Case Studies

Solving a Medical Device Malfunction to Avoid FDA Resubmission


A large medical device manufacturer was experiencing critical malfunctions of their product in the field. After internal investigations, they discovered that a tolerance stacking issue was the root cause of the problem. Although all of the components fell within customer-specified tolerances, we discovered that if each component approached the upper limit of the tolerances simultaneously, it would trigger a failure. To redesign the product or change the tolerances, the customer would have to resubmit to the FDA for approval, a lengthy and costly process.


As a critical supplier of multiple components and subassemblies, PGI was brought in to work with the customer’s engineers to develop a solution that would avoid FDA resubmission. None of the other component suppliers were able to provide a viable solution. Our team realized we could handle things differently – we were proactive and worked to find a solution within our processes. PGI took a systems approach in understanding how the component parts worked together. We found that if we modified our own processes to maintain tolerances within the lower end of specifications, we could solve this unintended design issue without needing to resubmit to the FDA.


Multiple rounds of testing proved this solution to be effective and eliminated field failures, saving our customer from FDA resubmission. PGI’s ability to work directly with the customer’s engineers and find a creative solution eliminated the malfunction. Because of our commitment to customer relationships, we were the only supplier willing to invest the time and energy to find a solution.

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