Medical Device Link.

Originally Published PMPN November 2003

NEWS

By the end of the year, in vitro diagnostics sold in Europe may have to offer device instructions and labeling in every language of the European Union member states. Kevin Bolen, vice president of marketing for Bowne Global Solutions (BGS; New York City), says there are currently about 11 different languages; however, this number is slated to increase in the coming year when 10 new countries join the European Union in May 2004. Although companies have had five years to comply, many are still scrambling to meet the deadline. “A lot of companies are coming to us because they forgot about it,” says Bolen. 

BGS, a division of Bowne and Company, Inc., provides translation and localization services to help companies market culturally connected products. One of BGS’s top vertical markets is the life sciences industry, which includes both pharmaceutical and medical device companies. “For life sciences, selling in multiple countries means different sets of regulatory requirements,” says Bolen. “Many of those requirements have to do with the language in which content is provided to the end customer.” 

BGS offers translation services in 64 languages. In addition to text translation, the company considers the cultural impact of images that are used. For example, “the color red in Asian cultures is often associated with luck,” says Bolen, “so a lot of Asian packaging is in bright red colors.” However, in Western cultures, the color red is often associated with danger. With OTC drugs, “we may be looking at the actual style and layout of the package to see if it’s going to be offensive to a culture,” in addition to basic translation of inserts and instructions, says Bolen. “Different cultures react differently to different environments,” he explains. “The marketing campaign you built in the United States may not be appropriate in all markets based on attitudes toward doctors and medication, or such things as culture and images.”

DePuy Spine, one of BGS’s clients, manufactures spinal implant instruments. “We have labels and inserts translated into 11 languages,” says Daphne Germain, regulatory affairs associate for DePuy. Turnaround for translation services is about three to four weeks, and turnaround for labels is two to three weeks. If there are any ambiguous words or terms, a representative from BGS will contact her and ask for clarification. “[BGS] usually catches it because I don’t know how it can be interpreted in different languages,” Germain says. 

Bolen advises companies to “think about going global the minute you start thinking about your packaging.” Don’t try to design from a U.S. perspective and then try to adapt that for a European market, he says.

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