Drug-device combination products in the twenty-first century: epinephrine auto-injector development using human factors engineering

Abstract

Introduction: The systematic application of human factors engineering (HFE) principles to the development of drug-device combination products, including epinephrine auto-injectors (EAIs), has the potential to improve the effectiveness and safety of drug administration.Areas covered: A PubMed search was performed to assess the role of HFE in the development of drug-device combination products. The following keywords were used in different combinations: ‘human factors engineering,’ ‘human factors,’ ‘medical products,’ ‘epinephrine/adrenaline auto-injector,’ ‘healthcare’ and ‘patient safety.’ This review provides a summary of HFE principles and their application to the development of drug-device combination products as advised by the US FDA. It also describes the HFE process that was applied to the development of Auvi-Q, a novel EAI, highlighting specific steps that occurred during the product-development program.Expert opinion: For drug-device combination products, device labeling and usability are critical and have the potential to impact clinical outcomes. Application of HFE principles to the development of drug-delivery devices has the potential to improve product quality and reliability, reduce risk and improve patient safety when applied early in the development process. Additional clinical and real-world studies will confirm whether the application of HFE has helped to develop an EAI that better meets the needs of patients at risk of anaphylaxis.