In this month’s “Roundtable Q&A,” industry leaders provide insights on medical packaging topics, including the use of new materials, commonly overlooked issues by medical device designers and manufacturers, and combating counterfeiting with help from the packaging.

Question 1: How have new material options enhanced the variety of medical device packaging options?

Kelly Doyle
Light Gauge Tool Design Manager, Brentwood Industries
Advancements in materials and equipment have lead to faster extrusion times and improved performance. These advancements aid converters, such as thermoformers, to offset the continuing rise of resin prices by producing packaging with lower scrap and higher run speeds.

Chris Osborn
Director of R&D, Perfecseal
The new materials, such as PA, PLA, PETs, COC, nano clays, etc., represent a change that will allow customers to:

• PA (nylon)—Reduce the mass of their film
• PLA—Incorporate a bio-based resin
• PET—Reduce interactions between the package and the product
• COC—Provide mid- to high-moisture barrier

Advances in packaging films are linked to advances in the raw materials that are available to convertors.

Question 2: What is the most commonly overlooked issue when it comes to medical device packaging?

KD: A common miscalculation in the process is not allocating enough time to the development of the packaging itself. The device is top priority, but getting the packaging partner involved early can help the development process run much smoother. Revisions and enhancements are necessary to achieve the highest level of performance in package development. Time must also be considered for all the testing and validations that must take place prior to the launch of the device.

Thomas A Misik
VP Sales, Belco Packaging Systems Inc.
The biggest down-time complaint we hear is when a shuttle tray sealer stops because the operator sealed the Tyvek lid to the heat platen, instead of the thermoformed tray. We see MDMs specifying blank die-cut Tyvek lids with the intention of labeling the package post sealing. Operators can have difficulty recognizing the top of the lid from the coated side, causing a machine jam and maintenance issue when installed incorrectly. A simple solution is to mark the lid with a simple “dot” or other identifier to minimize the risk of this upside-down issue interrupting your production.

CO: Opening convenience of the package. Companies focus on maintaining sterile barrier; they often overlook simple things like, “How is the nurse going to interact with the package?” Will they know how to open it? Will they be able to easily present it to the sterile field? Can the package be opened with one hand and in one smooth motion? Do you need to reposition hands to complete opening of the package?

Question 3: How is medical device packaging able to aid medical device manufacturers combat counterfeiting of their products?

KD: Tray design can help in defending against counterfeiting by giving the device manufacturer a distinctive package that coincides with their marketing campaign. For instance, using a clear material that closely contours the device will make it easier for the end user to identify the device and the manufacturer. The connection between device and manufacturer is the key and can be as simple as engraving a company logo or part number into a tray.

CO: Anticounterfeiting technologies can be integrated into packaging materials at relatively low costs and without changing the function or look of the package.

Question 4: Final Word: Any thoughts/comments on packaging, materials, counterfeiting, or another related area that you would like to share with medical device manufacturers to aid them?

CO: Medical companies need to consider the total cost of their packaging materials when making a material selection. Additionally, they need to consider if users like to interact with the package; if the packaging material maintains the sterile barrier; how much mass the packaging materials use to maintain the sterile barrier; if thinner packaging films would offer more feet on a roll, on a pallet, in a trailer, or in a container; etc.