College of Science and Engineering at the University of Minnesota
College of Science and Engineering

Medical devices fellows to visit Japan

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Rhonda Zurn, College of Science and Engineering,, (612) 626-7959

Preston Smith, University News Service,, (612) 625-0552

Trip aims to help Minnesota medical start-ups understand Japanese regulatory process

MINNEAPOLIS (05/03/2011) — The University of Minnesota Medical Devices Center Innovation Fellows will begin a week-long mission on May 6 to learn more about the Japanese medical device industry to help medical start-up companies in Minnesota.

During their trip to Tokyo, Nagano, and Osaka, the four fellows will meet with various leaders in the medical device industry ranging from corporate executives to government officials and physicians at top medical centers. The highlight of the trip will be a meeting with the executive staff and reviewers at the Pharmaceuticals and Medical Devices Agency in Japan, the equivalent of the United States Food and Drug Administration (FDA).

Success in the field of medical devices increasingly relies on having a global strategy, and Japan is seen by many as one of the dominant players in the global medtech economy. Japan in particular is known for having maintained high standards of quality and safety in medicine as well as medical devices.

“While the Japanese market and obtaining Japanese regulatory approval is often seen as important for medical device companies, details of the regulatory process remain quite elusive due to the language barrier, especially for small start-up companies such as those coming out of the University of Minnesota,” said Kiyoyuki Miyasaka, one of this year’s four medical device innovation fellows. “One of the primary goals of our trip will be to gather specific information on where to begin this regulatory process and develop a roadmap of how to proceed.”

Miyasaka, who was born and raised in Tokyo, has an engineering degree from the U.S. and a medical degree from Japan. He initiated the idea for the fellows to visit Japan and has coordinated many of the details with the help of various industry and state groups such as the BioBusiness Alliance of Minnesota and the Minnesota Department of Employment and Economic Development.

“Because of my background, I believe I am situated to bypass the highly technical and costly language and cultural barriers that would normally be associated with an endeavor such as visiting Japan,” he said.

Primary funding for the trip came from the University of Minnesota Global Programs and Strategy Alliance, Japan-North America Medical Exchange Foundation, University of Minnesota Pediatric Intensive Care Unit Fellows Fund, Japan Society of Pediatric Intensive and Critical Care Medicine, Nihon Kohden Corporation, and other Japanese health care organizations.

The Medical Devices Center Innovation Fellows are part of a year-long, full immersion educational and intellectual property development program for medical devices at the University of Minnesota. A cross-disciplinary team, with a combination of degrees in engineering, medicine, and biosciences, interface daily with faculty, medical professionals and industry collaborators to develop and test ideas for new medical devices with the goal to improve health care worldwide. The Medical Devices Center is part of the University of Minnesota’s Institute for Engineering and Medicine, a cooperative program between the University’s College of Science and Engineering and the Medical School.

For more information and online updates during the trip, visit

On July 1, 2010 the Institute of Technology changed its name to the College of Science and Engineering.