Co-design open-source medical devices: how to minimize the human error using UBORA e-infrastructure*

In the complex context of the medical device industry and healthcare systems, the reduction in cost may increase access to medical technologies moving towards global health equity. This paper is focused on the description of UBORA, an e-infrastructure based on a new concept of biomedical engineering which promotes the open-source approach for co-designing medical devices, fostering innovative ideas, needs-based, low-cost and safe technology. UBORA structures the entire design process using EN ISO 13485:2016, standard related to medical technology for inspiration. As a proof of concept, this paper shows an example of the development of an open source medical device for hand rehabilitation, designed using UBORA. We demonstrate the straightforward pathway to gather information on safety requirements. Finally, we describe a usability test of the e-infrastructure performed during the 4 th WHO Global Forum on Medical Devices in India.