BackgroundA novel medical device has been developed to address an unmet need in standardising and facilitating heart rate recording during neonatal resuscitation. In a time critical emergency resuscitation, where failure can mean death of an infant, it is vital that clinicians are provided with information in a timely, precise and clear manner to capacitate appropriate decision making. This new technology provides a hands free, wireless heart rate monitoring solution that easily fits the clinical pathway and procedure for neonatal resuscutation.To understand the requirements of the interface design for this new device, a human factors approach was implemented. This combined a traditional user-centred design approach with an Applied Cognititive Task Analysis (ACTA) to understand the tasks involved, the cognitive requirements and the potential for error during a neonatal resusciation scenario.MethodFourteen clinical staff were involved in producing the final design requirements. Two paediatric doctors supported the development of a visual representation of the activities associated with neonatal resucitation. This was used to develop a scenario based workshop. Two workshops were carried out in parallel and involved three paediatric doctors, three neonatal nurses, two advance neonatal practitioners and four midwives. Both groups came together at the end to reflect on the findings which emerged during the separate sessions.ResultsThe outputs of this study have provided a comprehensive description of information requirements during neonatal resuscitation, and enabled product developers to understand the preferred requirements of the user interface design for the device. The study raised three key areas for the designers to consider, which had not previously been highlighted. These related to: 1) interface layout and information priority - heart rate should be central and occupy two thirds of the screen, device, 2) size and portability – to enable positioning local to baby’s head and allow visibility from all angles and 3) auditory feedback - to support visual information on heart rate rhythm and reliability of the trace with an early alert for intervention, whilst avoiding parental distress.ConclusionThis study demonstrates the application of human factors and the ACTA method, which identified user requirements previously not identified. This methodology provides a useful approach to aid development of the clinical interface for medical devices
