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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).

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).

Masashi Matsunaga

Biospire Japan Ltd. / Biospire UK Ltd.
CEO

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

  • Marketing
  • Business planning
  • Funding
  • Business operation systems

As an experienced global business development strategist, Dr Masashi Matsunaga provides business soft-landing, clinical and regulatory support to the UK and European market. He also enables to support IP management, marketing and pitch-deck brush-up in the MEDISO support package. He is based at Harwell Science & Innovation Campus, a core UK innovation hub located near Oxford.

Yoshimi Naruo

Orizuru Therapeuics, Inc. Associate Director, IP&Legal Ph.D., Patent attorney

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

  • Regulatory compliance
  • Specialized support fields

Education: Ph.D. in Bioinformatics/Systems Biology, Tokyo Medical and Dental University. Conducted research in systems biology at RIKEN for 3 years (student internship). Experience: 5 years of experience in drug regulatory affairs at an originator pharmaceutical company, followed by 2 years as an in-house IP specialist handling invalidation and infringement matters at a generic pharmaceutical company. Patent prosecution primarily in the fields of pharmaceuticals, biotechnology, and food at an IP law firm. Fulfilling a long-held aspiration to join a startup, she took on the role of Vice President of Legal IP & Strategy at Splink, Inc., where she contributed to winning the Grand Prix at the 3rd IP BASE AWARD hosted by the Japan Patent Office and the 2022 WIPO Global Awards hosted by the World Intellectual Property Organization (WIPO). Currently, she is responsible for intellectual property and legal affairs at Orizuru Therapeutics, Inc., a company aiming to commercialize regenerative medicine derived from iPS cells. She leads the formulation of IP strategies and the development of an IP portfolio. Her strength lies in creating IP strategies with a focus on pharmaceutical regulatory affairs, and she strives to provide practical advice in the face of limited resources and uncertainties surrounding technology and commercialization.

Minori Kosuge

Senior Manager, Regulatory Affairs and Quality Assurance
Rokken, Inc.

Main specialty areas

  • medical devices

Specialized support fields

  • Regulatory compliance
  • Etc

- Experience of working for 15 years at a Japanese medical device company: Technical writing, regulatory affairs (US 510k submissions, translation for QSR inspection), R&D of patient monitor and its related programs. - Experience of working at Japanese SaMD startup companies: experience of negotiation with PMDA and consultation for regulatory affairs/quality assurance.
- Currently working as a regulatory affairs/quality assurance consultant and an in-house regulatory affairs/quality assurance specialist.
Support available for class II active medical devices and SaMD, for Japan and US.

Makoto Shigematsu

Representative Director, Kai Fostering Partners Inc.

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

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

He worked on a new project research and development, trial manufacture, mass production, and commercializing of glass delay line element for VTR at Asahi Glass Co., Ltd. He moved to CSKVC by making use of his relevant experience. As a venture capitalist, he engaged mainly in establishing, financing, fostering, and managing venture companies. He practiced monetizing of novel technologies, timely financing, establishing organization and management, sharing an exit strategy as a milestone, active use of intellectual property rights (open and close), and business talks and negotiations (not bargaining) hated by engineers. He has providing support for company’s growth fostered by competition and cooperation, while being employed by traditional companies for 20 years and by venture companies for 20 years with an understanding exactly the opposite of the corporate culture of both.

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