Development of a Mobile Digital Therapeutic Application for Post-Stroke Cognitive Rehabilitation

A healthcare organization faces significant challenges in delivering effective, accessible, and personalized neurorehabilitation for stroke survivors, especially regarding cognitive deficits that often remain undetected or untreated. Existing solutions lack integration into the home environment, are difficult to scale, and do not meet stringent regulatory standards for medical devices. There is a pressing need for a comprehensive digital health application that facilitates at-home therapy, ensures patient engagement, and complies with medical device regulations to enable prescription and reimbursement pathways.

A healthcare startup specializing in digital health solutions for neurorehabilitation, aiming to create a scalable, regulatory-compliant mobile health application for post-stroke cognitive therapy.

• Create a mobile application supporting the at-home neurorehabilitation of post-stroke cognitive deficits.
• Develop a personalized therapeutic pathway leveraging AI algorithms to adapt exercises based on individual patient needs.
• Ensure compliance with international medical device standards (e.g., MDR Class IIa), including thorough documentation and quality assurance processes.
• Design an engaging, multi-element exercise engine that motivates sustained patient participation.
• Support clinical trials and facilitate prescription and reimbursement processes for the final product.
• Guarantee high scalability, security, and integration capabilities to accommodate a broad user base.

• Diagnostic module to assess baseline cognitive functions and tailor therapy accordingly.
• Exercise engine supporting a variety of therapeutic activities based on neuropsychological expertise.
• AI-supported personalization system creating individualized therapeutic paths for each patient.
• Multi-element motivation system to enhance patient engagement and adherence.
• Robust documentation procedures covering design, development, and clinical validation processes.
• Regulatory compliance features aligned with MDR certification requirements to facilitate approval.

• Regulatory bodies' systems for certification documentation submissions
• Clinical trial data repositories for validation purposes
• Patient health records systems for integration with existing healthcare infrastructure
• AI/machine learning models for personalized therapy generation

• Scalability to support up to 50,000 concurrent users in initial phases with plans for expansion
• Data security compliant with healthcare regulations (e.g., GDPR, HIPAA)
• High availability with 99.9% uptime for seamless patient access
• Performance optimized to deliver exercises and assessments with minimal latency
• Rigorous validation and testing aligned with medical device standards

The project aims to deliver a scalable, secure, and regulatory-compliant mobile health app that enables at-home neurorehabilitation, improving cognitive outcomes for post-stroke patients. Success metrics include supporting clinical trials leading to product certification within 12 months, enabling prescription and reimbursement pathways, and reaching a broad patient base, potentially impacting millions worldwide suffering from post-stroke cognitive deficits.