Newel Health announced that it has entered into a partnership with Gerresheimer to support pharmaceutical and biotech companies in developing digital endpoints, digital medical devices, and integrated drug+digital solutions. The collaboration combines Newel Health?s H-Core platform, regulated digital medical devices, and AI capabilities with Gerresheimer?s drug delivery and primary packaging expertise, extended through digital health solutions and established pharmacy touchpoints, to deploy integrated drug and digital therapies that enable real-world data generation and personalized medicine at scale. The collaboration brings together Newel Health?s expertise in regulated digital medical devices (SaMD), based on its H-Core platform, clinical-grade algorithms, AI-enabled analytics, and patient-centric digital experiences; and Gerresheimer?s system-level capabilities across drug delivery, primary packaging, digital health, and established pharmacy touchpoints, enabling the integration, deployment, and activation of digital components along with drug-based therapies and patient workflows.

Together, Newel Health and Gerresheimer position themselves as strategic partners for pharma companies who are seeking to embed digital endpoints, real-world data, and AI into clinical development and commercialization, without needing to build a full digital and device stack internally. Under the partnership, Newel Health and Gerresheimer will work with pharma and biotech companies to design and validate digital endpoints using data generated by connected devices and sensors, enabling more continuous and objective measurement of patient status in clinical studies and post-market settings. They will develop and operate digital medical devices (SaMD) built on Newel Health?s H-Core platform, supporting monitoring, decision-making, adherence tools, and symptom tracking aligned with specific therapies and clinical pathways.

They will enable real-world data (RWD) access and AI-driven insights by combining connected devices, SaMD, and secure data infrastructure to generate high-quality, longitudinal datasets and advanced analytics for sponsors. They will build integrated drug+device+digital solutions, where Gerresheimer?s connected drug delivery and connected device platforms are engineered together with Newel Health?s H-Core?based SaMD, AI models, and user experience into a coherent, regulatory-grade solution around the medicine. This combined approach allows pharmaceutical companies to move beyond isolated pilots and build scalable, repeatable digital and data assets that can be deployed across therapeutic areas and markets.