Background: Academic literature and international standards bodies suggest that user involvement, via the\r\nincorporation of human factors engineering methods within the medical device design and development (MDDD)\r\nprocess, offer many benefits that enable the development of safer and more usable medical devices that are better\r\nsuited to usersââ?¬â?¢ needs. However, little research has been carried out to explore medical device manufacturersââ?¬â?¢\r\nbeliefs and attitudes towards user involvement within this process, or indeed what value they believe can be\r\nadded by doing so.\r\nMethods: In-depth interviews with representatives from 11 medical device manufacturers are carried out. We ask\r\nthem to specify who they believe the intended users of the device to be, who they consult to inform the MDDD\r\nprocess, what role they believe the user plays within this process, and what value (if any) they believe users add.\r\nThematic analysis is used to analyse the fully transcribed interview data, to gain insight into medical device\r\nmanufacturersââ?¬â?¢ beliefs and attitudes towards user involvement within the MDDD process.\r\nResults: A number of high-level themes emerged, relating who the user is perceived to be, the methods used, the\r\nperceived value and barriers to user involvement, and the nature of user contributions. The findings reveal that\r\ndespite standards agencies and academic literature offering strong support for the employment formal methods,\r\nmanufacturers are still hesitant due to a range of factors including: perceived barriers to obtaining ethical approval;\r\nthe speed at which such activity may be carried out; the belief that there is no need given the ââ?¬Ë?all-knowingââ?¬â?¢ nature\r\nof senior health care staff and clinical champions; a belief that effective results are achievable by consulting a\r\nminimal number of champions. Furthermore, less senior health care practitioners and patients were rarely seen as\r\nbeing able to provide valuable input into the process.\r\nConclusions: Medical device manufacturers often do not see the benefit of employing formal human factors\r\nengineering methods within the MDDD process. Research is required to better understand the day-to-day\r\nrequirements of manufacturers within this sector. The development of new or adapted methods may be required\r\nif user involvement is to be fully realised.
Loading....