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 value when they are on the equipment, what BioDot plans to highlight at ALFC this October, and we’ll close with Rob’s advice for people selling into this technical market.

Presented in partnership with BioDot, a Gold Sponsor of ALFC 2025. Learn more at BioDot.com.

Listeners can get 25% off their ALFC registration by using code ALFC25 at alfc2025.com. Virtual registrations are available!

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-specific interactions on gold. We translate the chemistry into practical decisions for assay developers and product managers.

Presented in partnership with Kimialys, Gold Sponsor of ALFC 2025. Podcast listeners can enjoy 25% ALFC in-person and virtual registrations by using code ALFC25 at checkout.

Guests

Claude Noguès, Ph.D., CSO, Kimialys

Cyril Gilbert, CEO, Kimialys

Host

Mitzi Rettinger, CRO, DCN Dx

Pat Vaughan, Ph.D. COO, DCN Dx

What you’ll learn

• How ligand orientation and usable surface area on gold influence LoD, reproducibility, and matrix tolerance

• Where K-One coated gold bioconjugates can help, and the caveats to keep in mind when translating results

• Buying criteria that actually matter

• Scale-up watchouts

Who should listen

LFA and rapid test developers, R&D and product managers, operations leaders, and quality and verification leads.

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 settings.

Kellie shares practical ways to prevent cost and complexity creep, the error traps that trip up home and clinic use, and how upstream choices such as reagent dispensing shape downstream reliability. She also walks through how to train the next generation as veteran experts retire, where to automate, and how suppliers can support resilient, distributed strip production for rural and resource-limited settings.

Presented in partnership with ⁠Imagene Technology⁠, Gold Sponsor of ALFC 2025 and a long-time supporter of the conference. Imagene’s IsoFlow reagent dispensing systems are used by LFA manufacturers worldwide.

⁠ALFC 2025⁠ is happening October 14-15 in La Jolla, CA. Expert Insights listeners can get 10% off ALFC 2025 by using code INSIGHTS at checkout. Visit ⁠alfc2025.com⁠ for more details about the conference and to register.

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 DCN Dx’s Mitzi Rettinger and Pat Vaughan, Ph.D., to break down what developers get wrong—and what the best teams are doing differently. From membrane selection to reader alignment, Klaus shares hard-earned insight into the technical decisions that make or break performance.

We also preview his upcoming lunch & learn session at ALFC 2025: “Considerations in the Development of Quantitative Lateral Flow Tests.” Whether you’re deep in optimization or just scoping feasibility, this episode delivers clear, actionable guidance for developing quantitative tests that work.

Presented in partnership with Cytiva, Platinum Sponsor of the 2025 Advanced Lateral Flow Conference.

In this episode of Expert Insights, Mitzi Rettinger sits down with Sarah Barchard, Senior Clinical Trials Manager at DCN Dx and co-author of our Expert Insights whitepaper on de-risking IVD studies for regulatory success. Sarah shares the most common and costly pitfalls she’s seen in hundreds of diagnostics programs, and walks through practical strategies for getting clinical, regulatory, and data teams aligned early. The conversation spans intended use, pre-submission engagement, biostatistics, human factors, and what it actually looks like to “fix” a struggling clinical trial before it derails a submission.

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 AI use cases without falling for hype

What to ask when AI vendors pitch you “breakthrough” tools

Red flags that signal a lack of scientific grounding or operational relevance

Where generative AI is already proving valuable—especially in decision support, knowledge retention, and complex workflows

How to think about regulatory alignment, validation, and change management in AI-driven environments

Jeremy also offers a preview of his keynote at ALFC 2025, where he’ll be speaking directly to diagnostics and point-of-care leaders about what it takes to build responsible, useful AI into real-world diagnostics programs.

Whether you're on a product team exploring AI-driven image analysis, in leadership evaluating LLM pilots, or simply trying to stay current, this episode delivers a strategic view on what matters now in AI for diagnostics.

Subscribe to Expert Insights for conversations with the people shaping the future of diagnostic science—from assay development to AI deployment.

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 from real-world case studies, Dr. Vaughan shares insights on how experience and technical expertise can help mitigate risks and ensure successful assay development and commercialization.

Why Listen?

This episode dives into the key considerations for selecting an LFA development organization, with a focus on identifying and avoiding the pitfalls of working with inexperienced providers.

You’ll gain insights into:

-Real-world case studies where DCN Dx turned around failing projects to deliver successful, market-ready products.

-The long-term risks and hidden costs of partnering with cheap lateral flow developers.

-Key qualities to look for in a development partner, including manufacturability, scalability, and regulatory readiness.

-Specific guidance in how to evaluate RFP responses from prospective LFA development partners.

-Gain access to our free, downloadable rubric to evaluate potential lateral flow assay development partners and ensure your project stays on track.

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 delays and ensuring a smooth path to commercialization.

Dan and Emily share their expertise on structuring a regulatory strategy that minimizes risk while optimizing approval timelines. They explore the importance of pre-submission consultations, the nuances of FDA versus IVDR requirements, and how early collaboration between regulatory and clinical teams can streamline the approval process. Whether you're working through a 510(k), de novo, or PMA pathway, this episode provides valuable insights to help you plan an effective regulatory approach.

Listeners will gain a deeper understanding of how regulatory strategy impacts clinical study designs, the importance of harmonizing global compliance efforts, and the best practices for engaging with regulatory agencies early in development.

This episode breaks down the essential elements of a strong regulatory strategy for IVD developers. You’ll learn:

-How to determine the right regulatory pathway for your IVD device (510(k), de novo, or PMA).

-The role of pre-submission consultations in mitigating risks and expediting approvals.

-Key differences between FDA and IVDR requirements and how to harmonize global compliance efforts.

-How early collaboration between regulatory and clinical teams can prevent costly delays.

-Real-world examples of successful regulatory strategies that accelerated market entry.

Whether you're an entrepreneur, scientist, or regulatory professional, this episode offers practical insights to help you bring your diagnostic device to market efficiently.

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 use of sustainable materials, and breakthroughs in personalized medicine. He also discusses the challenges and opportunities for startups versus established companies and what regulatory shifts might mean for the industry.

This episode is packed with insights that will help diagnostics developers, scientists, and industry leaders understand where the market is headed and how to navigate the evolving landscape.