J.Jpn. Surg. Soc.. 126(5): 435-442, 2025

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Feature topic

THE ROLE OF SURGEONS AS PRINCIPAL INVESTIGATORS IN THE DEVELOPMENT OF MEDICAL DEVICES

This paper explores the role of surgeons as principal investigators in the development of medical devices, focusing on the case study of “Project ENGINE,” a collaborative research initiative at the University of Osaka. Originating from dissatisfaction with existing endoscopic instruments during the early adoption of NOTES procedures, the project evolved from a small research group into a formal industry–academia consortium. It emphasizes the importance of extracting universal clinical needs, rapid prototyping, repeated evaluation/feedback, and early involvement of commercial partners. The project employs an “open innovation” model and integrates all phases of device development, from need identification and design to intellectual property management and academic dissemination. Over 13 years, ENGINE has partnered with 50 companies and successfully brought nearly 30 devices to market. Internal audits identified key success factors for commercialization: securing intellectual property; obtaining external funding; academic publications; and early engagement with sales companies. Challenges include maintaining doctors’ engagement and managing the business risks of corporate partners. Ultimately, the study highlights how academic surgeons can lead device development not just as evaluators/end-users, but also as innovators/producers, providing meaningful contributions to both medical practice and science. The paper underscores the value of transforming device manufacturing into a scholarly, academic pursuit.

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