Viewing posts categorised under: Medical Device Translation
Do I Need to Translate to Sell Medical Devices in the European Union?

Do I Need to Translate to Sell Medical Devices in the European Union?

by Translation Guy on January 12, 2017
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While a significant percentage of doctors in the European Union speak and read English to a high standard, not all of them do. But more importantly, that figure is much lower among the general population and potential users of your medical device. What about the regulations though? In a previous post we talked about some of the opportunities the European Union presents for US medical device firms looking to expand abroad, such as the unified regulatory approval process, but also the requirements for translation. Let’s take a closer look at those translation requirements. In most EU countries, or if your medical device is intended to be used by patients or users from the general public, your firm will need to translate the patient or user information into the national language(s) of each EU country you intend to commercialize the medical device in. This information typically includes the instructions for use (IFU) as well as the device's packaging and labeling. Translating this information allows those who will use the medical device to know how to properly use it. That said, translation is not always mandatory. In a small number of EU countries, labeling in English only is permissible when the medical device is intended for professional use only. Even if translation is not compulsory, however, there are other reasons for your medical device firm to opt for translating user information. Chief among them is exposure to liability. In the case of an injury or death associated with your medical device, choosing not to translate relevant information about the device can unnecessarily expose your firm to liability lawsuits or having to pay for damages. In addition, not translating patient information has the potential to prevent you from being covered by liability insurance. In other words, translating user information is an easy way to guarantee continued success for your medical device. Translation doesn’t just help you speak your medical device user’s language and allow them to properly use the device; it helps ensure regulatory compliance and reduces liability exposure. For additional information or to discuss your specific translation requirements, please get in touch at 212-355-4455 ext 208 or kclark@resptrans.com.

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Opportunities for US Medical Device Firms in the European Union

Opportunities for US Medical Device Firms in the European Union

by Translation Guy on December 29, 2016
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While the United States is currently the largest market for medical devices, the European Union presents significant opportunities for US medical device firms looking to expand abroad. The European Union's medical device market represents the second largest in the world; it's worth 100 billion euros and accounts for 31% of the entire globe's medical device market. (To compare, the US accounts for 40%.) A few of the reasons the European Union is an attractive place to expand are that it has a large population, it spends a significant amount on health care and medical devices, and it offers a unified regulatory framework.  

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New Opportunities for Medical Device Firms in Emerging Markets

New Opportunities for Medical Device Firms in Emerging Markets

by Translation Guy on December 14, 2016
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With more than two billion underserved patients in emerging markets around the world, medical device firms have plenty of room for global growth. This includes underserved patients in countries like India and China, as well as in regions like Latin America, Southeast Asia, the Middle East and Sub-Saharan Africa. While each market has its own unique characteristics, there are still some important points in common. Let's take a look at some of the influences on emerging markets that will be relevant for medical device firms for the next 15 years or so.  

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Five More Reasons We Should Be Your Next Medical Device Translation Provider

Five More Reasons We Should Be Your Next Medical Device Translation Provider

by Translation Guy on June 23, 2016
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While we devote a lot of attention to assessment translation issues here on the blog, that’s not all we do. Not by a long shot. As a leading provider of high-stakes translation to compliance-intensive industries, medical device translation is also one of our main specialties. We’ve worked with Zimmer Biomet, Smith & Nephew, Celgene and many other life sciences companies. We make it our job to help ensure the health, safety and market viability of your stakeholders through translation. Don’t believe it yet? Here are five more reasons we should be your next medical device translation provider:  

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The Meaning of Patient Care

The Meaning of Patient Care

by Translation Guy on April 27, 2016
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Professional translation is content neutral, but not so translators’ hearts. We happily translate whatever crosses our company’s threshold, and we take pride in our service to all, in the quality of our deliverable, in the quality of our service and in the pleasures of the friendships and friendly associations we enjoy with customers and vendors new and old. But personally, I like health care best. Especially when we work directly with LEP (limited English proficient) patients in the midst of their trials. I feel as if our work is of more consequence when we can touch the lives of people in crisis and ease their path as they journey across the terrifying landscape of illness.  

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Translating for the CE Mark: Marketing Medical Devices in Europe

Translating for the CE Mark: Marketing Medical Devices in Europe

by Translation Guy on October 14, 2015
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Want to sell your medical device in the European Union? Europe accounts for 30% of the world's medical device market. To get a slice of that pie takes a CE mark first.  

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China Medical Device Labeling Gets Sticky in 2013

by Translation Guy on October 22, 2012
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China’s State Food and Drug Administration (SFDA) will require all outside labeling and packaging of devices to be in Chinese by April 2013. Failure to provide Chinese labeling and packaging text will result in market banishment. We asked TranslationGuy, noted industry analyst, if this law was a good idea. “Hell yes, it’s a good idea. More translation is a good idea. Your average Chinese Joe has a right to know what it says on the label before they stick a medical device inside him. It’s good for business, my business most of all! Plus, good translation saves lives. Who wants to be on the wrong side of that one?” But not just any translation. SFDA officials require that “overseas medical equipment manufacturing enterprises should establish quality management system to ensure that … medical equipment complies with Chinese regulations.” So I pulled the adding machine off the top shelf, blew off the dust, and set to figuring if we were going to have to build a new word mill below the translation memory pond to handle all that new Chinese label demand. China's medical device market has grown to $8.8 billion, the second largest in Asia after Japan. The number of foreign medical device manufacturers selling, sourcing, or manufacturing in China has grown exponentially. However, there are still quality control problems with recalls and scandals. The Chinese medical device market still relies on imports, and the unique Chinese combination of fast economic growth and rapidly aging population ensure growing demand.  China’s medical device sales are estimated to reach $45 billion in the next decade. “Besides increased awareness, one of the key factors contributing to the market growth is patient demographics in China. As the disease incidence caused by the aging population continues to rise in the country, there will be strong demand from patients seeking advanced medical procedures and techniques that can provide safe and effective diagnoses or treatment, ultimately driving an upsurge in the use of medical devices,” say experts. Some useful resources for those interested. Regulations for the Supervision and Adminstration of Medical Devices. That’s the law. Also of possible interest, Brief Introduction of Medical Device Regulations in China by Chang Yongheng, Deputy Counsel in the SFDA’s Department of Medical Devices. From 2007 but a good overview.

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Trade Show to Hell

by Translation Guy on June 14, 2010
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This week was MD&M East at the Javits Center here in NYC, so I stopped by for some face time with a few of my medical device clients, got to handle some of the incredible sci-fi contraptions that we translate about, and then walked the floor, doing the meet and greet, prospecting among the booths (I am way too cheap to rent a booth), which naturally got me thinking about haunted houses. Richard Wiseman is one of a number of researchers who have investigated what makes haunted places feel haunted. If you don't believe in ghosts, why are you more likely to get a chill down your spine in one place than another? Magnetism, infrasound, psychological factors, whatever, some places are just more shivery than others, and that's why we call them haunted. I've noticed the same unexplained phenomena on trade show floors since the downturn. Parental Advisory:  Scary Trade Show stories may not be appropriate for younger viewers. Not that I've ever seen some rep handing out spooky business cards, no haunted furniture, no dust-covered skeletons. Something far creepier. Bad coffee. Bright fluorescent lights far overhead shining soullessly across the bald heads filling archipelagos of curtains and signage, each booth a little brand island populated by sales guys and sales engineers and sales associates tempting passersby with eye candy, and bowls of candy like little eyes, and the little eyes of the sales guys, squinting and sizing, and it’s so, so, what? Not a haunting, not even a flaunting like it was back in the good old days, and a lot more girthlings than guantlings. It’s most of all daunting, if the rhyming device employed in this sentence is to be carried through to its bitter end. Dauntingly, everyone wants to be somewhere else. The engineers want to be engineering over their spreadsheets, the salesmen want to be pinging back at their desks, and all would rather die a thousand virtual deaths at the hands of their sons on Xbox than drink overpriced cocktails in some Times Square hotel bar. Yet all are bound to their booths by the powerful enchantments of management wizards. Am I mirroring? Yes. This is a blog, so call it a fun-house mirror. Like most everyone else, I hate working the floor. But I lurch from booth to booth draped in the heavy, ghostly chains of commerce, because I am too cheap to rent a booth. Nothing looks more pathetic to me than a translation services booth. Despite my good intentions, I didn't have the heart to research beforehand, so I picked prospects based on signage. I began my intro with one likely suspect, and suddenly a witch jumped out of a curtained corner. "I do all the translation here! German, French, Greek. I do it all!" "Gee, I guess I should hire you to work for me," I said, which is my exit line when talking to an amateur who thinks they know what we are doing, but doesn't. But I couldn't leave the field without receiving a parting shot. "But that could change...perhaps you have other ways you wish to use your time..." I laughed.  "No. It will never change. I won't bullshit you. We will never use your service! All these other guys say, 'OK, I'll take your card, I'll give it to the right guy,' or whatever, even though they are just going to toss it in the trash as soon as you round the corner. But I won't do that." "Thanks. I guess that concludes my pitch. So how's the show working out for you this year?" "It's terrible!!" "I've been picking up on that. When the sales guy tells you he's doing 'OK' in that certain tone, you can tell he's not making his numbers." "See? Bullshit! I told you I wouldn't bullshit you!" I felt for her, for pitiful me too, for all my sales brothers and sisters caught up in this daunting venture. So as my demeanor changed, they began to bare their blackened sales souls to me. "My feet hurt." "I want to get out of this booth, but I can't leave." "This show is costing me too much money." "I hate the Yankees!" That last disclosure was a bit too much for even my newfound empathy, so it was time to go. On the bright side, I did get a free Wiffle ball and bat from the New England Business Development Council, which they assured me had no connection to the Red Sox. See you at the show next year!

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Medtronic: A Benchmark for Medical Device Translators

by Translation Guy on March 21, 2010
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Medtronic is the world's largest medical device manufacturer, and it also does a lot of its own translations. So it's no surprise that the company has become a leader in the translation industry as well, enjoying a reputation for careful attention to ROI and best practice. Medtronic's internal translation groups (Technical Literature department in Europe, Global Translation Solutions department in the U.S.) provide translation and localization services to internal customers all over the world. A very diverse and international team of translation specialists, project managers and technical staff work with high-tech localization tools to ensure best-in-class translation services. I recently had the chance to talk with Micah Bly, Localization Manager at Medtronic Global Translation Solutions, in Minneapolis. He described a translation strategy that in many ways is unique in the medical device industry. Medtronic uses both internal translation teams and outsourced language service providers to localize and translate lots of different content into lots of different languages. Medtronic’s internal translation teams are staffed at a fixed percentage of peak demand capacity and provide translation and localization services for a set number of key target languages. Because of their volume and workload balancing model, they are able to get best value out of internal resources, and they have also developed the management skills and operational knowledge to stay at the head of the translation pack in the medical device community. And you don't see a lot of that.  Fact is, most companies that translate for themselves are far outside their core competency and way over their heads, losing money without even knowing it. Not these guys. The Medtronic model is built around flexibility ― setting up partnerships to manage target languages not covered by internal teams and to fill in for when the workload is above and beyond the call of internal translation duty. That way they never get caught short, either on delivery or in their translation wallet. “Most of the actual translation work happens at the vendors, with the internal teams adding the extra ‘Medtronic touch’ with additional language QA and product knowledge. There are only a few types of projects where the internal linguists act as front-line translators (software UI and projects with 95% matching, etc.),” says Micah. “We would have to have an immense pool of people sitting around idle most of the time, if we were going to do the actual translations ourselves. We focus on managing the process, the resources, and, most of all: the quality. We are more serious about translation quality than most companies, because in our case, a bad translation means we could be putting a patient at risk. That fact colors almost every decision we make when designing translation processes.” Flexible, long-term partnerships with translation providers ensure that the quality of translations stays top-notch no matter who is doing it. Flexibility is also the key to the Medtronic approach to translation technology. Among the software providers, the Medtronic translation teams are known as tough customers, since they are not about to get locked into a single solution. Medtronic invests in translation workflows, rather than in wider global localization workflow solutions. Their internal client production processes and tool requirements drive their workflow automation requirements, not the other way around. Sounds like best practice to me. So even for language service providers like us, who are supposed to be the experts, there's a lot to learn about translation from Medtronic, which does our business as a sideline. Geesh.

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All our customers speak English

by Translation Guy on January 3, 2010
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Frank Pastormerlo, whose job is to prospect and qualify new clients for us in the medical device industry,  is still learning the ropes. He came into my office today in a state of shock.  "Is it true that everyone in the medical device industry speaks English?" "No way." I said, "It's a global business. There's plenty of people that don't speak English. Where did you hear that?" "I just got off the phone with this guy who said they didn't need to translate because everyone in their business spoke English." I love moments like these, were I can kick back in my chair and start pontificating instead of working. (Frank didn't seem quite so pleased since he had a lot more calls to make, but what the hell, I'm the boss, right?) "Well, he only ever talks to people that speak English, because that's the only language he speaks. And that's probably true of everyone in his company.  All the people that don't speak English avoid him and his friends as if they were football hooligans running towards them throwing bottles." Think about it. When was the last time you had a successful conversation with someone who didn't speak the language you speak. If you were lucky you managed to find your way to the bathroom. But usually those cross-language encounters end with shrugs and sheepish smiles. Most of us live our lives in a bell jar of a single language, or if we are lucky one or two more, and outside of that it's the dome of silence. All those opportunities for love and fortune, good times and bad, lie beyond the pale, even beyond our recognition. "I can't say that hooligan stuff!" Smart guy, Frank. He wants the close. OK, I'll teach you the Willy Brandt line, I'll teach you how to say it in German!" If I'm selling to you, I speak your language. If I'm buying, dann mussen Sie Deutsch sprechen Frank's expression becomes pained. "He's not a sales guy. He does clinical trial stuff." Pause. "I think I'm just going to make more calls now."

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