Abstract
Many medical devices on the market are labelled “user-centred”; however, a large percentage of them are not designed to adequately reflect the needs and features of the end-users. Design issues have led to accidents in which poor experiences impair product functionality and even threatens users’ safety. This study explored the user information factors that hindered the success of new medical devices that were effective, safe and easy to use, and also the correlations between these factors. A case study methodology was utilised to gain improved understanding of the factors that substantially influence the user performance of new products. In specific, the project processes of sixteen medical devices produced by two carefully selected manufacturers were analysed, through analysing the project archives of the devices, interviewing team members playing key roles in the development processes, and validation workshops. The results also revealed that the design of most of the devices in the study was based on insufficient user insights. This owed to the issues embedded in both the ways of obtaining user information and using the information. These are as follows: 1) unreliable information sources; 2) linear and unidirectional data delivery manner; 3) inconsistent ways of translating and presenting data; and 4) lack of central governance of project information.
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References
Blache, L., Robbins, P., Brown, S., Jones, P., Liu, T., LeFever, J.: Risk Management and its Application to Medical Device Management, 1st edn. Institute of Physics and Engineering in Medicine, York (2007)
Renda, G., Jackson, S., Kuys, B., Whitfield, T.A.: The cutlery effect: do designed products for people with disabilities stigmatise them? Disabil. Rehabil. Assist. Technol. 11(8), 661–667 (2016)
American College of Clinical Engineering: Enhancing Patient Safety - The Role of Clinical Engineering (2001). http://accenet.org/downloads/ACCEPatientSafetyWhitePaper.pdf. Accessed 20 Dec 2017
Perrow, C.: Normal Accidents: Living with High Risk Technologies. Princeton University Press, New York (2011)
NHS England: Preventing medical device incidents (2016). https://www.england.nhs.uk/patientsafety/medical-device-incidents/. Accessed 1 Aug 2017
Smyth, C.: Thousands of patients killed by drug and equipment errors (2014). https://www.thetimes.co.uk/article/thousands-of-patients-killed-by-drug-and-equipment-errors-k7m7c5zjpcx. Accessed 2 Oct 2017
Rinkus, S., et al.: Human-centered design of a distributed knowledge management system. J. Biomed. Inform. 38(1), 4–17 (2005). https://doi.org/10.1016/j.jbi.2004.11.014
National Patient Safety Agency: Design for patient safety: user testing in the development of medical devices (2010). http://www.nrls.npsa.nhs.uk/resources/?EntryId45=74946. Accessed 7 Dec 2017
Sharples, S., Martin, J., Lang, A., Craven, M., O’Neill, S., Barnett, J.: Medical device design in context: a model of user–device interaction and consequences. Displays 33(4), 221–232 (2012)
Yang, F., Renda, G.: The design briefing process matters: a case study on telehealthcare device providers in the UK. Disabil. Rehabil.: Assist. Technol. 14(1), 91–98 (2019)
Flyvbjerg, B.: Case study. In: Denzin, N.K., Lincoln, Y.S. (eds.) The Sage Handbook of Qualitative Research, pp. 301–316. Sage, Thousand Oaks (2011)
Bryman, A.: Social Research Methods. Oxford University Press, Oxford (2001)
Smith, J.A.: Semi-structured interviewing and qualitative analysis. In: Smith, J.A., Harre, R., Van Langenhovc, L. (eds.) Rethinking Methods in Psychology. Sage, London (1995)
Kvale, S.: Interviews: An Introduction to Qualitative Research Interviewing. Sage Publications, Thousand Oaks (1996)
Kvale, S., Brinkmann, S.: InterViews: Learning the Craft of Qualitative Research Interviewing. Sage, Los Angeles (2009)
Gish, L., Hansen, C.T.: A socio-technical analysis of work with ideas in NPD: an industrial case study. Res. Eng. Des. 24(4), 411–427 (2013)
Yang, F., Al Mahmud, A., Wang, T.: User knowledge factors that hinder the design of new home healthcare devices: investigating thirty-eight devices and their manufacturers. BMC Med. Inform. Decis. Mak. 21(1), 166 (2021). https://doi.org/10.1186/s12911-021-01464-3
Maltz, E., Kohli, A.K.: Market intelligence dissemination across functional boundaries. J. Mark. Res. 33, 47–61 (1996)
Dayan, M., Di Benedetto, C.A.: Team intuition as a continuum construct and new product creativity: the role of environmental turbulence, team experience, and stress. Res. Policy 40(2), 276–286 (2011)
Fredrickson, J.W.: Effects of decision motive and organizational performance level on strategic decision processes. Acad. Manag. J. 28(4), 821–843 (1985)
Armstrong, S.J., Hird, A.: Cognitive style and entrepreneurial drive of new and mature business owner-managers. J. Bus. Psychol. 24(4), 419 (2009)
De Brentani, U., Reid, S.E.: The fuzzy front-end of discontinuous innovation: insights for research and management. J. Prod. Innov. Manag. 29(1), 70–87 (2012)
Eling, K., Griffin, A., Langerak, F.: Using intuition in fuzzy front-end decision-making: a conceptual framework. J. Prod. Innov. Manag. 31(5), 956–972 (2014). https://doi.org/10.1111/jpim.12136
Xue, L., Yen, C.C., Boucharenc, C., Choolani, M.: The design evolution of medical devices: moving from object to user. J. Des. Res. 7(4), 411–438 (2008)
Phillips, P.L.: Creating the Perfect Design Brief: How to Manage Design for Strategic Advantage, 2nd edn. Allworth Press, New York (2012)
Keller, R.T.: Cross-functional project groups in research and new product development: diversity, communications, job stress, and outcomes. Acad. Manag. J. 44(3), 547–555 (2001)
Gilley, A., Dixon, P., Gilley, J.W.: Characteristics of leadership effectiveness: implementing change and driving innovation in organizations. Hum. Resour. Dev. Q. 19(2), 153–169 (2008)
Hoegl, M., Gemuenden, H.G.: Teamwork quality and the success of innovative projects: a theoretical concept and empirical evidence. Organ. Sci. 12(4), 435–449 (2001)
Haug, A., Stentoft Arlbjørn, J.: Barriers to master data quality. J. Enterp. Inf. Manag. 24(3), 288–303 (2011)
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This study was supported by the Department of Education of Guangdong Province (Grant 2020GXJK135 and Grant 2020KZDZX1136). The funding sources had no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript.
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Yang, F., Wang, L., Ding, X. (2022). Why Some “User-Centred” Medical Devices do not Provide Satisfactory User Experiences? An Investigation on User Information Factors in New Device Development Processes. In: Soares, M.M., Rosenzweig, E., Marcus, A. (eds) Design, User Experience, and Usability: UX Research, Design, and Assessment. HCII 2022. Lecture Notes in Computer Science, vol 13321. Springer, Cham. https://doi.org/10.1007/978-3-031-05897-4_22
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