A comprehensive portal site for Medical Innovation Support Office (MEDISO).Medical Innovation Support Office

Mirai Miyahara

President of i Access Consulting Inc.

Miyahara holds a Master's degree in Business Administration from the Graduate School of Economics at Tohoku University. She possesses 17 years of professional experience in Regulatory Affairs, QMS, business planning, and overseas marketing at a leading medical device company and Notified bodies in Japan. With a specific focus on multi-country regulatory compliance and extensive experience in overseas medical device markets, Miyahara has demonstrated proficiency in navigating the regulatory landscapes of diverse markets, including Japan, China, India, East Southern Asia, EU and the U.S. She has a proven track record of achieving success in supporting medical companies with regulatory compliance, facilitating international expansion, and establishing strategic partnerships with local entities. Miyahara is also an adviser for JETRO medical devices international expansion program.

Katsuhiro Fukunishi

Tsutomu Uchiyama Ph.,D.

Founder, Uchiyama IP Strategies

Patent attorney/Ph.D.
After working as a researcher in molecular biology for Daiichi Pharmaceutical Co., Ltd. (current Daiichi-Sankyo), he passed the examination for patent attorneys in 1996. He worked in the intellectual property departments of three companies as an in-house patent attorney, practitioner, manager and global IP head (Eisai)—Takeda Pharmaceutical Company Limited, SoftBank Investment, and Eisai Co., Ltd.—for a total of 20 years, where he was involved in patent practice and patent strategies, as well as patent portfolio management including patent filing, patent clearance and intellectual property due diligence.
In April 2017, he founded Uchiyama IP Strategies. Currently, utilizing his experience, he mainly assists venture companies, small and medium-sized enterprises, and academia in patent strategy and contractual matters in drug discovery, regenerative medicine, and biotechnology research.

Satoshi Ogawa

TMI Associates Partner (Attorney)

Satoshi Ogawa, Ph.D., is a partner at TMI Associates specializing in life sciences and healthcare. After earning his Ph.D. in Life Sciences from Kyoto University, he joined TMI Associates as an attorney. Following a three-year secondment at a law firm in New Delhi, India, he has been based at TMI’s Kyoto Office since 2019. Dr. Ogawa advises both Japanese and international clients on cutting-edge technologies, including regenerative medicine, digital health, and AI-driven healthcare solutions. His work covers startup support, patent licensing, industry–academia collaboration, regulatory compliance, and intellectual property disputes. He works extensively with universities, startups, pharmaceutical and medical device companies, venture capital firms, and public institutions. He also serves as an advisor to BioCommunity Kansai (BiocK) and HVC KYOTO, and contributes to conflict-of-interest (COI) committees and institutional review boards (IRBs). Dr. Ogawa is passionate about advancing innovation and helping clients navigate complex legal and regulatory challenges in the life science ecosystem. His publications include “Startup Intellectual Property and Legal Guidebook – Key Points for Early-Stage Bio and Life Science Ventures” (METI-Kansai) and “Healthcare Business Legal Consultation Handbook” (Chuokeizai-sha).

Mineki Takechi

Cardio Intelligence Inc. Chief Development Officer
Director

After working at Fujitsu Ltd. on the development of products and services such as image processing system and cloud information service for home healthcare, as well as research and development in information retrieval and AI, and new business development, I engaged in the construction of a pulmonary hypertension patient registry at the International University of Health and Welfare Mita Hospital. Since 2020, I have been serving as CDO at Cardio Intelligence Inc., responsible for the development of software medical devices for arrhythmia analysis and regulatory affairs. Since 2021, I have also been serving as COO, overseeing overall business planning and execution.