Medical Device Packaging Evolution

Historically, medical device converters have been lead by two factors, safety and cost. More recently, functionality and sustainability are emerging as topics of importance as well. Functionality encompasses a broad array of product qualities. Sustainability brings to discussion qualities that will be more eco friendly and allow medical packaging to fit nicely within the recycling stream as well as waste reduction. Without making cuts detrimental to the integrity of their packaging, suppliers are offering improvements in safety, functionality, and sustainability while incorporating new technologies to cut costs. These new technologies are hitting on all four market demands in anticipation of rising needs for medical care, and costs associated with new governmental changes.

Safety First
80% of medical device recalls are attributed to unsterile packaging due to defects and performance flaws. Recalls result in enormous amounts of money wasted for manufacturers. In addition, 80% only represents the number of defects that are caught. Undetected compromised packaging increases the risk of infection. Packaging safety is best categorized as cleanliness, sterility, product protection and performance.

It has been reported that 3 million people die every year from infections contracted in hospitals while being treated for unrelated ailments. These infections are caused by small micro organisms that are picked up during any point in the device manufacturing and distribution stream. There are growing preferences by Class 2 & 3 medical device manufacturers to reduce particulate counts contained in manufacturing and packaging areas of production. Reducing particulate count lessens possibilities of harmful airborne bacteria and other hazardous agents. Medical device packagers are doing their part to control the rate of infection by acquiring clean room certifications. Clean room certification requires a plant to undergo physical transformations as well as procedural improvements to decrease the accumulation of particles.
New packaging designs are being introduced that improve performance. Hospitals are requesting specialized kits customized for specific procedures. In some cases kits are customized for a specific doctor’s preferences. Specialty kits are decreasing the number of mistakes made in operating rooms by ensuring that the necessary tools are accounted for in one package.

As more stipulations are put on packagers and certifications become a requirement, rather than a request, safety of packages and devices contained in them will constantly improve. New sterilization techniques are on the horizon, once again changing the way packaging needs to perform.

Cost, a Factor that Remains in the Forefront
Cost is driving innovations in medical packaging. Increasing cost of health care along with constant pressure to make medical care more affordable cause manufacturers to looking to their suppliers for assistance with cutting costs. On January 1st, 2013 the excise tax related to the Affordable Healthcare Act will be implemented. At that time a 2.3% tax will be tacked on to all medical manufacturers per unit cost. This cost is a significant increase to be passed on to consumers if manufacturers are unable to find areas where cost savings can be obtained.

MDM’s are seeking suppliers that offer broad product portfolios. The ability to purchase complete packaging solutions from one supplier creates cost savings associated with logistics. Another benefit of having a fully integrated supplier is quality control. MDM’s are always looking for the best solutions for product protection and convenience.

Off-shoring offers a significant decrease in labor costs. MDMs are expanding their productions overseas in locations like Asia, the Middle East, Africa and Mexico. China was the premier location for cost saving alternatives; however, rising labor wages there are driving MDM’s to consider “near shoring.” Low cost high skilled labor can be found in Mexico and other Central American and Caribbean countries, making them attractive to manufacturers. As medical device manufactures are constructing plants in other countries, packagers are also following suit in order to supply their customers in close proximity.

Increasing energy prices apply upward pricing pressure on the material component of packaging. Best ways to offset costs include down-gauging film and eliminating steps in the converting process. In order to maintain packaging strength and functionality suppliers are developing innovative solutions. Solutions run the gamut from changing structures to lighter weight PE and PET, to more recently eliminating coatings.
MD Packaging converters will continue to look for more ways to aid their customers and provide the cost savings they need.

The Importance of Performance
Functionality and performance are critical within the medical device market. A small defect can result in a life threatening event. Medical device packaging must be compatible to sterilization, act as a barrier against harmful external contaminants, be easy to open, and allow for aseptic delivery.
Medical devices are often times used in emergency situations. Technicians have little time to carefully disseminate the proper handling of each package. MDM’s are asking their suppliers to make packages that are easily identifiable with openings that are intuitive. With a quick glance, technicians should be able to recognize the device and decipher where and how it opens. Labeled tabs and seals with large identifying markers are a few ways this is being accomplished.

Innovations in seal technology are eliminating coatings used with Tyvek® and other paper material allowing converters to provide products with improved breathability. New film technology also lends itself to fiber free peels.

Aseptic presentation is important when creating medical device packaging designs. Packaging must function in a way to prevent the medical device from being exposed to unprotected surface areas.

Medical Packaging and the Environment
Hospitals are large producers of waste. Demand for improved sustainability in the MDM market is being felt most by packaging converters.
Sustainability is controlled by choosing film options that are easy to recycle. Converters can create resin mixes that are easily separated for placement in the recycle stream. PE and PET have great qualities including clarity of material, toughness, and ease of process for converters. The hospital environment leans itself to allowing for a smooth recycling stream transition for these types of packages. PET and PE can be recycled and returned to the market at a very clean and high grade due to the already sterile environment of hospitals.

Meeting Needs and Lining Up with the Trends
This is an exciting time for medical device packagers. Even with urgent cost saving demand, there are solutions emerging that fulfill them while providing benefits in performance, quality, and sustainability.

Through the acquisition of Amcor’s Marshall, NC facility in 2010, which has been serving the market since 1985, Printpack Medical joined the medical device packaging market. They bring with them an extensive expertise in flexible packaging and capital to invest in the medical device packaging industry. Their commitment to quality is demonstrated with several certifications including ISO I3485:2003 and ISO I4001:2004 as well as installation of a Class 8 Clean Room.

Printpack provides cost savings with the development of KwikBreathe,™ an uncoated Tyvek® header bag designed to breathe 2-3 times faster than other competitive products that utilize coated Tyvek®. This bag is unique because it creates a plastic to plastic, fiber-free, easy opening peel seal by allowing a natural seal between uncoated Tyvek® and the specialized Kwickbreathe™ header strip. This bag is ideal for heavy and bulky kits as well as smaller more compact items. Customers can choose from a variety of bag styles and sizes. DirectSeal® is another innovation from Printpack Medical that allows uncoated Tyvek® or paper to seal directly to coextruded film.

Printpack also offers thinner gauged forming films that perform as well as their heavier counterpart. These lighter options use less material, creating less waste and more cost savings.

Printpack has long been focused on the customer and recognize that medical device packages are seen by the end user as part of the entire MDM brand.