Abstract 

This article examines the key challenges and best practices in developing parenteral drug delivery systems that pair drugs with specialised devices. It addresses the complexities of clinical trials, regulatory requirements, and the integration of drug and device development for combination products. The importance of bridging studies and human factors research is highlighted as essential for ensuring safety, efficacy and usability.

The article emphasises early cross-functional collaboration and strategic planning to reduce risks, accelerate development and improve patient outcomes in the evolving field of parenteral drug delivery.