Newel Health and Gerresheimer launch strategic collaboration

Newel Health, a company that designs, develops, and operates digital medical devices (SaMD) for life sciences partners, and Gerresheimer, an innovative system and solution provider for drug delivery systems, medical devices, pharmaceutical primary packaging, and digital health solutions, have announced a partnership. They will support pharmaceutical and biotech companies in developing digital endpoints, digital medical devices, and integrated drug and digital solutions.

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 commercialisation, without needing to build a full digital and device stack internally.

"Gerresheimer's expertise in drug delivery, manufacturing, and connected devices, together with Newel Health's science, H-Core platform, and digital medical devices, will support pharma companies to bring personalised medicine to patients safely and reliably," said Ervin Ukaj, chief executive officer, Newel Health.

"By combining our SaMD expertise, real-world data, and AI capabilities with Gerresheimer's global footprint, connected device, packaging and Digital Health capabilities, we help pharma design and scale digital endpoints, regulated digital medical devices, and integrated drug and digital solutions across multiple indications."

"Our collaboration with Newel Health underlines Gerresheimer's position as a system and solution provider at the interface of drug, device or packaging and digital solutions," said Mithun Ratnakumar, director, head of digitalisation and new business models at Gerresheimer. "Together, we enable pharma companies to deploy compliant, scalable solutions without having to build or operate the full digital and device infrastructure themselves."

Partnership scope: digital endpoints, real-world data, AI, and devices

Under the partnership, Newel Health and Gerresheimer will work with pharma and biotech companies to:

1. 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.
2. Develop and operate digital medical devices (SaMD) built on Newel's H-Core platform, supporting monitoring, decision-making, adherence tools, and symptom tracking aligned with specific therapies and clinical pathways.
3. 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.
4. Build integrated drug, device and digital solutions, where Gerresheimer's connected drug delivery and connected device platforms are engineered together with Newel'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.