Overcoming device component-related challenges and risks in prefilled syringe development

Abstract

Developing medicines to serve patients is a complex, highly regulated process in which multiple interdependent factors must be aligned. If one aspect is not thoroughly evaluated, it may adversely affect others and ultimately the final product, leading to delays, additional costs and, in the worst case, market access barriers. This is particularly true for prefilled syringes (PFS) as combination products, where an already challenging market environment is further compounded by intricate regulatory requirements and a highly complex development process.

This paper argues that many recurring issues in PFS development are not isolated technical failures, but the consequence of four systemic challenges: diverging regulatory requirements for drugs and devices, division of competencies between drug and device development teams, fragmented supply chains for device components, and non-standardized characterization and evidence generation across stakeholders. Using examples such as break-loose and glide forces, silicone oil, particles, endotoxins, and biocompatibility, the paper illustrates how these challenges manifest as concrete risks along the development pathway, including transitions from vial to syringe and interactions with notified bodies under the MDR. It then outlines system-level strategies to mitigate these risks, including clearer system ownership, integrated risk management and design spaces, earlier and closer collaboration with device experts and suppliers, and more harmonized standards and regulatory expectations. The overall aim is to support a more efficient, predictable and sciencebased pathway to safe, effective and user-appropriate prefilled syringes.