Crimson Audit & Review

Content Audit, Review & Consulting for Medical Device Makers

The $400 Million “Gray Swan”

Posted by crimsonlanguage on 2012/12/01

On Thursday, I presented with JoAnn Hackos from Comtech Services on DITA/XML for the medical device industry. A very interesting topic, indeed, and definitely the future of publishing for the medical device industry. DITA/XML is also quite relevant in today’s economic climate – it’s estimated that device companies could see a potential $400 Million savings by implementing this Oasis standard industry-wide. However, to realize these savings, device manufacturers must first move to single-source publishing systems and processes.

One critical point underscored during the presentation was this: single-source publishing systems create single-point failure risks – in the case of labeling content, this means errors that might affect patient safety or compliance (labeling errors are the #1 cause of recall). Not only that, but single source content is *leveraged*, meaning errors at the single source can be multiplied out many times.

In 2007, The Black Swan by Nassim Taleb hit the NY Times bestseller list. A Black Swan is an event with an economically large impact…very much like a leverage single-point failure event. However, a true Black Swan is also unexpected – which is definitely not the case here. In fact, the risk to device makers is quite predictable. So, we might actually call this a “Gray Swan”. Not only that, but in the case of single-source systems, we can also do something about it. That something is called “Quality at the Source”.

In the case of DITA/XML tagged content, Quality at the Source means well-written, global English/original source as well as expertly translated and QA’d derviative source – including tested, high quality resources and “state of the art” risk management processes. And, with millions of dollars in savings available from single-source system improvements, these upgrades in quality are not only possible, they are required.

At Crimson, we are extremely quality systems and risk management-minded. Which is the reason we are the first translation company registered to ISO 13485 and ISO 14971. It’s also the reason we hold the only patent for translation risk managment (for medical device labeling). I am an active supporter of the DITA/XML standard in the medical device industry because I believe, properly implemented, DITA/XML provides a roadmap for elevating not only the quality and effectiveness of device labeling in particular, but also medical devices in general.


One Response to “The $400 Million “Gray Swan””

  1. JoAnn Hackos said

    Excellent information for anyone in the medical device industry.

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