Custom DTx for Mental Health 

Business analysts study the market to identify gaps in existing mental health solutions, user pain points, and emerging trends like AI-driven therapy or VR-based interventions. The results are used to define relevant functionality.

Another key step is identifying applicable regulations (e.g., HIPAA, GDPR) and establishing a compliance framework. For example, software-based interventions that are intended solely for wellness or behavioral support typically fall outside of the FDA’s regulatory scope. In contrast, prescription digital therapeutics (PDTs), due to their therapeutic claims and direct clinical applications, require FDA clearance before they can be marketed and used. Business analysts also determine non-functional requirements (e.g., performance, usability) and the necessary integrations for the software-to-be.

Software architects choose between native or cross-platform mobile apps, web apps, or hybrid platforms and design a secure architecture for the DTx product.

UX designers map specific workflows for patients, therapists, and administrators. Additionally, using calming color schemes, intuitive layouts, and minimalistic designs allows for reduced cognitive load and enhanced usability.

The development process differs depending on the chosen regulatory clearance pathway. If you don’t plan to submit the DTx product to regulators, ScienceSoft’s consultants usually recommend iterative development to release the first shippable version as early as possible and start getting payback. Then, you can gradually evolve the product based on user feedback. Feedback can reveal in-demand features, unexpected UX issues, etc. Mind that the MVP must still comply with general data privacy and security regulations, such as HIPAA in the US or GDPR in the EU, even if it is not undergoing regulatory approval.

If you do plan to achieve FDA clearance or CE marking, it means the product can’t be released to the market before it receives the approval of the regulators. In this case, the only pre-launch feedback you can get is from clinical advisors, other non-patient participants (e.g., caregivers, healthcare providers), or controlled trials. If you plan to release new product versions after regulatory approval, they may require resubmission if the changes are significant and impact the therapeutic functionality.

For any DTx product (and especially for PDT), clinical validation in parallel with development is essential to test its therapeutic efficacy in a controlled environment. Clinical trial documentation is also a critical requirement for FDA clearance, as it provides evidence of the product's safety and measurable clinical benefits.

After the release, clear guides and tutorials for patients and therapists can help reach higher adoption rates. It’s better to establish a dedicated support team to address user concerns, fix bugs, and roll out updates based on evolving clinical guidelines or user needs.