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Published on: December 11, 2019
On the design and development of a handheld electrocardiogram device in a clinical setting
Alejandra Zepeda-Echavarria1, Niek C M Ratering Arntz1, Albert H Westra1
1Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
Insights
Researchers developed the miniECG, a four-electrode device, to explore if limited leads can diagnose cardiovascular diseases (CVDs) beyond atrial fibrillation (AF). This hospital-based development streamlines clinical research technology creation.
Area of Science:
- Biomedical Engineering
- Cardiology
- Medical Device Development
Background:
- Cardiovascular diseases (CVDs) represent a significant global health challenge.
- Electrocardiography (ECG), particularly the 12-lead system, is crucial for CVD detection and diagnosis.
- Advancements in portable ECG technology, often limited to atrial fibrillation (AF) detection, necessitate further investigation into broader diagnostic capabilities.
Purpose of the Study:
- To assess the diagnostic potential of a four-electrode ECG system for various cardiovascular diseases (CVDs).
- To describe the development process of the miniECG, a novel four-electrode handheld ECG system for clinical research.
Main Methods:
- Assembled a multidisciplinary team of engineers, cardiologists, and clinical physicians.
- Engaged in iterative design, incorporating user input and evolving intended use.
- Ensured device safety and functionality through rigorous testing within a clinical research context (TRL6).
Main Results:
- Successfully developed the miniECG, a four-electrode handheld ECG system compliant for scientific research.
- Demonstrated a hospital-based development approach facilitating a streamlined process for clinical research technology.
Conclusions:
- The miniECG system shows potential for broader CVD diagnosis beyond AF using a limited electrode configuration.
- The described hospital-led, multidisciplinary development model can accelerate the creation of other clinical research technologies.
Abstract:
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 four-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.
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