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

厚生労働省

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サポーターの紹介
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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.

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).

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.

Yutaka Kono

Guest professor
Drug Discovery Science Division,Institute for Open and Transdisciplinary Research Initiatives, Osaka University

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

  • Business planning
  • Funding
  • Business operation systems
  • Etc

Eiichi Yamaguchi

Eiichi Yamaguchi, Ph.D. President A1 Partners

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

  • Marketing
  • Business planning
  • Funding
  • Business operation systems

Ph.D from Faculty of Pharmaceutical Sciences Kyushu University. Currently engaged in management and business development consulting for pharmaceutical companies, biotech ventures, and consulting firms. Over 20 years expertise of business development at Shionogi Co., Ltd., a major pharmaceutical company as well as bioventure companies. Senior Director, Business Development & Corporate Planning Dept., Shionogi. A lot of global business experience such as the first Managing Director, Shionogi Singapore, Vice President, Shionogi Qualicaps, Inc., North Carolina, and Shionogi New York. Board of Director & President & COO, a bioventure company. The first chairman, Japan Pharma Alliance Association. The Vice Chairman, Public Private Alliance Conference associated with Infectious diseases led by Dr. Shigeru Omi. Also engaged in Director, International Committee, JPMA. Last but not least, selected as Mentor for Blockbuster Tokyo 2021

Masakazu Masujima

Partner, Mori Hamada & Matsumoto

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

  • Regulatory compliance
  • Funding
  • Business operation systems
  • Specialized support fields

Masa is a guru of startup legal advisory space in Japan. Based on the experiences at Palo Alto office of Wilson Sonsini Goodrich & Rosati, his advice is West Coast style; progressive, risk-base and proactive. Through more than 2 dacades of dedication to the startup space, he has advised IPOs, M&As and major cross-border fundraising for may startups, including biotech and healthcare ones, and have also worked with entrepreneurs through a variety of touch situation, such as disputes between founders, problems with investors as well as intellectual property disputes. Masa has served as a council member of numerous Government committees, such as Regulatory Reform Promotion Council, the Regulatory Sandbox Committee, the Digital Market Competition Council and the Industrial Structure Council. He is admitted to NY bar and Japan bar, and a licensed patent attorny in Japan.

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