title: Drug-device combination products in the twenty-first century: epinephrine auto-injector development using human factors engineering.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Kaléo, Inc. , 111 Virginia Street, Ste. 300, Richmond, VA 23219 , USA ; +1 804 545 6374 , +1 804 545 6219 , eric.edwards@kaleopharma.com.
authors.forename: Eric S
authors.initials: ES
authors.lastname: Edwards
authors.forename: Evan T
authors.initials: ET
authors.lastname: Edwards
authors.forename: F Estelle R
authors.initials: FE
authors.lastname: Simons
authors.forename: Robert
authors.initials: R
authors.lastname: North
mesh_terms: D000707:Anaphylaxis / Q000188:drug therapy*; D004837:Epinephrine / Q000008:administration & dosage* / Q000009:adverse effects; D006804:Ergonomics; D006801:Humans; D007267:Injections; D015203:Reproducibility of Results
chemical_list: D004837:Epinephrine
keywords: adrenaline auto-injector; combination products; epinephrine auto-injector; human factors engineering; risk reduction; safety