Open Source Medical Devices

Abstract

To accelerate the pathway to affordable and quality healthcare for all, this thesis aimed at defining and exploring the added value and the limits of a new design paradigm related to the Open Source Medical Devices (OSMDs). The design methodology, the key enabling technologies and the legislative framework for their deployment to healthcare providers and patients were identified. The thesis contributed to the definition and implementation of the UBORA Platform, an e-platform for open-source co-design of new solutions to face the current and future global healthcare challenges. Through the platform, the author designed several needs-based medical technologies, starting from on-field surveys carried out in this thesis: Palpreast, an innovative wearable device for breast self-examination, based on textile sensors; affordable 3D printed adsorption columns as spare parts for oxygen concentrators. Results demonstrated the OSMD design, empowered by the framework proposed in UBORA, is a valid approach in the design of safe, effective medical and needs-based medical technologies.