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).
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.
Minori Kosuge
Senior Manager, Regulatory Affairs and Quality Assurance
Rokken, Inc.
Main specialty areas
- medical devices
Specialized support fields
- Regulatory compliance
- Etc
- Experience of working for 15 years at a Japanese medical device company: Technical writing, regulatory affairs (US 510k submissions, translation for QSR inspection), R&D of patient monitor and its related programs.
- Experience of working at Japanese SaMD startup companies: experience of negotiation with PMDA and consultation for regulatory affairs/quality assurance.
- Currently working as a regulatory affairs/quality assurance consultant and an in-house regulatory affairs/quality assurance specialist.
Support available for class II active medical devices and SaMD, for Japan and US.
Yoshinori Shinoki
Pharma Initiative Support LLC
Main specialty areas
- medicines
- medical devices
- regenerative medicine products
Specialized support fields
- Regulatory compliance
- Marketing
- Business planning
- Business operation systems
He graduated from the Department of Biopharmaceutical Sciences, Kyoto Pharmaceutical University, and is a licensed pharmacist. At Sawai Pharmaceutical Co., Ltd., and Eli Lilly Japan K.K., after taking charge of clinical development, business planning, etc., he acquired experience in planning and implementing various clinical development plans as a project leader for newly developed items in the project management department. In addition, he led NHI price negotiation strategy, post-marketing clinical startegy, and market planning. After that, he built up clinical development department at Global CRO. he also led the planning of the clinical development for Japan for small and biological products, as well as negotiating with regulatory authorities. Recently, in addition to medicines, he also led the development of clinical development strategies of medical devices and the products of regenerative medicine (gene therapy products and cell/tissue processed products).
Yuki Yamakage
Representative Director, Takashi Shimada Office Co., Ltd.
Managing Partner, BD Consulting Ltd.
Main specialty areas
- medical devices
- regenerative medicine products
Specialized support fields
- Marketing
- Business planning
- Etc
I have experience working for a global medical device company in insurance strategy development and insurance applications for products in a wide range of medical specialties and disease areas, as well as market access work (relevant academic societies, patient groups, government agencies and industry associations). I have now set up my own private practice and provide support to medical device and pharmaceutical companies and new entrants in terms of healthcare and care systems and insurance strategies. I have experience in the insurance application category (C1/C2 applications) for innovative medical devices. I also have a lot of experience in training employees and conducting seminars, most recently on SaMD insurance applications. My motto is to provide consulting services that address the concerns of my clients after explaining information on insurance applications for medical devices in a way that is easy to understand for beginners.
Akihiko Okuno
SK Intellectual Property Law Firm (SKIP) Managing Partner
SCM BioMedica Co., Ltd. Co-Founder
Main specialty areas
- medicines
- medical devices
- regenerative medicine products
Specialized support fields
- Specialized support fields
Master's degree in Cell Structure Research, Department of Applied Bioengineering, Graduate School of Agriculture and Life Sciences, University of Tokyo, Japanese Patent Attorney, Information Security Administrator, and JPAA Intellectual Property Management Consultant certification. As a FoundX supporter of the University of Tokyo, He supports the intellectual property strategies of many IT and bio-related startups. He specializes in supporting the planning of intellectual property strategies in a variety of fields including biotechnology, pharmaceuticals, and medical devices. In addition, together with Dr. Yoshimasa Tanaka of Nagasaki University (a genius researcher who developed Opdivo with annual sales of over 1 trillion yen together with Dr. Tasuku Honjo, winner of the Nobel Prize in Medicine and Physiology), he established SCM Biomedica Co., Ltd. He co-founded the company and is currently trying to manage his own drug discovery startup.
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)
