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Remote Synchronous Usability Testing Yields Reliable Data for User-Centered Design Development of Physical Medical Devices

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Design in the Era of Industry 4.0, Volume 2 (ICORD 2023)

Abstract

Remote testing has been exploited in software development for several years. Until recently, virtual support in the design of physical tools and appliances has received much less attention. The years of pandemic travel restriction have created a completely novel set of requirements for usability testing, whereby the physical interaction between the experimenter and the end user has been no longer possible. In this frame, the host of new communication platforms that became available provided means for innovative protocols of remote synchronous interaction. Here, we successfully apply them for the testing of medical devices in the user-centered design development. The proposed protocol is validated along the development of a medical applicator tool, the SYMPLX, designed for the use in the operating room by cardiologists and cardiothoracic surgeons (the end users). The applicator is aimed at facilitating the combination of a protective pouch made of biosynthesized cellulose, the Hylomate, and a target pacemaker or defibrillator upon their implantation in cardiovascular patients. The testing with end user rendered a number of videos featuring a reproduced model of the operating room, where the clinical procedure was performed with the use of SYMPLX. The ensuing analysis extracted four quantitative descriptors of the performance, with sufficient reliability and reproducibility to evaluate design improvements, as well as user-related variability and learning process. Altogether, we describe and validate a new flexible and cost-effective protocol that can support the remote design of medical devices and has the potential to be optimized for other physical tools.

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Data Availability Statement

The raw data supporting the conclusions of this article are available in the Supplementary Material.

Ethics Statement

Ethical review and approval were not required for the study on human participants in accordance with the Local Legislation and Institutional Requirements. After the online studies, participants gave verbal consent to the video data generated in the online studies.

Author Contributions

NK, AF, BJ, and LS contributed to conception and design of the study. BJ and LS did part of the data collection. AF performed the statistical analysis. AF, BJ, and LS wrote the sections and first draft of the manuscript. AF and NK supervised the planning and execution process, provided resources for the data collection, and gave critical review and commentary on the draft of the manuscript. All authors contributed to manuscript revision, and read and approved the submitted version.

Funding

This work was funded by Innosuisse—Project number 53303.1_IP-LS.

Conflict of Interests

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Acknowledgements

We thank Prof. Dr. Med. Christoph Starck and his team at “Deutsches Herzzentrum” in Berlin for the collaboration and Dr. Med Timo Nazari, Dr. Med. Eulert-Grehn Jaime Jürgen, Julius Kaemmel and Vasileios Exarchos for the participation at the usabil-ity testings. A special thank goes to Julius Kaemmel that organized and distributed all the physical material for the usability testings in Berlin.

Supplementary Material

The Supplementary Material for this article can be found online at: https://drive.google.com/drive/folders/1q1HwgWGkP2rqrRRknemXJoAiRTgvHW5E?usp=sharing.

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Correspondence to Laurin Schaffner .

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Schaffner, L. et al. (2023). Remote Synchronous Usability Testing Yields Reliable Data for User-Centered Design Development of Physical Medical Devices. In: Chakrabarti, A., Singh, V. (eds) Design in the Era of Industry 4.0, Volume 2. ICORD 2023. Smart Innovation, Systems and Technologies, vol 342. Springer, Singapore. https://doi.org/10.1007/978-981-99-0264-4_22

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  • DOI: https://doi.org/10.1007/978-981-99-0264-4_22

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  • Publisher Name: Springer, Singapore

  • Print ISBN: 978-981-99-0263-7

  • Online ISBN: 978-981-99-0264-4

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