We are senior scientists and engineers who speak the languages of business, quality assurance, and regulatory affairs. We provide the translation necessary to go quickly from “blue sky” research concepts to commercialized products. Our experienced team can communicate with physicians, marketing, and research personnel to determine concept feasibility, and with quality assurance, technical support, and manufacturing staff to develop marketable products.
Founders
Cynthia G. Pritchard, PhD, CEO
Dr. Pritchard has over 35 years of R&D experience in this industry and has brought over 40 products from research into development through clinical trials and manufacturing to market launch. She has extensive practical experience in FDA/IMDRF/ISO requirements, clinical project management, design control, and documentation and has written more than 70 successful submissions to CDRH and CBER divisions of the U.S. FDA and to European and Canadian regulatory agencies. Dr. Pritchard obtained a BS in microbiology at the University of South Florida, a PhD in Virology at Virginia Tech, and was a Damon Runyon Postdoctoral Fellow in Biochemistry at Harvard Medical School.
Billy C. Usrey, DMin, COO
Dr. Usrey brings experience in management systems design and implementation from 30 years in industrial and medical device manufacturing and university settings. He began his career as an industrial engineer before becoming a management and systems consultant. He later set up and managed manufacturing systems in various industries from electronics to diagnostics to medical devices. He has broad practical knowledge of project management, in working to FDA- and ISO 13485-mandated design control and documentation, as well as group communications and facilitation. Dr. Usrey obtained a BS in industrial management at the University of Tennessee, Knoxville, a MDiv from Duke University, and a DMin from Columbia Theological Seminary in Atlanta. His doctorate concentrated on group formation and communication and the development of learning organizations.