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Optimal Usability Test Procedure Generation for Medical Devices.

Jeehoon Shin1, Hyuk Lee2

  • 1College of Informatics, Korea University, Seoul 02841, Republic of Korea.

Healthcare (Basel, Switzerland)
|February 11, 2023
PubMed
Summary

This study introduces a systematic method for designing medical device usability test procedures, reducing costs and time. Applying this to a sinus surgical navigation system cut testing time by 21%.

Keywords:
medical devicetest proceduretesting costusability testvalidation

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Area of Science:

  • Medical device engineering
  • Human-computer interaction
  • Healthcare safety

Background:

  • Medical device usability testing is crucial for user safety and error identification.
  • Mandatory usability testing increases manufacturer costs, highlighting the need for efficient procedures.
  • Current guidelines for designing high-quality usability test procedures are insufficient.

Purpose of the Study:

  • To propose a systematic method for designing and implementing effective usability test procedures.
  • To introduce cost- and time-saving strategies within the usability testing framework.
  • To validate the proposed method by applying it to a specific medical device.

Main Methods:

  • Development of a systematic procedure for usability test design.
  • Integration of methods to reduce testing time and associated costs.
  • Application and evaluation of the proposed procedure using a sinus surgical navigation system.

Main Results:

  • A structured approach to usability test procedure design was successfully developed.
  • The implemented methods led to a significant reduction in overall testing duration.
  • A 21% reduction in total time was achieved for the sinus surgical navigation system's usability test compared to previous methods.

Conclusions:

  • The proposed systematic method effectively streamlines medical device usability testing.
  • This approach offers a viable solution to mitigate the increasing cost burden of mandatory usability evaluations.
  • The findings demonstrate the practical benefits of optimized usability test procedures in reducing development time and resources.