DCN Dx Expert Insights

DCN Dx

DCN Dx Expert Insights is a podcast for teams developing and commercializing in vitro diagnostics. Each episode brings together scientists, clinical researchers, regulatory specialists, manufacturing experts, and industry leaders to examine the decisions that determine whether an IVD program reaches the market. Topics include assay development, clinical evidence, regulatory strategy, biospecimens, manufacturing, scale-up, product development, and commercialization. Subscribe to Expert Insights on Spotify, Apple Podcasts, or your preferred platform, and visit dcndx.com for additional tools and resources. LISTEN AND FOLLOW Spotify: https://open.spotify.com/show/16GcmTI4U7dhzKSQe0mUhO Apple Podcasts: https://podcasts.apple.com/us/podcast/dcn-dx-expert-insights/id1793226272 Subscribe on YouTube: https://www.youtube.com/channel/UCgMr7XR64b1Q1_0nG-X8b1Q?sub_confirmation=1 MORE FROM DCN DX Explore IVD articles, podcast transcripts, and technical resources: https://dcndx.com/insights/ Learn more about DCN Dx: https://dcndx.com/ Discuss your IVD program with our team: https://dcndx.com/contact/

  1. 1d ago

    Wellness or Medical Device? FDA's 2026 Wellness Guidance and the WHOOP Warning Letter

    In July 2025, FDA told WHOOP that its Blood Pressure Insights feature was an unauthorized medical device. WHOOP disputed FDA’s position and kept selling it. In January 2026, while the dispute was still open, FDA reissued its general wellness guidance. FDA closed the warning letter in June after WHOOP modified the feature and its labeling. Working through this question for your own product? Request a call with DCN Dx: https://dcndx.com/wellness In this episode of Expert Insights, Emily Friedland talks with Blythe Karow, Founder and CEO of The Karow Advisory Group, and Dan Simpson, RAC, Director of Regulatory Affairs at DCN Dx, about where a product intended for wellness becomes a regulated medical device and why the same line-drawing questions apply to at-home diagnostics. They discuss how risk, intended use, claims, form factor, and presentation can shape FDA’s view of a product. DCN Dx offers a fixed-fee Wellness Regulatory Assessment. In two to four weeks, you receive a written assessment of how FDA’s current general wellness policy may apply, the likely regulatory path, and whether FDA contact is warranted. WHAT YOU’LL HEAR IN THIS EPISODE - What FDA’s January 2026 guidance clarified for noninvasive sensing functions such as blood pressure, and Blythe’s view of its effect on the modified WHOOP feature - Why a patch that uses a subcutaneous needle falls outside FDA’s low-risk general wellness policy, whatever the marketing language - Dan’s experience with FDA 513(g) responses for at-home lateral flow assays proposed for wellness uses - How a claims matrix, a tiered review process, and rules for influencer content can keep marketing language from crossing into medical-device claims - Blythe’s read on the WHOOP warning letter, the stoplight-color dispute, and the risks of bundling a wellness feature with two cleared medical-device features Full transcript and show notes: https://dcndx.com/insights/technically-wellness-gray-zone-between-consumer-health-regulated-diagnostics/ GUESTS Blythe Karow | Founder and CEO, The Karow Advisory Group Blythe is a MedTech strategist with twenty-five years across medical devices, wearables, and regulated health technology. She founded The Karow Advisory Group, where she advises CEOs, investors, and executive teams on product strategy, commercialization, and U.S. market entry, from early-stage startups to Fortune 50 companies. She was previously Co-founder and CEO of Evren Technologies, where she led the Phoenix transcutaneous vagus nerve stimulation device to FDA Breakthrough Device Designation in 2021, and Head of Digital Health Strategy for spinal cord stimulation at Boston Scientific. She writes The Device Files, a widely read Substack on MedTech strategy and the regulation of wearables and consumer health, whose readership grew sharply through her coverage of the WHOOP case. She is an Entrepreneur in Residence at Yale and holds a biomedical engineering degree from Johns Hopkins and an MBA from the University of Virginia’s Darden School. Dan Simpson, RAC | Director of Regulatory Affairs, DCN Dx Dan is Director of Regulatory Affairs at DCN Dx and a RAC-credentialed, ASQ-certified medical device auditor with more than 15 years in IVD and medical device regulatory and quality roles. Before DCN Dx he led regulatory affairs at ERI Group and spent 14 years running quality and regulatory affairs at Corgenix Medical Corporation. He works with IVD manufacturers on FDA 510(k), De Novo, and PMA submissions as well as IVDR conformity assessment, across point-of-care, OTC, companion diagnostics, and high-complexity assays. HOST Emily Friedland | VP of Clinical Research, DCN Dx ABOUT DCN DX EXPERT INSIGHTS DCN Dx Expert Insights examines the technical, regulatory, clinical, and manufacturing decisions that shape the development and commercialization of in vitro diagnostics.

    Wellness or Medical Device? FDA's 2026 Wellness Guidance and the WHOOP Warning Letter
  2. Aug 24

    Planning Around a Respiratory Season That Won’t Hold Still

    Why respiratory trials built on last year’s calendar are falling behind, and what sponsors need to do differently to catch the season on time. Respiratory disease patterns have stopped following the calendar sponsors are used to. Flu and RSV still show up seasonally, but COVID no longer waits for winter. CDC surveillance data now shows COVID peaking twice a year, once in late summer and once in winter, and last year’s spike in June and July caught most sponsors off guard. In this episode, Emily Friedland, VP of Clinical Research at DCN Dx, sits down with David LaMarche, Chief Strategy and Growth Officer at ERA Health Research, a clinical trial network with sites in Washington state and West Texas. David explains what he’s watching happen at the site level: patients who used to show up for testing now stay home with a runny nose, and sponsors who wait for wastewater data or CDC prevalence numbers before activating their sites are already behind the wave by the time the numbers confirm it. For IVD sponsors and CROs, getting the timing wrong costs a whole season. A rigid protocol, one that requires same-day sample shipping or leans on a comparator with a narrow stability window, can quietly shrink a site’s patient pool before the season even peaks. Emily and David get into why the fix starts earlier than most sponsors think: a CRO chosen by summer, product staged at sites ahead of the wave, and sites trusted to start testing on their own read of what’s walking through the door instead of waiting on a health department report. Access the companion graphic here: https://5217333.fs1.hubspotusercontent-na1.net/hubfs/5217333/Collateral/Expert%20Insights/DCN%20Dx_Respiratory%20Program%20Planning%20Timeline.pdf What You’ll Hear in This Episode -COVID’s two peaks a year, late summer and winter, that break single-wave trial plans. -Why waiting on wastewater data means missing the front end of the wave. -What has to be locked down each spring and summer: sites, CRO contracts, staged IP. -How same-day sample shipping costs sites the after-school rush and weekend patients. -Why hands-on device training before the first positives changes data quality and staff confidence. Guests 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 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. David LaMarche, Chief Strategy and Growth Officer, ERA Health Research - David LaMarche is Chief Strategy and Growth Officer at ERA Health Research, where he leads growth strategy, site selection, and sponsor and CRO relationships across the network’s clinical trial sites in Washington state and Texas. He joined ERA in 2023 after serving as President of Eastside Health Network in the Seattle area and spending nearly 20 years at Virginia Mason, where he built value-based payment models and led the Heart Institute. David holds an MBA from Anaheim University’s Akio Morita School of Business and a B.A. in Business Administration from Washington State University. ABOUT DCN DX EXPERT INSIGHTS DCN Dx Expert Insights examines the technical, regulatory, clinical, and manufacturing decisions that shape the development and commercialization of in vitro diagnostics. LISTEN AND FOLLOW Spotify: https://open.spotify.com/show/16GcmTI4U7dhzKSQe0mUhO Apple Podcasts: https://podcasts.apple.com/us/podcast/dcn-dx-expert-insights/id1793226272 Subscribe on YouTube: https://www.youtube.com/channel/UCgMr7XR64b1Q1_0nG-X8b1Q?sub_confirmation=1 MORE FROM DCN DX Explore IVD articles, podcast transcripts, and technical resources: https://dcndx.com/insights/

    Planning Around a Respiratory Season That Won’t Hold Still
  3. Aug 5

    Before the Protocol: What Sponsors Miss About Sites and Human Factors

    A site management CEO and a human factors specialist on what sponsors miss before a diagnostic study ever starts. Most conversations about IVD clinical research happen from the sponsor’s side of the table. This episode flips that. Emily Friedland, VP of Clinical Research at DCN Dx, sits down with Missy Farrell, founder and CEO of , and Karen Seidler, Ph.D, CEO and Principal at , to talk about the two stages that happen before a protocol is finalized: the human factors work that determines whether real users can operate a device safely, and the site feasibility work that determines whether a clinic can deliver the study a sponsor designed on paper. For sponsors and CROs, the payoff is practical. Missy explains why prevalence numbers on a feasibility questionnaire routinely mislead sponsors about who a site can enroll, and Karen walks through why combining a human factors validation study with a clinical study creates logistical problems that are hard to see coming. Together they make the case for treating these two disciplines as sequential, not overlapping, and for asking sites and device teams sharper questions much earlier in development. ABOUT DCN DX EXPERT INSIGHTS DCN Dx Expert Insights examines the technical, regulatory, clinical, and manufacturing decisions that shape the development and commercialization of in vitro diagnostics. LISTEN AND FOLLOW Spotify: https://open.spotify.com/show/16GcmTI4U7dhzKSQe0mUhO Apple Podcasts: https://podcasts.apple.com/us/podcast/dcn-dx-expert-insights/id1793226272 Subscribe on YouTube: https://www.youtube.com/channel/UCgMr7XR64b1Q1_0nG-X8b1Q?sub_confirmation=1 MORE FROM DCN DX Explore IVD articles, podcast transcripts, and technical resources: https://dcndx.com/insights/ Learn more about DCN Dx: https://dcndx.com/ Discuss your IVD program with our team: https://dcndx.com/contact/

    Before the Protocol: What Sponsors Miss About Sites and Human Factors
  4. Jul 23

    Where Programs Fail: Bridging Assay Development and Manufacturing for Lateral Flow

    Your lateral flow assay performs at the bench. Will that performance hold on the manufacturing line? Manufacturing introduces conditions the assay may not have faced at the bench. Reagent delivery must remain consistent throughout longer runs, while materials move under tension on production equipment. Changes in dispensing and drying can expose signal variation, nonspecific binding, material failures, or yield loss. For immunoassay developers, finding those problems after the assay design is locked can send the program back into development. The better time to address them is during development, while the chemistry, materials, and process can still be evaluated together. In this episode of Expert Insights, DCN Dx Chief Operating Officer Pat Vaughan, Ph.D., who leads assay development, engineering, and manufacturing operations, joins host Trevor Brown, M.Sc., Chief Revenue Officer, to explain what changes between the bench and the manufacturing line. They discuss what immunoassay developers should evaluate before the design is locked and how assay scientists and manufacturing engineers can work together from the start. ABOUT DCN DX EXPERT INSIGHTS DCN Dx Expert Insights examines the technical, regulatory, clinical, and manufacturing decisions that shape the development and commercialization of in vitro diagnostics. LISTEN AND FOLLOW Spotify: https://open.spotify.com/show/16GcmTI4U7dhzKSQe0mUhO Apple Podcasts: https://podcasts.apple.com/us/podcast/dcn-dx-expert-insights/id1793226272 Subscribe on YouTube: https://www.youtube.com/channel/UCgMr7XR64b1Q1_0nG-X8b1Q?sub_confirmation=1 MORE FROM DCN DX Explore IVD articles, podcast transcripts, and technical resources: https://dcndx.com/insights/ Learn more about DCN Dx: https://dcndx.com/ Discuss your IVD program with our team: https://dcndx.com/contact/

    Where Programs Fail: Bridging Assay Development and Manufacturing for Lateral Flow
  5. 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
  6. 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 ABOUT DCN DX EXPERT INSIGHTS DCN Dx Expert Insights examines the technical, regulatory, clinical, and manufacturing decisions that shape the development and commercialization of in vitro diagnostics. LISTEN AND FOLLOW Spotify: https://open.spotify.com/show/16GcmTI4U7dhzKSQe0mUhO Apple Podcasts: https://podcasts.apple.com/us/podcast/dcn-dx-expert-insights/id1793226272 Subscribe on YouTube: https://www.youtube.com/channel/UCgMr7XR64b1Q1_0nG-X8b1Q?sub_confirmation=1 MORE FROM DCN DX Explore IVD articles, podcast transcripts, and technical resources: https://dcndx.com/insights/ Learn more about DCN Dx: https://dcndx.com/ Discuss your IVD program with our team: https://dcndx.com/contact/

    Stuck in a Holding Pattern: The IVDR Revision and Planning for Two Markets at Once
  7. 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/ ABOUT DCN DX EXPERT INSIGHTS DCN Dx Expert Insights examines the technical, regulatory, clinical, and manufacturing decisions that shape the development and commercialization of in vitro diagnostics. LISTEN AND FOLLOW Spotify: https://open.spotify.com/show/16GcmTI4U7dhzKSQe0mUhO Apple Podcasts: https://podcasts.apple.com/us/podcast/dcn-dx-expert-insights/id1793226272 Subscribe on YouTube: https://www.youtube.com/channel/UCgMr7XR64b1Q1_0nG-X8b1Q?sub_confirmation=1 MORE FROM DCN DX Explore IVD articles, podcast transcripts, and technical resources: https://dcndx.com/insights/ Learn more about DCN Dx: https://dcndx.com/ Discuss your IVD program with our team: https://dcndx.com/contact/

    QMSR Is in Effect: What IVD Manufacturers Still Need to Do
  8. 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 ABOUT DCN DX EXPERT INSIGHTS DCN Dx Expert Insights examines the technical, regulatory, clinical, and manufacturing decisions that shape the development and commercialization of in vitro diagnostics. LISTEN AND FOLLOW Spotify: https://open.spotify.com/show/16GcmTI4U7dhzKSQe0mUhO Apple Podcasts: https://podcasts.apple.com/us/podcast/dcn-dx-expert-insights/id1793226272 Subscribe on YouTube: https://www.youtube.com/channel/UCgMr7XR64b1Q1_0nG-X8b1Q?sub_confirmation=1 MORE FROM DCN DX Explore IVD articles, podcast transcripts, and technical resources: https://dcndx.com/insights/ Learn more about DCN Dx: https://dcndx.com/ Discuss your IVD program with our team: https://dcndx.com/contact/

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

Ratings & Reviews

5
out of 5
2 Ratings

About

DCN Dx Expert Insights is a podcast for teams developing and commercializing in vitro diagnostics. Each episode brings together scientists, clinical researchers, regulatory specialists, manufacturing experts, and industry leaders to examine the decisions that determine whether an IVD program reaches the market. Topics include assay development, clinical evidence, regulatory strategy, biospecimens, manufacturing, scale-up, product development, and commercialization. Subscribe to Expert Insights on Spotify, Apple Podcasts, or your preferred platform, and visit dcndx.com for additional tools and resources. LISTEN AND FOLLOW Spotify: https://open.spotify.com/show/16GcmTI4U7dhzKSQe0mUhO Apple Podcasts: https://podcasts.apple.com/us/podcast/dcn-dx-expert-insights/id1793226272 Subscribe on YouTube: https://www.youtube.com/channel/UCgMr7XR64b1Q1_0nG-X8b1Q?sub_confirmation=1 MORE FROM DCN DX Explore IVD articles, podcast transcripts, and technical resources: https://dcndx.com/insights/ Learn more about DCN Dx: https://dcndx.com/ Discuss your IVD program with our team: https://dcndx.com/contact/