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Case Study

Digital strategy to build real world evidence for a medical device

Design a patient mobile application to capture, analyze, and present data insights to patients using a neuro device that treats neuropsychiatric disorders


Our client develops cranial electrical stimulation (CES) medical devices for depression, anxiety, pain and insomnia, and needed a better strategy for real world data capture, analysis, and insights generation. Our client needed a survey of the connected medical device and digital therapeutics market in mental health for insight into industry best practices and trends. A strategy was needed to capture patient reported outcomes (PROs) to prove efficacy and influence reimbursement decisions.


A digital and AI strategy was developed based on industry trends and best practices, including inspiration from the consumer space. A companion mobile application was designed to increase user engagement with the device,  capture clinical grade real world data, and improve outcomes. The application was designed to collect medical device usage data, symptoms, and clinically validated questionnaires, creating a comprehensive dataset on users and treatment outcomes. Longer term, this dataset will enable personalized treatment recommendations, promote adherence to treatment schedules, and enable enrollment of users in clinical trials involving the device for accelerated assessment of therapeutic response.

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