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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.

2026年4月28日（火）～2026年5月6日（水）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).

Kenichi Yamahara

Professor at the Laboratory of Molecular and Cellular Therapy, Institute for Advanced Medical Sciences, Hyogo Medical University
Representative Director of CTEX Co., Ltd.

Main specialty areas

  • medical devices
  • regenerative medicine products

Specialized support fields

  • Regulatory compliance
  • Marketing
  • Business planning
  • Business operation systems
  • Specialized support fields

From the time of a former position at the National Cerebral and Cardiovascular Center, he planned and implemented the formulation of the amnion-derived mesenchymal stem cells and investigator-initiated clinical trials for acute grafts versus host disease/Crohn's disease under the support by Health and Labour Sciences Research Grants/AMED. He often had PMDA consultations on the products of regenerative medicine and acquired knowledge of laws and regulations. Taking advantage of the experience, he founded a venture, Japan Biomedical Co., Ltd., which manufactures the domestic bovine serum NeoSERA® for the products of regenerative medicine by satisfying the standards for biological materials in January 2017. Furthermore, in order to aggressively develop investigator-initiated clinical trials of cell therapy making use of university hospital infrastructures, he founded a venture, CTEX Co., Ltd., from Hyogo Medical University in February 2018. Recently, he participated as a medical expert in the company developing the regenerative medical product and is a principal investigator for investigator-initiated clinical trials for the development of cell therapy in the medical device category (adopted by AMED). Currently, he is working on the practice of cell therapy development initiated at the university hospital while concurrently serving in the basic and clinical departments of Hyogo Medical University.

Kumi Sakurai

早稲田大学大学院理工学研究科で生体工学を専攻後、慶應義塾大学病院で10年以上にわたり血液研究に従事。その後、外資系医療機器メーカーであるベックマンコールター（2005年～）、日本メドトロニック（2007年～）、セントジュードメディカル（現アボットメディカル、2015年～）のマーケティング部門にて、医療機器の市場導入や事業戦略を担当。2019年、医療機器・ヘルスケア機器の開発支援を専門とするインキュベーター、プレモパートナー株式会社を共同創業。研究者・スタートアップ・大企業を対象に、事業戦略策定から薬事・保険償還・上市までを一気通貫で支援し、国内外のネットワークを活かして医療機器の事業化を推進している。
文部科学省　科学技術・学術審議会専門委員、東京都AMDAPカタライザー
早稲田大学大学院修了（工学修士）。金沢工業大学大学院修了（MBA）

Main specialty areas

  • medical devices

Specialized support fields

  • Marketing
  • Business planning
  • Business operation systems

After earning a master’s degree in Biomedical Engineering from Waseda University, Kumi Sakurai engaged in over ten years of hematology research at Keio University Hospital. She then transitioned to the medical device industry, joining Beckman Coulter in 2005, Medtronic Japan in 2007, and St. Jude Medical (now Abbott Medical) in 2015, where she worked in marketing and business strategy for innovative medical technologies. In 2019, she co-founded Premo Partners Inc., an incubator specializing in the development and commercialization of medical and healthcare devices. Premo Partners supports researchers, startups, and large corporations throughout the entire innovation process—from business strategy formulation, market analysis, and regulatory and reimbursement planning to commercialization. Leveraging extensive domestic and international networks, the company provides end-to-end support to accelerate the delivery of essential medical technologies to patients and healthcare professionals. Through its comprehensive expertise in regulatory pathways, evidence generation, and global market access, Premo Partners plays a vital role in fostering Japan’s MedTech ecosystem and bridging it with the global healthcare innovation community.

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.

Hikaru Saito

Saisei Ventures LLC Partner

Main specialty areas

  • medicines
  • regenerative medicine products

Specialized support fields

  • Regulatory compliance
  • Marketing
  • Business planning
  • Funding
  • Business operation systems
  • Specialized support fields

As a partner of Saisei Ventures, a newly established global venture capital firm that invests in advanced biotech companies in cell and gene therapy, Dr. Saito is responsible for Japan operations including company creation, integrating Japanese science and technology with the Western ecosystem. Prior to joining Saisei, he started career as a research scientist at Astellas Pharma Inc. and then as a Senior Manager of Business Development and as a Senior Investment Manager at Astellas Venture Management, a CVC arm based in Silicon Valley, USA, where he was a lead role for deal process, due diligence and transactions for venture investments in RNA therapeutics, cell and gene therapy. He was providing business support to portfolio companies based on the expertise, experience, and global network. He also led the development of strategic partnerships with venture capital funds, accelerators, and institutional investors based in the U.S. and Europe. Prior to joining Astellas, he was a Visiting Fellow at the Institute of Medical Science, University of Tokyo, and a Research Fellow of the Japan Society for the Promotion of Science. He received his B.S. in Biotechnology and M.S. and Ph.D. in Biomolecular Molecularl Engineering from Tokyo Institute of Technology.

Kazufumi Nakamura

Mitsui & Co. Global Investment, Inc.　Investment Director

Main specialty areas

  • medicines
  • regenerative medicine products

Specialized support fields

  • Business planning
  • Funding
  • Business operation systems
  • Etc

Kazufumi Nakamura is an Investment Director focused on the investment in biotech in US and China. By leveraging his experiences and networks in Pharma, Biotech and Academia, he connects companies to those experts to expand business and gain scientific insight to help the companies succeed with their important missions.
Kazufumi has over 20 years of healthcare and life sciences experience, spanning business development, investment, entrepreneurship and R&D. Prior to joining MGI, he co-founded a biotech to accelerate innovations through academic institutions in Japan. Previously, he engaged in business development and conducted scientific evaluation, and license-in and license-out of pharmaceutical products at Santen Pharmaceuticals. In addition, he was responsible for creating relationships with the leading academic institutions and innovators, gaining Santen early access to innovation. Prior to Santen, he held a number of clinical development roles at Janssen Pharmaceuticals, including the development of Alzheimer’s disease and Rheumatoid arthritis programs.

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