Design and 3D printing of a modular phantom of a uterus for medical device validation

Abstract

Purpose The purpose of this study is to describe the design and validation of a three-dimensional (3D)-printed phantom of a uterus to support the development of uterine balloon tamponade devices conceived to stop post-partum haemorrhages (PPHs). Design/methodology/approach The phantom 3D model is generated by analysing the main requirements for validating uterine balloon tamponade devices. A modular approach is implemented to guarantee that the phantom allows testing these devices under multiple working conditions. Once finalised the design, the phantom effectiveness is validated experimentally. Findings The modular phantom allows performing the required measurements for testing the performance of devices designed to stop PPH. Social implications PPH is the leading obstetric cause of maternal death worldwide, mainly in low- and middle-income countries. The proposed phantom could speed up and optimise the design and validation of devices for PPH treatment, reducing the maternal mortality ratio. Originality/value To the best of the authors’ knowledge, the 3D-printed phantom represents the first example of a modular, flexible and transparent uterus model. It can be used to validate and perform usability tests of medical devices.