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

厚生労働省

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).

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—.

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.

Akihiko Watanabe, Ph.D.

President, GlobalHumanScienceInnovation; Senior Consultant, Headland Strategy Group; Visiting Professor, Gifu Pharmaceutical University; BD Consultant, United Immunity; Executive Advisor, SOKK Japan

Main specialty areas

  • medicines
  • regenerative medicine products

Specialized support fields

  • Marketing
  • Business planning
  • Funding
  • Business operation systems

With R&D expertise atJapanese and global pharmaceutical companies as a backbone, he has been engaged in marketing, BD, management planning and fundraising, in addition to R&D. In the Editorial Committee of the Pharmaceutical Society of Japan, he organized roundtable discussions and special issues on practical application of academia seeds. He has been thinking about how Japanese bio-ventures can succeed. Over the past five years, he has worked at bio-venture companies as CBO or VP of BD and open innovation. He is also engaged in the making and analysing stratetgies of management, business, R&D, and marketing for pharmaceutical companies and bio-ventures on commission from a US consulting firm.

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.

Shinichi Watanabe

WNW IP ATTORNEYS

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

  • Specialized support fields

Shinichi Watanabe began his career as a patent attorney in 2003, and with the valuable experience gained at global patent law firms. His practice primarily deals with filing and prosecution of domestic and international patent applications in the pharmaceutical and biotechnology fields. Backed up by a wealth of practical experience and technical expertise, he is actively engaged in IP counselling and advises start-up pharmaceutical and biotech companies on patent filing strategies. Recently, he is interested in AI and machine learning, and now also working on support in the interdisciplinary area between life science, IT and AI.

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