Medical Translation Insight

Anybody who has ever been involved in a regulatory submission project knows about the challenges of working with tables - particularly if the source files are in PDF format. If the PDF files contain uneditable materials, translators have to reach deep into their toolbox. But extracting tables isn't easy -- even if the files are editable.

The Acrobat for Life Sciences blog published step-by-step instructions on how to use Acrobat 9.1 to convert tables between Excel and PDF formats, both for single files and in batch mode.

Another option is to use the service provided by ReportMiners. Their standard fee of $100 per conversion drops to $25 for recurring reports and maybe worthwhile for complex, multi-file reports.


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The latest version of the Medical Device Directive 2007/47/EC broadened the definition of "medical device" to include software that is intended for diagnostic or therapeutic purposes. This means many medical device manufacturers are rushing to localize software so that their products can retain the CE Mark.

What is covered by the new definition? Just about any software and language appearing in a user interface, including those for tiny devices. If the device is intended for really high-end professional use, manufacturers might be able to convince a national competent authority that English software is acceptable but this argument does not usually work.

For medical device companies that are thinking about being "flexible" in their approach to the new requirements, Jaap Laufer of the Emergo Group gives the following advice: Do so at your own risk.

In his recent audio conference Industry Update: EU Labeling for Medical Devices he gave the following case study:

A few years ago, a device company released an automatic defibrillator. In the tradition of whistleblowers everywhere, one of the company's competitors called the authority and said, "Look, in this and this case something went wrong with the use of this product. And it went wrong because the display was not in the national language."

As it happened, the device was contained symbols but the symbols were not explained in the instruction for use. But even if it had been, under these circumstances, under emergency circumstances, obviously the national language should have been displayed on the LCD screen and prompted the lay user to perform a certain action, which he failed to do. And as a result, a patient had to be hospitalized and it was alleged, died a week later. Whether that was true or not is not relevant. It prompted the national competent authority into great action, and it almost killed the company.

So, device manufacturers beware: Localization requirements are not to be taken lightly. If you want to avoid translating the user interface of a device, you better have a very good reason or, even better, a formal exemption.


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Anime and Manga have long since become household words around the world. Now it appears that American aficionados can finally get their fill of animated medical heroes.

The Canadian Medical Association Journal reported that Black Jack, the brooding surgeon who operates outside of medical convention, has finally come of age in America 25 years after his debut in Japan. Most of the episodes involve Black Jack doing some good deed, and the manga contains frequent medical details.

Separately, Godhand Teru is coming to American TV. For the un-initiated, Teru Mahigashi is a surgeon just out of medical school. Saving lives and helping people is the point of his chosen profession, and he seems pretty good at it, when he's not screwing up.

Manga lovers rejoice!

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When it comes to medical translation, our challenge is not quite as profound but can be similarly perplexing: "How do you ensure quality: by controlling the source text or the translation process?"

Controlling the source refers to implementation of authoring guidelines. This can include things like controlled English, authoring memories, and can be implemented either with or without a content management system (although many medical device and pharmaceutical companies find it easier to implement rules and controls through such a system).

Control of the translation occurs through proper handoffs from writer to translator (context, references, complete set of materials), maintenance of translation memory databases and terminology glossaries, and elimination of author's alterations (i.e., changes to the source text after translation has begun).

Each approach is an improvement over a situation where there is a total lack of control. But it's actually not an either/or issue: You will only control multilingual quality by controlling both items.

Unfortunately, while this sounds straight-forward, it is difficult to do well. Do you have any advice to share?


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Ever wonder how converting to a DITA/XML content management system would play out in real life? What if we added globalization? What if it showed nearly $100,000 savings for the first two deliverables (in 9 languages)? The folks at CaridianBCT are sharing their experiences: from planning to process development and implementation.

In a recent article posted on Digital Conversion Laboratory's web site, Jennifer Linton provides extensive details on CaridianBCT's efforts. And together with her colleague Jason Arnsparger, Jennifer leads a live presentation and discussion in an audio conference Building a Global CMS: Challenges & Lessons Learned.

Both of these resources are highly recommended for anybody at a pharmaceutical or medical device company who is thinking about, starting on, or stuck in a DITA conversion.


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The folks at Cross Cultural Health Care Program (CCHCP) run a consulting and education service for medical interpreters. Part of their offering is a selection of 21 bilingual medical glossaries.

The glossaries cover languages such as Bosnian, Japanese, and Tigrigna. Most glossaries contains around 2,600 terms but some are limited to 1,000 entries. At a cost of between $11 and $35, these medical glossaries seem like a terrific bargain.

While you are over at CCHCP's web site, be sure to also check out their very useful Guide to Common Medications.


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How wonderfully geeky is this?

If you are the kind of person that regularly ponders questions like: "Hmmm, which Sans-serif, Humanist font would work best here?" or "Who created the Times font?", then the Periodic Table of Typefaces is for you!

It covers a number of major fonts and includes information about the family and classification of each, the designer, the year the font was designed, and a ranking as cribbed from a number of internet sources.

So, download the hefty image (3150x2100, 1.6MB JPEG), set it as your desktop, and give your inner font geek free range.

[Thanks to Lifehacker for the tip!]

Further reading about fonts and multilingual desktop publishing:

• Who thought there would be a full-length movie about fonts? Well, there is.
• It's too bad that Asian fonts are not covered in the periodic table of typefaces; there are cool developments underway for instance with unified Chinese and Japanese fonts.
• Speaking of double-byte fonts, getting multilingual layouts "right" takes some planning.
• Want to add tools to your DTP tool chest? Check out this collection of free tools.

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Today's Wall Street Journal is chock-full of Asian news. On the pharma side, two different stories act as good reminders of Asia's multiple roles in today's drug business, and of the tough issues that come along with globalization.

Indian drug regulators reportedly have determined that a baby who died last fall in a clinical study should have been excluded from the trial because of pre-existing health problems.

Meanwhile, a stir in China over J&J baby products appears to have passed. A Chinese chain of supermarkets pulled dozens of products off their shelves recently, after an activist group had said they contained cancer-causing chemicals. But after an investigation, China's health officials concluded that the chemicals aren't used as additives in the products, and said they're safe to use, the WSJ reports. The supermarket chain has started selling the products again.

A separate article details some of Philips Healthcare's efforts to broaden their marketing push in India. The company has been focusing on emerging markets because spending on medical equipment has been slowing in the US and Europe. One interesting bit in the article points out that Philips has realized that to be successful in these markets, "it must adapt its products and in some cases, completely redesign them to make them attractive in emerging markets in terms of cost and function."

The three stories are good reminders that Asia is not only a manufacturing and testing center for multinational medical device and pharmaceutical companies, but also an increasingly important market.


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

A contact at a medical device company recently asked me this question. The short answer? Preparation. Prepare documents, prepare yourself, prepare your team, prepare the vendor. This involves asking lots of questions of all parties involved.

Few medical device clients have instituted cross-departmental task forces to deal with translation or localization or multilingual labeling. For many departments, translation is a "black hole" and individuals do not understand what goes into a quality translation. Similarly, few translation managers prepare localization kits in support of their translations.

The person in charge of translations is sometimes not in the loop when it comes to product development schedules or engineering change orders. Requirements are thrown "over the transom" causing everybody downstream to switch into reactive mode. This then extends to the translation vendor who also does not receive any advance notice and is left to re-prioritize schedules and resources at a moment's notice.

While it sounds obvious, miscommunication and lack of preparation are often to blame when projects go awry.

Many pharmaceutical and medical device companies feel that their current documentation processes are inefficient. Since a 2006 poll, when a whopping 75% of companies said that they feel that way, few things have changed. Then as now, most drug and device companies are planning to either investigate or implement a solution.

On one hand, it is easy to wonder at the lack of progress. On the other hand, the documentation practices at medical device and biopharma companies are unusually complex, in part because they involve so many different parts of the company (labeling, clinical, non-clinical, regulatory, and medical affairs).

The biggest pain points are related to:

• formatting of documents,


• re-creating documents from other documents and data sources that already existed within their organization, and


• inefficient creation, review and approval processes.

One of the explanations may be that many drug and device companies still rely on formats like MS Word and QuarkXPress for their documentation. However, as the demand for information continues to grow, companies are experiencing a widening gap between their capabilities and requirements.

Even though XML can solve issues like redundant content creation and exhaustive time spent on formatting of documents, few companies embrace it. However, as more drug and device companies realize that XML can reduce translation costs by 60%, use of the technology is sure to become more widespread.



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A recent post in Intercultural Communication and Translation News alerted me to the fact that Berlin has launched a new "friendliness" campaign to keep tourists flocking to the German capital during a time of economic crisis.

I love this tidbit from the post:

"Berlin has a reputation in Germany of being a rude city, but we're a rude city with a heart," said Rene Gorka, head of Berlin Partners, a marketing group that promotes the city.

With an outlook like that, I'm sure they'll be swamped with tourists!

As recently as the 1940s, submissions to support the marketing of medicines were small single-volume dossiers containing fewer than 100 pages of data, most of which was manufacturing information.

An interesting article written by Tim Felgate explores how these simple paper submissions evolved into today's electronic Common Technical Document (eCTD). The article explores the factors that have brought the eCTD to where it is today, as well as examining the issues that the pharmaceutical industry face. It concludes by highlighting some of the future developments that will impact the business.

In the current issue of Multilingual, Andrea Edmundson of eWorld Learning writes about how to adapt training programs in general and eLearning programs specifically for use in China.

This is a timely topic for many pharmaceutical and medical device manufacturers. These companies are moving more and more of their training efforts online or into CBT. In that process, the issue of cultural adaptation becomes much more important. (Not that they're unimportant in instructor-led courses but there, the instructor can make adjustments on the fly.)

Edmundson's article references the extensive work done by Geert Hofstede on how values in the workplace are influenced by culture.

So, when adapting a training program for use in China, course developers would do well to heed some of Hofstede's findings:

• The Chinese rank lower than any other Asian country in the Individualism ranking.
• Of note is China's significantly higher Power Distance ranking.
• China's religion is officially designated as Atheist by the State.

One conclusion from this: When it comes to globalizing eLearning or training programs, anything but the simplest courses will require considerable effort beyond "just" Chinese translation.


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TREMÉDICA is organizing a Latin-American Scientific and Professional Symposium on Medical Translation next week in Rosario, Argentina.

The program for the two-day event features a discussion on translations in a public health setting as well as a day of hands-on medical translation workshops. The March 27/28 meeting is geared towards linguists and doctors and is co-organized by Ocean Translations.

[Thanks to Multilingual News for the heads-up!]

We recently pronounced that 90% of in-country reviews are a waste of time.

Vacation schedules, internal politics, and miscommunication across time zones make translation in-country reviews an expensive and time-consuming process. Nevertheless, in-country reviews remain a reality for many medical device companies. How should these companies go about streamlining their in-country reviews?

At ForeignExchange, we have found that more and more clients improve their in-country reviews - by having somebody else do them. And for those device companies that aren't quite ready to outsource their reviews, a process we call R.E.V.I.E.W. optimizes in-country reviews:

R esearch and understand the situation between the client, the reviewers, and the vendor

E valuate the nature of overseas office (i.e., technology, staffing, capabilities)

V isit to build personal relationships

I nvolve reviewers in the development of translation and review processes

E nable the technology - upgrade local hardware and software for electronic reviews

W atch for opportunities to improve the process

Proper planning, communication, vendor relations, and a good R.E.V.I.E.W. allow technical writers to improve translation turnaround times, reduce translation costs - and it may even help avoid a few headaches. Happy reviewing!



ForeignExchange Translations provides outsourced third-party reviews and specialized medical translation services to medical device companies.
 
 

"St. Jude Medical is pleased to serve Spanish-speaking patients by providing them with information about their medical care in their preferred language."

So said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division, in the press release announcing FDA approval for the company's latest version of the Merlin.net Patient Care Network (PCN). The new version of the PCN provides a Spanish language option so that clinics can serve a wider population of patients. The DirectCall® Message feature provides pre-recorded messages that clinics can program to call patients to remind them of an up-coming scheduled follow-up transmissions, notify them if they have missed a scheduled follow-up transmission, inform them that their remote transmission has been received and all looks normal, or ask them to call the clinic to discuss the results of the follow-up.

[Hat tip to Medgadget]


Why do leading medical device and pharmaceutical companies entrust their Spanish medical translations to ForeignExchange Translations? Our process allows for known translation quality in the shortest amount of time. Ask us how!
 
 

Our recent entry on working with scanned PDFs drew a lot of comments and suggestions (here as well as on LinkedIn and facebook). No silver bullets but some good tool suggestions.

Of all the tools out there, these two look particularly promising:

• InstantOCR supports 12 languages and is free. Files are limited to 50 MB.


• OCR Terminal is also free but limits users to processing 30 pages per day. It seems to be very popular as its servers keep getting overloaded...

Has anybody tried them - in general and with clinical/dossier work specifically?

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In a world where translators are still being asked to translate web sites starting from text snippets pasted into a Word document, PDFs of screens, and sometimes even printouts of all the pages of a website, we can only hope that someday all content will be created in a structured environment like DITA XML.

In the meantime, pharmaceutical and medical device companies are mostly talking about, investigating, or implementing early stages of content management strategies. Several of our clients have had to struggle through a DITA implementation because the tool and implementation suppliers that they worked with were not really appropriate. So it's nice to see an event that promises to offer value-added content and information to attendees.

CMS/DITA 2009 will take place in late April in sunny St. Petersburg, Florida. If anybody is going, let us know how it was!


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Patients with disabilities are receiving more and more attention. In Europe, for instance, pharmaceutical companies must provide patient information leaflets in a way that is accessible to blind patients.

And now on of our readers pointed me to www.DeafMD.org. The site provides medical education and terminology in American Sign Language.

While there are sites and books for communicating in a healthcare environment, to my knowledge, this is the only tool for explaining medical terms to deaf people. Interestingly, video logs are called Vlogs in the deaf world.

[Thanks to Pauline for the tip!]

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Nobody thinks they have an accent - it's everybody else who sounds weird.

In China, every dialect is stigmatised in every place in which people don't speak that dialect. In Australia, speakers of the Aussie Yobbo accent would have to be the most stigmatised. America is no different; every non-New Yorker thinks that New York accents are THE most annoying in the world.

So imagine the fun when a group of non-native speakers try to imitate a "real" American accent. If these videos of non-U.S. Anglophones imitating American accents are any indication, our manner of speaking is two parts Valley Girl, one part cowboy, and one part superhero.

Yesterday, the New York Times ran a piece about J&J's possible reactions to the pending Merck/Schering-Plough merger. The article contained an interesting look at mergers and acquisitions in the pharmaceutical industry over the past 15 or so years:



For medical translation service providers, this is both good and bad news: On the one hand, mergers provide work through rebranding, integration, and legal efforts. On the other hand, consolidation means that overall, the net words translated get reduced. So it's no wonder that there is a lot of hand-wringing in the translation business anytime a new pharma merger is announced.


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As you may know, we produce weekly audio conferences on topics ranging from regulatory affairs to clinical research to quality management to technology to, of course, translation management.

Initially, this effort started as a way to educate ourselves on the challenges and developments faced by our clients. We soon discovered that others in the industry were also interested in these topics, and now they are open to the general public.

For February, the top five events were:

1. GCP for Medical Device Trials: Upcoming Revisions to ISO 14155


2. Industry Update: EU Labeling for Medical Devices


3. Managing Long-Term Registries: Strategies for Successful Management of Long-Term Clinical Programs


4. European Data Privacy: Are You Compliant?


5. Proteomics' Role in Biomarker Discovery and Validation

If you have any suggestions for audio conference topics, send us a note!

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The updated Medical Device Directive opens door to e-labeling or "alternative labeling". According to Jaap Laufer of Emergo Group, we have a glimpse of it coming at some point - but not anytime soon.

There are two problems that stand in the way:

1. There exists an enormous diversity of languages in Europe. And there is no dominant language - in fact, the moment this would be suggested, the smaller countries would balk.


2. Internet penetration varies greatly across Europe. Estonia and Holland have achieved almost 100% Internet penetration. On the other hand, across Greece, Portugal, and southern parts of Italy, Internet access can be sporadic. As a result, requiring the use of a computer to read device labeling is unrealistic.

Unlike the MDD, the IVDD does provide for electronic labeling but only in addition to the (authoritative) paper labeling.

For more details, check out Jaap Laufer's hot-off-the-presses audio conference on EU labeling. It contains excellent information from a a true expert in the field.

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

When it comes to books on international branding and marketing, there are lots and lots of choices. As anybody who has ever listened to one of my audio conferences knows, one that I like a lot is Another one bites the grass: Making sense of international advertising by Simon Anholt.

Though written a few years ago, the book is still highly relevant today. It is chockfull with great examples of international marketing blunders and illustrates why translations of advertising should be avoided at all costs.

The author laughs at advice like "use simple English" or "always make sure you have a native speaker check the translation". Rather, he says:

"Translating advertising copy is like painting the tip of an iceberg and hoping the whole thing will turn red: what makes copy work is not the words themselves, but subtle combinations of those words ... These are precisely the subtleties which translation fails to convey."

And:

"Translating [advertising] copy is like boiling lettuce. No matter how carefully you do it, the result is always disappointing."

Marketers in drug and device companies may or may not agree with all of his points but the book is a terrific read!

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The article called Strategic Partnering: Turning Suppliers Into Partners over at Duct Tape Marketing got me thinking: How come we don't see more of this in the medical translation space?

There sure is plenty of opportunity for partnering. Most pharmaceutical and medical device companies have much to gain - and much to offer - in these kinds of partnerships. For example, the example given about trading expertise for productivity certainly holds true in our business. Most medical device and biopharma companies have much more experience in areas such as quality systems or statistical analysis and could trade this expertise for improved service from medical translation suppliers.

Similarly, freelance medical translators and single-language vendors would benefit from partnering with multi-language vendors: Training and expertise regarding technology and sales, for instance, could be traded against the oportunity to enter a new market through an "affiliate" or through enhanced services in that geography.

These kinds of partnerships would be easy to establish and maintain. The partners would not have to invest vast sums or commit extensive resources. So, what gives? Why aren't there more partnerships in our space?


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

You have just been issued a FDA 483 warning letter -- now what?

Your main objective is to limit damage to the company and get into compliance as soon as possible. If you show contempt for the agency, chances are you will be forced into compliance through legal action, with increased expenses, a possible loss of business and adverse publicity. If instead you show FDA you are complying without the need for further action, chances are the agency will work with you to achieve compliance.

The investigator will try to elicit your response to each point in the FDA 483. In cases where your responses can be made without any uncertainty, make them. But if you are not sure of your response, it is better to explain to the investigator that you will supply a written response directly to an FDA office.

Alan Schwartz of mdi Consultants recently explained that, even if you respond verbally to each point, it is crucial to send a written response immediately. This assures your response is accurately given to all parties who have a say in whether a Warning Letter should be issued.

Observations on the FDA 483 are just the investigator's opinions. These observations are not always supported for additional legal action by the district office or the Division of Compliance in Washington, but the investigator is the main advocate for additional action.

And Schwartz should know. He is a former FDA supervisor of field investigations and now acts as Executive VP with mdi Consultants.

Check out the following resources for more information:

• Consultant Mary Ann Tourault provides background information on what a FDA 483 is and advice on how to respond


• Alan Schwartz' audio conference offers a detailed look at all aspects of an FDA 483


• Want to see past warning letters and responses? You can satisfy your curiosity on FDA's web site.

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Experts from testing labs, standards organizations, medical device manufacturers, and authorities met in Shanghai on February 24 and 25, 2009 to discuss how to align their understanding of international standards for medical electrical equipment safety. The conference focused on GB 9706.1-2007, which came into effect in China in July 2008 and is equivalent to the 2nd edition of IEC 60601-1 on medical electrical equipment safety.

More information is available on COCIR's web site.


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

Is it unethical to conduct clinical studies in developing countries?

More and more clinical trials are being conducted outside of the United States. And many of those international trials are being organized in developing countries. The New England Journal of Medicine's recent article on the globalization of clinical research says that this trend is fraught with both ethical and medical concerns.

The main reasons for conducting clinical trials in developing countries? Easier patient recruitment and lower costs. Sure, but the main draw is that there are fewer regulations, says U.S. News & World Report.

Aside from the ethical concerns raised in the NEJM article, there are business concerns about off-shoring clinical research. But it's no surprise that the world is shrinking - and clinical research is impacted by this, just like all other parts of the drug development process. What has lagged is our ability to effectively manage the studies that are being conducted around the world.

There are many challenges associated with globalization, centering on logistics, regulation, and communication. Language communication and translations also pose difficulties. For instance, language challenges associated with conversion to electronic data methods involving languages with alphabets other than Latin must also be taken into account. In multinational trials, documentation must be consistently and accurately translated to avoid miscommunications. Informed consent must take language and cultural differences into account. Finally, cultural factors which affect medical attitudes and patient compliance must be well understood.

It's no wonder that there is so much interest in learning how to organize, plan, and execute international clinical trials!


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.
 
 

We recently asked Why measure translation quality? If yours is one of the medical device or biopharma companies that believes in measuring linguistic quality, here is a good resource for you.

18 months ago, the folks at Palex Languages & Software conducted an interesting survey of translation QA tools. Translation Quality Assurance Tools: Current State and Future Approaches provides a good look at the automated QA tools out there. Their survey benchmarked eight tools across a number of quality and language dimensions.

Their conclusions? Even though QA tools are not yet reliable enough to be fully trusted, they do offer a significant increase in productivity. So why don't they play a bigger role in the translation supply chain? Lack of awareness.

Now that you are aware, check out the presentation!

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A couple of months ago, the Taiwan Patent Office (TIPO) launched a free online glossary of technical terminology.

As the East meets West blog of the European Patent Office points out, the glossary currently contains approximately 1.79 million Chinese and English patent-related technical terms extracted from patent abstracts and various technical and academic glossaries and including Chinese-English International Patent Classification terminology. Although the interface of the glossary is currently available in Chinese only, users can search for English or Chinese terms.

The glossary is available free of charge on the TIPO web site.


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

Anecdotally, it always seemed that there were many more women than men involved in medical translation. Looking at linguists, our company, and even our client contacts, there were few men to be found. At last, there is some proof for this hypothesis!

A couple of years ago, Simon Andriesen presented How to take medical translation
into account while writing at the AMWA Annual Conference. He included an interesting profile of the typical medical translator. In looking at the linguists that they work with, Simon found that:

• 80%+ have a linguistic rather than medical background


• in many cases, the linguist's spouse/partner is active in a medical profession


• most medical translators work as freelancers rather than in-house linguists


• women outnumber men 6:1

Not quite statistically valid but interesting nonetheless. So, how come there aren't more men in medical translation?

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A recent discussion on LinkedIn (login required) provided good information to buyers of software localization.

The discussion referenced a good article that shows how collaboration between software developers, UI designers, and translators is essential for successful software localization.

Read-up, medical device engineers and localization managers! The article gives good advice on how to organize a localization effort while avoiding some common mistakes.

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Many medical device and pharmaceutical companies that do business in Japan rely on their Japanese affiliates to handle the creation of regulatory documentation due to language and cultural considerations and the complexities of Japanese regulations. A problem with this approach is that often the US-based companies then don't know exactly what was submitted to the government, which can have serious implications.

We have found that Japan regulatory translations require a unique process, whereby content is created in the US, translated here and then edited and finalized in Japan. This process requires cooperation from the US headquarters, the translators, as well as the Japanese affiliates. It ensures that the English and Japanese versions stay consistent and that there are no questions about what is submitted. It has the side benefit of building cross-cultural teams, where both parties focus on their core competencies.

Do you have any other tips and tricks for streamlining work with Japanese affiliates?


ForeignExchange Translations provides specialized medical translations for regulatory submissions, labeling, and safety reports - in Japanese and dozens of other languages. Contact us to find out more.
 
 

In case you missed them, here are February's five top entries on the Medical Translation Blog:

1. 100% text repetitions: To review or not to review - There is a live debate going on in the comment section.


2. Language fact: British vs. American English - Pass the packet of crisps, would you?


3. Who believes in quality metrics? - As it turns out, not many people.


4. New book: Learning Machine Translation - Is the recession good for machine translation?


5. New "Guide on Translation" gets published - Provides a basic but good overview.

Happy reading and happy weekend!

CenterWatch reported today that the current wave of pharmaceutical consolidation is leading to increased pressures for drug sponsors to control costs and improve efficiency. This in term is leading to short-term pressures on clinical research organizations (CROs) and other suppliers involved in clinical research - projects are being canceled, delayed, or or re-conceptualized.

We have seen some of that in our business, both in terms of fewer project (due to cancellations and "in-sourcing" of work) and a new hyper-sensitivity to price. In some instances, this is also leading sponsors taking on the management of translations on their research studies, cutting out their CROs.

What about you? Are you seeing fewer clinical research-related translations being done?

Everybody talks about quality: Oh, we deliver great quality! We don't sacrifice on quality. We're all about quality. The problem with these statements is that they're impossible to verify and thus are meaningless.

Some of that cannot be avoided; language is inherently subjective. What may be a perfect translation to one person may be incorrect for the next person.

The subjectivity comes into play when we use words like "perfect" or "wrong". How often have you been in situations where somebody tells you "this is a bad translation – it reads as if it was done by a machine"?

Usually, when you dig deeper, it comes down to a particular turn of phrase or a word that should have been used differently. So, now you are arguing about whether the text should use "car" or "automobile", or maybe the active voice or the passive voice. In the absence of clear guidelines, it is very difficult to resolve these kinds of arguments.

It is easy to see where these disagreements come from. Each of us is a product of our unique background. Inevitably, we evaluate the world around us in the context of our experiences and beliefs regarding culture, society, and language.

Translation, at its core, aims to achieve equivalence between the source and target texts, yet that equivalence is difficult to achieve.

WHAT IS QUALITY?
I know, I know - we all think that we can spot poor translations. But are we as adept at recognizing a good translation?

In order to answer "yes" with any kind of conviction, we need to overcome the subjectivity mentioned earlier and form a common understanding of what quality actually is.

ISO 8402 defined quality, in part, as "The characteristics of a product that bear on its ability to satisfy stated and implied needs".

Translation quality really is the fulfillment of the requirements that have been defined and agreed upon with the client.

Quality exists at every level of the clinical translation process:

• The quality of a price proposal is the prime criterion for a client to award a project.
• The quality of processes determine how well projects are executed and complex tasks managed.
• Etc.

QC ALONE IS NOT ENOUGH
Every once in a while, I hear people say "We don't need quality measurements – we already perform thorough quality-control steps".

In fact, most translation processes include multiple QC steps. The same is true for medical writing, printing, design work, and so on. So, why do we still have quality problems? And why is there no firm sense of how good the quality is?

The same is true for quality metrics. In and of themselves, they don't improve quality. However, when used as part of a quality-improvement system, they play an important role in:

• Increasing productivity
• Reducing costs
• Enhancing customer satisfaction
• Improving communications
• Increasing product safety

So, if you are tired of arguments about "car" vs. "automobile", track objective quality metrics!

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Guest article:
By Maria Esposito
Freelance Health Journalist
mar19511@hotmail.com
http://medicine.reportednow.com


It's no secret that the cost of malpractice suits has continued to escalate, sparking continued debate as to what can be done to try to alleviate the problem. In this article, the authors suggest that the back-end approach of trying to reform malpractice laws by methodologies such as placing caps on damages has failed miserably. What they recommend is a front-end attack, reducing the number and frequency of medical errors, which would eliminate the need for the suit. The best way to accomplish this goal is by using healthcare information technology.

An important point to note here is that when the authors refer to medical errors, they are in fact referring to a bad outcome because of a medical practitioner’s failure to exercise standards of reasonable care. However, they go on to add, that not every bad outcome is actually the result of this type of failure on the part of the healthcare provider.

In this era of complex diagnostic tools and therapy options, the likelihood of medical error will increase because doctors have many more sources from which to collect information about a patient before they can make an accurate determination about the type and duration of continued treatment. If the doctor tries to gather this data in the old way, s/he will very likely miss an important piece of the puzzle that can lead to a misstep in diagnosis and the possible malpractice suit. However, using electronic medical records (EMRs) has been proven to reduce the number and frequency of medical errors by providing healthcare professionals with a much more complete picture of the patient’s history that what was available from a written chart. That's why doctors need to embrace this new technology.


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Latin America is getting a lot of attention among pharmaceutical companies. Brazil and Mexico are already among the top ten ex-US markets. At the same time, diverse regulatory requirements across these markets create significant obstacles to efficient development and registration of new drugs. Some efforts are being made to harmonize submissions across the continent but complete harmonization is still a ways off.

Because of this lack of harmonization, it can be difficult to obtain information on the local requirements across Latin America. The following three presentations touch on different aspects of the drug submissions process and, together, provide a fairly complete picture:

• A regulatory overview presented by Kendle at the 2008 RAPS conference


• Development of a Harmonized Dossier is a good presentation from the April 2008 CPDG Symposium


• Global Regulatory Strategy looks at various regions around the world, including Latin America (presented at the 2007 DIA Annual Meeting)

Not a big surprise but Australia is moving towards eCTD. The Therapeutic Goods Administration (TGA) recently released two documents:

• specification for module 1, and a


• draft guidance for industry

As noted on TGA's web site, "[i]t is expected that the media for receiving eCTDs initially will be CDs or DVDs and that there will be a transition period where both eCTD and hardcopy CTDs will be accepted prior to eCTDs becoming mandatory".

Thanks to the folks at eCTDBlog for the heads-up!

Thanks to the folks at lexicool.com, we recently discovered this useful tool: The glossifier is provided by the Melanoma Patients' Information Page (MPIP) and helps translators understand medical articles.

To use it, you simply type the URL of an article you wish to "glossify" in the box provided and the article will appear in your browser with all the words that are in the MPIP dictionary linked to their English definition. Very handy!


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John Yunker gave this presentation at DocTrain Life Sciences last year. Very interesting!