If You Fix It, They Will Come

Worth $29 billion, according to some estimates, Japan is one of the largest medical device sectors worldwide, and medtech companies of all sizes have participated in the market with varying degrees of success.

However, there are many cases in which foreign manufacturers have decided not to enter the Japanese market.

According to recent polling of the U.S. medical device industry by the American Medical Device & Diagnostics Manufacturing Association, 64 percent of companies already have entered the Japanese market or plan to enter, while 34 percent (small companies, in particular) have given up or hesitate. The reasons for their hesitancy include high regulatory costs (28 percent); the medical system is different and not attractive (24 percent); high burden of investment due to time lag (13 percent); high business costs (10 percent); lower income or reimbursement (7 percent); and shortage of manpower and resources (7 percent).

Study results showed that 69 percent of companies remain willing to come into the Japanese market if market conditions and capacity improve. This eventually may allow more advanced medical devices to reach Japanese patients and healthcare providers.

Yoshio Mitsumori is the president and CEO for Tokyo-based ADMIS, a consultant specializing in the medical device industry. He has more than 25 years of experience in the medical industry, including positions with the Itochu Corp., U.S. Surgical, National Medical Enterprises and Century Medical. A member of RAPS, he has spoken at many industry events and worked extensively in international trade of medical products and technologies. He can be reached at [email protected].