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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).

Mirai Miyahara

President of i Access Consulting Inc.

Main specialty areas

  • medical devices
  • regenerative medicine products

Specialized support fields

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

Miyahara holds a Master's degree in Business Administration from the Graduate School of Economics at Tohoku University. She possesses 17 years of professional experience in Regulatory Affairs, QMS, business planning, and overseas marketing at a leading medical device company and Notified bodies in Japan. With a specific focus on multi-country regulatory compliance and extensive experience in overseas medical device markets, Miyahara has demonstrated proficiency in navigating the regulatory landscapes of diverse markets, including Japan, China, India, East Southern Asia, EU and the U.S. She has a proven track record of achieving success in supporting medical companies with regulatory compliance, facilitating international expansion, and establishing strategic partnerships with local entities. Miyahara is also an adviser for JETRO medical devices international expansion program.

Kumi Sakurai

早稲田大学大学院理工学研究科で生体工学を専攻後、慶應義塾大学病院で10年以上にわたり血液研究に従事。その後、外資系医療機器メーカーであるベックマンコールター（2005年～）、日本メドトロニック（2007年～）、セントジュードメディカル（現アボットメディカル、2015年～）のマーケティング部門にて、医療機器の市場導入や事業戦略を担当。2019年、医療機器・ヘルスケア機器の開発支援を専門とするインキュベーター、プレモパートナー株式会社を共同創業。研究者・スタートアップ・大企業を対象に、事業戦略策定から薬事・保険償還・上市までを一気通貫で支援し、国内外のネットワークを活かして医療機器の事業化を推進している。
文部科学省　科学技術・学術審議会専門委員、東京都AMDAPカタライザー
早稲田大学大学院修了（工学修士）。金沢工業大学大学院修了（MBA）

Main specialty areas

  • medical devices

Specialized support fields

  • Marketing
  • Business planning
  • Business operation systems

After earning a master’s degree in Biomedical Engineering from Waseda University, Kumi Sakurai engaged in over ten years of hematology research at Keio University Hospital. She then transitioned to the medical device industry, joining Beckman Coulter in 2005, Medtronic Japan in 2007, and St. Jude Medical (now Abbott Medical) in 2015, where she worked in marketing and business strategy for innovative medical technologies. In 2019, she co-founded Premo Partners Inc., an incubator specializing in the development and commercialization of medical and healthcare devices. Premo Partners supports researchers, startups, and large corporations throughout the entire innovation process—from business strategy formulation, market analysis, and regulatory and reimbursement planning to commercialization. Leveraging extensive domestic and international networks, the company provides end-to-end support to accelerate the delivery of essential medical technologies to patients and healthcare professionals. Through its comprehensive expertise in regulatory pathways, evidence generation, and global market access, Premo Partners plays a vital role in fostering Japan’s MedTech ecosystem and bridging it with the global healthcare innovation community.

Miyuki Nagao

Globizz Japan Corporation　Tokyo Office Director

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

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

After graduating from a U.S. university, she began her career at Globizz Corp., the U.S. headquarters of Globizz Japan, where she was engaged in FDA registrations and regulatory research across the medical device, pharmaceutical, and food sectors. Through her involvement in a wide range of projects for international clients, she cultivated substantial, practice based expertise in FDA regulatory compliance. She subsequently joined Globizz Japan and currently serves as a Project Coordinator at the Tokyo office. In this capacity, she develops and proposes tailored support plans for companies seeking entry into the U.S. market, while overseeing comprehensive project coordination between U.S.-based consultants and clients. By working closely with a team of subject matter experts—including FDA consultants at the U.S. headquarters—she delivers highly precise and effective regulatory support. Drawing on her direct experience participating in FDA inspections, she also provides on site inspection assistance and collaborates with specialists to offer practical services, including interpretation support, Quality Management System (QMSR) development, Form 483 response preparation, and CAPA planning.

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.

Kensuke Suzuki

Nagashima Ohno & Tsunematsu
Partner, Attorney-at-law

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

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

Kensuke Suzuki is a partner at Nagashima Ohno & Tsunematsu. He represents both domestic and international clients, with a special focus on cross-border transactions, with respect to pharmaceutical, medical and healthcare business, M&A and corporate transactions, fund formation and management, and financial regulations. With expert knowledge of the Japanese medical, pharmaceutical, medical device, and other various healthcare-related regulations, he advises on a wide variety of business activities in the broad healthcare sector, such as regulatory compliance, data protection, mergers and acquisitions, alliances, business startups, financing, licensing and other commercial transactions. He was admitted to the Japan Bar in 2000 and worked as visiting attorney at Kirkland & Ellis （Chicago） from 2006 to 2007. He served as a special adviser to the Ministry of Health, Labour and Welfare from 2014 to 2015. He is fluent in Japanese and English.

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