International Labeling: Many Languages, Little Time

Complex Language Requirements Are Part of the Global Marketplace, But Proper Planning Can Steer a Path to Profitable Growth

Andres Heuberger
ForeignExchange Translations

As the US market for medical devices matures and grows more competitive each year, medical device manufacturers are looking overseas for customer and revenue growth. In fact, international sales are a substantial contributor to most device manufacturers’ earnings.

Fueled by booming overseas economies, exports have been growing by around 10% per year since the early 1990s. The International Trade Commission recently reported (http://hotdocs.usitc.gov/docs/pubs/332/pub3909.pdf) that in 2005, medical technology exports reached $25.5 billion annually. As a result, today you’ll find all types of medical device companies—large and small, across all categories—participating in the export boom.

That means all is well on the export front, right? Well, not quite. While the “global economy” may have arrived, there are many bumps in the road.

Growing Language Requirements

Product development is increasingly 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, manufacturers must be able to quickly and accurately respond to individual country requirements.

“We are aggressive at understanding language requirements,” said Jennifer Morse, manager of document services and document management at Codman, a subsidiary of Johnson & Johnson. She acknowledged, however, that staying in touch with rapidly changing regulations is easier said than done.

The sheer number of changes can seem overwhelming. Over the past few years, device manufacturers had to contend with:

• Japan’s Pharmaceutical Affairs Law (PAL)

• Korea’s Medical Device Act #6909

• Norway’s regulation #1690

But it is not just the number of changes that is difficult to manage. The Turkish Ministry of Health’s decision to deny reimbursement for products not labeled in Turkish became effective on Jan. 1 this year, a few short months after the decision was announced.

Large medical device companies can count on a staff of experienced international regulatory affairs professionals to help navigate these challenges. For instance, Codman’s European regulatory staff regularly meets with its counterparts in other Johnson & Johnson operating companies.

In many companies, the regulatory affairs group works closely with the division’s marketing and translation teams. A common view is that regulatory affairs helps understand the requirements,  marketing defines the strategy and labeling provides a realistic implementation timeline.

Not every device manufacturer, however, has the resources of a Codman. Many small and midsize companies lack dedicated translation managers, market-specific regulatory knowledge or even in-country subsidiaries to help them keep abreast of changes in local regulations.

As many device manufacturers seek to add to their international regulatory knowledge, they increasingly are looking to contract with outside experts. Japan’s recently introduced PAL is an example of this. Manufacturers look to companies such as Underwriters Laboratories to “pave a road through the PAL process,” said Joe Madden, sales manager for the company’s Medical Business Unit.

Madden pointed out that Japan is such a big market that manufacturers are not as concerned with the incremental cost as they are with efficiently navigating the new regulations. PAL regulations are particularly difficult to navigate, as they are available in Japanese only. “Industry perceives countries to use language as a barrier to trade,” Madden noted.

Translation Management: Quality Matters

Translation used to be viewed as a necessary evil—just another hoop to jump through before entering a foreign market. But this attitude is changing as device manufacturers are supporting an ever-increasing number of languages.

Today, Codman labels products in  23 languages. With this many languages, translation no longer is an afterthought. In fact, device manufacturers increasingly view 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.

While many manufacturers outsource their translations to specialized translation companies, some opt for a hybrid approach of outsourcing and handling translations in-country. Codman, for instance, decided to maintain successful translation programs in its Romanian and Bulgarian affiliates.

When adding languages, the biggest challenge is expanding quality assurance (QA) procedures to cover the new languages. “The time needed for this has increased dramatically,” said Morse. “We don’t need more time to create the English version, but the time required to proof all translated labeling information has grown with each new language.”

It is common for companies to perform a full QA cycle in-house. This step ensures a greater probability of high quality output and further emphasizes manufacturers’ focus on quality.

Regulatory bodies have come to expect a high standard of translation. For example, the Chinese State Food and Drug Administration performs random inspections of instructions, labels and packaging of medical devices. While this is gradually raising the bar on translation quality, 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?” Consider the following six key elements of outsourcing labeling translations:

1. Centralize translation management. Depending on the volume of work, this could be a full-time position or a part-time responsibility for an 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 internal users and must be able to resolve content or technical questions within the company.

Since many device manufacturers have grown through acquisitions, larger organizations establish “translation councils” to harmonize vendor selections, QA processes and technology across the company. Some diversified device manufacturers have put in place a formal working group that look to increase efficiencies and move toward a worldwide unified translation strategy across all their divisions.

2. Decide what to translate and then coordinate all work through one translation vendor. To manage costs when adding new languages, Codman only translates labeling for products that recently have been sold in that country. By combining all labeling translations with one vendor, Codman benefits from lower translation costs, reduced management overhead, as well as improved quality and consistency.

Where the translation volume exceeds the capacity of one translation company, or if a manufacturer has a dual vendor policy, dividing translation work by language often is the easiest approach. For example, maintaining separate translation suppliers for Asian, Eastern European, and Western European languages is a common tactic.

3. Carefully review and test potential vendors. At a minimum, your vendor should specialize in medical device work. In the case of translation, your vendor should also rely on translators who specialize in the device industry.

When buying services such as translations or regulatory consulting, more and more manufacturers look to obtain a larger number of services from a smaller number of suppliers. “Separate outsourcing can be a significant cost burden to manufacturers,” said Madden. “Manufacturers look for vendors who can offer combined solutions.”

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 both need to have auditable, documented systems in place. These systems should detail responsibilities, workflow, required documentation and approvals, as well as quality measurements (the American Translators Association, the European Committee for Standards and even the Society of Automotive Engineers publish standards for translation quality). Once the vendor and customer agree on appropriate quality and performance measures, hold the vendor responsible for measuring and reporting 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 starts and by regularly providing your translation vendor with work forecasts.

6. Clearly define the role of in-country affiliates. Beware of the temptation to have overseas affiliates or distributors do your translation. While some device companies use this approach effectively, many more companies are looking to minimize in-country reviews, let alone translation. Recently, the emergence of outsourced, third-party reviews to supplant affiliate reviewers has helped some device firms dramatically cut review times and, at the same time, improve the quality of the review comments.

In-country reviews also can be outsourced on a language-by-language basis. With this approach, manufacturers still benefit from a consistent process among all of their languages, without delays or significant costs.

Proper Planning Required

Managing regulations and translations is one of the least glamorous aspects of the medical device business, yet it is among the most critical. Any mistake, no matter how minor, can delay product approvals or launches or even cause widespread public relations disasters. For manufacturers that manage regulations and translations properly, they will be ideally positioned to beat their competitors to market.

Some device manufacturers saw the handwriting on the wall years ago and were able to prepare for the steady increase in languages to be supported. This allowed them to focus on building strong supplier relationships and implement aa leading-edge project-management system. The approach is so effective that his group (two localization coordinators, one quality assurance specialist and one system administrator) is able to produce on average 350 manuals per month.

Working with reliable suppliers is of key importance, said Morse. She suggested that manufacturers start by understanding their own outsourcing strategy and then define vendor profiles and the level of service desired from each. “We use regular communications with our suppliers as one more opportunity to get more value from our supply chain,” she noted.

No Avoiding Language Requirements

There are many hazards on the road to selling medical devices overseas. If it were not for the tremendous financial potential of overseas markets, surely most device manufacturers would be quite content to stay put. With the increasing complexity of regulations and compliance requirements, and the never-ending burden of translation, globalization is not getting any easier.

Successful device manufacturers accept that language requirements are part of global marketplace and are meeting the challenge head-on by rethinking their supplier strategies. With the proper planning and dedication of resources, they steer a path to profitable growth in international markets.

Andres Heuberger is president of ForeignExchange Translations, Inc., a provider of language services to the medical device and in-vitro diagnostics industries. He can be reached at [email protected].