Medical Translation Insight

At ForeignExchange, we are big believers in the importance of quality. We don't (just) pursue quality for its own sake but we use it to drive efficiencies in our business and provide improved value to our clients.

One of the important lessons that we learned is that translation quality does not have to be complex. While many companies are pursuing Six Sigma and lean training, in practice most of what will be needed initially is just a basic knowledge and experience with the 7 Quality Tools, also known as the 7 QC Tools.

Pete Abilla's shmula blog has a good overview of these tools:

1. Scatter Plot: Graphs pairs of numerical data, one variable on each axis, to look for a relationship.
2. Cause and Effect Diagram: (also called Ishikawa or fishbone chart) and Identifies many possible causes for an effect or problem and sorts ideas into useful categories.
3. Pareto Chart: Shows on a bar graph which factors are more significant. It is a sorted Histogram, but focuses on separation in the data.
4. Check Sheet: A structured, prepared form for collecting and analyzing data; a generic tool that can be adapted for a wide variety of purposes.
5. Histogram: The most commonly used graph for showing frequency distributions, or how often each different value in a set of data occurs
6. Control Charts: Graphs used to study how a process changes over time.
7. Flow Chart: Shows a picture of a process in a visual representation – a process map.

He also features this video to provide further insight into how the 7 QC tools are used:


Effective quality control reaches all aspects of an organization and does not require an advanced degree in statistics.

As you might guess, we have lots of related content. Take a look at the quality category or view the following articles:

• Good translations must be expensive
• Is Google Translate accurate enough for professional use?
• Why measure translation quality?

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

ForeignExchange's audio conference production team is busier than ever.

In addition to producing more regulatory, clinical, and translation events, we also added events for energy as well as food and beverage companies. After the first dozen or so events, it looks like there is a lot of pent-up demand for our kind of distance learning.

Here are the most popular audio conferences for last month:

1. MedDEV 2.7.1/3: Best Practices for Clinical Evaluation Reports
2. FDA's 510(k) De Novo Process - Overview and Current Challenges
3. Global Clinical Trials & ISO 14155 Compliance – Are You Ready to Update?
4. The FDA and Social Media
5. Companion Diagnostics - What Pharma Needs to Know About IVDs

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.
 

Every year around this time we like to remind our clients that, along with warmer days, barbecues and white pants, summer is also the season for holidays.

While work continues to hum along as usual at ForeignExchange, many of our medical translation linguists take their vacations during the summer months, which can present scheduling challenges for projects.

As clients are planning translation projects for the coming months, we ask them to please keep in mind the summer vacation factor and give us a heads-up about upcoming work, so we can plan accordingly. With advance notice, we have extra time to line up our teams for projects and things move along without a hitch. Thank you in advance and have a great summer!


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.
 
 

ForeignExchange Translations has over a decade of experience partnering with top drug and device companies as well as industry thought leaders. So we’ve learned a lot about how to gain access to, and stay compliant in, markets around the world. Through our internal expertise and our FX Certified Partner program, we’re now able to offer a variety of educational events for life sciences professionals, from intimate half-day workshops to audio conferences to networking breakfast presentations. The topics of these events go beyond translation, covering the entire product life cycle, from research to manufacturing to regulatory to marketing.

For years, we have offered educational audio conferences through our FX Conferences division. These biweekly distance learning seminars have drawn more than 40,000 attendees to learn about topics ranging from regulatory affairs to human resources to training. We recently introduced a Multilingual Compliance Learning Series, with live networking educational events in California, Minnesota and Pennsylvania. In addition to these offerings, an informal, intimate Learning Unplugged seminar series brings small groups together for hands-on workshops on focused topics such as, “Writing for Translation” and “Medical Device Software Localization.” This summer will see further events in Minneapolis, the U.K. and Boston, with more on tap for the fall as well. Drop us a line at education@fxtrans.com or visit www.fxtrans.com/education.aspx.

Do you think that social networks are only good for sharing what's for dinner, notifying the planet what flavor of coffee's in your cup or looking up old high school friends? It may be time to reassess.

Social media in the pharma space is a dicey subject. Companies really want to do it (that fact has driven the popularity our recent event The FDA and Social Media), but they are unsure of whether or how to proceed. We have previously talked about online communities EsTuDiabetes and Patientslikeme but they are still the exception.

Still, they are serious about getting into clinical research. Here is PatientsLikeMe's Jamie Heywood at TEDMED 2009:



So it was interesting to see Nature Biotechnology [PDF link] publishing the results of an online trial run by PatientsLikeMe. The article describes how PatientsLikeMe assessed the clinical benefit of an unapproved therapy by analyzing the relevant discussions on their web site.

Almost 600 patients suffering from amyotrophic lateral sclerosis (ALS) signed up for the study. After sifting through millions of data points, PatientsLikeMe reported that they found "no effect of lithium on disease progression" - in effect confirming the lack of clinical benefit found through traditional clinical trials.

The idea that social networks could speed up the process of finding new ways of saving and improving lives is really fricking cool. There are some tremendous advantages to using online communities in clinical research, and Pharmalot mentioned three: speed, access to rare patient populations, and availability of control participants.

On the other hand, big questions remain. The Wall Street Journal's Health Blog includes this quote in its coverage:

"The question now is what is the proper way of managing it and feeding it back into traditional science."

Clinical research is a multi-billion-dollar-a-year industry. It's unlikely that established providers and professionals will just sit back and let online communities make inroads into their business. Get ready for some well-fought and interesting fights!

(On a related note, take a look at how social media is impacting industries as diverse as translation, pharmaceuticals, and food and beverages.)


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.
 
 

Last weekend, I attended the International Japanese-English Translator’s Conference, or IJET. Amazingly, 2011 was the 22nd year that this niche organization of linguists has held the conference and they alternate locations annually, between Japan and an English-speaking country. This year, IJET-22 was appropriately held in the Emerald City of Seattle, which has strong Japanese influence, a large expat population and access to fresh fish for very good sushi.

I attended the conference to listen and learn from linguists, who are obviously at the heart of our work. Topics of presentations ranged from the nuances of the Japanese language to simultaneous interpretation to the use of technology. There was an excellent talk given by a longtime Japanese-to-English linguist, Lee Seaman, about the current trends in medical and pharmaceutical translation. Ms. Seaman cited the rise in combination products that deliver drugs via a device and how linguists must be more vigilant in keeping up their knowledge and skills. She also discussed the increasing use of content management systems within client companies that have the dual effect of raising consistency in language but also disembodying content from context.

Another excellent session was a panel discussion about pharmaceutical translations. Panel members included respected linguists who are experts in medical translations, including one practicing physician who does Japanese to English translation on the side. The panel, in cooperation with the Japanese Association of Translators, is writing a reference guide about the Japanese pharmaceutical industry which is intended to serve as a reference guide for translators. The panel's talk went through the intended sections and gave background on the pharmaceutical industry and its unique regulations.

All in all, IJET-22 was an educational and fascinating experience, and gave a window into the world of ForeignExchange’s fourth largest language and the people who translate it.

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

The 22nd installment of the International Japanese English Translation Conference is taking place this weekend. Japanese translators will get together in Seattle on May 14 and 15.

The IJET-22 program is tight, reasonably priced - and interesting. Separate presentations and panel discussions on medical device and pharmaceutical translation promise to be valuable.

Jason Heaton, ForeignExchange's Compliance Specialist, will be in attendance. (Jason is talking about translating for Japanese regulatory submissions at a different event). If you are heading to Seattle for the conference, be sure to say "konichi-wa" to Jason. Hope to see you there!

Looking for a bit more reading on Japan? Here you go:

• "Drug lag" persists in Japan
• Why do device companies treat Japan differently?
• Software localization requirements in Japan

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

After a popular presentation in Pennsylvania, FX Certified Partner Helen Colquhoun (whom we interviewed last week) is taking the show on the road. Or make that, across the pond.

Regulatory affairs professionals in the U.K. will have a chance to hear from Helen about the current state of global regulations as well as what can be expected this year and beyond. On Thursday, June 9th, Helen, who is CEO of Pleiad Devices, will be speaking at an event hosted by ForeignExchange Translations, Inc. It will be held at the Copthorne Hotel in Slough-Windsor from 8:30 until 11:00am.

Ms. Colquhoun's presentation is entitled, "Devices are from Mars, drugs are from Venus, but regulations are down to Earth." It will cover the differences and similarities of global device and drug regulations, approvals in the EU, human factors testing for the FDA as well as the state of regulatory affairs in Japan. Attendees will have an opportunity to ask questions and interact with Ms. Colquhoun and other industry professionals, and leave the workshop with practical tips that they can immediately implement at their own companies.

This event is part of ForeignExchange's continuing Multilingual Compliance Learning Series, following events in Minneapolis, Pennsylvania and Northern California. The event is complimentary so if you will be in the UK in early June, we would love to see you.

More information about the event can be found at:
http://info.fxtrans.com/devices-are-from-mars-drugs-are-from-venus-uk/


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.
 
 

This past weekend, the 15th annual New England Translators Association (NETA) conference was held at the Hancock Conference Center in the Copley Square area of Boston. The event does a great job of combining networking with educational opportunities.

The conference supports new and experienced translators alike. Edwin Genzler gave the keynote address, presenting on "Translation Turn in Higher Education." Some topics were designed to help those new to translation while others, such as sessions dedicated to machine translation and industry-specific translation, presented information relevant to those more experienced in the industry.

ForeignExchange's Sonia Monahan spoke on "Improving End-Translation Quality with Measurement Tools." Her presentation covered approaches to defining quality, integrating automated QA tools into translation and terminology management, and incorporating objective quality metrics into the translation cycle.

Sonia presented to a full room and the topic generated a lively discussion around the handling of rush projects, management of in-country reviews, and how to determine when to integrate automated QA tools into the translation cycle. Not everybody agreed on the specifics but there was common agreement that increased measuring of translation quality benefits linguists and clients alike.

Congratulations to NETA and Tapani Ronni on a great conference!

For more on ForeignExchange approach to measuring translation quality and our proprietary METRiQ methodology, take a look at the following:

• Is translation quality subjective or black/white?
• 5 questions about translation quality
• Quality is dead - long live measurable quality

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

As we mentioned earlier, ForeignExchange's FX Certified Partners are experts who work with us to provide education, consulting and knowledge to complement our offerings to our clients and the life sciences industry.

Today we are featuring an interview with Helen Colquhoun, CEO of FX Certified Partner, Pleiad Devices. Pleiad is a consulting company that provides clinical and regulatory expertise and support to medical device companies. They're based in the Boston area and the UK.

Helen is a frequent speaker on clinical and regulatory topics and recently presented to a large group of professionals at a ForeignExchange-hosted event in the northeastern U.S. She is also a popular audio conference speaker for our educational arm, FxConferences.com. Helen will be conducting another audio conference on the timely topic of ISO 14155 on June 16th.

We sat down with Helen recently to talk about her company's work, the changing landscape of clinical trials, and how translation fits into the mix.



For other video interviews, take a look at:

• What is Lean and what does it have to do with translations? with Woody Brown of Synthes
• 5 questions about translation quality with Sonia Monahan of ForeignExchange
• Air traffic control with Meg Muller of Ortho-Clinical Diagnostics

ForeignExchange Translations provides specialized medical translation services to pharmaceutical, biotechnology, and medical device companies.

At ForeignExchange, we have some pretty lofty aspirations. Our company vision statement pushes us to, among other things, provide clients with:

• Zero defects in project deliverables
• A 50% reduction in project turnaround time and costs
• Project teams comprised of the very best medical translation professionals

These items tend to raise questions from outsiders: "How do you expect to accomplish this?"

The ForeignExchange team puts tremendous efforts into all of these areas. Yesterday I was reminded yet again of this effort and of the tremendous progress we are making to make our "postcard from the future" become reality. The reminder came in the form of a status update from Maria Hopfgarten, who is overseeing our onboarding program for new hires.

Here is what Maria said in her quarterly update:

Quick summary:

• We trained 13 new employees (some actually started in December, but training happened in January) in Q1.
• We executed 129 training sessions.
• Our new hires "strongly agree" and "somewhat agree" that the training leaders were knowledgeable about the topic, offered helpful tips for their new jobs, and felt that the training offered them tools to better understand FXT and the business they are working in. 100% Strongly Agree that the training leaders were knowledgeable about their topic!
• 71% rated the overall on-boarding training program as Very Valuable, 29% as Valuable.
• Our managers "strongly agree" and "somewhat agree" that their hires got up to speed and started to be productive within the expected time frame and acquired the necessary skill set to perform in their job.
• Our new hires get up to speed on average after 2-3 months on the job. If they have previously been a long-term contractor with us, it only takes them 1-2 weeks to be fully up-to-speed.

Areas for improvements:

• Coordinate all job-specific training in addition to the general on-boarding training. I started doing that in February, but didn't do it for all Ops hires in January.
• Try to do training on-site in Colorado where possible.
• Space out training sessions that might be less important to the job.
• Stress the importance of reading process documents in DMS rather than "only" relying on the information in the training sessions.

Pretty great stuff. But the proof is in the pudding, and it is the feedback from trainees that confirms that we're on the right track. Here are two representative comments from new team members after the training:

Best training I have had--at any company. Bar none.

This was one of the most thorough onboardings I have experienced with a company. Even though I had L10N background, getting to learn about ForeignExchange from the ground up was very much appreciated and insightful.

So, how does ForeignExchange build "teams comprised of the very best medical translation professionals"?

By continually staying focused on hiring the right people, training them well, providing a flexible and challenging environment, and giving team members opportunities for advancement - professionally, financially, and personally.


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.
 
 

Translate, edit, proofread. This trilogy of steps is familiar to most, an anachronism to some, and misunderstood by many.

While translation is fairly obvious – the conversion of one language to another – and proofreading is something we all do (hopefully) when we write our reports and emails, editing is often a mystery. Yet it may well make the difference in readability, style, and quality in translated documents.

So, what is editing and why is it so important? One of our own editors has prepared a white paper that talks about this all-important step. Download it from our web site.

After reading our white paper, take a look at these related articles:

• Why measure translation quality?
• Is quality expensive or cheap - or both?
• 90% of in-country reviews are a waste of time

ForeignExchange pioneered Multilingual Compliance while working with pharmaceutical and medical device companies. It's based on the proposition that quality does not exist without rigorous systems—systems that are not merely effective, but are documented, measurable and auditable.

A couple of months ago, we established our second European office in Cambridge, England. The new location will allow ForeignExchange's team to better serve drug and device clients in the UK and across Europe, and we will be able to tap into the Cambridge Phenomenon.

To help manage our growth in Europe, we are currently hiring highly motivated team members in the following areas:

>> Document Localization Lead
Coordinate multilingual desktop publishing projects across internal and external resources. Interact with suppliers and clients to develop DTP specifications.

>> Resource Coordinator
Recruit and test linguistic and technical suppliers. Provide project resources to PMs.

>> Linguistic Lead
Set the linguistic strategy for assigned clients and projects, act as translator point of contact, and perform linguistic analysis and QA tasks.

>> Project Manager
Overall responsibility for project quality, costs, and schedule. Interface with sales, clients, linguistic, engineering and DTP team members.

>> Account Manager
Manage relationships with assigned client accounts, develop account growth strategies, and provide input to pre-sales planning, resourcing, and quoting.

If you know anybody who is looking for a career challenge, please point them our way. ForeignExchange offers one of the best teams in the industry plus:

• competitive base salary;
• incentive-driven compensation;
• attractive benefits;
• a professional, high-energy work environment;
• an anything-goes dress code;
• a strong voice in building our successful company!

Motivated individuals who are ready to make a difference can email a compelling cover letter and CV/resume to us at co-careers ~at~ fxtrans dot com.


ForeignExchange Translations is the leader in medical translation. We provide specialized medical translations for regulatory, marketing, and clinical groups at pharma and medical device companies.
 
 

Recently, Adam Asnes of Lingoport invited ForeignExchange's Andres Heuberger to sit down for a cup of coffee and discuss how medical device firms can expect to see return on investment from internationalizing their software.

Not quite a fireside chat, but the conversation does highlight that the medical device field is one of the last areas to be internationalized due to liability issues.



For more information about internationalization and our friends at Lingoport, take a look at the following:

• Primer: Software internationalization in action
• Internationalizing and localizing medical device software
• ROI for software internationalization

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