Jul 2013

Author: Nicole Feist, BA


A key step in the translational medicine “benchtop to bedside” process model is the move from research and preclinical (in vivo or in vitro) testing to a “first-in-human” (FIH) study. Despite all efforts to predict how the human body will respond—eg, by conducting robust preclinical testing and risk assessments—there are nevertheless basic anatomical differences between humans and test model subjects that can lead to key differences in performance of a device or therapy. Data gathered from the FIH study will drive the next step in the device testing process and will help move the device into a larger feasibility and pivotal trials; therefore, proper FIH design is crucial for bringing your medical device to market.