Expert Insights

DCN Dx

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. Jul 1

    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 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 talking to each other. In this candid discussion, host Emily Friedland (VP of Clinical Research, DCN Dx) sits down with two of the people who built and run it, Thomas Martinache (Associate Director, Data Management, DCN Dx) and Jill Hutton-Pugh (Clinical Trial Manager, DCN Dx), along with John Acampado (Senior Director of Clinical Strategy, Veeva). They get into what the old patchwork model cost, how DCN put the connected platform together piece by piece, and, most of all, what it changes for the sponsors who hire them: faster study startup, real-time visibility into enrollment and milestones, cleaner data with fewer manual handoffs, and a compliant foundation that an emerging IVD or MedTech company can grow on. The conversation leads into the team’s Veeva webinar on July 15, Platform Over Patchwork: How Consolidation Drives CRO Efficiency, where DCN Dx will share its journey of moving onto a single platform to drive operational efficiency in high-intensity trials, including 60% improvement in IMV preparation, 45% reduction in build time, and 30% faster study closeout. ⁠Register for that webinar here⁠: https://veeva.zoom.us/webinar/register/WN_m8krwBa4RLCnK17MpVZVCw#/registration Emily Friedland | VP of Clinical Research, DCN Dx Emily Friedland is Vice President of Clinical Research at DCN Dx, where she leads the company's clinical operations across IVD and medical device studies. She has more than two decades in clinical research, including a turn as Global Director of Clinical Operations at Teleflex and earlier roles at Singulex, Grifols, Celera, and Roche, spanning infectious disease, genetic testing, and women's health. She holds a B.S. from Virginia Tech and is based at DCN Dx's headquarters in Carlsbad, California. John Acampado | Sr. Director, Clinical Strategy, Veeva MedTech John leads strategy at Veeva MedTech, focused on helping CROs and sponsors build connected, scalable clinical solutions across device and diagnostics. He came to Veeva from the sponsor side, including time at Becton Dickinson, and brings that experience to Veeva’s MedTech product direction and to his work on the MDIC IVD standards working group. Jill Hutton-Pugh | Clinical Trial Manager, Clinical Operations, DCN Dx Jill Hutton-Pugh is a Clinical Trial Manager in Clinical Operations at DCN Dx and the clinical team's lead on its connected Veeva platform. She has two spent decades in clinical research spanning IVD, clinical safety, and pharmaceutical strategy, with study experience across infectious disease, HIV, interventional cardiology, and hypertension. Known for getting multidisciplinary teams aligned and projects finished on time, she has held clinical operations and monitoring roles at Teleflex, Conformal Medical, and Essential Medical, with earlier years at Merck in hospital sales and pricing. She holds a B.S. in microbiology from Ohio State University and pursued graduate business studies at both Ohio State and Temple. Thomas Martinache | Associate Director of Data Management, DCN Dx Thomas Martinache is Associate Director of Data Management at DCN Dx, with 15 years in clinical data management. He spent much of his career supporting CROs and sponsors in cardiology and oncology, in roles at Teleflex, HeartFlow, and BioClinica, before turning his focus to IVD. At DCN Dx he leads the data management team and the connected Veeva platform that runs across the firm's studies, supporting sponsors from protocol design and site selection through final statistical reporting and regulatory submissions.

    Off the Patchwork: What a Connected Platform Lets a CRO Do for Sponsors
  2. Jun 10

    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 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 running out, the dates for higher-risk classes have already passed, and the Commission's message has been consistent: no more extensions. Dan Simpson, Director of Regulatory Affairs at DCN Dx, and Sarah Barchard, Senior Clinical Trials Manager at DCN Dx, talk through what the waiting costs a company that has to sell in both the EU and the US, and why it pays to plan for both markets at the same time instead of one after the other. Dan takes the regulatory side: where the two systems differ, and how those differences shape design and development long before anyone files. Sarah takes the clinical side: where EU and US requirements pull in different directions during analytical and clinical work, and what it takes to run studies that hold up in both places. This conversation leads into their RAPS sponsored webcast, The IVDR Transition in 2026: Parallel Regulatory Planning for EU and US Market Entry, on June 17 at 12pm ET. It's free, and you can register through RAPS. Dan and Sarah will walk through the case studies behind what they discuss here. Register: ⁠https://www.raps.org/learn-develop/events/sponsored-webcast-the-ivdr-transition-in-2026-parallel-regulatory-planning-for-eu-and-us-market-entry.html⁠ Talk through your own program: ⁠dcndx.com/contact

    Stuck in a Holding Pattern: The IVDR Revision and Planning for Two Markets at Once
  3. May 8

    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 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/

    QMSR Is in Effect: What IVD Manufacturers Still Need to Do
  4. Apr 3

    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

    Specimen Strategy Is Development Strategy (And Why "We'll Source It Later" Fails)
  5. 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.

    Automation Beyond the Strip: Building Repeatable Rapid Test Production with KinBio
  6. 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.

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

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.