Our site uses cookies to improve the contents of the site and customize it according to individual use. Please confirm that you agree to our use of cookies by clicking Yes.

If you continue without explicit consent,
we will assume that you agree to our cookie policy.

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.

×

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).

Saaya Hirai

Globizz Corp.　Senior Manager

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

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

After graduating from a university in Taiwan, she began her career at Globizz Japan as a Business Planning Specialist. In this role, she developed proposals for Japanese companies seeking entry into the U.S. market and provided support for FDA compliance, including assistance with Quality Management System (QMS) development for medical device manufacturing facilities and FDA inspection readiness. She later transitioned to Globizz Corp., the U.S. headquarters of Globizz Japan, where she currently coordinates FDA submission projects and conducts regulatory research and registration activities. In addition, she supports Japanese companies in expanding their presence in the U.S. medical device market by accompanying them to major industry exhibitions, assisting with trade show participation, and joining business meetings to facilitate market development. Leveraging her proficiency in English, Japanese, and Chinese, she plays a key role as a bridge in international projects. Her support experience includes FDA submission strategy development, 510(k) submissions, Breakthrough Device designation requests, U.S. KOL interviews, reimbursement strategy support, and assistance with establishing U.S. corporate entities.

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—.

Kazuhiro Ikumi

MEDICOLAB Co., Ltd.

Main specialty areas

  • medical devices

Specialized support fields

  • Business planning
  • Funding
  • Business operation systems
  • Specialized support fields
  • Etc

Board-certified neurologist, CEO at MEDICOLAB, Co., Ltd. My initial job was a medical doctor at a tertiary care emergency hospital. I have 14 years of clinical experience in Parkinson's disease, dementia and other neurodegenerative diseases. MEDICOLAB, Co., Ltd. receives PR and development support from Fujitsu, NVIDIA, Amazon, and Microsoft. I am involved in business development in the CNS area and support researchers for their idea and trial products or services for commercialization.

Hidehiro Ando

President & Representative, Andy Pharma Partners Inc.

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

  • Marketing
  • Funding
  • Business operation systems

He graduated from the Department of Veterinary Medical Science, Faculty of Agriculture, University of Tokyo. He joined Tanabe Pharma Corporation (present Mitsubishi Tanabe Pharma Corporation). After being assigned to the research department of pharmacokinetics, he was involved in partnership-related business of international development department, research and development planning department, etc., including establishment of a joint venture with overseas companies. Subsequently, he worked in the technology transfer department of RIKEN (Institute of Physical and Chemical Research), a regenerative medicine venture, Bayer Yakuhin, a drug discovery venture, and he established a personal office. He has engaged in business development and licensing work for 40 years, and now, based on his experience and networks, he is supporting business development activities, such as licensing agreements and joint research of domestic and foreign pharmaceutical companies/ventures. He provides comprehensive support services ranging from looking for appropriate partners, preparing the draft of contract outline, contract negotiation, and alliance management with partners after the partnership agreement. Especially, based on experience of practicing on both sides of venture and pharmaceutical companies, he keeps in mind providing informative advice and proposals for specific action plans.

Katsuya Hashizume

Beyond Next Venutes Inc.

Main specialty areas

  • medical devices

Specialized support fields

  • Marketing
  • Business planning
  • Funding

For over 10 years, he has been consistently involved in investing in academia startups. Joined BNV in 2020, focusing on investments in startups in the medical device and digital health sectors. Appointed as an Executive Officer in August 2021. Leads the investment department while also overseeing the community management of portfolio companies. Prior to BNV, he has served as the leader of industry-academic investment group at JAFCO and the chief promoter of JST START. While investing in startups, he has been involved in the company creation of several acedemia startups, including Microwave Chemical (IPO), Biomedical Solutions (M&A) and Bly Medical (M&A). Completed graduate studies at the Keio University Graduate School of Media and Governance.

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