Building Labeling Into Design Controls for Drug–Device Combination Products

Drug-device combination (DDC) products present unique challenges in labeling due to their dual nature, integrating medicinal products with medical devices under complex regulatory frameworks. This presentation explores strategies to optimize labeling by embedding it throughout the Design Control process, ensuring compliance, usability, and global harmonization.

The discussion begins by defining DDCs and highlighting common pain points such as fragmented processes, regulatory ambiguity, and misalignment between development and commercial labeling. It then introduces a structured approach across six Design Control stages: Planning, Design Input, Design Output, Design Verification, Design Validation, and Transfer & Commercialization. Key recommendations include early involvement of labeling and artwork functions, creation of verifiable labeling requirements, integration of risk management measures, and use of traceability matrices for compliance. Human Factors Engineering and usability studies are emphasized to validate labeling effectiveness from a user perspective.

The presentation advocates for cross-functional collaboration, agile methods, and regulatory intelligence to bridge gaps between device and drug development processes. Practical tools such as process mapping, collaborative platforms, and global labeling strategies are discussed to minimize deviations and streamline submissions. 

By aligning labeling with design controls and fostering collaboration, organizations can reduce risks, improve user safety, and accelerate time-to-market for DDC products.

What You’ll Learn

This session takes a practical look at how labeling can be intentionally integrated into the Design Control process for drug–device combination products—rather than addressed late as a compliance exercise. Attendees will learn how to:

• Identify where labeling fits across the six Design Control stages and why early involvement matters
• Translate regulatory and user needs into clear, testable labeling requirements
• Connect labeling decisions to risk management, traceability, and usability expectations
• Use Human Factors and usability evidence to support labeling effectiveness and user safety
• Reduce rework, deviations, and submission delays by aligning development and commercial labeling early

Who Should Attend

This session is designed for professionals who are directly involved in labeling decisions or who influence how labeling is developed, reviewed, and maintained for drug–device combination products, including:

• Labeling, artwork, and IFU owners
• Regulatory affairs and regulatory strategy professionals
• Device, drug, and combination product development teams
• Human factors and usability practitioners
• Quality, design control, and risk management leads
• Project and program managers supporting cross-functional DDC teams

Speaker

• Cornelia Hain, CMC Device & Packaging Development Lead, Polpharma Biologics International AG