Medical Translation Insight

ForeignExchange and FX Conferences have a lot of educational events coming up in October and November.

On October 19th in Minneapolis, we’re hosting a networking breakfast event, “First, Do No Harm: Basics of Human Factors Engineering and Usability Testing,” presented by FX Certified Partner, Maria Shepherd. Sign up to attend here:

http://info.fxtrans.com/first-do-no-harm-mn/

(On October 11th, Maria is also presenting an audio conference on a similar topic for those who can’t see her in person: http://www.fxconferences.com/HFE-101-New-FDA-Draft-Guidance-on-Human-Factors-Engineering-and-Usability-Testing-P578.aspx.)

On October 21st in San Diego, we’re hosting a networking breakfast event, “Get Smart: Strategic Portfolio Management,” presented by Andrew Hunter and Noel Sobleman, both of Kalypso. Sign up to attend here:

http://info.fxtrans.com/get-smart-strategic-portfolio-management/

On November 2nd, in Bridgewater, New Jersey, we’re presenting, “Risk Management 2012: A Macro Look at Next Year’s Trends and Challenges” by John Kamp from the Coalition for Healthcare Communication and Ilyssa Levins of the Center for Communication Compliance. Sign up here:

http://info.fxtrans.com/risk-management-2012-a-macro-look-at-next-years-trends-and-challenges-nj

All breakfast events are complimentary and breakfast is provided but space is limited. If you need more information or have suggestions for future events, drop us a note at education@fxtrans.com.

At ForeignExchange, we strongly believe that translation suppliers cannot be all things to all customers.

Client requirements, technology, service delivery processes, resource utilization and many other things differ widely across language services and subject matters.

It's easy to talk about being medical translation specialists and our vision of saving lives - but it is hard to do. Our tight focus on medical translation has been neither. It has aided us in making decisions, grow profitably, hire a terrific team, and build long-term client partnerships.

But sometimes, when we talk to colleagues, linguists, and even clients about the depth of our focus, they ask "Isn't it limiting and counter-productive to be so specialized?" As much as anything, this question reflects the difficulty of 'saying no' and hesitation to embrace a target market.

For anybody who is on the fence about the value of focus and specialization, listen to this interview with Jennifer Neal.

Featured in a Marketing Mentor podcast, Jennifer doesn't talk about medical translation - or anything close to language services. Nonetheless, her insight and experiences are highly applicable and valuable to our industry.

If you're scared of embracing a target market, listen to the interview and let me know - Did it change your mind about target markets?


ForeignExchange's METRiQ quality system provides medical device and pharmaceutical companies with measurable, known medical translation quality.
 

ISO 14155:2011 is an international standard designed to guide companies as they fulfill the many different regulatory requirements for international clinical trials.

We recently sat down with Joy Frestedt and Pamela Wolff from Frestedt Incorporated, an FX Certified Partner, to talk about their work and the ins and outs of ISO 14155 and how it is impacting medical companies.



First issued in 2003, this 2011 update has attempted to unify many different standards for global clinical trials including requirements of the Global Harmonization Task Force, the International Conference on Harmonization Good Clinical Practice documents and some guidance information from the FDA. The goal of this work is to ensure clinical trial data generated anywhere in the world meets certain minimum standards.

With over 65 pages of detailed requirements, ISO 14155 now contains four administrative sections, three project management sections, two responsibilities sections and six annexes. Ensuring your companys' systems are compliant with every component of this global standard is complicated work.

For more expert insight, take a look at ForeignExchange's YouTube channel or jump directly to some of our past interviews:

• The human factor - interview with Maria Shepherd
• What's so special about medical device translation? - Andres Heuberger
• The changing landscape of clinical trials - Helen Colquhoun
• 5 questions about translation quality - Sonia Monahan

For daily updates, subscribe to Medical Translation Insight via email or RSS.
 

Two years ago, we wondered if the Greek crisis would spread from drug companies to translation suppliers. After that, things had gotten quiet and for a while, the situation seemed resolved.

Then, earlier this year, the situation in Greece got worse again. Not just for residents and bankers but also for pharmaceutical and medical device companies doing business in Greece.

Now things have come to a head. After having previously introduced a 'no cash, no delivery' rule, Swiss drug giant Roche has stopped delivering some drugs to select state-funded hospitals in Greece that haven't paid their bills.

While severe, Roche's move doesn't come as a complete surprise. Back in May, the Financial Times reported that the Greek government has only paid 1% of its medical bills in 2011 [subscription required].

At the time, Roche had cut its staff. Some medical device companies went even further. Covidien and Becton Dickinson, for instance, closed their Greek operations.

Roche has indicated that it may restrict drug shipments elsewhere as well, providing a stark example of how the European debt crisis that has jolted global financial markets is now directly impacting consumers.

As in Greece, those countries residents' health may be put at risk if hospitals run short of essential supplies and cancel patients' non-essential operations.

If you're not too depressed to keep reading, here are three recommendations:

• Practical tips for publishing Greek documentation
• Hello Europe. Be the first to meet my new device!
• EU expansion – east by southeast

ForeignExchange Translations provides specialized medical translation services to medical device and pharmaceutical companies - in Greek and dozens of other languages.
 

Uh oh... was the gold rush inspired by china's healthcare reforms too good to be true?

As we wrote previously, with a goal of providing universal coverage to the 1.3 billion Chinese, medical device and pharmaceutical companies rushed to take advantage of this boom. Now, however, the country faces serious obstacles to progress, leaving drug and device companies to wonder if the bonanza is over.

Complaints have long been heard that the cost of treatment in China has spiraled alarmingly. Now, user fees are at the heart of the problem.

CMAJ reported that

an effort by the Chinese government to reform hospitals by eliminating user fees faces tough opposition from clinicians. Also stymied — by a lack of physicians and money to pay them — is an effort to extend access to basic health care to 800 million rural residents, many of whom live in poverty

Even an economy as mighty as that of China has to worry about who pays for healthcare. This is exacerbated by huge income differences across China. In the article, CMAJ notes that their is a ten-fold difference in incomes between the country's richest city (Shanghai) and its poorest rural areas.

As the central government attempts to redistribute resources from the country's wealthy cities into rural regions, drug and device companies are paying close attention to the world's largest health care experiment.

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

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

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

Helvetica is, seemingly, everywhere. Cyrus Highsmith, a New York type designer who decided to live without Helvetica for a day, found this out the hard way.

When he woke up, Highsmith had virtually nothing to wear: the washing instructions in most of his clothes were set in Helvetica. He forsook his regular breakfast yoghurt: Helvetica label. Hungry, he dashed to the subway unable to pick up a copy of the New York Times because it employs Helvetica. So does the New York subway. No train ride. The menu in his regular Chinese restaurant was printed in Helvetica. No lunch. It was hard to buy anything as his credit cards and the new dollar bills in his wallet were also set in you know what. Back home and flopped in front of the TV, Highsmith was unable to switch on and relax because the remote control was a typographical hell of Helvetica, too.

This story is included in Simon Garfield new book, Just My Type.
If you are font geek who has a history of annoying friends and relatives with unwanted discussions of typeface minutiae, then this book is for you!

For more details, take a look at Woot's funny take, the author interview at 200% Meets, and Amazon.com.

And if you want to give your inner geek some more free reign, take a look at:

• Periodic table of typefaces
• Finally, an alternative to the metric system!
• Of Swiss fonts, Italian designers, and New York subways
• Eye charts from around the globe

At ForeignExchange Translations, we are font and language geeks. We help medical device and pharmaceutical companies look and sound just right, in any language. For expert medical translation services, contact us to today!
 
 

As we have written about before, style guides pay huge dividends in consistency, quality, cost, and turnaround time on projects. But on problem is that many style guides span 100 pages or more and cover everything from the fine points of template use to the details of punctuation preferences.

While having these documents can be a sign of a well-organized writing group, a smaller, project-specific style sheet of two to 10 pages can be used on large projects that call for cross-departmental work and/or the help of contractors. These mini style guides can bring disparate groups of writers and linguists up to speed quickly and ensure that the most important aspects of the company's writing style are consistent throughout its documentation.

This kind of coordination and consistency is important on most writing and translation assignments. However, it is critical to ensure efficient publication of electronic submissions.

To drive this point home - and provide hands-on, actionable tips - we have enlisted the help of Susan Sisk. In Using Short Style Guides to Harmonize Writers and Improve the Quality of Electronic Submissions, she will share insights on developing and managing the use of short style guides, and how best to use them to improve the quality of medical translation and writing projects in general and regulatory submissions specifically.

Make sure you take a look at the following articles as well:

• Terminology management at Medtronic
• Translation memory vs. glossary
• 90% of in-country reviews are a waste of time

In contrast to most other translation companies, ForeignExchange does not do "all things for all people".

We support the world's leading medical device and pharmaceutical companies with specialized medical translation services for regulatory, clinical, and marketing efforts. Contact us today for more details.
 
 

Last month, we wrote about how FDA 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. This "global coalition of regulators" has just gotten a shot in the arm - from Canada.

CMAJ reports that "Canada appears eager to clamber aboard".

OK, so nobody expects change to come quickly. CMAJ states that "FDA also stressed that it expects it will take years to fully develop and implement a global regulatory approach". With regulations to be harmonized, turf wars to be settled, and national interests to be protected, "years" could turn into decades.

Nonetheless, the Canadian Food Inspection Agency appears to view such a global coalition as a positive development. CMAJ's article goes on to quote a CFIA official as saying that beyond ensuring that food imports meet Canadian safety requirements, a global "approach helps to reduce duplication of efforts, maximize resources, facilitate identification of and faster responses to import threats."

It will be interesting to watch this story unfold.


ForeignExchange Translations provides specialized translation services to drug and medical device companies - in Canadian French and dozens of other languages!
 
 

The 2010 pharmacovigilance legislation required EMA to publish the format for the electronic submission of information on medicinal products for human use by 2 July 2011.

EMA is more or less on track, and the just-released Electronic submission of information on medicines give a good sense of the four-step approach that the agency will take towards implementation:

• Phase one: Notification of the electronic submission format
• Phase two: Electronic submission by marketing-authorisation holders
• Phase three: Processing and validation of the submitted information
• Phase four: Update of the format in compliance with the ISO IDMP standards

For medical translation professionals, phase one will be of particular importance. It outlines that:

The Agency published the format for the notification of the electronic submission of medicinal product information in July 2011, which lists all of the data elements required, including the description of the characteristics of the substances contained in medicinal products. The Agency updated this information in September 2011 to include the XML Schema Definition (XSD) for the individual data elements.

The Agency has published a list of controlled vocabularies, which companies should use to fill in fields of the extended EudraVigilance product report messages (XEVPRMs). This list is updated periodically. The XSD schema files and naming conventions for substances are also available.

[Thank you to Catherine Guilliaumet via the medical_translation list]


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

The revised MDD 93/42/EEC came into effect on March 21, 2010 and the changes will impact all medical device manufacturers that CE mark their products or plan to do so in future.

18 months later, questions remain about the updated regulation. One of the big questions is: How should software be designed to ensure the repeatability, reliability and performance of systems according to the intended use?

Complying with EU Requirements for Medical Device Software addresses how, in the event of a single fault condition in the system, appropriate means can be adopted and documented to show that risk has been eliminated or reduced as far as possible. Poul Schmidt-Andersen is an expert in the field, and in his presentation he covers how to establish suitable documentation to demonstrate compliance and satisfy Notified Body reviewers.

If you or your group is involved with medical device software development, you don't want to miss Complying with EU Requirements for Medical Device Software.

For more on the intersection of software and regulation, take a look at:

• When is software a medical device?
• What's the fuss about IEC 62304?
• Introduction to software localization
• Software localization requirements in Japan

ForeignExchange's QMS is certified to ISO 9001, ISO 13485, EN 15038 and compliant with ISO 14971. For your next medical translation and software localization assignment, request a detailed proposal from ForeignExchange.
 
 

In the conference and education sector, August is usually a slow month. Not so for us this year. We saw a slew of well attended audio conferences!

Here is the list of top events for the month:

1. Conducting Formative and Summative Usability Studies for Medical Devices
2. Government Enforcement on Medical Affairs and Commercial-Related Activities
3. FDA's Part 11 Inspections: How to Prepare Yourself to Prove Data Integrity
4. An Introduction to Regulatory Writing: Creating an Effective Message
5. Conducting Medical Device Studies Under the Revised ISO 14155

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.
 

Language changes and modernizations are a fact of life.

Wikipedia maintains a long list of spelling reform efforts. Many of these reforms were designed to ease the task of children or immigrants becoming literate. But especially today, integrating a language globally is critically important to any country or language group wanting to participate in the age of globalization.

Such were the considerations in Vietnam, when it was announced in August 2011 that the Vietnamese alphabet would be expanded to include the letters F, J, W, and Z.

While the Vietnamese script was based on Latin, it lacked these four letters. However, according to VietNam News, these letters did get used in foreign loan words, and there were other work-arounds: "W" (ve dup) is sometimes used in place of "U" in abbreviations. In informal writing, "W," "F," and "J" are sometimes used as shorthand for "QU," "PH," and "GI".

A week after the Department of Information Technology's claim, the Vietnamese Ministry of Education nixed it. The reasons? Cultural heritage, lack of money, and a proud tradition of not adhering to new regulations.

Or, according to Johnson, maybe it was just that inertia won out.

Interested in more? Take a look at some of our other articles about languages, laws, and cultures:

• China to update list of simplified Chinese characters
• Brazilian Portuguese changes spelling rules
• Slovak language law creates uproar

Want daily updates delivered to your email inbox? Sign up for an email subscription to the Medical Translation Insight.
 

It's shaping up to be a busy autumn at FX Conferences! Planning is well underway for more than 50 new audio conferences, packed with timely, important information designed to keep you ahead of the curve. You can count on FX Conferences for the latest developments in product labeling, human factors engineering, ISO 14155, clinical evaluations, supply chain management and much, much more.

To help our customers take full advantage of these great learning opportunities, we're offering for a limited time an "All You Can Learn" audio conference package.

For the deeply discounted price of US$499, you can have access to all of the new audio conferences produced from now until the end of December. You get the great speakers, the valuable take-home presentation materials and the helpful Q&A sessions with global industry experts, all included. And best of all, you can have your colleagues sit in and listen with you at no extra charge.

To find out more about this package, to see what events we have coming up, or to review our extensive archive of past events, visit our home page at www.fxconferences.com. You can also contact us at acsupport@fxconferences.com.

We look forward to having you join us this fall!


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

Drugs produced in offshore plants pose an increased quality risk compared to those prepared in the mainland United States, a new study suggests. The study was published in the Journal of Operations Management and specifically compared regulated drug manufacturing plants in the U.S. mainland and Puerto Rico.

OK, we kinda, sorta knew that (cf. examples from GlaxoSmithKline, Johnson & Johnson, Bristol-Myers Squibb, and Baxter) but it's nevertheless eye-opening to have this proven out.

What's scary is that language - and, presumably, translation - play an important role in those quality issues. The study's lead author noted:

We believe the quality differences we found in Puerto Rican plants were driven by challenges in transferring knowledge from headquarters to the plant, due to cultural differences, primarily differences in language and values.

Scarier still is the author's contention that

Facilities in more distant, less developed countries may face even greater obstacles to quality control than what we found in Puerto Rico

That is disheartening news for consumers and medical translators alike. Is the clock running on another Heparin scandal, just this time with a language twist?

[Thank you, Pharmalot, for the heads-up!]

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

• Drug safety down, translation demand up
• Managing quality in global supply chain
• The clock is running on another Heparin

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

The ForeignExchange team is getting ready for our company meeting in Colorado.

In preparation for our annual get-together, I came across The 4Ps of a Fully Alive Business:



The idea of these redefined Four P's really resonates. It reflects what the ForeignExchange team is working towards. We use different language in our vision statement but these traits act as the filter through which our business is run internally and how our service and team are experienced externally.

As our globally distributed team prepares to travel, have fun, learn, and reconnect next week, it is valuable to remember what medical translation in general and ForeignExchange specifically are all about.

Related and semi-related articles:

• Of crazy bears, amateur videos, and having fun in translation
• Running our business like an aquarium
• So you say you're customer-service oriented?

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.
 
 

Summer is over in our parts. And with that, our busy season starts. The end of the year, and particularly, the last three months are always our busiest time.

So before we all get too busy, let's make sure to catch up with our most-read content from the last month:

1. Human factors - Judging by the interest in generated, our interview with Maria Shepherd sure wouldn't make you think that human factor engineering is such an esoteric topic!
2. Nine free term extraction tools - Term extraction is good. Free is good. Combine them, and we're ecstatic!
3. Mark Twain on back translation (and the French language) - Back translation, through the lens of Mark Twain
4. Finally some useful tips on writing for translation - Hands-on tips in a concise format
5. Style guides: an investment worth making - You know you should; now you can

Happy reading and happy weekend!


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

The European Directive 98/79/EC on in vitro diagnostic medical devices, or IVD Directive (IVDD), became operational in June 2000.

Since then, the IVDD has provided IVD manufacturers with a single regulation for the European marketplace. Devices marked with the CE mark can be introduced into 32 European countries (European Union member states, European Free Trade Association countries, and Switzerland and Turkey).

Earlier this year, European Union regulators' public consultation on proposed revision resulted in strong support for adopting a risk-based classification for in vitro diagnostic devices from stakeholders.

IVD Technology published a good overview of the proposed Revision of Europe's IVD Directive 98/79/EC. The EC's summary of responses to the public consultation is also available for download [PDF link].

Medical translation professionals take note: While there is still a long way to go between now and the actual implementation of a revised IVDD (a draft is planned for early 2012), implementation probably will happen by 2015.


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

This comes from a recent article in MultiLingual. Terminology survey results reviews a 2010 survey organized by TermNet and was written by expert and industry veteran Barbara Inge Karsch.

Though the survey focused on the automotive, mechatronic (side note: I didn't know what this meant until I looked it up), and IT/communication sectors, it is still highly relevant to medical device and biopharma companies as well as medical translation professionals.

While the sample size was small (145 respondents) and U.S.-centric, it still includes interesting take-aways. Some highlights:

• Terminology is closely tied to translation and localization (at least in the U.S.)
• A substantial majority of people working for companies that translate materials said that "their companies did terminology management"
• Terminology is a "target-language affair" - coming late in the game, i.e., during translation and localization
• Translators may not be able to manage terminology but should proactively build and share glossaries

Especially when practiced on a larger scale and in corporate environments, terminology management is still often seen as "hocus pocus". It's great that organizations like TermNet and professionals like Barbara Inge Karsch work to demystify this black art.

For more on this topic, take a look at:

• Barbara's blog, BIK Terminology
• Translation memory vs. glossary
• ROI for terminology management

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

Social media, with its wide reach and accessibility, is a powerful tool for recruiting linguists, improving clinical research - and for increasing participation in healthy behaviors and improving people's health.

According to recent data from Pew Research Center’s Internet and American Life Project, minority Americans embrace mobile Internet access, social media sites, and applications to manage or track their health to a greater degree than non-minorities:

According to Pixel & Pills:

Social media crosses cultural and ethnic groups and it has global reach – in many countries patients can access Twitter or Facebook and other social communities and location services. Eight in ten Internet users look online for health information and African Americans and Latinos are leading the way using their mobile device to search for health information.

Sounds just like what the doctor ordered!


In contrast to most other translation companies, ForeignExchange does not do "all things for all people". We support the world's leading medical device and pharmaceutical companies with specialized medical translation services for regulatory, clinical, and marketing efforts. Contact us today for more details.
 
 

Those darn Brits! Always complaining about something...

Take a recent viewpoint in the BBC News Magazine. While the author of Why do some Americanisms irritate people? accepts "that sometimes American phrases have a vigour and vivacity", he also laments the "sloppy loss of our own distinctive phraseology through sheer idleness, lack of self-awareness and our attitude of cultural cringe".

Apparently, readers agreed.

Thousands of them wrote, listing their least liked Americanisms that had found their way into British English. Some of the items that provoked the strongest reactions are:

• "Can I get a..."
• Deplane
• Touch base
• Shopping cart
• Train station
• Oftentimes
• And many, many more...

Take a look at the whole list!

[Thanks, Mary, for the tip!]

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

• Sometimes English is not sexy but stupid
• English: One language, many voices
• British English A to Zed

For medical device and pharmaceutical companies who want to be understood around the world, ForeignExchange Translations provides specialized advertising translation services with measurable quality. Ask us why our clients rave about us!
 
 

I recently mentioned how my family spent a month in Australia. Well, we are back after having a wonderful time down under.

One of the things we enjoyed about Australia was to notice signs on roads, in parks, and all around us. Many look and read the same as in the U.S. - and many don't.

Here is a collection of signs advising how to use a toilet, to be careful of various wildlife, and other helpful tips (click on the images for larger versions):















I can't wait to go back for more Aussie fun!


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