2023
DOI: 10.2196/40463
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Iterative Development, Validation, and Certification of a Smartphone System to Assess Neonatal Jaundice: Development and Usability Study

Abstract: Background Medical device development is an area facing multiple challenges, resulting in a high number of products not reaching the clinical setting. Neonatal hyperbilirubinemia, manifesting as neonatal jaundice (NNJ), is an important cause of newborn morbidity and mortality. It is important to identify infants with neonatal hyperbilirubinemia at an early stage, but currently there is a lack of tools that are both accurate and affordable. Objective Thi… Show more

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Cited by 6 publications
(9 citation statements)
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“…Extensive evidence shows that multi-stakeholder engagement in the development and adaptation of mHealth systems is essential for successful scale-up and implementation (50)(51)(52). Picterus JP's development followed an iterative process in which end users tested the device on a dummy and on newborns and then offered feedback to optimise the system (17). The device has also been tested on newborns by 61 Dutch maternity nurses in their routine home visits to monitor NNJ in both urban and rural regions (unpublished results).…”
Section: Discussionmentioning
confidence: 99%
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“…Extensive evidence shows that multi-stakeholder engagement in the development and adaptation of mHealth systems is essential for successful scale-up and implementation (50)(51)(52). Picterus JP's development followed an iterative process in which end users tested the device on a dummy and on newborns and then offered feedback to optimise the system (17). The device has also been tested on newborns by 61 Dutch maternity nurses in their routine home visits to monitor NNJ in both urban and rural regions (unpublished results).…”
Section: Discussionmentioning
confidence: 99%
“…Picterus JP consists of a smartphone app to capture and upload images of the newborn's skin, a calibration card for accurate colour calibration in the images and a server for image analysis and storage (Fig. 1) (17). The app has undergone validation in Norwegian hospitals (17,18) and in pilot studies in Mexico and the Philippines (19,20), demonstrating signi cant positive correlation between Picterus JP's bilirubin values and TSB levels as well as higher accuracy over VA.…”
mentioning
confidence: 99%
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“…Picterus JP consists of a smartphone app to capture and upload images of the newborn’s skin, a calibration card for accurate colour calibration in the images and a server for image analysis and storage (Fig. 1 ) [ 17 ]. The app has undergone validation in Norwegian hospitals [ 17 , 18 ] and in pilot studies in Mexico and the Philippines [ 19 , 20 ], demonstrating significant positive correlation between Picterus JP ’s bilirubin values and TSB levels as well as higher accuracy over VA.…”
Section: Introductionmentioning
confidence: 99%
“…1 ) [ 17 ]. The app has undergone validation in Norwegian hospitals [ 17 , 18 ] and in pilot studies in Mexico and the Philippines [ 19 , 20 ], demonstrating significant positive correlation between Picterus JP ’s bilirubin values and TSB levels as well as higher accuracy over VA.…”
Section: Introductionmentioning
confidence: 99%