Whether you’re building a standalone therapeutic app or combining your solution with medical devices, wearables, or remote monitoring, 6B provides the expertise needed to turn your concept into a compliant, market-ready digital therapeutic — aligned with MHRA, FDA, and NHS standards.
What Are Digital Therapeutics (DTx) Apps?
Digital Therapeutics (DTx) are evidence-based software products that deliver therapeutic interventions to prevent, manage, or treat a specific medical condition. These apps are often classified as medical devices and must demonstrate clinical benefit and regulatory compliance. DTx can be used independently or alongside traditional treatments and are increasingly prescribed within healthcare systems.
Features and use cases may include:
- CBT-based interventions for mental health, insomnia, or anxiety
- Condition-specific tools for diabetes, asthma, hypertension, or chronic pain
- Behaviour change programmes for smoking cessation or weight loss
- Daily tracking, goal setting, and symptom logging
- Personalised therapy content and real-time coaching
- Integration with wearables, remote monitoring devices, or EHRs
- MHRA, UKCA, CE, and FDA regulatory pathways
- DCB 0129, UK GDPR, and ISO 13485/27001 compliance
At 6B, we help you design and develop DTx apps that are clinically robust, user-friendly, and compliant — ready for pilot, prescription, and scale.
Our Digital Therapeutics App Development Process
As an experienced Digital Therapeutics App Development company, 6B supports the full product lifecycle — from early-stage validation to commercial rollout and ongoing optimisation.
We begin by aligning on your therapeutic goals, target population, and regulatory classification. Whether your app is classed as a standalone medical device or part of a combination product, we help map out clinical workflows, user journeys, and data models that meet both treatment and compliance needs.
Design is focused on clinical efficacy and patient usability — with responsive, inclusive interfaces built for iOS, Android, or web delivery. We work closely with clinicians and regulatory teams to ensure that the app’s structure, logic, and content align with the intended clinical outcomes.
Development uses secure, scalable infrastructure with built-in audit trails, access controls, and real-time monitoring. We support integration with wearables, third-party APIs, and EHR systems — and prepare your product for ISO 13485, DCB 0129, and global regulatory submissions.
Benefits of Building a Digital Therapeutics App
Custom DTx apps enable healthcare and life sciences innovators to create targeted, data-driven interventions that reach patients directly — without the need for in-person visits or medication alone.
With a 6B-built DTx app, your organisation gains:
- Regulatory-ready architecture aligned with MHRA, CE, and FDA expectations
- Faster patient access to evidence-based digital care
- Improved health outcomes through clinically validated interventions
- Real-world data capture to inform future studies, refinements, or reimbursement
- Personalised user experiences to support adherence and engagement
- Interoperability with healthcare infrastructure, devices, and analytics platforms
Whether your focus is a single-condition therapeutic or a multi-pathway platform, we ensure your solution is scalable, secure, and safe to deploy in regulated environments.
Why Choose 6B for Digital Therapeutics App Development?
6B combines regulatory understanding, clinical insight, and digital expertise to deliver compliant, impactful therapeutic software.
Our team has worked across digital therapeutics, software as a medical device (SaMD), and NHS-integrated platforms — with experience navigating ISO 13485, DCB 0129, and other critical standards from concept to release.
We support full regulatory alignment, including documentation, clinical evaluation planning, and post-market surveillance features where required. Every build prioritises patient safety, data protection, and accessibility — meeting global health tech benchmarks for compliance and usability.
We don’t just develop software — we help you scale. From prototype to full launch, and from MVP to international rollout, we provide the technical depth and strategic guidance needed to help your DTx product succeed in complex healthcare environments.
Speak To Our Digital Therapeutics App Development Experts
Whether you're developing a new digital health product or extending an existing solution with Digital Therapeutics App Development, 6B brings the technical expertise, healthcare insight, and experience needed to accelerate delivery.
