(SeaPRwire) –   This strategic alliance merges Newel Health’s H-Core platform, regulated Software as a Medical Device (SaMD), and AI technology with Gerresheimer’s specialized knowledge in drug delivery and primary packaging. Enhanced by digital health offerings and existing pharmacy networks, the partnership aims to implement combined drug-and-digital treatments that facilitate large-scale personalized medicine and real-world data collection.

BASEL, Switzerland, May 27, 2026 — Newel Health, a developer and operator of digital medical devices (SaMD) for the life sciences sector, and Gerresheimer, a global provider of drug delivery systems, medical devices, primary packaging, and digital health solutions, have announced a strategic partnership. The alliance is designed to assist pharmaceutical and biotechnology firms in creating digital endpoints, regulated digital medical devices, and combined drug-plus-digital therapies.

The partnership unites the unique strengths of both organizations:

• Newel Health’s proficiency in regulated software as a medical device (SaMD), powered by its proprietary H-Core platform, clinical algorithms, AI analytics, and user-focused digital interfaces; and
• Gerresheimer’s comprehensive system capabilities in drug delivery, primary packaging, digital health, and pharmacy networks, which facilitate the seamless integration and deployment of digital tools alongside traditional drug therapies and patient care pathways.

By joining forces, Newel Health and Gerresheimer serve as key strategic allies for pharmaceutical firms looking to integrate digital endpoints, real-world evidence, and artificial intelligence into clinical trials and commercial launches, eliminating the need to construct their own digital and hardware infrastructure from scratch.

“Gerresheimer’s deep knowledge of drug delivery, manufacturing, and smart devices, paired with Newel Health’s scientific foundation, H-Core platform, and digital medical software, will empower pharmaceutical companies to deliver personalized healthcare safely and consistently,” stated Ervin Ukaj, CEO of Newel Health. “By merging our SaMD capabilities, real-world data, and AI tools with Gerresheimer’s international reach, connected devices, packaging, and digital health solutions, we enable drug developers to design and expand digital endpoints, regulated medical software, and integrated drug-digital programs across various therapeutic areas.”

“This alliance with Newel Health highlights Gerresheimer’s role as an integrated solution provider operating at the intersection of pharmaceuticals, medical devices, packaging, and digital technology,” remarked Mithun Ratnakumar, Director and Head of Digitalization & New Business Models at Gerresheimer. “Working together, we allow pharmaceutical companies to launch compliant, scalable digital solutions without the burden of building or managing the underlying digital and device frameworks.”

Scope of the Alliance: Digital Endpoints, Real-World Evidence, AI, and Integrated Solutions

Through this collaboration, Newel Health and Gerresheimer will assist pharmaceutical and biotech partners to:

• Create and validate digital endpoints utilizing data from smart devices and sensors, allowing for more consistent and objective tracking of patient health during clinical trials and real-world monitoring.
• Build and manage digital medical devices (SaMD) powered by Newel’s H-Core platform, which assist with patient monitoring, clinical decision-making, medication adherence, and symptom tracking tailored to specific treatment plans.
• Facilitate access to real-world data (RWD) and AI analytics by linking smart devices, SaMD, and secure data systems to provide sponsors with high-quality, long-term datasets and sophisticated insights.
• Construct unified drug-device-digital systems, combining Gerresheimer’s smart drug delivery and connected device technologies with Newel’s H-Core-based SaMD, AI algorithms, and user-friendly interfaces into a single, regulatory-compliant solution.

This integrated strategy empowers pharmaceutical firms to transition from isolated pilot projects to establishing scalable, repeatable digital and data assets that can be rolled out across diverse therapeutic fields and global markets.

About Newel Health

Newel Health (a member of the Future Health Ventures Group) specializes in the design, development, and operation of software as a medical device (SaMD) alongside pharmaceutical, biotech, and medical technology partners. Utilizing its proprietary H-Core platform, Newel integrates clinical studies, behavioral science, and AI-powered analytics within a compliant regulatory framework to offer customized digital therapies for chronic conditions.

The company’s product portfolio features Rohkea, an MDR Class IIa virtual reality digital therapeutic for chronic pain management, and Amicomed, an approved digital therapeutic for hypertension distributed via insurance providers, corporate wellness initiatives, and direct-to-consumer channels. These offerings are part of a growing pipeline of H-Core-based applications targeting cardiometabolic disorders, neuroscience, and chronic pain, designed to address clinical demands and assist pharmaceutical partners in scaling digital endpoints, SaMD, and integrated drug-digital initiatives.

About Gerresheimer

Gerresheimer is a leading global partner and developer of innovative systems and solutions for the pharmaceutical, biotech, and cosmetics sectors. The company provides a broad range of pharmaceutical packaging, drug delivery devices, medical equipment, and digital tools to support patient therapies. Gerresheimer focuses on ensuring the secure transport and dependable administration of medications. Employing more than 13,000 people across 39 manufacturing facilities in Europe, the Americas, and Asia, Gerresheimer maintains a strong international footprint with localized production capabilities.
www.gerresheimer.com

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