Clinicians, do diverse study subjects have access to translated materials?

The following is an interesting post from a LinkedIn connection. Have you built into your study the participation of diverse groups based on race, ethnicity, and gender? Do you have translated documents to support those populations? Many language providers out there claim to provide specialized translations specifically for life science initiatives, yet few fulfill the necessary requirements to pass muster with your Regulatory Affairs team.

Source: Fomat Medical Research     Diverse study subjects require translated materials                                                                          

Hispanic cancer patients rarely participate in clinical trials, but researchers want to tailor a Spanish DVD to help change this. To create a relevant educational tool, Moffitt Cancer Center researchers investigated why awareness of and participation in trials are so low in this population.

Using focus groups with 36 Spanish-speaking cancer survivors from Tampa and Puerto Rico, researchers found that a language barrier, as well as a cultural idea that only doctors, not patients, guide treatment decisions, may help account for low participation rates.

Looking for ways to improve knowledge and participation for Hispanic patients, the researchers used feedback from the focus groups to help develop a Spanish booklet and video to educate and empower patients to participate in treatment decisions.

The study was published online in May by the Journal of Health Communication: International Perspectives.

The 45.5 million Hispanics living in the United States are the nation’s fastest growing ethnic group, and there is a need to develop health care educational materials that target their language and culture. These educational materials should not be merely translated from English, the researchers said, but should be adapted to meet the group’s informational needs in a culturally appropriate way.

Idem Translations Receives ISO 17100 Certification from Leading International Testing Organization

Palo Alto, CA (PRWEB) January 23, 2017

Idem Translations, a provider of translation and localization services for life science companies, has achieved ISO 17100:2015 certification following a comprehensive audit performed by international testing and inspection organization, TÜV SÜD America. ISO 17100 is the globally recognized standard that establishes guidance for critical processes within translation, quality of service, delivery requirements, translator evaluation and selection, technical resource specifications and general management guidelines for translation service providers. ISO 17100:2015 replaces the previous European standard for translation services, EN 15038:2006, thus addressing changes within the industry.

Idem Translations is among the first U.S. translation providers specialized in life science to receive
ISO 17100 certification by TÜV SÜD America. Idem is proud to have successfully passed TÜV SÜD America’s stringent auditing procedures, validating the company’s strict approach for producing superior translated content for its clients.

“Our clients work in regulated industries where safety and traceability are the very foundation of their development and manufacturing processes. They rely on Idem Translations to ensure that translation processes follow the same quality control steps that are both repeatable and auditable,” said Jessica Alexander, Vice President of Quality & Operations at Idem Translations. “Updating our ISO certification to 17100 signals our commitment to continually reduce risk throughout the translation process, and provides a guarantee to clients that translation will be one less thing they’ll have to worry about.”

“Companies like Idem Translations that invest in multiple ISO standards like ISO 9001, ISO 13485 and ISO 17100 recognize the importance of certification not just to clients but to the overall mission of continuous process improvement,” said Dr. Christopher Devine, President of Devine Guidance International. “More than just standards, these certifications mean that the company is focused on meeting tough industry requirements that result in exceptional vendor care.”

Idem will be at RAPS 2016. How about you?

Calling all regulatory professionals!

Idem will be exhibiting at RAPS Convergence in Santa Clara, California, September 17-20. You won’t want to miss this year’s fantastic lineup. If you’re interested in sessions that address updates to regulations and guidance around the globe, this is a perfect opportunity to stop by and speak to us about your future translation needs.

Let’s put our heads together at RAPS and see how we can make translations the easiest part of your job! Schedule a meeting with us today.

We’re giving away a Fitbit, so stop by for your chance to win. See you there!
Booth 135




Translating Instructions for Use: Read This First

Your next device or therapy will be available for commercial use in markets outside the U.S. and you have been tasked with finding someone to translate the Instructions for Use. You know you need a professional translator whose work will pass regulatory requirements, so you do a little research online and find a vendor with a decent website and respectable client roster. Great!  Before you call, prepare yourself to provide key information that your new translation vendor will need.

Do you know which languages you’ll be translating into? You may only want to translate one or two foreign languages at initial launch, but have you considered subsequent version releases that will include more languages? This is important, because it will help you determine the size and format your IFU should be.

Foreign languages expand with translation – a standard rule of thumb is about 30%. Your printer can help design the appropriate format, such as map fold or booklet, and provide specifications.

Make sure the source file and specifications are available to the translation vendor at the onset of the project; a pdf is a good reference document, yet it won’t help with multilingual translation and lay out.  It may seem counterintuitive to include your printer in translation issues and yet they go hand in hand.

By planning a few key elements before actual translation takes place, you can save time and money.

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Translation versus Localization – What’s the Difference?

If you’re new to translations, you may hear the term localization bandied about. Perhaps you’ve called a translation services provider and explained your project needs, and they launch into a description of the ways in which they’ll localize your files.

You’re a clinician. References to translation and localization have wholly different meanings in your world. So, what’s the difference?  Simply stated, translation is the process of changing words from one language to another.  If you need a document translated from English to German, that’s known as translation.  Localization is more like cultural adaptation. Beyond the primary meaning, localization also addresses norms and style that are familiar to the local population.  Date formats are a classic example because they can be a major source of confusion between Americans and other nationalities: at best they are a headache, at worst they introduce patient risk, especially with respect to software localization on medical devices and applications.

Other terms include internationalization, which refers to the upstream process of planning to ensure content can be translated or localized without disrupting functionality. All of these activities can be couched within a larger framework known as globalization, which represents the way that people, company, and governments interact around the globe. If you’d like to learn more, contact Idem today for a free consultation. We’d be happy to help!

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Dear Idem: What do we do if the user interface on our medical device isn’t translated?

Dear Idem Translations,

We plan to translate the user interface for our device, but we aren’t ready to tackle this  in the immediate future. We have an opportunity in another market outside the U.S. right now, and although the UI isn’t translated, we will translate the instructions for use. Will this pass muster with the notified body? Do you have recommendations for how to handle?  

Translating software strings can be a complex process, especially if the software wasn’t developed with translation in mind (but that’s a separate topic for another time). It’s a good sign, though, that Engineering is thinking long-term about non-English users.  For compliance in your immediate plans, it’s critical that all actionable instructions are clear and easy to follow in the IFU, even if the user is operating with an English screen they cannot read.

There are several ways you can tackle this problem. In the screenshots you replicate in the IFU, you can use indicators such as arrows, callouts, or different colors to draw the user’s attention to actionable elements, so long as they don’t detract from overall usability. Too many arrows cluttering the instructions could confuse the user, so use them sparingly.

In the text of the IFU instructions, you can also embed on-screen commands (in English) while providing translations directly after. For example, if your instructions in English read:

Tap and hold the ‘Open’ button.

your instructions in French could read:

Appuyer et maintenir le bouton ‘Open’ (Ouvrir).

You might also a reference table for on-screen text. This table would contain terms used in the English GUI in one column and the translated terms in the column directly beside it.

Most importantly, though, talk to your translation provider to create a strategy that will work for your specific software and the content of your IFU.  They’ll be happy to help you optimize.

Contact us – we’ll step you through the process!

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Crowdfunding – the New Medical Device Mania

Crowdfunding has become a household word among technology companies, and is now making its way to the forefront of the medical device industry. Sites like Kickstarter and Indiegogo are seeing a rise among would-be investors getting in on the ground floor of these ventures, with the promise of blockbuster returns. Certain sites are targeted specifically to the medical device developer community; examples such as Crowdacure aim exclusively on medical device development.
The reasons for this burgeoning activity are essentially the same as what one might find in technology: investor appetite for early-stage development is on the wane since so many of them would prefer to invest in ventures whose devices are closer to market release. This, coupled by the FDA’s perceived inability to move devices more rapidly through regulatory channels results in device manufacturers’ willingness to seek approval with offshore regulatory bodies (particularly the EU). What’s more, researchers and early-stage device manufacturers are trying to rein in costs so as to make their technologies affordable for everyone. Quite often, it’s the only way for companies to fund research and development for non-traditional diseases or conditions that aren’t a target for regular funding pathways, either because the population affected isn’t large enough or vocal enough.
The funding path from unorthodox sources like the ones described is, of course, fraught with risk. A multitude of eager investors may hedge their bets on therapies that will never see the light of day or receive FDA clearance, and there’s no specific language to date that addresses the legal implications of such a practice. Certainly the FDA is in no hurry to make a ruling on how products are financed, limiting its reach to issues that might pose a threat to public safety.
It’s easy to see the attraction for the medical device startups to go this route, and it could be a faster, more economical method for getting much needed therapies out to the public sooner and more affordably. What are your thoughts about this practice? Are you currently involved in or thinking about a crowdfunded approach to funding your medical device development?