Biodesignと医療機器開発

抄録

Biodesign is a process that realizes innovation through the development of medical technology (devices and systems), initiated at Stanford University in the late 1990s. It enables the practice of human–centered design in the complex landscape of medical and healthcare, where stakeholders are intricately involved, serving as a trusted approach to value–based innovation in the field. Currently, Biodesign has expanded to approximately 10 countries across Asia, Oceania, Europe, South America, and Africa, establishing hubs with individuals who have completed the Stanford Biodesign faculty course.

Particularly in Silicon Valley, a hub for driving innovation, Biodesign demonstrates a strong impact by fostering the construction of innovative projects and developing individuals capable of leading them at the pre–incubation stage, prior to entering incubation facilities. Understanding the distinct characteristics of the processes involved in the development of medical devices and pharmaceuticals, it is crucial to advance individual projects.

Medical device development often follows the identification of wishes and wants perceived by experts, such as specialized physicians, resulting in the proposal of new products and the progression of research and development. Projects initiated in such a manner frequently face challenges related to what is commonly referred to as the “exit strategy” in Japan, leading to project stagnation. Biodesign addresses this by examining business perspectives in the early stages of development, generating technology solutions starting from the needs in healthcare settings, and thus creating projects with a high probability of reaching patients.

Whether in the context of medical device development projects or aiming at patient treatment, Biodesign is considered valuable for designing new solutions with drugs―essentially new technologies―and strategically thinking about the design of the patient's treatment experience.