Gateway to Medical Device Development, Commercialization, and Global Expansion

Overview

In recent years, with the advancement of AI and digital technologies, the development and commercialization of software-based medical devices (SaMDs) have been progressing both domestically and internationally. In order to bring SaMDs to market, it is necessary to consider development and commercialization strategies from various perspectives, including whether the program qualifies as a medical device, as well as pharmaceutical regulations and medical fee schedules.

This installment of our overseas expansion support web lecture series focuses on the market licensing of SaMDs (Software-Based Medical Devices). The lecture will explain the applicability of programs to medical devices, regulatory affairs, and reimbursement considerations. This lecture will provide companies and researchers considering SaMD development with a comprehensive, practical overview of key points to consider for market licensing.

Target

Executives, business leaders, and researchers of companies considering the development and commercialization of SaMD.

- Personnel responsible for determining whether the program qualifies as a medical device, and for compliance with regulations such as pharmaceutical affairs and medical fee schedules.

- Personnel involved in market licensing, business strategy planning, and business development for SaMD.

・Those interested in the development, commercialization, and regulatory trends of SaMD in the medical device and digital health fields.

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

〇Date and time: Thursday, August 27, 2026 from 16:00 to 17:00

Location: Zoom Webinar

How to participate: Pre-registration via Peatix

https://peatix.com/event/5132195

Speakers:

[Masanori Otake] Digital Health Committee, American Medical Devices and IVD Manufacturers Association (AMDD)

~~Introducing the Speakers~~

After gaining experience as a Medical Representative (MR) at Pharmacia Co., Ltd. (at the time), he transitioned to medical device regulatory affairs and quality control. He gained practical experience in regulatory affairs and quality control for the first domestic approval of an ophthalmic excimer laser, clinical trials for the da Vinci surgical robot, and radiation therapy equipment at three foreign and domestic companies. Currently, he serves as the Director of Policy Promotion at a major medical device company, and also holds positions at the American Medical Devices and IVD Manufacturers Association (AMDD) as Vice Chairperson of the Digital Health Committee, the Diagnostic and Therapeutic Devices Committee, and the RAQA Committee, as well as serving as Secretary of the Legal Affairs Committee of the Japan Federation of Medical Devices Manufacturers Associations. Other positions include Councilor of the Japanese Society for Artificial Organs, Specially Appointed Researcher at the Biodesign Division of the TR Center, University of Tokyo Hospital, Visiting Researcher at the Waseda University Institute for Medical Regulatory Science, and PhD (Biomedical Sciences).

〇 Time Schedule

16:00 - 16:05 Introduction of UTokyoBD

16:05 - 16:45 Webinar Lecture

16:45 - 17:00 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 fiscal year 2025, the University of Tokyo has been commissioned to run the "AMED Medical-Engineering Collaboration Global Expansion Project: International Expansion Support Project," and the University of Tokyo Biodesign is in charge of operating the MEDIC portal site. This project provides support for medical device development and disseminates information, primarily for companies aiming to expand overseas.

Department of Biodesign, Translational Research Center, University of Tokyo Hospital (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"