Medical Translation Insight

Clinical research studies continue to shift south and east.

The advantages of outsourcing to emerging countries are clear: reduced costs, easier patient recruitment, and access to larger numbers of qualified patients in a growing spectrum of diseases.

Even so, sponsors remain challenged to address regulatory differences and overcome linguistic and cultural barriers. Foreign sponsors also have the additional burden of ensuring that international ethical standards are maintained.

The current issue of Applied Clinical Trials has a good article on this topic. Language & Culture in Global Clinical Trials shows that by taking language, culture, and socioeconomic factors into account, sponsors are protecting the public image of clinical research. In addition, the authors recommend that to overcome barriers to global clinical trials, sponsors

must establish a local presence; work with reputable investigators and sites; and partner with language service providers and CROs that have experience in a particular area.

The article contains many good references and is available on ACT's web site.

For more on the globalization of clinical research, take a look at the following articles:

• Overseas clinical trials - appalling or good business?
• The challenges of global clinical trials
• Insurance for international clinical trials

ForeignExchange Translations provides specialized medical translations for clinical research - from patient recruitment to ICFs to diaries - in 40+ languages. Contact us for more information.
 

Our recent article on the use of styles in word processors generated a lively discussion on the pros and cons of this formatting aid.

One of the active commentators on LinkedIn's Content Wrangler Community group [login required] was Christine Kent. She contributed tons of hands-on tips.

It turns out that Christine really knows what she's talking about. She runs the Christine Kent's Microsoft Word blog, where she shares her advice and insight. Love it or hate but there is no way of avoiding MS Word in our business. For any medical translator, technical writer, or project manager, Christine's blog should be required reading!


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

Over the past few days, it's been widely reported that Google Health is shutting down. Check the NY Times, Medgadget, and Bob on Medical Device Software for a good sampling of the coverage.

When we first wrote about the move to electronic health records (EHR) 18 months ago, we stated that

it's a question of "when?" not "if?" the health care backbone will be run by companies like Google and Microsoft

Microsoft HealthVault and other EHR services are still around but are struggling to gain traction. As the New York Times article notes, "7 percent of consumers had tried online personal health records, and fewer than half of those continued to use them".

In the comments to the WSJ article about Google Health's demise, several folks lament the service's end. One commentator opined that

Google Health is a failure of execution, not of idea. Will these kinds of records be the future? Yes.

At least according to this person, it appears that "when?" is still the right question to ask regarding EHR.


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.
 
 

Last week's video interview on medical device translations raised a question for at least one reader: What is a combination product?

Combination products, as the name implies, are products that share the attributes of two categories of products. In this article we will discuss the particular combinations of medical device and medicinal product.

FDA's definition of a combination product comes in four parts:

(1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;

(2) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products;

(3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use; or

(4) Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use.

Examples of combination products include prefilled syringes, alcohol swabs, inhaled insulin, coated artificial joints, and drug-eluting stents. Some of these are highly complex marvels of modern engineering while others are straight forward to manufacture.

Combination products are relatively new, and they present challenges in translation, packaging, and regulatory guidelines. For instance, industry, through groups like the Combination Products Coalition, is looking to shape the regulatory discussion and rule-making. As an aside, you have to just love the intro on their web site:

Are you tired of letting the regulatory environment lead you? Would you like to shape your regulatory environment?

More resources and explanations can be found at the following sites:

• Emergo Group provides a hands-on view of combination products
• FDA's Combination Products web site features further definitions as well as information on regulatory guidelines and events.
• Implementing GMP for Combination Products: What Applies When? looks at the challenge of implementing a quality system that complies with Good Manufacturing Practices and Quality System Requirements.

Did you like this post? Subscribe to Medical Translation Insight via email or RSS.
 

ForeignExchange President Andres Heuberger recently took some time out from visiting clients in the medical device hub of Minneapolis to sit down for a short interview. Andres talked about the challenges and key differences inherent to medical device translations.

He discussed the effects the new Medical Device Directive have had on companies, software translation and the challenges of translation documentation for combination products. Check out the video and let us know what you think.



ForeignExchange supports 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.
 

Is translation stuck in a corporate basement, like Milton in Office Space? Or to put it differently, after all of the hard work that goes into a translation, does anybody really read our work?

"Nobody reads the manual" is an oft-voiced complaint amongst technical writers and translators. We ourselves have previously wondered whether or not translation is the least important most important thing.

While many industry veterans are used to seeing our profession marginalized, things may be changing.

This was driven home to me on a recent business trip. Walking through Boston's Logan airport, I saw not one but two billboards advertising translation services.



Transperfect (above) actually had 2 billboards in Terminal A alone. 10 seconds after passing their first one, I saw this one from Xerox:



It seems like Xerox' campaign is still going strong after six months.

But the translation surprises didn't stop there. On the plane, I caught up with Wired. In two different issues, I found the following language-related full-page advertisements (click for larger version):





That's an awful lot of money being spent on translation-related advertising. So, what does it mean?

It looks like the translation business is emerging from the corporate basement but is it really? Or is it just a head fake, like Lionbridge's NPR sponsorship during the dot-com boom?

What do you think?


Subscribe to Medical Translation Insight via email or follow us on Twitter.
 
 

Inline tags are a fact of life for most anybody involved with localizing software. These tags - you know, <>, [], {} - may represent formatting information (such as bold), surround hyperlinks or may be used as other types of markers.

Inline tags can usually be moved around in a sentence to suit the translation. Depending on the file format, some tags can be added or deleted as required.

Medical translators have many ways to work around the (generally) non-translatable tags during their translation work. But things get tricky at the end of the translation. Proofreading a text with tags is challenging and ensuring that all the tags are there and in the right place can be time-consuming and error-prone.

So it was great to see the Gloc247 blog posting hands-on instructions on how to check inline tags in both MS Word and MS Excel documents.

Check out the detailed how-to article and learn how to improve the quality of localized file that contains inline tags.

Here is some more good stuff for you to sink your teeth into:

• Man vs. machine in proofreading
• Preparing files with untranslateable content
• How to delete duplicates in an Excel glossary

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

This guest post is contributed by Patricia Walling, a healthcare blogger who can be contacted at patwalling85 ~at~ gmail.com.


Technology is becoming more and more prevalent in the field of translation as computer linguists become better at programming good grammar recognition. With the advent of technologies like Phrazer poised to replace translators in a clinical setting, and CAP tools becoming a reasonable replacement for human editors, it can be quite easy to think that in the future people won't be necessary for translations.

I will probably make a lot of people happy by submitting that this could never happen. Languages are defined by their usage rather than by any algorithm, and every language is constantly evolving. Perhaps this problem could be solved if computers used in translation were made to speak regularly with human beings out loud rather than in a text based context.

Yet even then, as humans do, they would need to be edited by people who speak regularly themselves. There is a multiplicitousness in any language, which varies by age, formality, locale and a number of other variables that can only be really understood by fluency, and we know that everyone has their own perceptions of what is correct. A spoken language is not as easily standardized as procedures like in medical coding, and it is the human element that is required for good translation. Without that, we'll only continue to get embarrassments like Engrish and "spun" articles.

Of course, there are arguments against this, and many people in medical professions won't hardly care but as long as we're still arguing about how many editors a translation needs and playing games like telephone, it will be quite difficult to entirely replace human translators.


ForeignExchange's METRiQ quality system provides medical device and pharmaceutical companies with known translation quality - on every technical translation assignment.
 
 

Typography is so much more than what you see in a book or magazine. Typography lovers and design aficionados know that Helvetica, the font that changed the world and warranted its own April Fools gag, embodies this sentiment more than any other font.

Helvetica has become one of the world's most popular typefaces, and a new book highlights one of its most famous uses. Helvetica and the New York City Subway System tells the story of how the subway system, this most New York of places, became a realm dominated by a Swiss typeface.

For decades the New York City subway system was a visual jungle of confusing and often redundant signs in mosaic, terracotta, cut stone, porcelain enamel, wood, and paint. This began to change in 1966 when Unimark International was hired to instill order and clarity to the system.

If you want to learn about typography, sign systems, New York, and the dangers of taking anything (even Helvetica) for granted, buy a copy of Helvetica and the New York City Subway System.

And if you want to know more, take a look at the following:

• The New York Times' book review
• What's the difference between Helvetica and Arial?
• The life and times of a typeface - Helvetica, the documentary

ForeignExchange Translations provides medical device and pharmaceutical companies with desktop publishing in 40+ languages, dozens of DTP applications, and serif as well as sans-serif fonts.
 
 

Localization World 2011 started one day early for the attendees of the Life Sciences Business Roundtable.

ForeignExchange's Sandra La Brasca is on the Life Sciences Roundtable organizing committee. The theme for this event was "Quality Enhancement Tools" and featured a presentation from Sandra entitled: "Quality Enhancement Tools Part I: Quality is Subjective -- Myth or Reality?"

Other presentations highlighted the importance of solid terminology management (by Uwe Muegge) and source content control strategies by Brigitte Herman of Siemens Healthcare. The evening wrapped up with a very relaxing evening at a very nice restaurant at the Puerto Olimpico.

Tuesday started with another topic about quality and focused on how leveraging a true partnership between supplier and client can result in improved quality deliverables as well as faster time to market. The next presentation aimed to spark a discussion about the RFP/RFI process, what are the challenges that it creates for both client and suppliers and best practices.

Next Maarten Milder from Medtronic presented on the pros and cons of insourcing vs. outsourcing and the benefits of each approach, followed by a presentation about how Siemens implemented an online in-country review management tool to help streamline the validation process for translated materials.

The last two presentations focused on cross-cultural interactions. Part 1 highlighting the differences between technical and marketing material and how to mitigate for these differences. Part 2 was structured as a panel discussion where, after a short introduction by St. Jude Medical's Richard Korn (he shared recent research about how cultures can be classified), the panelists compared their experiences around cross-cultural interactions and how these pertain to translation/localization in the drug and device sector.

All in all, an educational and insightful day - and a great way to start Localization World Barcelona!


ForeignExchange supports 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.
 
 

One of the most challenging components of the recently updated Medical Device Directive (MDD) 93/42/EEC is the increased focus on language translation for software and labeling.

For instance, the updated MDD states that software that is integral to the operation of a medical device must be translated into the languages of the countries in which the device will be sold. This leaves many device companies scratching their heads, or more likely, negotiating with notified bodies: Is our software considered a device?

Our friends at Eisner Safety Consultants can help with the answer.

COCIR, the European industry association representing the radiological, electromedical and IT industries, issued a decision diagram [PDF] to determine if software is considered a medical device per the MDD including the amendment.

The document was featured on Eisner's blog and includes a clear definition of what software includes, which is a wide range of items. Be sure to refer to the footnotes for some details that refer back to the MDD.

For related content, take a look at these articles:

• Risk-based software validation for medical devices
• Medical software ready to take on the world
• Introduction to software localization

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

Our post on Why translators need editors continues to draw interest and comments. As with many things in the translation business, it's not a new issue - but one that is still able to roil the blood of translation professionals.

"Not new?", you might wonder. Indeed.

The Patenttranslator's Blog recently posted an article that was published in the May 2003 edition of the ATA Chronicle, the magazine of the American Translators Association.

It's a great article. One of my favorite quotes is right at the beginning:

"Whereas other translation services send their materials to professional translators who work in many fields, XYZ sends its translation projects to bilingual category experts – people who trained and worked in the field."
...
It always makes me laugh when I read statements like the ones above that often appear on the websites of translation agencies. If you run a search, you can easily find dozens of agency websites that are all "different" in the same way – they don’t trust a hapless translator to translate anything accurately until his or her translation has been checked by another translator, then rechecked by yet another translator, then proofread by a proofreader who has at least a PhD., and then checked one more time "for readability" by yet another editor who is possibly God Herself.

In the article, Steve Vitek, who works as a translator himself, makes some really good points in favor of having fewer people involved in the translation process.

Go ahead and read Steve's article, and then see if you still think that translators need editors!

While on the topics of "being different" and translation process, you might be interested in the following posts:

• Argh! You translated A and they published B!
• We are everything that they are not
• I say tomato, you say error

To stay abreast of medical translation issues, subscribe to Medical Translation Insight via email or follow us on Twitter.
 
 

ForeignExchange produces all kinds of educational events for our clients and for interested parties in the medical device and pharmaceutical space.

Our seminars and workshops have become popular. But it is still our audio conferences that draw the broadest topics and attract the largest audiences.

Here are the most popular audio conferences for last month:

1. Best Practices for Writing Safety Narratives
2. Device Master Records & Device History Records: Are You Compliant?
3. FDA on the Edge: What's Next for 510(k)?
4. Clinical Trial Insurance and Indemnification Issues
5. The FDA's New Emphasis on Supplier Controls – What Device Manufacturers Need to Know

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.
 

There is precious little real-world information available to translation managers in medical device and pharmaceutical companies. Associations like RAPS, DIA and STC might deal with translation in passing. And translation conferences like Localization World likewise only touch peripherally on the unique translation needs of drug and device companies.

Our educational events and video interviews aim to fill some of this gap. They are not sales pitches in disguise but feature real-world scenarios and insight.

Here is another example of this: Tom Enroth, Technical Communications Specialist at ev3, recently sat down with us to discuss his role and the challenges of putting together his company's ever-expanding catalog of IFUs while managing ever-shrinking time lines.

The interview is 8 minutes short. It's well worth watching for Tom's real-world insights.



For more on Tom and other real-world translation managers, take a look at the following:

• I am the air traffic controller of translations
• What is Lean and what does it have to do with translations?
• Is translation the least important most important thing?

ForeignExchange Translations provides specialized medical translation services to pharmaceutical, biotechnology, and medical device companies.

When authoring user manuals, IFUs, and just about anything else that needs to be written in a medical device or pharmaceutical company, we use structural elements like titles, headings, sub-heads, and picture captions to help readers make sense of the document.

Typically, we want to format each of these elements consistently. For example, we may want all the body text in a smaller lighter font and the title in a larger heavier type. We may want a lot of vertical space before all the major headings, but none before the captions under pictures.

Most word processors use "styles" to collect such formatting instructions. Styles make it easy to be consistent. And that's a good thing for the authors, the readers, and the translators.

Despite the numerous advantages to using styles, it's amazing to see how many authors don't want or don't know how to use styles. We won't tackle the "how to" item here.

"Don't want to" is easier to address because using style is a joy and save time and money. Still not convinced? Maybe this video can help:



So, for all of the translation buyers who wonder "why are there DTP numbers on my quote?", make sure that you are using styles appropriately and consistently.


Did you enjoy this post? Subscribe to Medical Translation Insight via email or RSS.
 
 

After a thorough "recasting" in the European Union, the EU's directives on Waste Electrical and Electronic Equipment (WEEE) and, especially, Restriction of Hazardous Substances (RoHS) will significantly impact the medical device field.

According to Massdevice.com, medical as well as in-vitro diagnostic devices had previously been exempted from the RoHS. Except for active implants, this exemption will not be extended in the next version. As a result, there will be important new considerations for component procurement, design, manufacturing, and support. Device manufacturers need to understand that obtaining exemptions is likely to become more complex as well.

The original directive has been in place since 2003.

As usual there will be a transition period. General medical devices as well as monitoring and control instruments (so-called category 8 & 9 equipment) will have three years to comply with RoHS following the directive's adoption; IVDs will get even longer (five years) to comply with "RoHS2".

From a medical translation perspective, the impact is likely to be limited. Labeling changes should be covered under the CE Mark requirements. However, some manufacturers may add additional visual indicators such as "RoHS compliant" labels, green leaves, check marks, "PB-Free" markings, or the closely related WEEE trash-can logo to indicate compliance.

To learn more about the rationale for the WEEE/RoHS Directive, how these directives relate to other legislation (e.g., EuP), and why complying with the RoHS directive may not be straightforward, take a look at WEEE and RoHS Revisions: Implications for Medical Device Manufacturers.

With the final step to approve legislation in the Council of the European Union "very near", we'll be sure to provide further updates.

[Hat tip to Emergo Group]

Link to Directive 2011/65/EU [PDF].

ForeignExchange Translations provides specialized medical translation for regulatory affairs groups at medical device and pharmaceutical companies. Contact us to learn more.
 
 

A few weeks ago, we mentioned that memoQfest 2011 was a conference to remember. Well, it has just gotten better!

Since our last update, the folks from Kilgray made available all of the presentations, both in video and PDF format. For example, here is our own Sandra LaBrasca discussing how ForeignExchange drives efficiencies through our METRiQ quality methodology:

There is some really high-quality content here. If you didn't make it to memoQfest 2011, here is your chance to catch up. And if you did make it, you get a free refresher.


ForeignExchange's METRiQ quality methodology provides medical device and pharmaceutical companies with known translation quality - on every medical translation assignment.
 
 

Summer is here. Well, kind of. In many of ForeignExchange's hometowns, summer this year has been something we hear other people talk about.

As we wait for warmer temperatures, we are lucky that we keep busy at work. The medical translation business is booming, and we are grateful for the chance to work with more and more of the world's leading drug and device companies.

And, oh yes, we also write a blog on medical translation. Here are the top articles from this past month, based on the number of times they were viewed:

1. We are hiring in Cambridge, England - A lot of translation professionals want to experience the Cambridge Phenomenon!
2. Is Google Translate accurate enough for professional use? - Written 2 years ago, recent developments made this article relevant again
3. Why translators need editors - TEP is familiar to most, an anachronism to some, and misunderstood by many
4. Interview with Helen Colquhoun, CEO of Pleiad Devices - Terrific insight from a regulatory and clinical expert
5. 7 quality tools move quality from abstract to concrete - Translation quality does not have to be complex

Happy reading and happy weekend!


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

China is one of the most attractive markets for medical device manufacturers worldwide and has grown to be the second largest in Asia (after Japan). However, given recent problems with heparin, di-ethylene glycol and melamine poisoning, quality issues have become paramount. Add to the that the challenge of navigating the Chinese regulatory system and medical device manufacturers face a daunting task, to put it mildly.

It's no wonder then that our audio conference Navigating China's Medical Device Regulations is drawing such huge interest. Chang-Hong Whitney will provide first-hand insights and guidance, drawing upon the experience and knowledge gleaned from daily dealings with SFDA officials and through managing numerous registration projects in China:

• Overview of Chinese regulations for medical devices
• Recent changes to the regulatory requirements
• Requirements for getting medical products approved for the Chinese market
• Time and costs for getting regulatory approval of medical products in China
• Regulatory issues to watch for and obstacles while seeking approval in China

China may seem like a tremendously inviting market. But without a proper understanding of the requirements for getting a medical device approved, the time and costs involved, or issues to watch for, China is a very inhospitable place.

If you would like to learn more about China, take a look at the following:

• China center for medical device standards is unveiled
• Securing regulatory approval for IVDs in China
• Language fact: Chinese

ForeignExchange Translations provides specialized medical translation services to medical device companies - in Chinese and dozens of other languages. Contact us to find out why our clients rave about us!
 
 

Like other subject areas, clinical research has a jargon all of its own. It is a "language" that can be learned but novice medical translators often struggle with basic terms and with the understanding what a clinical trial is (and is not) all about.

So we were happy to note that Renate Cisne featured nine English-only clinical dictionaries on her new medicalese blog. We are listing eight of them here (the link to the Sanofi one is broken) but be sure to subscribe to medicalese!

• Clinicaltrials.gov
• Amgen
• Boehringer Ingelheim
• Eli Lilly
• GlaxoSmithKline
• Novartis
• Pfizer
• Roche

If you have a few more minutes, take a look at the following articles:

• How do you pronounce "Boehringer Ingelheim"?
• List of pharmaceutical glossaries
• Overseas clinical trials - appalling or good business?

Did you like this post? Subscribe to Medical Translation Insight via email or RSS.