第33回日本心血管インターベンション治療学会；CVIT2025学術集会

Let's gather our concentrated wisdom to bring Japan-based medical devices to the world!
Chairs：Fumiaki Ikeno( Stanford University /MedVenture Partners, Inc, USA), Ken Kozuma(Teikyo University, Japan), Shinichi Takae(Ministry of Health, Labour and Welfare, Japan)
 Panelists：Kentaro Hayashi( HICKY, Inc. / The University of Tokyo, Japan), Kensuke Ishii(Pharmaceuticals and Medical Devices Agency, Japan), Yuichi Tamura(Cardio Intelligence Inc. / International University of Health and Welfare, Japan)
Introduction of HBD Activities
Chair：Shin Iwamoto(Pharmaceuticals and Medical Devices Agency, Japan)
The future outlook of heart failure/SHD treatments: How to evaluate patient reported outcomes
 Chairs：Shin Iwamoto( Pharmaceuticals and Medical Devices Agency, Japan), Shigeru Saito(Shonan Kamakura General Hospital, Japan)
Panelist：Shinya Yamamoto( Osaka University Hospital, Japan)

In order for Japan's medical device industry to increase its international competitiveness and provide superior domestic technologies to the global market, it is essential that industry-government-academia collaboration, as well as institutional, funding, and evaluation systems, be in place. This session will bring together experts, entrepreneurs, government officials, industry associations, and policymakers from Japan and abroad to discuss the challenges and strategies for the global expansion of Japan's medical devices from multiple perspectives.
From the perspectives of startup promotion, investment promotion, regulatory reform, and overseas expansion support, Diet members and key persons from relevant ministries and agencies will take the stage to introduce specific measures to accelerate medical device innovation. In addition, representatives from the PMDA, academia, and startups will discuss the current and future states of product evaluation, clinical needs, and regulatory responses.
In the latter half of the panel discussion, we will share the results and future prospects of the Japan-U.S. collaborative program “Harmonization By Doing (HBD)” and examine the nature of the evaluation, including patient-reported outcomes (PRO) for heart failure and structural heart disease (SHD) treatment devices.
Through this session, we will present a roadmap for Japan's medical devices to be accepted worldwide and discuss how to collaborate to achieve this goal.