The Life Sciences Business Round Table, organized as a pre-conference session of the Localization World conference in Paris earlier this week, was an uplifting experience.
It was moderated by the co-chairs of the Life Sciences Advisory Board – Clio Schils from Lionbridge and Richard Korn from St. Jude Medical – this event had some 27 attendees and was one of the highlights of the whole conference.
This one and a half day session gave much food for thought and insights, with some of my main takeaways being:
1. Current Translation Requirements for Medical Devices
The way medical devices are currently regulated and registered in Europe leaves some leeway (or, uncertainty) in terms of what actually needs to be translated in individual countries. The EU medical device directives have been included in the local legislations, and there is a whole infrastructure of competent authorities as well as notified bodies in each country.
But manufacturers may still face a degree of latitude, primarily in the area of devices for professional use. The survey conducted among individual European agencies regarding the language labeling requirements for professional-use-only devices in Europe, presented by Helen Colquhoun from CROMSOURCE, has revealed the exceptions, or inconsistencies, among individual countries.
On one hand, translation is a clear risk management measure, allowing manufacturers to address the risk of any litigation for non-compliance, regardless of what language version users actually require or choose to use. On the other hand, some may choose to “follow the money”, and translate some content only in case of a specific business opportunity or need in a given country – especially in case of smaller organizations.
The way the three medical device directives are currently reviewed by the EU Commission, may result in a new regulatory setup not dissimilar to the more centralized way medicines are authorized in Europe. By its own admission, the EU commission described the current framework as being “too fragmented and difficult to follow and fraught with national variation.”
Eventually, medical device authorization in Europe may end up managed by the same agency, the European Medicines Agency, as one of the two agencies currently shortlisted to assume the role (the other being the Joint Research Center – JRC).
2. Fast Track to Optimization
Medical device companies are moving rapidly to optimize and better organize their translation setups and processes. This was clearly demonstrated in the presentation delivered by Laura Gosselin from Waters Corporation, and Babs Sekel from Agilent Technologies, Inc., two leading global manufacturers of scientific instruments.
Much is being achieved by greater use of technologies – TMS, CMS or structured and controlled authoring. Content validation and the overall move to XML are another example.
In many cases, companies may face an uphill struggle internally, when the organization of translations may not get the attention and the resources they would deserve. But translations for either marketing purposes or local authorization are increasingly recognized as important contributors, and this allows organizations to initiate changes that result in a more streamlined process. In this regard, life sciences are quickly catching up on what the development may be in other industries.
3. The Evergreen Topic of In-country Review
The in-country review process has been a recurring theme during the Round Table. The presentation by Moti Daswani, an in-country reviewer from St. Jude Medical based in France, showed the real-life challenges of the review process from the perspective of someone for whom such reviews are a non-core responsibility.
But it also demonstrated the real benefits of such an involvement in final language quality by local representatives, or field staff, who have hands-on product knowledge and direct customer exposure in a given country. So, in many ways, this is a dream scenario, and one that many organizations have successfully incorporated into their language QA processes. With medical devices, this in-country language QA step is all the more important. In general, what seems important is involvement of reviewers early in the process, clear roles and responsibilities, defined processes, and sound planning.
All in all, this was a fabulous event. Huge thanks to the organizers and the whole Life Sciences Advisory Board.