Usability Assessment of an Intraoperative Planning Software

Federico Sternini, Giuseppe Isu, Giada Iannizzi, Diego Manfrin, Noemi Stuppia, Noemi Stuppia, Federica Rusinà, Alice Ravizza

2021

Abstract

Usability is a crucial aspect of medical device safety. The brand-new European Regulation requires the manufacturer to assess the usability of the new medical devices. In this study, we evaluate the usability of a new medical device intended to assist the intraoperative planning with the visualization of 3d patient-specific organ models. The usability study started from the early stage of the device design and iterated through an early formative, completed with desk-based activities, late formative, completed with a focus group, and summative phase, that comprised a user test, and questionnaire filling. The identified usability issues are mitigated, the safety of the device user interface is confirmed and the training contents are defined and confirmed. Additional information regarding the user experience is collected and analyzed to identify further improvements of the device.

Paper Citation

in Harvard Style

Sternini F., Isu G., Iannizzi G., Manfrin D., Stuppia N., Rusinà F. and Ravizza A. (2021). Usability Assessment of an Intraoperative Planning Software. In Proceedings of the 14th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2021) - Volume 5: HEALTHINF; ISBN 978-989-758-490-9, SciTePress, pages 483-492. DOI: 10.5220/0010252904830492

in Bibtex Style

@conference{healthinf21,
author={Federico Sternini and Giuseppe Isu and Giada Iannizzi and Diego Manfrin and Noemi Stuppia and Federica Rusinà and Alice Ravizza},
title={Usability Assessment of an Intraoperative Planning Software},
booktitle={Proceedings of the 14th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2021) - Volume 5: HEALTHINF},
year={2021},
pages={483-492},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0010252904830492},
isbn={978-989-758-490-9},
}

in EndNote Style

TY - CONF

JO - Proceedings of the 14th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2021) - Volume 5: HEALTHINF
TI - Usability Assessment of an Intraoperative Planning Software
SN - 978-989-758-490-9
AU - Sternini F.
AU - Isu G.
AU - Iannizzi G.
AU - Manfrin D.
AU - Stuppia N.
AU - Rusinà F.
AU - Ravizza A.
PY - 2021
SP - 483
EP - 492
DO - 10.5220/0010252904830492
PB - SciTePress