Expert Insights
Expert Insights
Podcast Description
Expert Insights offers an inside look at the diagnostics industry, with practical advice and real-world examples from experienced professionals. Hosted by Mitzi Rettinger, Chief Revenue Officer at DCN Dx, this podcast focuses on the key decisions and challenges involved in developing and commercializing diagnostic technologies.
Each episode features conversations with industry experts who share their experiences in assay development, clinical research, manufacturing, and regulatory processes. From overcoming technical hurdles to ensuring a smooth path to market, Expert Insights provides clear, actionable guidance for diagnostics developers, R&D managers, and innovators.
Subscribe to Expert Insights on Spotify, Apple Podcasts, or your preferred platform, and visit dcndx.com for additional tools and resources.
Podcast Insights
Content Themes
The podcast centers on key themes related to diagnostics technology, including assay development, clinical research, manufacturing processes, and regulatory challenges. Specific episode examples include discussions like 'Developing Your Lateral Flow Development Skills' where practical training in assay development is emphasized, reflecting a focus on actionable guidance for listeners needing real-world insights.
Expert Insights offers an inside look at the diagnostics industry, with practical advice and real-world examples from experienced professionals. Hosted by Mitzi Rettinger, Chief Revenue Officer at DCN Dx, this podcast focuses on the key decisions and challenges involved in developing and commercializing diagnostic technologies.
Each episode features conversations with industry experts who share their experiences in assay development, clinical research, manufacturing, and regulatory processes. From overcoming technical hurdles to ensuring a smooth path to market, Expert Insights provides clear, actionable guidance for diagnostics developers, R&D managers, and innovators.
Subscribe to Expert Insights on Spotify, Apple Podcasts, or your preferred platform, and visit dcndx.com for additional tools and resources.
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.
Disclaimer
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