An MD&DI October 1999 Column
Companies that adopt a broad perspective on the translation process can gain a competitive advantage in foreign markets.
For many medical device companies, translation activity is not accorded very much thought or planning in advance. In fact, management often looks at the entire product documentation process as a necessary evil: another regulatory hoop to be jumped through, another expense to be incurred before a product can be put on the market and start improving livesand making money.
Though common, this aversive view of medical device documentation and translation can prevent these activities from being seen for what they really are: tremendous opportunities to effectively communicate a company's expertise and professionalism to end-users. However, translation undertaken without careful advanced planning often produces an expensive, confused result that actually detracts from a product's sales performance. In the worst case, inadequate translation can lead to problems ranging from customer complaints and ill will to removal of a product from overseas markets, and even criminal legal penalties.
Given this potential for dire consequences, why is it that translation and documentation are so often overlooked? Part of the reason lies in the engineering-driven structure of most device companies, which can lead to the neglect of other more consumer- or service-oriented business activities. Often, this understandable bias shows up as a narrow perspective on each process or task, which leads to poor decision making. For example, how does one effectively write an operator's manual for a sophisticated surgical system? One company's seemingly logical solution was to assign a different engineer to each system component. The results were predictable: different terminology for the same device components, hugely divergent writing styles, and a text that was difficult to understand because it was oriented to the perspective of the engineer as opposed to the end-user.
Contrary to popular belief, materials that are poorly written in English will not improve in translation. This fact is especially important in the medical device field, in which many products are intimately involved in life-and-death clinical situations. A poorly executed documentation strategy can increase time to market, increase the cost of translation, and decrease the market's estimation of a productthe equivalent of a life-and-death business situation.
Fortunately, by adopting a broader perspective on the translation process, companies can not only avoid many of these pitfalls but can actually leverage their translated documentation into a source of competitive advantage, rather than just another cost of doing business.
DETERMINING THE TOTAL COST OF TRANSLATION
Analyzing the total cost of translation (TCT) for a specific project can begin by distinguishing between activity costs and opportunity costs.
Activity Costs. Activity costs comprise the expense of creating the English language documents (including, for example, the cost of a writer's time, of desktop publishing time, and of management time) and direct translation expense (i.e., the invoice paid to the translation company or the cost charged to a company's budget from an internal translation department). These are the costs most commonly associated with the translation process, but they are far from complete. Like the barely visible tip of an iceberg, these costs may represent as little as 10% of the TCT. The other 90% lies in the opportunity costs of the translation system.
Opportunity Costs. Opportunity costs are defined as the value of a foregone alternative. For example, if, due to limited resources, a company chooses to market to Spain versus Denmark, then the opportunity cost of selling in Spain is the potential value of the Danish market. Informed choices demand a thorough understanding of opportunity costs. They include time-to-market expenses, such as documentation time, translation time, and time for overseas review; documentation overlap, or the cost of translating repetitious materials; plain English simplification, which represents the direct cost of translating verbose, unsimplified materials; and the potential liability expenses arising from poorly written or poorly translated material. Once a company has identified its hidden opportunity costs, it can begin to investigate how they relate to strategic translation decisions.
APPLYING THE TCT PERSPECTIVE
For a company newly embarked on a translation program, a reasonable first step might be to solicit estimates on its existing materials. Most firms try to select the translation provider with the best cost/value proposition, which is usually interpreted as the lowest price. However, as we learned from the above analysis, such a conclusion is inaccurate since it does not take into consideration the more important opportunity costs.
To further illustrate this point, if we take the example of a 60-page user's manual produced in the usual way, with release scheduled in nine European Union (EU) countries, the following situations could arise:
- The English language material was not written with the idea that one day it would need to be translated for overseas markets. In fact, it was not written by a documentation specialist at all.
- The length of the material has a direct impact on the cost of translation. Multiplied by nine EU languages, the volume of text in the manual will have a significant impact on the cost of translation.
- The company probably has additional documentation that overlaps with the material being translated. Documentation such as instructions for use (IFUs), marketing materials, sales presentations, or client-education materials often share similar verbiage.
- It is generally in the company's interest to maximize its overseas distributors' "buy in" to the translated material by including them in the review process. However, most firms can ill afford a lengthy turnaround that increases time to market.
Under the traditional approach to translation, none of these factors would normally be considered in a company's vendor selection process. Rather, it would simply attempt to get the best price and turnaround from a reasonably qualified provider. However, what would happen if the firm were to take the more comprehensive TCT approach?
To begin, the first two items in the above list are related. If a company's instructional material was written without considering the translation impact, it probably contains too much verbiage. This is where a plain English simplification of the material can yield a huge payoff. Plain English simplification is a unique approach to technical writing that focuses on structuring essential information: it pares down text, stripping it of repetition and presenting ideas intuitively and logically from the outsider'snot the insider'spoint of view. Although it does require an initial consulting investment, the long-term benefits can be substantial.
For instance, by employing plain English simplification, a typical company might be able to reduce the amount of its documentation by 35%. Applying this number to our example of the user's manual, a 60-page document that normally costs $7000 per EU language to translate would see its cost decrease to $4550. Multiplied by nine languages, the company could save $22,050 in translation expense on just one project.
The issue of documentation overlap is one that is seldom considered by medical device companies. The reason for this is simple: until very recently, the only way to control for repetitious material was by hand. Many a regulatory affairs professional has had the mind-numbing experience of going through a company's IFUs, searching out the new material and highlighting it so that the company would not be charged again for previously translated sections. Although still employed by some device manufacturers, this methodology raises serious questions of consistency, turnaround, and resource allocation.
The introduction of sophisticated translation-management software has greatly simplified this process. For example, the translation firm can, for each of its clients, construct a language capital database (LCD) that holds the electronic version of the English documentation in syntactical relation to each translated version of the document. On a practical level, this means that new material can be passed through the LCD in order to identify any previously translated sections. The translation cost incurred is only for new sections, which can result in significant savings. This methodology provides additional benefits, such as decreasing turnaround time (since there is generally less translation to perform), ensuring terminological consistency between projects, and eliminating the need to prep the documents prior to translation.
Because of time-to-market delays, companies may be tempted to abandon overseas review altogether, even though the practice supports the important corporate goal of greater distributor integration. Distributors can be extremely slow in providing requested input on a translation project; when they do return their comments, they often focus on low-value-added, subjective or stylistic changes. This situation can strain the working relationship between the device company and its distributors or overseas subsidiary. However, a simple solution lies in restructuring the task.
Using the information in an LCD, a project lexicona complex glossary that details terminology definition, position, and contextcan be created for overseas review. Providing reviewers with a project lexicon instead of the entire text enables them to work with a condensed, summary document, decreasing review time and concentrating reviewer attention on high-value-added input.
ONGOING TRANSLATION NEEDS
What if a company is not starting from scratch? What if it already has a large amount of translated material and a process in place? Can the TCT perspective provide any assistance? The important question to answer is, "What is the most effective way to structure the translation process, going forward?" Even if a company has a volume of previously translated material, it is always worth considering the opportunity costs of future translations.
For instance, if a company has already incurred the expense of translating existing material, it may not be worthwhile investing in a plain English simplification of its documentation. However, if the annual translation budget is projected at approximately $20,000 or more, it may be cost-effective for the company to construct an LCD from the previously translated material. Depending on the amount of overlap between the old material and the new, a cost savings from 20% to more than 40% can be realized.
For device companies looking to gain a competitive advantage from their translated documentation, a change of perspective is required. This change begins with the realization that 90% of translation costs are opportunity costs and therefore go unaccounted. Once the total cost of translation is identifed, there are various tools and strategies, such as the language capital database and distributor review of lexicons, that can be employed in order to improve quality and time to market, and reduce direct translation costs.
Marc H. Miller is CEO of Crimson Language Services (Boston and San Francisco), which specializes in translation process consulting for the medical device industry. He can be reached at [email protected].