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.

Episodes

  1. Hype or Help? How to Evaluate Generative AI in Diagnostics with Jeremy Elser, Ph.D., Head of Science Operations at Palantir,

    07/08/2025

    Hype or Help? How to Evaluate Generative AI in Diagnostics with Jeremy Elser, Ph.D., Head of Science Operations at Palantir,

    How do you separate signal from noise when it comes to AI in diagnostics? In this episode of Expert Insights, host Mitzi Rettinger sits down with Jeremy Elser, Ph.D.—a strategist, data scientist, and Head of Science Operations at Palantir—to explore the real-world potential and limits of generative AI in diagnostics R&D and operations. Together, they discuss: How diagnostics leaders can evaluate AI use cases without falling for hype What to ask when AI vendors pitch you “breakthrough” tools Red flags that signal a lack of scientific grounding or operational relevance Where generative AI is already proving valuable—especially in decision support, knowledge retention, and complex workflows How to think about regulatory alignment, validation, and change management in AI-driven environments Jeremy also offers a preview of his keynote at ALFC 2025, where he’ll be speaking directly to diagnostics and point-of-care leaders about what it takes to build responsible, useful AI into real-world diagnostics programs. Whether you're on a product team exploring AI-driven image analysis, in leadership evaluating LLM pilots, or simply trying to stay current, this episode delivers a strategic view on what matters now in AI for diagnostics. Subscribe to Expert Insights for conversations with the people shaping the future of diagnostic science—from assay development to AI deployment.

    31 min
  2. What's Behind Winning Regulatory Strategies for IVDs?

    03/12/2025

    What's Behind Winning Regulatory Strategies for IVDs?

    In this episode of Expert Insights, host Mitzi Rettinger sits down with Dan Simpson, Head of Regulatory Affairs at DCN Dx, and Emily Friedland, VP of Clinical Research at DCN Dx, to discuss the critical role of regulatory strategy in bringing in vitro diagnostic (IVD) devices to market. From FDA approvals to international compliance, understanding the regulatory landscape is key to avoiding costly delays and ensuring a smooth path to commercialization. Dan and Emily share their expertise on structuring a regulatory strategy that minimizes risk while optimizing approval timelines. They explore the importance of pre-submission consultations, the nuances of FDA versus IVDR requirements, and how early collaboration between regulatory and clinical teams can streamline the approval process. Whether you're working through a 510(k), de novo, or PMA pathway, this episode provides valuable insights to help you plan an effective regulatory approach. Listeners will gain a deeper understanding of how regulatory strategy impacts clinical study designs, the importance of harmonizing global compliance efforts, and the best practices for engaging with regulatory agencies early in development. This episode breaks down the essential elements of a strong regulatory strategy for IVD developers. You’ll learn: -How to determine the right regulatory pathway for your IVD device (510(k), de novo, or PMA). -The role of pre-submission consultations in mitigating risks and expediting approvals. -Key differences between FDA and IVDR requirements and how to harmonize global compliance efforts. -How early collaboration between regulatory and clinical teams can prevent costly delays. -Real-world examples of successful regulatory strategies that accelerated market entry. Whether you're an entrepreneur, scientist, or regulatory professional, this episode offers practical insights to help you bring your diagnostic device to market efficiently.

    16 min

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.