[March 17th] MEDIC by UTokyoBD presents the 5th installment of their overseas expansion support lecture series.｜News｜A portal supporting medical device development

[March 17th] MEDIC by UTokyoBD presents the 5th installment of their overseas expansion support lecture series.

2026.2.19

Overview

Since fiscal year 2025, the University of Tokyo Biodesign has been commissioned by AMED (Japan Agency for Medical and Engineering Sciences) to operate the MEDIC portal site and provide development support and information dissemination to companies aiming for overseas expansion.

The ultimate goal of expanding into the U.S. is not FDA approval. The path to success in the medical device business involves various considerations beyond product development and regulatory compliance.

This fifth installment in our overseas expansion support web lecture series features Mr. Haruyama from Globits, Inc. in the United States. He will share his firsthand insights on hot topics in the US, including negotiation strategies for smooth FDA approval, insurance reimbursement strategies based on relationships with local doctors, and the impact of the Trump administration on the medical device business. This is a must-see session with content you won't hear anywhere else.

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: March 17, 2026 (Tuesday) 17:00-18:00

Location: Zoom Webinar

How to apply: You can apply via the Peatix link below.

Speakers:

[Takahiro Haruyama] Group Representative, Globits Consulting

~~Brief Biography~~

He worked in manufacturing, branding, and overseas sales in Japan, and has experience working in the UAE and the United States. He left the company after serving as an executive officer in the United States.

Subsequently, he co-founded a medical device sales company in the United States with a Japanese medical device manufacturer, gaining practical experience in the American medical device market. In the U.S., he acquired factories through M&A and successfully exported from the U.S. to 25 countries worldwide.

After the joint venture was dissolved, he was invited to join a domestic medical device company, where he held two positions: head of domestic medical device development and head of the introduction of foreign medical devices into Japan. He was involved in the development of artificial joints in the field of orthopedics and consumables in the field of respiratory medicine.

Leveraging our experience and expertise in the medical device business in both Japan and the United States, we understand the difficulties foreign companies face entering the US market and provide support to the FDA and local businesses.

〇 Time Schedule

17:00 - 17:05 Introduction of UTokyoBD

17:05 - 17:45 Webinar Lecture

17:45 - 18:00 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.

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"

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