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Newel Health and Gerresheimer partner to advance integrated digital therapies

Image Credit: Newel Health.

June 2026 | Jack Overell – Head of Production, SAE Media Group

Newel Health and Gerresheimer have announced a strategic collaboration aimed at supporting pharmaceutical and biotech companies in developing and scaling integrated drug and digital therapies.

The partnership brings together Newel Health’s expertise in regulated digital medical devices (SaMD), artificial intelligence (AI), and its H-Core platform with Gerresheimer’s capabilities in drug delivery systems, pharmaceutical packaging, and connected digital health solutions. The combined offering is designed to help sponsors embed digital endpoints, real-world data (RWD), and AI into clinical development and commercialization programs.

At its core, the collaboration seeks to enable pharmaceutical companies to deploy end-to-end drug-device-digital solutions without the need to build and operate complex digital infrastructure internally. By integrating connected devices, secured data systems, and AI-driven analytics, the partnership supports the generation of high-quality longitudinal data and more personalized patient care pathways.

Focus on Digital Endpoints and Real-World Evidence

Under the agreement, the two companies will jointly support the development and validation of digital endpoints, using data collected from connected devices and sensors. This approach enables more continuous and objective monitoring of patient outcomes across both clinical trials and post-market settings.

Newel Health will lead on the development of digital medical devices built on its H-Core platform, enabling therapy-specific applications such as remote monitoring, adherence tools, symptom tracking, and decision-support capabilities. These solutions are designed to align with clinical pathways while meeting regulatory requirements.

Gerresheimer will contribute its system-level expertise across drug delivery, connected devices, and primary packaging, alongside established pharmacy distribution and patient touchpoints. This allows digital components to be effectively integrated into existing treatment workflows.

Scaling Drug + Device + Digital Solutions

A key goal of the collaboration is to move beyond isolated digital pilots and enable scalable, repeatable digital health solutions across therapeutic areas. By combining connected drug delivery platforms with SaMD, AI models, and patient interfaces, the companies aim to deliver fully integrated, regulatory-grade ecosystems around medicines.

The approach also supports the growing demand for real-world data and AI-driven insights in drug development. By linking connected devices with secure data infrastructure, the partnership enables sponsors to access richer datasets to inform clinical and commercial decision-making.

Ervin Ukaj, CEO of Newel Health, stated that the collaboration will help pharmaceutical companies bring personalized medicine to patients in a reliable and compliant manner by combining digital medical devices, AI capabilities, and real-world data with global drug delivery systems.

Mithun Ratnakumar, Head of Digitalization & New Business Models at Gerresheimer, added that the partnership reinforces Gerresheimer’s role at the intersection of drug, device, and digital solutions, enabling companies to deploy scalable and compliant technologies without building full-stack capabilities internally.

Positioning for the Future of Digital Health

As pharmaceutical companies continue to integrate digital technologies into their pipelines, partnerships such as this reflect a broader industry shift toward connected, data-driven therapies. The collaboration positions both Newel Health and Gerresheimer as strategic partners in enabling next-generation treatment models that combine therapeutics with digital innovation.

For pharma and biotech companies, the partnership offers a pathway to accelerate the adoption of digital endpoints, improve patient engagement, and generate real-world evidence at scale – without the operational burden of developing in-house digital ecosystems.



WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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