ハギワラ　ノブヒサ   Nobuhisa Hagiwara   萩原　誠久    所属   その他 その他    職種   非常勤嘱託
言語種別	日本語
発表タイトル	New System is Necessary to Develop Medical Devices from Japan.
会議名	第79回日本循環器学会学術集会
主催者	日本循環器学会
学会区分	全国規模の学会
発表形式	口頭
講演区分	シンポジウム・ワークショップ パネル（公募）
発表者・共同発表者	◎内田毅彦, 萩原誠久
発表年月日	2015/04/24
開催地 （都市, 国名）	大阪市
概要	Although Japan has a high potential to produce new medical devices, the country has a trade deficit of approximately 7-billion USD every year. One of the reasons why there are much less new medical devices produced in Japan is lack of ecosystem of medical devices. Necessary medical device ecosystem is the place where seeds, people, and money gathered such as the Silicon Valley in the U.S. In order to form appropriate ecosystem in medical device development, one way may be increasing success stories. Through them, experienced and skillful people would contribute development programs thereafter. The more programs, the more money comes in. The more activities, the more people are getting together. This virtuous cycle should be gradually forming the ecosystem. How to increase success stories in medical development? Given the current situation in Japan that seed money is relatively easily available but not yet Devil Valley is overcome, an incubator system may work. In the incubator system, a skillful team that has enough experience in medical device development actually implements the development processes collaborating with inventors such as physicians. The he incubator covers the roles in, financial model, regulatory affair strategy, business plan, and fundraising.The authors including the one used to serve as a Medical Officer/Reviewer of the U.S. Food and Drug Administration and a Medical Director of Boston Scientific will provide with their professional views of medical device ecosystem in Japan and introduce their activities.