In This Economy, Cut Back But Not Too Much

With economic fears rippling through manufacturing industries, you might be asked to cut back wherever you can. But there is a risky trend to avoid, says Wendy Mach. “Medical device manufacturers (MDMs) may be cutting back on their sample sizes for testing programs,” she says. Mach is the packaging section leader for Nelson Laboratories.

The danger comes from cutting too much. “MDMs need to make sure that they are using an appropriate sample size that enables them to catch defects.” Are there opportunities for savings? Perhaps, says Mach. She describes Nelson’s typical plan as follows:

• XX samples received initially. (XX stands for the company-specified sample size based on statistical rationale.)
• All samples are subjected to the transportation and distribution test.
• Upon return, ~50% are tested for strength, integrity, and microbial barrier (baseline time point).
• The remaining 50% are accelerated aged, and then the same tests that were perfomed at the baseline are repeated.

However, if MDMs “have a lot of money and don’t want to be risk takers,” Mach says they often follow this sequence:

• XX samples received initially.
• XX samples are run through testing for strength, integrity, and sometimes microbial barrier (baseline time point).
• All samples are subjected to the transportation and distribution test.
• Upon return ~50% are tested for strength, integrity, and microbial barrier (baseline postship test).
• The remaining 50% are accelerated aged, and then the same tests that were performed at the baseline are repeated. (Sometimes there are multiple time points here, and sample size is adjusted to cover all testing).

There are other ways to help customers economize in testing efforts and expenses, reports Karen Greene, technical director for DDL Inc. “When evaluating current and future testing requirements, MDMs can consider opportunity to leverage package shelf life or aging studies. Changes in sterile barrier package size and dimensions do not necessitate a new shelf life/aging study. If an MDM can demonstrate that identical sterile barrier packaging materials are used and the sterilization method and dosage remain unchanged, then previously executed shelf life/aging studies can be leveraged. This approach can be a significant time saver as the MDM expands a product line.”

“Regarding the execution of a zero-time sterile barrier package design validation study, MDMs can look to developing a strong worst-case device and package design rationale,” Greene adds. “That is, those responsible for packaging validation should work with their teams to determine what combination of devices and package design configurations can be rationalized as worst case relative to their effect on sterile barrier integrity (weight, profile, device and package orientation, case count, etc.) and device safety and efficacy. Large or multiple-division MDMs should reach out internally to determine potential opportunities to create more comprehensive sterile barrier package design validations for their organization. This will save time and money in the long run.”

Given today’s economic pressures, it is critical for companies to best use their resources. The challenge lies in identifying risk and spending resources wisely to mitigate it.

Daphne Allen
Editor