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

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.

Masakatsu Noguchi

SMILE CURVE, Inc.

Ph.D. in life sciences. Worked at consulting firm Dream Incubator, consulting in industry-academia collaboration, business support for tech startups (bio, semiconductor, environmental energy), new business development for large corporations, and overseeing government mega-projects. Previously employed at Abbott Japan and Singapore, managing product marketing for diagnostic tests, pharmaceuticals (women's health), and Asia-Pacific marketing for medical IT. As Business Development Director at Sanamedi, facilitated the commercialization of new medical devices, handled regulatory applications and market launches, and supported investments in and assistance to startups. Additionally served as an evaluator for AMED, and as a mentor for NEDO and university accelerator programs. Currently working independently, he serves as a specially appointed associate professor in the Hiroshima University and as an strategic advisor of MEJ.

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.

Teppei Konishi

Biomy Inc. CEO

He completed his graduate studies at the Graduate School of Engineering Science, Osaka University. At NTT DOCOMO, he specialized in big data analysis and AI-driven video analysis research, contributing to new business development. After leaving NTT DOCOMO, he served as CTO at an IT venture before founding Biomy Co., Ltd. There, he led the development of a personalized medical platform utilizing AI technology, collaborating with domestic and international pharmaceutical companies and research institutions. He also secured a Class II medical device manufacturing and sales license.

Kiyoaki Kojima

Partner

Kiyo advises clients in corporate formation, governance, and compliance matters; mergers and acquisitions; joint ventures; leasing and licensing matters; distribution and franchise arrangements; and a wide range of commercial transactions.An important part of Kiyo’s practice includes his work with international companies in relocating and/or establishing ventures in the U.S. He assists companies and investors with incentives and site selection; real estate acquisitions and construction agreements; corporate formation and governance; asset purchases and joint ventures; regulatory compliance; and contracts of all types to help ensure a seamless U.S. launch or transition.He also counsels clients in virtually all areas of labor and employment law, including drafting and/or interpretation of employment agreements, company policies, and handbooks; union-avoidance training; countering discrimination and harassment claims; hire, fire and discipline issues; and dispute resolution procedures. Active in the community, Kiyo is a member of the Atlanta Bar Association, a board member of the Japan America Society of Georgia, and a board member of the Japanese Chamber of Commerce of Georgia. He also serves in “advisor” or “supporter” roles in various entities in Japan, such as InnoHub, MEDISO, and IDEC Yokohama.