Open-Source Medical Devices: Concept, Trends, and Challenges Toward Equitable Healthcare Technology

Abstract

Medical technology has transformed the practice of medicine and patient care, with a wide set of relevant breakthroughs achieved during the last decades. However, in many cases, medical technology is developed in secrecy, and patients’ or medical professionals’ needs are considered as a minor part of the decision-making process, instead of being driven by relevant emergent social needs. In contrast with the biomedical industry, many product fields are now involving stakeholders and future users, since the beginning of the product development process, embracing the new paradigm of “open innovation” and showing interesting results in terms of improved performance, safety, and costs, among others. However, healthcare industry is still reluctant to taking advantage of the enormous potentials of open-source and collaborative approach toward a social development of medical devices. In order to highlight the potentials of open-source and collaborative engineering and design approaches for the future of biomedical industry and to help with its transformation, this chapter is focused on: (1) adequately defining the concept of open-source medical device (OSMD) and its boundaries, (2) presenting pioneering cases of success in the OSMD field and discussing their relevance, and (3) introducing the UBORA e-infrastructure and community, as key initiative in the field. This chapter serves also as an introduction to the whole handbook and to the more relevant concepts employed along this work.