Rationale for Replacement of the Destructive Test by Non-Destructive One in Medical Devices Manufacturing

Abstract

Due to expanding demand for the level of testing on one side and reduction of costs on the other side, the question how to replace expensive destructive testing of medical devices without compromising the quality of final product arising urgently. This situation is common within all highly regulated industries – in this article is addressed the problem from medical device manufacturing industry. Based on real data containing testing and validation datasets, logit model and classification tree model are estimated for establishing the relationship between result of destructive test and measurements of explored device. Results point to possibility of replacing destructive test by non-destructive one in our case.

Keywords

• classification tree model
• destructive test
• logit model
• medical devices manufacturing
• non-destructive test