Medical Device Manufacturers Cut Documentation Costs by Over 50% and Labeling Turnaround Times by 75%

Modular Approach to Labeling Automation Designed for Manufacturers of Stretchers & Beds, Radiological, Imaging, and Other Capital-type Devices

"The results we've achieved were so remarkable in terms of productivity, efficiency, and cost savings that several other divisions within our company realized that they could benefit as well"

                                                                                                 - GE Healthcare
Boston & San Francisco, April 2, 2011 
 
Crimson Life Sciences, a division of TransPerfect, today announced the introduction of its DTP-Free Labeling Solution for medical device manufacturers. Crimson’s DTP-Free Solution is an integrated collection of advanced software components (including Astoria Content Management, GlobalLink Translation Management, and Microsoft SharePoint), tied together by a modular strategy that encompasses guided authoring, DITAbased xml publishing, Notified Body-endorsed translation risk management, simplified translation review, and output to web or print – including label creation with seamless ties to engineering software systems, ERP and accounting systems. By merely implementing portions of Crimson’s DTP-Free Labeling approach, companies such as GE Healthcare have reduced translation expense by 90% and turnarounds by 75%.
 
An Industry-Wide Issue: Costs Double, but Labeling Still #1 Cause of Recalls
 
Crimson, the first medical device supplier certified to ISO 13485 and ISO 14971, is the only translation company to be exclusively devoted to the medical device industry. Crimson has been continually serving the labeling and translation needs of medical device manufacturers for nearly 20 years and today client companies represent a broad cross-section of the industry. Surprisingly, these very different companies all face the same problem: ballooning content volumes (driven by labeling, translation, and marketing requirements), combined with fragmented content management strategies have lead to skyrocketing labeling costs and risks. In fact, most device manufacturers’ labeling processes are twice as expensive as necessary – and still represent the number one cause of costly recalls.
 
Manufacturers Search for Labeling’s “Holy Grail”
 
Crimson’s President and Founder, Marc H. Miller, explains, “20 years ago, medical device manufacturers were smaller and less global than today. Many served a handful of international markets and everyone had much simpler labeling and marketing documentation requirements. In this environment, simple file management systems (such as Documentum or WindChill) provided an adequate solution because neither the volume of content nor the delivery requirements were as complex as today. Authors simply worked in unstructured Quark, FrameMaker, InDesign, and MSWord files because the downstream implications, including translation and printing costs, were nominal.”
 
Today, research indicates that the situation has changed dramatically and now stands at a critical juncture: Traditional, unstructured authoring is twice as expensive and takes twice as long as comparable structured authoring approaches. Manufacturers have taken notice and several have chartered internal initiatives or are investigating xml publishing options.
 
According to Miller, “The rapidly increasing number of authors, products, and languages has driven device manufacturers to begin the search for labeling’s “holy grail”: a system that helps authors to reduce content volume, translation expense, risk, and turnaround, and position the company for e-Labeling and electronic content delivery. So far, manufacturers’ have been unsuccessful in their search because they have been focused on a single-technology solution. In reality, however, the solution is a number of custom and/or commercially-available modules that encompass all phases of the labeling lifecycle, from authoring to output.” Crimson’s DTP-Free Labeling ties together a number of proven components into a seamless whole that delivers the industry’s much-sought-after labeling solution.
 
Translation Management + XML Publishing = Significant Savings
 
Crimson’s solution is unique because it offers manufacturers multiple points of entry, based on their unique challenges and requirements. For instance, if translation is a vital concern, the GlobalLink suite of translation management software provides a simple method for online translation review and translation memory sharing among multiple vendors. Since control of source content is a primary concern for manufacturers like GE Healthcare, proven technology for implementing an advanced DITA-based solution is a starting point for others. With its built-in xml/DITA publishing capabilities, the Astoria system alone can reduce translation budgets and turnarounds by 50%.
 
Says Miller, “We are at a unique moment in the search for a comprehensive solution to the content management problem that has been growing in the medical device industry over the past decade. Key processes and technologies are now sufficiently evolved so that they can be integrated into a solution like DTP-Free Labeling.” Given the intense cost and quality pressures faced by today’s medical device manufacturers, Crimson’s DTP-Free Labeling Solution arrives not a moment too soon. Savings in this area translate directly to manufacturer’s bottom line in the form of improved earnings and faster time-to-market. Quips Miller, “That’s the kind of translation our clients are most interested in.”
 
About Crimson Life Sciences
 
Crimson is a division of TransPerfect Translations and is the world’s largest translation practice devoted exclusively to Class II and Class III medical devices and List A and List B IVDs. Crimson is the world’s first translation firm registered to ISO 13485, ISO 14971, and ISO 9001. TransPerfect, registered to ISO 9001 and EN 15038, is the world’s largest privately held language services provider with 56 offices worldwide.

 

 

 

Crimson Life Sciences has become
TransPerfect Medical Device Solutions.


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