Considerations for device selection in parenteral applications.

Mark Tunkel, Global Category Director, Services at Nemera, looks at the challenges involved in the selection of drug devices for combination products and the optimisation of the development process.

While patient centricity is the foundation for developing a robust device selection plan and completion of a successful combination product development initiative, developers need to remember there is a larger ecosystem that must be considered to ensure success. This ecosystem includes providers, namely healthcare professionals, but also health systems; payers, in order to consider factors such as value-based care; and regulators, as the market for product introduction and the intended filing approach can significantly impact device selection approaches and development strategies. These factors then need to be considered within the available or emerging technology landscape.

With respect to patient centricity, at the earliest stages of establishing the functional requirements and user needs for a device, it is critical to fully understand the patient journey, as well as any related clinical processes, to ensure every decision considers their needs first. Understanding both this journey and interactions with the healthcare system and healthcare provider experience enables the capture of the complete process patients go through in managing their
disease – both from a self-administration standpoint and from a longitudinal perspective – as they progress with their condition and treatment through the healthcare system and life stages.