When asked about the regulatory issues of medical devices in Asia, a European speaker at Engel's recent Medical Days event in York, Pennsylvania, said outright that he has no interest whatsoever in Asia. He told the audience that North America and Europe are leading the market, and Asian firms will only later "copy products and do their own things."

He represented a German supplier of automation equipment used in high-end medical molding. That could be a reason for his lack of interest in Asia, since Asia mostly produces commodity medical products.

But that same reason translates to great opportunities for Western medical molders. Asia, including developed regions such as Japan and South Korea and developing countries like China and India, demands state-of-the-art medical devices.

A recent Medical Design article discussed the opportunities and challenges for entering the Chinese market.

To get started, take this piece of advice from the U.S. embassy in Beijing: "We encourage U.S. firms to participate in CMEF (China Medical Equipment Fair)." The embassy advises companies interested in exporting to visit www.export.gov.

An effective strategy for entering the Asian medical device market is to track down diseases to find niche markets. Japan suffers a lot of neurological disorders, and heart disease is rapidly growing in India, for example.

On the regulatory aspect, the article said, a roadblock to marketing products in China is the stringent product registration process, which usually takes about a year or more, depending on the type of product. But that's true for all foreign markets. If anything, the Chinese standards are lower than the Western ones.