The Stanford Biodesign program was first introduced in Japan in 2015 at three national universities to develop medical technology innovation and its talent. This study aimed to (1) show the outcomes of leadership talent development, (2) indicate the educational results of the program, and (3) objectively analyze the ways in which the program executed in Japan, effectively promoted entrepreneurship orientation and the origination of new businesses. The latter is especially relevant as Japan has low entrepreneurial awareness and new business entry rates compared to the United States and Europe. Herein, fellows were subjected to questionnaires, interviews, and a survey based on academic papers, extant literature, and treatises issued by the Nihon Biodesign Gakkai (Academic Society of Japan Biodesign). Overall program performance showed notable results, despite indicating a need to improve business-related programs and team learning which is greatly influenced by Japanese culture. An externship program, planned and developed in Japan, was most inspiring and served to expose participants to role models. Comparing Japan Biodesign education elements to factors of general entrepreneurship promotion in Japan, sampled and organized from relevant White Papers, proved its educational effectiveness in entrepreneurship promotion from an objective viewpoint. Within the 4-year timeframe, the results indicated that leadership talent was indeed developed. Medical device innovation should progress through the stages of establishing new ventures, followed by contriving medical devices with novel, impactful value. This study revealed that Japan Biodesign education provides a platform for achieving these goals, despite the challenging Japanese new business environment.
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