DCN Dx Expert Insights

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 f

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

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

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

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 fo

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

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

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

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 th

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

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 t

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

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, Mitz

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

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,

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

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 fail

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

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 Pred

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

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 a

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

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,

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

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 ex

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

Quantitative formats are no longer niche. They’re fast becoming standard in respiratory panels, chronic disease monitoring, and decentralized clinical trials. But buildin

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

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 s

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

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 c

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

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

What's Behind Winning Regulatory Strategies for IVDs?

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

2024 Review and 2025 Predictions for Lateral Flow Diagnostics

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 adva

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

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