title: The role of human factors in the design and development of an insulin pump.
abstract: This article discusses human factors (HF) processes and how they are applied during the development of a medical device to minimize the risk that the user interface design could lead to patient errors, adverse events, and product recalls. This process is best defined as "prevention through design." The HF design process is exemplified by three distinct phases: (1) preliminary analysis, (2) formative design evaluation and modification, and (3) design validation. Additional benefits of employing HF principles during medical device development are briefly reviewed, including reduced patient risk by eliminating design flaws, increased patient adherence through the reduction in the complexity of therapeutic regimes, and reduced likelihood for product recalls.
authors.affiliation: Tandem Diabetes Care, San Diego, California 92121, USA. noel.schaeffer@tandemdiabetes.com
authors.forename: Noel E
authors.initials: NE
authors.lastname: Schaeffer
mesh_terms: D020811:Biomedical Technology / Q000295:instrumentation* / Q000592:standards; D003920:Diabetes Mellitus / Q000188:drug therapy*; D004867:Equipment Design; D004869:Equipment Safety; D006804:Ergonomics / Q000295:instrumentation* / Q000592:standards; D017408:Guidelines as Topic; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects; D007332:Insulin Infusion Systems / Q000592:standards; D057052:Medical Device Recalls; D019300:Medical Errors / Q000517:prevention & control; D061214:Patient Safety; D017060:Patient Satisfaction
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin