DCN Dx Expert Insights
DCN DxDCN Dx Expert Insights is a podcast for teams developing and commercializing in vitro diagnostics. Each episode brings together scientists, clinical researchers, regulatory specialists, manufacturing experts, and industry leaders to examine the decisions that determine whether an IVD program reaches the market. Topics include assay development, clinical evidence, regulatory strategy, biospecimens,... more
| Publishes | Twice monthly | Episodes | 24 | Founded | 2 years ago |
|---|---|---|---|---|---|
| Number of Listeners | Categories | Life SciencesHealth & FitnessMedicineScience | |||
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Latest Episodes
What does FDA Breakthrough Device designation mean for an in vitro diagnostic (IVD)? Learn what it takes to qualify, what evidence supports a request, and how designation can shape development and clinical study planning. In this episode of Expert In... more
After a federal court vacated FDA’s final rule for laboratory-developed tests (LDTs) in 2025, did the LDT pathway fully reopen? Not exactly. In Season 3, Episode 15 of Expert Insights, host Emily Friedland, VP of Clinical Research at DCN Dx, speaks w... more
In July 2025, FDA told WHOOP that its Blood Pressure Insights feature was an unauthorized medical device. WHOOP disputed FDA’s position and kept selling it. In January 2026, while the dispute was still open, FDA reissued its general wellness guidance... more
Why respiratory trials built on last year’s calendar are falling behind, and what sponsors need to do differently to catch the season on time. Respiratory disease patterns have stopped following the calendar sponsors are used to. Flu and RSV still sh... more
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... more
Your lateral flow assay performs at the bench. Will that performance hold on the manufacturing line? Manufacturing introduces conditions the assay may not have faced at the bench. Reagent delivery must remain consistent throughout longer runs, while ... more
Many IVD clinical studies still run on a patchwork of disconnected tools: a file share here, a spreadsheet there, a separate system for clinical operations and another for the data. The handoffs between them put time, money, and clean data at risk. S... more
The 2026 IVDR transition deadlines are here, and a lot of IVD companies are sitting still. After the European Commission proposed a revision to the regulation in December 2025, many manufacturers are waiting to see what survives before they file. By ... more
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Apple Podcasts | #4 |  Ukraine/Science/Life Sciences |
Apple Podcasts | #43 | Ukraine/Science |
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Frequently Asked Questions About DCN Dx Expert Insights
What is DCN Dx Expert Insights about and what kind of topics does it cover?
A practical, industry-facing series focused on bringing in vitro diagnostic programs from concept to market. Episodes consistently center on hands-on topics like manufacturing scale-up, design for manufacturability, regulatory strategy, quality systems, and data-enabled platforms for diagnostics. Across conversations, guests share real-world lessons on integrating human factors, specimen strategy, site readiness, and parallel regulatory planning to avoid costly redesigns and delays. A notable pattern is the emphasis on end-to-end support for developers — from early development considerations and formative usability testing to post-market data collection and PCCPs for AI-enabled devices — underscoring a pragmatic, risk-mitigated path to mark... more
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How many listeners does DCN Dx Expert Insights get?
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How many episodes of DCN Dx Expert Insights are there?
DCN Dx Expert Insights launched 2 years ago and published 24 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.
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What guests have appeared on DCN Dx Expert Insights?
Recent guests on DCN Dx Expert Insights include:
1. Missy Farrell
2. Karen Seidler
3. John Acampado
4. Dan Simpson
5. Kevin Gunning
6. Jim Bousshell
7. Daniel Levenson
8. Pat Vaughan
To view more recent guests and their details, simply upgrade your Rephonic account. You'll also get access to a typical guest profile to help you decide if the show is worth pitching.