¾ÅÉ«

¾ÅÉ« Translations Offers Tips For Successful
Strategic Planning

The Medical Dealer - April, 2004

In 2003, the U.S.-based medical device industry generated total revenues in excess of $190 billion, approximately 45% of which was generated abroad. While many large medical device companies can typically capitalize on these foreign opportunities, small- to medium-sized organizations may often find their resources stretched - especially when product development cycles are not sufficiently advanced to attract investors to make commitments in the face of the rapid regulatory changes in the medical device market.

One of the most overlooked yet significant expenses in the global product development process is translation. For large-scale rollouts, translation costs can often approach the million-dollar mark by the time a device reaches worldwide release. For the unprepared medical device executive, this can present significant hurdles to accessing a far wider market for their products.

"If you plan properly, translation can be any company's trump card in effectively bringing a new medical device to market," explained Liz Elting, CEO and President of ¾ÅÉ« Translations, one of the world's largest translation companies and one of the very few to be officially ISO 9001:2008 certified. "If used correctly, translation can even the playing field, enabling small- and mid-sized companies to compete against larger companies despite the fact that they have fewer resources."

¾ÅÉ« has three basic suggestions on how to manage this process to minimize the investment risk:

1. Identify your target market and understand the regional regulations that will affect your translation requirements.

A medical device developer may direct research to specific regions where an uncharacteristically high target population exists. In this scenario, it is important to identify the volume of research candidates you plan to include in your studies, as well as the type of documentation that might typically be included in this process in order to determine the volume of translation you may need for submissions to the local or regional authority. These are important factors in determining strategy and budgetary parameters for managing your translation needs.

Once target regions are identified, consider the regulatory requirements of both the country and the region; each may require that specific types of material be translated. For example, the European Medical Device Directive (covering every country in the EU) requires translation of all user documentation. A specific host country may require that all clinical research documentation be translated and submitted in the local language as well. However, in most cases, the bulk of translation costs can be deferred until you obtain CE Marking approvals and are ready to start selling your product in individual countries. The same is true of products that may be destined for Japan or China, each of which retain their own sets of rules and regulations for localized documentation prior to device approval.

2. Prioritize your specific translation needs.

By the time you determine a favorable location for your research and submissions, you should develop a checklist of the required stages of the approval process, as well as the types of documentation that you will need to translate at each stage. Most typically, your IRB or Ethics Committee will require the following to be translated into local languages at a minimum for the primary stages of product development:

• Study protocols
• Informed consent documentation
• Clinical research data
• Packaging and labeling and/or user documentation.

This list of documents requiring translation will expand at each stage of product development and approval, but ideally so will your investment capital.

Another issue to consider is the level of quality assurance that your corporate policy, ethics committee, or host country will require. Addressing this issue is critical to identifying the most cost-effective means of translation with acceptable quality assurance parameters.

There are many criteria to consider when selecting you best translation resources. Each of your resource options will come with a distinct set of advantages and disadvantages. Some of the most frequently used resources for medical device companies include:

• Professional translation agencies
• Local distributors/authorized representatives
• Existing internal resources (i.e., bilingual staff)
• Full- or part-time translation coordination teams
• Translation verification

3. Develop a plan to manage your translations including both operational and budgetary factors.

Once you have assessed your translation needs and options, you should be ready to select the optimal resources for providing the specific translation services that you will require. If you choose to contract with a professional translation agency, you should typically be able to start initial consultations at little or no cost to help gauge your budgetary requirements. Some issues to consider in your selection process might include:

• Is ISO certification of your translator's QA process an important factor? If so, this will immediately narrow the field of potential translation partners to less than 10 companies worldwide.
• Is physical proximity to your offices a factor?
• What is the agency's proficiency level in the following:
  • Specific areas of medical expertise
  • Qualified linguistic ability in the target language or group of languages
  • Ability to work in the various media formats you may require?
• What is the agency's billing policy?
• • Cost
  • Tracking capabilities
• How flexible is the agency you are evaluating?
  • Capacity to meet your growing needs over time and reap the benefits that accrue from that agency's familiarity with your specific product, requirements, preferences
  • Sufficient resources and track record for meeting demanding deadlines and decreasing time to market
• Does the agency use the right technology, such as CAT Tools (Translation Memory) to help you manage cost?

"The key to translation lies in identifying your requirements and selecting the solution that best meets your specific needs," concludes Elting. "With some frontloading and planning, translation need not be a nightmare and can even be a competitive advantage when you want to be first to market."

About ¾ÅÉ«
With revenue of over $250 million, ¾ÅÉ« is the largest privately held language services provider in the world. From offices in 66 cities on 5 continents, ¾ÅÉ« offers a full range of services in over 100 languages to multinationals worldwide. With a global network of over 4,000 linguists and subject-area specialists, ¾ÅÉ« is the largest translation company to be fully ISO 9001:2008 and EN 15038:2006 certified. ¾ÅÉ« is headquartered in New York and has regional headquarters in London and Hong Kong. For more information, please visit our website at www.transperfect.com.