Medical Translation Insight

Summer’s winding down here at ForeignExchange headquarters. Kids are headed back to school and we’re buckling down for a busy autumn. We have two Learning Unplugged educational events coming up in Minneapolis and in Boston.

On September 14th at the Courtyard Marriot in Waltham, Massachusetts, we’re hosting a “Writing for Translation” seminar, which helps content creators write materials that are translation-ready, to save time and money and increase quality.

On September 19th at ForeignExchange’s Minneapolis office we’re hosting, “Best Practices for Medical Device Software Localization,” to help device companies develop global-ready software that will work and be effective in any language and culture.

Both events are complimentary and breakfast is provided but space is limited. If you'd like to attend one of these sessions, send an e-mail to education@fxtrans.com. For more information, check out the Learning Unplugged page of our Website:

http://www.fxtrans.com/services/LearningUnplugged.aspx

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

According to the European Medical Device Directive (MDD) amendment of 2010, software is now included in the definition of a medical device.

It doesn't matter if the software is integrated into the actual device or a stand-alone product. This inclusion is an acknowledgment of the fact that software is so integral to the functioning and therapy of a device. Software validation will also be an Essential Requirement under the MDD.

Annex I of Essential Requirement 12.1 now states that software must be validated, taking into account the principles of development lifecycle, risk management, validation, and verification. Given this new attention on software by global regulators, proper medical software localization is now even more important.

ForeignExchange's own Sandra LaBrasca and Jason Heaton co-authored an article entitled, "Do No Harm: The Importance of Getting Medical Translation Right" for the August issue of MultiLingual. Download a PDF of the article from our web site.


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

In order to gain simultaneous market authorization in all European Union (EU) member states as well as Iceland, Lichtenstein and Norway, global pharmaceutical companies must submit regulatory dossiers to the European Medicines Agency (EMA) by means of the centralised authorization procedure (CP).

EMA has set up strict guidelines in terms of terminology and stylistic and formatting requirements to enable the Quality Review of Documents (QRD), and demands full compliance with these requirements prior to granting its opinions.

ForeignExchange, through its partnerships with a number of large pharmaceutical clients, identified the need to develop a tool to partly automate the QRD control in order to ensure full compliance to facilitate and speed up the drug approval process. The tool, called, QRDetect™ has proven to speed up the document QC process by up to 75% and ensure compliance with EMA regulations. We’ve prepared a case study about QRDetect™. Download it here to read more:

http://info.fxtrans.com/qrdetect---a-tool-to-automate-qrd-compliance/


ForeignExchange Translations provides specialized medical translation services to pharmaceutical and medical device clients. Contact us to find out why our clients rave about us!
 

It's been a couple of years since we wrote about Chevy Nova and other global marketing myths.

Since then, I must have seen dozens of lists of supposed examples of translated product names and slogans that are said to have offended and/or confused consumers. A recent example is here (nothing against the good folks at AGM).

Many of these are demonstrably wrong. So why do people (translation service providers no less) keep talking about these "myths"?

I can't say for sure but my guess is that it's mostly an attempt by translation service providers to distinguish themselves from the competition and to tout their own superior quality.

Is this effective? Hard to say. But because translation companies can't objectively prove that they're output is consistently better than whoever supposedly created these linguistic atrocities, it may be a hard sell with clients.

It wouldn't surprise me if the message actually back-fired. If a prospect sees this kind of marketing, wouldn't many of them naturally ask "OK, so how do you make sure that doesn't happen?".

If you don't have a convincing answer (one, ideally, that goes beyond the industry chorus of "we have 10,000 translators and have separate editors and proofreaders"), prospects will assume that their work is just a typo away from being added to the list of advertising blunders.


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

Here is a good interview with direct marketing guru Brian Carroll. In it, he basically talks up the same stuff that he writes about in his blog and his book. But one-on-one, it just sounds better.

And it is very relevant for anybody selling translation services in general and medical translation services specifically.

A couple of the the key take-aways:

1. You're not selling to one or two decision makers anymore
2. Stop thinking that your goal is to attain a sales meeting

These couldn't be more true in our experience.

The good news is that most of our competitors don't know this - or ignore this!


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

ForeignExchange has long believed that being a leading provider of medical translations means going beyond translating words. We have strived to align ourselves with top companies and experts in the life sciences to keep abreast of the environment in which our clients work and the challenges they face. This has benefited us immensely in our work and our client relationships but it has also allowed us to provide resources for the industry at large. Are you taking advantage of all of the resources ForeignExchange provides?

Our numerous audio conferences bring you key information and guidance on the latest challenges and hot topics, and their format makes it easy to participate from the office, at home or on the road. Many companies use our audio conferences for staff training and continuing education. www.fxconferences.com

Our white papers are free and available for download from our Website. Covering topics from regulatory affairs to clinical studies to language facts, the white paper library is updated monthly, so check back regularly. http://www.fxtrans.com/resources/Whitepapers.aspx

We provide regular in-person, local educational events, from large networking breakfasts to small group workshops. These are held in various regions around the U.S. and the world and have been met with great feedback from attendees, who appreciate the non-salesy approach and practical takeaways. http://www.fxtrans.com/education.aspx

Our monthly newsletter is a good capsule of the latest language and industry-related topics that we tailor for readers in the life sciences. We spend every month developing interesting, timely content to provide our readers. You can sign up to receive the Multilingual Compliance Newsletter here: http://www.fxtrans.com/subscribe.aspx


And of course, finally there's our humble Medical Translation Insight blog which you're reading now. It is updated daily with interesting, thought-provoking, sometimes humorous posts about our industry and the life sciences. Bookmark the blog and check in daily.
 

Part of ForeignExchange's vision talks about "working with the best team." That not only means our internal team but also with our vendors, the publishing specialists, translators and editors whom we subcontract project work. Finding that "best team" isn't easy and we have members of our linguistic services team dedicated to finding the right people.

In this very connected world, recruitment almost always involves the Internet and email. But that can sometimes be like drinking from a fire hose. So our linguist recruiters came up with the idea of using social media as a means to connect with, and learn more about, potential partners. It has worked.

For most professionals, LinkedIn is the place to make business connections, share ideas and learn about opportunities. One member of the ForeignExchange recruitment team started the "Medical Translators and Editors" group on LinkedIn as another possible way to find linguists. She could never have guessed that the group would take on a life of its own as a place not only for recruitment, but for idea sharing. There are currently over 1,700 1,900 members of this LinkedIn group and it is growing.

Our recruitment staff has been able to sit on the sidelines and watch as the members interact, promote themselves and trade ideas. It provides a worthy alternative to more mainstream translation forums like ProZ and Translator's Café and it has been a low key way to find very good, seasoned linguists through a mutually beneficial setting. The LinkedIn group has also unexpectedly opened doors for us to join other Web-base business communities such as the European Medical Community.

Most people know that networking is the best way to make business connections. Social media is an excellent tool for this and particularly LinkedIn, which was created with business connections in mind. The added benefit of pulling together a global group of serious, like-minded professionals for idea sharing has been an a welcome surprise.

Are you a medical translator or editor and a member of LinkedIn? Join the group!


ForeignExchange is growing! If you would like to make a difference in your work, take a look at our career opportunities and send us a note.
 

Teutonic forces are at play in the drug and device industries: The fundamental business model of pharmaceutical and medical device companies is changing. The way in which drug and device companies sell and market product is different than it was 10 years ago - or even one year ago.

We have produced popular events to help companies get started with social media and assess the risks and benefits of social networking sites. But over the past couple of years, industry's sense was that companies are doomed if they do, and doomed if they don't.

Pixels & Pills recently provided a great perspective on this push-and-pull situation. Why Pharma Needs a New Marketing Standard argues that "[c]hallenging the status quo has become a critical success factor to succeeding in this new economy":

The difference between the winners and losers is going to come down to who is willing to admit this change is occurring, and who is forward-thinking enough to lead their organizations to quickly drive a data-driven marketing standard that serves as the backbone for the brand in this new environment.

And to highlight the point visually, they featured the following excellent graphic (click to enlarge):



What a fascinating look at real-world Twitter use and the impact that drug and device companies are having!

OK, so drug and device companies are atwitter about social media. We have covered this in some detail:

• Pharma (still) fears social networking
• Medtronic wants to be your friend
• Are social-network-based clinical trials getting ready for the big time?

Speaking of social media... be sure to follow ForeignExchange at @fxtrans and subscribe to our blog.

"Globalization is a fact of 21st century economic life", says FDA. But backing this statement with actions has proven difficult for the agency.

A few years ago, discussion around the Food and Drug Administration Globalization Act prompted a lot of outrage over lax overseas inspection practices. One Representative noted how she "was shocked to learn that for each overseas facility that exports drugs to the United States, FDA is able to complete an inspection only once every 8 to 12 years."

Unfortunately, calls for FDA to add overseas inspection staff went largely unanswered. In 2009, we wrote that:

...FDA has only 2 inspectors watching drug factories in China and that the EU inspects fewer than 19 Chinese pharma factories annually

Now, coping with the fact that U.S. imports of regulated products including medical devices, drugs, food and cosmetics have increased three-fold over the last decade, FDA is attempting not one but two paradigm shifts.

In a landmark agreement, FDA and generic drug manufacturers have found a way to fund FDA's inspections of overseas manufacturing plants every two years, i.e., the same frequency required of domestic plants. The New York Times covered this huge announcement over the weekend.

While this agreement has been in the works for a while, it now appears ready for passage. This will fundamentally change (read, speed up) the pace of foreign inspections.

Longer term, the agency is formulating a long-term global regulatory plan that relies less on regulators' own staff and more on data and resource sharing with other countries, FDA recently said in an article published in The Gray Sheet [subscription required].

But while FDA wants to create a "global coalition of regulators", the agency's international work has been limited - and remains superimposed on its old model of inspections-based oversight.

What's more, FDA is not the only regulator grappling with globalization challenges. And, like FDA, its counterparts around the world face are also hampered by insufficient resources to handle these challenges. The same Gray Sheet article quotes an FDA official saying that a "global problem like this requires a global solution and global responsibility".

Maybe it's just me but I won't hold my breadth for a speedy regulatory solution. Having manufacturers underwrite underwrite foreign inspections seems to be a much surer way to ensure quality in global supply chains.


ForeignExchange Translations provides specialized medical translation services to pharmaceutical and medical device clients. Contact us to find out why our clients rave about us!
 
 

Once a month, we present the most popular audio conferences and webinars. It's that time again, and below is the list for July.

It's been a solid month but the "off-label promotion" event was by far the most popular event. This is a timely topic, and Alan Minsk did a great job reviewing the relevant regulations. If you missed it the first time around, be sure to take another look!

Here is the full list:

1. Off-label Promotion – What FDA Looks For & What You Need to Know
2. Process Validation – Implementing the Finalized FDA Guidance
3. Negotiating Clinical Study Agreements With Academic Medical Institutions
4. Usability and Clinical Testing for Home-use Medical Devices
5. Global Clinical Trials & ISO 14155: 2011 Compliance - Are Your Quality Systems Up to Date?

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.
 

Free is good. We like free. Especially when it comes to tools.

So when The International Business Edge! featured an article on free term extraction tools, our ears popped up.

Terminology extraction aims to automatically extract relevant terms from a given text. As the Business Edge post mentions, many of these tools were developed to aid in SEO keyword identification or indexing but they can still be helpful to translators.

The nine tools that they list are:

• fivefilters.org
• maui-indexer (downloadable too)
• TerMine (downloadable too)AlchemyAPI keyword / terminology extraction
• Terminology Extraction
• Wordfast (part of PlusTools 4)
• KEA
• topia.termextract
• Araya Bilingual Term Extraction Tool

The implementations and intended uses of these tools vary but they're all worth a look!

[Thanks to CSOFT's Twitter feed for the tip!]

2011-08-16 UPDATE: And then there were ten! It took Barbara Inge Karsch to remind us via her blog that there is a great tenth tool as well - memoQ. Of course, this functionality is only free if you already own the tool but because we're big fans of memoQ, we'll include it anyway.

Further information on terminology extraction (and additional tools, too) can be found at Wikipedia. For more on the topic of terminology management, check out these past articles of ours:

• Low-cost terminology management
• glossifier helps you understand medical articles
• ROI for terminology management

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

The great American satirist, Mark Twain, was not only a keen observer of American rural life but also was a savvy world traveler and lover of languages.

In 1865, Twain caught wind of an article about him in a French magazine. The article's writer couldn't understand why American readers found Twain's writing so clever. So Twain found the French translation of one of his stories, "The Notorious Jumping Frog of Calaveras County," and back-translated it into English. The result, of course, reads nothing like Twain's original English story, giving Twain fodder for further humor.

What does this have to do with medical translation? Well, clinical trial translations are often subject to back translation as a quality validation method and while we like to think our back translations are better than that of Mark Twain's "Jumping Frog" story, there are some potential pitfalls to the process. You can read the entire article about Twain's translated tale on daily-pulp.com.

And then download our white paper on back translation in the drug industry .

And if you still want more, take a look at the following articles:

• Back translations - useful or waste of time?
• The gold standard of back translation
• Is Google Translate accurate enough for professional use?

ForeignExchange provides specialized medical translations for clinical trial applications, protocols, informed consents, patient diaries, INDs, patient recruitment, and health economic research in dozens of languages. Contact us for more information about our clinical translation services.
 
 

Human factors engineering can be a fairly esoteric topic and it's one that medical device companies are only recently coming to terms with. Designing medical devices that not only work well but are made with human use in mind – doctors, clinicians, patients – is not only a good idea, it's mandated by regulations. That extends beyond the device itself to also include the product's labeling and literature and, by extension, to translation.

We recently sat down with one of ForeignExchange's Certified Partners, Maria Shepherd, an expert in usability testing and data analysis to talk about her company, Data Decision Group, and the ins and outs of human factors engineering. Check out the video below. If you'd like a copy of Maria's presentation, drop an e-mail to education@fxtrans.com.



For more on this timely subject, listen to Maria Shepherd's audio conference on human factors engineering.

We make medical translation personal and relevant through ForeignExchange's YouTube channel - take a look today.
 
 

Did you know that the way you write your source documents can have a direct impact on how much translations will cost and how long they will take, not to mention the end quality?

English content that is poorly written, full of colloquialisms and complicated grammatical structures take linguists longer to translate, offer less potential for re-use and is less clear to a target audience of non-native English speakers. We've been offering seminars on writing for translation this year and attendees have found many of the best practices worthwhile. So we've decided to share a few tips in this month's newsletter.

When preparing a document to send for translation:

• Proof for spelling, punctuation, capitalization, section numbering, etc.
• Check proper names, titles, addresses, and names of divisions/institutions/associations. If these are to be translated, the writer should note this.
• Clarify "buzz" words and phrases. Eliminate any sentences and words with possible double meanings, or explain them in a short note.
• Make sure any last-minute author's or editor's changes are legible, clear, and consistent throughout the document.
• If you are authoring in Word, make sure that any comments or Track Changes have been removed/accepted.
• Be consistent - chose one capitalization style.
• Make sure the label in the text matches the button, label, placard, symbol or graphic.
• Every verb must indicate the doer of the action (active voice).
• Avoid contractions and apostrophes.
• Do not invent new terms.

These are only a few tips. There are plenty more (for example, check here and here). Feel free to add your own tips by leaving a comment below.


Let us know if you have questions about writing for translation or if you'd like to attend one of our "Writing for Translation" seminars in the future. Just contact us.
 

This year, I am getting a different perspective on July. I am spending it with my family in Australia. It's winter here ("winter" being relative, given the warm temperatures and never-ending sunshine), kids are in school, and locals are bundled up against the cool winds.

One's situation and location drives much of how the world is seen. Being here is a great way to be reminded that things are different around the world.

As I get ready to check out the birthplace of surf life saving, take a look at our most-read articles for July:

1. English: One language, many voices - The Voice Map drew a lot of attention in July
2. Automating QA in translation - Using tools to handle some aspects of QA
3. Launch of The Interpreter's Launch Pad - A good new resource for medical interpreters
4. Medical translation validation - the good, the bad and the ugly - Risk management for labeling projects
5. Marketing to your own team - When companies start cutting corners, employees can tell

Happy reading and happy weekend!


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

Indian regulations continue to evolve. Just a few months ago, we wrote about the evolution of Indian medical device regulations.

Now, the Times of India reports that tough new rules are in the pipeline to monitor human clinical trials. According to the article:

In an interaction with the media at the National Institute of Nutrition (NIN) here on Monday, Katoch said there will have to be surveillance on the human subjects to see if they are developing any side effects of the drugs being clinically tested on them. While the local ethics committees are supposed to be monitoring this, not all instances of harmful side-effects get noticed.

A law to regulate "bio-medical research on human participation" is expected to be introduced in the Indian Parliament later this year. Stay tuned for more!

[Thanks to GCPWorks' Twitter feed for the tip]

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

• India, it's not just for clinical research anymore
• Drug patents in India - 1 step forward, 2 steps back
• Languages in India - a detailed look
• Clinical Trials: Why is India Irresistible?

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.
 
 

(Not this kind of style guide)

A translation style guide is a collection of rules that define language and style conventions for specific languages in order to help maintain consistency, an important measure of quality in translated materials.

An adequate style guide can vary in length and detail of information, but here are some of the most important elements in what would constitute a good style guide:

• It should be clear and simple to follow.
• Outline the style, tone and register that should be maintained in the target language.
• Include language-specific information if it will differ from the source language, such as:
  - Punctuation: spaces, commas, dashes, etc.
  - Spelling: capitalization, personal names and titles, abbreviations and acronyms, etc.
  - Formatting: font choices, general symbols like &, # and so on.
  - Rules on how to handle bibliographies, citations and graphics.
• Information on adaptation for localization purposes: postal addresses, telephone numbers, currency and metric conversions
• Preferences that indicate how to handle company and product names, foreign words and phrases, etc.
• Consider cultural differences so that they do not translate in an unnatural, awkward way.
• For software translation, information on how to handle user interface components such as menus, dialogue boxes, error messages, etc.
• Common errors to be avoided such as false cognates, use of active versus passive voice, etc.

These are some of the main elements that should be included in a style guide, but as a general rule, a style guide should contain any instructions that will enhance consistency in the target language. We find that working with clients on style guides pays huge dividends in consistency, quality, cost and turnaround time on projects. So they're definitely worth the effort.

For more on this topic, take a look at the following:

• Using Short Style Guides to Harmonize Writers and Improve the Quality of Electronic Submissions
• Even software help needs help sometimes
• Doing more with less

Find out how ForeignExchange Translations can help you develop a style guide for your medical translation projects.
 

I read an interesting article recently entitled, "Understanding the 505(b)(2) Approval Process." What I found most interesting was the clear and concise explanation of the clinical trial and the submission processes for the FDA. The clinical trial process is not new to me. I've been working with clients to help them with this work for over 10 years. Part of the submission section was new to me.

For me and most other medical translation professionals, the basics of the submission process are clear. However, I did not know that there were three separate paths a company could pursue, based on their product – the main one is 505(b)(1). This path is for new drugs. The second one is 505(b)(2). This is for drugs that are not completely new products, yet they are not generics. Drugs chosen for this path may have the same active ingredients as a previously approved drug, but now the drug is formulated in a different delivery mechanism or with a different indication.

Why is this significant? This second path allows a developer to come up with a new approach for a previously approved drug, while using the original clinical data. This is a huge benefit. The cost and time are radically reduced.

The third path for submissions is for generics. Generics have an abbreviated process for approval (called the ANDA versus the NDA). A generic manufacturer only needs to complete studies that demonstrate the generic product to be bioequivalent to the original product. Again, this is a major time and money saver.

This new understanding will better prepare me for my work with our clients. Our clients have clinical and submission needs, and they come to us to help them through it. In my seven years at ForeignExchange, I have helped many. This article will be another bit of knowledge to help me down that path.

You can read the full article here: http://www.cedrugstorenews.com/userapp//lessons/page_view_ui.cfm?lessonuid=&pageid=D5B9DCC03556C28694B51161244B36F9.

Entry by Bob Muzerall

Learn how ForeignExchange Translations helps drug and device companies conduct clinical trials in countries around the world.

eBay loves all things crowdsourced. From testing new features to allowing users to decide the next fashion collection to be sold on the site to, yes, translation.

Lingotek recently shared this via their Twitter feed:

RT @Crowdsourcing_: eBay Saves 90% with Lingotek’s Collaborative Translation Platform #crowdsourcing #crowdsource crowdsourcing.org/l/2622

The underlying article at crowdsourcing.org is really a case study but it's still interesting. Machine translation may not be the professional translator's primary enemy, after all.

If the translation quality was satisfactory and the "Project Data" presented in the case study is accurate, it's fair to assume that more and more companies would prefer to spend $0.025 rather than the "industry going rate" of $0.23 per word.

If you don't have a clear way to distinguish yourself from this kind of offering you better hold on - it's going to be a wild ride!

For some further reading on this topic, take a look at the following:

• Crowdsourcing will hurt software localization firms
• The "X" market for translations
• Buying translations on eBay

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.