Digital Therapeutics (DTX) Development

If your product is intended to treat, manage, or prevent a medical condition and makes therapeutic claims, yes. FDA clearance (510(k) for products with a predicate, De Novo for first-in-class) is required before US commercialization. Wellness products that avoid therapeutic claims can operate outside FDA jurisdiction but cannot claim therapeutic benefit.

ISO 13485 is the international quality management standard for medical device manufacturers, including software. FDA-cleared DTx must be developed under a quality management system that meets FDA 21 CFR Part 820 requirements, which aligns closely with ISO 13485. Bacancy holds ISO 13485 certification, which is rare among healthcare software development partners.

A focused DTx product from concept to 510(k)-ready platform ships in 12 to 18 months. Complex adaptive DTx with AI intervention engines ship in 15 to 24 months. Post-clearance market launch and evolution runs continuously under design controls.

DTx development cost depends on project scope, therapeutic complexity, regulatory pathway, and clinical validation depth. FDA regulatory submission (external regulatory consultants and FDA fees) and clinical validation studies are separate from engineering costs and add significantly to total program cost. Our team provides a Sprint 0 estimate based on your specific indication, patient population, and regulatory strategy before commitment.

Yes. Our team supports the technical documentation package required for 510(k) and De Novo submissions, including software architecture documentation, verification and validation testing, cybersecurity validation, usability engineering (ISO 62366), and traceability matrix. We work alongside your regulatory affairs team or external regulatory consultants.

Yes. Our AI solutions practice builds adaptive intervention engines using reinforcement learning, digital biomarker analysis, and adherence prediction models. AI in FDA-classified DTx requires additional documentation (predetermined change control plans, model bias testing, real-world performance monitoring), which our team handles under design controls.

Every DTx we build includes post-market surveillance software for adverse event reporting, medical device reporting (MDR), real-world outcome tracking, and cybersecurity vulnerability monitoring. Support contracts include ongoing regulatory reporting infrastructure and design change management.

Yes. Our team supports clinical validation studies including protocol design consultation, IRB documentation infrastructure, REDCap or custom study data collection, and clinical outcome measurement software. Study execution runs through your clinical research team or CRO partners.