Zepeda-Echavarria Alejandra, Ratering Arntz Niek C M, Westra Albert H, van Schelven Leonard J, Euwe Froukje E, Noordmans Herke Jan, Vessies Melle, van de Leur Rutger R, Hassink Rutger J, Wildbergh Thierry X, van der Zee Rien, Doevendans Pieter A, van Es René, Jaspers Joris E N
Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
Department of Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
Front Digit Health. 2024 Aug 9;6:1403457. doi: 10.3389/fdgth.2024.1403457. eCollection 2024.
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.
心血管疾病（CVDs）是一项需要关注的全球负担。对于心血管疾病的检测和诊断，12导联心电图是一项关键工具。随着技术进步，心电图设备正变得越来越小且可供家庭使用。这些设备大多导联数量有限，旨在检测心房颤动（AF）。为了研究四电极配置是否能够提供足够信息来诊断其他心血管疾病，有必要进行进一步研究。在乌得勒支大学医学中心，我们组建了一个多学科团队，开发了用于临床环境科研的四电极心电图手持系统miniECG（技术就绪水平6）。本文描述了miniECG开发过程。从组建一个包括工程师、心脏病专家和临床医生的多学科团队，到团队成员在设备设计输入、设计以及安全性和功能性测试方面的贡献。最后，我们详细介绍了开发过程是如何基于用户输入和预期用途演变通过迭代设计步骤构成的。miniECG是一款符合荷兰医学中心内患者科研使用要求的设备。我们认为基于医院的开发带来了一个简化的过程，该过程可应用于临床环境中用于科研的其他技术的设计和开发。
