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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.

2025年12月26日（金）～2026年1月5日（月）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.

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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).

Eiichi Yamaguchi

Eiichi Yamaguchi, Ph.D. President A1 Partners

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

  • Marketing
  • Business planning
  • Funding
  • Business operation systems

Ph.D from Faculty of Pharmaceutical Sciences Kyushu University. Currently engaged in management and business development consulting for pharmaceutical companies, biotech ventures, and consulting firms. Over 20 years expertise of business development at Shionogi Co., Ltd., a major pharmaceutical company as well as bioventure companies. Senior Director, Business Development & Corporate Planning Dept., Shionogi. A lot of global business experience such as the first Managing Director, Shionogi Singapore, Vice President, Shionogi Qualicaps, Inc., North Carolina, and Shionogi New York. Board of Director & President & COO, a bioventure company. The first chairman, Japan Pharma Alliance Association. The Vice Chairman, Public Private Alliance Conference associated with Infectious diseases led by Dr. Shigeru Omi. Also engaged in Director, International Committee, JPMA. Last but not least, selected as Mentor for Blockbuster Tokyo 2021

Shin-ichi Kamachi

CRO-K Co.,Ltd

Main specialty areas

  • medicines
  • regenerative medicine products

Specialized support fields

  • Regulatory compliance
  • Business planning
  • Business operation systems

Completed doctoral course at Kyushu University Graduate School of Pharmaceutical Sciences. After joining Chugai Pharmaceutical Co., Ltd. Research Institute in 1977, he worked consistently on pharmaceutical research and development. He has experience in approving one small molecule drug and four biopharmaceuticals. He also has the experience of being the first Japanese company to recommend approval for a central review of EMA. He took early retirement in 2004 and mainly assists with biopharmaceutical CMC and non-clinical testing. After establishing the Japanese branch of an American biopharmaceutical consulting company (Biologic Consulting Group, BCG), he currently serves as a senior consultant for CLOCK Co., Ltd., providing support and advice on the development of biopharmaceuticals.

Tetsuo Miura

Specially Appointed Researcher, Center for Clinical Sciences, National Center for Global Health and Medicine

Main specialty areas

  • medicines
  • medical devices

Specialized support fields

  • Marketing
  • Business planning
  • Business operation systems
  • Etc

I worked as a product and business development manager primarily in the fields of diagnostic equipment-reagent systems and medical devices at major foreign pharmaceutical and domestic medical device companies, and also participated in global product development teams at the US and French headquarters. I have medical science knowledge in the fields of infectious diseases, immunology, cardiovascular diseases, metabolism, reproductive medicine, and laboratory medicine, as well as information on the medical field. After mandatory retirement, I served as a senior researcher at the National Center for Global Health and Medicine, responsible for developing and implementing international collaborative clinical research and clinical trials for pharmaceuticals and medical devices with clinical trial networks in Southeast Asian countries. Currently, as part of an industrial-medical collaboration project, I also provide guidance and support to companies in product development with an eye toward exit strategies such as obtaining pharmaceutical or WHO PQ approval, and being included in guidelines in cooperation with related medical sectors and societies.

Mineki Takechi

Cardio Intelligence Inc. Chief Development Officer
Director

Main specialty areas

  • medical devices

Specialized support fields

  • Business planning
  • Business operation systems
  • Etc

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.

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).

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