The Kymanox® device design and innovation team refined a dose accuracy protocol for a customer to be used as part of Design Verification activities and in 510(k) submissions.

Challenge

Kymanox needed to analyze a preexisting dose accuracy protocol and improve the setup.

Solution

Kymanox re-created the setup and any unclear assumptions which could lead to differences in future setups were identified as well as weaknesses in the protocol which could lead to inferior data quality. NEUMA executed testing to determine if revised test setup yields results with less noise and more repeatability.

Results

Kymanox identified multiple points of clarification to the customer to establish a more robust and repeatable setup which could be utilized in the future with new and different personnel. Kymanox identified setup improvements which better isolated the test setup from external disturbances. Kymanox executed device testing which produced data with fewer environmental artifacts than the preexisting setup.