Medical Translation Insight

These days, mobile health (mHealth) seems to be everywhere. As the use of health text messaging, mobile phone apps, remote monitoring, and portable sensors has expanded, they have changed the way healthcare is being delivered in the U.S. and in Europe.

But with rapid change and innovation come questions, false starts, and regulatory uncertainties. Just like when drug and device companies (and FDA) struggled to come to terms with social media, they are now having difficulties dealing with the regulatory hurdles around developing mobile apps for patient use.

In Europe, for instance, the Medical Device Directive (MDD) is playing catch-up with respect to mobile apps. In the U.S., mHealth provides are trying to navigate FCC regulation of the radio spectrum, the impact of HIPAA and other privacy laws on data being transmitted, and FDA's role as gatekeeper to the market for mobile medical applications.

Fxconferences.com features two presentations that will shed light on this quickly developing field: Mobile Medical Apps for Europe: What You Need to Know from a Regulatory Point of View and mHealth Converges – The Impact of FCC, HIPAA/Privacy and FDA Challenges.

Also take a look at these past articles; it's amazing to see how far we've come in a short amount of time:

• FDA to regulate medical apps
• Walkman, PS3, medical device?
• Is Nintendo the next Medtronic?

ForeignExchange Translations provides specialized medical translation services to the world's largest medical device and pharmaceutical companies.
 

The annual meeting of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) is currently underway in New Orleans. ForeignExchange is well represented by Janis Shea and Sonja Jacobsen.

Despite a poor layout (sessions and exhibitors are spread-out over 3 floors), the conference is once again very well attended. More than 3,000 participants from 50+ countries are attending sessions focused on patient-centered outcomes research, evidence, and drug development.

Among the 1,600 sessions, several stood out: Fitting within the "focusing on the patient" theme of the conference, one particularly interesting session discussed the nuances around patient-reported outcomes and patient-centered outcomes. Not surprisingly in the current economic environment, many sessions deal with costs and payer issues.

Several topics were of particular interest to medical translation professionals. For instance, "Translatability Assessment of the Youth Quality-of-Life Instrument-weight Module" (yes, that really was the session title!), went into great detail on how to evaluate the translatability of a source text, linguistically and culturally.

The presenters gave a couple of great examples:

1. Questions referring to youth and "your boyfriend or girlfriend" are not acceptable in Muslim countries
2. The definition of depression varies across cultures – it could be understood as anything from slightly sad to clinical depression

Practitioners of linguistic validation are comfortable with these issues. For other medical translators who may not be as familiar with the concept, you can think of it as "quality at source".

There are a couple of days left at ISPOR's annual conference. If you're not in New Orleans, join the Twitter discussions at @ISPORorg and #ISPORNewOrleans.

For more on PROs, linguistic validation, and back translation, take a look at the following articles:

• The gold standard of back translation
• Linguistic Validation Practices for PRO and QoL Measurement Tools
• FDA final PRO guidance will increase demand for linguistic validation

ForeignExchange Translations provides specialized medical translation services to the world's largest medical device and pharmaceutical companies.
 

For years, medical device manufacturers were wondering if e-labeling was ever going to become a reality in the EU. Then, earlier this year, the seemingly impossible did happen.

And now it looks like every regulatory authority across Europe is joining the fray. Eisner Safety reports that the UK MHRA (Medicines and Healthcare Products Regulatory Agency) "released a Guidance on EU Commission Regulation 207/2012 on electronic labeling of medical devices".

The guidance was published a few months ago and can be accessed via MHRA's website.

Device manufacturers are thrilled by all of this progress but for many medical device companies the question is no longer "when?" but "how?". If your organization needs help getting started with e-labeling, take a look at Medtronic's presentation, eLabeling in Europe -- How to Start and What to Expect from Notified Bodies.


ForeignExchange Translations provides specialized medical translation services to the world's largest medical device and pharmaceutical companies.
 

Everybody is talking about the next revision to the IVDD. We recently wrote about how upcoming EU IVD regulations are likely to cause translation headaches for device manufacturers. But the regulations are far from final and much can still change.

The current state of the IVD regulation proposal is described in a good bit of detail on Erik Vollebregt's blog, medicaldeviceslegal. His just-released article The IVD regulation proposal in a nutshell gives a terrific overview and includes lots of external references and sources.

He has also made available the following presentation:


One of the next events to shed light on the regulations will be EDMA's workshop in Brussels this summer. See you in June!


ForeignExchange Translations is the leader in medical translation. Find out why the world's largest medical device and pharmaceutical companies work with us.
 

Anybody who is active in and around medical translation knows how hard it can be to learn and stay abreast of medical language. Even for those of us who have been at it for a long time, terminology, abbreviations, and jargon are a constant challenge.

In her article Hints and Links for Medical Translators, Palma Chatonnet-Marton collected an impressive list of resources that every medical translation professional should know. She divides them into three categories that she calls rules:

"we understand our source texts, we use good terminology and we keep ourselves updated on grammar and style issues"

The article is chock-full of useful advice and terrific resources.

Palma's article is highly recommended reading - head on over to the Translation Journal to read it.

You might also be interested in the following articles:

• Medical glossary in eight European languages
• Medical translation? Yes, please
• WHO style guide good resource for medical translators

ForeignExchange Translations provides specialized medical translation services to the world's largest medical device and pharmaceutical companies.
 

Latinos are the fastest growing minority population in the U.S., comprising around 50 million people. Despite the fact that some in the drug & device space are asleep when it comes to Hispanics, more and more bilingual and bicultural resources are becoming available. There is Medgadget Español, Latina Wellness, and now Vida Vibrante.

As The New York Times reports, the site looks to fill the void for health resources that are culturally relevant to Latinos. Writers will attempt this by being a "relatable voice". In other words, talk about issues in a way that's relevant to Hispanics.

Hispanics tend to form and value strong communities. Vida Vibrante has an opportunity to leverage this community aspect and become a primary healthcare portal for Latino readers. I hope the site can pull it off!

For more information on this topic, take a look at the following:

• Language fact: Universal Spanish
• Trying to reach Hispanics online? Content is king
• Overcoming cultural barriers to global marketing

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

This is off-topic but funny in a language-geeky kind of way. Enjoy!



Have a few more minutes? Take a look at a couple of our other articles:

• Typos? What, me worry?
• 5 minutes before the crash
• Periodic table of typefaces
• Sharp spikes near groynes

ForeignExchange Translations provides specialized medical translation services to the world's largest medical device and pharmaceutical companies.
 

Global gateways to multilingual web sites are difficult. John Yunker has built a whole business around giving advice to corporations around this and related issues. (As an aside, if you haven't yet subscribed to his Blog, Global by Design, you should!)

Thanks to efforts by John and orthers, global companies are generally doing a good job with this. But even the mightiest global titans struggle when it comes to keeping online and offline materials in sync.

On a recent trip to Switzerland, I noticed the following flyer when returning my rental car (click for larger version):


Intrigued by the unusual domain I started up a browser and entered the domain:

www.fr.hertz.ch

Go ahead, try it. If you clicked on the link, you got an error page or maybe a page of Google search results. Either way, you didn't see the French page of Hertz Switzerland.

Sporting a multilingual web site since 1999 Hertz clearly understand the global nature of its business. Their online presence features a clear way to navigate countries and languages but it got tripped up in the real world when whoever designed the leaflet thought something like "Oh, a web site. They all start with 'www'."

But the problems continue: Notice how the flyer invites clients who want to print a receipt to click on "service consommateurs" and then to select "demander une facture". But as the following screenshot shows, a) "service consommateurs" cannot be clicked on and b) "demander une facture" doesn't exist - it's called "Duplicata de facture": (click for larger version)


Now, it's impossible to say whether or not the "www" link once worked nor whether or not the instructions printed on the leaflet matched an actual version of Hertz Switzerland's French web site. But the example shows just how hard it is to combine online with offline efforts - both at the time of creation and over time.

For more on multilingual web design and web localization, take a look at the following articles:

• Successful planning for Web localization
• 6 reasons NOT to translate your web site
• The global web is a tricky place

ForeignExchange Translations provides specialized medical translation services to the world's largest medical device and pharmaceutical companies.
 

For the past twelve years, ForeignExchange Translations has conducted annual surveys of our clients to determine what they think of our processes, our quality, our services, and our people. This important information allows us to gain valuable insights into how we are doing, how we can improve, and how we can continue to build strong business partnerships with our valuable customers.

This year, ForeignExchange took our survey to a new level and joined some of the world's leading companies by utilizing the Net Promoter Score methodology (NPS). By so doing we were not only able to find out if our clients would refer us, but how likely they would be to do so, and why. This critical feedback enables ForeignExchange to make whatever improvements are necessary to ensure our clients' long-term satisfaction.

ForeignExchange is pleased that 98% of those clients who responded to the survey are willing to refer us to their colleagues. In addition, ForeignExchange earned an NPS score of 53.6%.

A 50% score is considered excellent. Historically, most great companies are in the 50%-80% range. A few examples would include Costco (71%), FedEx (56%), Amazon (73%), and Southwest Airlines (51%).

Our Client Satisfaction Survey also included project-related questions related to effectively explaining and executing on proposals, timely/clear communication, and quality translations.

The following are remarks from our clients:

• "Foreign Exchange has consistently provided us with top quality translations that either meet or exceed our deadlines while maintaining outstanding and professional customer service support."
• "ForeignExchange puts an important emphasis on quality and detail."
• "Excellent service with tight adherence to timelines (often delivery is earlier than expected) and reasonable prices."
• "FX operates as a partner to your business. They put in the effort to know your business so they can become an integral part of your operation."
• "FX is very interested in doing a good job; their analysis of a project is very thorough; FX cares about their clients and nurtures the relationship."

ForeignExchange remains dedicated to understanding client feedback and working proactively to improve client satisfaction. Thankfully, this most recent Client Satisfaction Survey demonstrates that our customers continue to have very positive business partnerships with ForeignExchange Translations!

For more articles about client satisfaction, take a look here:

• Customer satisfaction does not equal customer retention
• The 5+1 things that will make clients love you
• Is quality expensive or cheap - or both?

ForeignExchange Translations provides specialized medical translation services to the world's largest medical device and pharmaceutical companies.
 

Earlier this year, Emergo Group conducted an annual survey of the medical device industry. The responses from roughly 3,500 device professionals (mostly QA/RA) were collected and tallied, and the results are now available here [PDF].

The survey contains a lot of valuable insight. While not shocking it's interesting to see that medical device firms remain firmly focused on Asia and BRIC countries.

Within Asia, Emergo notes that

"Medical device companies remain bullish about Asian markets. Japan is still #1 in healthcare spending but China will soon pass Japan and is the engine of growth in the region. Emerging markets in SE Asia are also garnering more attention."

More revealing is the industry's focus on Brazil and Mexico. A whopping 18.7% of respondents said that their companies were planning on introducing a device in Brazil for the first time in 2013. 13.6% said the same thing about Mexico.

This is great news for Latin American medical translation providers. Medical device companies will require a good bit of Spanish and Portuguese translation support and many of them will generate country-specific translations (as opposed to using existing translations from Portugal or Spain). If you work in these languages, get ready to get busy!

[Hat tip to Janis Shea!]


ForeignExchange provides specialized medical translation services to the world's leading medical device and pharmaceutical companies.