ARTICLE SUMMARY:
Too many companies seek device registration and market entry in Japan without considering reimbursement challenges in the country, according to veteran Asia medtech market consultant Ames Gross. In this edition of Consultants Corner, Gross stresses the need for companies to understand the process, engage early, and build trusting relationships in Japan to help ensure a path to profitability.
Welcome to Consultants Corner, where we check in with independent experts about questions they are answering or challenges they are solving for clients on the front lines of medtech regulatory, reimbursement, and market access.
Japan is the third-largest medical device market in the world, so it warrants important attention by medtech companies planning their global commercial strategy for new products. But for foreign device firms the country is not an easy one in which to make inroads.
The regulatory authorization process has long been viewed as opaque and challenging for outsiders, although the government has taken steps in recent years to improve predictability and engagement.
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Ames Gross (adgross@pacificbridgemedical.com) is president and founder of Pacific Bridge Medical, where he has helped hundreds of medical device companies with market access, regulatory, and business development issues in Asia. |
For reimbursement, the narrative is different. Many companies have an outdated understanding of Japan’s reimbursement realities, which have become more challenging over the past decade or so, explains Ames Gross, founder and president of Pacific Bridge Medical, an Asia medtech market access consultancy. As a result, he says, despite Japan’s large market size, manufacturers too often enter the market without a clear path to profit.
“Ten to 15 years ago, the reimbursements in Japan were often the same as the US or even a bit higher,” Gross notes in an interview. Back then, he relays, “a Western company may have had 10% of their sales in Japan, but overall, it could equate to 20% of the company's profits because of high reimbursements.”
