Medical Translation Insight

Thanks, xkcd, for explaining what's going on in the translation industry!



UPDATE - Here is another take on standards:




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With the passage of the FDA Food Safety Modernization Act (FSMA), a lot of attention has been devoted to the new recall authority granted to FDA.

FDA now has the authority to issue mandatory recalls when it deems it is necessary to protect against serious adverse health consequences. And this is not the only consequence of mandatory recall authority (see our recent audio conference for more details). And the U.S. is not the only country where food labeling is receiving increased attention.

Global standards for mandatory nutrition labeling on the back of food packaging appear to be in the offing but standards for the front of packages appear to be a distant dream.

CMAJ recently reported that guidelines will be crafted during 2011 by the Codex Committee on Food Labelling.

According to CMAJ:

Proponents hope the back-of-package labels — which would articulate general information about such things as fat, protein, fibre and calorie content — will serve as an impetus to all nations to adopt official labelling requirements, if only because they would soon become a requisite element of international trade.

International standards should "empower" countries to adopt back-of-package labelling standards, says Bill Jeffery, national coordinator for the Canadian office of the Centre for Science in the Public Interest. "Calling it a mandatory standard is really like saying to national governments: 'You're permitted to have a mandatory standard without running afoul of international trade law'."

Much of the debate is now centered around front-of-package vs. back-of-package labels. Coordinating global front-of-package standards for tobacco took decades to achieve - despite lots of evidence indicating that smoking was the cause of all kinds of illnesses.

It is likely that food labeling will travel down a similar path. Back-of-package labeling is a step on that journey towards standardizing nutritional labeling around the world.

For more on global labeling practices, take a look at some of our other articles:

• Cereal maker learns that "labeling" is a broad term
• Becton, Dickinson gets labeling right
• Electronic labeling for medical devices comes to Canada

ForeignExchange Translations provides specialized medical translations for bio-harmaceutical DFUs, packaging, and product labels.
 
 

As we noted the other day, big pharma is excited over and looking for revenue streams from developing markets. One reason for this interest: Marketing restrictions are less onerous than in the U.S. or Europe.

What does "less onerous" mean, you might wonder?

Reuters recently highlighted one example:

If you sleep less than six hours a night, you're increasing your risk of developing or dying from heart disease by 48 percent. At least, that's what U.S.-based pharmaceutical giant Abbott would have 1.2 billion people in India believe.

The article goes on to quote experts who note that ads are "implying that taking sleeping pills may help you live longer, whereas the data shows that taking sleeping pills is associated with increased mortality" and comparing drug marketing in emerging markets to the "Wild West".

We have written before how India has become a big attraction and huge market for pharmaceutical companies - what with soaring incomes, expanding insurance coverage, and more chronic disease. Promoting traditional Western medicines used for traditional Western maladies is one way to tap into these markets' potentials.

There are plenty of critics, of course. The Reuters article was widely covered and prompted many writers to voice their own (critical) opinion. Here is one example:

"It's their usual strategy, create anxiety about a disease people didn't know they have, so drug companies can sell them a pharmaceutical solution. Look out citizens of the developing world, big pharma has its marketing machine focused on you."

But with Abbott boasting that it will become the No. 1 Pharmaceutical Company in India, it's likely that Abbott and other pharmaceutical companies will increase their marketing efforts further.

[Hat tip to Pharmalot]


ForeignExchange translates clinical research for medical device and pharmaceutical companies into Indian languages - as well as dozens of other languages. Ask us for a detailed proposal on your next translation project.
 
 

Smartphones and tablets are revolutionizing healthcare delivery. FDA is catching on to this fact and released draft guidance that would allow it to regulate smartphone and tablet apps related to health and medical needs.

Sounds reasonable - but where do you draw the line? The folks at Brandwood Biomedical give this example:

[A]n app which controls the phones LED flash to turn it into a light source and is labelled as to be used for assisting with a patient examination would be subject to regulation as an ophthalmoscope – which means it would require a 510(k) submission.

Really? Does that mean that all of the flashlight apps would be subject to FDA oversight? That would quickly put a damper on the market for smartphone apps.

To help clarify this issue, FDA sets out four categories of mobile apps with separate regulatory approaches (from Brandwood Biomedical):

• Apps which display, store or transmit patient-specific medical device data in original format. These will be regulated as Medical Device Data Systems MDDS – which are Class I under regulation 21 CFR 880.6310
• Apps which control the intended use, function, modes, or energy source of a connected medical device. These apps are considered accessories to the primary connected device and subject to the same regulations as that device. So if the app is accessory to a Class II device – a 510(k) will be required, if it's an accessory to a Class III device subject to PMA, then so is the app.
• Apps which turn the mobile platform into a regulated medical device – Apps that "use attachments, display screens, sensors or other such similar components to transform a mobile platform into a regulated medical device" must meet the regulations for that device type. E.g. the electronic stethoscope apps which use the phones microphone is subject to 21 CFR 870.1875(b) (Electronic Stethoscope).
• Creating alarms, recommendations or creating new information (data) by analyzing or interpreting medical device data – Apps which contain algorithms to analyze or interpret data gathered from another device are considered accessory to that device and therefore again subject to the same regulations which apply to the device which gathers the primary data. Examples include apps which analyze blood glucose readings from glucose meters (Glucose Test Systems under 21 CFR 862.1345) or apps which analyze and display ECG data (Cardiac Monitors under 21 CFR 870.2300).

The next step is that FDA is looking for the public to comment and weigh in on its app regulation proposals. This sounds like one of those rare opportunities where input could have some real impact: According to the L.A. Times, FDA expects 500 million smartphone users across the world will be using some sort of healthcare app by 2015!

[Hat tip to @cwsampson]


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

Medical Devices Today has an interesting look of the continuing growing importance of internal markets for medical device manufacturers.

From clinical validation, to revenue generation, and regulatory approvals, Europe and growing markets in Asia and other developing markets are more and more attractive to device executives and investors.

Here is an excerpt:

Their searches have led them primarily to Europe, where a shared history and far more predictable regulatory path beckon. Start-ups in recent years have recognized Europe's markets as not only potential sources of revenue but also proving grounds for their devices which can be vetted by some of the more capable surgeons in the world.

Device executives looking to the Old World for commercial launches hope their products can gain enough regulatory approvals, commercial traction, and clinical data to force open the gates to the US market.

Read the full article on the Medical Devices Today website [subscription required].


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

Have you ever noticed when traveling, how years of driving habits can washed away after two days of driving in a different place? I have found this in my own experience as well - it's amazing how quickly I leave (bad) Boston driving habits behind when I visit Switzerland or South Carolina.

Traffic is like language. It generally works best if everyone knows and obeys the rules of grammar.

If you're absolutely unfamiliar with it, it will seem confusing, chaotic, and fast. Learn a few words, and patterns begin to emerge. Become more fluent, and suddenly it all makes sense.

This excerpt is from a terrific Book called Traffic - Why we drive the way we do.

The book is mostly about traffic, of course, but it has an entire chapter dedicated to driving around the world. Examples from Rome, New Delhi, New York, and elsewhere demonstrate how driving habits are influenced by culture - and how traffic also creates its own culture.

From "jaywalking" in Copenhagen to driving on the Italian autostrada to the comparative efficiency of intersections in Toyko and Beijing, the book is chock-full with great anectodes and information.

But there's also more to the book. Flipping through a few chapter titles and headings is rewarding all by itself:

• Why You're Not as Good a Driver as You Think You Are (doesn't apply to us, of course)
• Why Ants Don't Get Into Traffic Jams (and Humans Do)
• Why More Roads Lead to More Traffic (and What to Do About it)
• When Dangerous Roads Are Safer
• Why You Shouldn't Drive with a Beer-Drinking Divorced Doctor Named Fred on Super Bowl Sunday in a Pickup Truck in Rural Montana: What's Risky on the Road, and Why (our favorite)

If you're looking for a fun and educational summer read, be sure to pick up Traffic - Why we drive the way we do.


ForeignExchange provides specialized medical translation and localization services to pharmaceutical and medical device companies - in Chinese and 40+ other languages. So that you don't get lost overseas, ask for a detailed proposal.
 
 

More than ever, translation and interpreting support are hot topics in hospitals across the United States. The demand for in-person as well as over-the-phone interpretation is surging. In response, new companies, new services, and new resources are popping up left and right.

The recently launched Interpreter's Launch Pad is one such resource. It aims to provide "resources, tips, and a bit of fun to the lives of professional interpreters". The first two issues of their monthly newsletter covered topics such as note-taking skills for consecutive interpreters, technology trends in interpreting, and profiles of successful interpreters.

Subscribers to their newsletter receive a copy of Nataly Kelly's book, Telephone Interpreting. If you're not familiar with the book, it weighs in at 300 pages and covers every imaginable topic and issue around over-the-phone interpretation.

So, head on over to the Launch Pad today to sign-up for their newsletter and grab your free book!

[Thanks to Adam Wooten for the tip!]

For more on interpreting, take a look at the following articles:

• Certification for medical interpreters becomes reality
• Difference between consecutive and simultaneous interpreting
• The world's worst interpreter?

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

Well, here I am again, blogging about my recent attendance at the 2011 DIA Annual Meeting. It's hard to believe a year has passed since I reported from Washington DC. This year's event went from June 19th – 23rd and was held in the Windy City of Chicago. From my perspective, the conference was a success in that I learned a lot and met some great new people.

The location was great! Chicago is a wonderful city and they have a huge facility to host a show of this size (7,000 attendees, 300 exhibitors). The McCormick Center is gigantic. I am told it can host nearly 100,000 people. Based on the size, I would not doubt this.

The Annual Meeting provides learning and networking opportunities. For learning, each day was broken down into four sessions, two in the morning and two in the afternoon. Each of these four daily sessions had many individual sessions. The individual sessions were categorized into 18 separate tracks (learning areas). The tracks included clinical, planning, outsourcing, pharmacology, advertising, technologies, regulatory affairs, public policy, health economics, medical devices, and professional development, to name a few.

My approach was to attend two learning sessions each day, with the remaining two session times focused on networking and personal meetings. To me, the balance between the learning and networking worked well.

I learned an important lesson last year: join a Special Interest Area Community! There are 28 separate SIACs, covering everything from Medical Writing, Statistics, and Clinical Pharmacology to Outsourcing and eClinical. I joined the Professional Education, Training and Development (PETD) SIAC. This was a wonderful choice for me. I met and networked with a number of great people.

The PETD SIAC, is an active participant in shaping the personal and professional growth of DIA members. We sponsored 13 separate sessions including ones on "Pharmaceutical Medical Education", the "Revisions in Medical Device Directives", "Personal Stories from Top Pharmaceutical Executives", and "Tips, Tricks and Advice on Making You and Your Presentation Unforgettable". We also sponsored sessions for students training in the medical field and a daily workshop to help the dozens of presenters polish their speaking skills prior to going on stage. I was particularly interested in this last area. I spent an hour each day listening and coaching upcoming speakers get comfortable with their upcoming speaking stints.

Next year's event is scheduled for Philadelphia. I'm certainly looking forward to it. I hope to see some of you next year! And, I'd love to share more info on this past event. Just ask!


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.
 
 

Today, in our Minneapolis office, we're hosting the fourth in our “Learning Unplugged” seminar series entitled, "Designing for Translation." The layout of drug and device labeling and other documentation can have almost as great an impact on localization costs, turnaround time and quality as the content. Figuring out how you’re going to fit an ever-increasing number of languages into your Instructions for Use, Websites and marketing pieces can also be a real headache. Our seminar will be discussing topics such as how to create graphics, set margins, choose fonts and choose software to maximize efficiency and get the most out of translation spend. As with all of our seminars, we try to provide attendees with practical takeaways that can be implemented immediately.

Our speaker will be ForeignExchange's own Technical Services Lead, Amy Maxson. Amy has worked with ForeignExchange for four years and has over six years of localization industry experience. She holds a degree in Graphic Design from the University of Wisconsin-Stout and is based in our Colorado office. She's a font of knowledge when it comes to multilingual IFU and documentation design. Her seminar promises to be a valuable one!

Previous Learning Unplugged seminars have covered such topics as writing for translation, budgeting for translation and medical translation validation. Future events will include software localization and and overview content management. Stay tuned to this blog for news about ForeignExchange's upcoming educational events or drop an e-mail to us at education@fxtrans.com if you're interested in attending an event.

Does your company cater to the medical device, IVD, pharma, or biotech industries? Are you interested in sharing your expertise with other industry professionals?

The key element to the success of our ongoing FX Conferences audio conference series is the speaker relationships forged behind the scenes. We seek out and partner with thought leaders in the life sciences to bring our audience the latest information and guidance on industry hot topics - topics like regulatory submissions, clinical evaluations, human factors engineering and off-label promotion.

Many of our speaker partners have been working with us for years, having seen tangible value in showcasing their expertise to a targeted audience of life sciences executives. We share with our speakers all of the business development leads arising from each event, and offer the opportunity for revenue sharing as well. We strive to create win-win relationships with our speakers, and many of them have realized business opportunities as a result of their work with us.

Interested in finding out more? Get in touch with Rob Wagner at acsupport@fxtrans.com!



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

Here is our latest list of top audio conferences and webinars that we produced in June. It's been a solid month and a great first half of the year. We have some terrific events lined up for Q3 as well!

As a side note, our events team is on track to produced 75 events through the first six months of the year. For comparison purposes, we produced the same number in our first four years combined. We've come a long way!

1. When a 510(k) or PMA Goes Off Track - FDA's Appeals Process
2. eLabeling for Medical Devices in the EU
3. The 2011 ISO 14155 Revision: Keeping SOPs Up-to-Date
4. Navigating China's Medical Device Regulations
5. Best Practices for Medical Market Research

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.
 

Electronic records are everywhere these days - healthcare providers, patients, and now event manufacturers face that change. More and more pharmaceutical and medical device companies are preparing to submit applications to regulators electronically.

The healthcare IT standards organization Health Level Seven International (HL7) is creating a standard that will include guidelines on how to submit applications electronically for regulated drugs and medical devices to authorities around the world.

The most recent issue of AAMI News reports that HL7 plans to test the regulated product submission (RPS) in the fall of 2011, and the International Organization of Standardization plans to adopt the standard as early as 2013.

The article contains an interesting quote from Medtronic:

If anybody has ever looked at an XML file, it is scary. Software is going to be required for manufacturers to create submissions. There could be many different software packages that you could use, and some of them haven't been developed yet.

Beyond the fear factor, other challenges remain. The May 2011 status report [PPT link] given to the HL7 WGM in Orlando points out that RPS requirements will be "phased in" because eCTD is already in place and that, in any case, EMA and Japan will not accept a new standard until it is an ISO standard.

It sounds like there is some time, yet, for manufacturers to overcome their fears of XML.

[Hat tip to Eisner Safety]


ForeignExchange Translations provides specialized medical translations for electronic as well as paper-based regulatory submissions. Contact us to find out more.
 
 

Every single day another international labeling project is set up with its highest element of risk smack dab at the end of the project. Quality validation is hugely important, that goes without saying, especially in regulated industries. But even from a purely practical project management perspective, to allow the highest element of risk at the tail end of the project timeline would be absolutely unacceptable in almost all other circumstances. However, there are alternatives.

The cost-time-quality trinity can co-exist through smart implementation of a measured QA program. Measuring quality allows for focused, surgical improvements rather than siege-style QA processes. It is a methodology that may enable you to institutionalize quality into your localization process. By measuring the quality of your translations, you set the bar to the high standard you want and hold it there. It is no longer that black box at the end of a process. We’ve prepared a white paper about the pitfalls of medical translation validation. Download it here:

http://info.fxtrans.com/the-perils-of-medical-translation-validation/

The revised MDD 93/42/EEC went into effect a little over a year ago, having an impact on all medical device manufacturers that CE mark their products. There was no transition period for the amendment 2007/47/EC and many companies are still struggling with some of the new requirements and risk losing their CE mark certificate from their notified body if they are not in compliance.

In cooperation with one of our partners, Leo Eisner, we have prepared a white paper that provides a comprehensive overview of last year’s changes to the MDD, including changes to definitions, the essential requirements, technical documentation requirements, classification rules, labeling requirements, and new requirements for usability (user error) and clinical data.

The paper also covers how the New Machinery Directive and the Personal Protective Device Directive work in concert with the MDD Amendment. Download the white paper from our web site.


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

Here is a great promotional package from Genentech's Medical Affair Group - smart, informative, and eye catching (click for images):

But, as always, there are two sides to ever story. It's interesting to note the commentators are focusing not on the sleep, different design but the wastefulness of the packaging.

[Thanks, Mary, for the link!]

Here are a few more articles about packaging:

• Drug packaging aims to combine safety, compliance and design
• Mind your language! Bilingual packaging, branding in Canada
• Becton, Dickinson gets labeling right

ForeignExchange translates medical device and pharmaceutical packaging and labeling into dozens of languages. Ask us for a detailed proposal on your next medical translation assignment.
 
 

It's always interesting for us to see which of our articles get widely read and distributed. Sometimes, articles that we feel are great get very little attention. Other times, articles with modest expectations get a ton of views and comments. Still other times, older articles get a second life (this happened recently with our look at the differences between the Malaysian and Indonesian languages).

In June, there were some surprises yet again. Here is the list of most-read articles:

1. What's so special about medical device translation? - A look at what makes medical device work different from other types of translations
2. Tips and tricks for Microsoft Word - A plug for Christine Kent's Microsoft Word blog
3. Styles in word processors - joy or pain? - My, how technical writers care about styles!
4. Driving translation workflow efficiencies through measurable quality - ForeignExchange's presentation from memoQfest 2011
5. Translation quality made better by human experience - A guest post by Patricia Walling

Happy reading and happy weekend!


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

It's 2011, and there is an increasing awareness that a number of populations are not getting enough services from health systems in the United States, in Canada, and elsewhere. Patients who do not share the host country's culture and official languages are one of these underserved groups.

It was interesting to come across an article that made the point that cultural miscommunication and differences in attitudes about health care interfere with good health care for these patients as much as language barriers.

Cross-cultural Medicine - A decade later [PDF link] makes the point that health care providers need to be bi-cultural, not just bilingual. Examples given include:

Latino women are often reluctant to reveal personal or private problems if their children are used to interpret.

And how the notion of "informed consent" may be totally foreign:

Latinos feel they should agree with physicians out of politeness and respect, even when they really disagree or do not understand the issues involved.

There are, of course, linguistic challenges that are noted as well:

In most Spanish-speaking countries, canilla means shinbone... except in certain parts of Mexico where the word means wrist."

The good news is that these are all great insights. The bad news: The article is based on speeches given in 1991!

It's now 20+ years later, and we are still talking about how translation is a hot topic in healthcare settings and how patients at risk due to lack of translations.

Has anything really changed?


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

Our recent article on checking inline tags with Word and Excel referred to an interesting post on the Gloc247 blog. Their article Game localization tips: checking inline tags with Word and Excel ended with the following postscript:

If you are using Apsic Xbench you can use this technique in order to create a "tag glossary" for your automated checks. You just need to extract the tags as shown above, put them side by side in Excel, fire up TMBuilder and you're done.

While this method seems to work for the post's author, at ForeignExchange, we use a different methodology for our QA checks.

The ForeignExchange QA team has implemented processes and tools to ensure the quality of our deliverables. Yes, we use The ForeignExchange Apsic Xbench as well. In fact, editors are required to run either Apsic Xbench or QA Distiller on most of project deliverables.

In addition to tags, these tools find many other mechanical errors like missing punctuation, extra spaces, mismatched numbers, inconsistent target translations for the same source segment, and so on.

Additionally, when we translate content with a large number of tags, rather than trying to quality check the content with a series of manual manipulation, we tend to use a more systematic approach. We translate using TagEditor or MemoQ (or other CAT tools) which handle the tags more efficiently and accurately than allowing the linguists direct access within MS Word. Using TagEditor is a preventative measure for tag errors.

In general, ForeignExchange's proprietary quality methodology METRiQ, combined with the tools mentioned above (Apsic, QA Distiller, TagEditor and MemoQ), allows us to address quality upstream and ensures that we provide our pharmaceutical and medical device clients with the translation quality that they expect.

To read more about managing translation quality, take a look at the following articles:

• Do you Poka Yoke?
• Why measure translation quality?
• I say tomato, you say error!

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

Like most businesses, translation is fairly competitive. Translation companies that cannot provide distinguishable value to clients often live and die by "cents per word" pricing.

Across the industry, translation providers (like their customers) are streamlining, looking for efficiencies, and doing more with less. It can be tricky to strike the right balance with this.

The two extremes are relatively easy to identify and address: Don't improve enough and business suffers. "Improve" too much, and you're impacting quality and/or service to clients.

But it's the gray area in the middle that poses a challenge for many companies: When companies start cutting corners (the evil twin of "streamlining"), clients can't always tell. But employees usually can - and that can be just as bad.

A recent article over at Signal vs. Noise drives home this lesson:

You're not just sending out a message externally, you're sending one out internally too. If your employees don't believe it, the whole plan falls apart.

Most of our clients have so many connections and interactions with our company (and our people) that there is simply no way to control all of them. The only way to do so is to create a great culture, where people naturally act in a way that is aligned with the organization's values.

For more about ForeignExchange Translations' culture, take a look at these articles:

• A great team doesn't happen by accident
• Can translators save lives?
• We are everything that they are not

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

We have written before about dialects across the United States and Great Britain.

Evolving English is adding another twist to this. Their Voice Map is deceptively simple: Between November 2010 and April 2011, they asked people all over the world to submit a recording of their voice. Contributors either read a children's story or a list of six words.

The results are fascinating. If you have a few minutes (or hours - this is really addictive) to spend, hop on over to Evolving English's Voice Map and hear how broken English really is the language of the world.

Not ready to be done yet? Take a look here:

• No English? No job!
• Sometimes English is not sexy but stupid
• Can you read this? English is toughest (European) language to read
• It's official: English really is taking over the world!

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