Overview
- Newel Health and Gerresheimer have partnered to support the development of digital endpoints, regulated digital medical devices (SaMD), and integrated drug+digital solutions.
- The collaboration combines both companies’ expertise to enable AI-powered, data-driven, and scalable digital therapies for pharmaceutical and biotech companies.
The News
Newel Health and Gerresheimer have announced a strategic partnership to support pharmaceutical and biotech companies in developing digital endpoints, regulated digital medical devices (SaMD), and integrated drug+device+digital solutions. The collaboration combines Newel Health’s H-Core platform, clinical-grade algorithms, AI-enabled analytics, and patient-centric digital capabilities with Gerresheimer’s expertise in drug delivery systems, pharmaceutical primary packaging, connected devices, digital health solutions, and pharmacy networks.
Under the partnership, the companies will help pharma organizations design and validate digital endpoints using connected devices and sensors, develop H-Core-based SaMD for patient monitoring, treatment adherence, symptom tracking, and clinical decision support, and generate AI-driven real-world data through secure digital infrastructure. They will also co-develop integrated drug+device+digital solutions by combining Gerresheimer’s connected drug delivery technologies with Newel Health’s AI-powered platform, enabling scalable, regulatory-compliant digital therapies across multiple therapeutic areas.
Industry Perspective
As pharmaceutical companies increasingly integrate digital technologies into drug development, demand is growing for solutions that combine medicines, connected devices, AI, and real-world data. Digital endpoints and regulated SaMD are becoming essential for improving patient monitoring, supporting decentralized clinical trials, enhancing treatment adherence, and generating continuous evidence beyond traditional clinical settings.
Strategic Impact
The partnership positions Newel Health and Gerresheimer as end-to-end digital health partners for the pharmaceutical industry, enabling companies to accelerate the development of personalized therapies without building complex digital infrastructure in-house. By combining drug delivery, connected devices, AI-powered digital medical devices, and real-world data capabilities, the collaboration is expected to support scalable digital innovation across clinical development and commercialization.
Source: Newel Health
