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MEDISOA comprehensive portal site for Medical Innovation Support Office (MEDISO).Medical Innovation Support Office

厚生労働省

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.

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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.

Click here for inquiries

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).

Miyuki Shimizu

Medical Lab Partners Corporation

Main specialty areas

  • medical devices

Specialized support fields

  • Regulatory compliance
  • Marketing
  • Business planning
  • Business operation systems
  • Specialized support fields

She graduated from the Graduate School of Natural Science, Chiba University. She holds the degrees of doctor of medicine and master of management information. She worked on the development of medical devices and pharmaceutical products in a wide range of fields related to transfusions, surgical operations, general-purpose medical devices, dialysis, and rehabilitation at Terumo Corporation. She also has experience in a series of project developments from planning a project to commercializing at a medical practice, as well as experience in management. Since 2015, she has provided consulting services to more than 350 companies entering the medical industry as her current role. She is trying to provide consulting services with the viewpoint of the individual company in mind.

Tomohito Suzuki

Tohoku University Knowledge Cast Co., Ltd.
Senior Consultant, Medical Device Development Support Division

Main specialty areas

  • medical devices

Specialized support fields

  • Regulatory compliance
  • Business planning
  • Funding

D. in Pharmaceutical Sciences from Kyoritsu Pharmaceutical University (now Keio University). Formerly a medical device reviewer at the Pharmaceuticals and Medical Devices Agency (PMDA). At PMDA, a member of the team in charge of the cardiovascular field and was in charge of approval review and consultation for many medical devices including new medical devices. Seconded from PMDA to the University of Tokyo Hospital as a Project Assistant Professor at the Translational Research Center, where supported the development of medical seeds in academia. Seconded from PMDA to Division of Medical Device Research of the Department of Industrial-Academic Collaboration of the Japan Agency for Medical Research and Development (AMED) as a manager in charge of overseeing projects with medical device-related budgets. He has been in his current position since 2020. Based on his experience in reviewing at PMDA and supporting R&D in academia and AMED, he supports efficient development of medical devices for many manufacturers including venture companies.

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.”

Takayuki Hirose

Patent attorney, Hirose International Patent Firm

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

  • Specialized support fields

He graduated with a master’s degree from the Graduate School, University of Tokyo. Patent attorney. After working in the intellectual property department in a major company, he was involved in lawsuit-, adviser- and application-relating services at a lawyer's office, followed by establishing his own international patent attorney's office in 2017. He offers intellectual property strategies in cooperation with companies as an adviser for multiple companies, including the Japanese Organization for Medical Device Development, Inc., (JOMDD) and Shin Nippon Biomedical Laboratories, Ltd. Furthermore, he applies for patent rights and trademarks in a wide variety of areas. He is involved in intellectual property-related services that include medical devices and pharmaceutical products. When he applies for a patent in foreign countries, he offers application strategies by placing the most importance on client’s profit, for example, to give advice to receive a subsidy or to select a foreign agent at a reasonable price depending on the company’s size.

Tetsuo Miura

Specially Appointed Researcher, Center for Clinical Sciences, National Center for Global Health and Medicine

Main specialty areas

  • medicines
  • medical devices

Specialized support fields

  • Marketing
  • Business planning
  • Business operation systems
  • Etc

I worked as a product and business development manager primarily in the fields of diagnostic equipment-reagent systems and medical devices at major foreign pharmaceutical and domestic medical device companies, and also participated in global product development teams at the US and French headquarters. I have medical science knowledge in the fields of infectious diseases, immunology, cardiovascular diseases, metabolism, reproductive medicine, and laboratory medicine, as well as information on the medical field. After mandatory retirement, I served as a senior researcher at the National Center for Global Health and Medicine, responsible for developing and implementing international collaborative clinical research and clinical trials for pharmaceuticals and medical devices with clinical trial networks in Southeast Asian countries. Currently, as part of an industrial-medical collaboration project, I also provide guidance and support to companies in product development with an eye toward exit strategies such as obtaining pharmaceutical or WHO PQ approval, and being included in guidelines in cooperation with related medical sectors and societies.

About details of specialists

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.

See more about measures implemented by public institutions