Expert Insights

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.-specific requirements, and what FDA’s updated inspection approach under CP 7382.850 means for how teams document and maintain QMS records. Kevin Gunning, Principal Consultant at Gunning Quality Systems LLC, brings the quality systems implementation perspective: what it takes to build and maintain a QMS that holds up under QMSR, how organizations should think about the practical work of a gap assessment and remediation, and what teams with established ISO 13485 systems often overlook when they assume the transition is “mostly handled.” Kevin has spent more than 25 years implementing and managing quality systems at IVD and medical device companies, and has extensive firsthand experience on both sides of FDA and ISO audits and inspections. Together, Dan and Kevin cover the four gap areas that matter most for IVD manufacturers, what FDA can now request during an inspection that was previously off-limits, and how to scope a proportional remediation effort. Read the companion article here: https://dcndx.com/insights/qmsr-ivd-manufacturers-gaps-iso-13485/

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 Biospecimens at DCN Dx, about what experienced teams define early so their specimen sets and data packages hold up under regulatory scrutiny. Jim has spent decades building biorepositories and supporting diagnostic developers. The conversation covers how to align a specimen plan to an evidence plan from the start, where programs get burned on matrix selection, prevalence, comparator methods, metadata, and pre-analytical handling, and what a high-integrity, audit-ready data package should contain. Topics in this episode: -What "specimen strategy" includes and why it is separate from procurement -Early warning signs that a program is headed for specimen-related delays -The most common failure modes in specimen planning -The minimum inputs a developer needs to define before designing a collection -When banked specimens make sense versus prospective collection -How DCN Dx runs prospective collections: specimen types, special handling, site operations, and data packages -What "audit-ready" documentation means for IVD submissions -Where handoffs fail when collections, assay development, and clinical execution are split across multiple groups Learn more about DCN Dx's prospective biospecimen collections at dcndx.com/biospecimen-service

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. The conversation goes beyond dispensing and strip cutting to address the often-overlooked bottlenecks in vial filling, kit assembly, packaging, and sealing. Daniel explains how throughput challenges, moisture control, seal integrity, and alignment issues can affect lot consistency, and why automation must extend across the full production workflow, not just the strip. They also explore the role of in-line vision systems and defined critical-to-quality attributes (CTQs) in reducing manufacturing risk. As multiplex tests and more complex point-of-care formats become more common, developers must design flexibility, inspection, and traceability into their processes early. The result: fewer surprises, stronger process control, and a clearer path to scalable production. Guest Daniel Levenson is Business Development Manager at Shanghai Kinbio Tech Co., Ltd. He brings years of hands-on technical experience in rapid test manufacturing to his work supporting developers scaling into automated production.

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 discussion breaks down how modern lateral flow programs are being designed around readers, software, data pathways, and real-world use. The episode explores what this shift changes for teams defining new development programs, including how early design inputs affect performance targets, usability, regulatory strategy, and scalability. Pat also compares today’s realities with predictions he made in his 2024 year-in-review, highlighting where the industry moved faster (and slower) than expected. What you’ll hear in this episode: -Why lateral flow is now an integrated system, not just a strip with visual interpretation -How reader-assisted and semi-quantitative performance are shaping new development programs -Where teams underestimate complexity when moving from prototype to regulated product -What “born digital” results and AI-enabled interpretation require from a regulatory and operational standpoint Guest: Dr. Pat Vaughan is Chief Operating Officer at DCN Dx, where he works across assay development, engineering, clinical research, regulatory strategy, and manufacturing to support point-of-care diagnostic programs from concept through deployment.

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 decisions behind DCN’s integrated services model, why biospecimens became a priority for IVD developers, and how he evaluates what to build, buy, or collaborate on next. This is a strategy conversation, designed for teams who care about execution, risk, and real-world constraints of diagnostics services companies. What you’ll hear in this episode: -Why integration is the point: what changes when rapid testing CDMO capabilities and IVD clinical research (CRO) services operate as one platform. -Why biospecimens: what DCN has heard from customers, what offering prospective biospecimens collections changes for IVD developers, and how it fits the broader integration plan for DCN Dx. -Workforce development as strategy: why DCN teaches the Basic Lateral Flow Course. -Build vs. buy vs. collaborate: a CEO framework for deciding when new capabilities reduce friction for customers and align to corporate core values vs. simply expanding the menu of services. Guest: Charlie Mamrak is CEO of DCN Dx. He joined DCN Dx in 2020 after leading multiple diagnostics and life science tools companies, including SeraCare Life Sciences.

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. For AI-enabled device software functions, PCCPs are now a core concept in FDA’s approach to iterative software updates. In this episode, we break down what belongs in a PCCP, how it shows up in a marketing submission, and how teams can connect PCCP planning to design controls, risk management, and quality system processes so the plan is executable after authorization, not just well written on paper. What we cover (bullets) • What FDA means by a PCCP and when it is relevant for AI-enabled IVDs • The three core components FDA expects to see (and why each one matters) • How PCCPs interact with marketing submissions (510(k), De Novo, PMA) and public-facing submission summaries • Where teams get tripped up: scope control, evidence expectations, and operationalizing the plan inside the QMS • What the broader “PCCPs for Medical Devices” draft guidance signals for non-AI device changes (hardware, materials, software) Dan Simpson, RAC is Director of Regulatory Affairs at DCN Dx, supporting regulatory strategy, pre-submission engagement, and U.S. and global submission planning for diagnostics teams. Emily Friedland is the VP of Clinical Research at DCN Dx, where she leads and fosters growth within the clinical operations teams. Questions about whether a PCCP makes sense for your device, or how to structure one so it holds up through review and post-market execution? DCN Dx’s Regulatory Affairs Services help IVD teams develop successful regulatory plans and submissions. We support FDA pathways including 510(k), De Novo, and PMA, with early Pre-Sub positioning and submission development, and we can advise on accelerated programs like Breakthrough Devices and STeP when they fit the product. Our team aligns verification and validation expectations across software and cybersecurity, biocompatibility, labeling, shelf life, analytical and clinical performance, usability and human factors, and CLIA waiver flex studies. We also support QMS readiness (ISO 13485, CLIA, CAP) and post-market obligations. Contact us at dcndx.com.

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.

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.

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 comprehensive structure, and the vibrant learning community fostered in Carlsbad, California. They also discuss the value of hands-on labs, networking opportunities, and the benefits of learning in a collaborative environment.