This book focuses on the challenges and potentials of open source and collaborative design approaches and strategies in the biomedical field. It provides a comprehensive set of good practices and methods for making these safe, innovative and certifiable biomedical devices reach patients and provide successful solutions to healthcare issues. The chapters are sequenced to follow the complete lifecycle of open source medical technologies. The information provided is eminently practical, as it is supported by real cases of study, in which collaboration among medical professionals, engineers and technicians, patients and patient associations, policy makers, regulatory bodies, and citizens has proven beneficial. The book is also supported by an online infrastructure, UBORA, through which open-source medical devices can be collaboratively developed and shared for the democratization of medical technology and for promoting accessible biomedical engineering education.

I. FUNDAMENTALS.- 1. The medical industry: Present situation, global health concerns and outlook.- 2. General considerations for engineering open-source medical devices.-3. Systematic assessment of needs and viability analyses.-II. DESIGN METHODS FOR OPEN-SOURCE MEDICAL DEVICES.- 4. Creativity promotion: Collaborative design environments & open-innovation.-5. Safety-guided design methods for open-source medical devices.- 6. Design and simulation of open-source medical devices.- III. MANUFACTURING METHODS FOR OPEN-SOURCE MEDICAL DEVICES.- 7. Prototyping of open-source medical devices.- 8. Manufacturing of personalized open-source medical devices.- 9. Mass-production of open-source medical devices.- IV. MAKING A REAL IMPACT WITH OPEN-SOURCE MEDICAL DEVICES.- 10. Open-source medical device approval and certification.- 11. Marketing open-source medical devices: Managing quality and supply chain.- 12. Issues linked to the long-term sustainability of open-source medical devices.