Category Archives: Medical Device Regulation

“Scots Wha’ Hae” and Radical Localization for Medical Device Marketing Material

‘Scots, wha hae wi Wallace bled,

Scots, wham Bruce has aften led,

Welcome tae yer gory bed,

Or tae victorie.

As a Celtic Studies major in college and one-time resident of Scotland, I’ve watched with keen interest the impending Scottish independence vote. After 300+ years of union, it’s shocking to think this vote is too close to call (with an incredible 95%+ voter turnout). However, it’s also a very good example of the persistence of regional culture and identity in Europe – and underscores the importance of localizing (not just translating) your marketing content.

Marketing messages designed for the US may not resonate (or even translate) into e.g. French, German, or Turkish markets. That’s why many manufactures are now looking at “radical localization” – a complete rewrite of marketing content for local markets – only “guided” by the English original.

Of course, in these instances, it’s important to have a control in place to ensure that the localized material is acceptable from a Regulatory point of view. This is where technology can help: TransPerfect Medical Device Solutions offers clients  validated technology (Translation Review Portal; TRP) for easy, online review and auditable commenting of translated material – there’s even a preview function so you can see your material in formatted context.

If you *do* need to translate your content into EU target languages, TRP also makes a great platform for your overseas contacts to review and comment on translation quality – there’s even a built-in grading and scoring system so you can track results.

So, whether it’s review of translation accuracy or review of “radical localization” for compliance, technology from TransPerfect Medical Device Solutions can help. And, if Scotland *does* become independent and requires Gaelic for labeling, you’ll be ready!  😉

P.S. Although, romantically, I would love to see an independent Scotland, I know from a practical perspective that continued union is in Scotland’s best interest: No thanks!

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Medical Device Business “Too Hard”…for Google (?!)

Admitting something is “too hard” isn’t common at Google…but if you go to 28:54 of this video, you’ll hear Sergey Brin and Larry Page explain why medical device/healthcare is one of those areas.

Aside from feeling a little self-satisfied that you’re doing something that’s too difficult for Google, there are other points to consider here. Sure, device regulation is complex and difficult – and sometimes a little capricious and illogical. Still, regulation is meant to protect public health from faulty devices and bad actors – not everyone who makes a medical device puts patient safety first (witness the PIP breast implant scandal).

This is a common refrain from new technology companies: regulation is stifling innovation. The battle between taxicabs and Uber is one example. However, part of the cost of a cab comes from liability insurance – you can sue the cab company if you’re injured – a pedestrian can sue the company if they are struck by a cab…who are you going to sue if you’re struck by an Uber?

Technology companies (and some device companies) see regulation as an unnecessary burden, but many of these regulations are what help keep devices safe and effective. In this respect, a “least burdensome” approach to regulation is desirable – as the inscription above the temple of Delphi read: “Nothing in Excess”