Making Changes to Medical Device Packaging
Given design requirements and regulatory hurdles, how likely are
medical device manufacturers to redesign their packages?
Thinner, stronger materials may help medical packagers switch from thicker conventional ones, increasing performance while reducing costs. But are packaging professionals redesigning their packages? In this roundtable discussion, editor Daphne Allen explores the use of new materials with medical device packaging professionals. This year’s participants include Randy Troutman, certified packaging professional, project manager for global packaging development at Smith and Nephew Orthopedics; Jordan Montgomery, senior packaging engineer for Medtronic Cardiac Rhythm Management (CRM); and Yong Cho, staff packaging engineer for Edwards Lifesciences.
How are current packaging materials meeting your needs?
Troutman: The barrier material options currently available meet our needs for orthopedic device applications. We have heavy, often porous-coated products that do not lend themselves to the performance characteristics of flexible packaging. Our business produces custom-type products generally batched in low-volume orders, compared with companies that run high-volume form-fill-seal applications. We tend to use custom thermoformed trays and different types of lidding materials that best match our product requirements.
Montgomery: From a flexible-pouch standpoint, we do have several material combinations that suit our needs currently. However, we are looking at challenging our suppliers to come up with stronger materials, regardless of material gauge. It seems like the flexible pouches we get have either great puncture resistance or great abrasion resistance, but not both. We are trying to push our material suppliers and converters to come up with what we like to call the bulletproof pouch.
Cho: We are using trays, pouches, and form-fill-seal packaging. We are leaning toward the latest nylon films for form-fill-seal packages and header bags for puncture resistance. We are trying to downgauge. But we learned recently that you cannot downgauge too much, otherwise you are going to affect performance.
Why would a packaging professional switch materials?
Montgomery: The primary driving point for us would be if there were stronger pouches available. We would be more prone to use them for different product lines where we currently do not use them. Most of our high-end products are in thermoformed trays with adhesive-coated Tyvek lids, and we would not consider going to a pouch for those. But for some other types of implant tools or delivery tools that could potentially lend themselves to a pouch application, we may not consider it because we do not feel that there is a strong enough pouch.
Troutman: We, too, are looking for a bulletproof pouch that would allow us to reduce package size, [the number of] configurations, and the burden of waste on our end-users. There is potential for vacuum-forming sterile products, provided that MDMs can qualify current materials that meet the application’s needs. The challenge is identifying a film pouch structure that can withstand the rigors of sterilization and distribution over the product’s shelf life.
So it sounds like both of you would be interested in a move from rigid to flexible if the flexible materials could keep up.
Montgomery: That is also contingent upon product type. There are certain product lines that we probably would never consider it for.
Troutman: I agree with that completely. We have certain disposable products that economically should go into a flexible package, but because of the product configuration, we provide them in a rigid package to maintain their performance characteristics. Another driving factor to put products in rigid materials is to provide customers with a foolproof method for sterile product introduction into the sterile field. One other thing to consider is end-user perception based on sterility of the device. Generally, nursing professionals feel more comfortable with implantable devices packaged in double-barrier rigid packages.
Cho: We are looking into switching from rigid trays to flexible trays, and the cost savings are there. But smaller-volume kits with syringes and medications do not lend themselves to that kind of application. So trays still have their place.
What are some of the newer packaging materials that are of interest to you?
Troutman: Not necessarily a new material, but becoming more widely used in device packaging, is better-performing nylon/nylon preformed sterile barrier systems. One of the biggest challenges with current nylon/ nylon pouches is the yellowing caused by electron-beam or gamma radiation sterilization. Nylon/nylon structures yellow faster and more severely than the PET/PE structures that are commonly used with Tyvek. Although it is not necessarily a performance issue, customer perception could be affected by the overall aesthetics of the package.
Cho: We are looking at coextruded nylon-based bottom webs for form-fill-seal. They seem to provide the high strength. Formability and clarity are pretty good, and we have the ability to downgauge a few mil.
What about puncture and abrasion resistance?
Montgomery: The best we have seen to this point is nylon. Our basic position is to put the challenge out there to the vendors. Would it have to be nylon? No.
Troutman: Once a subsection of the industry migrates towards a certain material or application, the quality and amount of data supporting it is more readily available. As with nylon/nylon, we can learn from suppliers as to how the materials are being used in other packaging applications.
So having that documentation helps you in your testing or your evaluations?
Montgomery: Definitely. We are always interested in any sort of data that the vendor can offer, including testing, shelf-life, and biocompatibility data. It is definitely a key consideration when we are comparing materials.
Are converters providing that information?
Troutman: Converters give us a lot of information, but sometimes the information they give us is more marketing and sales based, rather than technical. The IoPP Medical Device Packaging Technical Committee created a task group that helped to standardize the data specification sheets that vendors supply to MDMs. Some material vendors have embraced this guidance, and others have not. It helps MDMs with information they need at their disposal to facilitate making educated decisions regarding packaging material performance.
Cho: I totally agree. I get a spec sheet, but really it is a marketing tool. I try to compare spec data from Company A to Company B, but how they measure sometimes might be different. It takes a lot of time to validate new materials rather than to rely on supplier-provided documentation.
Troutman: Looking forward, when suppliers come to MDMs with new materials and ideas, we would like to see more testing that might help us reduce costly and timely qualifications and validations. Understanding that the ultimate responsibility is with the device manufacturer, using the now established guidance of ISO 11607 and the improved standardized test methods established through ASTM, suppliers could provide better test data to allow for more opportunities for MDMs.
Do you run into that challenge when considering new materials for new products?
Troutman: The challenge when considering new materials is related to performance and speed to market. The path of least resistance is to package products in validated packaging configurations. I could be tied up anywhere from 12 to 18 months doing a stability study of new materials, not to mention the cost.
Is there anything a converter could do to help you get through that time period faster?
Troutman: As mentioned earlier, provide better information up front. For example, after review of a converter’s seal stability study, the test samples were not subjected to sterilization. Although good information, it does not tell me the whole story.
Montgomery: I agree. As an MDM, you are never going to get out of your validation activities all together. But at the same time, material converters can show a lot more foresight as far as taking their materials and doing accelerated aging after exposure to X number of megarads of radiation or X number of cycles of EtO sterilization and present that data. I would think they would want to do it for their own competitive advantage.
Cho: We do a lot of form-fill-seal. Since we are converting it, it behooves us to go through all the testing rather than just rely on their data. Information from a supplier is good to have, but it is a reference.
Troutman: There are so many bases to cover. It would be hard for converters to meet everybody’s needs with one study. There may be situations for certain markets and or applications that would warrant an all-encompassing study to help MDMs. It would be good to have better information on gamma sterilization effects on materials like discoloring, brittleness, and cracking.
Do you consider downgauging when you look at new materials?
Cho: Sure, because if you are going to be making an investment of time and money and effort, you want to get something in return in the form of cost reduction.
Montgomery: Another reason for downgauging is the current environment in Europe with its waste directive. Regulatory bodies are looking to manufacturers to eliminate waste at the source, so reducing the amount of packaging waste put into the European waste stream looks good for your company. So I think it always has got to be a consideration.
Troutman: You must consider weighing the effects of a cost savings versus the effects on the overall package performance and patient safety. Also, the amount of work required to implement a cost-savings or a downgauging project quickly can offset savings or process efficiencies, depending on production volumes.
Using the nylon/nylon flexible package example, as companies expand globally, some countries are not as willing as others to accept certain barrier materials based on historical usage of other such materials. The length of time it takes to gain regulatory clearance on sterile packaged products in different regions of the world can affect the materials used to package your products.
Montgomery: As far as making a change for getting product into the Japanese market goes, the change could take a very long time to implement. Oftentimes from a paperwork standpoint and submission standpoint, it is not worth it for us.
Do many companies want to streamline the amount of materials they are using?
Troutman: Absolutely. In a market like mine, we have small batch sizes of a large number of products. We have to maintain different package configurations to support our broad product offerings, therefore minimizing the variations of materials used is essential.
Cho: Sometimes the goal is to reduce the suppliers and SKUs, but there is another side. Purchasing may want alternate suppliers for certain critical packaging components so sometimes you are caught in the middle. You rationalize your supply base at the same time and have a secondary supplier qualified just in case. The amount [of work] that is required to revalidate or validate a new supplier can take a lot of effort. You are talking about whole stability and aging studies all over again. You have to balance the need for strategic options with being single sourced.
Troutman: Globally positioned suppliers are going to be at a great strategic advantage with the ability to provide similar materials in different regions of the world. Some suppliers right now claim global presence, but seem to have mainly contracts and agreements with like suppliers in other regions.
Do you need more than just a sales office and sales support in those countries?
Troutman: Absolutely. With rising petroleum costs, the cost to ship packaging materials is going to continue to rise. MDMs need service and product offerings that are manufactured to the same level of quality produced in the United States to support the global marketplace.
Are you looking into barrier materials?
Troutman: There is a need. MDMs are continuing to develop products that require protection from moisture, gas, and, in some cases, light, but the expertise with these types of materials is hard to find. Combination devices blur the line between devices and drugs or biologics. You are going to see more and more MDMs looking to suppliers for information for guidance on different types of enhanced barrier properties.
Montgomery: I agree. We are trying to look ahead into the pipeline for our products and determine from a packaging standpoint how we are going to be able to support future products. So different barrier materials, like Aclar laminations, are definitely a consideration.
Troutman: There is an opportunity for suppliers to set themselves apart from one another. When considering the device market, suppliers provide the same kinds of materials with varying proprietary technologies. For drug and biologic applications, material performance characteristics could enhance or prolong product shelf life.
Are you interested in peelable films?
Montgomery: I would say that the materials we are using are performing at a satisfying level.
Cho: Having quite a few form-fill-seal machines, we are looking at peelable films. Of course, with the Tyvek prices where they are and with DuPont being the sole supplier, there are a lot of companies that have converted their top webs from coated Tyvek. When you peel it, there is a clean peel and there are advantages. But it is going to take a lot of effort to qualify it on existing form-fill-seal lines.
What is the next big challenge for converters?
Cho: Too much consolidation may not be such a good thing for the customer. Have we seen better costs and quality as a result of consolidation? It is kind of hard to say.
Troutman: Controlling price and delivery charges to help manage and possibly reduce material costs. A challenge affecting MDMs in the future will be rising healthcare costs that are forcing hospitals to take a more-aggressive role in price setting. Proactively, it would be helpful to have suppliers that can provide guidance related to processing improvements that could yield cost savings helping to spread the burden among suppliers and MDMs.
Are you interested in participating in reverse auctions where converters bid for business at lower cost?
Troutman: The challenge we run into is material qualifications. Currently we do not have the luxury of picking between low bidders to realize a cost savings without replication of extensive testing.
Montgomery: That is exactly right. In those cases, a switch could affect regulatory submissions and qualified packaging processes you have in place for existing products. It is not necessarily easy to just open it up for bidding and pull the trigger on the lowest bidder. There are a lot more ramifications to making a change than just price.
Cho: Maybe with corrugated or cartons, you can do the reverse auction. I think reverse auctions may work in the consumer marketplace but not for MDMs.
How do you think you will get converters to help you reduce costs?
Troutman: Provide relevant test information for materials that could be used as alternatives to current solutions on the market. Various suppliers are working to provide MDMs with alternatives to the readily available, sometimes costly materials. Some package configurations are overpacked or consist of materials that are not necessary needed, but easy to implement because of the current data, etc.
MDMs need to continue pushing suppliers to develop better applications, better materials, and better ways to reduce cost. As an industry, our involvement and drive to push suppliers will help to facilitate the technological advancement of materials to support medical device advancement.
In closing, when considering material application changes and cost-savings initiatives, MDMs need to fully evaluate the trade offs of implementing the alternatives. MDMs should not jeopardize package performance, or more importantly, patient safety, in a quest to reduce costs.