Using Surrogate Devices for Destructive Test Methods to Validate Combination ProductsUsing Surrogate Devices for Destructive Test Methods to Validate Combination Products

Design Verification Testing (DVT) of drug-device combination products must demonstrate, in the laboratory, that the device constituent part meets the requirements set in the design inputs. This includes validation of the physical test methods for accuracy (through calibration) and method precision (with a Gauge Repeatability and Reproducibility study).

Physical test method validation can be performed with actual devices, however for destructive test methods this approach cannot distinguish between poor method precision and part-to-part variation, resulting in high estimates of measurement uncertainty. Instead, designing surrogate devices that look and perform like the devices being tested — but can be used in a non-destructive fashion — can better demonstrate method precision, reduce measurement uncertainty and validate for the appropriate method range.