DCN Dx Expert Insights

What does FDA Breakthrough Device designation mean for an in vitro diagnostic (IVD)? Learn what it takes to qualify, what evidence supports a request, and how designation can shape development and clinical study planning. In this episode of Expert Insights, Dan Simpson, RAC, Director of Regulatory Affairs at DCN Dx, joins host Emily Friedland, Vice President of Clinical Research, to discuss the practical benefits and limitations of FDA’s Breakthrough Devices Program. They cover: -How clinical utility, unmet needs, and access to care inform a Breakthrough request. -What evidence to include, and why more data isn’t always more useful. -Priority review, FDA sprint discussions, and clinical protocol agreements. -How 510(k) and De Novo pathways affect intended use and development decisions. -FDA’s READI-Home Innovation Challenge and the potential role of home-use diagnostics in reducing hospital readmissions. -When to seek regulatory input before committing to a clinical study. The conversation examines how earlier FDA engagement can help developers clarify evidence expectations while working toward marketing authorization. To discuss whether your diagnostic may meet the Breakthrough criteria, contact DCN Dx. Subscribe to Expert Insights for conversations about diagnostic development, clinical research, and regulatory strategy. #IVD #RegulatoryAffairs #Diagnostics

After a federal court vacated FDA’s final rule for laboratory-developed tests (LDTs) in 2025, did the LDT pathway fully reopen? Not exactly. In Season 3, Episode 15 of Expert Insights, host Emily Friedland, VP of Clinical Research at DCN Dx, speaks with Jesse Young, Ph.D., Medical Director of Clinical Device Trials and Research at TriCore Reference Laboratories, and Dan Simpson, RAC, Director of Regulatory Affairs at DCN Dx. They explain what the court decision did and did not settle, where FDA oversight ends and CMS/CLIA laboratory oversight begins, and why developers should still evaluate the regulatory and operational risks of an LDT strategy. The conversation covers: • Single-lab LDTs versus distributed IVDs • FDA enforcement discretion and future regulatory risk • RUO materials, clinical claims, and supplier responsibilities • Certificates of analysis and supply-chain controls • Laboratory validation, rare analytes, and funding constraints • Designing assays for reproducibility in another operator’s hands • Deciding whether an LDT is sustainable or should serve as a bridge to FDA clearance Read the full transcript and episode summary: https://dcndx.com/insights/court-vacated-fdas-ldt-rule-ivd-developers/ Discuss your LDT or IVD regulatory strategy with DCN Dx: https://dcndx.com/contact/ Learn about DCN Dx’s Wellness Regulatory Assessment: https://dcndx.com/wellness/ Contact TriCore Reference Laboratories: https://www.tricore.org/contact/

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.

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/

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/