A comprehensive portal site for Medical Innovation Support Office (MEDISO).
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.
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).
Mirai Miyahara
President of i Access Consulting Inc.
Main specialty areas
- medical devices
- regenerative medicine products
Specialized support fields
- Regulatory compliance
- Marketing
- Business planning
- Funding
- Business operation systems
Miyahara holds a Master's degree in Business Administration from the Graduate School of Economics at Tohoku University. She possesses 17 years of professional experience in Regulatory Affairs, QMS, business planning, and overseas marketing at a leading medical device company and Notified bodies in Japan. With a specific focus on multi-country regulatory compliance and extensive experience in overseas medical device markets, Miyahara has demonstrated proficiency in navigating the regulatory landscapes of diverse markets, including Japan, China, India, East Southern Asia, EU and the U.S. She has a proven track record of achieving success in supporting medical companies with regulatory compliance, facilitating international expansion, and establishing strategic partnerships with local entities. Miyahara is also an adviser for JETRO medical devices international expansion program.
Tsutomu Uchiyama Ph.,D.
Founder, Uchiyama IP Strategies
Main specialty areas
- medicines
- regenerative medicine products
Specialized support fields
- Specialized support fields
Patent attorney/Ph.D.
After working as a researcher in molecular biology for Daiichi Pharmaceutical Co., Ltd. (current Daiichi-Sankyo), he passed the examination for patent attorneys in 1996. He worked in the intellectual property departments of three companies as an in-house patent attorney, practitioner, manager and global IP head (Eisai)—Takeda Pharmaceutical Company Limited, SoftBank Investment, and Eisai Co., Ltd.—for a total of 20 years, where he was involved in patent practice and patent strategies, as well as patent portfolio management including patent filing, patent clearance and intellectual property due diligence.
In April 2017, he founded Uchiyama IP Strategies. Currently, utilizing his experience, he mainly assists venture companies, small and medium-sized enterprises, and academia in patent strategy and contractual matters in drug discovery, regenerative medicine, and biotechnology research.
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).
Masakatsu Noguchi
SMILE CURVE, Inc.
Main specialty areas
- medicines
- medical devices
- regenerative medicine products
Specialized support fields
- Marketing
- Business planning
- Business operation systems
Ph.D. in life sciences. Worked at consulting firm Dream Incubator, consulting in industry-academia collaboration, business support for tech startups (bio, semiconductor, environmental energy), new business development for large corporations, and overseeing government mega-projects. Previously employed at Abbott Japan and Singapore, managing product marketing for diagnostic tests, pharmaceuticals (women's health), and Asia-Pacific marketing for medical IT. As Business Development Director at Sanamedi, facilitated the commercialization of new medical devices, handled regulatory applications and market launches, and supported investments in and assistance to startups. Additionally served as an evaluator for AMED, and as a mentor for NEDO and university accelerator programs. Currently working independently, he serves as a specially appointed associate professor in the Hiroshima University and as an strategic advisor of MEJ.
Miyuki Nagao
Globizz Japan Corporation Tokyo Office Director
Main specialty areas
- medicines
- medical devices
- regenerative medicine products
Specialized support fields
- Regulatory compliance
- Marketing
- Business planning
- Business operation systems
After working at U.S. headquarters as an assistant for FDA registrations, FDA filings, and regulatory investigations for medical devices, pharmaceuticals, and food products, she moved to GLOBITS' Tokyo office to work as a project coordinator. While proposing and coordinating projects related to Japanese companies' entry into the U.S. market, she also provides support for attending and responding to FDA inspections in various fields, advises on FDA registration, conducts brief investigations, and teaches seminars.
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)
