In his book, “The World is Flat,” Thomas Friedman explores the concept of globalization by traveling to Bangalore, India, where he discovers that the global competitive playing field is being leveled. In other words, he concludes, the world is being flattened.

While Friedman’s trip focused on software engineering, the same concept can surely be applied to the medical device industry.

Thus, it was appropriate that the Advanced Medical Technology Association (AdvaMed; Washington) chose to take a page from Friedman’s book and title a Tuesday morning conference call “Global Trends in the Medical Device Industry: Is Medical Technology Facing a Flattening World?”

Ralph Ives, executive VP for global strategy at AdvaMed, told conference call listeners from the U.S., London, and everywhere in between, that the association is working with both the U.S. government and foreign governments to improve reimbursement and regulatory issues around the world.

Foreign average pricing, for example, is one issue AdvaMed has been working on since 2002, Ives said.

“We believe that countries should price according to their own market,” Ives said. But in Japan, he noted, there still is a tendency to use foreign average pricing. “We’ve been trying to convince Japan that the more appropriate method is to compare prices within their own country rather than the foreign market,” Ives said. “We’re working with our government and the Japanese government to show them the cost of doing business in Japan is far higher than the cost of doing business in the four markets they have selected.”

Another challenge Japan’s medical device industry is facing, which Ives discussed during yesterday’s conference call, is what he called the “medical device lag,” or the gap between when the most innovative products are on the market in the U.S. and Europe and when they are on the market in Japan.

“I think the Japanese recognize that, as a result of their regulatory structure, Japanese patients are three to four years behind getting products that are on the market in Europe and the U.S.,” Ives said.

AdvaMed’s solution: Expand the number of reviewers and reduce the time it takes to review a product.

Ives said there are only about 28 reviewers for all medical device products entering the Japanese market in contrast to the FDA, which has more than 10 times that number with roughly 300 reviewers.

Unless Japan changes its regulatory structure, “[Japanese] patients will take longer to get the innovative technology that the rest of the world enjoys,” Ives said.

Along with Japan’s regulatory issues, much of the discussion during the conference call focused on China.

About $25 billion worth of medical devices are imported into the U.S. each year, according to Ives, and about $2.4 billion worth of devices, excluding sunglasses, were imported into the U.S. from China in 2006.

In the wake of international fears over Chinese products, the country last month said it would spend more than $1.1 billion improving food and drug safety by 2010, and its regulators will be given stronger oversight powers (Medical Device Daily, Aug. 13, 2007).

Because all medical devices imported into the U.S. must comply with FDA regulations, Ives reassured conference-call listeners that every medical device sold in the U.S. from China and elsewhere must meet FDA requirements regardless of the regulatory standards where they are manufactured.

Ives said AdvaMed has been working with China’s State Food and Drug Administration and its General Administration of Quality, Supervision, Inspection, and Quarantine (AQSIQ) to ensure that the Chinese adopt a regulatory system that is recognized and approved around the world. “We want to cooperate both with our government, the Chinese government, and the Chinese medical device industry to try to assist the Chinese for adopting regulations that are consistent with global standards,” Ives said.

The best way to do that, according to AdvaMed, is through training. “We believe in training regulators in any country on the most effective regulatory practices — in our view, that is the best way,” Ives said.