Digital Therapeutics Platform
Addressing challenges in global healthcare with digital therapeutics
Multinational pharmaceutical and healthcare company seeks to develop digital therapeutics platform.
The new platform must encompass chronic and acute care meds across a number of healthcare conditions, not typically tracked or combined for review.
project snapshot
SITUATION
- Historically, pharma efficacy and patient wellness is determined by several key factors that are difficult to effectively track
- Patients, caregivers, devices, medication profiles are not integrated in a patient-centric, holistic fashion
- No current platform leverages AI algorithms that include adherence, patient wellness, social inputs and multi-med profiles for improved care
Challenges
- Initiative was complex due to the orchestration between AI, devices, social considerations, patients and caregivers
- Ecosystem is to include client and third-party devices
- Global rollout of new platform to the European Union, Canada and the United States
- Includes chronic and acute care meds across auto-immune, infertility, behavioral/cognitive and others not typically tracked or combined for review
SOLUTION
- Guided and mentored program execution through org-level Agile and SDLC training
- Performed security assessment and architected secure dataflows and other controls
- Collaborated with client to implement AWS patient / physician cloud portals along with performant data ingestion and analytics
- Addressed interoperability issues on multiple supported devices (including mobile)
- Designed and implemented a robust and comprehensive automation framework with continuous system validation (CSV) for validation and software verification
Results
- Successfully executed automation for formal platform validation and software verification
- Platform, while still in development, is targeted for FDA submission in 2024