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).
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.
Makoto Shigematsu
Representative Director, Kai Fostering Partners Inc.
Main specialty areas
- medicines
- medical devices
- regenerative medicine products
Specialized support fields
- Marketing
- Business planning
- Funding
- Business operation systems
- Specialized support fields
He worked on a new project research and development, trial manufacture, mass production, and commercializing of glass delay line element for VTR at Asahi Glass Co., Ltd. He moved to CSKVC by making use of his relevant experience. As a venture capitalist, he engaged mainly in establishing, financing, fostering, and managing venture companies. He practiced monetizing of novel technologies, timely financing, establishing organization and management, sharing an exit strategy as a milestone, active use of intellectual property rights (open and close), and business talks and negotiations (not bargaining) hated by engineers. He has providing support for company’s growth fostered by competition and cooperation, while being employed by traditional companies for 20 years and by venture companies for 20 years with an understanding exactly the opposite of the corporate culture of both.
Masatoshi Tachibana
BPM Consulting Office Representative
Main specialty areas
- medicines
- medical devices
Specialized support fields
- Regulatory compliance
- Marketing
- Business planning
- Business operation systems
He worked in the medical device division of a precision equipment company for over 25 years, working in a series of tasks spanning the product life cycle, including marketing (domestic and overseas market research, business development), product planning, legal and regulatory compliance, quality management system construction. He has experience managing numerous projects, including those outside the company also. His policy in conducting business is to maximize the performance of the organization by promoting overall optimization, making decisions based on a bird's-eye view, and building good relationships with all of stakeholders. Based on these knowledge and policies, He provides fact-based and risk-based support to ventures and small and medium-sized enterprises aiming for practical application in the medical field.
Rou Irisawa
IRISAWA Consulting LLC
Main specialty areas
- medicines
- regenerative medicine products
Specialized support fields
- Regulatory compliance
- Etc
Worked at Chugai Pharmaceutical Co., Ltd. for 27 years, primarily in antibody drug research and development, CMC regulatory affairs, and quality assurance, from preclinical trials stage to BLA stage. Involved in the BLA of Japan, US and EU approval for the CTD-Q of Actemra, Japan's original first antibody drug. And also involved in Japan BLA for several biologics Genentech original. Since 2017, involved in the development of many new modalities, including three SAKIGAKE designated cell products, and participated in 21 times PMDA consultations responsible for CMC regulatory and QA for cell products and gene therapy products. In 2023, became independent as a CMC regulatory consultant. Author of ""CMC Pharmaceutical Design - CMC Pharmaceutical Strategy in the Era of New Modality Pharmaceuticals"" (Yakuji Nipposha, 2022), and is the overall supervisor of the Japanese translation of A-CELL (CMC Development Guidance for CAR-T). Fellow at Tama University's Medical Care Solutions Research Institute, and a top performer in the regular course of Pharmaceutical Evaluation Science at the University of Tokyo Graduate School of Pharmaceutical Sciences in 2024. Certified in generative AI skills (November 2025). Currently involved in various projects, including serving as CMC lecturer at seminars on how to proceed with the development of CMC for antibody drugs, cell products, gene therapy products, etc for small company to semi-major company.
Yoshiki Kawabata
President, MedX Inc.
Main specialty areas
- medical devices
- regenerative medicine products
Specialized support fields
- Regulatory compliance
- Marketing
- Business planning
- Funding
- Business operation systems
- Specialized support fields
Advantage from over 35 years of multiple company & responsibility experience in medical device industry, helping foreign companies to enter into Japanese market. Key highlights in the past achievements are : with Johnson & Johnson Mdecial Company, worked with US R&D team to develop new product which reflecting Japanese patient and physicians needs - three years resided in Cincinnati, Ohio: HeartFlow Inc., which developed the first "program device" - FFRCT, enabling non-invasive detection of FFR, applied and received regulatory approval and reimbursement as a first product and company. : in Palette Lifesciences Japan, establishment of new subsidiary for start-up company which transferred the business from exclusive distributor. Started with minimum number of direct resources and having multiple partnerships with logistics, finance and regulatory affairs, revitalized the business and achieved a 149% growth over the last year of distributor.
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)
