Strategic CDMO Partnerships in Combination Drug–Device Development: Accelerating Time to Market While Mitigating Risks

Developing combination drug–device products is a complex endeavor, with multiple potential pathways and inherent risks. Early decisions, such as selecting a platform device versus developing a bespoke solution, can significantly influence timelines, costs, and regulatory strategy. Key milestones and decisions include conducting biocompatibility and functional validation testing, navigating evolving regulatory requirements, ensuring supply continuity, and aligning device development activities with critical drug development and clinical trial phases.

This session will explore how CDMO partnerships enable pharmaceutical and biotech companies to defer significant investments in device manufacturing, assembly, and packaging until there is greater confidence in market adoption. It will also highlight how CDMOs collaborate with platform device manufacturers and other ecosystem partners to implement practical, standardized assembly and packaging solutions that accelerate time to clinic and commercialization.