MAR 2016

Published by ORTHOWORLD Inc., BONEZONE delivers strategic sourcing & product commercialization solutions to orthopaedic device company decision makers and their partners.

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42 BONEZONE • March 2016 U nique Device Identifcation (UDI) and sterilization should be driving infuences for the orthopaedic device packaging industry in 2016 and beyond. With increased regulatory guidelines in the form of FDA's UDI guidance on convenience kits, along with tightening price pressures, the way device packaging is done is due to change. "We've seen a considerable push to move from hospital- sterilized product to single-use terminally sterilized devices, taking things that normally would be autoclaved at a hospi- tal and instead providing that device directly to the hospital, already packaged and sterilized," says Brian Nissen, Principal Project Engineer at Quality Tech Services. Additionally, getting a product to market is a long process, says Stu Krupnick, Director of Marketing at UFP Technologies. "Anything that we can do as a supplier to speed up the process is of value," he says, and as more implants move toward ster- ile packaging, "That requires that the packaging maintain the sterile barrier, which can be challenging, because some of these items are sharp or abrasive." The Impact of UDI Developments in UDI regulations are driving change in the packaging market. In January 2016, FDA released a draft guidance document titled UDI: Convenience Kits. The document was meant to clarify the defnition of convenience kit, reducing the number of accepted exemptions and requiring more individual devices to be marked with UDIs. Specifcally, it noted that a non-sterile orthopaedic device tray or set would not be a convenience kit. FDA states that, because the implants and devices contained within are not meant to remain packaged together, that kit cannot qualify for the exemption. This document followed the July 2015 draft guidance which indicated that direct marking on the device itself is required if the device is intended to be used more than once and intended to be reprocessed before each use, in order to ensure identifca- tion of the devices through their distribution and use. Nissen's colleague, Gerry Gunderson, Vice President, Sys- tems, says that pending UDI labelling regulations are part of SUPPLY CHAIN MANAGEMENT Identifable and Sterile: Trends Driving Device Packaging Chris Mosby ORTHOWORLD Packaging Advice for OEMs Do Your Research—Gerry Gunderson, Vice President, Systems at QTS: "Customers will assume that they need a double-barrier system. They don't think through that decision, or question the reasons why. As a contract manufacturer, we see very similar devices from different customers and we see a wide variety of packaging styles for, essentially, the same device—a device intended for the same surgical site." Consult with Experts Early—Stu Krupnick, Director of Marketing, UFP Technologies: "Sometimes, packag- ing is one of the last things to be considered. Being brought in later forces us to move very quickly through the product development process: creating designs, samples, prototypes, all the way through production. We can move quickly, but it may limit the solution that we can provide to a customer in terms of certain materials. It limits our ability to innovate." Utilize Existing Designs—Tom Williams, Senior Vice President Marketing and Strategy at Millstone Medi- cal Outsourcing: "Not thinking about packaging early in the development process is one mistake [OEMs make], and it can cost time later. Another mistake is not utilizing existing designs. If a device company can utilize something that is pre-existing, it lessens both the cost and time to market." Know Your Customer— Brian Nissen, Principal Project Engineer, QTS: "Package designers spend far too little time with their customers. The customer of packaging is not usually a doctor. The customer is usually perioperative nurses and scrub nurses, those are the people interacting with the packaging. We've found that even a few hours with a scrub or surgical nurse is worth several months of engineering experience."

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