The 41st Medical Device Business Seminar:

The 41st Medical Device Business Seminar: "Insurance Strategies for Medical Device Development - Key Points for Commercialization Based on the 2026 Medical Fee Revision"

2026.8.6

第41回医療機器ビジネスセミナー「医療機器開発の保険戦略～令和8年度診療報酬改定から読み解く事業化のポイント～」

Commercializing medical devices requires not only obtaining regulatory approval and certification, but also a development and business strategy that takes into account insurance coverage and medical fee schedules.
On the other hand, for companies and startups entering the market from other industries, the insurance system and the concept of market access can be difficult to understand.
In this seminar, experts in each field will provide practical explanations on topics such as the 2026 revision of medical fees and the latest system trends, business development strategies with insurance reimbursement in mind, and legal and regulatory responses for the social implementation of medical devices, including AI and SaMD.

◆Details and registration : https://www.fbri-kobe.org/kbic/event/detail.php?event_id=953
◆Date and Time: Wednesday, September 9, 2026, 13:30 – 17:00 (Registration starts at 13:00)
◆Venue: Kobe Kimec Center Building, 10th Floor, Seminar Room, 1-5-2 Minamimachi, Port Island, Chuo-ku, Kobe City, 650-0047
Kobe New Transit Port Liner, alight at "Medical Center Station," directly connected via a connecting passageway, 2-minute walk. ◆Event format: Venue only ◆Capacity: 80 people ◆Participation fee: Free, advance registration required ◆Application deadline: September 7, 2026 (Monday) 17:00
◆Organizers, etc. Organizer: Kobe Biomedical Innovation Cluster Promotion Organization Supporter: Kobe City ◆Program 13:30 – 13:35 Opening remarks 13:35 – 14:35 "The 2026 Medical Fee Revision and the Latest Trends Surrounding Medical Devices"
Sho Nagata, Director of the Medical Devices Policy Office, Pharmaceutical Industry Promotion Planning Division, Medical Affairs Bureau, Ministry of Health, Labour and Welfare, 14:35 – 14:50 "Support for the Commercialization and Market Development of Medical Devices in Kobe"
Kobe Biomedical Innovation Cluster Promotion Organization, Cluster Promotion Center, Medical Devices Group, Group Leader: Masanori Yasuda 14:50 – 15:00 Break 15:00 – 15:45 "For Whom Does That Medical Device Value? – Value Design and Insurance Reimbursement Strategies Starting from the Early Stages of Development"
Yosuke Hara, Representative Director, Healthcare Business Research Institute Co., Ltd., Specially Appointed Associate Professor, Department of Medical Engineering, Graduate School of Medicine, Kobe University, and Medical Device Commercialization Promotion Advisor, Kobe Biomedical Innovation Cluster, will present at 15:45 – 16:30 "Legal and Regulatory Compliance for Medical Devices and SaMD in the AI Era"
Hirokazu Yamaguchi, Attorney at Law, STORIA Law Firm 16:30 – 17:00 Business Card Exchange Session ◆Contact Information Kobe Biomedical Innovation Cluster Promotion Organization Cluster Promotion Center Medical Devices Group MAIL kiki-plat@fbri.org TEL 078-306-0719

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