Skip to main content

Abstract

This chapter introduces methods and considerations for evaluating the usability of medical devices. It divides evaluation methods broadly into usability inspection methods and usability testing methods. Inspection methods are similar to editing a user interface or conducting a design review. Usability testing methods ask real potential users to conduct real tasks with a device or with a prototype. Along the way, researchers keep track of participants’ success rate, error rate, time on task, and other human-product performance measures. This chapter discusses exactly how and when to use each method, and provides guidance on how to get the most out of your activities.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 64.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 84.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 119.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  • Brooke, J. (1996). SUS: A “quick and dirty usability”. Usability Evaluation in Industry, 189.

    Google Scholar 

  • Brooke, J. (2013). SUS: A retrospective. Journal of Usability Studies, 8(2), 29–40.

    Google Scholar 

  • Faulkner, L. (2003). Beyond the five-user assumption: Benefits of increased sample sizes in usability testing. Behavior Research Methods, Instruments, & Computers, 35(3), 379–383.

    Article  Google Scholar 

  • Gao, M. (2019). Multi-cultural usability assessment with system usability scale. Doctoral dissertation, Rice University.

    Google Scholar 

  • Gould, J. D., & Lewis, C. (1985). Designing for usability: Key principles and what designers think. Communications of the ACM, 28(3), 300–311.

    Article  Google Scholar 

  • Hildebrand, E. A., Branaghan, R. J., Wu, Q., Jolly, J., Garland, T. B., Taggart, M., et al. (2010, September). Exploring human factors in endoscope reprocessing. In Proceedings of the human factors and ergonomics society annual meeting (Vol. 54, No. 12, pp. 894–898). Sage, CA/Los Angeles, CA: SAGE Publications.

    Google Scholar 

  • Hudson, W. (2001, May/June). How many users does it take to change a website? SIGCHI Bulletin.

    Google Scholar 

  • Jaccard, C. R. (1956). Objectives and philosophy of public affairs education (No. 761-2016-51596, pp. 12–18).

    Google Scholar 

  • Kortum, P. (2016). Usability assessment: How to measure the usability of products, services, and systems. USA: Human Factors and Ergonomics Society.

    Google Scholar 

  • Macefield, R. (2009). How to specify the participant group size for usability studies: A practitioner’s guide. Journal of Usability Studies, 5(1), 34–45.

    Google Scholar 

  • Nielsen, J. (1994). Heuristic evaluation, w: J. Nielsen and R. L. Mack (Eds.), Usability inspection methods.

    Google Scholar 

  • Nielsen, J., & Landauer, T. K. (1993). A mathematical model of the finding of usability problems. In Proceedings of the INTERACT’93 and CHI’93 conference on Human factors in computing systems (pp. 206–213).

    Google Scholar 

  • Nielsen, J., & Molich, R. (1990). Heuristic evaluation of user interfaces. In: Proceedings of ACM CHI’90 (pp. 249–256).

    Google Scholar 

  • Perfetti, C. (2001, June). Eight is not enough. Retrieved August 23, 2020 from https://articles.uie.com/eight_is_not_enough/.

  • Polson, P. G., Lewis, C., Rieman, J., & Wharton, C. (1992). Cognitive walkthroughs: A method for theory-based evaluation of user interfaces. International Journal of Man-Machine Studies, 36(5), 741–773.

    Article  Google Scholar 

  • Rubin, J., & Chisnell, D. (2008). Handbook of usability testing: How to plan, design, and conduct effective tests. Indianapolis, IN: Wiley.

    Google Scholar 

  • Sharfina, Z., & Santoso, H. B. (2016, October). An Indonesian adaptation of the system usability scale (SUS). In 2016 International Conference on Advanced Computer Science and Information Systems (ICACSIS) (pp. 145–148). Washington, DC: IEEE.

    Chapter  Google Scholar 

  • Shneiderman, B. (1998). Designing the user interface (3rd ed.). Boston: Addison-Wesley.

    Google Scholar 

  • Spool, J., & Schroeder, W. (2001). Testing web sites: Five users is nowhere near enough in CHI 20 Extended Abstracts (pp. 285–286). New York: ACM Press.

    Google Scholar 

  • U.S. Food and Drug Administration. (2016). Applying human factors and usability engineering to medical devices: Guidance for industry and Food and Drug Administration staff. Washington, DC: U.S. Department of Health and Human Services Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation.

    Google Scholar 

  • Van Der Sluis, P. C., Ruurda, J. P., van der Horst, S., Goense, L., & van Hillegersberg, R. (2018). Learning curve for robot-assisted minimally invasive thoracoscopic esophagectomy: Results from 312 cases. The Annals of Thoracic Surgery, 106(1), 264–271.

    Article  Google Scholar 

  • Virzi, R. A. (1992). Refining the test phase of usability evaluation: How many subjects is enough? Human Factors, 34(4), 457–468.

    Article  Google Scholar 

  • Wiklund, P. E., Michael, E., Kendler, J., & Strochlic, A. Y. (2011). Usability testing of medical devices. Boca Raton, FL: CRC Press.

    Google Scholar 

  • Wharton, C., Rieman, J., Lewis, C., & Polson, P. (1994). The cognitive walkthrough method: A practitioner’s guide. In Usability inspection methods (pp. 105–140).

    Google Scholar 

  • Zhang, J., Johnson, T. R., Patel, V. L., Paige, D. L., & Kubose, T. (2003). Using usability heuristics to evaluate patient safety of medical devices. Journal of Biomedical Informatics, 36(1–2), 23–30.

    Article  Google Scholar 

  • Zorn, K. C., Gautam, G., Shalhav, A. L., Clayman, R. V., Ahlering, T. E., Albala, D. M., et al. (2009). Training, credentialing, proctoring and medicolegal risks of robotic urological surgery: Recommendations of the society of urologic robotic surgeons. The Journal of Urology, 182(3), 1126–1132.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Resources

Resources

  • Kortum, P. (2016). Usability assessment: How to measure the usability of products, services, and systems. USA: Human Factors and Ergonomics Society.

  • Nielsen, J. (1994, April). Usability inspection methods. In Conference companion on human factors in computing systems (pp. 413–414).

  • Rubin, J., & Chisnell, D. (2008). Handbook of usability testing: How to plan, design and conduct effective tests. Indianapolis, IN: Wiley.

  • Wiklund, M. E., & Wilcox, S. B. (2005). Designing usability into medical products. Boca Raton, FL: CRC Press.

  • Wiklund, M., Kendler, J., & Strochlic, A. Y. (2015). Usability testing of medical devices. Boca Raton, FL: CRC Press.

Rights and permissions

Reprints and permissions

Copyright information

© 2021 Springer Nature Switzerland AG

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Branaghan, R.J., O’Brian, J.S., Hildebrand, E.A., Foster, L.B. (2021). Usability Evaluation. In: Humanizing Healthcare – Human Factors for Medical Device Design. Springer, Cham. https://doi.org/10.1007/978-3-030-64433-8_4

Download citation

  • DOI: https://doi.org/10.1007/978-3-030-64433-8_4

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-030-64432-1

  • Online ISBN: 978-3-030-64433-8

  • eBook Packages: EngineeringEngineering (R0)

Publish with us

Policies and ethics