MDMs: Save Time, Effort, and Cost of Your Stability Tests

Medical device manufacturers (MDMs) do a lot of testing to make sure their products and packages are safe. Are they doing too much though? Don’t the results of decades of testing the same packaging materials prove that these materials are safe?

That’s the premise of the Wicked Stability project underway by the Kilmer Innovations in Packaging (KiiP) group.

After introducing the idea at thePACKout conference a couple years ago and getting a positive response from the community, the KiiP group is taking the next step: collecting industry data from MDMs that prove the hypothesis.

That’s where you come in. KiiP needs your data. Now through November 30, MDMs interested in participating in this project can submit as much — or as little — stability testing data as they want to Canyon Labs, an independent laboratory responsible for collecting, scrubbing, and analyzing the information in support of the Wicked Stability hypothesis.

To remain objective and lend credibility to the project, KiiP is accepting data on any commonly used materials. Recent data is preferable, although there is no expiration date on what can be submitted.

The process.

MDMs interested in contributing data should send an email to [email protected]. In return, the sender will receive a document of frequently asked questions, a confidentiality disclosure agreement (CDA), and a data collection spreadsheet.

Once the signed CDA and completed spreadsheet have been submitted, Canyon Labs will begin the data-scrubbing process; in essence removing any company-specific information in preparation for a blinded, statistical analysis of stability data across the industry.

A minimum of four to five companies is needed to perform the analysis. KiiP will then share the completed data evaluation with participants in a blinded form.  

The outcome.

So how will this data analysis bring about change? Assuming it backs up KiiP’s hypothesis, MDMs can use it to justify a reduction in the amount of stability testing they perform or to substantiate why a particular product does not need to be tested.

The next logical step: involving regulatory agencies — the ultimate gatekeepers of these processes — to get their stamp of approval.