Defined Therapeutic Mechanism
A specific intervention — CBT for insomnia, ACT for chronic pain — tied to the outcome.
Award-Winning Digital Therapeutics (DTx) Development
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 About Your DTxWhat 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 defined clinical characteristics, not anyone who downloads the app.
Measurable Clinical Outcome
HbA1c, PHQ-9, ISI score change — not engagement or satisfaction metrics.
Clinical Evidence
Methodologically sound evidence supporting 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)
FDA-regulated, prescription-required software.
SaMD — Software as a Medical Device
Lower-risk functions may qualify for 510(k).
Payer-Covered DTx Programs
Payer evidence built in from the start.
Behavioral Health DTx
CBT, DBT, ACT, ERP delivered digitally.
Chronic Disease DTx
Structured interventions, not trackers.
Substance Use Disorder & Recovery
Relapse prevention, MAT adherence, craving tools.
Neurological & Cognitive DTx
Cognitive rehab for TBI, stroke, ADHD.
Pediatric DTx
Developmental fit and parental workflows.
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.
Discuss 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
Technology decisions follow the regulatory and clinical model, not the other way around.
Regulatory Strategy Comes Before Product Design
Regulatory classification, intended-use statement, and risk class defined before any wireframes or architecture.
Clinical Protocol Specification Is a Design Document
Intervention, session structure, dose, and personalization logic as a clinical spec engineers build to.
Software Quality Documentation Built Alongside the Product
Requirements traceability, design V&V, and hazard analysis built during development, not at submission.
Evidence Infrastructure Built In From Sprint One
Outcome measures, protocol fidelity tracking, and data export built in from sprint one to cut evidence cost.
Engagement Design Validated With the Clinical Population
Usability and engagement validated with representative patients before go-live, never the dev team.
Regulatory Submission Prep Is an Integrated Workstream
Technical file, software docs, clinical evidence, and predicate analysis run in parallel with final development.
The Full Stack of What DTx Compliance Involves
Beyond HIPAA, DTx carries FDA, clinical research, and international standards.
Who Builds DTx With Us
From pharma and CROs to DTx startups — 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 DTx has a defined mechanism, target population, measurable outcomes, and study-backed evidence.
[ 2 ]
Do we need FDA clearance to build a digital therapeutic?
It depends on intended use. Software that treats, prevents, or diagnoses a condition is a medical device; wellness software may not be.
[ 3 ]
How long does it take to build a DTx product?
A single-indication behavioral DTx runs eight to fourteen months; a multi-module product with full regulatory documentation, fourteen to twenty-four.
[ 4 ]
What clinical expertise do you bring?
We're software builders, not clinicians — ten years in clinical environments, working alongside your protocol and study-design experts.
[ 5 ]
How do you approach patient safety?
Crisis detection is non-negotiable. PHQ-9 item 9 monitoring, crisis flows, emergency routing, and FDA post-market adverse event reporting.
[ 6 ]
Who owns the product?
You do. Full IP transfer at project close — code, protocol and regulatory documentation. No licensing fees, no ongoing dependency.
Get in touch
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