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Until recently, academia typically did not engage with the development of medical technology but instead developed techniques, processes, and lab-evaluated studies that were picked up by industry. With the introduction of rapid prototyping and access to information via the internet, more and more medical technology is being developed within academia from conception to product. However, academia still suffers from siloed research groups, access to partial knowledge, and anticipating, at the outset, the requirements of a final product necessary to engage all the required multidisciplinary input. Support for the design and development of the technology can often be provided by other academic departments; however, the current environment of isolated research, often due to funding remit restrictions and limited resources, limits this. In this paper, we highlight lessons learnt within academia about using regulatory standards within a multidisciplinary research project to assess the usability of a novel medical device; specifically, the current guidance is not sufficient for new practitioners to apply regulatory processes straightforwardly. We report on the assessment of a novel medical device being evaluated to regulatory standards, using the system under ‘normal use’, and discuss how using ecological validity as a guide can help ensure that the device is effective, efficient, and most importantly safe.

Pain management is often considered lower priority than many other aspects of health management in hospitals. However, there is potential for Quality Improvement (QI) teams to improve pain management by visualising and exploring pain data sets. Although dashboards are already used by QI teams in hospitals, there is limited evidence of teams accessing visualisations to support their decision making. This study aims to identify the needs of the QI team in a UK Critical Care Unit (CCU) and develop dashboards that visualise longitudinal data on the efficacy of patient pain management to assist the team in making informed decisions to improve pain management within the CCU. This research is based on an analysis of transcripts of interviews with healthcare professionals with a variety of roles in the CCU and their evaluation of probes. We identified two key uses of pain data: direct patient care (focusing on individual patient data) and QI (aggregating data across the CCU and over time); in this paper, we focus on the QI role. We have identified how CCU staff currently interpret information and determine what supplementary information can better inform their decision making and support sensemaking. From these, a set of data visualisations has been proposed, for integration with the hospital electronic health record. These visualisations are being iteratively refined in collaboration with CCU staff and technical staff responsible for maintaining the electronic health record. The paper presents user requirements for QI in pain management and a set of visualisations, including the design rationale behind the various methods proposed for visualising and exploring pain data using dashboards.