Internationalizing and localizing medical device software
2 comments Written by ForeignExchange Translations on Tuesday, November 30, 2010
Internationalization and localization for medical technology products tends to have special business drivers and can take on life-and-death importance. First, there's adapting products for better worldwide sales, then there are issues like reducing liabilities and saving lives. Together, they present unique challenge when localizing medical device software applications.
On Thursday, December 16th, 2010, Adam Asnes, CEO of Lingoport, and yours truly will host an interactive session to discuss basic principles and processes that make medical device localization different. Join us for the one-hour session - registration is now open. I look forward to having you on the call!
And while you are still here, why not take a look at some related articles?
- Developing software for global device markets
- Reduce localization costs? Focus on quality!
- ROI for software internationalization
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.
Categories: education, medical devices, software localization
Lessons learned from a clinical study gone bad
1 comments Written by ForeignExchange Translations on Monday, November 29, 2010
Today's news that J&J must pay $130 million to Basilea for botching a pair of clinical trials is a good reminder of the business risks involved in clinical translation work.
Five years ago, Johnson & Johnson and Basilea signed a licensing deal for an anti-MRSA antibiotic that Basilea had been developing. Together with ICON Clinical Research, J&J then attempted to run clinical trials. I say "attempted" because both ICON and J&J had their knuckles rapped by FDA in the form of separate warning letters (if you are interested, here is the J&J warning letter and here is the ICON warning letter).
The warning letters listed lots and lots of GCP issues. For instance, FDA said that J&J violated the protocols of its own study, by failing to ensure that patients were storing the drug properly when using it at home, not documenting some doses given to patients, not conducting thorough examinations of all patients, enrolling patients who should not have been eligible for the study, and hiring unqualified investigators.
So now that J&J has to pay Basilea, J&J is likely to want to pass the buck. ICON could be forced to compensate J&J. Others could be dragged into the fight as well.
It's easy to see how medical translation providers could get involved in these kinds of situations as well. FDA's warning letter to J&J specifically mentions translations a couple of times:
"Based on the source documents for Subject #140107, and translations of those documents that you provided..."And:
"This study monitor also recommended that this site not be used because the site declined use of Spanish Informed Consent Forms when demographics of the region indicated a large population with native and preferred language of Spanish."Translations aren't at issue in this dispute but they certainly could be. At ForeignExchange, we maintain ample professional liability ("E&O") insurance but it would be an unhappy morning when a regulatory agency or global pharma company calls and says "We seem to have a little issue with one of your translations..."
(As an aside, to be properly prepared when FDA comes calling for a GCP audit, be sure to attend our audio conference Preparing for FDA GCP Inspections – Essentials for Sponsors and Clinical Sites.)
Find out more about ForeignExchange's specialized medical translation services for international clinical trials.
Categories: clinical research
Want to play doctor?
0 comments Written by ForeignExchange Translations on Friday, November 26, 2010
Hello, my name is Doctor Smith. Where does it hurt?
If you have always dreamed of being a doctor but can't find the motivation to pore over long, complicated medical case studies, you can now test your skills on your nearest iPhone or iPad.
A new game, Prognosis : Your Diagnosis [sic], is a fun attempt at bringing clinical case studies to an iOS device near you. Though it's not clear how accurate and educational the game really is, the interface and goofy screen shots certainly provide the foundation on which to deliver great fun.
According to the app's web site, new cases are added weekly, and users can share their own "interesting cases" and get full credits for them.
The game is available free of charge at iTunes. No word on plans to port the game to Android - nor on the release time line for Eat to Beat, the company's "Diabetes, Blood Pressure and Cholesterol game".
[Hat tip to Medgadget]
For more smartphone-related news, take a look at the following articles:
- Translation moves to smartphones
- Localizing Android applications
- When cell phones become medical devices
ForeignExchange's METRiQ quality system provides medical device and pharmaceutical companies with measurable, known software localization quality. To learn more, contact ForeignExchange Translations.
Categories: off topic
Happy Thanksgiving - and don't kill anybody with your turkey
0 comments Written by ForeignExchange Translations on Thursday, November 25, 2010
It's the time of year when we spend time with family and friends, give thanks for the riches in our lives - and ignore holiday food safety alerts.
Food safety is a big albeit under-communicated concern. Big enough, in fact, for both the CDC and FDA to take it on. The FDA Law Blog reports on the topic of foodborne illness and mentions that the
"statistics of 5,000 deaths and 325,000 hospitalizations are widely cited in the press, in blogs maintained by personal injury lawyers, in government reports, and even in food safety legislation pending in Congress"On it's Holiday Food Safety web page, FDA features a Holiday Food Safety Video - in English and Spanish. (As an aside, notice that the Spanish video is 35% longer than the English one; text expansion in action!)
So regardless of what you are cooking over Thanksgiving, have a happy and safe holiday!
[We are thankful for the FDA Law Blog]
For expert medical translation services, ask about ForeignExchange's specialized services for medical device and pharmaceutical companies.
Categories: USA
Stem cell research continues, moral or not
1 comments Written by ForeignExchange Translations on Wednesday, November 24, 2010
Over the past week, a couple of new clinical trials involving stem cells were announced. StemCells has filed for Swiss regulatory approval for the first clinical trial of its nerve stem cells in patients with spinal cord injuries as much as a year old and ReNeuron announced that the first patient has been treated with a stem cell therapy for stroke in a U.K. trial.
Ever since researchers first reported that they had isolated human embryonic stem cells in 1998, stem cell research has been the subject of lots and lots of controversy. Much of the disagreements center on the fact that the embryonic stem cells come from, well, embryos. Pro-life and religious groups argue that an embryo represents a human life and that embryonic stem cell work is equivalent to murdering human lives.
For medical translation providers, working on these kinds of assignments raises important questions about the value of the research, ones job, and life in general. Should we pursue stem cell research just because we can? If I translate documents from a stem cell clinical trial, am I participating in the taking of human life?
As the responses to our recent survey Refusing translations on ethical, moral, political, or religious grounds? highlighted, the answers are deeply personal.
And as these clinical research announcements show, the research into and using stem cells (embryonic and otherwise) continues.
[Thanks, Justin, for the tip!]
Are you on Twitter? Follow ForeignExchange at @fxtrans.
Categories: clinical research
California priorities don't include translated prescription labels
0 comments Written by ForeignExchange Translations on Monday, November 22, 2010
Policymakers and healthcare advocates have grappled with the challenge of providing useful labeling of prescription drugs to non-English-speakers in the U.S. With a large immigrant population and a medication errors being a growing concern for FDA, accurate translations of drug labels are correctly viewed as being critical.
And some progress has been made: Since 2009, for instance, New York City pharmacy chains have offered translated medicine labels to customers.
However, efforts to legislate similar services elsewhere have run into trouble. In California, SB 1390 would have established meaningful patient-centered prescription labeling by requiring pharmacies to provide labels in a readable and understandable format, including at least 12-point font and in the patient's primary language. The bill also would have required pharmacies to provide interpreter services.
The bill didn't find widespread support (it's main sponsor was the California Pan-Ethnic Health Network). After an earlier version of the bill was "gutted" by the Board of Pharmacy, the bill failed in Assembly Business and Professions Committee and died for good.
While the pharmacy lobby may applaud this turn of events, healthcare advocates across the land are deeply troubled. "As California goes, so goes the nation", as the old saying goes.
Interestingly enough, medical translation providers are also disappointed. One article discussing the debate in California referred to SB 1390 as an "unprecedented opportunity for those who provide translation services". Who knows, maybe we can apply for a bailout from the California legislature?
Here are three other articles that we have written about translating prescription labels:
- 50% of translated Spanish medicine labels have errors - yikes!
- Three videos to show that the topic of multilingual healthcare is getting much broader attention
- Pharmacists believe that they are damned if you do, damned if you don't provide language assistance services
For expert medical translations of regulatory, clinical, and marketing content in 40 languages - including Spanish - request a detailed proposal from ForeignExchange Translations.
Categories: healthcare, USA
e-labeling medical devices in Europe - will it ever happen?
1 comments Written by ForeignExchange Translations on Monday, November 22, 2010
We have asked this before but it bears repeating: When will e-labeling become reality for devices?
And we are not the only ones asking.
Manufacturers of general medical devices have long cast envious glances at their colleagues in the IVD space. While there are challenges with providing labeling alternatives, the cost and time savings more than make up for these difficulties.
As far as general medical devices go, Medtronic has long been a proponent of e-labeling. A few years ago, the company was part of a European pilot. As reported in MDDI, the pilot found that a surprisingly large number of doctors are receptive to CD-ROM manuals. Of the 637 implanting physicians in 11 EU countries who participated in the survey, 35% said they preferred CD manuals for implants (namely, pacemakers and defibrillators) to paper manuals and 28% regarded them as equivalent and did not mind which was provided. Just 4% of doctors surveyed would not accept CDs and required paper manuals. There were no significant differences between countries.
One of the leading experts on European medical device labeling is Joachim Wilke, Medtronic's Director of Regulatory Affairs & Policy in Europe and the chair of Eucomed's Alternative Labeling Task Force. We are excited to have him hosting an audio conference on the status of the upcoming legislation on e-labeling for medical devices in the European Union.
Based on the most recent available EU Commission draft, it covers the scope of medical devices being considered for e-labeling, as well as general requirements and envisaged provisions for risk assessment, user information and Notified Body surveillance. The presentation will review topics still under discussion and provide information about the political process and expected time scenario – as well as factors which could lead to potential delays.
If your work involves European labeling, regulatory affairs, or risk management, you don't want to miss this presentation! To register, visit FXConferences.com.
ForeignExchange Translations provides specialized medical translations for medical device IFUs, operating manuals, and product labels.
Categories: europe, labeling, medical devices
Finally, an alternative to the metric system!
0 comments Written by ForeignExchange Translations on Friday, November 19, 2010
Sure, everybody is talking about how great Wolfram Alpha is. And sure, it's neat to fit a polynominal to given data, translate a DNA base sequence and find occurrences in the human genome, or even get the color swatch from hue, saturation and lightness input but really, how is all that scientific mumbo-jumbo helpful?
Luckily, there is an alternative for the real world - the Weird Converter!
Using the known measurements of unusual objects like the length of the world's longest snake, the weight of a Blue Whale, and the volume of the average human stomach, Weird Converter answers life's really tough questions, like:
How many Jennifer Anistons in 1 elephant?Or:
How many bathtubs in an average human stomach?So, go ahead and let out your inner geek and throw some tough questions at the insanely awesome Weird Converter!
[Tip of the hat to Woot]
Speaking of inner geek - be sure to take a look at the these other über-geeky tools and sits:
- Periodic table of typefaces
- Binary translator for communicating with your CPU, friends
- Eye charts from around the globe
Stay in touch with ForeignExchange on Facebook, Twitter, YouTube, and LinkedIn.
Categories: off topic
Redwood City group learns about world-class translation management
0 comments Written by ForeignExchange Translations on Thursday, November 18, 2010
Yesterday morning, ForeignExchange hosted the latest event in its Multilingual Compliance Learning series. The successful half-day event was held in Redwood City, California, and featured, Richard Korn, a 15-year translation veteran and Senior Manager, Localization & Packaging Development at St. Jude Medical.
Richard focused on the importance of planning the entire cycle (i.e., upstream, long before translation hits) with the translation supplier to determine processes and workflows that are effective for an individual organization's needs. Although the norm is to focus on content, then workflow. Richard has found it more beneficial for St. Jude to reverse this and focus first on workflow and then on content.
He also suggested that, when possible, it is helpful to conduct ROI analysis for translation, thus obtaining support from higher management. This support means budget, support/staffing, and so on.
Richard discussed quality and the importance of working with subject matter experts. He also stressed the importance of measuring quality and using technology where it is effective. He suggested incremental (managed) changes in tools/technologies like CMS to save costs and improve efficiencies but he really stressed that this needs to be well planned and not a passionate decision based on the promises/sizzle the software rep sells you on. He noted the importance of MSAs, and gaining detailed information from suppliers to best determine who is giving you what... and what exactly is being paid for.
There were many well recognized companies represented -- Novartis, Gilead, Animas, Roche, Genentech, and Abbott Vascular, just to name a few. The attendees engaged with Richard and questions seemed to focus on ways to improve in-country reviews. One interesting nugget of advice that Richard gave is to include translation review in the job description of those doing the review. While it sounds overly simplistic, he said it has a surprisingly positive effect.
Thanks to Richard Korn for his terrific presentation and to all participants for making it an interactive and productive event.
For a detailed proposal on your next clinical, regulatory, or marketing medical translation assignment, contact ForeignExchange Translations.
Categories: education
Can translators save lives?
4 comments Written by ForeignExchange Translations on Wednesday, November 17, 2010Our answer is an emphatic YES.
In fact, our entire company is built around this concept. Our vision statement reads:
ForeignExchange Translations Saves Lives.
We do so by reducing time-to-market for our drug and device clients, and by ensuring that end users have access to accurately translated product information.
We are committed to being the acknowledged leader in medical translations and to maintaining an uncompromising culture of quality.
We will continually strive to 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
I get asked frequently about this though: "How does a translation company save lives?"
Everybody at ForeignExchange views their work in a way that directly impacts the lives of patients around the world.
If we are late with a deliverable, a regulatory deadline may be missed and a live-saving device or drug not be available to patients. If we make a mistake in a translation, a patient could die. Conversely, if we are accurate and speedy in our work, patients lives get improved through the availability of improved devices and therapies.
Sure, at a baseline we are translators and sure, like workers everywhere, all of us still have to deal with the minutiae and frustrations of our jobs. But our vision statement makes sure we don't forget that we are part of something bigger and something much more important.
We take that responsibility seriously, and we cherish the opportunity to save lives.
There are thousands of translation suppliers to select from. Why do medical device and pharmaceutical companies rely on ForeignExchange? Ask us for the opportunity to speak with our clients and find out!
Categories: business
Is quality expensive or cheap - or both?
1 comments Written by ForeignExchange Translations on Tuesday, November 16, 2010
The answer, of course, is: it depends.
It depends on whom you ask. It depends on whether it is a rhetorical question or a quest for quantifiable numbers. And it depends on the timing of the question.
A couple of years ago, Renato Beninatto made a splash in the translation industry by proclaiming that quality doesn't matter. While not intended to be taken literally, his point that "quality, from a sales perspective, and the way it is talked about in the translation industry, is totally irrelevant, it doesn't mean anything" is right-on.
Contrast that with quality expectations held by typical medical device clients. When we asked the client panelists during our company meeting about translation quality, they all stressed its importance - yet all struggled to define translation quality.
We all think that we can spot the absence of quality. "Did a machine translate this?" is an oft-heard complaint. And who hasn't shared a laugh about the supposed Chevy-Nova-in-Latin-America fairy tale?
But how do you define and put a price on the existence of quality? That's much harder to do.
Different clients and medical translation providers have taken different approaches to this: SLAs, KPIs, metrics, performance penalties, client satisfaction surveys, E&O insurance, and quality certifications are just a few ways in which medical translators aim to increase the perceived quality of their language services.
But it's all in the realm of "perceptions". Danilo Nogueira's great article Translation Economics 101 discusses perceived quality vs. fair prices. One big take-away from Danilo's article is the elasticity of pricing due to timing: If a translation provider is not busy, they might provide the same level of service and quality at a lower cost.
Medical device and pharmaceutical companies' views of translation quality and pricing also differ around timing. During an RFP, quality is "assumed" and "a given". But when things go wrong at an operational level, quality all of a sudden is "worth paying for".
And things really can go wrong. As we noted the other day, translation mistakes can lead to product recalls and improper surgical procedures. It is scary to look at the human and financial costs of language mistakes.
For medical translation providers, then, the challenge is to make translation quality objective enough so that drug and device clients can decide how much quality to pay for. It's not enough to talk about streamlining (or automating) service-delivery processes. Unless the impact on final quality can be measured and assessed, the real price of translation quality remains unknown.
[Tip of the hat to Terena Bell for pointing out Economics Of Language Services In Healthcare]
For expert medical translations of regulatory, clinical, and marketing content in 40+ languages, request a detailed proposal from ForeignExchange Translations.
Categories: quality
Take two chips and IM me in the morning
2 comments Written by ForeignExchange Translations on Monday, November 15, 2010
It's been a year since we wrote about efforts by Proteus Biomedical and Novartis to embed computers and sensors inside drugs and devices to monitor (in real-time) when a patient takes a drug and how they respond to it.
Last week Novartis announced plans to seek regulatory approval within 18 months. Initially, Novartis will use the technology to monitor transplant recipients, in conjunction with one of its existing drugs.
The chips get activated by the patient's stomach acid and will send biometric data that gauges the drug's effectiveness via Bluetooth. For a look at how Proteus' Raisin technology works, take a look at this article.
While Proteus and Novartis are giddy with excitement over the vast therapeutic and revenue opportunities that they see, there are plenty of people who worry about conspiracies and much more sinister happenings.
What do you think - is this a huge step forward for medicine or a huge step backwards for mankind?
ForeignExchange Translations provides specialized medical translation and software localization services to drug and device companies. Contact us to learn more.
Categories: medical devices
Top audio conferences in October
0 comments Written by ForeignExchange Translations on Friday, November 12, 2010
Every month we take a look back to see which of our medical device and pharmaceutical educational events drew the biggest audiences.
In case you missed any of these, no worries - you can still order CDs or download audio files. A great way to catch up with all of our ACs is with the 2010 AC Package.
So without further delay, here are the top five audio conferences for October:
- Medical Device Vigilance - Reporting Requirements in the EU
- Hydrophilic Coating Options for Medical Devices
- Part 11 Compliance and CDER Tag-Along Inspections
- Successful Vendor Management in Clinical Trials
- Effective Translation Process for Japan Regulatory Submissions
Interested in other popular educational events? Take a look at the top events for September, August, and July.
For a detailed proposal on your next clinical, regulatory, or marketing medical translation assignment, contact ForeignExchange Translations.
Categories: education
Fasten your seat belt! How not get thrown off the bus around the world
1 comments Written by ForeignExchange Translations on Thursday, November 11, 2010
Have you ever been in a foreign country and found yourself committing a cultural faux pas? Well, who hasn't? I know I have my fair share of missteps.
So, I was excited to hear about Fasten Seat Belts.
The site provides an innovative, and visual, way to learn languages and pick up cultural tips. The videos describe various "Dos and Don'ts" (gestures, traditions, manners, etc.) for Europe and Asia.
Asian countries covered include Japan, China, Korea, India, Thailand, and Vietnam. All in all 28 countries are covered with videos that offer a chance to learn cultural tips and expressions in the local language.
For instance, did you know in Korea, passenger sitting on a train who are grabbing your bags are not trying to steal for you?
Instead of shouting for help and running to the police, do yourself a favor and head on over to Fasten Seat Belts.
[Tip of the hat to Lifehacker]
Here are a few more articles that we have written on global culture:
- Of email and cultural differences
- Culturally accessible e-learning
- International business etiquette not a hit on iPhone
- Trying to reach Hispanics online? Content is king
ForeignExchange Translations provides specialized medical translation and software localization services to pharmaceutical and medical device companies. Contact us to learn more.
Categories: off topic
How has medical translation changed in the last decade?
0 comments Written by ForeignExchange Translations on Tuesday, November 09, 2010ForeignExchange turned 12 years old last month. Our team is proud of what we have achieved during this time.
I often get asked how the medical translation field has changed over the past decade or so. It's a good question because in so many ways the field of medical translation really hasn't changed much.
In my experience, though, there are four big differences between today and when I started ForeignExchange:
- Regulations
- Technology
- Globalization
- Measurable quality
How, you ask? I am glad you asked. Take a look at he following short video featuring yours truly for a more detailed discussion of how medical translation has evolved:
So, what do you think? Are these game-changers or are there other, more important things that have changed?
Stay in touch with ForeignExchange on Facebook, Twitter, YouTube, and LinkedIn.
Categories: business
The best team in medical translation meets in Denver
0 comments Written by ForeignExchange Translations on Monday, November 08, 2010A couple of weeks ago, the ForeignExchange team got together in Denver for our annual company meeting. This was the 9th year for our entire team to get together for a week of meetings, fun, and learning.
It's a big effort and investment to put on a meeting like this but our annual get-together is a key aspect of what makes ForeignExchange "tick". It is one of the ways in which we build a cohesive team. After spending a week together, we all know what ForeignExchange stands for, what distinguishes us from other medical translation providers, and what our strategic direction is.
Most important, though, is the opportunity to spend time with one another. Team members who may not see each other all year have an opportunity to reconnect. New employees get to meet folks from other offices and departments. And all of us have a chance to appreciate the depth and breadth of our amazing team.
Some of the highlights of this year's meeting included our client panel, a beautiful fall day spent outside, the team presentations on the last day, and the reception we held for our medical translators who were in town for the ATA conference.
Next year promises to be busy and exciting for ForeignExchange. Not everything will work out according to plan but thanks to our amazing team, 2011 is guaranteed to be another huge success for our company, clients, and translators!
Throughout the year, you can stay in touch with ForeignExchange on Facebook, Twitter, YouTube, and LinkedIn.
Categories: off topic
Monthly roundup: Most popular posts in October
0 comments Written by ForeignExchange Translations on Friday, November 05, 2010
October was a crazy month. Q4 is typically the busiest time of the year for us, and this year is no exception. In addition, we held our annual company meeting in Denver. It was lots of fun but also added to the workload.
On our blog, content was dominated by translation-industry-related topics. Not surprisingly, then, the articles that attracted the most attention were about medical translation and language issues:
- Recession? What recession? European growth continues - ForeignExchange is expanding in the UK and the Twin Cities
- We are everything that they are not - To be successful, a business needs to have a clear sense of its strengths and weaknesses
- Language blogs worth reading - A selection of other good translation/localization blogs
- Similis smiles on translators - If you haven't heard about Similis, you know have a good reason to check it out now
- Kazakh: A question of alphabets - Is nice... Is a good... Is Kazakhstan!
Quality matters, or: Is risk a four-letter word?
3 comments Written by ForeignExchange Translations on Thursday, November 04, 2010
The other day, we wrote about how our client panelists during ForeignExchange's annual company meeting reinforced the importance of quality in medical translation.
For our panelists (and most of the professionals in device and drug companies whom I have met), this was not just important but deeply personal. They are acutely aware of the impact that their jobs have on patients' lives because translation and language mistakes really can be a matter of live and death.
Sometimes, translation accuracy plays a big role in determining the safety of drugs during law suits. Other times, translation discrepancies between a device software interface and the accompanying user guide lead to a product recall.
More seriously, translation mistakes sometimes lead to falsely implanted total knee arthroplasties. Rarely, language issues endanger patients' lives.
How do medical translation providers protect themselves and end-users from this? Different providers will use different means, ranging from reliance on their individual know-how to obtaining E&O insurance to relying on multiple sets of eyes performing incremental QA steps.
Increasingly though, the words "risk management" are entering the vocabulary of the translation profession. While this activity sometimes focuses on trivial areas (e.g., "good" documentation disciplines), more and more medical translation providers look to add value through their risk management practices.
In ForeignExchange's example, we have relied on ISO 14971, not just to minimize risk but to improve our work flows. We have found that effective risk management adds real, measurable value: By reducing failure rates, we are able to provide faster turnaround times, reduce our costs, and significantly improve client satisfaction levels.
And by practicing effective risk management, we can rest at night, knowing that we are saving, not endangering, patients' lives.
ForeignExchange's METRiQ translation quality methodology provides medical device and pharmaceutical companies with measurable translation quality - every time.
Categories: quality, risk management
Is translation the least important most important thing?
2 comments Written by ForeignExchange Translations on Tuesday, November 02, 2010
Originally uttered by Don Draper in Mad Men, the sentiment sums up the feelings of many labeling, packaging, regulatory, and, yes, translation professionals. "Nobody reads the manual" is a frequently voiced concern and objection to spending money.
During our annual company meeting in Denver last week, we were reminded why this blasé attitude is off the mark.
Part of our company meeting is dedicated to a client panel. This year, three representatives from medical device companies participated in our get-together. The two-hour discussion between clients and ForeignExchange staff was tremendously inspiring.
Meg, Woody, and Tom made a compelling case for the importance of translation quality. While people tend to be dismissive of medical device labeling, the product doesn't ship without it. And if it's wrong, products get recalled and patients can die. When products get recalled, it has a tremendous impact on a device company's operation, processes, and staff.
Those sentiments extend to translation. "Nobody cares about translation" may be right most of the time - but clients and users sure do care when they find a mistake. Our client panel actually argued that quality is a powerful differentiator, especially in near-comoditized products and services - and that certainly applies to translation.
So what are medical translation providers to do?
First and foremost, translation companies need to build a culture of quality. This needs to extend from top to bottom of the organization. Everybody needs to realize the importance of their actions and feel empowered to contribute to quality.
Predictability of quality is of key importance to medical device companies. Translation services that are sometimes error-free and sometimes riddled with mistakes aren't good enough. Robust systems for risk management, QA, and overall project execution are needed to guarantee clients that their translations are correct - every time.
Organizations that have built a culture of quality realize that quality issues are to be embraced, not hidden. Viewed as positive opportunities for improvement, all employees will identify and solve problems. Repeatable quality doesn't happen without wide-spread ownership of problems.
And wide-spread ownership of problems doesn't happen without management support. Translation quality cannot be delegated to one or two people. Quality must be supported, funded, and rewarded at every level of the organization.
These concepts are deceptively simple. It has taken ForeignExchange years to get to where we are today, and there is always more to do. But last week, our clients provided the motivation and reinforcement for our team to stay committed to our company vision and to make sure that translation quality remains the most important thing for us.
ForeignExchange's METRiQ translation quality methodology provides medical device and pharmaceutical companies with measurable translation quality - every time.
Categories: quality
World-class translation management: From vendor selection to in-country review
0 comments Written by ForeignExchange Translations on Monday, November 01, 2010
After the success of our premier Multilingual Compliance Learning event earlier this year, we are expanding the series.
On November 16, we are hosting a half-day event entitled "World class translation quality: from vendor selection to in-country review" at the Hotel Sofitel in Redwood City, California. The featured speaker, Richard Korn, is well-known to medical device and translation professionals alike.
Richard has worked in the translation industry for over fifteen years. At St. Jude Medical, Richard oversees the company's translation services, including software, help, and linguistic testing. He also manages the packaging and labeling group for the company's Cardiac Rhythm Management Division. Richard serves on the advisory board for the Life Sciences Localization Roundtable at Localization World.
The event will cover topics such as:
- What is translation quality in the life sciences?
- How to select the right translation provider
- How to set up best practices for translation
- How to measure translation quality
- Solving the in-country review puzzle
Medical device and bio-pharma representatives can register on our web site. This event is, of course, complimentary. We look forward to seeing you in the Bay Area!
For a detailed proposal on your next clinical, regulatory, or marketing medical translation assignment, contact ForeignExchange Translations.
Categories: conferences, education




