Co-design open-source medical devices: how to minimize the human error using UBORA e-infrastructure^.

Area of Science:

• Biomedical Engineering
• Medical Device Design
• Global Health Technology

Background:

• Reducing medical device costs can enhance access and advance global health equity.
• The medical device industry requires innovative, safe, and needs-based technologies.
• Existing design processes can be complex and costly, hindering accessibility.

Purpose of the Study:

• To introduce UBORA, an e-infrastructure promoting open-source co-design of medical devices.
• To demonstrate UBORA's structured approach to medical device development, inspired by EN ISO 13485:2016.
• To validate the pathway for identifying safety requirements and assess the e-infrastructure's usability.

Main Methods:

• Description of the UBORA e-infrastructure and its open-source biomedical engineering concept.
• Application of UBORA in developing an open-source medical device for hand rehabilitation.
• Usability testing of the UBORA e-infrastructure during the 4th WHO Global Forum on Medical Devices.

Main Results:

• UBORA successfully structures the medical device design process, incorporating safety requirements.
• An open-source hand rehabilitation device was developed as a proof of concept.
• Usability testing confirmed the e-infrastructure's practical application and potential.

Conclusions:

• UBORA offers a viable framework for co-designing innovative, low-cost, and safe medical devices.
• The open-source approach through UBORA can contribute to improved global health equity.
• The e-infrastructure streamlines the development pathway and demonstrates user-friendliness.