Allison Kumar, founder of Arina Consulting, brings over a decade of experience from the FDA’s Center for Devices and Radiological Health (CDRH) and extensive tenure in the IVD and biotechnology industry. With five years as a Senior Program Manager and another five as a Senior Pre-market Reviewer at FDA, she has fostered collaborations and streamlined regulatory processes for novel technologies in both government and industry spheres. Her expertise spans diverse areas such as TBI, combat casualty care, and emergency response, contributing significantly to high-priority development efforts.

Allison’s industry background encompasses management roles in quality systems, regulatory affairs, and laboratory operations, enabling her to craft innovative strategies that facilitate effective communication with investors and regulatory bodies throughout a product’s life cycle. Holding degrees from Virginia Tech, Georgetown University, and the Harvard T.H. Chan School of Public Health, Allison is uniquely positioned to guide medical device development programs and support investor due diligence with actionable insights derived from her vast regulatory experience.