Originally Published MDDI April 2002NEWS & ANALYSIS Gregg Nighswonger

April 1, 2002

2 Min Read
Industry Urged to Take Broader View of Transatlantic Trade

Originally Published MDDI April 2002


Gregg Nighswonger

Medical device manufacturers in the United States were recently urged to take a more global view of issues affecting the industry. More specifically, they were encouraged to look more closely at the many issues that are influencing trade with the European Union, which represented 43% of the total U.S. domestic exports of medical equipment, including ophthalmic products, in 2000.

Speaking at the AdvaMed annual meeting in Carlsbad, CA, Edward J. Ludwig, President and CEO of Becton Dickinson, noted that manufacturers must manage divergent factors that require both a local, or in-country, structure and a global organization. He emphasized that not all businesses are the same—even within the same company. Each company, or division for that matter, has unique factors that tend to push for or against global and local influences. In this sense, he suggested, regulatory processes can represent a strategic resource, prompting firms to invest in regulatory staffing and systems. A key element is being involved in standards development and global harmonization efforts, Ludwig added.

U.S. manufacturers could learn much by looking more closely at current activities of the European Union, according to Imelda Mary Read, who represents the United Kingdom in the European Parliament. Speaking in Carlsbad, she commented on the overall importance of the device industry. "It's a fascinating field, medical devices, developed into one of the most exciting and dynamic areas of modern day healthcare," she said.

Read views the device industry as a growing sector. "By 2006, the total medical technologies and devices market worldwide is expected to be more than 260 billion euros," she said. "It's an industry of great importance to the European Union for economic reasons. On average, EU countries export 29% of their medical technology production, compared to 23% of the United States."

Read recommends however, that U.S. firms begin to take a broader view of transatlantic trade, suggesting that anticipated growth of the EU cannot be ignored by any companies wanting to do business with Europe. "It's perfectly feasible," said Read, "that the European Union will be significantly larger in terms of member states and population in just a few years' time. In just a few months' time, by January 2004, we are likely to have 10 new members, going from 15 to 25 in just 21 months."

Read said there are critical differences between the markets in Europe and the United States—especially with regard to the regulation of medical products. "When you look at the European healthcare market, EU legislation doesn't fully control the agenda because legal competencies are divided between the EU and the member states' governments," she said. "The internal market is managed by the EU, as are product safety requirements, and competition rules."

Copyright ©2002 Medical Device & Diagnostic Industry

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