This is the first in a series of lectures on supporting overseas expansion, presented by MEDIC by UTokyoBD.｜News｜A portal supporting medical device development

This is the first in a series of lectures on supporting overseas expansion, presented by MEDIC by UTokyoBD.

2025.11.13

Overview

Among Japanese medical device startups and manufacturers, there is a growing trend to seek validation and FDA approval in the US market, with the aim of gaining investor trust and expanding globally. However, when actually entering the market, many companies tend to overlook the "true cost of entry."

The path to success involves a wide range of costs, not just the fees for filing an FDA application, but also establishing a quality management system, conducting clinical trials, marketing, and developing distribution networks.

This webinar will break down the overall picture of these "total costs" and explain practical strategies for making the most of limited resources.

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.

Date and Time, Location: Thursday, November 27, 2025, 13:00 - 14:00, held as a 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 - 13:45 Webinar Lecture: "The Reality and Strategies of Entering the US Medical Device Market for Japanese Companies"

13:45 - 14:00 Q&A Session

Requests to Participants

By registering for this lecture webinar, you will also be automatically subscribed to the MEDIC portal site's email newsletter. Subscribing to the newsletter will allow you to receive the latest information and event announcements regarding medical device development as soon as they become available. Please refer to the MEDIC portal site for details.

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.

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

Organized by: 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)

View all news