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

Saaya Hirai

Globizz Corp.　Senior Manager

After graduating from a university in Taiwan, she began her career at Globizz Japan as a Business Planning Specialist. In this role, she developed proposals for Japanese companies seeking entry into the U.S. market and provided support for FDA compliance, including assistance with Quality Management System (QMS) development for medical device manufacturing facilities and FDA inspection readiness. She later transitioned to Globizz Corp., the U.S. headquarters of Globizz Japan, where she currently coordinates FDA submission projects and conducts regulatory research and registration activities. In addition, she supports Japanese companies in expanding their presence in the U.S. medical device market by accompanying them to major industry exhibitions, assisting with trade show participation, and joining business meetings to facilitate market development. Leveraging her proficiency in English, Japanese, and Chinese, she plays a key role as a bridge in international projects. Her support experience includes FDA submission strategy development, 510(k) submissions, Breakthrough Device designation requests, U.S. KOL interviews, reimbursement strategy support, and assistance with establishing U.S. corporate entities.

keiji Asada

Amenichi Consulting, LLC, CEO

Graduated from Auburn University with a degree in Chemical Engineering. Currently, serving as the CEO of Amenichi Consulting, LLC, a consulting firm specializing in regulatory compliance (FDA) and marketing support for companies entering the U.S. market, particularly in the fields of pharmaceuticals, medical devices, and regenerative medicine products. With extensive industry experience and expertise, he assists clients in developing business plans, securing funding, and establishing operational structures. Additionally, he provides comprehensive support, from the formulation to the execution of business strategies, to help clients enhance their competitiveness. Furthermore, he leverages his network to match clients with the most suitable business partners. With a global perspective, he offers customized services tailored to the needs of each client, aiming for sustained growth and success. Amenichi was established in 2018 and has supported over 50 companies since its inception.

Tomokatsu Hongo

Keio Innovation Initiative, Inc
Corporate Officer

Ph.D. in Biological Chemistry from Nagoya University. At Summit Pharmaceuticals International Corporation, I was engaged in VC fund management, investment and sales support for bio-ventures, and domestic sales agency business for overseas bio-ventures. In 2016, I joined Keio Innovation Initiative (KII) as an investment manager in the medical and health field. I have been investing in drug discovery, regenerative medicine, and medical device ventures by leveraging his business experience in the pharmaceutical industry and career as a researcher, and providing a wide range of hands-on support, not only in terms of funding, but also in business development.

Hiroki Yamada

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

Mineki Takechi

Cardio Intelligence Inc. Chief Development Officer
Director

After working at Fujitsu Ltd. on the development of products and services such as image processing system and cloud information service for home healthcare, as well as research and development in information retrieval and AI, and new business development, I engaged in the construction of a pulmonary hypertension patient registry at the International University of Health and Welfare Mita Hospital. Since 2020, I have been serving as CDO at Cardio Intelligence Inc., responsible for the development of software medical devices for arrhythmia analysis and regulatory affairs. Since 2021, I have also been serving as COO, overseeing overall business planning and execution.