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

Yuki Yamakage

Representative Director, Takashi Shimada Office Co., Ltd.
Managing Partner, BD Consulting Ltd.

I have experience working for a global medical device company in insurance strategy development and insurance applications for products in a wide range of medical specialties and disease areas, as well as market access work (relevant academic societies, patient groups, government agencies and industry associations). I have now set up my own private practice and provide support to medical device and pharmaceutical companies and new entrants in terms of healthcare and care systems and insurance strategies. I have experience in the insurance application category (C1/C2 applications) for innovative medical devices. I also have a lot of experience in training employees and conducting seminars, most recently on SaMD insurance applications. My motto is to provide consulting services that address the concerns of my clients after explaining information on insurance applications for medical devices in a way that is easy to understand for beginners.

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.

Hiroaki Kato

Visiting Professor, The Graduate School of the Digital Hollywood University

He is a former government official of the Ministry of Health, Labour and Welfare and is working as a doctor specialized in digital health, including telemedicine, AI, and IoT. As an ophthalmologist, he has experience in more than 1,500 surgical operations. He developed instruments for cataract operations and ophthalmic consultation services. He is a rare person who has experience in three areas—medical practice, medical systems, and business—which are required for medical care and the healthcare business, and he understands these areas, providing support for the development of new business covering the full range of medical care. He is also familiar with Japanese medical venture companies and works as a consultant, advisor, and director for large enterprises and venture companies. He wrote 41 books, including Medical Care 4.0 — Medical Care in the Fourth Industrial Revolution Era—.

Hirohumi Shido

I am a UI/UX design expert and specialize in driving product development. As a product manager at a medical startup, he was in charge of renewal and new planning for multiple SaMD products. My experience ranges from planning to obtaining regulatory approval, and I have won a Good Design Award for a healthcare product. These experiences have made me realize the importance of experience design and usability in SaMD products with a diverse mix of stakeholders.

Yutaka Kono

Guest professor
Drug Discovery Science Division,Institute for Open and Transdisciplinary Research Initiatives, Osaka University