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DCN Dx Expert Insights

DCN Dx

24 episodes

DCN 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.

More about the show

Topics include assay development, clinical evidence, regulatory strategy, biospecimens, manufacturing, scale-up, product development, and commercialization.

Subscribe to Expert Insights on Spotify, Apple Podcasts, or your preferred platform, and visit dcndx.com for additional tools and resources.

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MORE FROM DCN DX Explore IVD articles, podcast transcripts, and technical resources: https://dcndx.com/insights/

Learn more about DCN Dx: https://dcndx.com/

Discuss your IVD program with our team: https://dcndx.com/contact/

Episodes

  1. What Breakthrough Designation Does and Doesn't Do for an IVD

    · 34 min

    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…

  2. After the Court Vacated FDA’s LDT Rule: What IVD Developers Still Need to Get Right

    · 57 min · S3 E15

    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…

  3. Wellness or Medical Device? FDA's 2026 Wellness Guidance and the WHOOP Warning Letter

    · 44 min · S3 E11

    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…

  4. Planning Around a Respiratory Season That Won’t Hold Still

    · 39 min · S3 E11

    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…

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

    · 57 min · S3 E10

    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…

  6. Where Programs Fail: Bridging Assay Development and Manufacturing for Lateral Flow

    · 42 min · S3 E9

    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…

  7. Off the Patchwork: What a Connected Platform Lets a CRO Do for Sponsors

    · 44 min · S3 E8

    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,…

  8. Stuck in a Holding Pattern: The IVDR Revision and Planning for Two Markets at Once

    · 36 min · S3 E7

    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…

  9. QMSR Is in Effect: What IVD Manufacturers Still Need to Do

    · 36 min · S3 E6

    In this episode, Emily Friedland, VP of Clinical Research at DCN Dx, talks with two guests who come at QMSR from different directions: the regulatory strategy side and the quality systems implementation side. Dan…

  10. Specimen Strategy Is Development Strategy (And Why "We'll Source It Later" Fails)

    · 36 min · S3 E5

    Specimen strategy is one of the most common sources of avoidable delay in IVD development. Teams that defer specimen decisions until after the evidence plan is set tend to discover the mismatch at the worst possible…

  11. Automation Beyond the Strip: Building Repeatable Rapid Test Production with KinBio

    · 16 min · S3 E4

    As rapid diagnostic programs transition from R&D to scaled production, small sources of variation can quickly become major risks. In this episode of Expert Insights, Mitzi Rettinger, Chief Revenue Officer at DCN Dx,…

  12. Point-of-Care in 2025: Lateral Flow Grew Up. Where Will the Technology Go Next?

    · 43 min · S3 E3

    In this episode of Expert Insights, DCN Dx’s Mitzi Rettinger speaks with Dr. Pat Vaughan, DCN Dx’s Chief Operating Officer, about what point-of-care really meant in 2025, how development expectations have shifted, and…

  13. The DCN Dx Model: Integration, Scale, and What Comes Next with DCN Dx CEO Charlie Mamrak

    · 17 min · S3 E2

    A DCN Dx Expert Insights conversation with Charlie Mamrak, CEO at DCN Dx, hosted by Mitzi Rettinger. Most IVD programs don’t lose months because a single experiment failed. They lose months at the seams: development…

  14. Predetermined Change Control Plans (PCCPs) for AI-Enabled IVDs

    · 26 min · S3 E1

    A DCN Dx Expert Insights conversation with Dan Simpson, RAC, Director of Regulatory Affairs at DCN Dx, and Emily Friedland, VP of Clinical Research at DCN Dx. FDA’s Predetermined Change Control Plan (PCCP) mechanism…

  15. BioDot on Making LFAs Manufacturable: What Strong Lines Look Like Before You Scale

    · 34 min · S2 E10

    BioDot’s Director of Sales for the Americas, Rob Rich, joins Mitzi to talk about the practical side of lateral flow manufacturing. They cover where precision dispensing and web handling pay off, the early decisions…

  16. K-One on Gold: Turning Surface Chemistry into Real LFA Performance with Kimialys

    · 35 min · S2 E9

    Surface chemistry on gold nanoparticles is one of the quiet levers that decides how your lateral flow test performs in the real world. In this episode of Expert Insights, host Mitzi Rettinger and DCN Dx COO Patrick…

  17. Rugged by Design: Making LFA Work in the Clinic, at Home, and in Production with Kellie LaRochelle, CEO, Imagene Technology

    · 32 min · S2 E6

    Lateral flow succeeds when real-world constraints drive design: ease of use, ruggedness, and affordability. Few guests can speak to those tradeoffs from the bench, the exam room, and the factory. In this episode,…

  18. Making Quantitative Work: Practical Guidance from Cytiva’s Klaus Hochleitner

    · 24 min · S2 E7

    Quantitative formats are no longer niche. They’re fast becoming standard in respiratory panels, chronic disease monitoring, and decentralized clinical trials. But building a quantitative lateral flow test that’s…

  19. Hype or Help? How to Evaluate Generative AI in Diagnostics with Jeremy Elser, Ph.D., Head of Science Operations at Palantir

    · 31 min · S2 E5

    How do you separate signal from noise when it comes to AI in diagnostics? In this episode of Expert Insights, host Mitzi Rettinger sits down with Jeremy Elser, Ph.D.—a strategist, data scientist, and Head of Science…

  20. From Bench to Program Lead: Lateral Flow Development Lessons That Stick

    · 24 min · S2 E4

    In this episode of DCN Dx's Expert Insights podcast, Helen Hsieh, Senior Scientist and Program Manager at DCN Dx, shares her journey from academic biophysics to leading client-facing diagnostics programs. She digs into…

  21. The Hidden Costs of Cheap Lateral Flow Development: Why Experience Matters

    · 42 min · S1 E3

    Understanding the True Costs of “Cheap” LFA Development In this episode of DCN Dx’s Expert Insights, Mitzi Rettinger interviews Dr. Pat Vaughan, COO of DCN Dx, to explore the risks of working with inexperienced or…

  22. What's Behind Winning Regulatory Strategies for IVDs?

    · 16 min · S2 E3

    In this episode of Expert Insights, host Mitzi Rettinger sits down with Dan Simpson, Head of Regulatory Affairs at DCN Dx, and Emily Friedland, VP of Clinical Research at DCN Dx, to discuss the critical role of…

  23. 2024 Review and 2025 Predictions for Lateral Flow Diagnostics

    · 30 min · S2 E2

    In this episode of Expert Insights, DCN Dx’s Chief Revenue Officer, Mitzi Rettinger, sits down with Chief Operating Officer Dr. Patrick Vaughan to discuss the latest advancements in lateral flow, from decentralized…

  24. Developing Your Lateral Flow Development Skills With DCN Dx’s 2025 Basic Training Course

    · 22 min · S2 E1

    In this episode of Expert Insights, Mitzi Rettinger and Melanie Bader discuss DCN Dx’s 2025 Basic Lateral Flow Training Course. Melanie, a seasoned Research Scientist and Training Specialist, shares her extensive…

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