Design Validation for Drug-Device Combination Products

Design validation for combination products is the documented demonstration that the integrated drug, device, packaging and labeling system meets intended use, user needs, and risk-based expectations under real or simulated real-world conditions.

This includes confirming the following:

• The drug + device + packaging + labeling work together as intended
• The product can be used safely and effectively by intended users
• It performs under realistic conditions of use
• It remains suitable across its shelf life, transport, storage, and handling
• Human factors, usability, and patient risk controls are adequately validated

A key aspect of the validation phase is evaluating usability and demonstrating that intended users can perform critical tasks without patterns of use error that would create unacceptable risk. Equally, system level (and not sub-components in isolation) is required when validating combination products.

1. Summative Evaluation/Human Factors Validation

   • Summative Validation Study Execution: Leading the final, formal testing with representative users in simulated environments to prove safety and effectiveness.
   • Use Error Root Cause Analysis: Performing deep-dive investigations into any errors observed during validation to determine if design remediation is required.

2. System-Level Validation

   • System-level validation of combination products involves confirming integrated performance across the full product system, including:
     • Drug formulation
     • Container closure
     • Delivery path
     • Needle
     • Device actuation mechanism
     • Safety features
     • Dose control features
     • Packaging and sterile barrier, where applicable
     • Labeling and instructions for use (IFU)
   
   
   • The validated configuration should represent the final marketed product as closely as possible. This typically includes:
     • A commercial-equivalent device configuration
     • The final drug formulation, or a scientifically justified surrogate
     • Final primary packaging
     • Final labeling, IFU, and artwork
     • Final sterilization state, where applicable
     • A commercial-equivalent assembly process
   
   
   • In addition, system performance should be validated under dynamic, real-world conditions such as transport vibration, temperature cycling, and repeated actuation.

The next blog post in this series will walk through the manufacturing transfer and high volume manufacturing planning phase, which is a structured process of moving a combination product from development/low-volume pilot production into a validated, scalable, commercial manufacturing environment.

Learn more about how West can help you address complex combination product development challenges.