News | November 30, 1999

Going Global: The Challenges of Selling in Multiple Markets: Part 2

By Andres Heuberger


•Regulatory Affairs Management: So many rules, so little time
•Translation Management: Quality matters

If it were not for the tremendous financial potential of expanding overseas, surely most medical device manufacturers would be quite content to stay put. What with the ever-increasing complexity of regulations and compliance requirements, and the never-ending burden of translation, globalization is not getting any easier. Nevertheless, globalization is inevitable.

With proper planning and effective management, the companies that make the commitment to "going global" will be best prepared to serve the world well into the next century.

This is the second in a series of articles examining the challenges of selling in multiple markets. The first article investigated organizational, business, and resource challenges. Today, we explore challenges in the areas of international regulatory affairs and translation management.

Regulatory Affairs Management: So many rules, so little time

Increasingly, product development is being conceptualized on a worldwide scale to maximize return on investment. Country-by-country approvals stretching out over many years are giving way to parallel submissions with the goal of near-simultaneous approvals. To accomplish this, of course, regulatory professionals must be familiar with and must be able to quickly and accurately respond to individual country requirements.

Easier said than done. While large medical device companies can rely on a full staff of experienced international regulatory affairs professionals, small and midsize manufacturers often lack these resources. They also typically lack in-country subsidiaries to help them keep abreast of changes in local regulations.

As countries become more vigilant, regulations multiply. Although the basic goal of global regulatory affairs has remained the same (keeping our needs in check with our wants), the frequency and number of changes has forced regulatory affairs professionals to specialize in specific market requirements and, often, to duplicate their efforts across multiple international markets.

While this duplication of efforts with international filings is a constant source of frustration, there are signs of relief on the horizon. Representatives of industry and government are working towards establishing international regulatory standards. These standards would set global criteria for safety and would improve time-to-market while protecting all countries, no matter how scarce their regulatory resources.

Of course, establishing standards that everyone agrees upon is no easy task. The Global Harmonization Task Force is currently developing consensus standards and is working towards this goal.

Don't expect immediate relief. The conclusion of these efforts is still several years away. In the meantime, device companies wishing to expand their global presence will enter new markets, relying on their regulatory affairs staff to solve the riddle of managing multilingual compliance.


Translation Management: Quality matters

Translation has long been viewed as a necessary evil—just another hoop to jump through before entering a foreign market. But this attitude is rapidly changing for a number of reasons.

More and more device manufacturers are beginning to see translation as a competitive advantage—an opportunity to speak to their customers and prospects in their native languages, thus demonstrating commitment to a local market and gaining a leg up on their English-only competitors.

For those companies that don't view translation as a competitive advantage, they should at least view it as a potential for competitive disadvantage. As companies become more established in foreign markets, they will demand higher quality translations with faster turnaround times. Companies that aren't prepared to measure translation quality (or use vendors who can provide measurements for them) will be left behind.

In addition, regulatory bodies will come to expect a higher standard of translation. And if a mistakes should slip through (in an instruction manual for instance), the potential for liability and negative public relations is substantial.

With all this in mind, the question companies most often ask is: "How do we make the most of our translation budget while at the same time managing quality and deadlines?" While an in-depth answer exceeds the scope of this article, consider the following six key elements:

  1. Centralize translation management within your company. Depending on the volume of work, this could be a full-time position or a part-time responsibility for existing employee. Ideally, this in-house translation manager will have some experience with technical communications and possess sensitivity to language issues. The translation manager should be well organized, ought to be willing to explain translation issues to company-internal users and clients, and must be able to resolve content or technical questions within the company.
  2. Decide what to translate and then coordinate all work through one translation vendor. Combining instructions for use, operation manuals, marketing literature, sales support materials, packaging, online content, and labeling with one vendor will result in lower translation costs, reduced management overhead, as well as improved quality and consistency.
  3. Carefully review and test potential vendors. At a minimum, your vendor should specialize in medical device translation work. Your vendor should also rely on translators who specialize in the device industry. There are simply too many complex terms and phrases involved to take chances.
  4. Measure translation quality. Put in place a process to document, measure, and audit translation activities. To do this, both the vendor and the customer need to have auditable, documented systems in place. These systems should detail responsibilities, work flow, required documentation and approvals, as well as quality measurements (different organizations, including the American Translators Association, the German standards organization DIN, and the Society of Automotive Engineers publish standards for translation quality). Once vendor and customer agree on appropriate quality and performance measures, hold the vendor responsible for measuring and report this quality data.
  5. Translation is still a human process. Despite efforts to improve machine-translation tools, the number of words to be translated dictates the amount of time required to translate a document. But you can do your part to limit turnaround times by "leveraging" past translations using a translation memory database, by limiting the number of project change orders after the project start, and by regularly providing your translation vendor with work forecasts.
  6. Clearly define the role of affiliates. Beware of the temptation to have in-country affiliates or distributors do your translation. While some device companies use this approach effectively, there are many more companies who are looking to minimize in-country reviews, let alone translation. Recently, the emergence of third-party reviewers to supplant affiliate reviewers have helped some device firms dramatically cut review times and, at the same time, improve the quality of the review comments.



Managing regulations and translations are probably the least glamorous aspects of the medical device industry, yet they are among the most critical. Any mistake, no matter how minor, can delay product approvals, launches, or cause widespread public relations disasters. There is no room for error or ambiguity.

Most device companies simply can't afford to ignore global markets. For the companies that manage regulations and translations properly, they will be ideally positioned to beat their competitors to market and establish a long-lasting relationship with their consumers.


Click here for sidebar How to Select a Translation Vendor.

The next article in this series will examine challenges in the areas of packaging, labeling, and manufacturing.

Andres Heuberger is president of ForeignExchange Translations Inc., One Richmond Square, Providence, RI 02906. Tel: (401) 454-0787; Fax: (401) 454-0789; E-mail:; Web site: