Medical Translation Insight

Regulatory affairs professionals in the Northeastern U.S. will have to chance to hear from an industry expert about the current state of global regulations as well as what can be expected this year and beyond. On Thursday, March 24th, Helen Colquhoun, CEO of Pleiad Devices, a clinical consulting firm based in Boston, will be speaking at an event hosted by ForeignExchange Translations, Inc. It will be held at the DoubleTree Guest Suites Philadelphia West in Plymouth Meeting, Pennsylvania from 8:30 until 11:00am.

Ms. Colquhoun’s presentation is entitled, “Devices are from Mars, drugs are from Venus, but regulations are down to Earth.” It will cover the differences and similarities of global device and drug regulations, approvals in the EU, human factors testing for the FDA as well as the state of regulatory affairs in Japan. Attendees will have an opportunity to ask questions and interact with Ms. Colquhoun and other industry professionals, and leave the workshop with practical tips that they can immediately implement at their own companies.

This event will be the fourth in ForeignExchange’s Multilingual Compliance Learning Series, following events in Minneapolis, Northern California and Denver. The workshop is complimentary so if you’ll be in the Philadelphia area in late March, we’d love to see you.

More information about the event can be found at:
http://info.fxtrans.com/devices-are-from-mars-drugs-are-from-venus/


Stay in touch with ForeignExchange on Facebook, Twitter, YouTube, and LinkedIn.

Internationalization and localization for medical technology products tend to have special business drivers and can take on life-and-death importance. First, there's adapting products for better worldwide sales, then there are issues like reducing liabilities and saving lives. Together, they present unique challenge when localizing medical device software applications.

If you would like to learn more about medical software localization, join us for our Multilingual Compliance Learning event in Denver.


ForeignExchange localizes software applications and training programs for medical device and pharmaceutical companies. For specialized medical software localization services, contact us today!

Of the "holy trinity" of cost, time and quality, quality is perhaps the most difficult to define. Yet in medical translation, it is definitely the most important.

Not only does international compliance often ride on accurate translations, lives depend on them. But how do you measure it? And how to do you improve it?

Translation quality is a hot topic and there are a growing number of tools, standards and certifications associated with it. ForeignExchange is conducting research on how client-side companies, linguists, and other translation companies interpret, measure, and value quality. This research will be used not only for our own improvement but also for future publications on the topic and possibly work on some new industry standards.

We would like your help with our research and have set up a short survey about translation quality. The survey will take less than five minutes and can be found at http://translationquality.surveyconsole.com

Thank you in advance for your help!


ForeignExchange supports clients' medical translation needs with comprehensive terminology management services and technology. Contact us to find out more!
 
 

A friend of mine forwarded this picture (click for a larger version) from Malaysia to me with the following:

[This] was taken somewhere in M'sia. For as long as I remember, there have been increasing number of English words being "Malay-fied", like sains, teknologi, industri, persona... etc. You get the drift. So, at first glance, "babi" may just be "baby". Yes?

Well, babi is the Malay word for pig. Can you imagine Muslim babies drinking pig's milk?

I thought I'd share this perfect example of the need for careful translation. Have a good weekend!


ForeignExchange translates medical device and pharmaceutical materials into Bahasa - as well as dozens of other languages. Ask us for a detailed proposal on your next medical translation project.
 
 

In medical translation, ROI calculations are few and far between. And really, why bother with fancy financial models? If medical device and pharmaceutical companies want to sell in foreign markets, translation is a must.

But things are a little different when it comes to terminology management. Sometimes confused with translation memories, clients often view glossaries as valuable but nice-to-have tools to assist translators. In part, that's because, again, ROI calculations are hard to find.

So it's nice to see tekom tackling this issue. A few months ago, they ran an article on the growing importance and cost-savings possibilities of terminology management. "An Bedeutung gewonnen" is in German but here is the English version via Google Translate.

The article is well worth a look. For medical translators and clients alike, the data, ROI calculation, and even the "practical tips" at the end provide good ammunition for convincing purse-string holders that an investment in terminology management makes excellent business sense.


In contrast to most other translation companies, ForeignExchange does not do "all things for all people".

We support the world's leading medical device and pharmaceutical companies with specialized medical translation services for regulatory, clinical, and marketing efforts. Contact us today for more details.
 
 

It's an accepted fact in medical translation that quality is non-negotiable and that patients' lives are impacted by the existence (or absence) of quality. But as an example from Egypt highlights, accurate translations can have lives hanging in the balance as much as translation mistakes.

A U.S. citizen was jailed as a drug trafficker in Egypt in December after he imported a shipment of non-drug hemp oil. He was freed from jail only late last month when mobs of protesters overran prisons across Cairo, but he remains in legal limbo.

Mostafa Soliman, who operates a company called Health Harvest, has so far been refused a new passport by the U.S. Embassy in Cairo, which means he cannot leave the country. If he stays in Egypt, he faces a possible death penalty if convicted of drug trafficking.

Language and translation issues are to blame for his predicament.

When the shipment of bottled hemp oil arrived at Egyptian customs in December, authorities translated "hemp oil" as "hash oil. Because Arabic does not have a distinct word for "hemp", any concoction from the cannabis plant, whether high THC or low THC, is simply called cannabis.

This situation exists in every language combination and translators have to wrestle with it frequently. Luckily, the stakes are usually lower than in this case.

For more information, see the article in The Reason and HIA's press release.

[Thanks to Mary Shillue for the tip and Dolly Dearner for the editorial help!]


Stay in touch with ForeignExchange on Facebook, Twitter, YouTube, and LinkedIn.
 
 

Client stories are great. Theory is always neat and precise, and nothing shows how something works in the real world like a first-hand account from a client. We recently posted such a case study, showing how one of our clients uses quality to drive translation efficiency.

Here is another example, this time on the topic of translation memories (TMs). At Localization World 2006 in Montreal, Jim Niziurski of Ortho-Clinical Diagnostics and ForeignExchange's Sonia Monahan co-presented "Translation memory challenges in a compliance environment":

And for more on TMs in medical translation, take a look at the following articles:

• Preparing files with untranslateable content
• 100% text repetitions: To review or not to review
• Primer: Machine translation vs. translation memory

Subscribing to Medical Translation Insight via email or RSS provides you with daily news regarding language, technology, and regulations.
 
 

We produce so many educational events that it's sometimes hard to keep an overview. Worldle is a great tool to help with that.

As an example, we created a word cloud of recent audio conferences (click for larger version):


Pretty cool stuff - but careful: don't mess with the site unless you have some time to spare.

Anyway, back to our topic at hand: In case you missed them, here are our top audio conferences for January:

1. Advanced Human Factors Engineering
2. Medical Device Vigilance - Reporting Requirements in the EU
3. Intended Use & Indications for Use – Does Anyone Know What They Mean? Does FDA?
4. Risk Management Best Practices for Medical Devices
5. Global Clinical Trials & ISO 14155 Compliance – Are You Ready to Update?

If you have a suggestion for a topic you would to present, send us a note!

Interested in other popular educational events? Take a look at the top events for December, November, October.


For a detailed proposal on your next clinical, regulatory, or marketing medical translation assignment, contact ForeignExchange Translations.
 

You've probably heard of Six Sigma, the quality methodology developed by Motorola and now embraced by companies everywhere. What about Lean? In a nutshell, Lean is a methodology, pioneered by Toyota, for eliminating waste from a manufacturing process. So what does Lean have to do with medical translations?

We recently sat down with Woody Brown of Synthes to learn more about Lean, his role as a Process Improvement Manager, and how Lean can be applied to medical translation.

Check out the video on ForeignExchange's YouTube channel:



Here are three related articles:

• Child adoption, queueing, waste - and medical translation
• 5 questions about translation quality
• Quality matters, or: Is risk a four-letter word?

ForeignExchange is the only company that provides clients with measurable translation quality. Our METRiQ quality system provides medical device and pharmaceutical companies with known translation quality - on every assignment. Find out more!
 
 

Medical device manufacturers are required by FDA and other global regulatory bodies to demonstrate how human factors considerations have been met during product design and development. FDA takes these human factors requirements seriously, requiring that the manufacturer perform a systematic assessment of the intended user, how the device will be used, the environment in which it will be used, and existing use-related hazards.

While the needs for and concepts around usability testing aren't new (see this 10-year old FDA guidance and 12-year old MDDI article which are both still very useful), the growing importance of IEC 60601 has led to a keener interest in usability testing.

Interestingly, usability testing isn't just for the physical medical device; labeling is getting more attention as well.

That's a good thing, too. Many new hardware components have resource allocated to optimize their usability but it is frustratingly common to see well-considered hardware undermined by poorly written/designed/conceptualized documentation.

A good starting point for information is the informative presentation Usability Testing on Medical Device Labeling [PDF]. By attracting more attention to the usability testing and its benefits, we can hope that device labeling will show similar improvements as did pharma labeling in Europe after the introduction of readability testing requirements for PILs.

Have a few more minutes? Good. Take a look at the following articles:

• Medical software ready to take on the world
• The human factor
• All you need to know about web usability
• Talk about "usability", not "quality"

ForeignExchange translates IFUs, software UIs, and training programs for medical device companies. For specialized medical translation services, contact us today!
 
 
 

In theory, the “global marketplace” sounds like an inviting source of untapped markets and unlimited sales. But for those medical device and pharmaceutical companies that mismanage language, support, and IT aspects, the global marketplace can be a very inhospitable place.

Horror stories are commonplace, running the gamut from huge budget overruns, to global product recalls due to production or translation errors, to lost market share for products that did not make it to market in time, and to products translated so poorly they embarrassed in-country sales staff.

Many organizations suffer from a lack of preparation, experience and know-how regarding translation. Any help is appreciated, and a recent piece in The New York Times is really helpful.

Avoiding I.T. Slip-Ups When Going Global does a nice job looking at some of the gotchas involved with overseas expansion. The article looks at how much customization is needed, dealing with international support issues, logistics, and privacy.

Throughout the article highlights language issues. Talking about international support issues, one of the quoted folks mentions that their overseas customers know just enough English to be "dangerously misunderstood".

Head on over to the Times' site - it's a quick read that contains real-world information.


Ready to localize your web site? Get more details about ForeignExchange's expertise in translating pharmaceutical and medical device web sites.
 
 

Did you know that January is named after Janus (Ianuarius), the god of the doorway? The name has its beginnings in Roman mythology, coming from the Latin word for door (ianua).

In Finnish, the month is called tammikuu, meaning month of the oak, but the original meaning was the month of the heart of winter, as tammi has initially meant axis or core. In Czech this month is called leden, meaning ice month. In Ukrainian it is січень meaning cutting or slicing perhaps referring to the wind. Similarly, in Croatian January is called siječanj, also meaning cutting or slicing. In Sámi it is known as ođđajagimánnu, meaning simply "new year's month".

Now that you are fully armed with January-related info and trivia, take a look at our top articles for Ianuarius:

1. New year, new Spanish language rules - New Spanish spelling rules came into effect on 1/1/11
2. Project management and yellow lobsters - What is a great PM?
3. Why do word counts vary from tool to tool? - Tools struggle to consistently define a "word"
4. 5 questions about translation quality - A conversation with Sonia Monahan
5. Client case study - using quality to drive translation efficiency - A J&J company discusses how quality improvements helped drive efficiencies

Looking for more great stuff to read? Take a look at our top articles for December, November, and October. Happy reading and happy weekend!

The latest edition of TRADULÍNGUAS' newsletter features four helpful finance glossaries. For medical translators who also work in finances, add these to your tool kit:

BANK OF CANADA (EN / FR)

DEUTSCHE BANK (EN / DE)

BANK OF PORTUGAL (PT / EN)

UBS BANKING LEXICON (EN / FR / IT / DE)

Be sure to take a look at the entire newsletter and consider subscribing - TRADULÍNGUAS published helpful resources in an easy-to-digest format.

Interested in terminology and glossaries? Take a look at these other resources that we published:

• Glossary of Spanish acronyms and abbreviations
• Swiss legal German-English dictionary
• Medical glossary in nine European languages

Stay in touch with ForeignExchange on Facebook, Twitter, YouTube, and LinkedIn.
 
 

In the translation world, it is very important to provide the client with exceptional linguistic service and a high-quality finished product. What do you do, then, when the client asks for Bahasa, and you assume you should translate into Malaysian, when they really needed Indonesian? And what exactly is the difference? They are both called Bahasa, and by all accounts are very similar.

The islands of Southeast Asia have, for centuries, been a global hub of travel, trade, and commerce. As such it has developed into a myriad collection of peoples, cultures, and languages. Island societies, however, have a tradition of developing pockets of very different cultures, as islands are often easily accessible by boat, but cut off from other societies by large bodies of water. The island nations of Malaysia and Indonesia are no different.

Both Bahasa Malaysia and Bahasa Indonesia are standardized "isolects" of Malay, a major language of the Austronesian family. (The term "isolect" is a neutral term, often used in Malayic linguistics, to refer to those Malay languages that are neither strictly a language nor a dialect. However, for simplicity in this article, I refer to them both as languages.) Yet, while both these languages are considered "Malay", they differ greatly because of how they were impacted by the geography of the islands, and how they were historically influenced by outside interaction.

Sanskrit, the earliest linguistic influence on the islands, came from India in the form of Buddhist and Hindu traders. Next came Muslim traders who brought both a significant Arabic influence (most often seen in borrowed vocabulary), as well as a potent Islamic influence that created the area's prevailing religious culture.

The largest language influences, however, came during the years of European exploration and colonization. Portuguese influence came in the early 1500s, but was restricted primarily to the islands of Indonesia, as the English had control over the areas to the north. The Dutch arrival in the 1600s pushed Portuguese influence out, and treaties with the English solidified Dutch rule in Indonesia (the Dutch East Indies), and English rule in the Malaysian archipelago and northern coast of Borneo. These colonial influences irrevocably changed the Malay language in two very distinct ways.

Bahasa Malaysia
Bahasa Malaysia (or Malaysian in English) refers to the standardized and official language of the nation of Malaysia. The term "Bahasa" simply means "language of." Therefore, Bahasa Malaysia translates as "the language of Malaysia."

While "Malaysian" is the name given to the version of Malay found in Malaysia, it is nearly impossible to identify a "standard" dialect of Malaysian spoken indigenously in Malaysia. For example Bahasa Malaysia, the standardized and official dialect of Malaysian business and government, is similar to Bahasa Melayu, the dialect commonly spoken in Peninsular Malaysia. However in East Malaysia and Brunei, they speak a dialect called Bahasa Baku that differs in vowel pronunciation and tends to be spoken much faster.

One of the major ways Malaysian differs from Indonesian is its influence by and incorporation of the English language. When speakers of Malaysian incorporated English vocabulary, they rarely changed the pronunciation of the word. For example, the word "immigration" in Malaysian is "imigrassen". While the spelling has changed, the pronunciation has little to no variation.

Bahasa Indonesia
Indonesian (the standardized and official language of Indonesia), on the other hand, has been strongly influenced by both Portuguese and Dutch occupation. For example, immigration in Indonesian – "imigrasi" – takes a distinctively Dutch form ("immigratie" in Dutch). Indonesian also has a tendency to modify incorporated vocabulary. Some vocabulary that may have a similar root or sound among several languages (such as "school" in English is also "school" in Dutch and "escola" in Portuguese) becomes "sekolah" in Indonesian.

Furthermore, there are specific words that have very different meanings in each language. For example, "budak" in Malaysian means "children," but in Indonesian it means "slave." Polisi in Malaysian takes the English pronunciation and means "policy" (such as an insurance policy). In Indonesian, however, it means "police." But the Indonesian word for policy is "polis," which is the Malaysian word for police.

It is commonly said that Indonesians can understand Bahasa Malaysia, but Malaysians have difficulty understanding Bahasa Indonesia. This is often attributed to the greater number of words borrowed from Portuguese and Dutch, as well as a greater number of indigenous languages that have shaped local vocabulary and speech patterns.

Multiple variations
Between Malaysia and Indonesia, there are over 100 distinct Malay isolects. These isolects are characterized by mixing Malaysian and Indonesian with vocabulary and syntax from local indigenous languages. Some of the larger include Iban (spoken by the Iban people of northern Borneo), Minangkabau (native of western Sumatra), Javanese (also called Bahasa Jawa, is a mix of Indonesian and the Sanskrit-based indigenous language of Java), and Riau-Johor Malay (this dialect group is spoken in the southern part of the Malay Peninsula and in the Riau archipelago in Indonesia, and it bears the closest resemblance to the national standard language of Malaysia, Singapore, and Brunei). Because of the strong local influences found in these isolects, they can sometimes be mutually unintelligible from other isolects.

Written language
Both modern Malaysian and Indonesian use a Latin alphabet called Rumi, although Indonesian uses a different orthography and incorporates accent marks, both commonly found in the Dutch and Portuguese languages.

Back in the 15th and 16th centuries, during the height of Muslim influence, there was an Arabic-based writing system called Jawi. Slowly, however, European colonization of the area made the Latin alphabet the primary orthography. Although Jawi still exists today, mostly as a co-official writing system (with Rumi) in Brunei, efforts are being made to preserve Jawi script and revive its use among Malays in Malaysia.

It is important, therefore, that the next time you are asked to translate Malay, be careful and make sure to clarify which language they are referring to. It can save both you and your client a lot of trouble and headache.

[Thanks, Anna, for the article!]

Looking for more language facts? Take a look at:

• Language fact: Maltese
• Languages in India - a detailed look
• Language fact: Chinese

ForeignExchange translates medical device and pharmaceutical materials into Bahasa - as well as dozens of other languages. Ask us for a detailed proposal on your next medical translation project.
 
 

Many smaller medical device and pharmaceutical companies are grappling with wanting to automate translation processes but not having enough budget clout to justify the expense that comes with this undertaking.

The good news is that the options for low(er)-cost solutions are rapidly expanding. We have previously written about our move to memoQ and neat solutions for low-cost terminology management.

And now here is another resource: Dig-IT! gave a recent presentation called Translation Automation On A Budget [PDF link]. The slides are well worth a look. They cover topics like:

• Free translation memory systems
• Translation memory sharing
• Free and budget software for localization project management
• Free machine translation solution
• CrowdSourcing platforms

While there is a lot of really good information, there isn't that much real-world information in it. I am not sure how the presentation was billed but I find it always adds a lot of "meat" when a topic like this includes case studies.

Nevertheless, it's great to see more and more cost-effective technology solutions being brought to market. There are a lot more groups within medical device and pharmaceutical companies that can make a $5,000 investment as opposed to an investment of $500,000.


ForeignExchange's METRiQ quality system provides medical device and pharmaceutical companies with measurable, known software localization quality. To learn more, contact ForeignExchange Translations.