Monthly Email Newsletter
May 2006
IN THIS ISSUE:
I. Message from the Editor
II. Articles:
***
FEATURED INDUSTRY: Medical Devices
1. Tips for Translation and Regulatory Compliance in the Medical Device Industry
2. The U.S. Medical Device Industry and Global Market Trends
3. Useful Links
***
FEATURED LANGUAGE: German
4. German Quick-Glance
5. German Speakers on the Web
6. Useful Links
III. Attend our Panel at the 42nd DIA Annual Meeting
IV. Enter our Translation Bloopers, Mishaps, and Woes Contest
V. Industry Tip Sheets Available
VI. In Our Next Issue
VII. Your Feedback
VIII. How to Subscribe/Unsubscribe
I. MESSAGE FROM THE EDITOR
The medical device industry has become increasingly competitive as a number of multinational firms are aggressively pursuing the global market, focusing greater attention on international sales and revenue, joint ventures, and mergers and acquisitions. This demand for medical and dental equipment and supplies has realized double-digit growth rates in much of the world. In order to facilitate expansion, medical device firms are recognizing that they must look at developing economies for future growth. As a result, the medical equipment industry has become a global industry.
In this issue of the Global Communicator we offer translation and regulatory tips for the medical device industry, as well as a look at the size of the industry in the U.S. and global market trends.
Our featured language is German, which is spoken by more than 120 million people in 38 countries of the world. Read our
"German Speakers on the Web" article for more information on just how many of them are logging on and find out how fast this online demographic is growing.
And finally, we are pleased to announce that due to a significant increase in customers located in the mid-west, Global Languages Solutions (GLS) has expanded its physical presence to include a new office in Chicago, Illinois.
Since this newsletter is meant to create a virtual community where we share the latest news and advice, we invite you to
contact us with your suggestions, story ideas, statistics, and website tips.
Inna Kassatkina
Editor
II. ARTICLES
*** FEATURED INDUSTRY: MEDICAL DEVICES
1. Tips for Translation and Regulatory Complaince in the Medical Device Industry
The distribution of medical devices across borders has done away with translating packaging and labels as a luxury or value-add and, instead, made it a highly regulated, and more often than not, required process. There is more to medical device packaging and label translation than replacing words with the native language. It is imperative to achieve a translation quality that moves beyond language, cultural, and regional differences, as well as meets all local and international regulatory guidelines.
Based on more than a decade of providing translation services to leading companies in the healthcare and life sciences industries, GLS offers the following tips for translation and regulatory compliance:
- LABELING. Do not assume that you can use English-language labels in foreign countries. In the European Union (EU) countries, for example, several directives, including the Clinical Trials Directive, Medical Device Directive (MDD) and In-vitro Diagnostics Directive (IVDD), have specific provisions that make translation of medical labels mandatory into the language or languages of the country in which the products are being tested, distributed, or sold. See the following directives which govern what labeling and instructions for use must accompany your product: Directive 98/79/EC of 27 October 1998 (IVDD) and Directive 93/42/EEC of 14 June 1993 (MDD).
- INDUSTRY EXPERTISE. If you do not have the expertise within your company, hire an international regulatory consultant and work with a translation firm who has expertise in the specific in-country guidelines. A consultant who is thoroughly familiar with the labeling and packaging regulations in foreign countries can review all regulatory compliance issues and provide expert guidance to your translators as they begin the translation process. For example, drug manufacturers and medical device companies who plan to test or market their products around the world must meet various in-country regulatory requirements. One of such regulatory requirements is proper translation, design, and content of all labeling and instructions for use. Specifically, the European Union has issued several directives regulating the CE mark, which is required prior to distributing medical and in-vitro diagnostic devices in the EU. Pharmaceutical companies looking to distribute in the U.S. must have certification that the foreign-language labeling is complete and accurate.
- MACHINE TRANSLATION. Do not use a canned machine translation program. Errors in translating medical labeling or instructions for use could lead to regulatory and/or product/civil liability. Therefore, it is especially important to work with professional translators who have medical and pharmaceutical translation experience, education, or both. Machine translation is not precise enough to accurately translate the highly technical terminology used in medical labels, and worse, could cause a misinterpretation of the actual meaning altogether.
- GEOGRAPHIC STRATEGY. Consider developing medical labels for each geographic region with similar regulatory requirements. More and more medical device companies develop region-specific labels or instructions instead of trying to fit all languages into one universal piece. For example, for the countries of NAFTA (United States, Canada, and Mexico), in which FDA-approved drugs and devices can be marketed, the labels would include English, French, and Spanish languages.
- INTERNAL POINT PERSON. Assign a point person within your organization for the management of all translation projects. As translation mistakes can delay product approvals and launches, managing translations becomes a critical component of the medical device and pharmaceutical global distribution process. By centralizing the translation process within your organization you will benefit from consistent quality of all translations, faster turnarounds, and reduced translation costs.
For more information about translation tips and tools in the pharmaceutical, medical device, clinical research, and healthcare industries, visit
www.globallanguages.com, call us at
+1-949-798-1400 or
e-mail us.
2. The U.S. Medical Device Industry and Global Market Trends
The U.S. Department of Commerce, International Trade Administration (ITA) states the U.S. is the largest single country consumer of medical and dental equipment and supplies, with a market valued at nearly $80 billion in 2005 (including diagnostic products) and that U.S. medical technology companies lead the world in medical device production.
Even though total U.S. industry shipments have remained solid, the rate of growth has slowed somewhat in recent years. Nevertheless, the U.S. is expected to remain competitive globally due to the U.S. lead in innovative technology, increased experience in exporting, aging populations in Japan and the EU, and through international harmonization of standards and regulatory requirements.
The medical device industry has become increasingly competitive as a number of multinational firms pursue the global market, focusing greater attention on international sales and revenue and mergers and acquisitions. This demand for medical and dental equipment and supplies has realized double-digit growth rates in much of the world. In order to facilitate expansion, medical device companies are recognizing that they must look at developing economies for future growth. As a result, the medical equipment industry has become a truly global industry.
The major competitors
According to the ITA, the U.S. medical devices industry’s main competition resides in Germany (Siemens), Japan (Hitachi Medical Corp. and Toshiba), the Netherlands (Philips Electronics), and Italy (Marconi Medical Systems) in high-technology products. It is important to note that most of these foreign companies manufacture a significant amount of their products in the United States.
3. Useful Links
For information on the medical device industry, visit these trade publications online:
http://www.fdp.com
http://www.thompson.com
For information on global and U.S medical device regulations:
http://www.pjbpubs.com/raj_devices/back_issues.htm
http://www.mdss.com/
http://www.ghtf.org/
http://www.fda.gov/cdrh/index.html
http://www.abhi.org.uk/healthcareindustry/regulation/medicaldevice.aspx
*** FEATURED LANGUAGE: GERMAN
4. German Quick-Glance
German (Deutsch) is a West Germanic language. It is a member of the western group of the Germanic branch of the Indo-European language family and one of the world's major languages. Spoken by more than 120 million people in 38 countries of the world, German is — like English and French — a pluricentric language with Germany, Austria, and Switzerland as the three main centers of usage.
According to Wikipedia, it is also spoken in two-thirds of the South Tyrol province of Italy (in German, Südtirol), in the small East Cantons of Belgium, and in some border villages of the South Jutland County of Denmark. In addition, some German-speaking communities still survive in parts of Romania, the Czech Republic, Hungary, Russia, and Kazakhstan.
Outside of Europe and the former Soviet Union, the largest German-speaking communities are found in the U.S., Brazil, and in Argentina where millions of Germans migrated in the last 200 years; but the great majority of their descendants no longer speak German.
Worldwide, according to the Guinness Book of Records, German accounts for the most written translations into and from a language. Furthermore it belongs to the three most learned and to the ten most spoken languages worldwide.
5. German Speakers on the Web
How robust is the number of German speakers who are logging onto the Internet? According to Internet World Stats listing of users by language, German ranks 5th, right behind Spanish. What is even more surprising is the growth numbers realized by this language segment. This same ranking lists German at a more than 106% growth in users from 2000-2005.
According to Global Reach (2004), 6.9% of the Internet population is German. According to Netz-tipp (2002), 7.7% of WebPages are written in German, making it second only to English.
Interested in the other top languages online? Visit
www.internetworldstats.com/stats7.htm.
6. Useful Links
Local newspapers and country- or language-specific search engines can be great sources of information about political, economic, and social issues that are important to Russian-speaking people. Business articles will also help you to identify new business contacts, refine your marketing methods, and assess whether economy is strong enough and the timing is right to launch your new business expansion abroad.
NEWSPAPERS AND ONLINE NEWS RESOURCES:
http://www.germannews.com/index_e.asp
http://www.germnews.de/
http://www.pipeline.de/news/index.php
http://www.zitty.de/
http://www.baz.ch/
SEARCH ENGINES:
http://de.yahoo.com/
http://ch.search.yahoo.com/
http://www.google.de/
http://www.google.ch/
http://www.google.at/
PORTALS:
http://www.deutschland.de/home.php?lang=2
http://www.anglogermantrade.com/
III. GLS JOINS PHARMA INDUSTRY LEADERS AT 42nd DIA ANNUAL MEETING
As drug development expands globally, today's pharmaceutical project managers need to master management techniques, tools and measures that transcend language and cultural barriers. Industry leaders including Pfizer and AstraZeneca are using new technologies to improve business performance by allowing their global team members to collaborate and to manage information on local, international, and global levels.
How does a manager know when providing resources in multiple languages will help or hurt a project's performance? How can one choose from the abundance of providers of business intelligence and language technologies? Find out when the president of GLS, Inna Kassatkina, joins Mary Stober (Global Project Resources) and Don DePalma (Common Sense Advisory) on an expert panel at the 42nd Drug Information Association Annual Meeting on June 22 in Philadelphia, PA. The panel will discuss global project management case studies, when to localize and when to internationalize the content of clinical study materials, and how to improve the project management process in order to streamline costs and development time. For additional information about the upcoming panel, please
contact GLS.
IV. ENTER OUR TRANSLATION BLOOPERS, MISHAPS, AND WOES CONTEST
The translation of materials, packaging, labels, etc. or the provision of an interpreter is more than a luxury - often it's the law. In an effort to demonstrate that quality translations are not only imperative, but that inaccurate translations can sometimes be confusing, damaging, and, yes, humorous at times, Global Language Solutions is holding a translation blooper contest.
Have you had an experience with a translation or the interpretation of a phrase or word that has confused your client, patient, or subject? If so, we want to hear from you!
Send GLS your favorite blooper, mishap, or woe. We'll select the best, publish them in a future issue of the Global Communicator (anonymously, of course), and shower the top three with praise…and a prize, too.
In need of some motivation? Here is one of our personal favorites: "You must be able to read English. If you are unable to read this, you will not be eligible for the study."
Now it's your turn. Send us your entries by July 1, 2006.
V. INDUSTRY TIP SHEETS AVAILABLE
Download one of our useful, easy-to-follow tip sheets for translation services across a variety of industries, including legal, healthcare, pharmaceutical, and medical devices. Also available is a tip sheet on what to look for in a translation firm.
Visit our website to review additional
industry resources.
VI. IN OUR NEXT ISSUE
*** FEATURED TOPIC: Pharmaceutical
*** FEATURED LANGUAGE: Chinese
V. YOUR FEEDBACK
Have questions? Or a story idea or topic you would like us to address in a future issue?
Contact us.
VI. HOW TO SUBSCRIBE
