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Who We Are

We are senior scientists and engineers who also speak the languages of business, quality assurance, and regulatory affairs. We provide the translation necessary to go quickly from "blue sky" research concepts to practical products. Our experienced team can communicate with physicians, with marketing, and with research personnel to determine concept feasibility, and with quality assurance, technical support, and manufacturing staff to develop marketable products.

Cynthia G. Pritchard, PhD, CEO
Dr. Pritchard has over 30 years in the medical industry, and has helped bring more than 30 products from research into development through clinical trials and manufacturing to market launch. She served in positions of increasing responsibility at Syva (Roche), Serono, Becton Dickinson, Gene-Trak Systems (Abbott), Pharmanetics and StemCo Biomedical, integrating various assay chemistries with instrumentation and developing cell-based therapies. She has a strong regulatory and quality assurance background, with extensive experience in GTP/GCP/GMP, ICH and ISO requirements, clinical project management, design control, and documentation, and has written over 30 successful submissions (510(k), IDE, DMF, IND) to CDRH and CBER divisions of FDA. Dr. Pritchard obtained a BS in microbiology at the University of South Florida, a PhD in virology at Virginia Tech, and postdoctoral training in molecular biology in the Department of Biological Chemistry at Harvard Medical School.

Patrick D. Mize, PhD
Dr. Mize has over 30 years of experience in the chemical and medical device industry. His expertise includes product development in immunoassays, coagulation, and design and synthesis of enzymatic substrates, inhibitors, and fluorescent compounds. Dr. Mize has a strong regulatory and quality background with international experience in project management, design control, and agency submissions, integrating a variety of assay chemistries and instruments. He has served in positions of increasing responsibility at Burroughs Wellcome (Glaxo Smith Kline), Union Carbide, Becton Dickinson, Pharmanetics, and Inverness Medical Innovations. Dr. Mize obtained a BA in Chemistry at Florida Atlantic University and a Ph.D. at Duke University.

Melinda D. Ross, MT, ASCP
Melinda is a development scientist skilled in product optimization, performance characterization and quality control. Her particular expertise is in managing R&D and QA labs to GLP, cGMP, ISO requirements and in maintaining projects under Design Control. Her 16 years of postgraduate laboratory experience include clinical chemistry, hematology/hemostasis and microbiology. She received her BS in Zoology from NC State and her MT certification from Duke University.

Billy C. Usrey, DMin
Dr. Usrey brings experience in management systems design and implementation from 25 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, later setting up and managing manufacturing systems in various industries from electronics to medical devices. He has broad practical knowledge of project management, in working to FDA-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.

Steven G. Wilson, PhD
Dr Wilson has over 25 years of experience in the medical diagnostic/drug monitoring/biologics industry. Steve has served in senior positions at large corporations and at small start-up companies, using his creative problem-solving genius to bring more than 16 products from research through clinical trials to market launch. He has a strong background in development and integration of various chemistries into manual and automated systems in such diverse areas as microbiology, molecular biology, immunochemistry, hemostasis, and cell therapy, and extensive experience in manufacturing these products under GLP/GMP/ISO requirements. Dr Wilson obtained a BS in biology/chemistry at Purdue University, his MS and PhD in medical microbiology from Creighton Medical School, and served as a postdoctoral research fellow at Uniformed Services University of the Health Sciences in Bethesda, MD.