Product Development and Business Implications

Abstract

Abstract Inadequate understanding of vascular motion boundary conditions can have severe consequences on device design, product development timelines and costs, and may ultimately compromise clinical and financial performance. In general, each dollar spent on studying boundary conditions early will result in net savings later because changes to product design and manufacturing get more expensive in later stages. This chapter provides six anecdotes from medical device industry veterans where the knowledge of vascular motion boundary conditions, or lack thereof, affected other aspects of the business. These include R&D delays due to redesigns, increased infrastructure costs due to product launch delays, mismatched expectations between business functions, clinical trial suspensions, product cancelations, and patient harm. Even the most thorough vessel motion boundary condition investigations can be incomplete because sometimes you do not know what to look for, especially for groundbreaking products and/or complex vascular environments. Generally, improvements are made with every new product generation with previous learning, but sometimes new problems are discovered because of unanticipated issues from changes that were originally thought to be beneficial or inconsequential. But change is necessary for improvement, and all of the contributors to this chapter agree that improving knowledge about the dynamic blood vessels will ultimately improve product performance, which makes good business sense.