This is the second installment in the overseas expansion support lecture series presented by MEDIC by UTokyoBD.｜News｜A portal supporting medical device development

This is the second installment in the overseas expansion support lecture series presented by MEDIC by UTokyoBD.

2025.12.11

Overview

Among Japanese medical device startups and manufacturers, there is a growing trend towards seeking validation in the US market and FDA approval, with the aim of gaining investor trust and expanding globally.

Building upon the first installment, which provided a detailed breakdown of these "total costs," this webinar will offer a practical explanation of how to develop sales strategies in collaboration with distributors and other partners, as well as regulatory strategies for FDA approval in comparison to those of the PMDA, when expanding into the United States.

This lecture is a must-see for companies considering expanding into the U.S. market, or for anyone preparing for future business plans.

Target

Executives and business leaders of companies considering expanding into the US market for medical devices and regenerative medicine products.

- Personnel involved in the practical aspects of regulatory strategy, such as FDA approval and QMS development.

- Business development manager aiming to build partnerships and expand sales networks in the United States.

・Those interested in the global strategies of Japanese companies and the policies of the medical device industry.

〇Date and time: December 18, 2025 (Thursday) 13:00 ~ 14:00

Location: Zoom Webinar How to participate: Register here

Guest Speakers

[Keiji Asada, Representative Director and CEO, Amenichi Consulting, LLC.]

Keiji Asada has been involved in regulatory strategy and business development in the pharmaceutical and medical device fields for over 20 years. Currently, as CEO of Amenichi Consulting, LLC., a consulting firm that supports companies aiming to enter the US market, he provides support to companies both in the US and internationally, focusing on FDA compliance, as well as developing regulatory strategies, marketing support, business plan development, fundraising, and organizational structure building.

Since its establishment in 2018, Amenichi has supported more than 60 companies, helping them achieve numerous FDA approvals and successful market entry. Mr. Asada, who holds ISO 13485 and MDSAP Lead Auditor qualifications, leverages his extensive international experience and broad industry network to provide comprehensive support, from introducing optimal business partners to strategy implementation, contributing to the growth and strengthening of companies' competitiveness from a global perspective.

〇 Time Schedule

13:00 - 13:05 UTokyoBD, Introduction to this Web Lecture Series

13:05 - 13:45 Webinar Lecture

"Entering the US Medical Device Market for Japanese Companies, Vol. 2: How to Approach Sales Strategies and FDA Strategies in the US"

13:45 - 14:00 Q&A Session

Contact information for inquiries regarding this seminar

The University of Tokyo Biodesign Office: medic_contact_us@biodesign.tokyo

About MEDIC by UTokyoBD (University of Tokyo Biodesign)

Since 2015, we have been developing the "Biodesign" program, which originated at Stanford University in the United States and aims to cultivate human resources for medical device innovation development, based at the University of Tokyo.

Since 2025, the Biodesign Center at the University of Tokyo has been commissioned to run the "AMED Medical-Engineering Collaboration Global Expansion Project: International Expansion Support Project," which involves operating the MEDIC portal site. This project provides support for medical device development and disseminates information, primarily for companies aiming to expand overseas.

Organizer: UTokyoBD (University of Tokyo Biodesign)

Sponsored by: Japan Agency for Medical Research and Development (AMED) "FY2025 Global Medical-Engineering Collaboration Project: International Expansion Support Program"

Cooperation: Life Science Innovation Network Japan (LINK-J)

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