I have 20 years of experience as a high complexity CLIA in vitro diagnostics (IVD) laboratory director at various academic hospitals and medical schools. I am an expert in the development, validation and implementation of IVD in clinical environment. Serving on the FDA Medical Device Committee, I am a national expert in regulatory oversight of IVDs.I am also a federally funded translational principle investigator, with research focusing on innovative diagnostic technologies, especially point-of-care testing and high sensitivity technologies.I am on scientific advisory boards of various diagnostic companies, and have founded a start up company commercializing technologies out of my research. Our team has successfully commercialized diagnostics that won FDA Breakthrough Device designation and 510(k) clearance.