{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,13]],"date-time":"2026-02-13T12:18:39Z","timestamp":1770985119514,"version":"3.50.1"},"reference-count":40,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2024,8,9]],"date-time":"2024-08-09T00:00:00Z","timestamp":1723161600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Digit. Health"],"abstract":"<jats:p>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.<\/jats:p>","DOI":"10.3389\/fdgth.2024.1403457","type":"journal-article","created":{"date-parts":[[2024,8,9]],"date-time":"2024-08-09T05:17:50Z","timestamp":1723180670000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":2,"title":["On the design and development of a handheld electrocardiogram device in a clinical setting"],"prefix":"10.3389","volume":"6","author":[{"given":"Alejandra","family":"Zepeda-Echavarria","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Niek C. M.","family":"Ratering Arntz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Albert H.","family":"Westra","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Leonard J.","family":"van Schelven","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Froukje E.","family":"Euwe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Herke Jan","family":"Noordmans","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Melle","family":"Vessies","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rutger R.","family":"van de Leur","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rutger J.","family":"Hassink","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thierry X.","family":"Wildbergh","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rien","family":"van der Zee","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pieter A.","family":"Doevendans","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ren\u00e9","family":"van Es","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joris E. N.","family":"Jaspers","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1965","published-online":{"date-parts":[[2024,8,9]]},"reference":[{"key":"B1","article-title":"Cardiovascular diseases (CVDs) (cited May 30, 2024)","year":""},{"key":"B2","doi-asserted-by":"publisher","first-page":"2529","DOI":"10.1016\/j.jacc.2019.10.009","article-title":"The global burden of cardiovascular diseases and risk factors: 2020 and beyond","volume":"74","author":"Mensah","year":"2019","journal-title":"J Am Coll Cardiol"},{"key":"B3","doi-asserted-by":"publisher","first-page":"1333","DOI":"10.1056\/NEJMoa1406656","article-title":"Demographic and epidemiologic drivers of global cardiovascular mortality","volume":"372","author":"Roth","year":"2015","journal-title":"N Engl J Med"},{"key":"B4","doi-asserted-by":"publisher","first-page":"459","DOI":"10.2459\/JCM.0000000000000803","article-title":"The 12-lead ECG: a continuous reference for the cardiologist","volume":"20","author":"Boriani","year":"2019","journal-title":"Journal of Cardiovascular Medicine"},{"key":"B5","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1186\/s12913-017-2585-5","article-title":"What do we know about the needs and challenges of health systems? A scoping review of the international literature","volume":"17","author":"Roncarolo","year":"2017","journal-title":"BMC Health Serv Res"},{"key":"B6","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1186\/s12913-023-09917-3","article-title":"Successes and challenges towards improving quality of primary health care services: a scoping review","volume":"23","author":"Endalamaw","year":"2023","journal-title":"BMC Health Serv Res"},{"key":"B7","article-title":"Hart- en vaatziekten | Zorguitgaven | Volksgezondheid en Zorg","year":""},{"key":"B8","doi-asserted-by":"publisher","first-page":"E008833","DOI":"10.1161\/CIRCOUTCOMES.121.008833","article-title":"Trends in consumer wearable devices with cardiac sensors in a primary care cohort","volume":"15","author":"Al-Alusi","year":"2022","journal-title":"Circ Cardiovasc Qual Outcomes"},{"key":"B9","doi-asserted-by":"publisher","first-page":"889","DOI":"10.1016\/j.hrthm.2020.02.023","article-title":"Wearables in cardiology: here to stay","volume":"17","author":"Dagher","year":"2020","journal-title":"Heart Rhythm"},{"key":"B10","doi-asserted-by":"publisher","first-page":"67","DOI":"10.1007\/s40138-022-00248-x","article-title":"The use of wearable ECG devices in the clinical setting: a review","volume":"10","author":"Kamga","year":"2022","journal-title":"Curr Emerg Hosp Med Rep"},{"key":"B11","doi-asserted-by":"publisher","first-page":"149","DOI":"10.3389\/fphys.2015.00149","article-title":"Electrocardiographic patch devices and contemporary wireless cardiac monitoring","volume":"6","author":"Fung","year":"2015","journal-title":"Front Physiol"},{"key":"B12","doi-asserted-by":"publisher","first-page":"161","DOI":"10.1016\/j.jacc.2008.09.030","article-title":"Utilization and impact of Pre-hospital electrocardiograms for patients with acute ST-segment elevation myocardial infarction: data from the NCDR (national cardiovascular data registry) ACTION (acute coronary treatment and intervention outcomes network) registry","volume":"53","author":"Diercks","year":"2009","journal-title":"J Am Coll Cardiol"},{"key":"B13","doi-asserted-by":"publisher","first-page":"625","DOI":"10.1038\/s41551-018-0302-2","article-title":"Medical devices must be carefully validated","volume":"2","year":"2018","journal-title":"Nat Biomed Eng"},{"key":"B14","doi-asserted-by":"publisher","first-page":"402","DOI":"10.1093\/eurjcn\/zvaa031","article-title":"Instant electrocardiogram feedback with a new digital technique reduces symptoms caused by palpitations and increases health-related quality of life (the RedHeart study)","volume":"20","author":"Carnl\u00f6f","year":"2021","journal-title":"Eur J Cardiovasc Nurs"},{"key":"B15","doi-asserted-by":"publisher","first-page":"1582","DOI":"10.1016\/j.jacc.2020.01.046","article-title":"Wearable devices for ambulatory cardiac monitoring: jACC state-of-the-art review","volume":"75","author":"Sana","year":"2020","journal-title":"J Am Coll Cardiol"},{"key":"B16","doi-asserted-by":"publisher","first-page":"2539","DOI":"10.3390\/s21072539","article-title":"Smart wearables for cardiac monitoring\u2014real-world use beyond atrial fibrillation","volume":"21","author":"Duncker","year":"2021","journal-title":"Sensors"},{"key":"B17","doi-asserted-by":"publisher","first-page":"e44003","DOI":"10.2196\/44003","article-title":"Electrocardiogram devices for home use: technological and clinical scoping review","volume":"7","author":"Zepeda-Echavarria","year":"2023","journal-title":"JMIR Cardio"},{"key":"B18","doi-asserted-by":"publisher","first-page":"102","DOI":"10.1161\/CIRCEP.120.009260","article-title":"Accuracy of a smartwatch-derived ECG for diagnosing bradyarrhythmias, tachyarrhythmias, and cardiac ischemia","volume":"14","author":"Caillol","year":"2021","journal-title":"Circ Arrhythm Electrophysiol"},{"key":"B19","doi-asserted-by":"publisher","first-page":"278","DOI":"10.1016\/j.jelectrocard.2017.11.004","article-title":"Diagnostic accuracy of multi-lead ECGs obtained using a pocket-sized bipolar handheld event recorder","volume":"51","author":"Nigolian","year":"2018","journal-title":"J Electrocardiol"},{"key":"B20","doi-asserted-by":"publisher","first-page":"73","DOI":"10.1016\/0094-5765(89)90054-4","article-title":"The NASA technology push towards future space mission systems","volume":"20","author":"Sadin","year":"1989","journal-title":"Acta Astronaut"},{"key":"B21","doi-asserted-by":"publisher","first-page":"S67","DOI":"10.1016\/j.injury.2019.10.071","article-title":"Regulatory clearance: how are outcome measurements critical?","volume":"51","author":"Fink","year":"2020","journal-title":"Injury"},{"key":"B22","doi-asserted-by":"publisher","first-page":"404","DOI":"10.1007\/s00464-015-4263-1","article-title":"Current state of micro-robots\/devices as substitutes for screening colonoscopy: assessment based on technology readiness levels","volume":"30","author":"Tapia-Siles","year":"2016","journal-title":"Surg Endosc"},{"key":"B23","volume-title":"Device for Recording a Multi-Channel-ECG and a Method There for","author":"van der Zee","year":"2019"},{"key":"B24","volume-title":"ISO 14971:2019 Medical Devices \u2014 application of Risk Management to Medical Devices","year":"2019"},{"key":"B25","volume-title":"IEC 60601-1:2005 +AMD1:2012+AMD2:2020 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance","year":"2015"},{"key":"B26","volume-title":"IEC 60601-2-25:2011 Medical Electrical Eqipment - Part 2-25: Particular Requirements for the Basic Safety and Essential Performance and Electrocardiographs","year":"2011"},{"key":"B27","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1093\/ehjdh\/ztae002","article-title":"Detection of acute coronary occlusion with a novel mobile electrocardiogram device: a pilot study","author":"Zepeda-Echavarria","year":"2024","journal-title":"Eur Heart J Digit Health"},{"key":"B28","doi-asserted-by":"publisher","first-page":"100410","DOI":"10.1016\/j.jacadv.2023.100410","article-title":"Detection of ischemic ST-segment changes using a novel handheld ECG device in a porcine model","volume":"2","author":"de Vries","year":"2023","journal-title":"JACC Adv"},{"key":"B29","doi-asserted-by":"publisher","first-page":"3068","DOI":"10.1161\/01.CIR.0000134695.65733.64","article-title":"Medical device development","volume":"109","author":"Kaplan A","year":"2004","journal-title":"Circulation"},{"key":"B30","first-page":"1","volume-title":"ISO 13485:2016 Medical Devices Quality Management Systems Requirements for Regulatory Purposes","year":"2016"},{"key":"B31","article-title":"OJ. Regulation 2017\/745 of the European Parliament and of the conuncil of 5 April 2017 on medical devices, amending Directive 2001\/83\/EC, Regulation (EC) No 178\/2002 and Regulation (EC) No 1223\/2009 and repealing Council Directives 90\/385\/EEC and 93\/42\/EE","year":"2017"},{"key":"B32","doi-asserted-by":"publisher","first-page":"2578","DOI":"10.3390\/s23052578","article-title":"Medical devices with embedded sensor systems: design and development methodology for start-ups","volume":"23","author":"Arandia","year":"2023","journal-title":"Sensors"},{"key":"B33","doi-asserted-by":"crossref","DOI":"10.1109\/ICoDT255437.2022.9787446","article-title":"An enhanced agile-V model for system engineering in complex medical device development","author":"Khan","year":"2022"},{"key":"B34","doi-asserted-by":"publisher","first-page":"372","DOI":"10.3389\/fphys.2022.825918","article-title":"Can seismocardiogram fiducial points be used for the routine estimation of cardiac time intervals in cardiac patients?","volume":"13","author":"I\u015filay Zeybek","year":"2022","journal-title":"Front Physiol"},{"key":"B35","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1038\/s41598-017-07248-y","article-title":"Gyrocardiography: a new non-invasive monitoring method for the assessment of cardiac mechanics and the estimation of hemodynamic variables","volume":"7","author":"Jafari Tadi","year":"2017","journal-title":"Sci Rep"},{"key":"B36","doi-asserted-by":"crossref","DOI":"10.1007\/978-3-030-04462-6","volume-title":"FDA and Intellectual Property Strategies for Medical Device Technologies. FDA and Intellectual Property Strategies for Medical Device Technologies","author":"Halt","year":"2019"},{"key":"B37","doi-asserted-by":"publisher","first-page":"e46694","DOI":"10.2196\/46694","article-title":"iCHECK-DH: guidelines and checklist for the reporting on digital health implementations","volume":"25","author":"Perrin Franck","year":"2023","journal-title":"J Med Internet Res"},{"key":"B38","doi-asserted-by":"publisher","first-page":"5942","DOI":"10.1109\/JBHI.2022.3207947","article-title":"Cuffless blood pressure estimation during moderate- and heavy-intensity exercise using wearable ECG and PPG","volume":"26","author":"Landry","year":"2022","journal-title":"IEEE J Biomed Health Inform"},{"key":"B39","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1038\/s41598-018-33675-6","article-title":"Definition of fiducial points in the normal seismocardiogram","volume":"8","author":"S\u00f8rensen","year":"2018","journal-title":"Sci Rep"},{"key":"B40","doi-asserted-by":"publisher","first-page":"1130478","DOI":"10.3389\/fphys.2023.1130478","article-title":"Doppler radar remote sensing of respiratory function","volume":"14","author":"Ishrak","year":"2023","journal-title":"Front Physiol"}],"container-title":["Frontiers in Digital Health"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fdgth.2024.1403457\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,9]],"date-time":"2024-08-09T05:17:58Z","timestamp":1723180678000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fdgth.2024.1403457\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,8,9]]},"references-count":40,"alternative-id":["10.3389\/fdgth.2024.1403457"],"URL":"https:\/\/doi.org\/10.3389\/fdgth.2024.1403457","relation":{},"ISSN":["2673-253X"],"issn-type":[{"value":"2673-253X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,8,9]]},"article-number":"1403457"}}