Tag Archives: medical device labeling

Emergent Innovation or The Benefits of Content Management Without the Risk

modular deviceInnovation takes many forms. In rare cases, it’s creation from scratch, completely novel, utterly unpredicted. More commonly, it’s a union of existing elements, combined in some new or unique way and adjusted for a specific purpose. When applied to biological systems, this is called “emergence” – a higher-level system emerges from a set of lower-level components. Many medical device innovations follow this pattern.  Here’s an example from one of our clients – a device that keeps a heart beating (that’s right, when you see it live, the heart is in there, pumping away: incredible) so that it can be transported over longer distances for a life saving transplant. All of the components of this remarkable device existed before they were combined in this specific manner and for this specific purpose: emergence-based innovation. The benefit of an “emergent systems” approach like this is that it reduces risk – of course, there’s the overall risk of the emergent system to consider – but the basis for the system is proven and reliable.

TransPerfect Medical Device Solutions takes a similar approach – we’ve combined validated XML publishing technology with guided authoring capabilities and translation process automation (including online translation review) to produce what we call “The EnCompass System” for labeling automation – a system that can eliminate over +50% of the cost of a traditional, document-based labeling systems: emergence-based innovation! And, our approach has the benefit of lower risk because the modules that make up the EnCompass System have been validated by the world’s leading medical device manufacturers.

The EnCompass System is tomorrow’s content management solution today – and based on industry standards (DITA/XML) so your content won’t be held hostage by proprietary formats.

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“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!

What Do Walgreens and Medical Device Content Management Have in Common?

WalgreensAnswer: both employ automation to reduce cost. At Walgreens,  software algorithms are being used to help guide and standardize patient treatment. Based on “big data” from over 100 million patients, the pharmacy chain is proving that professional services can be semi-automated with helpful results. You can read about it here.

A similar scenario is playing out in the medical device industry. Manufacturers are learning that they can automate content by structuring it with XML/DITA. The process requires patience and effort (though easier than developing a software system for patient treatment). However, it yields big savings and risk reduction. Starting with the XML systems provided by  Astoria Software and Vasont Systems, and continuing through the translation process automation technologies of the GlobalLink suite, TransPerfect Medical Device Solutions has the services, know-how, and technologies necessary to automate your content and achieve sustainable cost and risk reduction.

Blood Makes Noise: The Theme Song

On the surface, Suzanne Vega’s Blood Makes Noise might seem like an unusual choice as background music for a medical device blog. After all, it describes a panic attack.

However, as anyone will tell you (with 20+ years experience) in medical device content development and content management (including regulatory, labeling,  and marketing) an occasional sense of panic is not-so-very out of the ordinary.  Uncontrolled content has that effect – especially if it prompts a significant recall, derails a key project, jeorpardizes product compliance, or requires destruction of printed materials.

If you’ve ever felt even a little anxious about the cost or complexity of medical device content, you’ll identify with Suzanne’s perspective:

Original version [20-year-old video is dated]: http://www.youtube.com/watch?v=v6qvIhygLTs 

Alt version: http://www.youtube.com/watch?v=HvM430UcW-I

House version: http://www.youtube.com/watch?v=AuZm8U7Bkrc

Organized and structured content, supported by best processes and ready for automation, that’s the EnCompass perscription.

The Official Blog of EnCompass Content Management & Automation Services

Blood Makes Noise is the official blog of

EnCompass_Logo

EnCompass: content management and automation services for medical device manufacturers.

And, we are pleased to add, one of a limited number of blogs with it’s own theme music:

https://bloodmakesnoiseblog.com/2013/04/07/blood-makes-noise-the-soundtrack/