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

Nao Yoshizawa

GRiT Partners　Law offices/Willsame.co.ltd/Cabinet office advisor for National bioecnomy strategy/Keio university Medical school

After leaving the law firm Nishimura Asahi, [the individual] established the law firm GRiT Partners and assumed the role of managing partner. They also serve as the representative of Willsame Corporation and hold qualifications as a lawyer, patent attorney, CFE (Certified Fraud Examiner), Applied Information Technology Engineer, Information Processing Security Support Engineer, and IT Strategist. They have served as a committee member for the formulation of standards in electronic commerce and related information transactions at the Ministry of Economy, Trade and Industry, as an expert in the Cabinet Office's bioecnomy strategy, and as an advisor to Biock. They have been involved in the establishment of the Japan Chapter of Aging2.0 in Silicon Valley and served as a mentor for Alchemist Accelerator. A graduate of the law faculty at Hitotsubashi University, they completed intellectual property and machine learning programs at Stanford University, as well as multiple AI programs at MIT. They serve as a program committee member for the Graduate School of Pharmaceutical Sciences at the University of Tokyo and the Medical Innovation Human Resources Development Course at Tokyo Medical and Dental University. With a deep understanding of international perspectives on digital health, they provide advisory support for startups and pharmaceutical companies' DX (Digital Transformation) programs. They founded the Life Science Incubation Council and focus on launching projects and connecting them with ecosystems both domestically and internationally.

Tadashi Sameshima

I have been engaged in product development and business operations of medical devices and regenerative medicine products for 37 years at Terumo Corporation. I have experienced the development of medical devices such as extracorporeal circulatory and blood transfusion devices, as well as the development to commercialization of cellular products. In addition, I am able to provide specific advice on various stages of development based on my participation in joint research with universities, collaboration among companies, discussions with government agencies, and activities of industry associations.

Osamu Tabuchi

JMDC Inc. Quality Assurance Office manager

I am a dedicated professional with extensive experience in safety management and post-marketing surveillance (PMS) in the pharmaceutical industry. After joining SANWA KAGAKU KENKYUSHO CO., LTD., I focused on risk management for diabetes medications and treatments for dialysis complications. My work included PMS literature development and cardiovascular event evaluations, contributing significantly to drug development.
At CureApp, Inc, a company specializing in software as medical devices, I served as the Safety Management Officer. I successfully established the safety management system and operational processes for Japan's first therapeutic app. My involvement in risk management for various therapeutic applications, including those for hypertension, allowed me to engage deeply with the core aspects of product development.
Currently, I am the Head of Quality Assurance at JMDC, Inc, where I oversee GxP compliance and reliability assurance. I am actively involved in building a new PMS framework that combines e-source data with additional collected data, as well as managing certification acquisition and maintenance.

Tomohisa Hayasaki

GVA LPC Attorney-at-Law / Partner
The Leader of The Team ""Medical / Healthcare / Cosmetic Industry""

After registering as a lawyer, I have been handling disputes such as corporate and labor disputes, as well as providing legal support for the designing lawful business models of new businesses and for funding. In addition, I have been providing legal support for businesses in the field of medical and beauty based on my knowledge of laws relating to medicals including the Japanese Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and the Japanese Medical Care Act. In particular, I have been providing extensive support for numerous businesses operating in new field such as Software as Medical Device (SaMD) and Non-Software as a Medical Device (Non-SaMD), telemedicine/home call medical services, and also for companies utilizing medical information by employing new technologies such as AI. I am also addressing legal issues faced by companies using advance technologies. Furthermore, I have expertise in the latest marketing trend and offer advice on marketing strategies based on the Japanese Act against Unjustifiable Premiums and Misleading Representations, advertising regulations in Japan such as medical advertising regulations, and medical and pharmaceutical devices regulations.

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）

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.