Behavioral Analysis Saved Unnecessary Costs on FDA Revalidation


A pharmaceutical client added an exhaust sound suppressor to their autoinjector to quiet the device. The FDA thought that this fundamentally changed the device by removing an auditory signal of injection completion and wanted revalidation of the new design for usability. They came to Battelle to design the revalidation study. 


By reviewing the existing risk analyses and past usability test results along with academic literature citations on behavioral principles, our behavioral analysis experts determined that the “auditory cue” did not impact injection behavior because of the speed of the injection process. Human reflexes are not fast enough to stop the process in time to avoid a full injection, with or without an auditory cue. Battelle wrote a technical paper detailing our behavioral analysis findings in support of not conducting a new user study. 


Based on Battelle's work, our client was able to inform and educate the FDA, resulting in the FDA repealing the need for user revalidation. By not needing to conduct a full summative study, including three user groups, our client saved considerable time and money and avoided a four to five month product launch delay.