Medical Translation Insight

Smartphones are getting, well, smarter. Whether you want to use your mobile phone as a medical device or as an on-the-fly translator, there's "an app for you".

Recently, translation applications available on the iPhone have grown exponentially. There are now more than a dozen translation applications in Apple's AppStore. Some are language-specific and some are task specific.

Two promising new arrivals are Jibbigo and PicTranslator.

According to Slashdot, Jibbigo turns the iPhone into a translator that converts English speech into Spanish, or vice versa. Users simply speak a sentence or two at a time into the iPhone and the iPhone will respond with an audible translation, as shown in this demo:


PicTranslator lets you take a picture of the text you want translated, choose the language you want to translate from, and have PicTranslator translate it for you. As described on Lifehacker, once you know the (hopefully correct) translation, you can even ask PicTranslator to help you pronounce the foreign-language version. Here is a demo:


While tools like PicTranslator and Jibbigo will not replace professional medical translators anytime soon, they will be a boon for doctor-patient communications and users with casual translation needs.

Want to know more about machine translation? Check out these three articles:

• To automatically translate email messages, we have in the past covered Miilos.
• In machine translation, an important question is "What is good enough quality?".
• Machine translation is terrific - but user beware!

Are you on Twitter? Follow ForeignExchange Translations at @fxtrans!
 
 

If you have participated in hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an unmitigated hazard is high or low, or went off on a tangent evaluating very unlikely hazard scenarios, or wrestled with group members who consider hazard analysis meetings a waste of time.

This presentation looks at what is required under IEC60601 and ISO14971, and provides guidance on how to motivate groups to perform hazard analyses, structure meetings effectively and make them meaningful. It discusses documentation formats and hazard evaluation strategies, as well as presenting ideas on how to get the most benefit out of the risk management process.

But hurry! If you purchase Hazard Analysis for Medical Devices Under IEC60601 and ISO14971 by November 5, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.


Want to find other educational offerings? Visit our audio conference portal at FXConferences.com.

With every new release of MS Office, anxiety takes hold amongst translation service providers: What are the implications of this new version with existing software and tools, particularly TRADOS' translation memory application? How will we deal with bugs; what plug-ins might be needed?

Office 2007 files, while not necessarily "new", are no exception: .docx files in particular are no friends of TRADOS, leaving linguists to wonder whether upgrading to the next version of TRADOS is worthwhile. While it's possible to save down .docx files to .doc, this is not an ideal solution since the formatting of the document is often compromised, not to mention the additional formatting time that conversion may take.

Nevertheless, as more and more organizations to implement Office 2007 on an exclusive level, this issue poses a real threat, with the implication that linguists will need to upgrade to newer versions of TRADOS.

The earliest TRADOS version compatible with Office 2007 is TRADOS 2007 (8), which also supports Office 2003 and offers full support of Word translation in TagEditor with advanced Word features. Even newer is SDL 2009 Studio, which is a completely new translation environment with a new translation memory format. This also supports Office 2007 and older.

At ForeignExchange, we encourage the use of TRADOS 2007 (8) but not the use of SDL 2009 Studio, which, as mentioned earlier, creates TMs in a new format. It's also interesting to note that TRADOS is no longer the only solution out there. Other translation memory environments such as MemoQ are rising in popularity and may solve some of these issues.

And watch out for Office 2010. A public beta release will be available shortly, and until then it is unknown how the latest Office version will interact with TRADOS. If past is prologue, we can all expect interesting times, filled with late nights and software upgrades.


Further reading if you are confused by all of this talk about "translation memories":

• What you need to know about translation memories
• Translation memory vs. glossary
• Machine translation vs. translation memory

Looking for expert translation services for your pharmaceutical or medical device company? Ask us about ForeignExchange's approach to measuring translation quality.

eCTD 2010 is the second annual conference dedicated to European eCTD developments. This year's agenda (all content in German) looks really interesting.

Updates on the state of e-submissions throughout Europe coupled with participation from regulatory heavy-weights from industry promise to make this a terrific event. There is also a session on RPS and plenty of opportunity for networking. And all this at a reasonable cost - early-bird registrations are only €405.

The event will take place in on February 17 and 18, 2010 (February 19 is dedicated to workshops) in Berlin. I know - Berlin in February wouldn't be my first choice either but when the content is good, sacrifices must be made...


ForeignExchange Translations has extensive experience in translating electronic submissions for pharmaceutical companies. Contact us to learn more about our specialized language services.
 
 

Manufacturers of pharmaceutical drugs in general and birth control pills in particular are used to law suits. So Bayer probably wasn't all that surprised when it first became the target of law suits. But over the past six months, law suits around Bayer's Yasmine and Yaz oral contraceptives are mounting daily - more than 125 legal actions are on the books.

When the law suits fly, all manner of claims and statements get closely examined for clues. And so it was last week, when Swissmedic, the Swiss medical authority, commented on the relative risk of drospirenone [German link], an active substance used in Bayer's Yaz. Bayer wasted no time in picking out the positive morsels from the Swissmedic release and using it to bolster its position.

What's interesting in this situation is that there is this additional issue of translation. As BNET Pharma reported, Bayer's translation of the Swissmedic study may be questionable.

Translations are likely to play a key role as this situation unfolds: The drugs were developed in Germany (earlier this year, an FDA inspection there generated a warning letter because of concerns over Bayer's cGMP compliance), and the law suits are being filed in the U.S.

As the legal wrangling will probably last for years, attorneys as well as German/English translators will be kept busy.


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

Fall is the time for conferences... After reporting on the Medical Localization Roundtable at Localization World and RAPS' Medical Devices & IVDs: A Practical Approach to the Japanese Market event, here are some highlights from TM-Europe International Conference 2009 in Warsaw, Poland.

ForeignExchange's Sandra La Brasca attended the conference, which this year was focused on quality management as well as terminology and translation management in European institutions. Of particular interest were the quality panel and the Warsaw Pact debates.

What is striking when quality is brought up among translation/localization professionals is that while we all recognize that quality is a sine qua non, there still seems to be a sense of awe surrounding the word. Mention of ForeignExchange's METRiQ quality measurement system sparked a lot of interest, particularly because it provides a platform for an objective and systematic quality assessment.

The quality panel gave the participants a chance to discuss and argue about quality and its meanings. Fundamentally, the takeaways were:

• Clarify the requirements
• Define quality milestones and benchmarks
• Put in place a system of checks and balances
• Measure and report

To be truly valuable, quality needs be measurable and closely tied to all levels of the client-vendor relationship.

This created an interesting segue into the Warsaw Pact debate which focused on the relationship between clients and translation service providers. The debate was animated but clearly highlighted the importance of building partnerships with our clients.

Other highlights of the conference were discussions around new translation memory technology, machine translation, and crowdsourced translations.

TM-Europe posted an official conference report. From our perspective, this iteration of TM-Europe offered an excellent forum for professionals of the industry to share views and experiences!


To stay abreast of medical translation developments, sign up for an email subscription to Medical Translation Insight.

Being a medical translator is hard work. Don't believe me? Just check out this video...



Enjoy and have a good weekend!

[Via medicaltranslt's Twitter feed]


For expert medical translation services, ask about ForeignExchange's specialized services for medical device and pharmaceutical companies.

We love it when you can make your toys do double-duty as business or personal health tools. After justifying the purchase of a Nintendo DS by way of using it as a glucose meter and multilingual dictionary, you can now set your eyes on getting an Xbox 360.

Medgagdet reported that a researcher at the University of Warwick has been using an Xbox 360 to model and simulate cardiac arrhythmia in the hopes of understanding their initiation and propagation and to develop better treatments.

Who knew that a Microsoft Xbox 360 could not only stimulate one's mind, but could also be used to investigate cardiac abnormalities? As quoted in the Medgaget article, the researcher said:

"These game consoles aren't just glorified toys. [They] are pieces of very powerful computing hardware. I can see this ... being most useful for students and early-career scientists to just quickly and cheaply grab that extra bit of computing power they otherwise wouldn't be able to get."

That's right! Now where did I put my Halo game...?


When it's time to take a break from gaming, subscribe to Medical Translation Insight via email or RSS!

Companies that develop medical devices today have the option of informally meeting with the FDA staff in what is called a "pre-IDE meeting." This meeting will ultimately review their marking application in order to gain clarity about the agency’s expectations regarding the preclinical and clinical testing requirements for their device. In most cases, it is critical to take advantage of this opportunity.

This presentation describes how to optimize the pre-IDE submission of information to FDA, as well as the meeting that follows this submission, in order to maximize the information derived and facilitate your device development plan.

But hurry! If you purchase Pre-IDE Submissions and Meetings: Best Practices by October 29, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.


Want to find other educational offerings? Visit our audio conference portal at FXConferences.com.

Tuesday's preconference day kicked off Localization World 2009. The Medical Localization Roundtable was attended by about 30 people, roughly the same as the June event in Berlin.

While the expanded format of four sessions did little to attract additional attendees, the quality of the discussions was terrific.

One of the standout sessions was the joint presentation by Elizabeth Judd-Cummings of LifeScan and Sonia Monahan of ForeignExchange Translations. Their workshop, Measurably improve translation quality in 60 days, provided the audience with a replicable methodology for measuring translation quality and used a case study format to demonstrate how this known translation quality can be used to reduce a medical device company's business objectives (in the case of LifeScan, reducing translation times by 75% to drive faster time to international markets).

The workshop generated spirited a discussion amongst attendees on how to adapt this methodology to different companies and industries. What was nice about the session was that attendees left the workshop with actionable advice that they could apply back in their offices.

for those of you who missed this excellent session, take a look at Sonia's presentation Bridging the Linguistic Quality Gap: How to Measurably Improve Translation Quality, where she presents a number of real-world case studies around this same topic.


Contact ForeignExchange to learn how we can help you measure the quality of your translations and achieve your business objectives.

The Regulatory Affairs Professional Society (RAPS) hosted a two-day conference last week, focusing on Japan regulatory filing. It was well attended by medical device and IVD company representatives and industry consultants.

The conference agenda covered diverse topics, from reimbursement strategies for IVD companies, to QMS applications, cultural tips for doing business in Japan and updates to the Pharmaceutical Affairs Law.

Jason Heaton of ForeignExchange Translations talked about establishing an effective process for creating Japan regulatory submissions, a topic that is on a lot of companies' minds. Feedback was positive and some good questions were raised: What about dialect differences? How is review handled? Who has ultimate responsibility for translation quality?

For more details on this topic, look for an article on a similar topic in the November issue of the RAPS Focus magazine.


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

Social media is all the rage. Despite recent indications that FDA is realizing this, medical device and pharmaceutical companies are still generally scared of social media.

The following quote from John Mack, as quoted in Healthcare Social Networking: Is pharma ready to join the conversation?, in nicely sums up the prevailing sentiment:

"Pharmaceutical marketeers must feel like they are doomed if they do and doomed if they don't engage in social media marketing"

Evidence is mounting that an active Internet presence and social media participation is helpful to patients and manufacturers alike. The latest iteration of comScore's annual study Online Marketing Effectiveness Benchmarks for the Pharmaceutical Industry found that patients turn to interactive digital media like never before.

Twitter is a good example of this. While it cannot take the place of all forms of patient interaction, there are compelling uses for the tool - in fact, 140 uses!

So while many companies remain skittish about the Internet, things are changing, albeit slowly, with more and more drug and device companies actively participating in social media, through blogs, Twitter accounts, online communities, and YouTube channels.

It's been interesting to see that all this dialog has spawned a growing number of people who are monitoring social media by medical device and pharmaceutical companies. This cottage industry of observers and prognosticators announces which companies tweet the most or have the most followers, provides commentary on social media strategy, and offers advice to nervous social media managers.

If you are interested in keeping up with these goings-on, there is no better place than Dose of Digital's Pharma and Healthcare Social Media Wiki. The wiki is a veritable who's who of social media in the drug and device space. Check it out and use it to convince your management about the benefits of social media.

Speaking of social media... be sure to follow us at @fxtrans and subscribe to our blog.

While the electronic Common Technical Document (eCTD) is not yet a truly global standard, it is surely moving in that direction.

For sponsor organizations, the challenges in making the transition to electronic submissions lie in two areas, specifically: convincing upper management and implementing a "clean" eCTD process.

Support from upper management is vale to the success of the eCTD implementation. Gina Ross of Beckloff Associates recently suggested that the reason for this is because shifting the paper submissions to the eCTD will impact the entire organization and could cause an organization to rethink, perhaps, how they do business.

To help prepare for this dialog with management, Gina advocates organizing answers to the 5 "W" questions: Why? When? What? Where? How?

Once management support has been ensured, the focus shifts to implementing an eCTD process. Moving from paper to electronic submissions can take anywhere from three to six months. During this time, the main focus is on modifying document preparation processes, particularly in the following areas:

• Organization of information. For instance, in the traditional format submissions are organized according to the Forms FDA 1571 for an IND and 356h for NDA, ANDA, and 505(b)(2). In contrast, the eCTD is organized according to the TOC Headings and Hierarchy guidance document.
• Pagination. In traditional submissions, consecutive pagination is required within the volumes or across the entire submission. Not so with the eCTD. Pagination stats with each section.
• Last-minute changes. In traditional submissions, late-stage changes or additions create rework and tremendous stress. In the eCTD format, last-minute changes are much easier to implement, thanks to file granularity.
• Life cycle management. Within traditional formats, life cycle management is done at the submission level. Within the eCTD format, life cycle management also exists at the individual file level and is management through the use of operation attributes.

And it pays to focus on the details - regulatory agencies are demanding. FDA, for instance, is getting tougher with refuse-to-file letters.

As quoted in a presentation by Antoinette Azevedo of e-SubmissionsSolutions.com, FDA's top 12 issues for eCTD success are as follows:
   12. SPL must be in "SPL" folder
   11. Use elements and leaf titles correctly
   10. Always reference all files in the XML backbone(s)
   9. Include Module 1 in all eCTD submissions
   8. Make sure all application numbers are 6 digits
   7. Make sure all sequence numbers are 4 digits
   6. Do not use node extensions
   5. Verify that all MD5 checksums are correct
   4. All documents should conform to eCTD granularity
   3. All XML must use standard components
   2. Be sure all PDF hyperlinks & bookmarks are correct
   1. Include TOCs in all PDF documents

But pharmaceutical companies aren't the only ones struggling with the transition to eCTD. Many translation suppliers are asking more fundamental questions like: What is eCTD? Do I need to work in XML? Which modules require translation?

As more and more regulatory agencies encourage or mandate eCTD its use, eCTD adoption rate will continue to raise. Implementing an eCTD represents a major step for any sponsor organization though. Managing the shift as smoothly as possible requires management support, lots of interaction with regulatory authorities, and support from external suppliers.


Further reading:

• Preparing compliant eCTD submissions provides a detailed look at the pitfalls and success factors in preparing effective eCTD submissions
• Learning to embrace the eCTD is a Bio-IT World look at real-world case studies around eCTD submissions
• The "why" and "how" of eCTD conversions provides step-by-step advice for sponsors, CROs, testing facilities, and medical writers
• ANDA vs. 505(b)(2) compares these two different regulatory pathways

ForeignExchange Translations provides specialized translation services for regulatory submissions by pharmaceutical and medical device companies. Contact us to learn more.

Everybody likes a freebie, right?

When it comes to buying translation tools, it's easy to spend hundreds or even thousands of dollars/euros/pounds. So it's nice to see L10NWorks' collection of free translation and localization tools.

Some of the tools, do one specific thing. For instance, the Portuguese Reformer utility adjusts strings written in old-world Portuguese to be compliant with new spelling reforms in Brazil, and vice-versa.

Others are full-fledged applications designed to compete with commercially available solutions. OmegaT is such an example. It is a translation workstation, fully equipped with a translation memory system, project support, and a bitext aligner/converter - all for free.

Take a look at L10NWorks' collection of free translation and localization tools and enjoy a "cost-nix".

[Thanks to Ruben de la Fuente for the tip!]


To stay abreast of translation technology, advice, and news, follow us on Twitter!

We have previously reported on efforts by the International Medical Interpreters Association (IMIA) to facilitate interpreter access to non-English-speaking patients in the United States. IMIA's Guide on Translation was well received and the organization's annual conference is a must-attend event for anybody associated with medical interpreting.

So it is understandable that the IMIA folks are proud of the first-ever U.S. interpreting standard. This certification provides professional medical interpreters with the opportunity to become officially certified (see the official press release).

The recently-founded National Board of Certification for Medical Interpreters (NBCMI) acts as the certifying body and offers three levels of certification:

• Certified Medical Interpreter (CMI)
• Qualified Medical Interpreter (QMI)
• Screened Medical Interpreter (SMI)

The CMI certification will first be available in Spanish and is the culmination of 20 years worth of effort. Congratulations to IMIA, NBCMI, and all medical interpreters on this accomplishment!


Need interpreting services for your pharmaceutical or medical device company? Ask us about ForeignExchange's specialized interpreting services.

It isn't glamorous, and sometimes it isn't even considered a core competency necessary for our business. But in the medical device industry, software validation often consumes a huge portion of the budget for new software products, even when that wasn't the original intent.

Unfortunately, software testing methods haven't kept pace with innovations on the product development side. Just as we look to new and improved ways to complete software development, medical device companies also need to be looking for new and improved ways to validate that software.

This audio conference examines the various approaches to software validation, and discusses how and why to consider risk as part of the validation process. The presentation also looks at ANSI/AAMI/IEC 62304:2006 Medical Device Software - Software Lifecycle Processes, and how it uses risk to drive software verification and validation.

But hurry! If you purchase Risk-Based Software Validation for Medical Devices by October 22, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.


Want to find other educational offerings? Visit our audio conference portal at FXConferences.com.

If you have attended past iterations of the Medical Localization Roundtable, you know that this is a unique opportunity to get together with translation managers from other device and drug companies. In fact, the Medical Localization Round Table is the only forum for pharmaceutical and device companies to discuss translation and localization issues.

For this latest iteration, the event is re-christened "Life Sciences Round Table" and sports the best-ever program. Participants from Philips Healthcare, St. Jude, CaridianBCT, Siemens Healthcare, Boston Scientific, and other companies will discuss their experiences and best practices.

ForeignExchange is pleased to once again help organize the event. We are also actively engaged in two sessions: "Introduction into Medical Localization" is ideal for new-comers to medical translation. The session discusses what medical translation is and how it differs from other types of translations.

"Measurably Improve Translation Quality Within 60 Days" is a workshop designed to help translation managers with advanced knowledge streamline the quality, timing, and costs of their translation efforts. (See our recent post for more details on this session.)

We hope to see you in Santa Clara next Tuesday, October 20!


For Twitter updates from Localization World and other industry events, be sure to follow us.

In Japanese, "Nemawashi" refers to the binding of a plant's roots by a gardener when moving a plant. Nemawashi is a long and painstaking process by which each root is carefully cut and bound one at a time, to avoid shocking the plant. Only after all roots are cut and bound individually can the plant be moved.

The same concept seems to apply when medical device and in-vitro diagnostic companies look to revamp their Japanese regulatory processes - how do you work with your Japanese affiliates to avoid a shock to the system?

To provide some of the answers RAPS is holding Medical Devices & IVDs: A Practical Approach to the Japanese Market over the next two days (October 15 and 16, 2009). If you can't make it to the DC area, you can still participate - RAPS will be streaming a live webcast of the two-day event.

The seminar agenda looks terrific. Thanks to presentations from industry, FDA's CDRH, and consultants, attendees stand to take away concrete, actionable advice.

ForeignExchange Translations' Jason Heaton will share our experience and advice on how to streamline translation processes for effective Japan regulatory submissions. If you are attending (whether live or over the Web), be sure to say Konichiwa.


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

"Garbage in, garbage out" goes the old warning: If the source text is of poor quality, expect the translated text to be no better.

English is the main language used by global medical device and pharmaceutical companies. But drug and device companies must provide instructions for use in the native language of the countries to which they export.

Up until a few years ago, little thought was given to improving the source materials for translation: few companies had any meaningful control over the authoring of content and translation was not a big ticket budget item. Non-native speakers writing in English? Sure! Using different terminology for the same thing in different documents? No problem. Engineers writing end-use instructions? Why not?

As the number of languages continues to grow and the time allocated to translation continues to shrink, pharma and device companies have started to realize that better authoring can lead to better, faster, and less expensive translations. Content management systems are being implemented across device companies like never before. Writing for translation is suddenly a topic for discussion. And pharma companies are increasingly looking to technology (e.g., translation memories, electronic data capture) to streamline global trials.

Larger drug and device companies are starting to pay attention to controlled authoring and Simplified Technical English. Long a mainstay of quickly and accurately producing voluminous documentation for cars, airplanes, weapon systems, and other heavy equipment, the practice is gaining favor in the life sciences as a way to combat GIGO.

In addition to time and budget pressures, industry's interest in controlled authoring is aided by the emergence of XML. More and more companies are already deploying XML for structured product labeling, authoring systems, e-submissions, and document management.

You can't make a silk purse out of a sow's ear, but drug and device companies can use controlled authoring to improve the quality, timing and cost of their translation efforts.

For further insight into controlled authoring, take a look at these resources:

• Frans Wijma's audio conference Achieving Compliance and Beyond with Simplified Technical English shows companies how to address 99% of the challenges behind global documentation processes, such as high cost, ease of translation, damage to product, delayed time-to-market and inadequate customer support.
• Uwe Muegge provides a good summary of how to use controlled language to streamline translation processes.
• Updated: The "godfather of machine translation", Jeff Allen, compiled an extensive list of resources around controlled language, authoring systems, and related topics as part of his LinkedIn page (scroll to the bottom to "Jeff Allen's Files") and on his new blog.

If you liked this article, be sure to subscribe to daily email updates from Medical Translation Insight.

Our audio conferences are designed to provide expert insight and advise for the kinds of challenges faced by regulatory, clinical, quality, and translation professionals.

In September, most of the interest was in clinical research topics. Here were the top five educational events during the month of September:

1. QA Oversight of Vendor Management


2. Clinical Trial Insurance: Managing Common Problems and Pitfalls


3. Current Trends in Clinical Neuroscience: A Focus on Multiple Sclerosis


4. Site Activation: How to Get Beyond the Classic Pitfalls


5. Proactively Manage Project Financials: Scope of Work, Cost to Complete & Scope Change

If you have any suggestions for audio conference topics, send us a note!

Interested in other popular educational events? Take a look at our top audio conferences for August, July, and June.


Are you on Twitter? Follow us at @fxtrans.

Here is some excellent news for anybody involved in English/French translations: TERMIUM, the Government of Canada's terminology and linguistic database, is now accessible free of charge.

For decades, TERMIUM has been an important and reliable component in every French/English translator's toolkit. Today, the database contains almost 4 million terms in French and English as well as a growing list of Spanish terms.

But it's not just the terminology database that makes TERMIUM so invaluable. The service also provides access to resources like Word Tailoring and The Canadian Style, which is indispensable when working with Canadian (as opposed to French) clients.

TERMIUM used to be sold on CD, for thousands of dollars. Over time, the price dropped as the model shifted to a Web-based subscription. Most recently, access cost $25/month. Not bad but free is better still.

For more information, review the announcement and visit the new Language Portal.

[Picked-up on Twitter from @kvashee via @NTceline and @petergarner]


ForeignExchange Translations provides specialized translation services to drug and device companies - in Canadian French and 35 other languages!
 
 

The definition of "medical device" is shifting, quickly and dramatically.

The revised MDD now includes stand-alone software in the definition. In other words, if software has a medical purpose, it probably can/must be CE marked.

And smart phones are quickly becoming the conduit of choice for collecting and researching, disseminating, and evaluating clinical data.

As Bob on Medical Device Software points out, its unique user interface, display, and broadband capabilities make the Apple iPhone a particularly attractive platform for medical applications. For example, the AirStrip OBSERVER suite of applications is custom-designed for the iPhone, makes some components available for download at the Apple App Store, and received FDA clearance for some modalities.

While most medical apps fall into the reference category, applications are getting more sophisticated and are taking advantage of the devices networking abilities. A trio of applications developed by researchers at the University of Utah aptly demonstrate these advances.

Another factor is the appeal and widespread use of these devices. The Wall Street Journal reports [login required] today that 64% of U.S. physicians are using smart phones.

There are several big questions and unknowns hanging over these developments: First and foremost, there is the question of data security. As quoted in the same WSJ article, Deborah Peel of Patient Privacy Rights worries that "the vast majority of health information technology has not been designed to ensure that patients control access to that data and use of that data". So, paradoxically, the more ways that doctors can access patients' records, the more their confidentiality is threatened.

Second, what is the quality threshold for smart phone applications? Just because something is on the iPhone doesn't mean it's necessarily a quality application.

Regulators around the world are bound to tackle these questions. FDA, for instance, is already looking at this issue and sooner or later will regulate certain phones. It's certainly not the end of the world to be classified as a medical device, but verification and validation of these applications won't be easy.

As these applications get developed and become part of a networked medical device, language will also become an issue again. Translation service providers will need to become familiar with smart phone development and localization issues and support consistently translated content across multiple platforms and media.

Like it or not, we live in interesting times...

Related content:

• Science journal Nature jumps on iPhone bandwagon
• Localizing Android applications
• Translation moves to smartphones

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

Measuring translation quality is easy to say but hard to do. Even though tracking quality is an important aspect of pharmaceutical and medical device companies' business, they have had to accept that translation quality is often fuzzy and unclear.

But no longer.

The upcoming Localization World conference features a session on Measurably improve translation quality in 60 days. This session will show participants how to set objective quality standards, implement them internally and across translation service providers, and how to track progress towards measurably improved translation quality.

Drawing on real-world experiences by LifeScan and ForeignExchange Translations, this session will demonstrate the methodology to define, analyze and measure success in meeting translation quality requirements.

Importantly, the presenters will highlight how the goal of improved translation quality is not about translation nor about quality. Instead, attendees will learn how to use this replicable methodology to achieve their larger business objectives.

If you are looking for hands-on, actionable advice on how to use translation quality improvements to reduce costs and time to market, join us in Santa Clara on October 20, 2009!


Learn how ForeignExchange can help you improve your translation quality and achieve your business objectives.

While being an economic powerhouse in many industries, Japan struggles in the medical device and pharmaceutical sectors. The country's market has long been hampered by regulatory roadblocks and stagnant, uncompetitive domestic producers.

But what a difference a year makes - if you are a medical device manufacturer, that is. Pharmaceutical and biotech companies are still very much experiencing (and frustrated by) the Japanese new drug lag.

The Japanese drug lag emerged in the late 1980s and worsened throughout the 1990s. A combination of regulatory, healthcare policy, political, and economic challenges caused new drug approvals in Japan to take about 30 months longer than in the U.S.:



Japan has taken a two-pronged approach to speeding-up drug approvals, as described by pharmalicensing.com:

The first major change took place by conducting the revision of GCP, for safety concerns of clinical trials and to set up an internationally harmonized guideline. It also recognized foreign clinical trials to help minimize expensive duplication of effort. While this was taking effect and getting settled, the second development occurred in 2001-2002, with the revision in the Pharmaceutical Affairs Law. This law stipulated on the regulations relating the efficiency, quality and safety. Setting up of the Pharmaceutical and Medical Device Association is also a major step taken toward /improving and reducing the drug lag.

Have these efforts made a difference? It's still too early to tell.

A couple of years ago, just as the situation got even worse and some pharma companies were pulling out of Japan, industry began to see some improvements. And a few months ago, PhRMA politely applauded the innovations and progress being made in Japan - but is also pushing for further, faster change:

"PhRMA appreciates the ongoing efforts on the part of the U.S. Government and the Government of Japan and hope that any future reforms will continue to move in this direction."

Hopeful signs all around - but for now the Japanese new drug lag is still very much a reality.


Further reading:

• Reducing Japan's drug lag in biotechnology provides a good overview of MHLW's new policies
• Clinical Investigations in Asia draws on the benefits and challenges of managing clinical trials in Japan and elsewhere in Asia
• Japanese "device lag" disappearing? celebrates progress being made in streamlining Japanese device reviews

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

Once upon a time, sponsors had to make regulatory submissions in multiple formats such as paper, eCTDs, and various hybrids. The advent of the electronic Common Technical Document (eCTD) promised to simplify and standardize all of these submissions.

Thanks to efforts by ICH, the United States, European Union, Japan, and Canada have adopted the eCTD specification [PDF link].

And indeed, submissions have become much simpler in these markets: "Ten years ago when sponsor’s looked to market their product globally, they would need to compile their applications individually according to each country’s specific format. Now, with CTD and eCTD, they’re minimizing the rework for at least 6-10 countries", notes the current issue of Applied Clinical Trials.

But the article goes on to say that while eCTD has made submissions easier across the ICH countries, many other countries are either ignoring the harmonized format or are putting in place new submission formats (Venezuela is a recent example of this).

Different regionally requirements represent another stumbling block. For instance, Study Tagging Files are required for a US eCTD, but not for an EU eCTD, and the files are not allowed in Japan.

So, what do pharmaceutical companies do about this? Shire, for one, seems to be fairly relaxed about it: "We've sent eCTDs to all the countries we have applications in and they are accepting them. From experience, we've learned that since there's not a standard or the standard is different in each country, we're finding if you push the envelope, they will take one standard."

Others are proactively pushing for regional harmonization, as Pfizer did at the recent MRCT conference in Korea.

So while significant progress has been made, the global eCTD standard is still a ways off.


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

SharePoint is the fastest-growing product in the history of Microsoft. More than 100 million licenses have been sold worldwide and thousands of companies have adopted it.

At first, drug and device companies were concerned about the robustness of SharePoint's 21 CFR 11 implementation. While some vendors have bridged the gaps in SharePoint itself, companies like EMC integrated SharePoint and Documentum, essentially geting the best of both worlds.

In this video (via the eCTDBlog) a marketing manager at EMC explains the approach and benefit of this integration (if video doesn't play, go to YouTube to watch it):



And it's easy to see why drug and device companies have come around and embraced SharePoint along with companies in other industries: Faced with increasing demands to improve their organizational effectiveness through information sharing and collaboration, life science companies also have the need for controlled and compliant document management systems.

"Using SharePoint in an FDA-Regulated Environment" takes a look at recent experiences at Tufts Medical Center. The presentation provide an interesting case study of how a research laboratory is using SharePoint.

It seems that especially in these uncertain economic times, life science companies are looking to improve their information flow. For translation service providers that means that multilingual content management systems will become even more prevalent.


For translation services for regulatory, quality, and clinical research texts, take a look at ForeignExchange Translations' specialized services.

Belated best wishes to all of our translator colleagues!

The annual celebration coincides with the the feast of St. Jerome, the Bible translator who is considered as the patron saint of translators. The celebrations have been promoted by FIT [PDF link] and have steadily gained traction since being officially launched in 1991. The South African Translators' Institute has a good overview of the holiday [PDF link].

It's interesting to see linguists the world over (not just Christians) accept and celebrate this holiday. It's a rare show of unity in our profession.


After you've recovered from the celebrations, be sure to subscribe to Medical Translation Insight via email or RSS!

Over the past month, our readership has grown by 25% - thank you and welcome to all of the newcomers out there!

In case you missed them, here are the posts that received the most attention in September:

1. Why international web sites fail - It's important to know how to work towards a successful global web presence; it's also important to know the pitfalls.


2. What you need to know about translation memories - A lot of translation managers in drug & device companies have only a vague idea of what a TM is; this article explains some of the inner workings.


3. Explore (medical) terminology with Wordnik - Judging by the popularity of this post, there is a big demand for better research tools.


4. Man vs. machine in proofreading - Newer isn't always better; there are a lot of advantages to proofreading on hardcopy.


5. Japanese "device lag" disappearing? - Momentous changes are underway in Japan, and medical device manufacturers the world over are rejoicing.

Interested in past months' most popular articles? Take a look at our roundups for August, July, and June. Happy reading!

For those medical device companies not prepared for the revisions to the EU's Medical Device Directive (MDD, 2007/47/EC), next March may just come in like a lion.

While many of the changes are obvious and easy to accommodate, some are more subtle and require a bit more digging. One of the most challenging components of the new directive is the increased focus on language translation for software and labeling.

For instance, the updated MDD states that software that is integral to the operation of a medical device must be translated into the languages of the countries in which the device will be sold. In the past, companies have been able to avoid software translation by stating that the great majority of professional device users can read English.

Software translation (aka "software localization") is no small feat in a medical device environment. It can be expensive, time-consuming, and a minefield for errors. But it doesn't have to be this way. Through implementing some best practices and avoiding common pitfalls, software translations can go smoothly.

Notified bodies are now placing particular emphasis on the risks presented by inaccurate labeling and translations. Inaccuracies in labeling and IFUs can lead to incorrect use of a device, resulting in injury, death, notified body action, lawsuits and bad publicity. The root causes of inaccurate translations are many, but fortunately, these can be sidestepped through careful preparation, translator screening and efficient processes.

The 2010 MDD Revisions and What They Mean for Translation is structured to help device companies prepare for the 2010 MDD deadline through a better understanding of its requirements as well as ways to implement best practices into labeling and software translation.

Spend one hour now to get educated, or spend days later arguing with notified bodies, affiliates, and regulatory affairs staff about how to fix your translation processes!


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