Firm Provides Accurate Translations of Package Inserts
Helps device manufacturer comply with European standards and gain access to global market
Target Therapeutics (Fremont, CA) designs, develops, and manufactures specialized disposable microcatheters, guidewires, microcoils, and angioplasty products used in minimally invasive surgical procedures. The devices aid in the treatment of diseased, ruptured, or blocked vessels of the brain, as well as other disease sites accessible through small blood vessels. Target sells its products globally, and must therefore provide instructions in several languages. The highest standard of translation is required to ensure that no mistakes are made in the labeling. In addition, an extremely accurate translation is essential to comply with CE mark requirements, as described in Council Directive 93/42/EEC concerning medical devices. The new standards were developed, in part, so that product instructions could be easily read not only by European medical professionals (who may be fluent in English), but also by patients who may only speak their native language.
Target's goal was to develop, validate, and print multilingual package inserts (a total of 225 documents for 20 products) in 12 languages. According to Judy Ramsay-Jensen, translations project coordinator at Target, "Multilingual communications are unavoidable if companies hope to gain or maintain a presence in the world market." As a medical device manufacturer, Target is mandated by the European Medical Devices Directive to provide directions for use (DFU) by June 1998 in the predominant languages of all countries in which it intends to market the product. Target selected Direct Language Communications (DLC), a multilingual communications firm based in San Francisco, to develop viable, presentable package inserts within the timeline. DLC offers qualified language specialists, comprehensive project management, and experience in compliance issues.
To address Target's requirements for clear and accurate translations, DLC customized a plan for the company, developing a schedule that incorporated translation, editing, and proofing, as well as in-country reviews by Target's worldwide partners. A file-maintenance procedure was created to parallel Target's internal system. "Regulatory standards in the medical device industry require that complete records be kept on all updates and revisions to documents," says Matt Sirisumphant, senior project coordinator at DLC. Translating product documentation is extremely detail-oriented work, particularly when it involves diagrams, he explains. "Each part must be accurately labeled with the appropriate translated part namea challenge when dealing with 12 languages across 20 products," says Sirisumphant.
DLC developed highly qualified teams of language translation specialists who have experience in the medical/scientific field. "New DFU formats evolved to capitalize on efficiencies in distribution, formatting, and printing," says Dianne Turner, director of client development at DLC. This proved to be beneficial to Target's competitive strategy for time to market. Ramsay-Jensen says, "DLC helped to clear all the hurdles in our race to meet project deadlines."
With help from DLC's translation experts, Target earned CE mark approval on October 1, 1996, thereby maintaining a strong presence in the European Community. Furthermore, the procedures and processes defined during the project were easily transferable to ongoing translation jobs DLC is doing for Target's parent company, Boston Scientific.