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Thu. Jul 17, 2025

Fri. Jul 18, 2025

Sat. Jul 19, 2025

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Introduction of HBD Activities

Outcomes of HBD Activities and Future Prospects

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 &ldquo;Harmonization By Doing (HBD)&rdquo; 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.

Riding on the winds of World Expo 2025 in Osaka, we will bring new medical devices that were created with Japan's concentrated wisdom to the world [Interpretation En. &harr; Ja.]<pre class="sc-erUUZj kdBqQD">&nbsp;</pre>

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

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[SP1-7]Outcomes of HBD Activities and Future ProspectsIntroduction of HBD Activities

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