A comprehensive portal site for Medical Innovation Support Office (MEDISO).
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 inquiriesIn 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).
Hiroki Yamada
Medii, Inc. CEO, M.D.,Ph.D.
Main specialty areas
- medicines
Specialized support fields
- Business planning
- Funding
- Business operation systems
- Etc
Kazuhiro Takekita
Osaka University Graduate School of Medicine, Department of Vascular Regeneration and Podiatry, Associate Professor
Main specialty areas
- regenerative medicine products
Specialized support fields
- Regulatory compliance
- Specialized support fields
He was involved in launching a project of regenerative medicine by using autologous skeletal muscle-derived cell sheets in the Department of Cardiovascular Surgery, Graduate School of Medicine, Osaka University. Subsequently, he was involved in the evaluation of regenerative and biological devices at the Pharmaceuticals and Medical Devices Agency (PMDA). He performed several duties related to the Health Labour Sciences Research Grant, clinical study of human stem cells, and advanced medical care at the Research and Development Division, Health Policy Bureau, Ministry of Health, Labour and Welfare. After that, he led the regenerative medical product evaluation unit as chief of the Office of Review for Regenerative Medical Product, PMDA. Also, he was involved in improving the legislation for regenerative medical products in the revision of the Pharmaceutical Affairs Law in 2014. From August 2017, he has been serving as a specially appointed lecturer in the Department of Cardiovascular Surgery, Graduate School of Medicine, Osaka University, where he promotes projects to develop various products derived from human-induced pluripotent stem cells.
Hirokazu Yamaguchi
Main specialty areas
- medical devices
Specialized support fields
- Regulatory compliance
- Specialized support fields
Akiyo Inoko Hewett
Inoko Law and Consulting, LLC Principal Attorney
Main specialty areas
- medicines
- medical devices
- regenerative medicine products
Specialized support fields
- Regulatory compliance
- Business planning
- Funding
- Business operation systems
- Specialized support fields
Akiyo is an international attorney licensed in both Japan and the United States. She has extensive experience advising Japanese companies on U.S. legal matters. She began her legal career at an Am Law 200 U.S. law firm, where she advised Japanese companies of all sizes and their U.S. subsidiaries on a broad range of legal matters, including corporate governance, commercial contracts, mergers and acquisitions, and compliance. She later joined AI Medical Service Inc., a Japanese healthcare startup, where she supported global commercial agreements, regulatory compliance, and the company's U.S. operations. As a Fractional General Counsel, she now advises multiple Japanese healthcare startups on U.S. market entry, business expansion, regulatory compliance, and day-to-day legal and operational matters.
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.
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.
- The Ministry of Health, Labour and Welfare／
- Pharmaceuticals and Medical Devices Agency (PMDA)／
- Japan Agency for Medical Research and Development (AMED)／
- Cabinet Office／
- Ministry of Economy, Trade and Industry／
- Ministry of Internal Affairs and Communications／
- Small and Medium Enterprise Agency／
- Organization for Small & Medium Enterprises and Regional Innovation, Japan／
- Union of Kansai Governments／
- New Energy and Industrial Technology Development Organization (NEDO)／
- Life Science Innovation Network Japan, Inc. (LINK-J)／
- Japan Science and Technology Agency (JST)／
- Japan External Trade Organization (JETRO)／
- INCJ, Ltd.／
- Osaka Prefecture／
- Tokyo Metropolis／
- Kanagawa Prefecture／
- National Institutes of Biomedical Innovation, Health and Nutrition (NIBIOHN)
