The Iterative Nature of Medical Device Design
Editor: Norell Bergendahl, M.; Grimheden, M.; Leifer, L.; Skogstad, P.; Lindemann, U.
Author: Shluzas, Lauren A.; Pietzsch, Jan B.; Paté-Cornell, M. Elisabeth; Yock, Paul G.; Linehan, John H.
Section: Design Processes
A one-year study, sponsored by The Institute for Health Technology Studies, was conducted by a team of Stanford University researchers to develop a linear model of the medical device development process, from concept to commercialization. The empirical field study involved interviewing and surveying individuals who had been involved with various stages of the development process, ranging from concept definition to post-market surveillance. Six medical device case studies were conducted to exemplify the device development process and its variations for different types of technologies. The focus of this paper is to examine variations to the linear device development model, specifically iterations that occur across development phases. Development variations for drug/device combination medical products and variations influenced by financial constraints are likewise explored. The data presented in this paper is intended to provide a foundation for creating new development models and guidelines which reflect the highly complex and iterative nature of medical device design.