The reality of today's challenging economic times is that we all need to accomplish more with less. Hospitals, surgery centers, and clinicians continue to look for ways to improve efficiency, reduce turnover time, and minimize waste while ensuring patient safety and care. Medical device manufacturers that meet these needs have a real opportunity for growth.

The role that medical-device packaging plays in improving the end-user experience of hospitals, surgery centers, and clinicians is one that should not be overlooked. Operating room nurses, surgeons, and technicians have exceptionally strong views about packaging and how they want it to perform. The results of a Healthcare Packaging Review panel sponsored by Rollprint Packaging Products, Inc. and an AORN (Association of Perioperative Registered Nurses) Survey performed by IoPP (Institute of Packaging Professionals) and presented at HealthPack 2009 confirm this.

The survey shows that operating room nurses rank speed of opening as most critical with respect to packaging. Respondents indicated that packages with more than one entry point facilitate easy opening in time-critical situations and that they prefer a package with a lip to one with a thumb notch. Additionally, being able to confidently provide aseptic delivery of the product was critical. As a result, package designs such as chevron pouches are favored over tear-open pouches and traditional header bags.

Medical device manufacturers and their suppliers have worked to develop packaging alternatives that address these concerns. For example, Rollprint's Duet pouch provides an alternative for packaging devices that are sterilized via ethylene oxide (EO) and intended for use in a sterile field. A strip or “header” of uncoated Tyvek on one end of the package minimizes the amount of Tyvek present in the package for cost-saving considerations while allowing for EO sterilization. Unlike a traditional header bag, the opening feature is at the other end of the pouch. A dual-corner peel configuration with a lip ensures easy access into the package and aseptic delivery of the product.

The survey also shows that product visibility is a desirable packaging feature. Operating room nurses and their associates feel that by visually verifying the product, the likelihood of selecting the wrong size or, worse yet, choosing the wrong product is significantly reduced. Product visibility also allowed them to assess the device for damage prior to opening the product, thereby saving valuable time.

Traditionally, aluminum foil composites have been used to package products that require oxygen- and/or moisture-barrier protection to ensure product efficacy and function. Today, clear high-barrier materials that can compete with aluminum foil on both barrier performance and economics are a reality. With moisture and oxygen transmission rates as low as 0.0008 g/100in2/day and 0.0008 cc/100in2/day, transparent aluminum-oxide and silicon-oxide coated composites provide effective packaging options and are helping drive the move to product visibility.

‘Green’ packaging gaining favor

Sustainability is now a standard part of our lexicon. It follows that the environmental impact of packaging material is of increasing concern to hospitals, surgical centers, and their staffs. The most common approaches to addressing package sustainability are to reduce the package size or to downgauge the materials. However, these actions largely go unnoticed by the end user.

Still, as hospitals and surgical centers develop waste streams for recycling, packages that can be easily recycled are gaining favor. Because most packaging materials used today are commingled plastics, symbol 7, they are challenging to recycle. Fortunately, packaging materials continue to advance and evolve. Rollprint's StreamOne all polyester lidding and StreamTwo, all high-density polyethylene peelable lidding materials were designed to provide device manufacturers viable recyclable options when sealing to PET and HDPE trays respectively.

Medical device manufacturers often face resource challenges when trying to design cost-sensitive packages that address the needs of the customer. In an ideal world, package considerations happen early in the process. This allows the device and the package to evolve together and provide time for simple design modifications that can drive a more cost-effective and easier-to-use package. As medical device manufacturers struggle with how to accomplish this given the resource limitations that are part of the current reality, they should look to the sterile packaging manufacturers for assistance.

Sterile packaging manufacturers have a wealth of information about their materials and the packaging support that is available can take a number of different routes. Regulatory requirements for packaging materials run the gamut from the straightforward heavy metals limitations to the all-encompassing ISO 11607 Packaging for Terminally Sterilized Medical Devices, which spells out the requirement for materials, sterile barrier systems, packaging systems, and validation. A packaging manufacturer fluent in these regulations can provide the documentation and support needed to ensure compliance and significantly ease the burden on the medical device manufacturer.

Prototyping is an excellent way to ensure that no surprises arise as the product moves toward commercialization and one for which packaging manufacturers should be able to provide assistance. Lab prototyping support ranges from the development of marketing samples for initial evaluation to providing device manufactures with package performance information that will paint an accurate picture of what will happen in a commercial environment.

Technical support is also available in the form of DOE assistance, validation support, laboratory testing, analytical analysis, field service support, and even technical presentations designed to expand knowledge.

There are a myriad of packaging options. Striving for the ideal material-and-configuration combination that meet end-user needs and expectations while controlling costs is definitely a worthwhile challenge. Packaging, when properly designed, creates value.

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PROTOTYPE LAB AFFORDS MATERIAL OPTIONS

Rollprint Packaging Products' newly opened prototype laboratory in Addison, IL, is equipped for the evaluation of a variety of material configurations. A Multivac thermoforming unit, coupled with the lab's tray sealers, enables the testing of a range of tray-lidding combinations. The lab also has cold-form foil packaging and pouch-making capability.

“Our goal in upgrading our prototyping capability is to provide our customers with package performance information that will paint an accurate picture of what would happen in a commercial environment,” explains Doug Dodrill, vice president of technology, Rollprint.

The ability to run a variety of material configurations on a commercial machine is a big asset in determining what packaging “behavior” is best for the product, says Dodrill. “For example, we can mate a thermoformed bottom web to an uncoated or coated paper, coated or uncoated Tyvek (spunbonded olefin by DuPont), or a high-density polyethylene peelable lidstock. Also, our bottom webs can be made from a wide range of materials including ones with barrier properties.”

In the area of cold-formed foil packages, Rollprint is providing prototyping capability for products which generally require a higher barrier level. This includes moisture-sensitive products such as dissolvable sutures, diagnostic devices or liquids, which maintain their properties by eliminating oxygen ingress. Cold-formed foil packages are frequently accompanied by peelable or weld-seal foil, depending on opening criteria.

The company is also able to seal lidding to preformed rigid tray prototypes with vacuum and gas flushing. Rounding out the lab is a retort-autoclave unit and container abuse test equipment.