Open-Source Approach for Medical Devices without Business Case : Offering the 3D Foot Plate Open Source and Expert Opinion on MDR Compliance for Open-Source Medical Devices

Medical devices developed for small patient populations, or only used in complex clinical cases and research settings, can be commercially non-viable. To ensure that also small patient populations can benefit from medical devices, these medical devices could be offered as Open-Source Medical Device (OSMD). Like all medical devices in the EU, OSMDs must comply with the Medical Device Regulation (MDR) to ensure patient safety. This project aimed to explore possibilities of offering Class I medical devices, by making an inventory of suitable open-source platforms, working out a complete case including all relevant documentation in accordance with the MDR, and assessing expert opinions on this approach via interviews and focus groups. The results yield: (1) an advice on which open-source platform is the most suitable for offering OSMDs, (2) a medical device, called 3D Foot Plate, that can be manufactured with off-the-shelf components using common household tools and accessible manufacturing methods, while providing all documentation necessary to comply with the MDR and (3) an analysis of expert opinions on regulatory routes for offering OSMDs. This project could be considered a showcase of how to offer open-source medical devices that comply with the MDR.