Before the Protocol: What Sponsors Miss About Sites and Human Factors

A site management CEO and a human factors specialist on what sponsors miss before a diagnostic study ever starts. Most conversations about IVD clinical research happen from the sponsor’s side of the table. This episode flips that. Emily Friedland, VP of Clinical Research at DCN Dx, sits down with Missy Farrell, founder and CEO of , and Karen Seidler, Ph.D, CEO and Principal at , to talk about the two stages that happen before a protocol is finalized: the human factors work that determines whether real users can operate a device safely, and the site feasibility work that determines whether a clinic can deliver the study a sponsor designed on paper. For sponsors and CROs, the payoff is practical. Missy explains why prevalence numbers on a feasibility questionnaire routinely mislead sponsors about who a site can enroll, and Karen walks through why combining a human factors validation study with a clinical study creates logistical problems that are hard to see coming. Together they make the case for treating these two disciplines as sequential, not overlapping, and for asking sites and device teams sharper questions much earlier in development.