ASK THE EXPERT
Richard Crane is vice president of new business development at J-Pac LLC, a medical device manufacturer and packager located in Somersworth, NH. He has had a twenty-five year career in the medical device arena, spanning areas from package engineering to medical device development, supplier side to OEM side, and technical and management ladder. Crane was also the winner of the 1991 Ameristar Packaging Competition Gold Star for the medical device category, awarded by Institute of Packaging Professionals, and led development and the global launch of several new medical devices for Fortune 100 device companies. He is also a patent holder.
MPMN: What is the most significant trend emerging in the medical packaging industry?
Crane: Customers are demanding a total process solution when it comes to packaging. In the past, it was enough to offer isolated competencies that the client would tailor to their needs. Now, the solution package needs to fulfill the entire spectrum of needs. Whether the solution is outsourced packaging or equipment that will be purchased for in-plant use, the benefit provided the customer must fulfill the needs of an entire process, not just a part.
MPMN: What are some of the negative effects sterilization can have on packaging, and how can they be avoided?
Crane: While the effects of sterilization on packaging can be significant, the process is the backbone of the medical device packaging business that we are in. Sterilization by an EtO process incorporates process variables that include heat, steam, and pressure excursions. Sterilization using a radiation source can wreak havoc with plastics through discoloration and embrittlement. Material selection and the development of a robust packaging process are inherent to a capable overall packaging solution that will withstand the rigors of any sterilization process and provide customers an acceptable product every time.
MPMN: Do you think that there is a need for a change in packaging materials? Why or why not?
Crane: The packaging materials in use for today's medical applications are functional and versatile. With the cost pressures that the entire medical device market is under, lower cost materials would be a benefit. But from the functionality perspective, the materials are more than adequate.
Pressures are mounting for lighter weight barrier packaging materials as the transition to combination products escalates. These barrier materials are also integral to point of use treatment kits and electrochemical diagnostics that are becoming more evident in today's healthcare marketplace.
MPMN: How has the rise of combination products impacted the packaging industry?
Crane: The combination products have really blurred the line between medical device and pharmaceuticals. Packagers who have traditionally worked with pharmaceutical products are now challenged to accommodate some sort of device component of the overall offering, and the medical device packager is challenged to handle a pharmaceutical component of what used to be a benign medical device. These unique devices require new packaging formats with many requiring modified atmosphere barrier packaging. As the regulatory pathway for the approval of these devices is still being clarified, so too is the supply chain for these products, including packaging. No doubt the trend toward these types of products will continue, and packagers that wish to play in this arena will need to offer a total process solution, as previously discussed.
MPMN: Medical packaging relies heavily on plastics and other environmentally unfriendly materials. What is the industry doing to reduce waste?
Crane: Quite honestly, the medical packaging community is working with many of the same materials that it was ten years ago. The rigors of validation make package material changes time consuming and costly, so change is slow coming. I believe that environmental improvements are being made from the perspective of package down-gauging and down-sizing, however the key materials in use seem to me to be basically unchanged.
MPMN: It appears as though device companies are requiring more oxygen- and moisture-barrier characteristics in packaging. How has this affected the industry?Crane: You are right in identifying this trend, and it is a game changer. Packagers need to provide processes that accommodate the limited WIP times of the materials in question. Entire package formats are changing from typical Tyvek pouches or lidded blisters to foil pouches or exotic barrier composites. The packages need to provide barrier protection, but meet the requirements of patient access or sterile delivery technique, not an easy balance to maintain. EtO sterilization is no longer a costly alternative as the barrier package is nonporous. Many of these applications ultimately utilize foil composites that block visibility of the product, which can change required product visual inspection timing from poststerile to presterile, which can sometimes be significant. The change to barrier packaging is not an isolated change...it affects the device development, manufacturing and packaging process clear back to the point of device material selection.
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