To help control bleeding and prevent adhesions after functional endoscopic 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 Surgical 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, Associate Packaging Engineer for Medtronic, tells PMP News that 10 cm³ of the gel is loaded into an off-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 syringes 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 cannula for nasal delivery. The lightweight molded cannula, designed by R&D engineers Ethan Sherman, PhD; and Jennifer Medina, of Medtronic’s Biomaterials Group, resembles both an accordion and a “bendy straw,” says James Inabinett, Senior Packaging Engineer at Medtronic.
For the NovaShield system, the packaging team was charged with “delivering 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 development 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 without any instructions to see how they handle them.”
Such voice-of-customer input helps guide package engineering, says Principal Packaging Engineer Lissa Venosh. By following it, “you can really incorporate features that offer a competitive 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 surgeons, 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 needed 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 sterility, adds Inabinett.
The packaging team provided thermoformers with sketches and concepts to help them develop a thermoformable part, he says.
When considering options from different suppliers, Venosh says that her team looks at three factors: how user-focused a design is, cost, and its ecoconsciousness 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 containment 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 to avoid sharp edges rubbing against the pouch,” says Venosh. “One edge of the tray mirrors the shape of a chevron pouch, which eases pack out and ensures consistency for e-beam
Snap fits were designed throughout all portions of the tray to lock all components in place. The filled syringe, for instance, is held in the largest pocket of the tray in order to direct users to that area first. In addition, a triangle was formed into the portion of the tray that holds the cannula, which shows operations how to load the tray.
“We try to adhere to intuitive design principles so that the design speaks to users on how to use the tray,” says Venosh.
NovaShield requires both oxygen and moisture barrier, Inabinett explains, so a barrier pouch was needed. The team chose an opaque barrier pouch from Mangar Industries with customer-focused iconic labeling showing package contents. “We started with a metallized pouch used for other products, but we saw some pinholes, and that led us to a new structure,” says Inabinett. “During benchtop testing, we saw one failure during bubble leak testing. Before we moved to a lidded tray, we went back to Mangar and switched to a laminated structure consisting of PE/foil/biaxally oriented nylon.”
Inabinett says such a discovery during benchtop testing demonstrates the importance of testing early during development. “We had huge benchtop challenges with punctures, but we were able to identify new materials, retest, and move forward,” he says. “We always do benchtop testing as close to the final testing as possible so we can learn as early as possible whether we will have any issues.”
“If we hadn’t done such testing early on, we would not have identified design flaws and would have delayed launch,” adds Venosh. “We also get as much input as possible from colleagues and other departments. Medtronic has a large network of talented and degreed packaging engineers with true passion with whom we collaborate.”
Inabinett advises other engineers to not “assume a double barrier is needed for a product. Double sterile barrier isn’t the only way to facilitate aseptic transfer, and it’s expensive.”
“We also know that users have limited space for storage, so we look at the footprint when developing a customer-focused design,” Venosh adds. “We strive for the least amount of material in the smallest size while still meeting all product requirements.”