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Pharmaceutical & Medical Packaging News, May/June 2015

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News pmpnews.com • Pharmaceutical & Medical Packaging News May/June 2015 14 T o help control bleeding and prevent adhesions after functional endo- scopic sinus surgery (FESS), Medtronic launched NovaShield Injectable Nasal Packing and Stent in December 2014. Made by the company's Ear Nose and Throat (ENT) division of its Surgi- cal Technologies business, NovaShield depends upon a unique packaging system for protection and delivery. A carefully designed tray delivers the complete system of components and syringes needed to prepare and deliver the sensitive nasal packing material. NovaShield consists of chitosan, a polymer produced from the chitin of shellfish that is formulated into a ready- to-use gel. Robert Kaczmarek, Associ- ate Packaging Engineer for Medtronic, tells PMP News that 10 cm³ of the gel is loaded into an of-the-self syringe. The prefilled syringe is then connected to another syringe via a luer connector. Using the two syringes and luer, healthcare practitioners "move the gel back and forth between the two syring- es to rehomogenize or reconstitute it to ensure it is in an ideal state for nasal dressing," says Kaczmarek. "The luer and one syringe are then discarded, and the NovaShield-filled syringe is then connected to a flexible-tip cannu- la for nasal delivery. The lightweight molded cannula, designed by R&D engineers Ethan Sherman, PhD; and Jennifer Medina, of Medtronic's Bio- materials Group, resembles both an accordion and a "bendy straw," says James Inabinett, Senior Packaging Engineer at Medtronic. For the NovaShield sys- tem, the packaging team was charged with "deliv- ering the two syringes, cannula, and the delicate luer connection that had to be stabilized during shipment," says Inabinett. "We decided to follow dual-path development to explore both a tray and an HDPE card. We'll often do a dual-path develop- ment with two or three suppliers." "The packaging team works with the R&D department and gathers as much voice of the customer input as possible," explains Inabinett. "We seek out nurse opinions, for instance, and give them initial package designs with- out any instructions to see how they handle them." Such voice-of-customer input helps guide package engineering, says Princi- pal Packaging Engineer Lissa Venosh. By following it, "you can really incor- porate features that ofer a competi- tive edge," she says. "We've learned a lot of things over time, and they have become our standard practice." Venosh says that her team "held 11 voice-of-the-customer reviews for NovaShield, which had five sur- geons, four nurses, and two surgical techs evaluating our packaging. All our customers rated interaction with our packaging design "Very Easy," during Validation." Because the product requires aseptic presentation, the package design need- ed to ensure that both the filled and unfilled syringes as well as the luer and cannula will be placed into the sterile field without compromising their steril- ity, adds Inabinett. The packaging team provided ther- moformers with sketches and concepts to help them develop a thermoform- able part, he says. When considering options from dif- ferent suppliers, Venosh says that her team looks at three factors: how user- focused a design is, cost, and its eco- consciousness or sustainability. Medtronic's team decided to pursue development of a containment tray inside a pouch, Inabinett says, but without overpackaging. Products with "several blades often use the contain- ment tray-and-pouch format," he says. Brookdale Plastics's design won because of "its use of a mid-way flange to keep the edge of the tray away from the pouch as much as possible Medtronic's Packaging Team Delivers Intuitive and "Very Easy" to Use Packaging Design Medtronic held 11 voice-of-the-customer reviews for NovaShield's packaging. Other Pharmapack presentations on the pharma supply chain include: "Pharmaceutical Serialization Stan- dards, Guidances, & Best Practices," Salil Joshi, Senior Director, Industry Development–Healthcare, GS1 US. " P h a r m a c e u t i c a l S e r i a l i z a t i o n : From Master Data to 'In-spec' GS1 Data Matrix Symbols – Essential Ele- ments and Common Pitfalls," George Wright, Vice-President, Consulting & Business Development, Product Identi- fication & Processing Systems Inc. "Creative Packaging Designs for Drug Serialization," William Fletcher, Managing Partner, Pharma Logic Solutions LLC. "The Sanofi Serialization Program," John Woodburn, North America Regional Project Leader, Sanofi Pas- teur, and Adriano Fusco, Global Mar- keting Manager, Antares Vision.—DA

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