Digital therapeutics (DTx) development is the process of designing, building, validating, and maintaining software that delivers clinically evidenced interventions to prevent, manage, or treat a medical condition. It includes regulatory strategy, device classification, clinical evidence architecture, IEC 62304 software lifecycle records, patient-adherence design, EHR and device integrations, cybersecurity, and post-market surveillance.
Digital Therapeutics ConsultingWe help define device class, regulatory pathway, reimbursement direction, evidence strategy, and market-specific requirements before development starts.
Custom DTx Software Development
DTx App DevelopmentWe develop iOS, Android, and cross-platform DTx apps with behavioral design, accessibility, patient engagement, and therapy-delivery workflows.
EHR, Device, and Analytics IntegrationsWe connect DTx products with EHR/EMR systems, wearables, RPM devices, analytics platforms, and outcome-tracking infrastructure.
Regulatory and Compliance ConsultingWe translate FDA, MDR, UKCA, HIPAA, GDPR, and reimbursement requirements into technical, product, and documentation decisions.
Support and MaintenanceWe support post-launch monitoring, software updates, security operations, change control, and ongoing product improvement.
10+ years in healthcare & life sciences delivery
End-to-end project leadership – from architecture to launch
High-performing teams, on-budget, predictable execution
Turns business goals into patient-centered software
Expertise in telehealth, RPM, DTx, SaMD, EHR/EMR
"DTx products fail when clinical evidence, patient engagement, and software delivery move separately. The strongest products connect therapy design, data capture, and regulated engineering from the first discovery phase."
Insights into our team achievements and valued partnerships
97
%Net promoter score
200
+Professionals in the team
150
+Custom software solutions delivered
10
Years on the market
4.9
Client rating across platforms
Digital therapeutics help healthcare, pharma, and medtech teams deliver evidence-based care beyond the clinic.
Continuous disease management can help reduce emergency visits and readmissions for chronic conditions.
DTx products reach patients between appointments without requiring more clinician capacity.
Software-based interventions can reduce direct treatment costs and routine clinical workload.
Patients receive structured therapeutic support at home, on their own schedule.
DTx can extend product value, support patient adherence, and fill gaps that traditional medicine does not cover.
Higher patient engagement and adherence translate into measurable improvements in symptom control and disease progression.
Let’s pressure-test your scope, evidence needs, and regulatory path.
Binariks supports healthcare teams with regulated software delivery, connected care platforms, and secure patient-facing products.
A gamified meditation app for a Swiss health tech company
We complemented the client's current product offering with a gamified meditation app, enhancing user engagement, cutting costs, and seamlessly integrating smart wearables.
Binariks reengineered the health coaching platform
A solution for remote monitoring of patients with congenital heart disease
A scalable Android app, an iOS app, and a web platform
Binariks turns DTx development into practical outputs your product, clinical, engineering, and compliance teams can use before launch and after release.
We define the product’s regulatory, clinical, and reimbursement foundation before full development starts.
We design and build the patient, clinician, admin, and backend layers needed to deliver the therapeutic experience.
We connect your DTx product with the clinical, device, and analytics systems needed for real-world use.
We prepare technical, security, and lifecycle materials needed for regulated DTx delivery.
I'm impressed by the skill and enthusiasm of the people working on this project.
The primary measurable outcome is the successful delivery of components and assigned tasks for the completed phases of the project.
They have a lot of knowledge. We’ve built our data warehouse, and they have laid the foundation for our data analytics strategy. The solutions are performing as expected and meeting our business objectives.
Binariks’ biggest strength is the quality of their people. We have a strong team leader who’s great at communicating with everybody and figuring things out quickly and smartly without getting too flustered or panicky. Overall, we have a great team structure with the right people and personalities.
We highly value their customer-first approach. If we have something going on, they’re easily available. Our clients are happy with their work.
The team at Binariks is vibrant, proactive, and efficient. Their autonomous nature complements their open approach.
The attitude towards work is something Binariks takes pride in. It's a combination of a high-skilled team and quite mature management that makes this company stand out. They have a high level of responsibility and technical skills.
Binariks was capable of taking a design, providing adequate timelines and resources, scoping the project out, and delivering it. In my experience, most people can't deliver, but Binariks delivered.
I appreciate how well they handle complaints. Developers don't always understand each other, and we're all working remotely. But Binariks has remained professional and humble. They always listen to what we want them to improve.
I love the people I interact with at Binariks. [...] They're professional and down to earth, very easy to talk with. The QA resources I've worked with are very motivated and always want to get ahead of the game. If improvements are needed, they get done in a timely manner.
Binariks' health technology expertise and their experience in building successful healthcare software solutions are their key differentiators. Additionally, they're extremely strong in having a complete, thorough, and high-quality architecture discovery phase.
Binariks pays attention to the details. They take a high level of accountability and responsibility for tasks assigned to them. We can rely on them as part of our team rather than an external agency just putting in hours.
Binariks' clear communication is the best – they're consistent with it and with deliverables. They log their hours accurately, and if there's an issue, they respond in a timely manner. The team also sends meeting minutes after every management call, and their invoices come like clockwork.
Their communication has been spot-on. They've been transparent about how much time they spend on each sprint as well.
Binariks brings real value to our business with their contributions, and their positive and "can-do" attitude.
They're agile and adaptable to change. They ask questions and don't make assumptions in order to understand your business and create the best possible solution. We've worked with lots of other partners, and they're one of the most organized and responsive.
What I really appreciate about Binariks is their mature technical expertise and high level of responsibility on given commitments: each expected increment was delivered as it was planned and just on time.
Their attitude towards their own work and their clients was impressive. They didn’t try to add unnecessary people to a project, it was a very lean and mature team.
They take a sense of ownership in these projects. Their team's focused and engaged in the work that they do. They're available all of the time and seem to be part of our team. Their team works well with our team's operation.
We like Binariks' consulting. When we have an issue, Binariks always provides the right solution.
They put a lot of emphasis on best practices for material design, quality user experience, and implementation. That’s going to be a key factor on customer retention.
Their communication skills are excellent. The project manager is particularly great to work with as he’s pushed me to communicate with them more.
Binariks selects the technology stack around your DTx product scope, regulatory context, integration needs, and deployment environment.
Binariks moves from product discovery to launch and post-market support with clear outputs at every stage.
We validate the clinical hypothesis, define intended use, target users, device class, and target markets.
Output: Intended use statement, device classification, discovery findings, regulatory direction.
We define system architecture, data model, integrations, tech stack, and clinical evidence needs.
Output: Architecture plan, integration map, evidence strategy, MVP scope.
We design patient and clinician workflows, accessibility requirements, behavioral logic, and clickable prototypes.
Output: UX flows, UI prototypes, accessibility notes, usability engineering plan.
We build the DTx product in controlled iterations with testing, risk updates, and security checks.
Output: Working software increments, QA reports, risk updates, test evidence.
We support technical file preparation, clinical evaluation inputs, and submission package review.
Output: Technical documentation, submission inputs, reviewer-response support.
We support production deployment, monitoring, adverse event workflows, and controlled software updates.
Output: Launch setup, monitoring plan, PMS workflow, maintenance roadmap.
We review your DTx concept through classification, compliance, and delivery constraints so you can move forward without costly assumptions.
Ross Chornyy
Senior Vice President
A digital therapeutic has to do more than work as software. It needs a therapeutic logic, patient engagement model, clinical data strategy, security foundation, and documentation path that can support review, reimbursement, and post-market use. Binariks helps connect these layers from the first discovery phase, so the product is easier to validate, maintain, and evolve after launch.
Product decisions connected to intended use, device class, and reimbursement pathway
Patient experience shaped around adherence, accessibility, and clinical protocol delivery
Clinical data infrastructure for outcome tracking and real-world evidence collection
Architecture prepared for EHR, wearable, device, and analytics integrations
Security and privacy controls for sensitive health data and regional requirements
Post-launch support for monitoring, change control, updates, and product improvement
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Explore Service — Healthcare Software TestingDigital therapeutics deliver clinically validated interventions, such as cognitive behavioral therapy, exposure therapy, guided rehabilitation, medication adherence support, and chronic disease self-management through a device the patient already owns. They extend care beyond the clinic, give clinicians continuous data on how patients are actually doing between visits, and address conditions where traditional care is expensive, inconsistent, or inaccessible. Used alongside medication or as standalone products, DTx products are associated with measurable improvements in adherence, symptom control, and long-term outcomes.
An MVP for a lower-risk DTx product with discovery through internal release takes about 6–9 months. A full-regulated build with MDR or FDA submission support generally takes 12–18 months to market. Clinical evidence generation for reimbursement pathways like DiGA or PECAN often extends the timeline by an additional 9–12 months, though some pathways (DiGA Fast Track, PECAN) allow provisional reimbursement while trials are ongoing.
Yes. Post-market surveillance isn't optional for a medical device. At Binariks, we run adverse event pipelines, conduct periodic safety update reports, maintain software under documented change control, and support ongoing infrastructure and security operations. Most clients move onto a dedicated support team after launch, with the same engineers who built the product.
A wellness or mHealth app helps people track steps or log meals, but does not make any medical claims and is not part of a medical treatment. A DTx product is regulated as a medical device, backed by clinical evidence of therapeutic effect, and treats, manages, or prevents a specific disease. That classification brings real obligations: CE marking or FDA clearance, IEC 62304 development, ISO 14971 risk management, and post-market surveillance. It also unlocks features not found in a generic wellness app: prescription, reimbursement, and integration into formal care pathways.
Security is built into the architecture stage. We build on HIPAA-eligible cloud services, encrypt PHI in transit and at rest, enforce role-based access control with full audit trails, and run threat modelling and penetration testing on every release. For EU products, we apply the same approach under GDPR, with data residency controls for country-specific requirements (French HDS, German data hosting rules). Every engagement includes a DPIA and a documented security posture that your compliance team can review.
We don't run clinical trials, but we architect the software and data infrastructure that enable them. Our team includes regulatory consultants who've walked products through DiGA, PECAN, FDA De Novo, and NICE pathways. We do clinical evidence planning, real-world data collection, outcome measurement instrumentation, and PMCF (post-market clinical follow-up) infrastructure. We work with your clinical partners or connect you with CROs we've collaborated with before.
Explore practical articles on healthcare software, clinical workflows, interoperability, and patient-centered product development from Binariks' experts.
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