Medical Translation Insight

Translation memories are important in helping to maximize quality and efficiency in translation. Consequently, ensuring good practices in using and maintaining translation memories must be vital to any translation company.

One of the interesting aspects about this is that it's not just a one-time effort. At ForeignExchange, we regularly examine our internal processes and procedures in order to identify opportunities for enhancement. As an example, we recently reviewed our standard procedures of how we use and maintain our translation memories (TMs), and we are now working on implementing improvements to our TM maintenance process.

Previously, it was more or less standard procedure to simply create project TMs upon project shipment and close, and then merge these segments into our master TMs to coincide with all earlier segments. In this way, we could capture every translation done for a client, documented with the project number, stage of translation, and any other relevant identifying information. If updated unclean files were not available to do a cleanup, then a post-alignment was generally done to capture the final translations. In either case, any translations done would usually be present in the master TM. Maintaining a complete history of translations was the primary goal of this method.

After some analysis, and more than a few internal discussions, we realized that the significance of translation memories in our work merited a more practical approach to our general maintenance procedures. Keeping a history of all translations was fine, but it was quickly apparent that much more could be done to derive further benefit from our TMs and add value to our translation processes.

Among the improvements we are now pursuing is the maintenance of our master TMs. To offer some transparency, we plan to prioritize client-approved segments by overwriting non-approved segments rather than simply merging everything to keep a composite history of work. While this will certainly vary to an extent, depending on the client's requirements, we believe prioritizing these final approved segments will reduce the number of duplicate entries and inconsistent translations. This will, in turn, lead to higher-quality TMs and higher-quality medical translations.

A second major improvement involves the updating of bilingual files at every linguistic step. While post-aligning final files sounds good in theory, it often creates a backlog of work and cost at project-end, resulting in delays in updating TMs for future projects. Furthermore, aligned files pose their own set of risks apart from unclean files. As some of our clients have come to require a final bilingual output (which we create from updated unclean files), we are moving into processes which require the updating of these bilingual files concurrently with each linguistic step. This greatly reduces the turnaround time in updating our master TMs, and also provides us with a simple means of re-creating TMs should they ever become corrupted or need repair.

As with any process change, it will likely take some time to truly see the results of this effort. Improved methods of checking updates and validating correct entry of segments will also be implemented. But perhaps most importantly, by further educating ourselves in the various uses and functions of translation memories, we hope to provide greater benefit to vendor and client alike.

For more about ForeignExchange's TM practices, take a look at the following articles:

• 100% text repetitions: To review or not to review
• Preparing files with untranslateable content
• When TMs jump the shark

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

It's been a couple of years since we presented Measurably improve translation quality in 60 days at Localization World Silicon Valley. When preparing for a client meeting, I recently came across the actual slide deck that ForeignExchange presented with Lifescan.

Since most of our readers didn't have a chance to be at the event, we uploaded slides to Slideshare and are featuring them here. They are as relevant today as they were in 2009!

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Corporate training departments can choose between a variety of tools to develop eLearning courses, each with their advantages and disadvantages in terms of cost, versatility, and learning curve. When training a global workforce, the "localization-friendliness" of the tool can have serious cost implications and become an important factor in the selection process.

Who better to explain the pros and cons of the most common tools than Xavier Marchand, COO of JBI Studios. In his February 24, 2011 presentation Localization Tools for eLearning: Articulate, Flash and Captivate, Xavier will discuss how

• to fully utilize the localization-friendly features of Flash, Articulate, and Captivate
• the three tools compare for ease of localization
• to approach foreign-language audio synchronization
• to handle subtitling in these eLearning tools vs subtitling video files

You can register for this event at fxconferences.com.

Even better - combine the February 24 event with one or more of Xavier's earlier presentations and use coupon FXMultiDiscount and get 25% off your overall order.

Here are Xavier's three past events:

1. Video Production and Localization for eLearning
2. Audio, Video & Subtitles: Localizing Multimedia Content
3. Best Practices: Recording and Translating Audio for eLearning

ForeignExchange provides specialized medical translations for training courses developed by pharmaceutical and medical device companies. Contact us to find out more!

OK, OK - we have taken our fair share of swipes at the seemingly endless problems that the EU is having in moving to electronic submissions. Delays in PIM, lack of enthusiasm on the part of pharma companies, and now this:

The latest status report [PDF link] for EMA's Electronic Application Form Project starts out by stating

Project has been delayed by up to 9 months due to the resignation of the project manager

A replacement team (yes, team - apparently the entire development and test team followed the PM out the door) has been hired and new deadlines have been set. While this can and does happen on projects, it is becoming embarrassing to witness the endless parade of problems around European eSubmissions.

[Thanks to exalon for the heads-up!]

Well, since you have some time to get up-to-speed on eSubmissions and eCTD, here are five excellent resources for you:

1. Electronic Submissions in Europe – eCTD and non-eCTD Submissions (NeeS)
2. Regional file format requirements for eCTD
3. Lifecycle Management of the eCTD and NeeS in Europe
4. Free CTD/eCTD templates
5. Effective eCTD Regulatory Strategy and eCTD Lifecycle Management

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

Linguists may have received emails about it from our project managers or linguistic leads. Or medical translators may have used it on one of our projects. Or you may have wondered why our supplier newsletter recently contained an article about "an attempt to overthrow the established order of a society." In any case, at ForeignExchange Translations, there is a lot of talk about Subversion (and don't worry, no revolutionary tendencies are required).

What is Subversion?
Subversion (svn for short) is an open source version control system, or revision control system, known as that has rapidly become a favorite of, primarily, developers. It is stable, flexible, capable, security-conscious, free, open source software, and scales well for any size project.

In Subversion, files are stored in a central location called a repository (typically a server online, but can also be created on a local PC), and checked out to a working version to be edited – edits are later returned ("committed" in Subversion language) to update the main copy of the file in the repository. Subversion maintains these edited revisions on an incremental level in order to maintain a permanent record of each version of the file or project.

What does this have to do with translation?
Because, at its core, Subversion is a revision control system, and we are translating, not developing software, you may be asking yourself now "What does this have to do with me?"

While it may not be the original intent, Subversion has some substantial benefits in medical translation, particularly for management of translation memories (TMs), as well as being a file transfer and project management tool. The tables below highlight some of these benefits, in comparison to non-Subversion practices:

While Subversion offers substantial benefits for medical translation professionals, this is not to say that the system is not without its flaws. As part of our current test phase, we have received some great feedback and questions from those of you that we have contacted, or collaborated with on one of our projects.

We will provide more information as we complete the test stage and move towards rolling out Subversion on a larger scale. In the mean time, take a look at Subversion yourself!

[Thanks, Justin, for the original article!]


ForeignExchange Translations provides specialized medical translations for regulatory, marketing, and clinical groups at pharma and device companies. Contact us to find out more.
 
 

2010 ended with an audio conference bang!

We had some of our best events last month and our 2010 AC package was a big year-end draw. On a related note, we just published our 2011 Audio Conference Package - it's an incredible deal at $1,199!

Here are our top audio conferences for December:

1. Intended Use & Indications for Use – Does Anyone Know What They Mean? Does FDA?
2. HFE 101 – Essentials of Human Factors Engineering
3. Risk-Based CAPA - New Guidelines and Expectations
4. Preparing for FDA GCP Inspections – Essentials for Sponsors and Clinical Sites
5. Quality Monitoring and Reporting with Statistical Trending Analysis

If you have a suggestion for a topic you would to present, send us a note!

Interested in other popular educational events? Take a look at the top events for November, October, and September.


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

Medical device regulations continue to change in India. The Central Drugs Standard Control Organization (CDSCO) oversees India's Drug and Cosmetics Act (DCA). Under the DCA, more than a dozen categories of medical devices are listed as drugs. There are an additional number of medical devices that are listed in the DCA as "notified medical devices". These are currently regulated under the DCA and require registration.

In recent years, there has been significant discussion - and some forward movement - on how to begin regulations on the rest of the medical devices in India. In another step forward, the CDSCO released draft version of the medical device guidance documents last August. The documents can be obtained from the CDSCO website [PDF links]:

1. Guidance Document on Common Submission Format for Registration of Medical Devices in India
2. Requirements for Conducting Clinical Trial(s) of Medical Devices in India

The guidance sets out the expectations of the Indian authorities for device technical files, manufacturing information, and certifications that must be submitted in support of licensing application. Brandwood Biomedical points out that the content is based on the templates from the Asian Harmonization Working Party and the Global Harmonization Task Force, reflecting a trend for emerging jurisdictions to look specifically at the overseas post-market track record of new products.

The folks at Pacific Bridge Medical summarize the two guidance documents as follows:

In the "Guidance Document on Common Submission Format for Registration of Medical Devices in India," there are general instructions on how to apply for medical device registration. The guidance lists the 15 commonly required components, including: a "covering letter" (essentially a signed summary of the application's purpose and contents), an authorization letter that serves as proof of a local agent, and Form 40 (a standard form that includes information on the device, manufacturing site, fees for registration, and more), Plant Master File, etc. Most of the Indian government issued documents are included as annexes in the guidance.

"Requirements for Conducting Clinical Trial(s) of Medical Devices in India" similarly provides basic instructions on how to apply for clinical trials for medical devices. Most companies will have to include 17 parts in the application. Key forms are included in this guidance. For example, significant technical data will be required for submission, such as design analysis data, biocompatibility data, animal study data (if applicable), and more.

From a translation perspective, the guidance documents have only a limited impact. Both documents stipulate that information be provided "in English only". Unless comments and opinions received by CDSCO indicated a strong need for local-language labeling, medical device manufacturers are likely to be able to use their existing English language labeling.

For more on India, take a look at the following:

• Growing importance of India, China for medical device, pharmaceutical firms
• India, it's not just for clinical research anymore
• Clinical trials: Why is India irresistible?
• Languages in India - a detailed look

ForeignExchange supports the medical translation needs of pharmaceutical and biotechnology companies. From R&D to clinical research to submissions and marketing, ForeignExchange's service, quality, and pricing stand alone.
 
 

"Eating words has never given me indigestion", Winston Churchill once said. While that may have been true for the British Bulldog, many a translation client has gotten indigestion, a headache, or worse after trying to understanding word counts underlying translation quotes.

Beyond the issue defining a "word" - is it source, target, reviewed, net, gross? - word counts are a perennial issue. For medical device and pharmaceutical companies collecting competitive translation proposals, it must seem confusing to receive different word counts from different translation companies.

There are generally two reasons for this:

1. Which software applications were used
2. How those applications were used

wintranslation's recent article Why do word counts vary from tool to tool? gives a good overview of the first point. They include the following good comparison:



The second issue, how tools are used, is only hinted at in the article. Footnotes, text in graphics and anchored boxes are examples of instances where the operator's know-how can make a big difference.

The process by which TMs are leveraged is another way that words counts can be impacted. For example, prior to ForeignExchange deploying memoQ, we used a process that we called "incremental leveraging" to decrease net word counts by 10, 15, even 20%, depending on the project.

With all of these variables, it's easy to see how word counts can vary tremendously. For translation suppliers who really understand their tools, this presents an opportunity to generate more accurate and more competitive proposals. For drug and device companies, it's a good way to "look under the hood" and kick the tires on suppliers' proposals.

[Thanks to Ruben de la Fuente for the link to wintranslation's article.]

We have written quite a bit about the confusion around "words". Take a look at the following articles:

• What is a "word"?
• 100% text repetitions: To review or not to review
• What you need to know about translation memories

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Software-as-a-service and other cloud-based solutions are all the rage. It's THE big thing, or so the experts proclaim.

The translation industry has certainly gotten into the act. Localization companies are tripping over themselves trying to (re)establish themselves as technology providers, and TAUS' super-TM-cloud keeps getting bigger and is moving onto the web.

One industry that has been a laggard in the rush to adopt cloud computing is medical devices. Of primary concern to healthcare IT in general is the privacy and security of information. Just about any article about cloud computing and healthcare and/or medical devices deals with this.

Interestingly, Is Cloud the tomorrow of Medical Devices Industry? takes a different tack. It includes some of the challenges (regulatory, privacy, security) faced by manufacturers trying to manage medical device data in the cloud but it also points to concrete market opportunities being created by that adoption of cloud-based technologies.

But as Bob on Medical Device Software points out, there are at least two big unanswered questions: Who's going to pay for it? and Interoperability.

The could be a potential market in cloud computing and medical devices but it sure looks like the old "hammer looking for a nail" issue.


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

Effective project management is the single most important factor to influence the success of medical translation projects. Yet it seems that great translation project managers are like yellow lobsters: they are very rare.

Some of this has to do with the relative youth of the translation industry. The industry is fragmented, and there is a dearth of best practices and standards to guide translation service providers.

That, in turn, leads project management ranks being staffed by young, inexperienced folks. Many of them mean well and work hard but they just don't know (yet).

Sometimes, "project managers" are really coordinators. They are passive and shuffle paper and files. Few translation project managers possess PMP, CMMi, ITIL, Prince2, or any other project management certification.

All of this presents tremendous opportunities for those project managers and translation companies that can stay focused on being proactive, that think about the end in the beginning, and hone their PMing skills.

In addition to the above-mentioned certifications, the web contains a wealth of information on how-to stuff around project management. Here is a random sampling:

• Lessons from the world's best project managers (bnet)
• 10 simple rules for project managers to live by and keep me happy (Musings from an overworked translator)
• Project Management War stories (blog)
• On queueing, oil change, and customer experience (shmula)
• 7 habits of highly effective project managers (PMinFocus)
• 5 steps to happy customers (Entrepreneur)

The good news is that translation PMs don't have to reinvent the wheel: Project management is an established profession, and there is no reason why great translation PMs should be as rare as yellow lobsters.


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

Two weeks into the new year, 2010 seems like old hat. The new year has started with a bang - what with our new Twin Cities office, great content, and terrific audio conferences. Nonetheless, December saw some very popular posts, and we want to be sure to share those with you.

So, without further delay, here are the top five articles from December:

1. Is Google Translate the new evil empire? - A boon for Google, a lump of coal for translators?
2. A terminology database is not a dictionary - Five principles of terminology management
3. Languages of the world - A neat map of world languages
4. Budgeting for translation - 3 different approaches - Three tools to make budgeting more accurate
5. Argh! You translated A and they published B! - Every translation professional has experienced this situation

Looking for more great stuff to read? Take a look at our top articles for November, October, and September. Happy reading and happy weekend!

Need expert web localization services for your medical device and pharmaceutical company? Ask ForeignExchange Translations for a quote.
 
 

Our latest video interview is with Sonia Monahan, ForeignExchange's Executive VP of Quality. In recent conversation, she touched on five questions that she frequently gets asked by translation managers at medical device and pharmaceutical companies, medical translators, and quality professionals:

1. How is translation quality viewed in the life sciences?
2. Can you define "translation quality"?
3. How can translation quality be measured?
4. Do clients recognize the importance of translation quality?
5. The role of technology

It's interesting to hear Sonia talk about how "quality is assumed" and the importance of risk management.

Take a look and see if you agree with Sonia's assessment:




ForeignExchange's METRiQ quality system provides medical device and pharmaceutical companies with measurable quality - on every software, technical, and marketing translation assignment.
 
 

Boston is biotech country, no doubt about it. As such, it gets its fair share of controversy but also news coverage.

A recent edition of the Emily Rooney Show on WGBH featured a 20-minute segment with Christoph Westphal, he of the recent newspapers and biopharma companies are caught in the same downward spiral" article.

The interview is worth listening to - not so much for it's rah-rah Boston talk but for the discussion about how FDA has been getting more conservative and thus approving fewer new drugs. For instance at 3:15 of the video, the host wonders aloud if FDA's drug patents are fundamentally flawed:

"It's an odd thing to me that the FDA ever did that in the first place. They put a limit on a patent."

Westphal points to patent expirations as one of the big reasons why biopharma companies may soon go the way of printed newspapers and dinosaurs. But he's also quick to point out the benefits from limiting patent protection to a period of roughly 20 years: it drives innovation and helps prices go down - a boon to consumers and patients.

Without this innovation, Westphal says, we wouldn't have many of the specialized therapies that we take for granted today:

"delays in getting drugs approved actually cost lives"

This is a view that is very much shared by everybody here at ForeignExchange. As we have written before, we see our vision as saving lives. Enabling biopharma companies to bring new therapies to market faster improves all of our lives.

[Thanks, Mary, for the link to the interview!]


Find out more about ForeignExchange's specialized medical translation services for international clinical trials.
 
 

We have previously written about how Excel (or any spreadsheet, really) can make for an effective and low-cost terminology management solution. When going with an approach like this, one big trade-off is the general lack of functionality.

One challenges that occurs frequently with glossary management is de-duping of entries. Here are two elegant and quick ways to deal with the issue of repeated entries.

LyteByte provides instructions for users still on Excel 2003:



Instructions for Excel 2007 are also available:



A big THANK YOU to Fabio Said who posted this on his Twitter feed.


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Our "regulation week" comes to a close with a visit to Australia, where, after protracted consultations, negotiations, and rescheduling, the Australian IVD regulatory framework was updated back in July 2010.

After having been exempt from any form of pre-market assessment by the Australian Government Department of Health and Ageing Therapeutic Goods Administration (TGA), in vitro diagnostic devices must now be included in the TGA's Australian Register of Therapeutic Goods (ARTG).

Specifically, for devices that were already on the market before July 1, 2010, a four-year transition period will apply for manufacturers to obtain inclusion on the ARTG. Any IVDs introduced on or after 1 July will need ARTG inclusion before they can be supplied to the market.

If past experiences in Europe are any indication, device manufacturers won't get "serious" about the new regulation until much closer to the end of the transition period. Several good resources exist to help device companies navigate the new regulations:

• IVD Technoloy's article Regulation of IVDs in Australia provides a good overview for experienced regulatory professionals
• The changing regulatory environment of in vitro diagnostics [PDF link] is geared to readers with a more basic understanding of regulatory frameworks
• TGA maintains an informative web site; Regulatory framework for IVDs is a good starting point for exploration

This brings our "regulation week" to a close. If you missed our other entries, take a look now:

• New year, new Spanish language rules
• Electronic labeling for medical devices comes to Canada
• Mexico recognizes devices, IVDs cleared by FDA, Health Canada

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

The Mexican Health Authority's Federal Commission for Protection against Sanitary Risks (COFEPRIS) has put into effect new rules recognizing medical device authorizations for Class I, II and III commercialized products in the U.S., as well as for Class II, III and IV commercialized products in Canada.

A recent article from Emergo Group explains the specifics of the new rule that COFEPRIS has made available, but many details remain forthcoming. The registration process for devices covered under the agreement will take 30 days, says COFEPRIS. The agreement will speed patient access in Mexico to the latest medtech products, it says, adding that it has been working on a new IT platform for the past year. COFEPRIS believes that domestic manufacturers will also benefit from the agreement as it will be able to dedicate more staff to deal with local procedures.

Great news for medical device and IVD manufacturers - and for Spanish medical translators!

For more details, take a look at the reform document [PDF link].


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

While e-labeling will not happen anytime soon in Europe, Health Canada has recently given its go-ahead to alternative labeling.

The two-month-old notice provides a new interpretation of Canada's Medical Devices Regulations and allows for electronic labeling of those medical devices that are sold exclusively to medical professionals.

According to Emergo Group, the usual rules apply:

The usual rules apply: All medical devices must be labeled in order to be sold or imported, and all labels — including electronic ones — must be legibly and prominently displayed. Manufacturers now have the option of providing only e-labeling via CD or DVD for devices not sold to the general public. For Class IV medical devices and IVDs that do not fall under the "near patient IVDD" definition, label information may be provided in downloadable format from an "easily navigable" website.

Manufacturers using e-labeling are obliged to provide paper copies of that information upon request to device users. Furthermore, manufacturers must provide attestations that e-label details match word-for-word those included on the paper labels of their devices.

For further details, take a look at Health Canada's Notice.

Before you leave, take a look at the following related articles:

• When will e-labeling become reality for devices?
• Mind your language! Bilingual packaging, branding in Canada
• Once seen as Holy Grail, elabeling provides new challenges

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

¡Prospero Año Nuevo!

Attention Spanish linguists and companies that uses Spanish translations: January 1, 2011 marks the date when the new Spanish spelling rules came into effect.

Developed by the Real Academia de la Lengua Española, the new rules contain several clarifications and modifications, including:

New names for the letters B, V, and Y
B is called "Be" in all countries (no longer should be called "be larga" in America)
V is called "Uve" (no longer "be corta")
W is called "Uve doble" (no longer "u doble" or "be doble")
Y is called "Ye" (no longer "Y griega")

New spelling for foreign countries
Iraq becomes Irak
Qatar becomes Catar

Less use of diacritic tildes
Old rule: "sólo" = only, "solo" = alone. Now, the tilde is unnecessary for both meanings
Old rule: "truhán", "búho", "guión". Since they can be pronounced as diphthongs, the tilde is considered unnecessary

The "o" (or) between numbers used to have a tilde which is no longer required. Old spelling: "Vinieron 5 ó 6 personas"; new spelling "Vinieron 5 o 6 personas"

A recent change also removed the tilde from the demonstratives "este/ese/aquel" (and the flexed variants in feminine and plurals) when they worked as pronouns (I. e. "Quiero este helado, éste que señalo", now becomes "Quiero este helado, este de aquí")

Discard hyphens in compounds using "ex", "anti" and "pro"
Old rule: Ex-presidente, anti-social, pro-vida
New rule: Expresidente, antisocial, provida.

For more information, see the articles (in Spanish, of course) at LA NACION and BBC, and then be sure to update your Spanish spellcheckers, translation memories, and glossaries!

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

Language is dynamic - take a look at other recent language developments:

• Brazilian Portuguese changes spelling rules
• China to update list of simplified Chinese characters
• Use of English still growing in global corporations

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