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.

Keywords:

• adrenaline auto-injector
• combination products
• epinephrine auto-injector
• human factors engineering
• risk reduction
• safety

Acknowledgments

The authors acknowledge P Patterson (Agilis Consulting Group), R Gunn (Kaleo, Inc.), P Meyers (Kaleo, Inc.) and S Guerlain (University of Virginia) for support in the design and development process of Auvi-Q as well as the human factors program, specifically the execution of the usability study.

Declaration of interest

ES Edwards is an employee and shareholder with Kaléo, Inc.; ET Edwards is an employee and shareholder with Kaléo, Inc.; FER Simons is on the medical advisory board of Sanofi; R North is an employee with Human Centered Strategies, LLC. The authors received writing/editorial support in the preparation of this manuscript from M Calle of Excerpta Medica, funded by Sanofi US. The authors have not received honoraria related to the preparation of this manuscript and are fully responsible for contents and editorial decisions for this manuscript.

Notes

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