Expert Insights

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. Since 2021, DCN Dx has been developing something different: one connected platform on Veeva, with the electronic trial master file, EDC, and CTMS all t...

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 late May, notified bodies reported that submissions had slowed so much that some have cut staff and a few may close. The old IVDD deadlines keep runni...

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 Simpson, RAC, Director of Regulatory Affairs at DCN Dx, covers the regulatory framing: what changed with the QMSR transition, how to map an ISO 13485-based QMS against QMSR’s U.S.-specifi...

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 time: during analytical validation, clinical performance work, or submission prep. In this episode of Expert Insights, Mitzi Rettinger talks with Jim Boushell, Senior Vice President of...

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, sits down with Daniel Levenson, Business Development Manager at KinBio, to discuss what truly changes when you move from manual processes to automated, repeatable manufacturing systems...

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 his predictions for what 2026 will bring. Drawing from Pat’s recent article and hands-on experience across assay development, engineering, clinical research, and manufacturing, the d...

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 to clinical, clinical to regulatory, scale-up to routine manufacturing, and specimen strategy to evidence generation. In this episode, DCN Dx CEO Charlie Mamrak explains the business d...

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 is designed to let manufacturers pre-specify certain post-clearance or post-approval changes, along with the protocol and acceptance criteria used to verify and validate those changes....

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 that prevent scrap and rework, how teams stage the move from benchtop to pilot, and why simple SOP choices often determine yield and reproducibility. Rob also shares what users actually...

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 Vaughan, Ph. D., talk with Kimialys’ Claude Noguès, Ph. D. (CSO) and Cyril Gilbert (CEO) about K-One, their patented approach to controlling ligand orientation and minimizing non-specif...

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, Kellie LaRochelle, CEO of Imagene Technology, former medical laboratory scientist, and primary care physician assistant, joins DCN Dx’s Mitzi Rettinger to connect the dots across those se...

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 reliable, scalable, and regulator-ready is no small feat. In this ALFC Sponsor Series episode, Klaus Hochleitner, Global Lead Technology Product Specialist for Diagnostics at Cytiva, joins...

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 Operations at Palantir—to explore the real-world potential and limits of generative AI in diagnostics R&D and operations. Together, they discuss: How diagnostics leaders can evaluate...

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 the practical realities of lateral flow development—from common pitfalls to real-world troubleshooting—and explains why materials matter more than you think.

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 low-cost lateral flow assay developers. While these options may seem cost-effective at first glance, they often lead to costly delays, redesigns, or outright project failures. Drawing fr...

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 regulatory strategy in bringing in vitro diagnostic (IVD) devices to market. From FDA approvals to international compliance, understanding the regulatory landscape is key to avoiding costly...

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 healthcare and AI-driven diagnostics to sustainability efforts and regulatory shifts. Looking ahead to 2025, Dr. Vaughan shares his predictions for regulatory harmonization, expanded us...

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 background and highlights the importance of structured training in lateral flow assay development. The conversation delves into what attendees can expect from the course, its comprehensiv...