The Labelling Challenge​ Navigating Design Control Stages to Optimise ​Drug-Device Combination Product Labelling​

This presentation explores the complexities of labeling in drug-device combination (DDC) products, emphasising the importance of integrating labeling considerations throughout the design control process. It outlines the unique challenges posed by DDCs, including regulatory ambiguity, process misalignment, and communication gaps between drug and device teams. Through a stage-by-stage walkthrough – from planning and design input to verification, validation, and commercialisation – the presentation highlights how cross-functional collaboration, regulatory intelligence, and early inclusion of labelling and artwork functions can mitigate risks and ensure compliance. Real-world examples underscore the consequences of misalignment, while practical strategies such as traceability matrices and human factors engineering are proposed to bridge gaps. The talk concludes with a call for unified goals, agile methods, and transparent communication to streamline labelling and enhance patient safety.