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Exploring the Variability of Human Factors and Usability Testing Methods for Evaluating Medical Devices - Preliminary Results

Published: 21 September 2023 Publication History

Abstract

The success of a medical device is based on its ability to be deployed according to its use specification to safely achieve the intended outcome. Central to this is the design of the device which, if poorly executed, contributes to ‘use error’ which affects the efficacy, safety, and user experience of a medical device. Human factors guidance provides recommendations to evaluate the user experience in a bid to improve design efforts and ultimately the safety and usability of medical devices. The heterogeneity of the industry means that the interpretation of these guidelines is subjective and adapted differently to suit the use specification of the devices. The aim of this study is to explore the perceptions of medical device industry professionals on factors influencing the evaluation of the user experience in the design of medical devices. A bespoke survey approach is currently being undertaken to achieve this objective and to interrogate the key issues. There is a lack of substantial evidence in the literature that indicates which user experience testing methods are most favoured and widely used in practice, across all stages of device development from concept to post-sales testing. This study is designed to shed light on industry practices; the variability of user experience testing methods of medical devices, as well as the preferred methods, and the aspects of user experience considered in medical device design.

References

[1]
O. V. Bitkina, H. K. Kim, and J. Park, “Usability and user experience of medical devices: An overview of the current state, analysis methodologies, and future challenges,” Int J Ind Ergon, vol. 76, p. 102932, Mar. 2020.
[2]
V. Hegde, “Role of human factors / usability engineering in medical device design,” in 2013 Proceedings Annual Reliability and Maintainability Symposium (RAMS), IEEE, Jan. 2013, pp. 1–5.
[3]
MHRA, “Guidance on applying human factors and usability engineering to medical devices including drug-device combination products in Great Britain,” 2021, Accessed: Oct. 29, 2021. [Online]. Available: http://www.nationalarchives.gov.uk/doc/open-government-licence/
[4]
M. Shaheen, T. Anees, M. J. Anjum, and A. Anum, “Usability Engineering Process for Medical Devices,” in Advances in Intelligent Systems and Computing, Springer Science and Business Media Deutschland GmbH, 2021, pp. 365–381.
[5]
IEC, “IEC 62366-1:2015(en), Medical devices — Part 1: Application of usability engineering to medical devices.” https://www.iso.org/obp/ui/#iso:std:iec:62366:-1:ed-1:v1:en (accessed Jan. 05, 2022).
[6]
J. U. Ocampo and P. C. Kaminski, “Medical device development, from technical design to integrated product development,” J Med Eng Technol, vol. 43, no. 5, pp. 287–304, Jul. 2019.
[7]
L. A. Medina, G. E. O. Kremer, and R. A. Wysk, “Supporting medical device development: a standard product design process model,” Journal of Engineering Design, vol. 24, no. 2, pp. 83–119, Feb. 2013.
[8]
A. G. Money, J. Barnett, J. Kuljis, M. P. Craven, J. L. Martin, and T. Young, “The role of the user within the medical device design and development process: Medical device manufacturers’ perspectives,” BMC Med Inform Decis Mak, vol. 11, no. 1, pp. 1–12, Feb. 2011.
[9]
M. Privitera, “Designing Industrial Design in the Highly Regulated Medical Device Development Process. Defining our valuable contribution towards usability,” The Design Journal, vol. 20, no. sup1, pp. S2190–S2206, Jul. 2017.
[10]
M. Tremblay, “Usability of a Co-designed eHealth Prototype for Caregivers: Combination Study of Three Frameworks,” JMIR Hum Factors 2021;8(3):e26532 https://humanfactors.jmir.org/2021/3/e26532, vol. 8, no. 3, p. e26532, Aug. 2021.
[11]
S. G. S. Shah and I. Robinson, “Medical device technologies: who is the user?,” International Journal of Healthcare Technology and Management, vol. 9, no. 2, p. 181, 2008.
[12]
C. Vincent and A. Blandford, “Designing for Safety and Usability: User-Centered Techniques in Medical Device Design Practice,” Proceedings of the Human Factors and Ergonomics Society Annual Meeting, vol. 55, no. 1, pp. 793–797, Sep. 2011.
[13]
M. S. G. Roma and E. de Vilhena Garcia, “Medical device usability: literature review, current status, and challenges,” Research on Biomedical Engineering, vol. 36, no. 2, pp. 163–170, Jun. 2020.
[14]
M. B. Weinger and D. M. Gaba, “Human Factors Engineering in Patient Safety,” Anesthesiology, vol. 120, no. 4, pp. 801–806, Apr. 2014.
[15]
C. Stephanidis, “Seven HCI Grand Challenges,” Int J Hum Comput Interact, vol. 35, no. 14, pp. 1229–1269, Aug. 2019.
[16]
M. F. Story, F. / Cdrh, and / Ode, “FDA Perspectives on Human Factors in Device Development Understanding Regulatory Requirements for Human Factors Usability Testing,” 2012.
[17]
J. R. Lewis, “Usability: Lessons Learned … and Yet to Be Learned,” Int J Hum Comput Interact, vol. 30, no. 9, pp. 663–684, Sep. 2014.
[18]
N. Bevan, “What is the difference between the purpose of usability and user experience evaluation methods?,” 2009, Accessed: Feb. 22, 2022. [Online]. Available: www.nigelbevan.com
[19]
K. Väänänen-Vainio-Mattila, V. Roto, and M. Hassenzahl, “Towards practical user experience evaluation methods,” Meaningful measures: Valid useful user experience measurement (VUUM), pp. 19–22, 2008, Accessed: May 21, 2022. [Online]. Available: https://www.academia.edu/download/30870165/523.pdf#page=21
[20]
E. L. C. Law, P. Van Schaik, and V. Roto, “Attitudes towards user experience (UX) measurement,” International Journal of Human Computer Studies, vol. 72, no. 6, pp. 526–541, 2014.
[21]
A. Walter, Designing for Emotion, vol. 53, no. 9. 2013.

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          ECCE '23: Proceedings of the European Conference on Cognitive Ergonomics 2023
          September 2023
          189 pages
          ISBN:9798400708756
          DOI:10.1145/3605655
          Permission to make digital or hard copies of part or all of this work for personal or classroom use is granted without fee provided that copies are not made or distributed for profit or commercial advantage and that copies bear this notice and the full citation on the first page. Copyrights for third-party components of this work must be honored. For all other uses, contact the Owner/Author.

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          Association for Computing Machinery

          New York, NY, United States

          Publication History

          Published: 21 September 2023

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          1. Human factors
          2. Medical devices
          3. UX research methods
          4. Usability testing

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          ECCE 2023
          ECCE 2023: European Conference in Cognitive Ergonomics
          September 19 - 22, 2023
          Swansea, United Kingdom

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