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Tailor-Made Design Guidelines for Human Factors and Usability for Medical Device Application: A Proposed Methodology

Part of: Design for Healthcare

Published online by Cambridge University Press:  26 July 2019

Kamya Nagarajan  and
Arlindo Silva

Abstract

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With increasing level of advancement and complexity in medical devices, there is a need for methodology, tools and techniques in practice to integrate Human Factors and Usability (HF/U) elements in design due to its increasing diversity of users and rapidly changing interface types. This paper proposes a methodology to develop a tailor-made HF/U design guidelines for medical device development with various sources and to develop heuristics for evaluation and score the product usability throughout the development process.

Keywords

User centred designDesign methodologyEvaluationEarly design phases
Type
Article
Information
Proceedings of the Design Society: International Conference on Engineering Design , Volume 1 , Issue 1 , July 2019 , pp. 995 - 1004
Creative Commons
Creative Common License - CCCreative Common License - BYCreative Common License - NCCreative Common License - ND
This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work.
Copyright
© The Author(s) 2019

References

Adamides, G., Christou, G., Christos, K., Michalis, X. and Hadzilacos, T. (2015), “Usability Guidelines for the Design of Robot Teleoperation: A Taxonomy”. IEEE Transactions On Human-Machine Systems, Vol. 45 No. 2, pp. 256–262. http://doi.org/10.1109/THMS.2014.2371048Google Scholar
Albert, W. and Tullis, T. (2013), “Measuring User Experience”, Morgan Kaufmann, May 23, 2013. Vol. 2 No. 1, pp. 123–130, Sage Publication. http://doi.org/10.1177/2327857913021024Google Scholar
Colle, H.A. and Hiszem, K.J. (2004), “Standing at a kiosk: Effects of key size and spacing on touch screen numeric keypad performance and user preference”. Ergonomics, Vol. 47 No. 13, pp. 1406–1423. http://doi.org/10.1080/00140130410001724228Google Scholar
Cantamessa, M., Montagna, F. and Cascini, G. (2016), “Design for innovation – A methodology to engineer the innovation diffusion into the development process”, Computers in Industry, Vol. 75, pp. 46–57. http://doi.org/10.1016/j.compind.2015.10.013Google Scholar
Ensign, L.G. and Cohen, K.B. (2017), “A Primer to the Structure, Content and Linkage of the FDA's Manufacturer and User Facility Device Experience (MAUDE) Files”. eGEMs (Generating Evidence & Methods to improve patient outcomes), Vol. 5 No. 1, p. 12. http://doi.org/10.5334/egems.221Google Scholar
Flewwelling, C.J, Easty, A.C., Vincente, K.J. and Cafazzo, J.A. (2014), “The use of fault reporting of medical equipment to identify latent design flaws”. Journal of Biomedical Informatics, Vol. 51, pp. 80–85. http://doi.org/10.1016/j.jbi.2014.04.009Google Scholar
Foster, B.L., Branaghan, R.J, Barker, D., Conahue, J. and Rundus, M.D. (2017), “What can medical device human factors learn from other industries?”, In proceedings of International Symposium on Human Factors and Ergonomics in Health Care, Vol. 6 No. 1, pp. 183–184.Google Scholar
Gummussoy, C.A. (2016), “Usability Guideline for Banking Software design”, Computers in Human Behaviour. Vol. 62, pp. 277–285. http://doi.org/10.1016/j.chb.2016.04.001Google Scholar
Hoehle, Hartmut; Aljafari, Ruba and Venkatesh, Viswanath (2016), “Leveraging Microsoft's mobile usability guidelines: Conceptualizing and developing scales for mobile application usability”, International Journal of Human Computer Studies, Vol. 89, pp. 35–53. http://doi.org/10.1016/j.ijhcs.2016.02.001.Google Scholar
Hwangbo, H., Yoon, S.H., Jun, B.S., Jin, Y.S. and Ji, Y.G., “A Study of Pointing Performance of Elderly Users on Smartphones”, International Journal of Human-Computer Interaction, Vol. 29 No. 9, pp. 604–618. http://doi.org/10.1080/10447318.2012.729996Google Scholar
Jin, Z.X., Ploucher, T. and Kiff, l. (2007), “Touch Screen User Interfaces for Older Adults: Button Size and Spacing”. In Proceedings of International Conference on Universal Access in Human-Computer Interaction, pp. 933–941. http://doi.org/10.1007/978-3-540-73279-2_104Google Scholar
Jones, J., Bubric, K., Biesbroek, S. and Laberge, J. (2018), “Human Factors Guidelines for the Design of Mobile Medical Environments”. Ergonomics in Design: The Quarterly of Human Factors Applications, Vol. 26 No. 3, pp. 9–16. http://doi.org/10.1177/1064804617744975Google Scholar
Kim, H., Kwon, S., Heo, J. and Chung, M.K. (2014), “The effect of touch-key size on the usability of In-Vehicle Information Systems and driving safety during simulated driving”, Applied Ergonomics. Vol. 45 No. 3, pp. 379–388. http://doi.org/10.1016/j.apergo.2013.05.006Google Scholar
Kim, J.M., Ishibashi, K. and Iwanaga, K. (2012), “Effect of Sizing and Spacing of Touchscreen Buttons of Performance on Number input Task: Comparison Between Younger and Older Adults” The Science of Design, Bulletin of JSSD, Vol. 59 No. 4, pp. 39–44.Google Scholar
Kuijk, J. v, Heimrich, K., Christiaans, H. and Daan, v. E. (2007), “Usability in Product Development Practice: After Sales Information as Feedback.”, In Proceeding of IASDR07, Hongkong, China.Google Scholar
Martin, J.L., Norris, B.J., Murphy, E. and Crowe, J.A. (2008), “Medical Device Development: The challenge for Ergonomics”. Applied Ergonomics. Vol. 30, pp. 271–283. http://doi.org/10.1016/j.apergo.2007.10.002.Google Scholar
MAUDE FDA database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm, Seen on 5 November 2018.Google Scholar
Norman, D. (1996), “Design as Practiced”. Bringing Design to Software. Winograd, T., New York, USA, ACM Press.Google Scholar
Ouden, E.d. (2005), “Development of a Design Analysis Model for Consumer Complaints, Department of Technology Management”, Section Product ND Process Quality. Eindhoven Technical University. PhD p. 165.Google Scholar
Quinones, D. and Rusu, C. (2016), “How to develop usability heuristics: A systematic literature review”. Computer Standards & Interfaces. Vol. 53, pp. 89–122. http://doi.org/10.1016/j.csi.2017.03.009.Google Scholar
Sauro, J. and Kindlund, E. (2005), “A Method to Standardize Usability Metrics into a Single score”, Proceedings of SIGCHI Conference on Human Factors in Computing systems, pp 401–409. http://doi.org/10.1145/1054972.1055028Google Scholar
Shah, S.G.S. and Robinson, I. (2007), “Benefits of and barriers to involving users in medical device technology development and evaluation”. International Journal of Technology Assessment in Health Care, Vol. 23 No. 1, pp. 131–137. http://doi.org/10.1017/S026646230705167.Google Scholar
Shrestha, S., Abdinnour-Helm, S. and Chaparro, B.S. (2008), “Using the Analytic Hierarchical Process to Create a Single Usability Score for Website Interfaces”, Proceedings of the Human Factors and Ergonomics Society Annual Meeting, Vol. 52 No. 16, pp. 1122–1126. http://doi.org/10.1177/154193120805201605.Google Scholar
Shorrock, T.S. and Williams, A.C. (2016), “Human Factors and Ergonomics methods in practice: Three fundamental constraints”. Theoretical issues in Ergonomics Science, Vol. 17 No. 5–6, pp. 468–482. http://doi.org/10.1080/1463922X.2016.1193352Google Scholar
Sun, X., Ploucher, T. and Qu, W. (2007), “An empirical study on the smallest Comfortable Button/Icon size on Touchscreen”. Lecture Notes in Computer Science (including Subseries Lecture Notes in Artificial Intelligence and Lecture Notes in Bioinformatics), Vol. 4559 No. 1, pp. 615–621.Google Scholar
Tao, D., Yuan, J., Liu, Shuang and Qu, X., “Effect of Button Design Characteristics on performance and perceptions of Touchscreen Use”. International Journal of Industrial Ergonomics, Vol. 64. pp. 59–68. http://doi.org/10.1016/j.ergon.2017.12.001Google Scholar
Vincent, C. and Blandford, A. (2011), “Designing for Safety and Usability: User centred Techniques in Medical Device Design Practice”. In Proceedings of Human Factors and Ergonomics Society. http://doi.org/10.1177/1071181311551164.Google Scholar
Wixon, D. (2003), “Evaluating usability methods: why the current literature fails the practitioner”. Interactions, Vol. 10 No. 4, pp. 28–34. http://doi.org/10.1145/838830.838870Google Scholar