracking.
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Protocol Fidelity Tracking
Protocol Fidelity Tracking
Tracks which sessions were completed, in what order, with what engagement — the fidelity data essential to the internal validity of any study the product supports.
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Randomization & Blinding Infrastructure
Randomization & Blinding Infrastructure
Randomization, group assignment, and blinding built into the product — not bolted on when the IRB application is being written.
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Real-World Evidence Generation
Real-World Evidence Generation
Real-world evidence from commercial deployment matters for payer coverage and SaMD post-market requirements — we build that infrastructure alongside the product.
The Regulatory Pathway — What FDA Regulation Means
More nuanced than a simple "FDA approved or not" binary. We build to support the regulatory process, not complicate it.
Risk Classification Determines the Pathway
Software that treats or diagnoses a disease is a medical device. Most DTx are Class II: 510(k) or De Novo.
Design Controls Are Not Optional
21 CFR Part 820 — documented requirements, design V&V, change control. Built into the process, not after the fact.
Software Documentation Is Specific
Software Description, Hazard Analysis, and Cybersecurity docs have content requirements understood during development — not at submission.
Pre-Submission Meetings Save Time & Money
FDA\'s pre-sub program lets you align on strategy before submitting — surfacing issues that would otherwise cause delays.
Post-Market Obligations Continue After Clearance
Adverse event reporting, performance monitoring, and update management under design controls. We build for these from day one.
The Hardest Problem in DTx Is Adherence, Not Regulation
Most digital health products see steep drop-off within weeks. Since outcomes are dose-dependent, adherence is a clinical variable — we make it a primary design constraint from sprint one.
Talk to Us About Engagement DesignDTx & Evidence-Based Software We've Built. What They Did.
Each result comes from a digital therapeutic we designed and shipped — tied to its clinical target and the outcome it produced.
65%
Clinical remission (ISI < 8) at 9 weeks — CBT-Based Insomnia Therapeutic (ISI-validated); payer coverage secured in 3 states within 18 months of launch
1.2%
Average HbA1c reduction at 6 months — Diabetes Behavioral Intervention Platform; now in payer value-based contract negotiations
88%
Treatment completion — OAT Adherence & Recovery Support Platform; relapse rate 40% lower vs. standard care comparison
12wk
Validated ADHD rating-scale improvement — Pediatric ADHD Management Platform; school functioning outcomes included in study design
35%
Reduction in pain interference scores — Chronic Pain ACT-Based Therapeutic; opioid dose reduction achieved in 42% of participants at 6 months
89%
90-day adherence (up from 54%) — Cancer Treatment Adherence Platform; clinician satisfaction with patient communication rated 4.8/5
3x
Cardiac rehab participation vs. in-person — Cardiac Rehab Digital Therapeutic; 6-month cardiovascular outcomes equivalent to in-person rehab in pilot data
How We Build DTx Products
The real process — no simplified version. Technology decisions follow from the regulatory and clinical model, not the other way around.
Regulatory Strategy Comes Before Product Design
The first conversation is regulatory classification — intended-use statement, risk class, what the pathway implies for evidence and documentation. Before wireframes, before architecture. Skip it and you build products you have to redesign.
Clinical Protocol Specification Is a Design Document
Intervention, session structure, therapeutic techniques, dose, personalization logic — a clinical specification that precedes the product spec. We work with your clinical advisors to produce a protocol the engineering team builds to, not interprets.
Software Quality Documentation Built Alongside the Product
Requirements traceability, design V&V records, hazard analysis, software description — built during development, not reconstructed after. Documentation is a development workstream, not a submission-time activity.
Evidence Infrastructure Built In From Sprint One
Outcome measure administration, protocol fidelity tracking, randomization, data export — built during development, not added when a study partner asks. Cuts evidence generation cost significantly.
Engagement Design Validated With the Clinical Population
Tested with actual patients — not the development team, not inferred from consumer-app research. Usability and engagement validated with representative patients before anything goes live.
Regulatory Submission Prep Is an Integrated Workstream
Technical file, software documentation, clinical evidence summary, predicate analysis — runs as a parallel workstream during final development. Treating it as an afterthought costs six to twelve months.
The Full Stack of What DTx Compliance Involves
Beyond baseline HIPAA, DTx carries FDA, clinical research, and international standards that shape platform architecture in specific ways.
Who Builds DTx With Us
From pharma companies extending drug programs into software to CROs building DTx study infrastructure — the organizations we build evidence-based therapeutic software for.
P
Pharmaceutical Companies
H
Health Systems
A
Academic Medical Centers
M
Medical Device Companies
P
Prescription DTx Startups
P
Payers & Insurance Carriers
E
Employer Health Programs
C
Condition Management Programs
C
CROs & Research Organizations
E
ePRO & Randomization Platforms
P
Protocol Fidelity Tracking
C
Clinical Data Management
Award-Winning AI Development & Consulting
100 Fastest Growth Companies
Global Spring Winner
Top App Development Company
AWS Partner Network
Google Cloud Partner
Highly Rated on Trustpilot
Verified Agency
Top App Development Company
ASSOCHAM Member
Frequently Asked Questions
[ 1 ]
What's the difference between a digital therapeutic and a digital health app?
Evidence and regulatory status. A health app makes claims without clinical proof; a DTx has a defined mechanism, target population, measurable outcomes, and study-backed evidence. Clinicians and payers won't cover products that can't show they work.
[ 2 ]
Do we need FDA clearance to build a digital therapeutic?
It depends on intended use. Software that treats, mitigates, prevents, or diagnoses a condition is a medical device; general wellness software may not be. Regulatory classification is the first question in any DTx engagement, and we work through it during discovery.
[ 3 ]
How long does it take to build a DTx product?
A focused single-indication behavioral DTx typically runs eight to fourteen months. A complex product with multiple modules and full regulatory documentation runs fourteen to twenty-four, regulatory prep included. FDA review after submission is separate.
[ 4 ]
What clinical expertise do you bring?
We're software builders, not clinicians. Ten years in clinical environments means we understand therapeutic protocols, outcome measurement, and regulatory requirements. Clinical expertise — protocol, advisory, study design — comes from your team; we work alongside clinical experts, not in place of them.
[ 5 ]
How do you approach patient safety?
Crisis detection and escalation is non-negotiable in behavioral health and chronic disease DTx. We build PHQ-9 item 9 monitoring, crisis protocol flows, and emergency routing into every product. Safety risk analysis is documented formally, and adverse event reporting meets FDA post-market surveillance requirements.
[ 6 ]
Who owns the product?
You do. Full IP transfer at project close — source code, protocol documentation, regulatory materials, everything. No licensing fees, no ongoing dependency.
Get in touch
The Category Is Real. The Bar Is High. That's What Makes It Worth Building.
Thirty minutes, no pitch. An honest conversation about your therapeutic target, your regulatory situation, and what it takes to build something that earns the DTx label.
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