Background: It is well established that considering users is an important aspect of medical device development.\r\nHowever it is also well established that there are numerous barriers to successfully conducting user research and\r\nintegrating the results into product development. It is not sufficient to simply conduct user research, it must also be\r\neffectively integrated into product development.\r\nMethods: A case study of the development of a new medical imaging device was conducted to examine in detail\r\nhow users were involved in a medical device development project. Two user research studies were conducted: a\r\nrequirements elicitation interview study and an early prototype evaluation using contextual inquiry. A descriptive in\r\nsitu approach was taken to investigate how these studies contributed to the product development process and\r\nhow the results of this work influenced the development of the technology. Data was collected qualitatively\r\nthrough interviews with the development team, participant observation at development meetings and document\r\nanalysis. The focus was on investigating the barriers that exist to prevent user data from being integrated into\r\nproduct development.\r\nResults: A number of individual, organisational and system barriers were identified that functioned to prevent the\r\nresults of the user research being fully integrated into development. The user and technological aspects of\r\ndevelopment were seen as separate work streams during development. The expectations of the developers were\r\nthat user research would collect requirements for the appearance of the device, rather than challenge its\r\nfundamental concept. The manner that the user data was communicated to the development team was not\r\neffective in conveying the significance or breadth of the findings.\r\nConclusion: There are a range of informal and formal organisational processes that can affect the uptake of user\r\ndata during medical device development. Adopting formal decision making processes may assist manufacturers to\r\ntake a more integrated and reflective approach to development, which should result in improved business\r\ndecisions and a higher quality end product.
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