A Novel University Course on Medical Devices Design and Certification at the University of Siena

This paper details the innovative course offered at the University of Siena, focused on Medical Devices Design and Certification. The course integrates key components such as the European Union Medical Devices Regulation (MDR) and practical design strategies tailored for the healthcare sector. Students gain a deep understanding of risk management and the importance of aligning design with the context of use, ensuring devices are both safe and effective. Human factors engineering is emphasized to optimize user-device interaction, while heuristic evaluations and usability tests are leveraged to refine user interfaces. The course also explores the burgeoning realm of Software as a Medical Device (SaMD), emphasizing its increasing significance in healthcare delivery. Sustainable design principles are taught, aiming to equip students with the knowledge to create medical devices suitable for Low and Middle-Income Countries (LMICs), thereby addressing global health disparities. Through project work, students apply their knowledge to design medical devices, fostering a blend of innovative thinking and practical skill development. This course prepares students to be industry-ready professionals capable of navigating and contributing to the future landscape of medical device development.