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Discover strategies to optimize the human factors engineering process for injectable products.
October 1, 2024
By: Amy Lukau
Human factors engineering (HFE) is a cornerstone in the development and life cycle management of combination products, especially injectables. From early concept to manufacturing, HFE helps minimize use-related hazards and risks and helps ensure patients can safely and effectively use injectable combination products.1,2,3 However, HFE often presents significant challenges. Many companies find themselves caught in cycles of multiple usability tests. For manufacturers of legacy products already on the market, evolving regulatory guidance and requirements such as those required for domestic (FDA) and international product development (IEC, ISO, etc.) may lead to the need for additional testing. Human factors results, rarely perfect to begin with, can be even more challenging for legacy products due to existing design and manufacturing constraints. These challenges highlight the need for a more efficient approach to human factors engineering, particularly for legacy products. One powerful tool for optimizing human factors engineering is the Use-Related Risk Analysis (URRA), especially when implemented early in the product development process. By identifying potential use-related hazards from the outset, URRA can significantly reduce the number of human factors evaluations needed. This approach, combined with other best practices, can help ensure the best possible outcomes for patients while efficiently navigating the complex landscape of regulatory requirements and manufacturing constraints for injectable products.
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