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

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.

Motohiro Kobayashi

University of Yamanashi Hospital, Clinical Trial Management Office, Associate Professor

With over 30 years of practical experience in pharmaceutical companies, ranging from basic research to clinical development, licensing activities, and regulatory audits. Subsequently, I served as a technical expert in the Innovation Commercialization Support & Strategic Consultation Division of the Pharmaceuticals and Medical Devices Agency (PMDA), dealing with regulatory consultation services for academia and venture companies (especially for regenerative medicine products and pharmaceuticals). Currently, I am working in the clinical research support department of a university, supporting physician-led clinical trials and clinical research. I have experienced numerous pre-meetings and face-to-face advice with PMDA. I also have experience in application support for public research and development projects (such as Seeds C, etc.) by the Japan Agency for Medical Research and Development (AMED). In particular, I can provide detailed support for the development of regenerative medicine products (including quality and non-clinical).

Hiroki Yamada

Medii, Inc. CEO, M.D.,Ph.D.

Miyuki Shimizu

Medical Lab Partners Corporation

She graduated from the Graduate School of Natural Science, Chiba University. She holds the degrees of doctor of medicine and master of management information. She worked on the development of medical devices and pharmaceutical products in a wide range of fields related to transfusions, surgical operations, general-purpose medical devices, dialysis, and rehabilitation at Terumo Corporation. She also has experience in a series of project developments from planning a project to commercializing at a medical practice, as well as experience in management. Since 2015, she has provided consulting services to more than 350 companies entering the medical industry as her current role. She is trying to provide consulting services with the viewpoint of the individual company in mind.

Mirai Miyahara

President of i Access Consulting Inc.

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.