EdgeOne Medical Inc.

Design Verification (DV) testing is the critical point in a Combination Product development program when all activities converge to generate the performance data necessary to support a successful regulatory filing. Any failure or delay during the DV stage of program has the potential to directly impact submission filing dates and initiation of clinical trials or commercial launch. Based on EdgeOne Medical’s extensive experience with design verification testing, this technical talk will highlight some key pitfalls that we’ve had to help our clients navigate to achieve success with their testing programs: test method validations; sample sizes and setting design input requirements.

Ability to achieve successful injection of drug or biologic depends on many factors including but not limited to needle diameter, drug viscosity, spring force, lubrication, plunger geometry and material properties. One additional challenge to be considered during verification of the drug delivery system is effect of back pressure from the patient (tissue). This talk will highlight various options and/or considerations for back pressure during feasibility and design verification testing. Concepts are broadly applicable to pen/auto injectors, on body delivery systems, pre-filled syringes and other delivery systems.