Roche
Roche
Transforming Neuroscience Care Through Digital Therapeutics
The challenge
Roche is a global leader in pharmaceuticals and diagnostics with a strong focus on neuroscience. Roche partnered with CitrusBits, in collaboration with Harman, to develop a digital therapeutic platform that supports behavioral therapy for individuals with autism spectrum disorder, embedding HIPAA compliance and FDA readiness into the development process.
Roche set out to address a critical gap in neuroscience care by creating a digital therapeutic platform for individuals with autism spectrum disorder. The vision was to support behavioral therapy through a solution that could be scaled globally, integrate into clinical workflows, and meet the highest standards of regulatory compliance. Roche needed a technology partner capable of combining deep expertise in connected systems with the rigor required for FDA and CE readiness.
The process
Working in collaboration with Harman Connected Services, CitrusBits contributed to the design and engineering of the digital therapeutic platform. The effort began with a clear understanding of the clinical goals and patient needs, followed by structured design sessions to ensure usability for individuals and caregivers. Engineering teams built the platform on a compliance-first foundation, mapping ISO 13485 quality standards and HIPAA requirements into the development lifecycle.
Integration was a central focus. The platform was designed to synchronize securely across devices and care settings, creating a unified journey for patients and clinicians. By aligning the user experience with behavioral therapy protocols, the system became both clinically viable and patient-centered. Continuous validation with healthcare professionals helped refine features, ensuring alignment with clinical practices and regulatory expectations.
The result
The collaboration produced a scalable digital therapeutic platform that combines Roche’s clinical expertise with Harman’s connected technology capabilities. The platform is prepared for regulatory submission, supports expansion into additional therapeutic areas, and lays the foundation for real-world adoption in neuroscience. Most importantly, it represents a step forward in improving accessibility, personalization, and outcomes for individuals living with autism spectrum disorder.
