Validating part process instead of machine process could save medical molders millions

Traditionally, medical device molders must re-validate a part each time a mold is run on a different machine. This can cost millions of dollars a year and lead to weeks or months of machine downtime, leading to lost revenue. The Medical OEM Consortium (MOEMC) set out in May 2016 to develop a more efficient and less costly part validation process for injection molding. It has succeeded in creating a “part process” that eliminates the need to fully re-validate the tool each time it is moved to a new machine. The findings from the proof of concept were released today in a white paper that is available as a free download (registration required) on the RJG website. Headquartered in Traverse City, MI, RJG provides injection molding training, technology and resources.

The white paper, “Part Process Transferability Using a Machine Independent Variable (MIV) Methodology for Multiple Machines,” describes the methods, materials, results and conclusions of the consortium’s research. Through the execution of this discovery exercise, the MOEMC has provided a broadened perspective on the acceptance of the “part process” method to allow the transfer of molds in the medical device industry as a practical alternate standard, said the group in a press release.

Medical OEM Consortium
The Medical OEM Consortium

In addition to reducing expenses and improving productivity, transferring a process from machine to machine based on a reduced verification run can help mitigate risk based on data-driven decisions (using available technology). This, in turn, can help drive continuous improvements and sustain the required statistical control, according to RJG.

“This is the future of medical molding,” said MOEMC member Scott Scully, Director, Corporate Molding/Tooling, at Terumo Cardiovascular Systems. “For too long, the cost of full validation to move a mold has kept the industry handcuffed by suppliers and has thwarted OEMs to move quickly on unexpected schedule demands. To remain competitive, we must change to validating the ‘part process’ instead of the ‘machine process.’ Those who do will out-compete those who don’t,” said Scully.

As described in the white paper, a Machine Independent Variable (MIV) method was deployed to effectively and efficiently transfer a validated “part process” across four distinctly different injection molding machines (IMMs). “Critical to Quality (CTQ) results for each transfer were required to meet Ppk targets to match the CTQs of the initial validation. Our results show the MIV transfer method, verified with eDART technology, can be used to replicate plastic parts in different IMMs with negligible part variation (dimensional results) using selected capable machines,” write the authors.

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