Design of Open-Source Medical Devices for Improved Usability and Risk Minimization

Abstract

Safe performance is essential for any medical technology and its assurance a requirement for reaching market and, hence, making societal impacts. Consequently, a wide set of methodologies, techniques and international standards propose strategies for detecting and minimizing design, manufacturing and operational risks and deal with the analysis and assessment of potential use errors and malfunctions during the operation of healthcare technologies. Open-source medical devices (OSMDs) are typically designed in a collaborative way, involving truly international and multicultural development teams and following development life cycles, through which the information is shared, and also manipulated and updated, within large communities of “makers”. Besides, OSMDs are sometimes manufactured and delivered through still unconventional supply chains. As compared with traditional in-house developments, open-source approaches bring new uncertainties to the process and related potential hazards, if systematic methods for promoting usability and minimizing risks are not adequately shared in the open-source community, applied and documented. At the same time, the openness of information throughout the whole development process should, ideally, promote design peer-review and failure detection at earlier stages, if the design principles for OSMDs and their special features are correctly considered.

In consequence, this chapter is prepared with the intention of summarizing the more relevant techniques and standards for usability promotion and risk minimization in biomedical engineering (BME) tasks linked to healthcare technology development. In addition, the final purpose is presenting an innovative and straightforward – user-friendly – methodology for developing intrinsically safe medical technologies, based on internationally accepted techniques and standards, and directly transferable to open-source medical devices. To illustrate the described methods and techniques, several case studies for electromedical devices, invasive devices, standalone software and protecting splints, among others, are presented, which serve to give proof of the flexibility and scalability of this method. Some key aspects linked to applying these methods to projects emerging from open-innovation schemes and delivered as open-source medical devices and technologies are discussed.