Human factors studies for injectable combination products: from planning to reporting.

Abstract

Human factors is the study of the interaction of people and technology to ensure the safety and effectiveness of that interaction and to improve human/device compatibility, including the user interface, instructions, and training programs to avoid use error. The enhanced focus on human factors usability assessments for injectable combination products is an acknowledgement by regulators and industry that the device mechanics are typically quite reliable and that device risk hazards are likely due to device usability. Use errors can occur when the device is not being used as intended or the design features are less than optimal. Human factors testing, analysis, and validation helps to identify and eliminate use errors by informing appropriate mitigation strategies to ensure the device design provides the optimum use of injectable drug/device combination products.