Expert Insights

DCN Dx
  • 5.0 (2)
  • MEDICINE
  • UPDATED BIWEEKLY

Expert Insights offers an inside look at the diagnostics industry, with practical advice and real-world examples from experienced professionals. Hosted by Mitzi Rettinger, Chief Revenue Officer at DCN Dx, this podcast focuses on the key decisions and challenges involved in developing and commercializing diagnostic technologies. Each episode features conversations with industry experts who share their experiences in assay development, clinical research, manufacturing, and regulatory processes. From overcoming technical hurdles to ensuring a smooth path to market, Expert Insights provides clear, actionable guidance for diagnostics developers, R&D managers, and innovators. Subscribe to Expert Insights on Spotify, Apple Podcasts, or your preferred platform, and visit dcndx.com for additional tools and resources.

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

    6D AGO

    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 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

    36 min
  2. Automation Beyond the Strip: Building Repeatable Rapid Test Production with KinBio

    MAR 18

    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, 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.

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

    FEB 19

    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, 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.

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

    FEB 6

    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 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.

    17 min
  5. Predetermined Change Control Plans (PCCPs) for AI-Enabled IVDs

    JAN 23

    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 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.

    26 min

  6. 10/08/2025

    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 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!

    34 min

  7. 10/03/2025

    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, 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.

    35 min

  8. 09/19/2025

    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 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.

    32 min
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Ratings & Reviews

5
out of 5
2 Ratings

About

Expert Insights offers an inside look at the diagnostics industry, with practical advice and real-world examples from experienced professionals. Hosted by Mitzi Rettinger, Chief Revenue Officer at DCN Dx, this podcast focuses on the key decisions and challenges involved in developing and commercializing diagnostic technologies. Each episode features conversations with industry experts who share their experiences in assay development, clinical research, manufacturing, and regulatory processes. From overcoming technical hurdles to ensuring a smooth path to market, Expert Insights provides clear, actionable guidance for diagnostics developers, R&D managers, and innovators. Subscribe to Expert Insights on Spotify, Apple Podcasts, or your preferred platform, and visit dcndx.com for additional tools and resources.

Information

  • Creator
    DCN Dx
  • Years Active
    2025 - 2026
  • Episodes
    15
  • Rating
    Clean
  • Show Website
    Expert Insights