医療系ベンチャー・トータルサポートオフィス：MEDISO ( Medical Innovation Support Office )

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.

●Support method：We provide support via online meeting or e-mail.
●Support source：Support is provided in cooperation with experts in R&D, consultants in pharmaceutical affairs, and experts from related organizations including the Ministry of Health, Labour and Welfare.
●Remarks：Consultation and support services are free of charge.

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).

Akihiko Okuno

SK Intellectual Property Law Firm (SKIP) Managing Partner
SCM BioMedica Co., Ltd. Co-Founder

Main specialty areas

medicines
medical devices
regenerative medicine products

Specialized support fields

Specialized support fields

Master's degree in Cell Structure Research, Department of Applied Bioengineering, Graduate School of Agriculture and Life Sciences, University of Tokyo, Japanese Patent Attorney, Information Security Administrator, and JPAA Intellectual Property Management Consultant certification. As a FoundX supporter of the University of Tokyo,　He supports the intellectual property strategies of many IT and bio-related startups. He specializes in supporting the planning of intellectual property strategies in a variety of fields including biotechnology, pharmaceuticals, and medical devices. In addition, together with Dr. Yoshimasa Tanaka of Nagasaki University (a genius researcher who developed Opdivo with annual sales of over 1 trillion yen together with Dr. Tasuku Honjo, winner of the Nobel Prize in Medicine and Physiology), he established SCM Biomedica Co., Ltd. He co-founded the company and is currently trying to manage his own drug discovery startup.

Kenji Harada

Director & Chief Venture Capitalist, Medical Incubator Japan K.K

Main specialty areas

medicines
regenerative medicine products

Specialized support fields

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

He graduated with a Ph.D. in Pharmacology from the Faculty of Pharmaceutical Sciences, the University of Tokyo, and is an immunologist by training. He is also a licensed pharmacist and a licensed first-class radiation supervisor. After obtaining his doctorate, he performed a wide range of tasks from basic research to preclinical research as a team leader at Toray Basic Research Laboratories (currently Pharmaceutical Research Laboratories), during which he was developing anti-inflammatory and central nervous system drugs. Subsequently, he was involved in planning and promoting collaborative research with universities and making assessments of platform technologies and drug candidates of American and European biotech startup companies from the technological and intellectual aspects. Furthermore, he conducted GMP inspections in pharmaceutical products and medical device areas multiple times. After starting his career as a venture capitalist, he consistently invested in the biotech sector in the U.S. and Japan. He served as a board member in some of the investees of the U.S. and Japan. Since August 2020, He has expanded his investments into European countries at his current company. He is also engaged in several Japanese governmental projects supporting Japanese startups and research projects.

Saho Murakami

VISIONEO LLC CEO

Main specialty areas

medicines
medical devices
regenerative medicine products

Specialized support fields

Regulatory compliance
Business planning
Funding
Business operation systems

After gaining clinical experience as an ophthalmologist, I served at the Pharmaceuticals and Medical Devices Agency (PMDA), where I was responsible for reviewing and providing consultations on pharmaceuticals, medical devices, and regenerative medical products in the fields of CNS, sensory organs, and anesthesiology. My work included designation reviews for Sakigake (pioneering) and orphan drugs, as well as post-marketing safety activities. Currently, I support business and clinical development across the healthcare and life sciences sectors, offering strategic and R&D advisory services to major corporations, startups, and venture capital firms.

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.

Tomohito Suzuki

Tohoku University Knowledge Cast Co., Ltd.
Senior Consultant, Medical Device Development Support Division

Main specialty areas

medical devices

Specialized support fields

Regulatory compliance
Business planning
Funding

D. in Pharmaceutical Sciences from Kyoritsu Pharmaceutical University (now Keio University). Formerly a medical device reviewer at the Pharmaceuticals and Medical Devices Agency (PMDA). At PMDA, a member of the team in charge of the cardiovascular field and was in charge of approval review and consultation for many medical devices including new medical devices. Seconded from PMDA to the University of Tokyo Hospital as a Project Assistant Professor at the Translational Research Center, where supported the development of medical seeds in academia. Seconded from PMDA to Division of Medical Device Research of the Department of Industrial-Academic Collaboration of the Japan Agency for Medical Research and Development (AMED) as a manager in charge of overseeing projects with medical device-related budgets. He has been in his current position since 2020. Based on his experience in reviewing at PMDA and supporting R&D in academia and AMED, he supports efficient development of medical devices for many manufacturers including venture companies.

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