Medical Translation Insight

Many medical device companies doing business in Japan rely on their Japanese affiliates to handle the creation of regulatory documentation, due to language and cultural considerations and the complexities of Japanese regulations. A problem with this approach is that U.S.-based companies often do not know exactly what was submitted to the government, which can have serious implications.

The Japan submission dossier preparation and translation process requires a unique approach. Cooperation among submission authors and reviewers, the translators and the Japanese affiliate is essential to make it work. When it does, a company can be assured that its English and Japanese submissions stay consistent, and there are no questions about what is submitted. It has the side benefit of building cross-cultural teams, where both parties focus on their core competencies.

Our own Jason Heaton is co-presenting a webcast with Minori Nakano-Carlsson of Medtronic on the topic of Japan regulatory submissions. The June 8th webcast is being sponsored and hosted by the Regulatory Affairs Professional Society (RAPS).

Jason and Minori-san will discuss how regulatory documentation gets translated, look at specific approaches companies take for their Japan dossier creation, identify the problems with the usual approaches, and present best practices for creating consistent, accurate and timely submissions. You can sign up for the 90-minute Webcast on the RAPS website: www.raps.org/Education-amp-Training/Webcasts/RAPS-Webcast-8-June-2011.aspx.

Jason presented on a similar topic for FX Conferences. If you can't make the RAPS Webcast, download his past audio conference instead.


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

ForeignExchange is hosting a three-part workshop series at our office in Minneapolis in response to feedback we received from the local translation community.

Technical communications, regulatory, clinical and marketing professionals have all told us that they like workshops that provide real world examples and practical, actionable takeaways. With that in mind, we're hosting three seminars this spring and summer around thorny issues faced by people who deal with translations:

• "Writing for Translation",
• "Budgeting for Translation" and
• "Optimizing, Reducing or Eliminating In-Country Review".

The workshops will be for a maximum of 15 attendees each and promise to be highly interactive and practical. Our first one, taking place today, April 28th, filled up quickly. But if you're interested in attending either of the other two, send an email to education@fxtrans.com.

We will be offering similar workshops in other cities later in the year so stay tuned. To learn more about ForeignExchange's educational offerings, visit www.fxtrans.com/education.aspx.


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This year, ForeignExchange has kicked off a new program, partnering with life sciences experts – regulatory consultants, CROs, risk management advisors, and others – to expand our offerings and stay current with all aspects of the drug and device industries. These "FX Certified Partners" are working with us to provide new informative content in the form of white papers and educational audio conferences, as well as step in to work with us on unique projects and provide a go-to list for us to refer to clients.

From time to time, we'll spotlight a different FX Certified Partner here on the blog. Today it's Data Decision Group. They are a full service medical marketing company that specializes in strategy consulting, marketing support and research for the medical device, diagnostics, pharmaceutical, and biotech industries.

The company's founder, Maria Shepherd, has been a popular speaker for us, focusing on Human Factor Engineering and this month, she has an upcoming audio conference on the topic in early May. You can find out more about the audio conference here (www.fxconferences.com/HFE-Usability-101-Human-Factors-Engineering-Usability-Testing-Basics-P578.aspx) and about Data Decision Group here (www.ddecisiongroup.com/).


ForeignExchange's educational arm, FXConferences, partners with leading industry experts to bring you key information and guidance on the latest challenges and hot topics, and our audio conference format makes it easy to participate from the office, at home or on the road.

It was a windy and rainy day that saw the start of memoQfest 2011. As usual the meeting was held in Budapest and hosted this year in one of Europe's most famous restaurants, the Gundel, a magnificent venue for what turned out to be a very enlightening conference. This year the conference's title was "Using translation technology to change or grow your business" and it proved to be very interesting.

The 3 day event (including the pre –conference) showcased a number of topics around the value of establishing new standards for technology and the business itself, the future of technology and a number of updates with regards to Kilgray's upcoming new releases of TM Repository as well as updates on their road map for the MemoQ suite of products.

The conference featured a number of presentations around terminology, XML and Xliff exchange as well as workflow and quality.

Martin Beuster discussed quality management and Sandra La Brasca of ForeignExchange spoke about different strategies for driving work flow efficiencies through quality measurement. Sandra's presentation included a synopsis of ForeignExchange's METRiQ methodology and tools to reduce costs and turnaround time by moving quality upstream.

All and all the conference was very informative, kudos again to the Kilgray team who did a superb job of organizing the conference as well as the networking events, culminating in a gala dinner and boat tour on the Danube which was a truly breathtaking event.

Keep doing what you are doing!


For more on memoQ, take a look at some of our related articles:

• Automate translation processes for less than $5,000
• Why do word counts vary from tool to tool?
• memoQ, here we come!

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