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

厚生労働省

Knowledgeable experts support
the practical application of medicines,
medical devices,
and regenerative medicinal products.

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.

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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.

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).

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.

Akihiko Okuno

SK Intellectual Property Law Firm (SKIP) Managing Partner
SCM BioMedica Co., Ltd. Co-Founder

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

  • Specialized support fields

Master's degree in Cell Structure Research, Department of Applied Bioengineering, Graduate School of Agriculture and Life Sciences, University of Tokyo, Japanese Patent Attorney, Information Security Administrator, and JPAA Intellectual Property Management Consultant certification. As a FoundX supporter of the University of Tokyo,　He supports the intellectual property strategies of many IT and bio-related startups. He specializes in supporting the planning of intellectual property strategies in a variety of fields including biotechnology, pharmaceuticals, and medical devices. In addition, together with Dr. Yoshimasa Tanaka of Nagasaki University (a genius researcher who developed Opdivo with annual sales of over 1 trillion yen together with Dr. Tasuku Honjo, winner of the Nobel Prize in Medicine and Physiology), he established SCM Biomedica Co., Ltd. He co-founded the company and is currently trying to manage his own drug discovery startup.

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.

Rou Irisawa

IRISAWA Consulting LLC

Main specialty areas

  • medicines
  • regenerative medicine products

Specialized support fields

  • Regulatory compliance
  • Etc

Worked at Chugai Pharmaceutical Co., Ltd. for 27 years, primarily in antibody drug research and development, CMC regulatory affairs, and quality assurance, from preclinical trials stage to BLA stage. Involved in the BLA of Japan, US and EU approval for the CTD-Q of Actemra, Japan's original first antibody drug. And also involved in Japan BLA for several biologics Genentech original. Since 2017, involved in the development of many new modalities, including three SAKIGAKE designated cell products, and participated in 21 times PMDA consultations responsible for CMC regulatory and QA for cell products and gene therapy products. In 2023, became independent as a CMC regulatory consultant. Author of ""CMC Pharmaceutical Design - CMC Pharmaceutical Strategy in the Era of New Modality Pharmaceuticals"" (Yakuji Nipposha, 2022), and is the overall supervisor of the Japanese translation of A-CELL (CMC Development Guidance for CAR-T). Fellow at Tama University's Medical Care Solutions Research Institute, and a top performer in the regular course of Pharmaceutical Evaluation Science at the University of Tokyo Graduate School of Pharmaceutical Sciences in 2024. Certified in generative AI skills (November 2025).　Currently involved in various projects, including serving as CMC lecturer at seminars on how to proceed with the development of CMC for antibody drugs, cell products, gene therapy products, etc　for small company to semi-major company.

Satoshi Fukushima

Globis Capital Partners & Co.

Main specialty areas

  • medical devices

Specialized support fields

  • Regulatory compliance
  • Marketing
  • Business planning
  • Funding
  • Business operation systems

He graduated from the Faculty of Economics, University of Tokyo. He was involved in investment activities in reformed fields of existing industries, including digital health, at Globis Capital Partners & Co. (GCP). He served as an outside director of several companies, including Medley, Inc., Kakehashi Inc., and Yoriso. Co. Ltd., and provided support to their management personnel mainly in strategy formulation, development of the organization, and finance. In addition to investigation activities, he provided support for fund structuring and open innovations provided by large companies in healthcare fields.

Before joining GCP, he was serving as an M&A advisor mainly in the technology, media, and telecommunication fields and worked on financing at the general headquarters of German Securities Finance Corporation.

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