Medical Translation Insight

OK, so I may be just a bit geeky when it comes to fonts. But really, who doesn't love typography movies, books, and even periodic table?

So when I read about a new game built around kerning, it probably comes as no surprise that I immediately went to check it out.

Kern Type lets you drag or nudge letters into their properly proportioned places and then rates your performance against typographic professionals. If you're one of the typophiles who put Just My Type on the best-seller list, you'll get more pleasure from this game than from all the slavering hordes that Hell and outer space can throw at you.

I scored 85% on my first try. Go ahead and embarrass me with your scores in the comments!


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Our recent article on understanding translation memories and how they work once again raised the question of who owns a translation memory (TM) database.

In the translation industry, misinformation and urban myths surround the topic of TM ownership. One point of view holds that the database is a result of work contracted for and paid for by the client, so the client has a right to receive the memory files once the project is complete. The opposing view point is that without the creative work of the translator, the TM files would not exist at all.

And it's not just in theory that these questions come up. We regularly encounter this question when starting to work with new clients. In a surprising number of cases, new clients tell us that they don't have/own their old TMs.

The question is important enough that SDL stated their position on Copyright protection for Translation Memories [PDF link]. The upshot: If you care about who owns the TM, make sure you have an agreement.

Still confused? Ross Smith collected a great list of resources on intellectual property, copyright, and translation tools.

To resolve the question of TM ownership, at ForeignExchange we incorporate this in all of our agreements with clients and subcontractors. Everybody involved in medical translation - client, translation company, individual linguist - should review these resources and formulate their own policies and legal framework so that they can answer the question "who owns the TM" once and for all.

Before you go, here are some additional resources around TMs and intellectual property:

• When TMs jump the shark
• Trademarks and translation
• Primer: Translation memory vs. glossary
• 100% text repetitions: To review or not to review

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Global marketing and advertising are ripe with with missteps and embarrassments.

Medical translation professionals deal with a unique challenge: How to adapt branding, imaging and marketing to local markets but stay "within the lines" or regulatory compliance? While some medical device and pharmaceutical companies take the route of providing translated content from headquarters, more and more drug and device companies assign responsibility to national or regional offices.

A recent article in The Wall Street Journal lends more credibility to this second approach. Drug Firms Up Ante in Japan talks about Western drug companies' efforts to increase sales in Japan.

As this graphic from the WSJ article shows marketing spend has jumped in support of these efforts:



And in trying to gain a larger market share, pharmaceutical companies are realizing that their marketing messages must be localized. Simply adding sales reps isn't enough - firms need to tailor their marketing to the uniqueness of the market.

This increased awareness will affect how companies translate (or write in local languages) their marketing collateral. While the WSJ article describes the changing situation in Japan, it's safe to expect a similar shift in other markets that are becoming more competitive.


Find out more about ForeignExchange's specialized Japanese translation services for medical device and pharmaceutical companies.
 

As we have seen before, human factors engineering (HFE) and usability testing is a hot topic these days.

FDA's draft HFE usability guidance was issued a few months ago and drew lots of commentary from industry. While there is not yet any target date for a final guidance to be issued, industry is already preparing for the inevitable: human factor engineering and usability testing will be critical to meet FDA's requirements.

To help medical device companies navigate this transition, we have teamed up once more with Maria Shepherd of Data Decision Group. A few days ago, Maria led a two-hour discussion in Minneapolis around the topic of HFE.

Attendees from Boston Scientific, Incisive, Medrad, Medtronic, Patterson, Smiths, and Teleflex shared war stories, challenges, and experiences navigating FDA's changing rules. Maria shared insights into guidance documents, standards (such as HE 75 and ISO/IEC 62366), as well as best practices, including how to turn HFE usability into a systemic process (click on image for larger version).



If you couldn't make it to Minneapolis, you can still benefit from Maria's expertise. She has produced two events on HFE. HFE 101: New FDA Draft Guidance on Human Factors Engineering and Usability Testing is intended for audiences that are just getting started with HFE and usability testing. Advanced Human Factors Engineering is useful for professionals who already understand HFE and are looking for more in-depth information.


ForeignExchange translates IFUs, software UIs, and training programs for medical device companies. For specialized medical translation services, contact us today!
 

To many people, translation memory (TM) is misunderstood - a black box that magically translates sentences into any language. Our medical device and pharmaceutical clients sometimes confuse TM with MT (machine translation) and assume that there is little or no human involvement in its use.

Of course, these are myths and the reality is, a TM is just a tool that aids medical translation professionals in their work. Like any tool, if it not maintained or used properly, it will not work properly. But in capable hands, and as part of a robust process, TMs help lower costs, save time and increase consistency, which makes everyone happy.

To help you better understand translation memories and how they work, ForeignExchange's own Rocío Abelleira put together the following instructional video:



For more of ForeignExchange's videos, check out our YouTube channel at
http://www.youtube.com/user/FETranslations#p/u

Imagine you just received the Chinese and Japanese translation of your manual, and are unable to decipher anything; even the numbers or measurements don't look familiar anymore. 10,000 kW now appears as "1 something", and your company is introduced as being founded in "35 something" rather than 1960. How could that be possible, let alone correct? Do you have any way to cross-check this?

An article in tcworld deals with these very questions. Dealing with numerals and measurements in Chinese and Japanese texts provides a good synopsis of the numerical system and the different measurements in Chinese and Japanese.

It's fascinating to note how different languages and cultures deal with numbers. And it's not just that the Arabic numerical system isn't as universal as one might think.

But even when using Arabic numbers, there are cultural differences to be taken into consideration. I struggle with this every time I travel between the U.S. and Europe; what is the meaning of "floor 1" in an elevator? Is it the ground floor or the first floor up?

But things can get even more confusing as the following example shows:



Taken from Wikipedia's entry on tetraphobia, this picture from an elevator in an apartment building in Shanghai shows that thre are no floors 4, 13, and 14 are missing - and that there is a "negative first" floor.

The tcworld article does a nice job explaining the differences in numerical systems and gives lots of examples around ordinal numbers, calendar dates, measurements, and how to use numbers within text. Highly recommended reading for any device or pharma professional dealing with Chinese or Japanese languages.

We have written extensively about Japan and China. Here is a sampling:

• Identifying written Cantonese
• "Drug lag" persists in Japan
• What does a Chinese keyboard look like?
• Why do companies treat Japan differently?

ForeignExchange Translations provides specialized medical translations for regulatory submissions, marketing campaigns, and clinical research studies - in Japanese and Chinese and dozens of other languages.

The Life Sciences Roundtable in Santa Clara was a resounding success with more attendees than ever before as well as an excellent ratio of client/LSP participation.

What made this roundtable particularly interesting what that the presentation ranged a number of topics that really explored all aspects of the medical translation arena. For instance, Jason Arnsparger from ForeignExchange co-presented with Jennifer Smiley from CaridianBCT on best practices for content management system (CMS) and translation management system (TMS) implementations.

The presentation was called "10 1/2 Tips for a Successful CMS Implementation", and included lessons learned from the CMS/TMS implementation at CaridianBCT, as well as ForeignExchange's experiences with their clients. The presentation started by emphasizing the importance of developing a solid underlying process, identifying pain points and assessing if a CMS/TMS is the right solution.

Jason and Jennifer went on to cover topics such as building a business case, process mapping, tool selection, system configuration, user adoption, ROI, and the importance of thinking global when making key decisions. The presentation was received very well by the audience and led to a lively discussion. Attendees were able to leave the roundtable with practical and concrete information to support them if and when they choose to go down the CMS/TMS path.

The one and a half days of roundtable were concluded once again with a commitment from all parties to continue the dialogue during these roundtables and possibly via a forum, so that as a group we can all participate in streamlining the work and making better products for our respective clients. In the end everyone agreed, no matter what topics they had come to discuss, quality is the key in medical translation and all of us are taking the responsibility seriously.


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The lines between consumer electronics and medical devices are blurring.

We have in the past written about medical applications of the Nintendo DS, Xbox 360, Wii Balance Board, and iPhone. Over the past couple of months, this trend continued and even accelerated.

For one, FDA now regularly reviews and clears medical iPhone and iPad. The New York Times has a good piece about Mobile MIM, an app that allows physicians to examine scans and make diagnoses based on magnetic resonance imaging, computed tomography, and other technologies if they're away from their workstations.

(There is even an entire web site dedicated to medical apps. iMedicalApps features "reviews and commentary by medical professionals".)

For another, the medical device sector has gotten a new, odd bedfellow. Sony announced that it has acquired Micronics and plans to enter the market for portable medical testing.

At a glance, this may surprise folks who use Sony Blu-ray discs or Playstations. What do these have in common with diagnostic devices? Well, as it turns out, more than one might think.

MedGadget explains that assay cartridges related to Micronics' microfluidic technology technology are

"...fabricated using micro-scale and nano-scale etching technology, in much the same way that data is etched onto Blu-ray or other optical storage discs. It is likely that Sony sees an opportunity to translate some of its optical disc technology and manufacturing know how into the microfluidics field."

Also, given that this is not Sony's first foray into the life science field, I am anxiously awaiting news of any Sony Stethoscope Walkman that may be coming to market.


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

Sure, the Quality Review of Documents (QRD) templates may be imperfect - but they are getting better.

Case in point: Over the past few months, we have seen a couple of updates to the templates. At the end of August, the templates relating to mutual-recognition, decentralised and referral procedures were updated. A few days ago, further updates to all templates in all 24 languages were published.

Head on over to the EMA web site for the latest information and templates.

[Hat tip to Catherine Guilliaumet and Renate Cisne]

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

• QRD compliance just got easier thanks to QRDetect
• QRD templates are imperfect, getting better
• Requirements for readability testing of PILs

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

We support ForeignExchange's medical translation clients with specialized educational programs. And as we do every month, here is a look back at our top webinars and audio conferences from the previous month.

In September, we saw tremendous interest in our medical device topics. A lot of significant developments are underway in regulatory affairs, engineering, and clinical research - and that was reflected in our events and the attendees that they drew.

Here is the list of top events for September:

1. Complying with EU Requirements for Medical Device Software
2. HFE 101: New FDA Draft Guidance on Human Factors Engineering and Usability Testing (for more on this topic, take a look at our in-person event First, Do No Harm: Basics of Human Factors Engineering and Usability Testing in Minneapolis next week)
3. Clinical Evaluation of Medical Devices in the EU
4. Avoiding FDA 483s, Warning Letters and Recalls with Harmonized Supplier Qualification
5. CLIA Waiver Submissions – Common Mistakes, Recent Trends and FDA's Plans for the Future

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.
 

For device and drug companies, translation is an integral part of filing, enforcing, and litigating intellectual property (IP). And the stakes are high - translations can cause significant problems with overseas filings, leave domestic patents open to challenge, and undermine litigation strategies. Despite this, few IP groups have policies in place to mitigate translation risks.

Intellectual Property Today recently featured a good article on how to manage the risks associated with patent translation. Managing Patent Translation Risks looks at different risks for different types of IP.

When translating prior art "the most significant risk is that of being mislead". And when a translation appears acceptable but is, in fact, of poor quality can cause problems years later, for example when a better translation is being produced during litigation.

When translating for overseas filing, the concern is that a poor translation won't "stand up in prosecution, much less enforcement".

If you are involved in IP translations, take a look at the IP Today article. You may also want to take a look the following resources:

• Patent translations - inherently risky?
• Global Patent Standards
• Supply and Demand Analysis of Patent Translation

ForeignExchange translates patents and other IP for medical device and pharmaceutical companies into 40+ languages. Ask us for a detailed proposal on your next medical translation project.

International Translation Day took place on the last day of September. While many in our industry rightly view the day as a celebration and recognition of our profession, the public at large or even buyers of translation services are unaware that such a day exists.

It's fascinating to me just how many such "holidays" and celebrations exists. According to Wikipedia, October is Clergy Appreciation Month (in the U.S. only) and Dwarfism Awareness Month (apparently worldwide).

But before we go crazy in our celebration of National Dental Hygiene Month, let's take a look back and review what made September a great month at Medical Translation Insight:

1. The sign says what? - Apparently, I wasn't the only one thinking these Australian signs were funny
2. A conversation about ISO 14155: Are companies struggling to comply? - In a word, yes
3. The human factor - Our interview with HFE expert Maria Shepherd made it on top of our list for a second month in a row
4. Using style guides to improve quality - Medical translation professionals and clients alike are interested in how to get more from style guides
5. Language issues lead to pharma quality problems - "We believe the quality differences ... were driven by ... differences in language"

Happy reading and happy weekend!


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Every day, another international labeling project is set up - with the highest risk right at the end of the project. The good news is that this risk can be managed.

In a new article in RAPS Focus entitled Perils of Translation Quality Validation in International Labeling Sonia Monahan, ForeignExchange's Executive Vice President of Quality, discusses our proven approach to risk management and measurable translation quality.

Sonia is also presenting an audio conference on the related topic of in-country review and how drug and device companies can eliminate it without sacrificing translation quality. Don't miss it!


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.
 
 

One of ForeignExchange's clients, a 12 billion dollar musculoskeletal health leader, has exacting requirements for subject matter expertise and writing style. Their project work is ongoing and demands consistency in translation to avoid confusion and damage to brand but has very aggressive timelines due to product release deadlines.

There was a strong need for lower costs without a sacrifice to quality. Through the establishment of long-term linguistic teams and support materials, we were able to save money while increasing quality and consistency in the translations.

ForeignExchange developed three separate linguist screening tests for the differing needs of each client group – Orthopedic, Dental, and Corporate Communications. These tests are given in addition to our Compliance Translation Certification with the following criteria:

• Orthopedic -- experience translating material for implantable medical devices for joint replacement. ForeignExchange created teams of three to four linguists per language pair to meet tight timelines and account for schedule conflicts. Our client selected the linguists with preferred style from those who had passed the technical test.
• Dental implant -- criteria for this group were still more selective. All members of the team must reside in the country of the target audience and possess a medical degree such as M.D., D.M.D., D.D.S., R.N.
• Corporate communications -- writing style is most important for this group. For effective translation of marketing literature, the core concept of the original must be maintained, but read as though it were crafted in the target language. Marketing writing contains more wordplay and cultural concepts, which are challenging to translate.

An expectation of consistent long-term work allowed ForeignExchange to set preferred pricing terms and turnaround times were reduced because time was not lost assigning linguists on a per project basis. Additionally, long-term teams do not need to be trained on the client style guide repeatedly.

Our client's in-country review teams have been pleased with translations, both in terms of technical accuracy and style. Redundancy in the teams ensures that tight timeframes are met.

Long-term teams of linguists provide greater consistency to translation, reducing the risk of reader confusion and strengthening our client's brand. Cost savings have been demonstrated in quarterly and annual business review meetings, which keep our client's financial auditors happy.


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

Next week, it's time for this year's U.S. edition of Localization World. Taking place in Silicon Valley from October 10 to 12, the conference provides a terrific opportunity to learn, share, and network.

At ForeignExchange, we are particularly excited about the part of the event that speaks to our medical translation focus: the Life Sciences Roundtable.

As in Barcelona earlier this year, the Roundtable has been expanded to 1 1/2 days in length. It starts in the afternoon of October 9th, 2012 and continues through the end of the day on October 10th.

This roundtable agenda is particularly interesting, focusing on topics around innovation, streamlining ("doing more with less"), and regulations. Speakers come from a cross-section of industry, including St. Jude Medical and NeuroPace. ForeignExchange' own Sandra La Brasca and Jason Arnsparger will both be in attendance, so come and say 'hi' in Santa Clara!


For expert medical translations of regulatory, clinical, and marketing content in 40+ languages, request a detailed proposal from ForeignExchange Translations.