CASE STUDY

The role of mechanical variation management in medical devices

A case study of drug delivery devices developed by Flex

The development of medical devices presents unique technical, regulatory, and economic challenges, requiring a multidisciplinary approach to ensure patient safety, reliability, and market competitiveness. Medical devices span a wide spectrum—from drug delivery systems to surgical robots—and must meet stringent functional, material, and regulatory requirements. A critical and often underestimated factor influencing their performance and manufacturability is mechanical variation, the inevitable deviation from nominal design that occurs during production.

biomechanics