Holistic Development & Industrialisation of Drug Delivery Devices & Combination Products


Mark Tunkel and Niyati Sapatnekar discuss Nemera’s holistic approach to development and industrialisation.

Over the past few years, new insights in biology, chemistry and engineering have led to the discovery of new molecules and drugs. This, in turn, has increased the necessity of well-adapted drug delivery device solutions to ensure their maximum efficacy, as well as the best patient outcomes. Staying on top of healthcare trends is critical not only for well-established drug providers but also for those smaller players intervening in and around the space. Industrialising new devices and introducing them to the market requires a rigorous process that navigates a variety of factors and strengths in contract development, and manufacturing expertise that can be applied in a flexible manner.

The complexities involved in selecting or developing the correct device for a combination product have never been more challenging. A convergence of trends, including significant growth in the global drug development pipeline, the need for more complex delivery devices to address targeted applications and drug attributes, and increased migration of care from the clinic to self-administration in home settings have driven demand for a wide range of solutions. This is coupled with a crowded and competitive landscape in the biologics, biosimilars and generics segments, where speed to market, differentiation, patient centricity and value creation are critical.

Beyond the patient, this includes an ecosystem of stakeholders including not only providers (healthcare professionals) but also health systems, payers (to consider factors such as value-based care) and regulators, as the market for product introduction and the intended filing approach can affect device selection and development strategies. These factors then need to be considered within the available or emerging technology landscape.

Therefore, developers need to adopt a holistic approach to developing a device strategy that is focused on the entire combination product, spans development stages and requires specialised expertise at every step of the process – all balancing a variety of factors and influences that need to be considered. This leads to better near- and long-term decision making across the lifecycle of drug products.

To read the full magazine : HERE

To read Nemera’s article: HERE

About Nemera
As a world-leading drug delivery device solutions provider, our purpose of putting patients first enables us to design and manufacture devices that maximize treatment efficacy. We are a holistic partner and help our customers succeed in the sprint to market of their combination products. From early device strategy to state-of-the-art manufacturing, we’re committed to the highest quality standards. Agile and open-minded, we work with our customers as colleagues. Together, we go the extra mile to fulfill our mission.
For more information, visit www.nemera.net

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