Helene Paxton has 45 plus years experience in medical devices and Infectious disease consulting. She has been an Infection Preventionist in Acute care Hospitals and LTAC’s. She is CIC certified with a PhD in Epidemiology. A Member of APIC, SHEA, and ASM. As a Founder of a medical device company she developed over 70 IVD products, many of which are still on the market place. Products were distributed worldwide, and included agents such as Dengue Fever, Leptospira, Rickettsia, and other agents of arthropod diseases. She was a recipient of multiple grants from the DOD for development of infectious disease kits. Became an Expert in Bio-Safety considerations with select agents with a full Biosafety level 3 production area. She continues to design FDA studies for 510K submissions.