(click to enlarge) U.S. medical device exports by region (2007).

According to the International Trade
Administration (ITA; Washington,
DC), the world medical device market
is expected to exceed $250 billion by
2012. As markets and opportunities
develop, this number could increase,
along with challenges. As a result, ITA
is targeting four areas—quality, regulatory structure, pricing and reimbursement, and intellectual property (IP)
issues—and is especially concentrating
efforts in China, India, and Brazil.

As more manufacturers move overseas, quality will become a global issue,
said Vince Suneja, director of the health
product and technologies team in the
Office of Health and Consumer Goods
at ITA. Suneja discussed the global market at the Medical Device Manufacturers Association’s annual meeting, held
in Washington, DC, in June. One main risk, he said, is the introduction of low-quality products, which can weaken
public confidence and negatively affect
trade. ITA employs quality initiatives
through training with industry and
FDA on good manufacturing practices
and counterfeit detection.

(click to enlarge) Global market shares by country (2007).

Differences in regulatory systems create trade barriers as well. In addition
to encouraging transparency, fairness,
and harmonization, ITA is working to ensure that devices aren't treated as
pharmaceuticals. Other trade barriers
include disparity in national reimbursement, which introduces adoption hurdles for more-complicated devices. ITA
discourages such discrimination against
imports and the use of foreign reference
pricing, a method of cost containment.

Although the U.S. market faces
challenges, it remains a leader. It has
held 45–47% of the global market in
recent years. The largest recipient of
its exports is the European Union at
46.4%, followed by Japan at 11.6%, according to the U.S. International Trade
Commission.