Unpacking FDA's New LDT Rule w/ Julie Ballard-Carrot Clinical

In this episode of The Med-Tech Talent Lab, we dive into the complex world of Laboratory Developed Tests (LDTs) with Julie Ballard, a clinical laboratory expert with over 25 years of experience in operations, quality systems, and regulatory compliance.

Julie shares her journey from working at Stanford Health Care to leading roles in startups like GRAIL, Genomic Health, and Guardant.

We unpack the implications of the FDA's groundbreaking LDT ruling, discussing its potential impact on patient care, lab operations, and the broader industry.

Julie explains the distinctions between LDTs and FDA-approved tests, the challenges labs face in adapting to the new regulations, and the critical steps they should take now to stay compliant.

Julie also sheds light on how these changes create opportunities for talent in regulat ...