Case Study: Boston Scientific achieves faster regulatory approval and lower validation costs with Minitab Statistical Software

Pulling Its Weight Tensile Testing Challenge Speeds Regulatory Approval for Boston Scientific

Boston Scientific, a leading medical device manufacturer, needed to confirm that diagnostic catheters produced at a new facility in Heredia, Costa Rica would perform as reliably as those from the original manufacturer. With only four weeks to meet regulatory requirements, the company faced a challenge validating pull-wire tensile strength without delaying production or incurring the cost of a full process validation. Boston Scientific turned to Minitab Statistical Software to help address the testing challenge.

Using Minitab, the team analyzed tensile test data with a 2-sample t-test and supporting variance checks to compare pull-wire strength under the two test methods. The results showed no significant difference in tensile strength, confirming the new process met specifications and satisfied regulators. According to Boston Scientific, Minitab helped save about a month on this phase of the transfer, reducing testing costs and keeping the project on schedule.

Boston Scientific

German Vindas

Manufacturing Engineer