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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- 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
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
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