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.
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.
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).
Tomohisa Hayasaki
GVA LPC Attorney-at-Law / Partner
The Leader of The Team ""Medical / Healthcare / Cosmetic Industry""
Main specialty areas
- medicines
- medical devices
- regenerative medicine products
Specialized support fields
- Regulatory compliance
- Marketing
- Funding
- Specialized support fields
- Etc
After registering as a lawyer, I have been handling disputes such as corporate and labor disputes, as well as providing legal support for the designing lawful business models of new businesses and for funding. In addition, I have been providing legal support for businesses in the field of medical and beauty based on my knowledge of laws relating to medicals including the Japanese Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and the Japanese Medical Care Act. In particular, I have been providing extensive support for numerous businesses operating in new field such as Software as Medical Device (SaMD) and Non-Software as a Medical Device (Non-SaMD), telemedicine/home call medical services, and also for companies utilizing medical information by employing new technologies such as AI. I am also addressing legal issues faced by companies using advance technologies. Furthermore, I have expertise in the latest marketing trend and offer advice on marketing strategies based on the Japanese Act against Unjustifiable Premiums and Misleading Representations, advertising regulations in Japan such as medical advertising regulations, and medical and pharmaceutical devices regulations.

Katsuhiro Fukunishi
Main specialty areas
- medicines
- regenerative medicine products
Specialized support fields
- Etc

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).

Akiyo Inoko Hewett
Attorney, Smith, Gambrell & Russell, LLP
Main specialty areas
- medicines
- medical devices
- regenerative medicine products
Specialized support fields
- Regulatory compliance
- Business planning
- Funding
- Business operation systems
- Specialized support fields
Akiyo Inoko Hewett is a bilingual and double-licensed attorney based in Atlanta, Georgia, United States. She graduated from Tokyo University of Foreign Studies and earned her J.D. at Keio Law School. After passing the Japanese bar exam and completing her legal training in Kushiro, Hokkaido, Akiyo relocated to the United States. She earned an LL.M. from Emory University School of Law in Atlanta, Georgia. Currently, Akiyo serves as an attorney at Smith, Gambrell & Russell, LLP, where she provides legal services to Japanese companies doing business in the United States and supports clients across a broad range of corporate matters. Her practice areas include international and domestic commercial transactions, regulartory compliance, healthcare law, and immigration law.

Taku Seriu
Seriu Medical Consulting Ltd. CEO
APCER Life Sciences. Senior Advisor to the Board
The Institute of Drug Development Career Promotion. Representative Director
Main specialty areas
- medicines
- regenerative medicine products
Specialized support fields
- Regulatory compliance
- Business planning
- Business operation systems
- Etc
A physician and Doctor of Medical Science, he began his career as an internist before leading clinical leukemia research at the Universities of Ulm and Heidelberg in Germany. After returning to Japan, he took on leadership roles including Head of Clinical Development at Nihon Schering, Executive Officer at Bristol-Myers Squibb, and Executive Vice President and Board Member at Otsuka Pharmaceutical, where he oversaw drug development, medical affairs, regulatory affairs, pharmacovigilance, and quality assurance.
He has led the development, approval, and post-marketing activities of more than 50 therapeutics and diagnostics across oncology, neuroscience, cardiovascular and renal diseases, infectious diseases, and rare diseases, contributing to global launches and appropriate-use initiatives.
He currently serves as President of Seriu Medical Consulting and Senior Advisor at APCER Life Sciences, supporting R&D strategy, safety and risk management, organizational development, and new business planning. He also advises startups on development strategy, TPP creation, and fundraising pitch preparation, and has a strong track record in post-acquisition organizational integration, aligning cultures, talent, and processes.
He teaches pharmaceutical medicine at several universities and is an editor and contributing author of Introduction to Pharmaceutical Medicine, the first textbook of its kind published in Japan. He continues to practice clinical medicine and remains committed to supporting those driving pharmaceutical innovation in Japan, guided by the principle: “Learn Together, Grow Together.”

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