10/08/2026
By the time an IVD protocol is finalized, most of the decisions that determine whether the study can be run as designed have already been made, often without input from the sites that will run it. The site feasibility questionnaire, which is supposed to capture those constraints, leaves out much of what would tell you whether a site can deliver.
Our latest Expert Insights episode is about that early stage of an IVD study. Emily Friedland, VP of Clinical Research at DCN Dx, is joined by Missy Farrell, RN, BSN, CCRC, founder and CEO of ClinicaGen Bio, a site management organization focused on non-interventional diagnostic studies, and Karen Seidler, Ph.D., founder and principal of Usable Solutions, who works in human factors and usability engineering for diagnostics and medical devices.
The conversation covers what these feasibility questionnaires miss, why the interventional pharma model is so often misapplied to non-interventional, minimal-risk studies, and where the definition of intended users and use environments belongs in the development timeline rather than at a summative usability study.
It is the first in a podcast series examining IVD clinical research from the perspective of the site. The link is in the comments.
