(Dr. David Ku, advisor)

"Design of a Small Diameter Tissue Engineered Vascular Graft Using the FDA Design Process"

Abstract

Cardiovascular disease (CVD) is the leading cause of death in the modern world, killing over 17 million people annually. Tissue engineering holds promise for providing a solution to atherosclerosis through design of small diameter biologic vascular grafts. Suitable small diameter vessel substitutes are needed since synthetic small diameter grafts have clinically unacceptable patency rates and an estimated 15-50% of patients need non-autologous alternative vessel substitutes. Tissue engineering methods for constructing small diameter vascular grafts have been explored for over fifteen years but have not yielded a commercially available product. To facilitate development of future tissue engineered vascular grafts, the FDA design process has been applied to the design of a tissue engineered vascular graft.

Design methods generally follow the process of clearly defining the problem, generating broad specifications to meet the users needs, and generating specific design concepts. Within this general framework, the FDA also requires risk analysis and clearly defined verification/validation tests to ensure that the design concept meets the design specifications.

The design of a tissue engineered vascular graft has been outlined. This includes an in-depth examination of the problem, relevant variables, and methods for assessing those variables. Design specifications, an analysis of corresponding risk, and validation/verification tests are outlined for a small diameter tissue engineered vascular graft.

The results of the design effort are then applied to existing vascular grafts in the literature to assess whether existing grafts meet the newly defined design specifications. While specific design concepts are not realized, considerations for future graft design elucidated by this design process are covered.