Towards Open Source Medical Devices. Current Situation, Inspiring Advances and Challenges

Open Source Medical Devices may be part of the solution towards the democratization of medical technologies pursuing Universal Health Coverage as part of the Sustainable Development Goals for United Nations. Recent technological advances, especially in information and communication technologies, combined with innovative collaborative design methodologies and manufacturing techniques allow for the mass-personalization of biodevices and help to optimize the related development times and costs, while keeping safety in the foreground through the whole life cycle of medical products. These advantages can be further promoted by adequately fostering collaboration, communication, high value information exchange, and sustainable partnerships and by extending the employment of open source strategies. To this end, within the UBORA project, we are developing a framework for training the biomedical engineers of the future in open-source collaborative design strategies and for supporting the sharing of information and the assessment of safety and efficacy in novel biodevices. An essential part of this open-source collaborative framework is the UBORA e-infrastructure, which is presented in this study, together with some initial success cases. Main future challenges, connected with regulatory harmonization, with educational issues and with accessible and open design and manufacturing resources, among others, are also presented and discussed