Medical Translation Insight

Talk about staying power.

Every once in a while a cliche, a turn of phrase, or an acronym comes along that proves durable. Think OMG. Think Yes We Can. Think Lost In Translation.

Come on, is there anybody who isn't yet sick of hearing something or another got lost in translation? As the Translation Guy said:

"Lost in Translation" sucks, and I'm talking both film and phrase

Maybe, but notwithstanding that the cliche itself doesn't translate well (in China, it was named "Lost in Tokyo," because "Lost in Translation" doesn't translate well to Chinese, so they based the title off the location in the film), the phrase has amazing endurance.

And now, there is even a song out by the same name. G-Eazy takes a cue from Bill Murray, sampling from a Japanese pop song by きゃりーぱみゅぱみゅ titled "PONPONPON". Take a listen:



What will be next? L.I.T. bath robes?

[Tip of the hat to Pigeons & Planes]

Have some more time? Take a look at these:

• Lost in translating
• 50 Things Successful People Have in Common
• Eye charts from around the globe

You can follow ForeignExchange on Facebook, Twitter, YouTube, and LinkedIn.
 

Another year is drawing to a close. While 2011 was a challenging year, it was also a rewarding one. At ForeignExchange, we have a lot to look back on and be proud of.

We opened two new offices in 2011, one in Cambridge, United Kingdom and one in Minneapolis, Minnesota. The diversity of our office locations shows the truly global nature of our business while also demonstrating how ForeignExchange is continuing to be "local."

Continuing on the theme of being local, in 2011, we kicked off our "Learning Unplugged" educational program and held over a dozen events attended by hundreds of people. Topics were varied, from writing for translation to usability testing to software localization. Feedback has been great and our slate of events for 2012 is filling up with some great educational offerings in even more locations around the world.

Speaking of education, our audio conferences continued to be popular in 2011. We produced over 150 of these distance learning events that were attended by thousands. And there's barely time to catch our breath: we've got 40 events already scheduled for 2012, with more being added weekly.

Our VP of Quality penned a book this past summer and it's quickly on its way to becoming a valued resource for the industry. "The Insider's Guide to Measured Translation Quality" has been so popular that we're already planning a second edition to be printed in 2012.

There was a lot to be proud of in 2011 and while it's nice to acknowledge accomplishments, it's even nicer to build on them and achieve more. 2012 will bring with it more challenges and we're ready to meet them head on. But first, we'll take a break and enjoy the holidays with friends and family. We'd like to take this opportunity to wish all our readers, clients and partners happy holidays and a Happy New Year. Thank you for reading and for your continued support.



For expert medical translations of regulatory, clinical, and marketing content in 40 languages - including Spanish - request a detailed proposal from ForeignExchange Translations.
 
 

Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices.

Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.

In order to set up an e-labeling system, companies must develop and implement internal controls and procedures that promote adherence to regulatory requirements including applicable statutes, laws, regulations, and directives. e-labeling provides several advantages in managing regulatory compliance but also poses some challenges.

On January 10th, regulatory expert Salma Michor, CEO of Michor Consulting EU, will be presenting an audio conference that looks at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling to gain competitive advantage. Register to attend here:

http://www.fxconferences.com/eLabeling-Medical-Devices-for-the-EU-Market-P597.aspx


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

The EudraVigilance Medicinal Products Dictionary (EVMPD) was developed by the European Medicines Agency (EMA) to aid pharmacovigilance activities in the European Economic Area and was designed to support the collection, reporting, coding, and evaluation of both investigational and authorized medicinal product information in a standardized manner.

On July 1, 2011, as a step in implementing new pharmacovigilance legislation in the EU, the EMA published the format in which pharmaceutical companies will need to submit information on all of their drugs authorized or registered—by whatever authorization route—in the EU. The new format will go into effect on July 2, 2012.

Obviously, this new format and the related reporting requirements will impact all companies marketing pharmaceuticals in the EU. We've prepared a white paper in order to help companies prepare for the July 2, 2012 deadline. You can download it here:
http://info.fxtrans.com/complying-with-emas-new-mandatory-requirement-for-medicinal-product-information/


ForeignExchange Translations provides specialized medical translations for electronic as well as paper-based regulatory submissions. Contact us to find out more.
 

We have some great educational offerings coming up in the coming weeks.

On January 11th we’re bringing our popular networking breakfast event, “First, Do No Harm: Basics of Human Factors Engineering and Usability Testing,” to Santa Clara, California. The complimentary seminar will be presented by FX Certified Partner, Maria Shepherd. Seats are filling up already but you can still sign up to attend here:
http://info.fxtrans.com/lu20120111-first-do-no-harm-basics-of-human-factors-engineering-and-usability-testing-ca

Thinking about implementing a content management system? As the demand for technical, training, marketing documentation and product labeling increases, so too does the need to deliver this content more quickly and in more languages. To meet these requirements, many regulated companies are migrating towards structured authoring and content management systems that enable the re-use and re-purposing of existing content. On January 12th, ForeignExchange’s own Jason Arnsparger discusses tips, challenges, best practices and lessons learned with CMS implementations. More information about this audio conference can be found here:

http://www.fxconferences.com/Best-Practices-for-Successfully-Implementing-a-Global-Content-Management-System-P747.aspx

We have a lot more exciting educational events planned for 2012. If you have suggestions or want to inquire about a customized, on-site educational seminar, don't hesitate to get in touch with us by sending an e-mail to education@fxtrans.com.

The folks at Brandwood Biomedical know a thing or two about Asian device markets. They proved this again by publishing a nice presentation summarizing China's medical device industry.

This presentation is helpful for people to get a quick grasp of China's current medical device market and healthcare trends. If you prefer, you can download the PDF file. Either way, it's recommended reading!

For more information on China, take a look at the following:

• China's IVD market is booming
• Navigating China's Medical Device Regulations
• What does a Chinese keyboard look like?

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

We have written before about Xerox' translation group (check here for a refresher).

Earlier this year, ClientSideNews featured a story about the Xerox Translation Quality Assessment (TQA). If you missed it, check here for the PDF file.

CSN's article looks at Xerox' "Translation Quality Assessment" process. Based on SAE J2450, it relies heavily on translator rankings. At Xerox, rankings

"go from T1, the least experienced, to T5, expert level. Translators can have different ranks for different document types and subject matters. All translations performed by T1 – 3 translators are proofread by T4 – 5 translators, using the Xerox TQA model."

TQA is applied in the linguist recruiting and testing phase. During production, translators' work is proofread until a text reaches the required quality as measured through TQA. After that, random spot-checks are carried out.

The loop is then closed:

"Regular TQA review meetings are arranged in order to analyze the TQA data and determine the T ranking of individual translators. T ranking decisions are based on the average TQA score, most frequently recurring error categories, volume of translations completed and proofreaders' comments."

While we take a different approach by measuring the quality of the output, TQA seems like an interesting approach and apparently provides Xerox with some performance data for it's linguists.

Does anybody have any other experiences with performance metrics and measurements for individual translators?

Looking for further information on managing translation quality? You have come to the right place!

• Quality is dead - long live measurable quality
• Bridging the Linguistic Quality Gap: How to Measurably Improve Translation Quality
• Automating QA in translation

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Indian medical device regulations continue to evolve - albeit very slowly.

The country's health ministry aims to amend the Drugs and Cosmetics Act to provide separate definition and regulation of medical devices. Pharmabiz quoted sources as saying that "[t]he salient features of the proposed bill would be to provide a separate definition of Medical Devices, their risk based classification for regulatory control, Clinical Trials on Medical Devices, Conformity Assessment Procedures, Penal provisions".

The health ministry plans to increase staff and infrastructure at the Central Drugs Standard Control Organization's medical device division to support this expansion of the government's regulatory scope.

But the legislation hasn't yet been submitted to Parliament. Apparently, regional and special interests put the bill on the hold. Stay tuned...

[Hat tip to Emergo Group]

For more on India, take a look at the following:

• The Continuing Evolution of Clinical Research in India
• Indian Rupee symbol ripping off Roger Federer?
• Languages in India - a detailed look

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

Informed consent forms (ICFs) are required in all clinical trials which are approved by an independent Ethics Committee before practical use in the trials. However, how much the average patient actually understands of the information contained in an ICF is often uncertain - and that's before it is translated into other languages.

Most ICFs are too complex to understand by an average adult subject. One obvious solution is to reduce the complexity and increasing the ease of readability. This can be achieved by simple measures such as encouraging investigators to participate in the preparation of ICFs, gaining an enhanced understanding of the site specific requirements (culture, language and dialect, literacy rate, and so on), and, of course, improving the deficiencies in translation processes.

The gold standard of back translation is one way to improve translations but fewer and fewer sponsors are able to justify the time and expense required to implement it.

The best way to enhance understanding of translated ICFs is to make sure that they are written and translated to match the reading levels of the target patient population. Many Institutional Review Boards, suggest that the reading level of an ICF should be no higher than an 8th grade level, as JHM IRB does here. That's easier said than done, however.

For one thing, most ICFs can't quite make it "down" to an 8th grade reading level. Pharmalot, reporting on a recent analysis of ICFs, stated that Informed Consent Forms Target 11th Grade Readers.

For another, some experts question the validity of the 8th-grade target. In Six Questions to Ask About Consent Form Readability [PDF link], readability consultant Mark Hochhauser notes that there is little research to support this target and asks: "If a consent form is
24 single-spaced pages, will readability alone make a difference?"

Hochhauser goes on to give a good example of how readability formulas are confusing and maybe even misleading:

" I analyzed a consent form that came to our IRB through Readability Suite (http://www.oleandersolutions.com/) which gives readability statistics for 17 formulas. The scores ranged from grade 11.5 to 16 — a difference of 41/2 grades. If the readability formula doesn't matter, use the lowest scoring formula. If you're using the Flesch-Kincaid formula in Microsoft Word be aware that older versions of Word do not report scores higher than grade 12."

By the time medical translators receive texts, the writing has been completed. That does not mean, however, that reading levels aren't important in translation.

Many medical translators end up making translated texts more difficult. The reason? Keeping translations easy to read yet faithful to the original is hard work - and the extra work is rarely being compensated.

It takes time to understand the intended audience, think of ways to express the target-language text in suitable language, adapt each translation to each culture, and then to measure the resulting translation. And the linguist cannot work in a vacuum either - all of these items have the be coordinated and agreed upon between sponsor, site staff, and translator.

But without this kind of coordination, comprehensibility of translated informed consent documents and patient recruitment will suffer.

While we're on the subject, here are three more helpful articles:

• Back translations - useful or waste of time?
• Requirements for readability testing of PILs
• Talk about "usability", not "quality"

Find out more about ForeignExchange's specialized medical translation services for international clinical trials.
 
 

The year-end is almost upon us. Many of us are busy wrapping up work before taking some time off.

This is also a busy time of year for our audio conference producers. Clients use left-over budget on educational event, for themselves and for others (our all-you-can-learn package has proven to be extremely popular this year).

As for November, our top events were heavily focused on FDA-related topics. Here are the top five from last month:

1. Best Practices for Writing Safety Narratives
2. Best Approaches for Your 510(k) Submission
3. Dealing With the New FDA: How the Focus is Changing
4. Off-label Promotion – What FDA Looks For & What You Need to Know
5. Advanced Human Factors Engineering

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


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

Congratulations, your software is now shipping throughout the world. Now, what happens to folks who need to enter data? What happens if your clients want to enter Japanese ideograms? Could they do that with a U.S. keyboard? Conversely, what if Japanese users need to type in U.S. text? Is your application able to handle switching from one locale to another and still let the user enter data?

The above is a common scenario for medical device manufacturers who are only just setting out on the road to internationalize their device software. Depending on the device, keyboard data entry may or may not be applicable.

Luckily, when it comes to software internationalization, few folks are as knowledgeable as our friends at Lingoport. And they just published a white paper called "Keyboards and Internationalization". You can access it on their web site or download a PDF version.

Data entry is, of course, only one aspect of getting ready for a global release. Device software also needs to be internationalized regarding display, sort order, search functionality, and many other areas. However, for those devices that require keyboard input, Lingoport's white paper offers a valuable resource.

For more information, also take a look at the following:

• A "fireside chat" between Adam Asnes and Andres Heuberger
• What does a Chinese keyboard look like?
• Why pseudo-translate?
• Sandra LaBrasca on localizing and internationalizing medical device software

ForeignExchange's METRiQ quality system provides medical device companies with measurable, known software localization quality. To learn more about our medical translation solutions, contact ForeignExchange Translations.
 
 

In our work with medical device and IVD companies, ForeignExchange's team has noticed that more and more of them are taking a careful look at which markets (and languages!) they support.

In these companies' efforts to reduce costs and gain efficiencies, smaller markets in particular, are on the "chopping block". I remember one device company, in particular, that considered whether or not to continue supporting the Greek market.

The regional manager mentioned that all the products the company ever sold in Greece would comfortably fit on a conference room table. They then compared this revenue to the hundreds of thousands of dollars spent on translating, packaging, shipping, and providing support for the Greek market, and the conclusion was both quick and easy: drop Greek translations.

Most situations aren't quite as clear-cut, of course. Clients tell us that some of the questions they look at include:

• How many markets are under consideration?
• What is the size of these markets, now and in the future?
• What products are currently selling in these markets as well as domestically?
• What are competitors doing?
• Do the selected markets support price points that allow for profit?

Medical devices companies are not about to turn their backs on international markets. But they are getting smarter about looking for ROIs through things like "SKU rationalization" that can do away with redundant products and inappropriate or wasteful packaging. Even the smallest packaging changes can have dramatic implications - positive or negative (e.g., even a small reduction in packaging weight, while maintaining product protection, will improve a company's bottom line).

Translation spend isn't the main cost but it certainly receives attention. Increasingly, device companies are looking at:

• Incorporating previous user feedback
• Shortening inserts, labels, and marketing documents
• Redesigning packaging, labeling, and documentation
• Writing with translation in mind

These last two items, in particular, have often been overlooked in the past: Companies tended to underestimate the importance of well-designed and well-written instructions and warnings (just look at the popularity of our events on Writing for a Global Audience and Optimizing Document Design for More Efficient Translation!).

Clear and simple language is less likely to be altered in translation. Instructions that are clear and accurate are a necessary part of a strong legal defense against product liability claims, not only in North America, but all over the world.

Rather than being a threat to our medical translation business, all of these efforts to do more with less present opportunities. Medical translators can provide ideas, guidance, and support to medical device companies. While some languages may get dropped, most client relationships will prosper as a result of these streamlining efforts!


You can follow ForeignExchange on Facebook, Twitter, YouTube, and LinkedIn.
 
 

Microsoft Word is so often the application everyone loves to hate that medical translation professionals overlook one basic fact: it is the de-facto standard for word processing and basic formatting work among most medical device and pharmaceutical companies.

That's generally OK but it does create challenges when we work with new clients. Sometimes client contacts will send us files (or receive files from us) and say "hey - why does this look so different?"

The following is a typical question/problem:

I have a document which was created in Word XP and is 226 pages. When I send it to a client who is using Word 2003, it looks totally different and is over 330 pages. How can I send the client the document without it changing? Also, they wanted a pdf version, which looks nothing like the word document. How can I get the word document to look like the pdf?

As we walk our clients through the causes and solutions, the most common answer involves print drivers.

Because MS Word is a WYSIWYG application, it tries to represent on screen the same result that you would get if you printed the document on the currently selected printer. And changing printer drivers will almost always change the layout at least slightly - and sometimes radically.

Sometimes the issue is with artwork, custom fonts, or inappropriate formatting. But usually it's much simpler, as is the solution that gets proposed by us and on the web (for samples check here and here): Print to PDF.

If you print or save the file into PDF format, installed fonts are irrelevant, formatting is static, and the document is not editable. At ForeignExchange, we generally supply a screen resolution PDF along with the file at final delivery.

Do you have any other tips or tricks on how to deal with MS Word reformatting issues?

[Thanks a lot, Megan, for the tip!]

Acrobat and Word are the tools of our trade, and we have written extensively about them. Here is a sampling of past articles:

• Tips and tricks for Microsoft Word
• Prepping messy files for TM usage
• Styles in word processors - joy or pain?
• Removing security from multiple PDF files

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

Back in the day, online marketplaces were 21st-century alternatives to garage sales: a place where you can get rid of your unused stuff.

It wasn't long before folks selling professional services thought "hey, I could probably sell my services here as well!". And voila, sites likes proz, Elance, and hundreds of others were born. Nowadays, there are so many of these online "platforms", it seems like a fully served and completely saturated market.

Well, it seems there's still room for more. I recently came across Coffee and Power, a new "hub for all kinds of mobile workers buying and selling small services". The site is still young (it features hundreds of jobs vs. Elance's tens of thousands) but among the offers being made are dozens for translation services.

Here is a sampling of postings:

• I will translate science papers from English to French - $5
• I will translate italian/portuguese/english - $15
• I will translate anything in English and to Irish Gaelic - $ 5
• I will translate from English to Brazilian Portuguese - $25

Some of the prices are ridiculously low, others are clearly teaser offers. And while I doubt that any medical translators can make a living using online marketplaces, I wonder if there are some translation services providers for whom this is becoming a big part of their income stream?

Related articles:

• Buying translations on eBay
• The "X" market for translations
• Will crowdsourcing change the translation business?

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

There were many good updates to our blog on November. Here is our monthly recap of top articles:

1. MedDRA, the Medical Dictionary for Regulatory Activities - MedDRA is widely misunderstood (or is it, not understood?)
2. TM ownership still not clear? - Our most-read article from October generated more interest this past month
3. TM sharing makes "TM ownership" moot? - Throwing fuel on the fire of the TM ownership discussion
4. Translation and the meaning of everything - Everybody is talking about David Bellos' book "Is That A Fish In Your Ear?"
5. Of mountains, moose, and translation - Our recap of ForeignExchange's 2011 company meeting

Happy reading and happy weekend!


You can follow ForeignExchange on Facebook, Twitter, YouTube, and LinkedIn.
 
 

Most folks who work in translation are all too familiar with the glazed eye syndrome; this also happens in medical translation (although: saving lives isn't boring at all).

But you know what? Boring is good.

Being "boring" has served as a solid foundation for our fast-growing business. ForeignExchange's team has focused on doing excellent work, being easy to work with, and reinventing the way translation quality is measured. While not glamorous, this focus has allowed us to attract leading medical device and pharmaceutical clients - and keep these clients for years and years.

And it appears that we are not the only ones to have figured this out. Austin Kleon recently published the following list in his advice to artists:



It's a great article and highly recommended reading.

[Via Lifehacker]


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