Medical Translation Insight

The importance of stylistic consistency is gaining increased recognition - in translation management, regulatory submissions, medical writing, and elsewhere.

For a medical translator who gets approached by a client who is looking to get started with a style guide, here is another resource: the style guide of the World Health Organization [PDF link].

As with any off-the-shelf style guide, the WHO style guide won't be a perfect fit for every organization out there. For instance, it starts off with the following note:

Within WHO-HQ, British rather than American spelling is normally used.

The general rule is to follow the spelling listed in the latest edition of The
concise Oxford dictionary.

Even for U.S.-centric medical device and pharmaceutical companies, the 100-page document provides a great reference, starting point for building a company-wide style guide, and resource for other reference materials.

[Hat tip to @erictranslates]

If you are interested in language consistency, take a look at the following:

• I say tomato, you say error!
• EU readability testing
• QRD templates are imperfect, getting better

Do you tweet? Follow us at @fxtrans.
 

Medical device manufacturers looking for rapid growth are looking outside the United States (and most device manufacturers are still located in the U.S.).

Going global is not a fail-safe proposition, however. Many device manufacturers have learned that what sells in the U.S. does not necessarily sell abroad. One of the most common mistakes is to view international sales simply as an "extension" of domestic operations.

Without a well-executed strategy, global expansion can be a very frustrating experience. It is critical that international marketing and sales activities be coordinated with the actions of other departments. For instance, a marketing department's desire to move into a new country needs to be coordinated with product development, finance, and regulatory affairs.

A few issues to be aware of:

• Manufacturers must be very careful about what they write in labeling their products, because many countries consider labeling to be advertising. Therefore, manufacturers must carefully study the advertising rules in force in each country as well as the Advertising, Labeling, and Distribution of Medicinal Product Directives of the European Union before they design the labeling of their products.
• Privacy rules often differ from country to country. Many European countries, in particular, have stringent rules regarding the collection and dissemination of customer and patient data. The Information Systems group will need to modify patient and customer databases for each country.
• Many countries do not allow comparative advertising. Although permissible in the U.S. for the last 30 years, in Germany, for instance, an advertisement cannot say "brand x is better than brand y".
• When selling to multiple markets, packaging and labeling should be "localized" for each market: colors, paper format, and overall designs should be custom-tailored to each market so as to avoid the "insensitive U.S. bully" image. However, the desire for market-specific packaging must be balanced with company-wide branding and image concerns. Should the German package really look and feel different from the Japanese or the U.S. package?
• Companies may decide to centralize manufacturing in the U.S. and ship worldwide from there. Alternatively, the company may build regional manufacturing and/or distribution centers. Supplying global markets with medical devices requires a global manufacturing and distribution strategy that involves upper management and a thorough financial analysis.

Ideally, device manufacturers would localize everything in an international marketing campaign - the look, color, images, text, everything.

In reality though, many companies aim for a "global look" that can be used around the globe. Here is an example from a few years ago:



For a medical translator, it's important to realize that this kind of campaign represents reality for medical device companies: The same layout, pictures, colors, and even paper sizes are used around the world. The text may (or may not) be localized, depending on the "pull" of local marketing managers.

While a full-scale localization effort may not be feasible, medical translation professionals can assist device manufacturers by advising them on what to keep and what to change. Most major U.S. medical device companies derive approximately 30-45% of revenue from international sales - they will appreciate the suggestions and advice!

Want to know more about international marketing? Take a look at the following articles:

• Advertising medical devices in China? Pay heed to regulations
• Why won't alleged advertising blunders die?
• To be effective, drug marketing must be local(ized)

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.
 
 

Over the past few years, FDA has been blamed for scandals at overseas manufacturing and been pressured to improve foreign inspections. While he agency is looking for a global solution, it also has responded by increasing international inspections.

Pharmalot recent report on the latest OSI Bioresearch Monitoring Metrics Overview [PDF link] highlights this:

...when we eliminate the US from the data, Eastern Europe and Latin America are getting more attention which, of course, reflects the growing number of clinical trials taking place in those regions. Of 116 foreign investigator inspections, 34 percent in fiscal year 2010 were conducted in Asia, compared with 34 percent in 2003. The number of inspections of Eastern European investigators grew to 9 percent, from nothing in 2003. Latin American went to 14 percent from 9 percent.

While the number of sites inspected may still be small, FDA is clearly shifting its attention overseas.


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

Our recent article on TM ownerships generated tons of discussion on LinkedIn. Take a look at the original article here and the LinkedIn discussion here. The baseline question "is TM ownership clear" can be answered with a resounding "no".

There are lots of great - and greatly divergent - comments in the discussion. If you have time, take a look.

One of the folks who took the time to write to a detailed response and has a unique perspective is Jaap Van Der Meer of TAUS. Jaap has been around the translation industry for a while so when he speaks, it pays to listen.

Here is Jaap's comment for those who missed it on LinkedIn:

This discussion and the level of interest illustrate that the industry is looking for new answers to the question of the value and ownership of TMs. That's what you would expect now that TMs are shared all the time.

"Cloud-sharing" of TMs becomes very popular among very large companies and small companies. Sometimes you may be asked - as a client, as a translator or as an agency - whether you agree that 'your' TMs are being shared. But in most cases the sharing and aggregation of TMs is happening without you even knowing it.

The value of this large-scale sharing of TMs is not the traditional benefit of translation memory leveraging, that is retrieving a match for a sentence. We need to start looking at TMs as data. The more TMs (data) you collect the more meaningful they become. You can extract terminology and instead of matching a sentence, you will be able to match phrases and strings of text. Companies use these TM data to improve the performance of MT engines; not just large companies such as Google, IBM and Microsoft, but also small and large language service providers.

As many of you know, we started addressing the opportunities and challenges of sharing TMs already in 2008 when we established the TAUS Data Association (TDA). An interesting statement came up in all these discussions among founding members that I like to share here: "Only by sharing your TMs, you increase the value of your TMs."
Words belong to all of us (speaking the language). Trying to hold on to these words and keeping them to yourself will, on the long run, prove to be an unsuccessful strategy. Not only is this practically almost impossible, it also puts you at a loss.

Now, clearly we must make an exception here for creative texts (sales slogans, tag lines, poetry, song texts, etcetera), trademarks and confidential and personal information. You cannot share these words just like that. The problem though is that it is very had to define the rules. Copyright law needs to catch up with the times. Whether you can share or not share 'your' TMs becomes increasingly a personal moral decision and most of the time this decision is actually taken without you even knowing about it.

It is no secret of course that I am a great advocate of sharing of TMs. The translation industry needs to multiply its capacity and grow its capabilities. Sharing translation data is crucial to the innovation and growth of our industry. Together with its founding members TDA has set up a solid legal framework for sharing TMs. As one of the members said: "TDA is the safest place to share your TMs."

It's an interesting perspective: sharing is happening anyway and is legal (see that point made by TM Marketplace here [PDF link]), so why worry about who owns what?

Do you agree? Disagree? Have a different take on TM sharing?

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

On November 30th in Waltham, Massachusetts, we're hosting a seminar entitled, "Designing for Translation" presented by our own Amy Maxson. Amy will be covering the pitfalls and best practices of document design to help optimize your IFUs, manuals and marketing materials to save money and time in the translation process. The event is complimentary and breakfast is provided but space is filling up. Sign up here:
http://info.fxtrans.com/LU20111130-Designing-for-Translation-MA/

On December 8th in Minneapolis, we're presenting an overview of Translation Memory technology. This seminar focuses on the mechanics, uses and limitations of Translation Memory. It will also cover guidelines for how you can get the most out of Translation Memory to maximize quality, minimize spend, and reduce turnaround times. Our presenter, linguist Gabriela Herce, will also show a demonstration of how Translation Memory works. Sign up here:
http://info.fxtrans.com/lu20111208-an-introduction-to-translation-memory-mn/

On the audio conference front, it's shaping up to be a busy autumn at FX Conferences! We've got more than 50 new audio conferences, filled with timely, important information designed to keep you ahead of the curve. Topics include product labeling, human factors engineering, ISO 14155, clinical evaluations, supply chain management and much, much more.

To help you take full advantage of these great learning opportunities, we're offering an "All You Can Learn" audio conference package. For one low rate of $499, you can have access to all of the live audio conferences and recorded events produced from September 1st through the end of December, which represents a savings of over 90% on our standard registration rates. You get the great speakers, the valuable take-home presentation materials and the helpful Q&A sessions with global industry experts, all included. Best of all, you can listen to these events with your colleagues at no extra charge. Get more info here:
http://www.fxconferences.com/AC-PACKAGE-2011-P594.aspx
 

ForeignExchange Translations achieved an astounding 98.87% on-time delivery rate for all projects in the third quarter of 2011. This well surpassed the company’s already lofty set goal of 95% and contributes to our larger aim of saving lives by helping drug and device companies get their products to market faster.

We are confident in setting such high on-time delivery goals due to our robust, ISO-9001-certified processes and the use of state-of-the-art technologies that augment our stellar team of project managers, linguists and publishing experts. The excellent results are also due to accurate forecasting and project estimates that come from a well-developed requirements gathering process. Setting aggressive but realistic expectations with clients means no surprises at the end of projects and online reporting mechanisms allow clients to follow progress in real time.

Here’s what our Executive VP of Quality Systems, Sonia Monahan, had to say: “We’re particularly proud of our on-time delivery rate since late deliveries can be a real pain point for clients and because getting products to market quickly means more than money saved; it means lives saved.”


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.

A couple of years ago, we declared that "California is hub of global device industry". A lot has changed since 2009. For now, the U.S. still reigns over medtech innovation - but for how much longer?

That's a question that Medical Product Outsourcing asked a few months ago. Reporting on a report from PricewaterhouseCoopers called "Medical Technology Innovation Scorecard: The race for global leadership.", MPO says that the U.S. has lost significant ground to emerging markets that increasingly are luring both "innovation resources" and activities overseas.

Among the conclusions from that report are:

• The United States currently ranks 7.1 on a scale of one to nine (with nine being the highest score) as a global leader of medtech innovation. While it is still significantly higher than other countries included in the Scorecard, America's rank fell slightly from 7.4 in 2005.
• The scores of other developed nations (France, Germany, Japan and the United Kingdom) range between 4.8 and 5.4. Among the developed countries included in the study, Germany and the United Kingdom show the strongest support for innovation. Japan has the least support.
• Despite its size, Israel ranks near the level of European nations, an indication of its ability to foster innovation.
• Emerging markets lag behind developed ones. China, with its powerful economic growth engine, is ranked 3.4. India and Brazil each scored 2.7.

The report's core finding of medtech innovation moving out of the U.S. was echoed by CMAJ when it reported that Swiss medical technology industry gobbling up market share.

A combination of government technology development programs, a talented and well-educated labor pool, a supportive academic community, and favorable tax rates have combined to allow the Swiss medtech industry to grow 6%–8% per year for each of the past 15 years. The Swiss industry is global in nature - roughly 70% of its products are exported and many companies don't have their roots in Switzerland.

And Switzerland is not alone in courting medical device companies. In a report on Ireland's growing medtech industry, Medical Device Today wrote that

Over the last three decades, Ireland has built a robust medical device community serving large multi-national device companies, built on favorable tax policies and a strong manufacturing and engineering base. But now Ireland is trying to incubate a robust start-up community as well, focused on R&D and innovation, hoping to create the next Medtroniic [sic] or Covidien rather than simply serving the current ones.

Medical translation professionals are starting to notice this shift as well. More and more medical device clients look for international if not global support from their translation suppliers. Here at ForeignExchange, we now regularly work with client teams that span continents. Based on this recent set of data, this looks to become even more prevalent in the future.


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

Before we get into the top audio conferences, here is a fun list of ten facts about the month of October:

1. Free rural delivery of mail began in the United States, October 1, 1896.
2. October is the tenth month of the year. October was the 8th month in the early Roman calendar.
3. Oscar Wilde, Irish-born dramatist, born October 16, 1854.
4. The birthstones for October are the tourmaline and the opal.
5. Halloween is celebrated on October 31.
6. Thanksgiving is celebrated in Canada on the second Monday of the month.
7. President Harry S. Truman made the first presidential telecast address from the White House, October 5, 1947.
8. October is National Cookie Month, National Chili Month and, yes, National Dessert Month.
9. The Statue of Liberty dedicated on October 28, 1886.
10. October 1 traditionally was the date on which the English pudding season started.

And now we return to our regularly scheduled program with our list of top events for the month of October:

1. Sample Size for Design Verification and Validation
2. FDA Imports: How to Deal with Holds, Detentions and Refusals
3. The FDA and Social Media
4. Best Practices for Literature Reviews, Clinical Evidence Reports and Clinical Study Reports
5. FDA's Part 11 Inspections: How to Prepare Yourself to Prove Data Integrity

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.
 

Medical translation professionals sometimes are confused when clients ask about a "medical dictionary" or "MedDRA". Is this a glossary? Translation memory? Is it already translated?

The Medical Dictionary for Regulatory Activities (MedDRA) was first initiated in 1993, then developed by the M1 expert working group of International Conference on Harmonisation. It was released worldwide in 1999 and today is managed by MSSO.

MedDRA is a pragmatic, clinically validated terminology used by regulatory authorities and the medical device / biopharmaceutical industry throughout the entire product life cycle, from pre-marketing to post-marketing activities, and for data entry, retrieval, evaluation, and presentation.

So, why is MedDRA important?

For many years drug and device firms performed medical terminology coding using their own private "in-house" dictionaries, resulting in a hodgepodge of dictionaries and coding schemas.

In order to bring consistency and uniformity to the coded data being submitted to it, regulatory agencies have committed to a standard coding dictionary, namely MedDRA. Today, MedDRA is the adverse event classification dictionary endorsed by ICH and is used in the U.S., European Union, and Japan. Its use is currently mandated in Europe and Japan for safety reporting.

MedDRA is available in Chinese, Czech, Dutch, French, German, Hungarian, Italian, Japanese, Portuguese, and Spanish. The subscription is required to access these languages (as well as English).

Our friends at Mousley Consulting have put together a terrific overview of the fundamentals of MedDRA [PDF link]. Take a look and get ready to answer questions about "international regulatory dictionary"!


ForeignExchange Translations provides specialized medical translations for regulatory, marketing, and clinical groups at pharma and device companies. Contact us to find out more.
 

The following was shared by our good friend Maria Shepherd of Data Decision Group.

The National Health Statistics report "Ambulatory Surgery in the United States, revision Sept, 2009" has recently been released, and provides statistics on the shift from hospital based inpatient procedures to hospital outpatient or freestanding ambulatory surgi-centers (ASCs) over the past two decades. (Although the revision dated September, 2009 is a new rev of the corrected 2006 report, 2006 is the latest version available, because government data tends to lag by approximately 5 years.)

This is really interesting and will impact testing of medical devices which will increasingly have to be used by personel who may or may not be sufficiently trained. In addition, the shift is slowly going to in-home care, which will also present challenges as to how the documentation and software will be presented.

Here is an excerpt:

According to the report, the two most influential drivers behind the shift from hospital-based to ASC based procedures are due to advances in medical technology and changes in reimbursement. Advances in medical technology have made surgery less complex, with reduced risk and have enabled the shift of many procedures to move from inpatient to ambulatory settings.

Chart 1. US Number of Procedures by Location

A detailed analysis can be downloaded from DDG's web site [PDF link].


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

A few weeks ago, we did it again.

Our annual company get-together was the largest and maybe best ever. We enjoyed a few days in scenic and tranquil Winter Park, Colorado. (Click on images for larger versions.)





As we do every year, we enjoyed the company of clients in a lively discussion of real-world translation issues among drug and device companies.

A key element of our annual meetings is for everybody in the company to spend time together. Sometimes that time is spend building things ...



... or performing crazy skits ...



... or dancing the night away.



A great team doesn't happen by accident, and ForeignExchange's company meetings are opportunities to reiterate our unique view of medical translation across our team.




Thanks to our growth over the past year, we had the largest team ever - 80 people were in attendance.



Amy, Sandra, Terry, Jessica, and Clémence, with help from Connie and Sonia and many others, did a terrific job of putting this event together. By Sunday, everybody left Winter Park motivated, reconnected, and just a little bit tired!




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.
 
 

October was a busy month at Medical Translation Insight: We have had big traffic numbers, some terrific articles, and lots of good interactions with our readers.

Here is a recap of the most-read articles from the past month:

1. TM ownership still not clear? - Our industry is long on opinions but short on consensus around this issue
2. Everything you wanted to know about translation memory - While lots of folks claim TM expertise, many others are just starting out
3. Human factors engineering a big hit in Minneapolis - HFE continues to be a hot topic, in Minneapolis and elsewhere
4. Updated QRD templates released - The European Quality Review of Documents templates may be imperfect but they are getting better
5. The value of long-term linguistic teams - A look at one aspect of ForeignExchange's Compliance Translation Certification

Happy reading and happy weekend!


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

We have written before about IEC 60601 and its importance to medical equipment manufacturers (look here and here).

For the uninitiated, since 2005 IEC 60601 Was the harmonized standard for medical electrical equipment recognized by most public health authorities globally. The recently released 3rd edition represented a significant change from the 2nd edition.

But all good things must come to an end, and this also goes for standards.

Over the next couple of years, ISO 62366 will replace ISO/IEC 60601-1-6. The new standard expands the scope to include all medical devices, not just electrical ones (see the ISO web site for details)

ISO 62366 is an international standard developed to reduce the risk of medical errors due to poor interface design. Process-based, its goal is to help device manufacturers 'design in' usability and 'design out' use errors.

Importantly for medical translation professionals, the standard also applies to documentation that may accompany a device as well as to the training of intended users. In other words: What used to be a nice-to-know will soon become a must-know standard.

Maria Shepard recently discussed the nine stages of ISO 62366:

1. Specify the application of the medical device -identify important characteristics relating to use
2. Identify the device's frequently used functions
3. Identify and list hazards/hazardous situations related to usability that could impact safety
4. Identify the device’s primary operating functions - those that relate directly to the safety of the device and also include the frequently used functions in Stage 2
5. Develop the usability specification
6. Prepare the usability validation plan - create the test plan to show how the product will be tested
7. Describe the process of validating the usability of the device primary operating functions; specify success criteria
8. Verify the user interface design against its usability specification; redesign as necessary
9. Validate the usability of the medical device - test the device to ensure that user goals have been met

For more on ISO 62366 - and human factors engineering - don't miss Maria's presentation Advanced Human Factor Engineering Usability.


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

• Conducting Formative and Summative Usability Studies for Medical Devices
• HFE 101: New FDA Draft Guidance on Human Factors Engineering and Usability Testing
• Implications of the Electro-medical Standards IEC 60601-1-11:2010 & Proposed IEC 60601-1-12

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Many, many moons ago, somebody once told me: "Broken English is the language of the world". Yet while English may appear to be taking over the world, translation is still highly relevant, necessary, and, in fact, is getting more important. (Good thing for us!)

Is That A Fish In Your Ear, written by David Bellos, looks at the history of translation. And in pursuit of the book's underlying attack on nomenclaturism, the author takes time to debunk persistent bits of linguistic folklore.

For instance, it is not true that the Eskimos have a hundred words for different kinds of snow but no word that simply means "snow". (But even if it were true, so what? Try walking into a Starbucks and just order a "coffee".)

Importantly, Mr. Bellos' book is not a technical how-to manual. Instead, it provides a humorous, speedy, and unabashedly positive look at translation.

While there are few, very things that translation cannot do (for example, it can't help us communicate with animals), Mr. Bellos cites lots of historical accomplishments, made possible by translation. In fact, he says "It is translation, more than speech itself, which provides incontrovertible evidence of the human capacity to think and communicate thought."

So take that fish out of your ear and put Mr. Bellos' words in them instead!


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

This year's ATA conference in Boston was just fantastic. The event drew a large audience from across the U.S. and around the world.

As we did last year in Denver, ForeignExchange Translations organized a happy hour for our medical translation partners. We were able to gather a big group of linguists and share ideas with folks we generally "talk to" over email.

The evening generated good discussions around turnaround time pressures, client deadlines, quality expectation, pricing, negotiations, and collaboration. Some folks commented that it had been great to see ForeignExchange speak about METRiQ at other events, and that it gave them good insight into our quality system and why we ask some of the things we do from translators.

The crowd had such a good time that the planned-for happy "hour" turned into three. Let's do it again next year in San Diego!


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