By John Simpson, Claire Ramus, Karima Yadi and Natacha Montemuino, MD, Claire Lageat
At BD, human factors activities are conducted throughout the phase-gated product development process and follow recommendations from both IEC 62366 and the FDA guidance on human factors. This includes conducting studies in an iterative fashion to identify and analyze incidents that have occurred and build the learning so that corrective actions are put in place to improve the device design. The goal of these efforts is to provide a final BD validated design and IFU along with a body of research that our customers can use to inform development of the content and structure for their validation study with their final combination device.
This rigorous process was followed with the BD Intevia™ 1 mL two-step autoinjector. It is designed to be compatible with viscous drugs up to 35cP and with different fill volumes up to 1 mL. This is possible without customizing the components, permitting biotech companies to have a “platform” autoinjector device.