Gateway to Medical Device Development, Commercialization, and Global Expansion

Gateway to Medical Device Development, Commercialization, and Global Expansion

  • medic
  • event
  • market-entry
  • manufacturing-scaleup
  • preclinical-clinical
  • business-strategy
  • marketing-strategy
  • reimbursement-regulatory
  • global-expansion

[Held on February 19th] MEDIC by UTokyoBD presents the fourth installment of their overseas expansion support lecture series.

Overview

In this webinar, Ms. Chiaki, who has been involved in overseas expansion in both clinical development and regulatory strategy at a major medical device manufacturer, will be speaking in two parts, sharing her frontline experience.

In this first session, we will hear about the achievements and practical examples of globalization as a medical device company in overseas expansion, including trial and error on the ground (M&A, production transfer, etc.).

The second session (scheduled for May 2026) will cover recent trends in pharmaceutical regulations, harmonization, and standardization, which are essential for overseas expansion.

This is must-see content that 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: February 19, 2026 (Thursday) 17:00-18:00

Location: Zoom Webinar

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

https://peatix.com/event/4821515/view

Speakers:

[Kazuhisa Senshu] Terumo Corporation

~~Brief Biography~~

1987: Joined Terumo Corporation, engaged in research and development and evaluation.

1999: Received a PhD in Engineering from Tokyo Institute of Technology for research on the surface structure of biocompatible materials.

2006: Worked as a Clinical & Scientific Manager at Terumo Europe, involved in global clinical research.

2015: Returned to Terumo Corporation, where I am responsible for global planning and promotion of clinical development and regulatory affairs.

2017: Appointed as Executive Officer, Chief Clinical & Regulatory Affairs Officer.

March 2024: Retirement

April 2024: Began working at Terumo as a full-time advisor, a position I hold to this day.

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.

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.

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"