Expert Insights

About Expert Insights

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/

Publisher

DCN Dx

Category

health & fitness · science

Language

en

Explicit

No

First episode

29 Jan 2025

Latest episode

14 Oct 2026

Latest episodes

25 episodes in the feed.

1. 

   14 Oct 2026

   What Breakthrough Designation Does and Doesn't Do for an IVD

   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

2. 

   18 Sept 2026

   After the Court Vacated FDA’s LDT Rule: What IVD Developers Still Need to Get Right

   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/

3. 

   4 Sept 2026

   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.

Who has been a guest on Expert Insights

Names identified in recent episode analyses. Showing up to five guests.

• Rob Rich
• Claude Noguès
• Cyril Gilbert
• Kellie LaRochelle
• Klaus Hochleitner

Reach and audience

Public platform figures. Ratings count people who left a rating, not total listeners.

Apple Podcasts (US)

5.0 / 5

2 ratings

Podcast Authority Score: 12 / 100

A composite of feed quality, social presence, YouTube performance and engagement. Read the methodology.

Quality

12

Social presence

0

YouTube

0

Engagement

32