John is a biotechnology Translational Science & Medicine consultant with a comprehensive and deep understanding of the development and application of pioneering molecular procedures to the translation of research-grade biomarker assays into clinical-grade clinically adopted diagnostic tests. John oversaw the translation of an early stage research Next Generation sequencing test to a US government reimbursed and now widely adopted Laboratory Developed CLIA-CAP test for transplanted kidney rejection. He advises commercial translation efforts at Stanford University (SPARK) and University of California in San Francisco (CATALYST).
AI/ML-related healthcare products/services have begun changing the healthcare landscape. Watershed events in AI diagnostics include recent FDA approvals in imaging and data integration and guidance for Software as a Medical Device. What role will AI/ML play and what should criteria be for reimbursement as healthcare pivots to value-base models?