Gateway to Medical Device Development, Commercialization, and Global Expansion

Overview

The University of Tokyo has been commissioned by AMED (Japan Agency for Medical and Engineering Sciences) to carry out the "Global Medical-Engineering Collaboration Project: International Expansion Support Project" since fiscal year 2025. The University of Tokyo Biodesign operates the MEDIC portal site and provides development support and information dissemination to companies aiming for overseas expansion.

Japanese medical device companies face several obstacles when entering overseas markets, particularly the US market. It is essential to identify and address these obstacles appropriately and to proceed with international expansion in a planned manner.

This is the sixth installment in our online lecture series supporting overseas expansion. This time, we have invited Professor Fumiaki Ikeno to speak about the challenges Japanese companies face from a US perspective, and how and with whom they should proceed with international expansion.

Target

Executives, business managers, and researchers 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: Thursday, April 16, 2026, 12:00-13:00

Location: Zoom Webinar

How to register: Please register via the Peatix event page below.

https://peatix.com/event/4933940/view

Speakers:

[Fumiaki Ikeno] Stanford University Biodesign Program Director, AMED Program Officer

~~Introducing the Speakers~~

After graduating from Jichi Medical University School of Medicine in 1992, he contributed to regional healthcare in Shizuoka, including remote areas, for nine years. In April 2001, he began research in the Department of Cardiology at Stanford University. In parallel with his research at Stanford University, he joined the Stanford Biodesign Advisory Faculty in 2014. He taught as Program Director and was deeply involved in the establishment of Japan Biodesign. To date, he has been involved in research and development, animal testing, and clinical trials for over 200 US medical device ventures, mainly in Silicon Valley. Leveraging his extensive advisory experience in the medical device field and broad knowledge of medical conditions in Japan and the United States, he participates in various projects with Japanese and US regulatory authorities in medical device development, striving to establish a cross-border medical device ecosystem.

〇 Time Schedule

12:00 - 12:05 Introduction of UTokyoBD

12:05 - 12:45 Webinar Lecture: "Some Obstacles Japanese Medical Device Companies Face When Entering Overseas Markets, Especially the Huge US Market"

12:45 - 13:00 Q&A Session

Request to participants of this webinar lecture

Those who register for this webinar are requested to subscribe to the email newsletter of the Medical Device Development Support Network Portal Site (MEDIC) operated by UTokyoBD. By subscribing to the newsletter, you can receive the latest information and event information on medical device development as soon as it becomes available.

Contact information for inquiries regarding this webinar

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.

The University of Tokyo has been commissioned by AMED to undertake the "AMED Medical-Engineering Collaboration Global Expansion Project: International Expansion Support Project" since fiscal year 2025, and the University of Tokyo Biodesign is in charge of operating the MEDIC portal site. This project provides support for medical device development and information dissemination, primarily for companies aiming to expand overseas.

Organized by: Department of Biodesign, TR Center, University of Tokyo Hospital (University of Tokyo Biodesign)

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