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.
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).
Hiroaki Kato
Visiting Professor, The Graduate School of the Digital Hollywood University
Main specialty areas
- medical devices
Specialized support fields
- Regulatory compliance
- Marketing
- Business planning
- Funding
- Business operation systems
He is a former government official of the Ministry of Health, Labour and Welfare and is working as a doctor specialized in digital health, including telemedicine, AI, and IoT. As an ophthalmologist, he has experience in more than 1,500 surgical operations. He developed instruments for cataract operations and ophthalmic consultation services. He is a rare person who has experience in three areas—medical practice, medical systems, and business—which are required for medical care and the healthcare business, and he understands these areas, providing support for the development of new business covering the full range of medical care. He is also familiar with Japanese medical venture companies and works as a consultant, advisor, and director for large enterprises and venture companies. He wrote 41 books, including Medical Care 4.0 — Medical Care in the Fourth Industrial Revolution Era—.

Yasuo Sasaki
Main specialty areas
- medicines
- medical devices
- regenerative medicine products
Specialized support fields
- Regulatory compliance
- Marketing
- Business planning
- Business operation systems
- Specialized support fields
He graduated with a doctoral degree in science from the Department of Chemistry, Graduate School of Science, Hokkaido University. He was involved in the research and development of pharmaceutical products as an employee of Asahi Kasei Pharma Corporation. He was mainly in charge of preclinical studies and regulatory affairs. From 2013, he provided support for research and development by academia, drug discovery venture companies, and small and medium enterprises centering on the eastern part of Shizuoka Prefecture. Since 2018, he has been providing support services as a freelance advisor or coordinator in the life science field.

keiji Asada
Amenichi Consulting, LLC, CEO
Main specialty areas
- medicines
- medical devices
- regenerative medicine products
Specialized support fields
- Regulatory compliance
- Marketing
- Business planning
- Funding
- Business operation systems
- Etc
Graduated from Auburn University with a degree in Chemical Engineering. Currently, serving as the CEO of Amenichi Consulting, LLC, a consulting firm specializing in regulatory compliance (FDA) and marketing support for companies entering the U.S. market, particularly in the fields of pharmaceuticals, medical devices, and regenerative medicine products. With extensive industry experience and expertise, he assists clients in developing business plans, securing funding, and establishing operational structures. Additionally, he provides comprehensive support, from the formulation to the execution of business strategies, to help clients enhance their competitiveness. Furthermore, he leverages his network to match clients with the most suitable business partners. With a global perspective, he offers customized services tailored to the needs of each client, aiming for sustained growth and success. Amenichi was established in 2018 and has supported over 50 companies since its inception.

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.

Hiroya Kuwahara
Department of Neurology and Neurological Science / Institute of Innovation Advancement
Tokyo Medical and Dental University
Main specialty areas
- medicines
- medical devices
- regenerative medicine products
Specialized support fields
- Marketing
- Business operation systems
M.D. (graduated from Tokyo Medical and Dental University), and Ph.D. (completed doctral course at Graduate School, Tokyo Medical and Dental University). Specialist and Attending Neurologist of the Japanese Society of Neurology, and Fellow and Board Certified Member of the Japanese Society of Internal Medicine. He is engaged in 1) clinical practice, research, and education in neurology, 2) research and development of fudamental technologies for drug discovery (especialy nucleic acid drugs and drug delivery system), 3) promotion of clinical research and industry-academia collaboration, at Tokyo Medical and Dental University. He has a career of a Deputy Director at Research and Development Division, Health Policy Bureau, at the Ministry of Health, Labour, and Welfare from 2018 to 2019, and was involved in establishing a nationwide system for promoting clinical research and accelerating venture companies in the healthcare field. He provides consultations on the needs of clinical practice, on collaborative research and field provision in relation to project implementation, and on clinical research and development.

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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