医療系ベンチャー・トータルサポートオフィス：MEDISO ( Medical Innovation Support Office )

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.

Click here for inquiries

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).

Ruka Takeuchi

Discovery Biotech Consulting　　Representative
PARKS　Commercialization Producer

Main specialty areas

medical devices

Specialized support fields

Marketing
Business planning
Business operation systems
Etc

I have been engaged in marketing and business development for more than 30 years in the life science market, mainly in the medical and pharmaceutical fields, both in Japan and overseas. Currently, I have established my own consulting firm and provide business consulting services to foreign and domestic companies from start-ups to small and medium-sized enterprises. I would be happy to be of service to you by drawing on my past business experience as well as my daily experience in providing hands-on support to various companies and projects.

Tomohito Suzuki

Tohoku University Knowledge Cast Co., Ltd.
Senior Consultant, Medical Device Development Support Division

Main specialty areas

medical devices

Specialized support fields

Regulatory compliance
Business planning
Funding

D. in Pharmaceutical Sciences from Kyoritsu Pharmaceutical University (now Keio University). Formerly a medical device reviewer at the Pharmaceuticals and Medical Devices Agency (PMDA). At PMDA, a member of the team in charge of the cardiovascular field and was in charge of approval review and consultation for many medical devices including new medical devices. Seconded from PMDA to the University of Tokyo Hospital as a Project Assistant Professor at the Translational Research Center, where supported the development of medical seeds in academia. Seconded from PMDA to Division of Medical Device Research of the Department of Industrial-Academic Collaboration of the Japan Agency for Medical Research and Development (AMED) as a manager in charge of overseeing projects with medical device-related budgets. He has been in his current position since 2020. Based on his experience in reviewing at PMDA and supporting R&D in academia and AMED, he supports efficient development of medical devices for many manufacturers including venture companies.

Hitoshi Fujimaki

TMI Associates Attorney-at-law (admitted in Japan and New York)

Main specialty areas

medicines
medical devices
regenerative medicine products

Specialized support fields

Regulatory compliance
Etc

Joined TMI Associates in 2016. Completed an LL.M. in National and Global Health Law at Georgetown University Law Center in 2023, earning the Food & Drug Law Certificate. Admitted to the New York State Bar in 2024. The practice focuses on pharmaceutical, medical device, and healthcare regulatory matters in both Japan and the United States, with extensive experience supporting R&D and commercial operations of Japanese companies domestically and abroad. Work includes licensing and collaboration agreements with overseas partners, joint research and development arrangements, CRO agreements, GCP compliance during clinical trials, promotional review, regulatory assessments (including medical-device classification), authority inspections, and broad advisories on pharmaceutical and medical-device regulations. Also advises on U.S. healthcare compliance issues, including the Anti-Kickback Statute, the Sunshine Act, and related federal and state requirements. Author of Introduction to U.S. FDA Drug and Medical Device Law and Regulation (Shojihomu, September 2024).

Hidehiro Ando

President & Representative, Andy Pharma Partners Inc.

Main specialty areas

medicines
medical devices
regenerative medicine products

Specialized support fields

Marketing
Funding
Business operation systems

He graduated from the Department of Veterinary Medical Science, Faculty of Agriculture, University of Tokyo. He joined Tanabe Pharma Corporation (present Mitsubishi Tanabe Pharma Corporation). After being assigned to the research department of pharmacokinetics, he was involved in partnership-related business of international development department, research and development planning department, etc., including establishment of a joint venture with overseas companies. Subsequently, he worked in the technology transfer department of RIKEN (Institute of Physical and Chemical Research), a regenerative medicine venture, Bayer Yakuhin, a drug discovery venture, and he established a personal office. He has engaged in business development and licensing work for 40 years, and now, based on his experience and networks, he is supporting business development activities, such as licensing agreements and joint research of domestic and foreign pharmaceutical companies/ventures. He provides comprehensive support services ranging from looking for appropriate partners, preparing the draft of contract outline, contract negotiation, and alliance management with partners after the partnership agreement. Especially, based on experience of practicing on both sides of venture and pharmaceutical companies, he keeps in mind providing informative advice and proposals for specific action plans.

Kiyoaki Kojima

Partner

Main specialty areas

medicines
medical devices
regenerative medicine products

Specialized support fields

Regulatory compliance
Business planning
Funding
Business operation systems
Specialized support fields

Kiyo advises clients in corporate formation, governance, and compliance matters; mergers and acquisitions; joint ventures; leasing and licensing matters; distribution and franchise arrangements; and a wide range of commercial transactions.An important part of Kiyo’s practice includes his work with international companies in relocating and/or establishing ventures in the U.S. He assists companies and investors with incentives and site selection; real estate acquisitions and construction agreements; corporate formation and governance; asset purchases and joint ventures; regulatory compliance; and contracts of all types to help ensure a seamless U.S. launch or transition.He also counsels clients in virtually all areas of labor and employment law, including drafting and/or interpretation of employment agreements, company policies, and handbooks; union-avoidance training; countering discrimination and harassment claims; hire, fire and discipline issues; and dispute resolution procedures. Active in the community, Kiyo is a member of the Atlanta Bar Association, a board member of the Japan America Society of Georgia, and a board member of the Japanese Chamber of Commerce of Georgia. He also serves in “advisor” or “supporter” roles in various entities in Japan, such as InnoHub, MEDISO, and IDEC Yokohama.

About details of specialists

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.

See more about measures implemented by public institutions