Medical Translation Insight

Speaking of conferences, the first-ever Worldware Conference will take place in Santa Clara in three weeks' time.

The program is organized around topics related to software internationalization and web localization. It looks like an interesting opportunity for service providers and localization managers at medical device companies.

Who is planning on going to Santa Clara?

Here is a good example to show that translations of device labels are some of the most important and risky work we do.

Dotmed reported on a story of two employees of a medical device manufacturer receiving prison terms for falsifying labels and quality records. While translators won't willfully make mistakes, the story is a good reminder of what can happen if, for example, a product is labeled "sterile" when it shouldn't be.

The scary thing is how easily something like this could happen. While translation memories are great tools, the discussion around our recent entry on whether or not to review 100% TM matches shows that there is real concern about a small but hugely important mistake getting through.


ForeignExchange Translations provides specialized medical translations for medical device IFUs, operating manuals, and product labels.
 
 

Spanish is the most translated language in the US. While Spanish is one of the easier languages to learn, technical texts are often considered difficult to translate into Spanish. One of the main reasons given is that there is no single variety of Spanish. There are, in fact, major differences between the Spanish of Spain and, say, South America.

But what are pharmaceutical and medical device companies to do? Do you need to provide multiple Spanish translations if you wish to market services to the general Hispanic population in the US or to sell your products to Spanish speakers in both South America and Spain? The experts will tell you that you must write specifically in the Spanish of your target audience. In other words, only Mexican Spanish will do for Mexicans.

The experts are wrong.

SECOND MOST SPOKEN LANGUAGE IN THE WORLD
First, a bit of background. Spanish and English are neck-and-neck for the title of third most spoken language in the world. As of 2005, each had more than 300 million native speakers. Both are behind Hindi (around 360 million speakers) and far, far behind Chinese with around 1 billion million speakers (source: Wikipedia).

But which Spanish are they talking about? As with other widely spoken languages, regional and local usage develops over the course of time, resulting in a veritable Tower of Babel of Spanish.

In the U.S., more than one-in-five residents of Arizona, California, New Mexico and Texas speak Spanish at home. The Hispanic population in and around Miami tends to be of Latin American or Caribbean ancestry. In contrast, the Spanish-speaking population in Dallas is predominantly of Mexican origin.

This kind of regionalism (some worriers would say balkanization) makes it difficult to target each group of Spanish speakers in "their" dialect. In Miami, if you want to reach Cuban-Americans, how do you avoid that this text also reaches (and potentially offends) people of Central American origin?

NOT THE ONLY LANGUAGE WITH MULTIPLE DIALECTS
The debate over Spanish dialects is easy to understand when compared to the differences in UK English and US English. Most of us find the small differences in meaning and pronunciation charming. But as with Spanish dialects, there are also some substantial differences in usage and vocabulary of the English language. (For a look at some of the difference, refer to the American-British / British-American dictionaries at TravelFurther.net.)

Despite these differences, we can communicate quite effectively across the big pond. Most Americans quickly adjust when they hear a Brit describe an activity of a "fortnight" ago. More importantly, Americans interpret uncustomary phrases and expressions in the context given.

CONTEXT, CONTEXT, CONTEXT
In fact, it all comes down to context. It is generally taken for granted that in any language, medical texts use terminology that is quite different from, say, financial texts. Likewise, a guide for janitorial staff uses a style, layout, and terminology that might differ from one for nuclear engineers. We expect readers to have a certain level of familiarity with the topic discussed. The more expertise we assume on the part of the reader, the more specialized the language will become.

For these difficult linguistic situations, the role of the Spanish translator is twofold. The translator must have both expertise in the subject being written about, and knowledge of the document's intended audience. With those two pieces of information, the skilled translator can indeed author a Spanish text that is clear and unambiguous to an educated reader from any Spanish-speaking country.

Companies that use a universal Spanish do so for practical reasons. It is often not possible to produce multiple Spanish versions of the same document and at the same time, reduce time to market and live within ever-shrinking budgets.

The following five guidelines will help you decide to produce universal Spanish or market-specific materials:

1. Distinguish between marketing communication and technical documentation
To save time and money, technical documentation should be written in a universal Spanish. Marketing documents, on the other hand, should be localized for a specific market. Ads, commercials, brochures, and collateral pieces must be copy-edited by local talent.

2. Accept linguistic differences
There will always be people who point out that certain words are slang terms in a country. While these instances should be investigated to avoid any offense to your local users, most of these claims are as bogus as the old fable that the Chevy Nova failed in South America because "no va" literally means "doesn't go" in Spanish.

3. Speak to your audience
As noted above, translators need to know who will read the Spanish documents. This way, linguists are able to match the words they use to the abilities of the end-user. Don't use technical jargon when lay persons will read the document.

4. Don't get too caught up in the details
Proponents of country-specific Spanish documentation often cite differing conventions for depicting times, numbers, and the like. For example, while a Mexican might write a check for $3,290.67, a Spaniard would write the same amount as $3.290,67. Insisting on a separate manual to account for differences like this example is rather like missing the forest for the trees. While a notation might be unconventional, it surely would not result in any confusion.

5. Inform users of your approach
Some companies, like Microsoft, preface Spanish manuals with a note that explains to the user that the document was written in universal Spanish that all of their customers could understand. This heads off criticism at the pass and alerts readers to the possibility for uncustomary terms.

Not everybody will be convinced that a universal Spanish is feasible or appropriate. However, translators need to adapt to the business realities of their customers. It is no longer feasible, or necessary, to write specifically in the Spanish of your Spanish target audience.

Instead, provide context and let them read universal Spanish!


Why do leading medical device and pharmaceutical companies entrust their Spanish medical translations to ForeignExchange Translations? Our process allows for known translation quality in the shortest amount of time. Ask us how!

The title of this recent entry over at Duct Tape Marketing is really relevant to translation in general and medical translation specifically.

Because there are no meaningful certifications or standards in the translation business, it's an arch-typical mom-and-pop industry with thousands of companies and hundreds of thousands of freelancers pursuing clients. Particularly in this area of shrinking translation budgets, having a pitch that gets you noticed and gets you business is critically important.

The primary challenge for most translation service providers is to answer the question of "What makes you special?". Few translation suppliers have a compelling answer.

Everybody talks about quality - but without measurement it's meaningless. Everybody lists the same impressive-looking clients - but because companies use dozens or hundreds of suppliers, it's not powerful either. Everybody says that they have experience in "medical translation" - but because they don't understand that labeling is totally different from regulatory submissions or clinical research work, the claim rings hollow. And everybody espouses their process - but if you just slightly scratch the surface, you realize that all suppliers are basically doing the same thing.

Our company is by no means excluded from this. At ForeignExchange Translations, we regularly talk about this and have taken steps (developing and living our company vision, defining what constitutes "good" work for us, etc.) to better explain what we do - both to ourselves and our clients. It's hard work getting your pitch to not suck!

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As I mentioned in the past, there is a marked absence of medical translation conferences. One of the organizations, we are actively involved in is the Medical Localization Roundtable at the bi-annual Localization World events.

The organization committee is in the process of preparing the agenda for the next Localization World in Berlin, Germany, which will be held from 8 to 10 June 2009. We feel our best resource to obtain this information is from the very people who are working at the heart of medical localization. Therefore, would you mind to take a minute to answer our three-question survey about our planned agenda at www.surveymonkey.com/s.aspx?sm=VV_2fod2RuKa_2bd70m3Asl7fw_3d_3d.

Thank you in advance for your help!

When it comes to multilingual desktop publishing (DTP) in a medical environment, there are two main considerations: First, what tool does the client use to develop the materials and second, how thorough is the translation supplier's analysis of the source documentation.

Sample document and specifications
The quality of any analysis relies first and foremost on a representative sample document supplied by the client. If a sample of the final version is not available at the pre-production stage, the sample should resemble the final version as closely as possible. At the very least, the client should provide an editable sample of the project, not a "static" print or PDF sample.

In addition to the sample, the client should provide complete DTP specifications. The software should be clearly identified by name, version number, and platform. An inventory of fonts, including vendor and classification numbers should also be provided. Remember: font "classification" is still chaotic. Avoiding confusion can mean the difference between a successful project and a missed deadline.

The client should also provide an approximate word and graphic file count. Counts based on the source are more reliable than projected counts based on targets that may vary widely. Graphic files should not only be counted but described in terms of the whether they are illustrations, images, or screen shots; the software used to create them; and the format in which they will be provided. Finally, the client should be as clear as possible about deliverables, specifically regarding how the documentation will be distributed to users, as print and/or electronic media.

Once the client has provided representative samples of the work and precise production and delivery specifications, all of the materials should be evaluated to determine if they support the project described by the client. When the specifications and expectations are fixed to the extent possible, the DTP specialist should then perform a more thorough analysis in order to cost-out the DTP portion of the project and to develop a reasonable staffing and scheduling plan.

Layout considerations
The general layout of documentation has a large impact on both budget and deadlines. Text-heavy documents that utilize a single-column layout with a minimal number of readily available or standard fonts are simple to manage. Sidehead or multiple-column formats, tables and alpha- or numerically-sorted lists complicate the task. Graphics with localizable callouts require more attention; callouts embedded in graphic files may demand even more time.

An important consideration at this stage is the use of styles. Documentation that exploits paragraph and/or character style sheets fully and applies them consistently and correctly is far easier to DTP than a custom-built document in which style sheets have been ignored or over-ridden.

Beyond layout considerations, DTP specialists need to evaluate the tools chosen to effect the localization. Not all applications support all target languages. Alternative tools may need to be adopted for certain targets (e.g., bi-directional languages like Arabic and Hebrew). Alternative fonts may also need to be identified to support certain languages while maintaining the graphic signature of the documentation.

Communication is key
In the end, however, any analysis is useless unless the results are communicated to all those involved in the process. Client contacts at drug and device companies need to understand how the project departs from original specifications and expectations.

Both the client and the translation supplier need to be aware of potential production difficulties before deadlines or quality are jeopardized. Translators need to have the clear understanding of the specifications that affect their part of the process.


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I recently came across this item on eBay and I thought "Ha, that's funny!"

But then I searched for "translation" and found 17 entries and thought "Holy @#&!, I thought reverse auctions were bad enough! Now translation services are being bought and sold on eBay?"

What's next, cereal boxes with coupons for a free 1000-word translation?

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A recent entry in the Yndigo blog referred to "dirty" documents common in legal translations. The same is true in translations of materials related to clinical trials and regulatory submissions: Often editable files simply are not available, and we have to work with scanned PDFs.

A typical dossier, for instance, may contain thousands of pages that are uneditable, usually because the source documents were created a long time ago and faxed or simply converted to a graphic format. Because time is critical in these projects, retyping this content is not an option.

Where text is reasonably legible and not in table format, OCR tools such as ABBYY FineReader or OmniPage offer good solutions. Realizing that there is an opportunity here, Adobe is paying more and more attention to drug and device companies and offers custom life science solutions. What's particularly interesting is that the recently released Adobe Acrobat 9 offers much-improved OCR features right in Acrobat.

While this is great news for pharmaceutical and device companies (more and more regulatory agencies require submissions in fully electronic formats), it's a mixed bag for translation suppliers. On one hand, OCR makes the job of translating these documents a lot easier. On the other hand, OCR is far from perfect and will often result in odd and hard-to-find typos and errors, making the job of editors and proofreaders more demanding.

What tricks and tips do you have for dealing with non-editable PDF files?


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The current issue of Regulatory Focus (login required) has an interesting article called "Regulatory Aspects of Pharma Business in Asia".

The article examines the format of regulatory submissions, language requirements, and requirements for site inspections and local trials across ten countries. Countries across Asia require basically the same information in their regulatory submissions but require it to be presented in a country-specific format. Asia provides tremendous opportunities for pharmaceutical companies but, as the article points out, navigating the requirements and avoiding the pitfalls can be difficult for small and mid-size companies.

Here are a couple of highlights:

Country
China
Format of MAA Dossier
Non-CTD format
Translations required?
Yes
URL for more info
eng.sfda.gov.cn/eng/

Country
Hong Kong
Format of MAA Dossier
Non-CTD
Translations required?
No
URL for more info
www.psdh.gov.hk/eps/webpage.jsp

Country
Japan
Format of MAA Dossier
CTD (with unique M1.2)
Translations required?
M1 and M2 only
URL for more info
www.nihs.go.jp/english/usefulinfo/drugs.html

Country
Korea
Format of MAA Dossier
Non-CTD
Translations required?
Yes
URL for more info
www.kfda.go.kr/open_content/english/index.html

Country
Taiwan
Format of MAA Dossier
Non-CTD
Translations required?
No
URL for more info
www.cde.org.tw/eng/prospects/future.html

Country
India
Format of MAA Dossier
Non-CTD
Translations required?
No
URL for more info
cdsco.nic.in

Country
Malaysia
Format of MAA Dossier
Non-CTD
Translations required?
Yes, for some documents
URL for more info
www.bpfk.gov.my

Country
Philippines
Format of MAA Dossier
Non-CTD
Translations required?
No
URL for more info
www.bfad.gov.ph

Country
Singapore
Format of MAA Dossier
ASEAN format
Translations required?
No
URL for more info
www.hsa.gov.sg/publish/hsaportal/en/home.html

Country
Thailand
Format of MAA Dossier
Non-CTD
Translations required?
Yes, for certain portions
URL for more info
www.fda.moph.go.th/eng/index.stm


ForeignExchange Translations provides specialized Korean, Thai, Chinese, and Japanese translation services to pharmaceutical and medical device companies. Contact us to learn more.

The International Medical Interpreters Association's new guide provides helpful information to clients, patients, and service providers alike.

As quoted in the Boston Herald, Izabel Arocha, president of the IMIA, said that "It's very important that hospitals be aware of standards for quality medical translation that are devoid of errors that could compromise patient health."

We couldn't agree more and applaud IMIA's efforts. The guide can be downloaded free of charge from www.imiaweb.org.

Poka yoke (pronounced "POH-kah YOH-keh") is finding its way into the language business. Japanese for "error-proofing", these safeguards were introduced during manufacturing processes to avoid the possibility of mistake. Wikipedia has some great examples of poka yoke, including how 3.5-inch floppy disks had the top-right corner shaped in a certain way so that the disk couldn't be inserted upside-down.

As John Smart points out in Avoiding the top 20 global documentation errors, there is a definite role for poka yoke in medical translation. And it starts at source.

He gives some great real-world examples:

• Sentences like "You cannot remove the Cluster service, but you can return it to an unconfigured state" get to be edited for brevity and clarity.
• Avoid the -ing gerund aids in understanding, e.g., "How to install the software" instead of "Installing the software".
• Ban all contractions (see this funny example of why not to use contractions) and possessive 's ("the device's packaging"), and you avoid errors in languages that do not have these forms.
• Remove unnecessary words (for example, "The manual has relevant data" - would you put irrelevant data in the manual?) to eliminate the possibility of error.

If you address these kinds of issues at the source, you don't just reduce the chance of translation mistakes, you fool-proof it.

Of course, not all translation problems are due to incorrect or confusing source-language text. But my removing ambiguities in the source, linguists have more time to focus on the quality of the translated text.

For more information, check out Zero Quality Control: Source Inspection and the Poka-Yoke System.


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Most people would agree that the successful communication of project expectations and deliverables significantly impacts the final quality of a localized product. Subject matter experts within drug and device companies have vast amounts of knowledge about their products that can easily get lost in the transfer to the translation supplier.

This loss of product knowledge reduces the efficiency of the medical localization effort by:

• decreasing the accuracy of the vendor's quoting and scheduling process;
• increasing the time spent by project managers and engineers; and
• producing inaccurate deliverables.

A localization kit offers a relatively easy solution to these challenges. Created by the client's translation manager, the kit documents the project-specific requirements that otherwise may be lost during the transfer of information to the vendor.

Five tips for creating effective localization kits
1. Standardized content
Each person completing a localization kit will have different ideas as to what should be included, what is important, and how to communicate information to the supplier. Set standards for the types of information to include, what level of detail is appropriate, and general presentation guidelines.

2. Organization
Every product component should have its own localization kit or, at least, its own sections of the main localization kit. This may seem like overkill but it's obvious that software deliverables, web sites, and marketing collateral have expectations that are quite different from one another.

3. Reference external documents
Your organization's linguistic and formatting style guidelines do not need to be repeated in the localization kit. Reference the correct version of these documents in the localization kit, along with information on how to access them.

4. Client approval
All kits should be approved internally prior to handoff to the localization vendor. For example, if a technical writer is compiling the localization kit for printed documentation, the print manager (or print vendor) approves all deliverables listed in the kit.

5. Involve vendor
It is beneficial to have the localization vendor review draft versions of the kit so that they have a chance to ask questions and provide feedback before the final project handoff.

Suggested contents of a localization kit
Every client has unique requirements, timetables, deliverables, and constituencies. As a result, localization kits will vary from company to company, if not from project to project. Nonetheless, a number of components should be included in most kits:

• Product, project, and component names.
• Contact information for the localization project managers, engineers, etc.
• Overview of the product and the target audience.
• Leveraging information (What is the history of the product? Where can the vendor leverage past translations or glossaries?)
• Source and target languages or locales.
• Expectations for review and delivery dates (by component, if necessary).
• Formatting or stylistic guidelines not included in a separate style guide or print specification.
• A handoff checklist. (The localization kit may often be accompanied by all or some of the files to be localized, test plans or specifications, in-country review guidelines or contacts, a product specification, etc.)
• File listings, including an indication of whether or not the files should be translated (this should include support files such as graphics)
• Deliverables, including versions of applications to be used, part numbers, naming conventions, directory structures, and delivery method.
• Quality expectations. (What is acceptable quality for this product? Is this a marketing brochure in which the localized content can be customized in order to sound better in the target market? Or is this a technical manual that must accurately reflect the English text?)
• Specific localization instructions that, depending on the component type, may include information such as:
  - which terms to translate or leave in the source language;
  - which strings are concatenated and how to handle them;
  - which operating systems to test the product on;
  - which browsers to use;
  - build and resizing instructions and guidelines;
  - test plans or testing guidelines;
  - formatting guidelines;
  - print specifications.

Build a strong foundation
Localization kits are not silver bullets. Assembling a localization kit can be an involved process, and they cannot substitute for regular communication between clients and vendors.

However, the benefits far outweigh any negatives. Once designed, a localization kit may be reused for future projects, often with only minor changes. And a localization kit can help avoid the cost, frustration, and delays that result from not clearly stating expectations. A project handoff that is accompanied by a thorough localization kit and the initial source files provides a strong foundation for any medical translation project.

Additional resources:

• Read Luigi Muzii's detailed instructions to building a localization kit.
• Angelika Zerfass really knows how to organize translation projects.
• A good example of a real-world localization kit is provided by Shopsite.

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As we mentioned a couple of weeks ago, proponents of Extensible Markup Language or XML have been hailing it as a revolutionary technology that can single-handedly solve all kinds of issues related to information authoring, publication, and translation.

There is some basis for such lofty praise. XML has the capacity to pare down time-to-market by reducing the need for rewrites and formatting. The ease with which text can be reused means lower costs for authoring and translation. Using XML can also improve branding and image, resulting from more cohesive content and formats. Even legal exposure can be diminished because there is a lower risk of incorrect or inconsistent labeling.

However, even the best of technologies has its limitations, and XML is no different. In particular, the cost of the XML implementation process may well outweigh the benefits for small teams, for organizations managing fewer than 1,000 pages, and for immature organizations relying on ad-hoc processes.

So how do you know whether XML is right for your company? There is a helpful tool available at www.managingenterprisecontent.com/myweb/ROI_Calculator.htm. This tool will help analyze the costs your company will likely face in converting to XML, and weigh them against the potential benefits of doing so.

Give it a try. You might be surprised at how much XML would (or would not) benefit your company.

How different are these languages?

Having a common root in Serbo-Croat, the three languages are very similar. Compared to Serbian, Croatian and Bosnian have developed a little further. These languages have acquired (invented, actually) new words and phrases. There are also some grammar, style and vocabulary differences between them.

The need to be seen as different languages is primarily political in nature. Speakers of the different languages understand each other in every way, and there is no need for any translations between these languages.

The language group is sometimes referred to as "BSC" (for instance, in the Hague tribunal - see this example). Some say that the languages differ even less than various versions of English (e.g., British versus American English).

UPDATE: In honor of International Mother Language Day, Radio Free Europe Radio Liberty ran an interesting article on this same topic.

ForeignExchange Translations provides specialized Croatian translation services to pharmaceutical and medical device companies. Contact us to learn more.

Not a day goes by when we don't hear or read about "globalization" or our ever-shrinking world. So, how come we still can't communicate one-on-one with the majority of the world's population?

Part of the problem is the shear number of languages involved: If you wanted to say hello to everybody in the world, you would have to learn at least 2,796 languages! A bit beyond most people's reach...

But don't let languages scare you. The Say Hello to the World project enables you to break out of a monolingual world by teaching you how to introduce yourself in dozens of languages.

Each language page features the English text, the corresponding local language version, and a pronunciation guide. For most languages, a sound file is available as well.

It's a big world out there. So go out and announce yourself:

Konichiwa. Watakushi-wa Andres, desu.

Of the European languages, Greek poses a number of unique challenges during translation and desktop publishing. While many device and drug companies face challenges specific to Greek, there are straight-forward solutions to overcoming them.

All-caps styles
Challenge:
Operating manuals frequently make use of an all-caps style for titles within the body of the text. The table of contents (TOC) might be setup to combine an initial cap followed by lowercase letters. In other words, the title "OPERATING INSTRUCTIONS" would be listed in the TOC as "Operating Instructions."

This technique works well in many languages. In Greek, however, there are certain letters (accented vowels, e.g., Ü Ý Þ ß ü ý þ and the final sigma "ò") that do not automatically map to the appropriate capital letter. For instance, the final sigma maps to a bullet point when the "all caps" style is applied.

The result is that to make the all caps titles appear correctly, editors must manipulate the TOC manually, i.e., replace the bullet with a capital sigma. In the case of larger manuals, where the TOC can run for a dozen pages or more, a full day of work would be required to perform the revision.

Suggested Solution:
The all caps style should not be used in IFUs or manuals that will be localized into Greek. Instead, develop Greek-specific templates and styles that provide for appropriate capitalization of titles.

Text expansion
Challenge:
When translated from English, Greek text typically expands by 30 percent and, depending on the translator, often more than that. As text length increases, so does the need for more desktop publishing time:
* Greek hyphenation dictionaries do not exist, requiring the manual hyphenation of formatted text.
* If the source templates were designed without text expansion in mind, quite a bit of work may be needed to prepare the master pages for Greek text.
* Given the larger number of pages, a Greek document will require more time for fixing reflowing text and for proofreading formatted pages.

Suggested Solution:
Carefully review your source-language templates to ensure that the longer Greek document will reflow with a minimum of manual rework.

Fine-tuning index entries
Challenge:
The "code pages" used by Greek operating systems are different from those used by Roman languages. This means that many applications or parts of applications cannot "read" Greek text and display it as gobbledygook.

An example of this limitation is the Marker editing tool in English FrameMaker, which cannot display Greek text, even though the Greek manual itself displays just fine. As a result, not even the simplest of index errors can be repaired by a desktop publishing specialist working on an English operating system.

Suggested Solution:
To ensure the accuracy of the index, the production process needs to account for the time needed by Greek linguists to review and fine-tune index entries and the compiled index on Greek operating systems.

Alpha-sorted elements
Challenge:
Another challenge that is related to code-page conflicts concerns alpha-sorted elements, e.g., footnotes with alpha designations, alpha-sorted lists, and the index. An English operating system provides A-Z alpha sorts, not Alpha-Omega sorts as required in Greek.

The result is that any automatically generated alpha sorts in the body need to be manually overridden in Greek documents, an additional and potentially time-consuming task. In the index, reference pages must be revised to ensure that the index sorts as necessary.

Suggested Solution:
Where possible, replace alpha-sorted lists and footnotes with numbered lists and footnotes; this will minimize the cost of manual rework and, in doing so, improve the overall quality of the documentation.

Greek is good
The production of Greek documentation presents a handful of unique challenges. However, with careful planning and the development of Greek-specific process steps, it is possible to hold down Greek publication costs and produce high-quality deliverables.

Over the past few years, Chinese has become on of our top five languages in IVD (in-vitro diagnostics) translations. Two recent news pieces helped me understand why.

In late 2008, Market Avenue released the 2008 Report on China's IVD (In-Vitro Diagnostics) Market. A couple of months earlier, Modern Medicine published a look at opportunities in emerging IVD markets, including China.

While the two pieces contain some conflicting information regarding market size and growth, there is no doubt a) that the Chinese IVD market is among the ten largest worldwide and b) that, in all likelihood, this growth will continue. As the living standard of the Chinese population keeps improving, people are paying more attention to their health. This will cause China’s per-capita expenditure on IVD-related items to surge, from the current mark of around $2 to gradually approaching the $28 figure found in developed countries.

All of the well-known multinational companies are well established in China: GE, Siemens, Roche, Johnson & Johnson, and Beckman Coulter have long been present. But the majority of the market is supplied by small to mid-sized domestic producers. It’s no wonder that more and more companies look to enter the Chinese market.

However, entering the Chinese market requires no small amount of forethought and planning, both from a regulatory perspective and when it comes to language translation.


ForeignExchange Translations provides specialized translation services to drug and device companies - in Chinese and 35 other languages!
 

The folks over at the Point Blank blog recently featured an article by our own Jason Heaton on a topic that he has spoken and written about extensively.

While the translation industry in general is in dire need of standardization, it's unclear whether or not EN15038 is the right approach. The experienced team at Eule Lokalisierung posted some of their questions and concerns.

Jason's recent presentation drew a large audience from leading device and drug companies. End-clients are looking for ways to improve and standardize the buying of translation services. Will the translation industry listen to its customers?

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Many drug and medical device companies have already translated their web sites into one or more non-English languages. However, many more companies have yet to begin this process.

Asking the right questions during the planning and budgeting stages help ensure that the final product is as usable and effective abroad as it is in the domestic market.

Questions to consider
To avoid the frustration and expense of an incorrectly planned web localization effort, include the following 11 questions in your process:

1. What is the return on investment?
Asked differently: Why are we doing this and how do we expect this effort to benefit us? Don't proceed until you have a convincing answer to this question.

2. Who will pay for globalization?
Web translation work is not cheap (you can budget from $50 to $100 per page per language, depending on the amount of text, the services, and the number of graphics included). View every web page on a cost-benefit basis -- you may not need to translate every page on your site at once.

3. How will you manage the work?
The responsibilities of maintaining a multilingual site extend beyond the initial translation effort. Most web sites are updated two to three times per year and require an ongoing management effort from one or more of the following:

• Translation vendor
• Globalization technology vendor
• In-house web team
• In-country offices
• International marketing agency

4. Will in-country offices be involved?
Depending on the objectives of the multilingual web site, it may be imperative that in-country offices be involved in the creation and/or translation of market-specific content. Be sure to consider added expenses for staffing, computer resources, training, and communications.

5. Which elements of the web site will change?
You may find that you only need a few minor design changes or an entirely new design - for each target market! For instance, because Asian users often share terminals, they prefer shallow sites with long, easily printable pages to graphics-heavy sites with lots of sub-pages.

6. Which elements will not change?
After testing the suitability of your color scheme, product names, and site layout for each of your target markets, you may find that you should not alter some elements of your site, including company logo, colors, and trademark names.

7. Where will the site be hosted?
You will gain better response times if the site is hosted in-country. On the other hand, a distributed hosting model is more complex and expensive. In addressing this issue, be sure to consider navigational issues such as how the translated sites will be linked to the main site.

8. Will translated sites have their own domains?
There are no hard-and-fast rules here. Pharmaceutical and medical device companies usually rely on local domains (e.g., www.wyeth.ca or www.bostonscientific.jp) but there are plenty of companies that include them as a subset of the parent URL (e.g., www.medtronic.com/ES/ or www.medical.philips.com/ch-de/).

9. How will the globalized sites be promoted abroad?
To meet stated objectives, globalized sites usually need to be supported by marketing budgets. Some of the expenses included are site registration efforts, direct marketing, print advertising, public relations, and the updating of already-printed marketing collateral.

10. Who will test the site?
Hint: "nobody" is not an acceptable answer. Some organizations rely on their in-country for this work while others will outsource the task to their translation vendor, marketing agency, or to a specialized testing services. Either way, be sure to allocate resources for the development of a robust testing plan.

11. How will you support overseas users?
International customers typically require assistance in their native language, during local business hours. Be sure to budget for an enhanced email and customer support infrastructures and to prepare for support requests in non-English languages.

Additional resources:

• John Yunker's Beyond Borders: Web Globalization Strategies provides step-by-step instructions on how to correctly localization Web sites
• Usability Sciences is a leader in providing usability testing for Web sites and software. Check out Jeff Schueler's audio conference on this topic.
• MultiLingual is choke-full with insight and actionable advise related to Web localization specifically and translation issues generally. Make sure you get a subscription to this great publication.

To accurately translate your corporate, therapeutic, and product web sites, leading medical device and pharmaceutical companies rely on ForeignExchange's specialized web localization services.
 
 

This recent call for help on the Wordfast mailing list caught my attention:

anybody got any experience with the medical translation branch of electronic Common Technical Document (eCTD)??

what are the formats used there (xml and pdf, I heard, but how do you manage to translate the xmls with wordfast??), how is the text (pharmaceutical-ish, or much more straight language, short sentences...??), any repetitions there?? any gloss (what would you recommend)????

any help appreciated...

The shift towards electronic submissions isn't easy - not for pharma companies, nor for translators. While pharmaceutical companies typically struggle with getting management support and managing timelines for the conversion to eCTD, many translators are dealing with more fundamental questions like: What is eCTD? Do I need to work in XML? Which modules require translation?

The technical specifications are defined in International Conference on Harmonization regional guidance documents. In addition, ICH eCTD Specification Version 3.2 provides the most detailed view of the requirements. FDA has individual specifications for Module 1 as well as Modules 2 through 5.

Wikipedia has a good overview of the organization of and content going into an eCTD. Content is generally defined by regional guidance documents. For instance, when submitting to FDA, the guidance document for Module 1 is Guidance for Industry, Submitting Marketing Applications According to the ICH CTD Format - General Considerations.

As even a cursory view of these document shows, eCTDs are large and complex. The best way to tackle them is through research. Here are some helpful resources:

• The Lazlo Letter put together a good list of eCTD software packages.
• When it comes to submissions in general and eCTD specifically, few people are as knowledgeable as Gina Ross. Her presentations on the subject are extremely insightful.
• The eCTD Blog is a good all-around resource - check it out

ForeignExchange Translations provides specialized translation services for regulatory submissions by pharmaceutical and medical device companies. Contact us to learn more.

When translating printed materials into English, it is important to know where in the world the translation will be used.

Wikipedia has a good entry on the difference between British and American English. Here are a few highlights:

-ce, -se
Nouns ending in -ce with -se verb forms: American English and British English both retain the noun/verb distinction in advice / advise and device / devise, but American English has abandoned the distinction with licence / license and practice / practise (where the two words in each pair are homophones) that British spelling retains. American English uses practice and license for both meanings.

ise, -ize
American spelling accepts only -ize endings in most cases, such as organize, recognize, and realize. British usage accepts both -ize and -ise (organise, recognise, realise). While -ize spelling is preferred by some authoritative British sources, it really is not in common use and would look wrong.

-yse, -yze
The distribution of -yse and -yze endings, as in analyse / analyze, is different: the former is British, the latter American. Thus, UK analyse, catalyse, hydrolyse, paralyse; US analyze, catalyze, hydrolyze, paralyze.

On the Internet, however, things are a bit different. To avoid supporting regional versions of the same language, many companies are implementing international English (or international Spanish, French). But as the Global by Design blog points out, for English this often simply means using American English. In fact, American English represents an astounding 80% of the English-speaking Internet. Apparently, when in doubt, use US English.

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Our recent post on Japanese and Chinese fonts generated the question: What is Unicode?

While there is a ton of information available on the web, Adam Asnes of Lingoport has done a good job summarizing it. Unicode Primer for the Uninitiated is easy to read, contains some history and shows just how quickly Unicode has become the character set standard on the web.

After you have digested this introduction, head on over to the Unicode Consortium for their technical introduction to the standard.

The Patent Docs blog posted an update to changes in the Japanese patent law. As of April 1, 2009, foreign applicants will have longer to file appeals against final rejections. Other changes include better protection for the licensee in the case of a non-exclusive license, especially at the application stage of a patent. For more details, see the Japan Patent Office's web pages (Japanese only).

This is good news for drug and device manufacturers. Firms spend enormous efforts to understand, adhere to, and navigate global patent standards. And as the world's number two market for both pharmaceuticals and devices, Japan receives particular attention.


ForeignExchange Translations provides specialized medical translations for regulatory submissions, labeling, and safety reports - in Japanese and dozens of other languages. Contact us to find out more.
 
 

Despite the advent of XML and HTML, much of the work translated by device and drug companies still gets formatted and printed using traditional tools. The choice of desktop publishing (DTP) or formatting application has far-reaching consequences when working in multiple languages. For one, some tools lend themselves better to foreign-language publishing than others. For another, different applications have various strengths and weaknesses, making them more or less applicable to certain types of documents.

Consider some of the following challenges:

• Manuals vs. MarCom: Technical documentation sets require the ability to manage chapters and indices. The design of marketing pieces requires the ability to handle graphics, special effects, and various print formats.
• Multi-language vs. single language: Pieces that contain multiple languages have different formatting needs than single-language documents.
• Single-sourcing: An increasing number of companies are switching to a write-once-publish-many process to support web, PDF and print publishing.
• Language-specific issues: Double-byte, right-to-left... 'nuff said.
• CAT tools: Computer-aided translation tools are increasingly common in the translation process. CAT tools do not support all DTP applications equally. This can have a significant impact on price and turnaround times.

Production times
Commonly used DTP/formatting applications include QuarkXPress, InDesign, FrameMaker, and MS Word. They are all available under MacOS and Windows. Each of these applications has been around long enough to attract its share of users and supporters (as well as detractors).

These four common applications differ widely in features, benefits, and optimal use. They also vary in their usability and the speed with which layouts can be created "from scratch."

The following is a comparison of the time required to format a typical page:

• Word: 6 minutes per page
• FrameMaker: 10 minutes
• InDesign: 15 minutes
• QuarkXPress: 20 minutes

So while QuarkXPress may be the tool of choice for design work, it is also the least productive when it comes to formatting translated texts. (These times are general estimates that include the time to cut-and-paste or import translated text into an existing template and to format that text using existing styles. The times also consider the level of translator familiarity and tool support available.)

One tools does not fit all
Before rushing to switch all of your layouts to Word or Frame, bear in mind the following six questions.

1. Which application is best for English documents?
FrameMaker is designed from the ground up to write and maintain multi-chapter books. InDesign, on the other hand, is intended as a mid-level desktop publishing application and is much for suitable to the production of brochures and short pieces. Choose the right application for your source documents.

2. Will you use translation memories?
TRADOS, the industry-standard translation-memory (TM) tool, provides filters to InDesign, Word, and FrameMaker. The difference is that the Word and FrameMaker filters work while the ones for InDesign and Quark do not.

As more and more companies use TMs, this distinction becomes important. You want to work with a supplier that will maintain a TM on your behalf. This TM will reduce the time required for future updates, improve consistency across translated documents, and provide you with (potentially significant) cost savings on your translation work.

3. What tools do your translators use?
Few translators and translation companies are "expert" users of any DTP application. Having said that, you will find more vendors that are comfortable with InDesign and Word than with FrameMaker and Quark. Sure, everybody will claim to know everything but once you kick the tires, you'll notice that many translators do not know a pixel from a pica.

4. Will you publish in double-byte languages?
Recent editions of FrameMaker, InDesign, and Word come with support for Japanese, Chinese, and Korean built in. If you want to produce Quark documents in these languages, you (or your translators) need to purchase three different versions of QuarkXPress.

5. Is turnaround time important?
Per-page production times in FrameMaker run between 25% and 50% of those in page-layout applications. There are significant time savings to be had!

A note on MS Word: While Word shows the fastest layout times in the list above, the production time very much depends on the type of document being formatted. Word does not do well with long, graphic-intensive documents. For these kinds of pieces, production times quickly double and triple.

6. How tight is your budget?
As always, time equals money. Most translation vendors charge for formatting work on an hourly basis. If it takes fewer hours to complete, it will cost the client less money.

And the winner is...
There is no single correct DTP application that will fit every situation. However, if you are working with single-language manuals and work in Asian and/or Middle Eastern languages, then FrameMaker and InDesign should come out on top of your list.

Take a look at ForeignExchange's desktop publishing and multimedia services and request a detailed proposal for your next multilingual desktop publishing project.

The adoption of translation memory (known as "TM") technology continues to soar among drug and device companies.

One of the questions that more and more clients ask is "Why do we need to pay for 100% matches? Shouldn't these sentences be free since they have already been translated?"

To answer this question, let's start with a look at how TM systems work.

Translation memory systems basically consist of a database in which a source-language segment (a segment is usually, but not always, a sentence) is stored together with the corresponding translated segment. This combination is called a translation memory "unit." During translation, new source segments will be compared to the database and a match value will be calculated.

A match value of 100% means that the new source segment is identical to a segment in the database, down to the last space, period, and letter. If the match value is below 100% and above a certain user-definable percentage (i.e., "fuzzy match"), there exist some differences in the segments, such as different words, plural vs. singular, or even just different numbers. If the match value falls below the user-defined percentage (typically, 75%), the text is considered "new."

Based on this description, it would be reasonable to conclude that 100% matches should, in fact, be free. This is where the wonderful art of language comes into play.

Consider, for example, the following two pairs of segments, with segments 1 and 2 stored in a TM database and segments 3 and 4 to be newly translated:
Segment 1: The blue house has been built by Mr. Jones.
Segment 2: It is displayed on the next page.

Segment 3: The green hospital has been designed by Mr. Smith.
Segment 4: It is displayed on the next page.

In this example, segments 1 and 3 would be considered as new text. They are similar, but for the purposes of translation, segment 3 needs to be translated from scratch.

Segments 2 and 4 are identical in English. However, when translated into French and German, the "It" would need to be translated differently because house is feminine and hospital is masculine in French, and, respectively, neutral and masculine in German. If the TM segment 2 were to be reused without editing, the German and French would be wrong.

Most translation vendors will charge a nominal fee for reviewing 100% matches. At ForeignExchange, our translation charges are discounted as follows:

• 10% of the per-word cost for text repetitions and 100% matches
• 25% of the per-word cost for 99%-95% fuzzy matches
• 50% of the per-word cost for 94%-75% matches
• 100% of the per-word cost for matches below 75%

In other words, if a translation is priced at $0.25 per word, then 100% matches would be charged at $0.025 per word. This provides sufficient compensation for the translator to review exact matches and to make minor adjustments such as the "It" in the example above.

Some companies insist that this quality-control step not be included in the translation process. For certain types of texts and for companies that can accept gender-agreement and other minor errors in their translations, this is absolutely appropriate.

However, for the majority of pharmaceutical and device companies that are not willing to accept these kinds of linguistic quality risks, 100% matches must be reviewed to ensure superior linguistic quality.


Confused by all of this talk about "translation memories"? Read on:

• What you need to know about translation memories is a good starting point for more information.
• Translation memory vs. glossary tries to clear up the common confusion between these two tools.
• Machine translation vs. translation memory looks at the difference in tools that aid vs. replace the human translator.
• We have produced three audio conferences on efficient TM design, leveraging and use.

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As a translation manager, it's essential to measure the quality of work produced by your staff and vendors. But translation quality is a difficult thing to measure, mostly because translation is so subjective. What one person may consider to be high-quality work may be substandard to someone else.

So in order to take the subjective nature out of measuring translation quality, many managers attempt to measure productivity. But even this is sometimes trickier than it seems.

What to measure?
First, there is the problem of identifying a valid measurement. Ideally, translation productivity should be measured on some kind of outcome basis, such as the number of documents created.

This is important not only so you can evaluate the performance of your current translation vendors and employees, but also so you can determine whether you are under- or overstaffed. When you are ready to staff a new project, this information will help you determine how many people you will need and how long it will take.

Individual vs. process
The most important point to keep in mind is that you must resist the temptation to rate each employee against his or her colleagues on the basis of the metric.

Everyone in an organization is embedded within a process, and high productivity only occurs in the context of an entire system set up to support it. It's vital that management uses its metrics to chart the entire effort and react only when the numbers reflect an overall problem in the process, not in any one person's individual performance.

Certainly you need to know if someone is not pulling his or her weight. But it's much more important that you're able to detect problems affecting the organization as a whole so that you can address those issues before they become too damaging.

Combine measurements
Finally, there's no one golden measurement, but if you combine metrics across quality dimensions, you can quickly home in on an accurate representation of translation quality that leaves nothing significant unknown.

It is important that device and drug clients take steps to measure translation quality themselves because few translation suppliers really know how to objectively measure translation quality.


ForeignExchange Translations delivers measurable translation quality to out pharmaceutical and medical device clients. Contact us to learn more.

Cyril Goutte, a researcher in the Interactive Language Technologies Group at the Canadian National Research Council's Institute for Information Technology, sent me an email a couple of days ago, announcing the release of his new book: Learning Machine Translation (Neural Information Processing).

The book looks first at enabling technologies: technologies that solve problems that are not machine translation proper but are linked closely to the development of a machine translation system. These include the acquisition of bilingual sentence-aligned data from comparable corpora, automatic construction of multilingual name dictionaries, and word alignment.

The book then presents new or improved statistical machine translation techniques, including a discriminative training framework for leveraging syntactic information, the use of semi-supervised and kernel-based learning methods, and the combination of multiple machine translation outputs in order to improve overall translation quality.

It seems like an interesting read. Has anybody purchased and read it yet?

The Street Static blog provides step-by-step instructions for turning your Nintendo DS into a portable translation dictionary. The process requires a free DS application called NewDictS, then takes advantage of StarDict's open-source dictionaries. When you're done, your Nintendo DS will provide terminology in Spanish, Japanese, Russian, French, or any other language you need.

What a great way to turn a DS into a business tool! And if you need more functionality to justify splurging on a DS, consider installing a browser or learning Chinese.


ForeignExchange translates medical device and pharmaceutical materials into Spanish, Chinese, Japanese, German, and dozens of other languages. Ask us for a detailed proposal on your next medical translation project.