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ORIGINAL RESEARCH article

Front. Digit. Health
Sec. Health Technology Implementation
Volume 6 - 2024 | doi: 10.3389/fdgth.2024.1403457

On the design and development of a handheld electrocardiogram device in a clinical setting

Provisionally accepted
ALEJANDRA Zepeda-Echavarria ALEJANDRA Zepeda-Echavarria 1*Niek C. Ratering Arntz Niek C. Ratering Arntz 1*Albert H. Westra Albert H. Westra 1*Leonard J. Van Schelven Leonard J. Van Schelven 1Froukje E. Euwe Froukje E. Euwe 1*Herke Jan Noordmans Herke Jan Noordmans 1Melle Vessies Melle Vessies 2*Rutger R. Van De Leur Rutger R. Van De Leur 2*Rutger J. Hassink Rutger J. Hassink 3*Thierry X. Wildbergh Thierry X. Wildbergh 4Rien Van Der Zee Rien Van Der Zee 5*Pieter A. Doevendans Pieter A. Doevendans 2René van Es René van Es 2*Joris E. Jaspers Joris E. Jaspers 1*
  • 1 Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht, Netherlands
  • 2 Department of Cardiology, University Medical Center Utrecht, Utrecht, Netherlands, Netherlands
  • 3 Department of Cardiology, Utrecht Central Museum, Utrecht, Netherlands, Netherlands
  • 4 Department of Cardiology, Meander Medisch Centrum, Amersfoort, Netherlands
  • 5 Other, Delft, Netherlands

The final, formatted version of the article will be published soon.

    Cardiovascular diseases (CVDs) are a global burden that requires attention. For the detection and diagnosis of CVDs, the 12-lead ECG is a key tool. With technological advancements, ECG devices are becoming smaller and available for home use. Most of these devices contain a limited number of leads and are aimed to detect atrial fibrillation (AF). To investigate whether a 4-electrode arrangement could provide enough information to diagnose other CVDs, further research is necessary. At the University Medical Center Utrecht in a multidisciplinary team, we developed the miniECG, a four-electrode ECG handheld system for scientific research in clinical environments (TRL6). This paper describes the process followed during the development of the miniECG. From assembling a multidisciplinary team, which includes engineers, cardiologists, and clinical physicians to the contribution of team members in the design input, design, and testing for safety and functionality of the device. Finally, we detail how the development process was composed by iterative design steps based on user input and intended use evolution.The miniECG is a device compliant for scientific research with patients within Dutch Medical Centers. We believe that hospital-based development led to a streamlined process, which could be applied for the design and development of other technologies used for scientific research in clinical environments.

    Keywords: Mobile ECG, Clinical scientific research, wearables, Design and development, TRL

    Received: 19 Mar 2024; Accepted: 17 Jul 2024.

    Copyright: © 2024 Zepeda-Echavarria, Ratering Arntz, Westra, Van Schelven, Euwe, Noordmans, Vessies, Van De Leur, Hassink, Wildbergh, Van Der Zee, Doevendans, van Es and Jaspers. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    ALEJANDRA Zepeda-Echavarria, Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht, Netherlands
    Niek C. Ratering Arntz, Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht, Netherlands
    Albert H. Westra, Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht, Netherlands
    Froukje E. Euwe, Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht, Netherlands
    Melle Vessies, Department of Cardiology, University Medical Center Utrecht, Utrecht, 3584, Netherlands, Netherlands
    Rutger R. Van De Leur, Department of Cardiology, University Medical Center Utrecht, Utrecht, 3584, Netherlands, Netherlands
    Rutger J. Hassink, Department of Cardiology, Utrecht Central Museum, Utrecht, 3512, Netherlands, Netherlands
    Rien Van Der Zee, Other, Delft, Netherlands
    René van Es, Department of Cardiology, University Medical Center Utrecht, Utrecht, 3584, Netherlands, Netherlands
    Joris E. Jaspers, Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht, Netherlands

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.