Advancements in Open Source Medical Devices Enhance Access for Niche Patient Populations

The University of Twente has launched its inaugural open-source medical device compliant with European Medical Device Regulation (MDR): a 3D base plate designed for medical use. This initiative aims to provide an alternative pathway for low-risk medical devices that may not be commercially viable yet possess significant clinical value for specific patient demographics.

A prime example of such a device is the 3D footplate, which serves as a medical imaging tool for diagnosing complex hindfoot pathologies. This device, categorized as a Class I Medical Device, facilitates the accurate positioning of the foot in relation to the lower leg, enabling the simulation of clinical stress tests during CT imaging. The resulting images yield quantitative data, such as relative bone movements, which play a crucial role in diagnosing conditions and planning surgical interventions.

Typically utilized in academic medical centers, including the Amsterdam UMC and Maastricht UMC, the 3D footplate faces challenges in achieving profitability due to its narrow market appeal. Traditional business models struggle to support such specialized devices, resulting in many innovations failing to reach potential users.

To address this issue, the University of Twente has developed the 3D base plate using a 'Design for Assembly' methodology. The resulting prototype resembles an IKEA product, featuring easy-to-manufacture components made through laser cutting and 3D printing technologies. This design approach minimizes production costs and simplifies assembly processes.

Additionally, the university has prepared comprehensive MDR documentation using established templates, including a risk assessment, risk mitigation strategies, evaluation tests, an assembly manual, and the technical file. This complete package, which includes a bill of materials and technical drawings, is made available through an open-source platform. Medical institutions can utilize this documentation to produce the base plate at cost-effective prices and tailor it to their quality management systems.

The introduction of the 3D base plate marks the beginning of the University of Twente's commitment to open-source medical devices, with plans for future developments already underway. The Biomedical Device Design & Production chair is actively exploring additional cases and expanding its design strategy for Class I Medical Devices. By offering these tools as open-source, the initiative enhances accessibility within the Netherlands and promotes collaborative efforts across low- and middle-income countries, ultimately contributing to global healthcare improvements.