# DCN Dx Expert Insights A podcast by 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/ Feed: https://feeds.async.com/5cda8a63-c15d-43ee-ac06-0ceff38e4e6d.rss ## Latest episodes - [What Breakthrough Designation Does and Doesn't Do for an IVD](https://invisiblenetwork.ai/podcast/1793226272/c3e5931026b9) (2026-10-14, 35 min): audio https://feedsmedia.async.com/86fe93ff-1681-411d-9bd0-42ac77930115/S03_E14_What%20Breakthrough%20Designation%20Does%20and%20Doesn%27t%20Do%20for%20an%20IVD.wav - [After the Court Vacated FDA’s LDT Rule: What IVD Developers Still Need to Get Right](https://invisiblenetwork.ai/podcast/1793226272/63816383a128) (2026-09-18, 57 min): audio https://feeds.async.com/e0dfea68-3565-49a8-94ad-844cf54737fc/S3%20E15_Jesse%20Young%20FULL_v3.wav - [Wellness or Medical Device? FDA's 2026 Wellness Guidance and the WHOOP Warning Letter](https://invisiblenetwork.ai/podcast/1793226272/0084e1da2535) (2026-09-04, 44 min): audio https://feeds.async.com/1d325b20-d08e-4212-a445-737dc255d84f/S3%20E11_Blythe%20Karow%20with%20Wellness%20Spot_Dan.mp3 - [Planning Around a Respiratory Season That Won’t Hold Still](https://invisiblenetwork.ai/podcast/1793226272/efc931cbc460) (2026-08-24, 40 min): audio https://feeds.async.com/4c3cd7b6-c19e-4ad6-95f4-2a525966bc82/S3E13_David%20LaMarche_Emily%20Friedland_v2.wav - [Before the Protocol: What Sponsors Miss About Sites and Human Factors](https://invisiblenetwork.ai/podcast/1793226272/2b9010fac52c) (2026-08-05, 57 min): audio https://feeds.async.com/5876695b-7e53-417f-9cda-74a3db2b1a88/v2_mixdown_S3E10_Missy%20and%20Karen.mp3 - [Where Programs Fail: Bridging Assay Development and Manufacturing for Lateral Flow](https://invisiblenetwork.ai/podcast/1793226272/099b4d520f4e) (2026-07-23, 42 min): audio https://feeds.async.com/4bbf5681-348a-4d09-a3e9-3739150c9dfd/Final%20mixdown_S3E9_Pat%20and%20Trevor.mp3 - [Off the Patchwork: What a Connected Platform Lets a CRO Do for Sponsors](https://invisiblenetwork.ai/podcast/1793226272/d5861a25cbd7) (2026-07-01, 45 min): audio https://feeds.async.com/2799dbf1-0d6d-4d38-ac85-9d585b03e00d/S3E8_mixdown_APEdit.mp3 - [Stuck in a Holding Pattern: The IVDR Revision and Planning for Two Markets at Once](https://invisiblenetwork.ai/podcast/1793226272/285aa20f3765) (2026-06-10, 36 min): audio https://feeds.async.com/0d8d0d71-10a9-445b-9ea3-a2cf4a95cddd/06092026_mixdownAPEdit_2.mp3 - [QMSR Is in Effect: What IVD Manufacturers Still Need to Do](https://invisiblenetwork.ai/podcast/1793226272/596004aa2822) (2026-05-08, 37 min): audio https://feeds.async.com/f5527835-34b2-400f-9ab6-1d1121fd3bcf/mixdown_APEdit_08May26.mp3 - [Specimen Strategy Is Development Strategy (And Why "We'll Source It Later" Fails)](https://invisiblenetwork.ai/podcast/1793226272/5afd5fbf92b8) (2026-04-03, 37 min): audio https://feeds.async.com/7e0e6cf9-4725-49a5-a213-74a05ae5ca49/Jim_Biospecimens_APEdit_MAR26.mp3 - [Automation Beyond the Strip: Building Repeatable Rapid Test Production with KinBio](https://invisiblenetwork.ai/podcast/1793226272/410e9dfb553d) (2026-03-18, 17 min): audio https://feeds.async.com/9712c4fe-7b7f-4b17-874f-4ab2068ff3c5/03072026_mixdownAPRv2.mp3 - [Point-of-Care in 2025: Lateral Flow Grew Up. Where Will the Technology Go Next?](https://invisiblenetwork.ai/podcast/1793226272/a44e47bf8729) (2026-02-19, 43 min): audio https://feeds.async.com/0227af02-8855-4f7a-9ac1-a4e5999e2d88/02122026_mixdown.mp3 - [The DCN Dx Model: Integration, Scale, and What Comes Next with DCN Dx CEO Charlie Mamrak](https://invisiblenetwork.ai/podcast/1793226272/6852f6812b29) (2026-02-06, 18 min): audio https://feeds.async.com/3ba20144-4c82-4554-9921-0a125d1f32fb/01252026_mixdownAPR.mp3 - [Predetermined Change Control Plans (PCCPs) for AI-Enabled IVDs](https://invisiblenetwork.ai/podcast/1793226272/9a3b272cd5ef) (2026-01-23, 26 min): audio https://feeds.async.com/1e61bb5f-c089-4265-9eb7-b6a310a09ce7/01172026_mixdown.mp3 - [BioDot on Making LFAs Manufacturable: What Strong Lines Look Like Before You Scale](https://invisiblenetwork.ai/podcast/1793226272/310bef845efa) (2025-10-08, 34 min): audio https://feeds.podcastle.ai/61fb591b-f10e-4548-b5fc-ee3e80009573/10032025_mixdown%20art.mp3 - [K-One on Gold: Turning Surface Chemistry into Real LFA Performance with Kimialys](https://invisiblenetwork.ai/podcast/1793226272/421ca5ddf32f) (2025-10-03, 36 min): audio https://feeds.podcastle.ai/31c3108a-97ff-4b42-a1e8-f7f24f3444f5/09262025_mixdownAPR.mp3 - [Rugged by Design: Making LFA Work in the Clinic, at Home, and in Production with Kellie LaRochelle, CEO, Imagene Technology](https://invisiblenetwork.ai/podcast/1793226272/81d301b249eb) (2025-09-19, 32 min): audio https://feeds.podcastle.ai/7c71fa6c-d6c5-4a5c-85ea-3654ecb6ab11/09162025_mixdown%20v2APR.mp3 - [Making Quantitative Work: Practical Guidance from Cytiva’s Klaus Hochleitner](https://invisiblenetwork.ai/podcast/1793226272/2477edd92f08) (2025-08-29, 24 min): audio https://feeds.podcastle.ai/c142742a-93fa-42a2-a2e5-0e1beff4eb0d/08022025%202_mixdown%20klausAPR.mp3 - [Hype or Help? How to Evaluate Generative AI in Diagnostics with Jeremy Elser, Ph.D., Head of Science Operations at Palantir](https://invisiblenetwork.ai/podcast/1793226272/e0b5a470c4ce) (2025-07-08, 31 min): audio https://feeds.podcastle.ai/8d53ac64-c758-49bb-807e-0efcab40fabe/06252025_mixdownAPR.mp3 - [From Bench to Program Lead: Lateral Flow Development Lessons That Stick](https://invisiblenetwork.ai/podcast/1793226272/42865f4022f0) (2025-06-12, 25 min): audio https://feeds.podcastle.ai/e5c8a191-3df5-4e9a-b237-577b43a9dcd1/06062025_mixdown.mp3 - [The Hidden Costs of Cheap Lateral Flow Development: Why Experience Matters](https://invisiblenetwork.ai/podcast/1793226272/907ec5ad69cd) (2025-03-25, 42 min): audio https://feeds.podcastle.ai/babe6d63-17d9-4bbf-a125-56b6bd5e1fd7/case%20studies_mixdown.mp3 - [What's Behind Winning Regulatory Strategies for IVDs?](https://invisiblenetwork.ai/podcast/1793226272/c8c266ae591d) (2025-03-12, 17 min): audio https://feeds.podcastle.ai/a1d4670b-44a5-4cf0-ba31-b5533da0a667/03082025_mixdownAPR.mp3 - [2024 Review and 2025 Predictions for Lateral Flow Diagnostics](https://invisiblenetwork.ai/podcast/1793226272/5821b96b2143) (2025-02-20, 31 min): audio https://feeds.podcastle.ai/b6f373db-5ca5-41fb-98f6-af7f9ff43f77/02182025_mixdown.mp3 - [Developing Your Lateral Flow Development Skills With DCN Dx’s 2025 Basic Training Course](https://invisiblenetwork.ai/podcast/1793226272/4a13c7e0be32) (2025-01-29, 23 min): audio https://feeds.podcastle.ai/54bcb04b-ff68-48aa-af8f-0af415d42d6c/melanie_mixdown%20v1APR.mp3 Shows are listed from Apple Podcasts' charts and directory, and Podcast Index where it is used. Every show and episode belongs to its publisher and plays from the publisher's own feed; this site hosts none of them.