Developing the appropriate regulatory strategy for a patient-centric, therapy-agnostic app
Case Study:
Developing a Regulatory Strategy for a Patient-Centric Digital App
This case study highlights how a biopharma company successfully launched a therapy-agnostic app to support the patient journey for a rare pulmonary disease, navigating regulatory requirements and patient engagement challenges.
Key highlights include:
- Challenge: Assess the regulatory landscape and organizational readiness for a patient-focused app that helps evaluate disease progression risks.
- Approach:
- Conducted multiple rounds of patient feedback to refine app features and ensure they met user needs.
- Evaluated app classification to determine if it would be regulated as a medical device.
- Mapped system architecture for data storage and integration with HCP clinical parameters.
- Reviewed organizational policies and governance structures to align with digital therapeutics requirements.
- Outcome: The app empowered patients and caregivers, fulfilled unmet needs, and established a roadmap for future digital therapeutics development.
Download the case study to explore how strategic planning can drive innovation in patient-centric digital solutions.
