Outsourcing Outlook on Packaging and Sterilization: Q&A

Charlie Ricci, vice president of sales and marketing at Life Science Outsourcing Inc. (Brea, CA) highlights a variety of packaging and sterilization items relevant to device makers.

MPMN: What capabilities should medical device OEMs demand of packaging service providers?

Ricci: First and foremost, a service provider must have quality processes supported by an FDA-registered and ISO 13485-certified quality system. Suppliers shouldn't take short  cuts, especially when packaging is the only means of protecting the product's integrity and sterility throughout its lifecycle. Containing costs is becoming more of a driving factor in the medical device industry, and working with a vendor that can help improve efficiency and share process improvement savings is critical to making the OEM-supplier relationship a success.

MPMN: What packaging and sterilization trends should concern medical device OEMs?

Ricci: As the move continues toward developing disposable instruments, sterile packaging and the use of labels indicating that devices are for single-use applications are growing in importance. While manufacturing costs will rise as a result of using sterile packaging for devices that were previously nonsterile and reusable, these costs will be more than offset by reducing the costs associated with sterilizing reusable devices and by lowering hospital infection rates. Nevertheless, because adding costs in a cost-cutting environment is tough, the OEM should work with a supplier that understands these sensitivities and can ensure that the product is packaged in the least expensive but protected manner.

MPMN: What types of equipment should a qualified packaging service provider have inhouse to best serve the medical device OEM?

Ricci: Although packaging service providers should be equipped with standard sealing and in-process testing equipment, most packaging vendors outsource package validation and sterilization operations. In contrast, the medical device OEM should partner with a packaging service supplier that maintains a full-service ISTA-certified package-testing laboratory. The ability to provide accelerated aging, bubble leak, drop and vibration, and other testing services in-house benefits the medical device OEM by accelerating validations and controlling costs. Because OEMs should choose suppliers that strive to reduce the complexity of the supply chain, they should look beyond standard sealing equipment when evaluating a vendor.

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