J.Jpn. Surg. Soc.
ISSN 1880-1129

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J.Jpn. Surg. Soc.. 126(5): 443-449, 2025

Feature topic

THE CURRENT STATE OF MEDICAL DEVICE DEVELOPMENT IN JAPAN AND THE APPEAL OF MEDICAL DEVICE DEVELOPMENT FOR SURGEONS

1) Department of Colorectal Surgery, National Cancer Center Hospital East, Tokyo, Japan
2) Department for the Promotion of Medical Device Innovation, National Cancer Center Hospital East, Tokyo, Japan

Masaaki Ito1)2), Nobuyoshi Takeshita1)2), Jo Tomioka2), Hiro Hasegawa1)2)

　Recent advances in surgical treatment, including endoscopic and robot-assisted surgeries, highlight the critical role of new medical device development, positioning surgeons as key leaders in this field. The authors’ first project involved developing a clip device for laparoscopic surgery, emphasizing the importance of integrating medical needs with corporate innovations throughout the device approval process. The National Cancer Center has established a robust framework for medical device development, increasingly relying on startups. The authors launched a startup aimed at developing a surgical robot, achieving a rare M&A and regulatory approval for ANSUR. Furthermore, advances in AI are enabling real-time support systems in surgery, exemplified by the newly approved SurVis. Despite ongoing trade deficits in the medical device market, there is a push for the global expansion of domestic products, fostering innovative solutions to clinical challenges.

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