MDMs: Submit Stability Data, Help Packaging Science!

The KiiP Wicked Stability project is working on a study to evaluate stability data of commonly used materials, with the aim of reducing testing and saving time. Ultimately, they hope to impact the industry by showing that commonly used sterile barrier systems are inherently stable after years of aging studies.

"We all have these redundant stability test activities, and we could focus our resources on more significant challenges that are actually going to provide value to patients and users of the products,” Jordan Montgomery, distinguished packaging engineer at Medtronic, said when describing the project's aims back in 2022.

Read our primer: KiiP Tackles Wicked Problems in Package Material Stability

After a lively oxidative induction time (OIT) deep dive by Wicked Stability members Henk Blom, PhD and Jordan Montgomery at the[PACK]out, the volunteer group is now officially seeking industry collaboration: they are asking medical device manufacturers (MDMs) to submit data for a blinded analysis of stability data across industry by November 30, 2024. Henk Blom and Jordan Montgomery present at the[PACK]out 2024.

Led by DuPont's Jennifer Benolken and Canyon Labs' Wendy Mach, the intent is to have medical device manufacturers submit data from  various stability testing that they've performed on commonly used medical device packaging materials for sterile barrier systems. By submitting your data—including peel strength and visual inspection data—you can contribute to this analysis.

Privacy: The effort will be hosted by an independent laboratory, Canyon Labs. MDMs will submit their data, and data will be scrubbed of any identifying information. Participants must complete a confidentiality agreement to participate.

The KiiP team will then take the data and perform statistical analysis to test their hypothesis that commonly used materials in medical device sterile barrier systems do not degrade significantly over time. Data will be collected from at least four or five participants before sharing it with the KiiP team.

Timeline: Data will be collected between May 13 and November 30, 2024. 

Benefits: Their hypothesis is essentially that there is not a significant amount of degradation occurring that would impact an MDM's ability to meet established requirements and get sterilized devices to the end user in an appropriate state. 

Provided their hypothesis is proven correct, MDMs could take the data analysis that the team develops and use it in their own justifications to support why they can reduce the amount of stability testing they need to do, or justify why they don't need to perform testing for a particular product or project, says Benolken.

Though hard dollar amounts saved would depend on a given company and project, a lot of what the team has talked about is all the time and effort and cost that could be better dedicated towards coming up with new innovative designs, and in focusing on things like packaging sustainability. Ultimately, the team hopes to involve regulators and get their blessing on the approach, so to speak.

The team has developed an FAQ document (below the survey question). Additional questions? Email [email protected]