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.