Vice President of Regulatory Affairs
Gary Barnett began his orthopedic career in 1983 as an industrial engineer. He progressed into product development, operations, project management, quality, and regulatory affairs.
Gary is an inventor/co-inventor on nine orthopedic device patents. Gary was part of a management that converted Trauma product manufacturing from a conventional process flow to just-in-time manufacturing. This resulted in transforming a $1M/year losing operation into profitability of $500k/year in three years. Gary has lead numerous product development teams to obtain user needs and develop products that exceeded these customer requirements.
Gary left a large orthopedic company to assist Nick Deeter, as a co-founder, to start OrthoPediatrics. While there, Gary wrote and implemented OrthoPediatrics’ Quality Management System. Gary led their team to successfully pass the initial FDA facility audit, receiving only one minor observation that required a response to the FDA. Additionally, Gary submitted and received FDA clearance for OrthoPediatrics first nine 510(k)s. This makes Gary one of the top pediatric device 510(k) submitters in the US. Also, Gary’s Quality and Regulatory Affairs efforts enabled OrthoPediatrics to obtain ISO-13485 certification.
Gary helped another start-up orthopedic device company in the Philadelphia area obtain ISO-13485 certification. He finished writing and implementing their Quality Management System, developed their Regulatory strategy, and submitted and received FDA clearance for their initial batch of 510(k)s. Recently, Gary has consulted as a remediation resource to address observations that resulted from audits by the FDA and Notified Bodies.
Gary holds an Industrial Technology degree and an MBA, both from Ball State University. Gary has two children, a daughter who is an optometry doctor in Wabash, Indiana, and a son who is an attorney in Chicago, Illinois. Gary and his wife reside in the Wabash area.