A comparative study of Japanese and US American medical device industries

Japan has an unfavorable balance of trade in medical devices, and large Japanese companies hesitate to enter the medical device industry. This paper investigates the process of the expansion of the American medical device industry. It was concluded that the propensity for risk in the U.S.A. and Japan is different; both countries have different industries and ways of thought which construct their manufacturing cultures. A system called Investigational Device Exemption (IDE) indicates that US Medical Industries are in a stronger position than their Japanese counterparts. The American system allows purchasing of developing medical devices before pharmaceutical acquisition. Japan has no foster policy for medical venture, nor are medical devices tested strictly before pharmaceutical approval. It is predicted that the Japanese economy will no longer be able to grow in a stable manner just by relying on the large corporation-led export of manufactured goods, whereas those SMEs with the sophisticated technology, by accommodating the needs of the medical institutions, will be highly competitive internationally in a narrow and specialized market. The author points out that promotion for the medical device industry may help Japanese economic revitalization. Japanese companies and their government will have to support developing "diversity" of the players.