Knowledgeable experts support
the practical application of medicines,
medical devices,
and regenerative medicinal products.
2024年12月27日(金)~2025年1月5日(日)は、休業とさせていただきます。
この期間中にお受けしたお問い合せ・ご相談の申込みについては、休業明けに対応させていただきます。
何卒ご了承のほどお願いいたします。
What is MEDISO
MEDISO provides support for business ventures, academia,
and individuals intending to put into practical use medicines,
medical devices, and regenerative medicinal products.
Click here for further details.
About the Medical Innovation Support Office
The medical innovation support office matches medical venture companies and academic institutions facing challenges in the practical application of medical products and devices for specialists* who provide detailed consultation and support for solving problems at each stage from research and development to practical use, as well as insurance coverage at clinical sites, while looking ahead to the overall comprehensive advances and dissemination into the global market.
* Specialists in each field provide support for the response to laws and regulations, marketing, business planning, fund rasing, management strategy, intellectual property management, and international development, etc.
This website is operated by Mitsubishi Research Institute, Inc., as a trustee under instructions from the Economic Affairs Division, Health Policy Bureau, and Ministry of Health, Labour and Welfare as a part of the total support for the medical ventures program sponsored by the Ministry of Health, Labour and Welfare.
Support targets
Ventures, academic institutions, and individuals aiming to put into practical use the medicines, medical devices, regenerative medicinal products, and novel drug-discovery technologies or medical materials subject to the Pharmaceuticals and Medical Devices Law.
Details of support
MEDISO provides support for the practical application of medicines, medical devices, regenerative medicinal products, and other products subject to the Pharmaceuticals and Medical Devices Law.
That support includes business planning, financing, advice on laws and regulations, and other assistance as required.
- ●Support method:We provide support via online meeting or e-mail.
- ●Support source:Support is provided in cooperation with experts in R&D, consultants in pharmaceutical affairs, and experts from related organizations including the Ministry of Health, Labour and Welfare.
- ●Remarks:Consultation and support services are free of charge.
In case the link does not work, please contact us at the email address below
mediso@ml.mri.co.jp
Specialists Introduction
We will introduce registered specialists
(updated as necessary).
Miyuki Nagao
Globizz Japan Corporation Tokyo Office Director
Main specialty areas
- medicines
- medical devices
- regenerative medicine products
Specialized support fields
- Regulatory compliance
- Marketing
- Business planning
- Business operation systems
After working at U.S. headquarters as an assistant for FDA registrations, FDA filings, and regulatory investigations for medical devices, pharmaceuticals, and food products, she moved to GLOBITS' Tokyo office to work as a project coordinator. While proposing and coordinating projects related to Japanese companies' entry into the U.S. market, she also provides support for attending and responding to FDA inspections in various fields, advises on FDA registration, conducts brief investigations, and teaches seminars.
Masakazu Masujima
Partner, Mori Hamada & Matsumoto
Main specialty areas
- medicines
- medical devices
- regenerative medicine products
Specialized support fields
- Regulatory compliance
- Funding
- Business operation systems
- Specialized support fields
Masa is a guru of startup legal advisory space in Japan. Based on the experiences at Palo Alto office of Wilson Sonsini Goodrich & Rosati, his advice is West Coast style; progressive, risk-base and proactive. Through more than 2 dacades of dedication to the startup space, he has advised IPOs, M&As and major cross-border fundraising for may startups, including biotech and healthcare ones, and have also worked with entrepreneurs through a variety of touch situation, such as disputes between founders, problems with investors as well as intellectual property disputes. Masa has served as a council member of numerous Government committees, such as Regulatory Reform Promotion Council, the Regulatory Sandbox Committee, the Digital Market Competition Council and the Industrial Structure Council. He is admitted to NY bar and Japan bar, and a licensed patent attorny in Japan.
Saaya Hirai
Globizz Japan Corporation Osaka Office Director
Main specialty areas
- medicines
- medical devices
- regenerative medicine products
Specialized support fields
- Regulatory compliance
- Marketing
- Business planning
- Business operation systems
After studying abroad in New Zealand during junior high school, she became interested in doing business with foreign countries, and after graduating from high school, she entered a university in Taiwan in English and Mandarin Chinese. At university, she majored in international business administration. During her studies, she experienced corporate internships in the U.S. and Taiwan, gaining insight into the business world from her student days. Currently, as a project controller at headquarters, she is in charge of overall project management and strategic planning for companies entering the U.S. market as a project coordinator.
Yoshiki Kawabata
President, MedX Inc.
Main specialty areas
- medical devices
- regenerative medicine products
Specialized support fields
- Regulatory compliance
- Marketing
- Business planning
- Funding
- Business operation systems
- Specialized support fields
Advantage from over 35 years of multiple company & responsibility experience in medical device industry, helping foreign companies to enter into Japanese market. Key highlights in the past achievements are : with Johnson & Johnson Mdecial Company, worked with US R&D team to develop new product which reflecting Japanese patient and physicians needs - three years resided in Cincinnati, Ohio: HeartFlow Inc., which developed the first "program device" - FFRCT, enabling non-invasive detection of FFR, applied and received regulatory approval and reimbursement as a first product and company. : in Palette Lifesciences Japan, establishment of new subsidiary for start-up company which transferred the business from exclusive distributor. Started with minimum number of direct resources and having multiple partnerships with logistics, finance and regulatory affairs, revitalized the business and achieved a 149% growth over the last year of distributor.
Miyuki Shimizu
Medical Lab Partners Corporation
Main specialty areas
- medical devices
Specialized support fields
- Regulatory compliance
- Marketing
- Business planning
- Business operation systems
- Specialized support fields
She graduated from the Graduate School of Natural Science, Chiba University. She holds the degrees of doctor of medicine and master of management information. She worked on the development of medical devices and pharmaceutical products in a wide range of fields related to transfusions, surgical operations, general-purpose medical devices, dialysis, and rehabilitation at Terumo Corporation. She also has experience in a series of project developments from planning a project to commercializing at a medical practice, as well as experience in management. Since 2015, she has provided consulting services to more than 350 companies entering the medical industry as her current role. She is trying to provide consulting services with the viewpoint of the individual company in mind.
Introduction of measures implemented by public institutions
We will describe the measures from public institutions for pharmaceutical companies,
medical device companies, companies manufacturing regenerative medicinal products, and venture companies.
- The Ministry of Health, Labour and Welfare/
- Pharmaceuticals and Medical Devices Agency (PMDA)/
- Japan Agency for Medical Research and Development (AMED)/
- Cabinet Office/
- Ministry of Economy, Trade and Industry/
- Ministry of Internal Affairs and Communications/
- Small and Medium Enterprise Agency/
- Organization for Small & Medium Enterprises and Regional Innovation, Japan/
- Union of Kansai Governments/
- New Energy and Industrial Technology Development Organization (NEDO)/
- Life Science Innovation Network Japan, Inc. (LINK-J)/
- Japan Science and Technology Agency (JST)/
- Japan External Trade Organization (JETRO)/
- INCJ, Ltd./
- Osaka Prefecture/
- Tokyo Metropolis/
- Kanagawa Prefecture/
- National Institutes of Biomedical Innovation, Health and Nutrition (NIBIOHN)