Jerry Gallwas is an analytical chemist by education with a special interest in medical device instrumentation for clinical use. After a stint in the military running the chemistry section of a 300 bed station hospital clinical laboratory, Jerry Gallwas joined Beckman Instruments in 1964. At that time, management had visions of entering the healthcare field with a family of clinical analyzers and consumables. He was a founding member of a team that established Beckman Diagnostics, and with the availability of microprocessor technology in 1976, they designed the company’s first automated clinical analyzer, the ASTRA. It ran the eight most requested laboratory tests in a minute anytime of the day or night and took the market by storm. Subsequently, Jerry Gallwas established and managed the laboratory information systems and quality control businesses. He then went onto serve as Manager of Strategic Planning as sales subsidiaries were set up around the world.
Beckman Diagnostics grew to over $300 Million by 1982 leading the company to be merged with SmithKline Corporation for $1,086 Million. During those years, Jerry Gallwas was active in the laboratory medicine community and served as president and board member of what is now the Clinical Laboratory Standards Institute (CLSI). In the 1970s Congress gave the mandate to FDA for regulation of the IVD industry the result of which is the current 510(k) registration system. Jerry Gallwas spent months in Washington DC negotiating on behalf of the industry as the regulatory system emerged. He retired from Beckman after 30 years of service as Director of Program Management overseeing $50M in R&D projects to consult for small medical device companies and the NIH SBIR commercialization program. He recently retired after 22 years as a board member of the Arnold and Mabel Beckman Foundation and currently serves on the boards of three medical device companies, including NOWDiagnostics (NOWDx).