Optimizing Access To International Markets Calls For Strategic Planning In Translation Strategies
Medical Product Outsourcing - July/August, 2004
The old adage that time is money is certainly relevant in the medical device industry. The web of regulatory and marketing concerns that medical companies face in taking their products into international markets is highly complex and may require several years to navigate, which delays the opportunity to profit from new product offerings in global markets. For many countries, notably EU members, the legal requirements for providing translated material are specific and time consuming, but handled correctly, the translation process can help enable companies to profit from global markets sooner rather than later.
Consider the following:
This article provides specific tips and recommendations that medical product developers and manufacturers can use to optimize the translation process. Throughout the course of this article, we will among other things cover the following:
EU Expansion: with the addition of 10 new member states, what are the new language challenges for medical device companies and how can third-party consultants help with their linguistic needs?
Translation Strategies: how can companies establish accurate terminology in new markets and with new technology?
The Outsourcing of Translation Services: when is it appropriate and when should companies rely on their internal resources?
Opportunities in the New EU: It's no secret that regulatory concerns are far from over at the point of attaining CE Marking approval for medical devices. Regulatory audits are ongoing, safety records must be maintained and documentation of all kinds must be carefully tracked.
Table 1 shows the major EU directives pertaining to the medical device industry, along with a quick summary of how translation fits in:
Table 1: Medical Device Directives and the Translation Requirement
|Directive||Directive-Level Decision||Member State Decision|
|Medical Device Directive (MDD)||X|
|Active Implantable Medical Devices Directive (AIMD)||X|
|In-Vitro Diagnostic Directive (IVDD)||X|
In terms of the law set forth in these EU Directives, only the newest of these directives, the IVDD, specifically enumerates translations as required for every country in which an IVD product is to be marketed. The MDD and the AIMD each leave the translation decision up to the individual member states to determine. To date, however, every member state has determined that translations of user documentation and labeling must accompany all medical devices sold within their borders. This includes the new member states of Hungary, Poland, Estonia, Latvia, Cyprus, Malta, Slovakia, Czech Republic, Slovenia and Lithuania. At one point, the medical products industry lobbied these new countries to accept English-language documentation, but the Czech Republic and Slovakia led the opposition by requiring translation, and other new members immediately followed with similar requirements. Table 2 indicates the applicable target languages for each of the 10 new EU countries.
Table 2: Language Requirement Grid (New EU Countries as of May 1, 2004)*
|Cyprus||Greek and/or English|
* Special circumstances may require different language pairs
Because translation is a critical component of marketing medical products at the global level and a regulatory requirement in many countries, it is worthwhile to develop an effective and efficient strategy for the total package of translation services up front. One of the most time consuming components of the translation process involves developing new terminology for groundbreaking products. Whether one is dealing with a trademarked brand name that requires cultural review or a new device component or material that has never before been marketed in a particular country, there are certain steps that medical device firms can take to mitigate the risk of inconsistent or inaccurate translations for new products or terms.
Develop a Glossary
When you know that your product is an innovation within a given market, work proactively with your translators to identify terms that may require the creation of new words in the target language. Such a glossary should anticipate linguistic questions that might otherwise delay a translation project because even the most experienced and skilled linguists may require additional time, thought and testing with completely new material.
In cases involving new compounds or materials, a company can work directly with its local research staff to ensure that it is receiving terminologies developed by scientific professionals who are intimately familiar with the product. If this is not possible, a company should make sure that its linguists engage in a "preflight" review process to identify terms that may require additional clarification and time.
In other cases involving trademarked brand names, it is important to consider that many names that might sound clever to an English-speaking audience may be offensive if transliterated (i.e. phonetically spelled using the alphabet of a target language) for use in another culture or language. (Examples of mistranslation abound and a short but humorous list is included at the end of this article). Consider the possibility of engaging in an in-language copywriting process (ILC) to ensure that your message is accurately conveyed. A good ILC should incorporate translation, back-translation and brainstorming/review time by native speakers of the target language who are specialized in ILC for your industry. Whether this is done internally or externally, it is an important process to ensure optimal penetration of your product abroad.
Build a Translation Memory
Translation Memory (TM) technologies are constantly improving, although they are not yet capable of replacing humans. Currently, TM is robust enough to provide electronic assistance to linguists as they move through large volumes of documentation to eliminate unnecessary repetition and ensure consistency of translated terminologies. In short, TM is currently an efficiency tool.
TM is especially effective for use in translating medical and technical documentation where similar phrases occur repeatedly. It is important to remember that TM does NOT work on a word-for-word basis. Because of the complexities of the human lexicon, as well as linguistic considerations such as gender and conjugation, TM works by identifying repeated "units" of text so that such considerations are factored into the translation. A human translator is always required to proofread at a bare minimum to ensure that the translation is complete and accurate.
If your translation memory is properly set up, your firm can see savings of up to 75% on repeat terms with equivalent reductions in turnaround time when you update existing documentation or for product literature covering new generations of existing devices. Best of all, you don't have to wait for a new project to set up your TM. Through a process generally referred to as Translation Memory Alignment, you can actually leverage pre-existing translations to initiate savings and consistency measures immediately.
In many cases, it is wise to convert your translator glossary (referenced above) into TM before you even begin the translation process. These processes can be combined into one service-especially if your translators have a focus on medical/technical material. If you plan ahead with glossaries and TM, you can save your company significant amounts of time in the overall translation process. This can lead to a faster and more efficient road to profiting from your new product.
Outsource or Manage Internally?
Deciding whether to outsource translations is an important question in developing your overall translation strategy. Several of the largest medical device manufacturers maintain full-time translation departments to manage their overall language needs and linguistic relationships, while others turn to the services of translation agencies to consolidate their globalization processes. Here are some tips on determining which approach might be best for your firm.
What is the most cost-effective or efficient means of translation at your disposal within acceptable quality assurance parameters and time limitations? Each of your resource options will come with its own set of advantages and benefits. Some of the most frequently used resources for medical device companies include:
Once you have assessed your translation needs and options, you should be ready to start selecting your best resources to handle translation.
If you choose to contract with a professional translation agency, you should typically start initial consultations at little or no cost to ensure that the agency has sufficient resources to keep up with your needs and to help gauge your budgetary requirements. Some parameters to consider in your vendor selection process include:
Other considerations are how flexible is the agency? What about its capability to expand with growing needs? Is it flexible enough to meet tight deadlines and speed time to market? Does the agency use the optimal technology such as CAT Tools (Translation Memory) to help you manage cost? Also, can the TM be transferred to ensure that you retain your investment in translation? Are there discounted rates for repetitive material?
If you have a distributor willing to take on the task of translating all relevant documentation, you may want to consider the same criteria recommended for assessing translation agencies. There are some pitfalls to avoid when using your local distributor for translation.
Your distributor will tend to be busy with urgent tasks other than translation. If your distributor plans to do the translation, there is a significant risk that timelines will be compromised. Conversely, if your distributor "passes off" the translation job, there is no guarantee that a qualified linguist or satisfactory process is applied during the translation process. Be prepared for these scenarios by having back-up plans to ensure that you get quality translations on a timely basis, thus improving your own on-time delivery for foreign orders.
Perhaps because a distributor's job is to sell product, there has been a notable tendency for them to emphasize or exaggerate the positive attributes of a product or to fail to thoroughly translate all of the safety issues, or both.
Most medical device firms use a verification process to confirm the accuracy of a translation. If your distributor does the translation, have a secondary review team available to provide reviewing services. As an alternative, you can use your distributors to conduct the verification process rather than the translation.
Today's leading medical product manufacturers usually have offices around the world, with employees on staff who speak many different languages. Many times, these multilingual employees are a tremendous resource for translation, especially for quick or short jobs that might require a spot translation. However, professional translation requires skill, training and experience. For employees who have no professional training, the quality of their translations can range across a wide spectrum. Further, they lack objectivity required of professional translators. Ideally, internal staffers familiar with the product or with company preferences regarding specific terminology are used for review purposes. Even then, however, it is difficult to have reviewers adhere to a schedule and provide objective feedback.
If you plan to use your internal resources for translation (assuming that they aren't full-time staff translators), make sure that they are properly scheduled for on-time execution of the translation. Also, you should ensure that there is a separate proofreader available to review their work-when translating, use of a separate proofreader is a MUST.
For firms whose translation needs are continuous, employing full- or part-time translation coordination teams is an excellent option that can help ensure that all existing translations are properly leveraged while simultaneously negotiating with translators (or translation agencies) based on the volume of work required.
At a minimum, your in-house translation coordinators should possess functional knowledge of the following:
The key to mastering the translation process so that it decreases time to market, as with any other part of your product development and manufacturing process, is to identify your volume, required level of quality control, budget and corresponding timelines to choose the best resources for your particular needs. With some frontloading and strategic capacity planning, translation work need not be a nightmare; in fact, it can even be a competitive advantage when you are racing to beat your competition into the marketplace.
About the Author
Ron Tan is Director of the Global Life Sciences Practice at TransPerfect Translations. He is recognized for developing translation strategies for medical device firms operating in global markets and is an expert on the specific language requirements of EU and Asian countries. With close to a decade of experience in this rapidly growing field, Tan has worked with virtually every major medical products company to develop translation solutions. TransPerfect is a leading provider of globalization solutions with ISO 9001:2000 certification. Based in TransPerfect's Los Angeles office, Tan works closely with each of the firm's 21 offices on 3 continents. He can be reached at firstname.lastname@example.org.
TransPerfect is a diversified family of companies providing a full array of international communication services in 22 offices worldwide, including document management, translation, and staffing solutions. TransPerfect is ISO 9001:2000 certified which means it has implemented the most rigorous quality assurance process, according to criteria set forth by the International Organization for Standardization. The wide range of services it provides includes imaging, reprographic services, electronic data discovery, multilingual OCR, electronic labeling, coding, on-site imaging and copying, as well as staffing, and a full suite of translation and interpretation solutions. Headquarters are in New York City.