Practical Seminar for Medical Device Startups Aiming to Enter the US Market: FDA Compliance × Business Strategy × Investor Perspective｜Event｜A portal supporting medical device development

Practical Seminar for Medical Device Startups Aiming to Enter the US Market: FDA Compliance × Business Strategy × Investor Perspective

2026.2.26

[Date and Time] Friday, February 20, 2026, 8:30 AM - 10:30 AM

[Venue] Online via Zoom *Simultaneous interpretation in Japanese and English will be provided.

[How to participate] Click here for application details.

[Capacity] 100 people

[Organizers] Greater Tokyo Biocommunity (GTB), Japan Bioindustry Association (JBA), Tsukuba Global Innovation Promotion Organization (TGI)

This seminar is a practical webinar focused on the US market expansion of medical device (including SaMD) startups, aiming to provide a comprehensive understanding of business strategies, FDA regulatory compliance, and investor perspectives in the US market.

When expanding into the US market for medical devices, it goes without saying that complying with FDA regulations is crucial, but that alone is not enough to guarantee business success. In this seminar, starting with regulatory strategy, three speakers will explain, from their respective expert perspectives, how to connect it to commercialization, fundraising, and partnerships in the US market.

First, we will provide an overview of the medical device business in the US market, outlining the challenges that Japanese startups often face when expanding into the US, and outlining the mindset needed for market entry and commercialization. Next, we will explain how to design a regulatory strategy in the early stages, focusing on the basic structure of FDA regulations and approval routes (510(k), De Novo, PMA), and practical points to avoid unnecessary retesting and setbacks. Finally, from an investor's perspective, we will introduce how US VCs evaluate medical device startups and how regulatory compliance and market strategies affect fundraising and partnerships.

This seminar will provide an opportunity for startups considering expanding into the U.S., as well as companies that are already making some preparations or considerations, to gain a comprehensive understanding of regulations, business, and investment.

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