Robinson Printing Helps Medical Device Maker Fit in Extra Languages

Robinson Printing (Temecula, CA) is currently helping Volcano Corp. (San Diego, CA) include up to 20 languages on one IFU (instructions for use). The project, which started in the summer of 2012, is a complex one, involving separate IFUs for more than a dozen models of the company’s products, including Eagle Eye Platinum catheters used for Intravascular Ultrasound (IVUS). Robinson was charged with maintaining the same IFU weight and thickness as earlier versions featuring fewer languages.

“We needed to increase the number of languages to address EU regulatory requirements,” explains Erin Thompson, associate product manager, IVUS Imaging, for Volcano Corp. “We had to ensure that the new IFUs did not exceed the original weight because any changes could affect the overall package weight, which would require package revalidation. We also weren’t changing the IFU content other than having it translated into different languages.”

Robinson Printing’s President Dave Robinson and General Manager Donna Beecham worked closely with Thompson’s team to explore options. Robinson says that expanding labeling to accommodate additional languages is becoming a pretty typical need throughout the industry. “We have many clients finding themselves in the same circumstance,” he says.

 
Robinson Printing provides map-folded inserts like these to Volcano Corp. for its multiple-language instructions for use.

Volcano’s original IFU was in booklet form and featured up to 10 languages, depending upon the market into which the product was sold. Robinson’s team explored a similar booklet format as well as several folded IFU options, presenting about 25 or 30 different configurations and folds to Volcano’s team.

“Some of what we presented were standard sizes, which we typically suggest for efficiency in terms of impressions on a press sheet,” explains Robinson. He adds that about 50% of Robinson’s customers do end up developing custom specifications.

For Volcano, “we estimated the number of pages that would need to be included in the new booklets and presented those options,” explains Beecham. “We then presented the folded map-style options. We took one language, laid it out in various formats, and then multiplied that layout for 20 languages.” Some languages are more “wordy” than others, she says, so Robinson’s designers had to take that into account. They also had to move some product diagrams around to fit into layouts. “We presented several dummies and layouts,” she adds.

Volcano ultimately chose a folded map-style IFU measuring 6.5 in. × 10 in. when folded into 16 panels. (The flat sheet measures 28 × 40 in.) Printed on front and back, the IFU uses 27-lb paper, the thinnest stock Robinson provides. Robinson optimized layouts so that printed photographs or diagrams did not show through the thin paperstock.

Thompson adds that Robinson made recommendations on font size and ink color to minimize “show through.” Robinson presented IFUs printed in “cool gray” colored ink, for instance, but Volcano opted to keep its original black ink to minimize any regulatory concerns.

Two IFUs have been completed so far, one in September and the second in October. “Now that we have a layout, things are going very smoothly,” says Beecham. “When Volcano has the new translations of its IFU content ready, they simply send us a Word document and we get started on layouts.”

Thompson reports that Robinson’s layout advice has yielded extra or blank panels, which will allow Volcano to add additional languages if needed for future markets.

Thompson adds that Robinson’s team has been “really responsive and helpful throughout the entire process,” particularly when it came to providing samples and handling the back-and-forth reviews during the proofing process. “Robinson is quick to respond,” Thompson says.

Robinson Printing uses MBO folding equipment for Volcano’s new IFUs along with machinery from Saber and Muller Martini for trimming. The cGMP-compliant, ISO 9001-2008 certified printer also has folding equipment from Vijuk to accommodate miniature inserts and outserts.

Robinson Printing will be exhibiting in Booth 5481 at Medical Design & Manufacturing West in Anaheim February 12-14, 2013. 

Visit Robinson Printing's Web site for more details.

 

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