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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).

Kazuhiro Takekita

Osaka University Graduate School of Medicine, Department of Vascular Regeneration and Podiatry, Associate Professor

Main specialty areas

  • regenerative medicine products

Specialized support fields

  • Regulatory compliance
  • Specialized support fields

He was involved in launching a project of regenerative medicine by using autologous skeletal muscle-derived cell sheets in the Department of Cardiovascular Surgery, Graduate School of Medicine, Osaka University. Subsequently, he was involved in the evaluation of regenerative and biological devices at the Pharmaceuticals and Medical Devices Agency (PMDA). He performed several duties related to the Health Labour Sciences Research Grant, clinical study of human stem cells, and advanced medical care at the Research and Development Division, Health Policy Bureau, Ministry of Health, Labour and Welfare. After that, he led the regenerative medical product evaluation unit as chief of the Office of Review for Regenerative Medical Product, PMDA. Also, he was involved in improving the legislation for regenerative medical products in the revision of the Pharmaceutical Affairs Law in 2014. From August 2017, he has been serving as a specially appointed lecturer in the Department of Cardiovascular Surgery, Graduate School of Medicine, Osaka University, where he promotes projects to develop various products derived from human-induced pluripotent stem cells.

Hiroaki Kato

Visiting Professor, The Graduate School of the Digital Hollywood University

Main specialty areas

  • medical devices

Specialized support fields

  • Regulatory compliance
  • Marketing
  • Business planning
  • Funding
  • Business operation systems

He is a former government official of the Ministry of Health, Labour and Welfare and is working as a doctor specialized in digital health, including telemedicine, AI, and IoT. As an ophthalmologist, he has experience in more than 1,500 surgical operations. He developed instruments for cataract operations and ophthalmic consultation services. He is a rare person who has experience in three areas—medical practice, medical systems, and business—which are required for medical care and the healthcare business, and he understands these areas, providing support for the development of new business covering the full range of medical care. He is also familiar with Japanese medical venture companies and works as a consultant, advisor, and director for large enterprises and venture companies. He wrote 41 books, including Medical Care 4.0 — Medical Care in the Fourth Industrial Revolution Era—.

Hikaru Saito

Saisei Ventures LLC Partner

Main specialty areas

  • medicines
  • regenerative medicine products

Specialized support fields

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

As a partner of Saisei Ventures, a newly established global venture capital firm that invests in advanced biotech companies in cell and gene therapy, Dr. Saito is responsible for Japan operations including company creation, integrating Japanese science and technology with the Western ecosystem. Prior to joining Saisei, he started career as a research scientist at Astellas Pharma Inc. and then as a Senior Manager of Business Development and as a Senior Investment Manager at Astellas Venture Management, a CVC arm based in Silicon Valley, USA, where he was a lead role for deal process, due diligence and transactions for venture investments in RNA therapeutics, cell and gene therapy. He was providing business support to portfolio companies based on the expertise, experience, and global network. He also led the development of strategic partnerships with venture capital funds, accelerators, and institutional investors based in the U.S. and Europe. Prior to joining Astellas, he was a Visiting Fellow at the Institute of Medical Science, University of Tokyo, and a Research Fellow of the Japan Society for the Promotion of Science. He received his B.S. in Biotechnology and M.S. and Ph.D. in Biomolecular Molecularl Engineering from Tokyo Institute of Technology.

Mineki Takechi

Cardio Intelligence Inc. Chief Development Officer
Director

Main specialty areas

  • medical devices

Specialized support fields

  • Business planning
  • Business operation systems
  • Etc

After working at Fujitsu Ltd. on the development of products and services such as image processing system and cloud information service for home healthcare, as well as research and development in information retrieval and AI, and new business development, I engaged in the construction of a pulmonary hypertension patient registry at the International University of Health and Welfare Mita Hospital. Since 2020, I have been serving as CDO at Cardio Intelligence Inc., responsible for the development of software medical devices for arrhythmia analysis and regulatory affairs. Since 2021, I have also been serving as COO, overseeing overall business planning and execution.

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.

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