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).
Akiko Yamamoto
Nissan Chemical Corporation
Risk Management ＆Compliance Office
Risk Management Department
Main specialty areas
- medicines
Specialized support fields
- Regulatory compliance
- Business operation systems
- Etc
Graduated from the Department of Pharmacy at Kyoritsu Collage of Pharmacy (currently Keio University) and received a Ph.D. from Gifu Pharmaceutical University. Engaged in work related to each process of pharmaceutical life cycle (research and development, sales promotion, licensing/alliance, quality assurance and Good Vigilance Practice(GVP)) at Nissan Chemical Corporation. Especially, as the corporate quality assurance department leader, managed the company's pharmaceutical quality system, and maintained and improved appropriate quality assurance systems for API manufacturing sites, manufacturing contractors, and contract testing facilities. Specifically, provided support during FDA inspections and global pharma quality audits, and advised on improvements and response policies for issues raised. Also has experience in implementing regulations and change processes when adding starting material, intermediate and API manufacturing sites, and testing facilities. In addition, has reviewed documents such as license and quality assurance-related contract contents, change applications and master files to be submitted to authorities.
Yutaka Tomioka
Project Researcher, Department for the Promotion of Medical Device Innovation, National Cancer Center Hospital East.
Chief Regulatory Scientist, ayumo Inc.
Chief Development Officer / Director, Atransen Technologies, Inc.
Senior Specialist, Premo Partners, Inc.
Main specialty areas
- medical devices
Specialized support fields
- Regulatory compliance
- Business operation systems
Ph.D. (Engineering). I began my career at the Pharmaceuticals and Medical Devices Agency (PMDA), where I worked in medical device review and reliability inspection (reliability standards compliance inspections and on-site GCP inspections for medical devices). My responsibilities included the approval review, consultation services, and reliability inspections for a wide range of medical devices, including novel medical devices. Drawing on my 10 years of experience at the regulatory authority, I moved to National Cancer Center Hospital East in July 2019 to support the development of medical devices originating in Japan. At National Cancer Center Hospital East, I supported medical device development led by both academic institutions and companies. I left my full-time position at National Cancer Center Hospital East at the end of 2025, and joined ayumo Inc. in January 2026 (current position), where I lead the regulatory affairs team.I also joined Atransen Technologies, Inc. in May 2026 (current position). I currently hold part-time positions at National Cancer Center Hospital East, Yokohama City University, and the National Defense Medical College, while also supporting a number of startups, pharmaceutical companies, medical device manufacturers, academic institutions, and small manufacturing workshops (machi-koba) in Ota Ward, Tokyo.
Kunishige Masui
Managing Partner
Main specialty areas
- medicines
- medical devices
- regenerative medicine products
Specialized support fields
- Regulatory compliance
- Funding
- Specialized support fields
Graduated from Kyoto University Faculty of Law, University of Tokyo Law School, and University of California, Irvine LLM. 2014 - 2021 at Nagashima Ohno & Tsunematsu; 2020 - 2021 at Smith, Gambrell & Russell, LLP （US law firm）. Established Masui & Partners in December 2021. Mr. Kunishige Masui assisted numerous startups, from angel rounds to companies nearing IPO, and has also assisted in the launch of many new businesses, including cross-border localization. He is well versed in the legal and financing issues that arise for startups and new business development, and provides support as a mentor for JETRO, Healthcare Innovation Hub, Kawasaki-NEDO Innovation Center （K-NIC）, Venture Café Tokyo, and IDEC. In addition to providing easy-to-understand explanations of foreign legal systems in comparison to those in Japan, he also specializes in removing obstacles to business growth by not only providing answers to "points that clients have actually consulted with" but also by digging into "points that need attention that clients are not yet aware of.”
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.
Yumi Kawata ,MD, PhD
Hedgehog MedTech, Inc.
Main specialty areas
- medical devices
Specialized support fields
- Regulatory compliance
- Marketing
- Business planning
- Funding
- Business operation systems
She is Founder and CEO of Hedgehog MedTech, Inc, a start-up Digital Therapeutics (DTx) company. Previously, she was a manager with SoftBank Corp, where she evaluated new Healthcare & Life Science investment opportunities, managed relationships with strategic partners. Prior to SoftBank, she was a Government Relations specialist with Medley, Inc, where she built and maintained the relationships with Ministry of Health, Labour and Welfare and Academia. She launched researches and POCs, contributing to the spread of telemedicine in Japan. She also served as a technical officer for MHLW. she was involved in the management of researches on Rare and Intractable diseases and Infectious Diseases.
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)
