An academician's approach to the application of human factors standards: A case study on a liver support system

Abstract

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.