Insulin Pump

Neuma refined a dose accuracy protocol for a customer to be used as part of Design Verification activities and in 510(k) submissions.

Approach

  • Analyze preexisting dose accuracy protocol and recreate setup.
  • Identify any unclear assumptions which could lead to differences in future setups.
  • Identify weaknesses in the protocol which could lead to inferior data quality.
  • Execute testing to determine if revised test setup yields results with less noise and more repeatability.

Key Accomplishments

  • Identified multiple points of clarification to the customer to establish a more robust and repeatable setup which can be utilized in the future with new and different personnel.
  • Identified setup improvements which better isolated the test setup from external disturbances.
  • Executed device testing which produced data with less environmental artifacts than the preexisting setup.