Welcome to Ask a Pathologist Podcast! Host Bianca Collings speaks with Staci J. Kearney and Ciara Martin from Elevation Strategic Development. Staci, a founder, and Ciara, a principal consultant, bring over a decade of experience each in driving diagnostic and medical device innovations.

Transcript: https://lumeadigital.com/implementing-digital-pathology-workflows/

In this episode, they offer crucial tips for implementing digital pathology workflows:

• Regulatory Foundation: While CLIA offers limited guidance, CAP guidelines and peer-reviewed studies are key to compliance. U.S. digital pathology thrives in the LDT (Laboratory-Developed Test) space.
• Pathologist's Role: Pathologists are critical "humans in the loop," enhancing workflows from image acquisition to AI development, not being replaced by technology.
• System Validation & Security: All digital pathology components (scanners, monitors, LIS interfaces) must be validated together. Prioritize privacy and security (HIPAA), often requiring IT collaboration.
• Getting Started: Leverage peer networks and vendor demos. Consider the user's needs and the technology's long-term lifespan (e.g., RUO vs. DX versions).
• Development Challenges: Product development is slow due to scientific complexity and the need to serve diverse users (histologists, pathologists, executives).
• Future Regulations: U.S. labs should prepare for potential FDA regulation of LDTs, mirroring Europe's stringent IVDR and AI Act, which could impact users modifying AI products.

This episode offers invaluable, practical advice for successfully navigating digital pathology implementation, from compliance and integration to future readiness.

Submit questions for our future recordings here: https://lumeadigital.com/ask-a-pathologist-podcast/

Sponsored by the Digital Diagnostic Summit and Lumea.