Abstract
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.
| Original language | English (US) |
|---|---|
| Title of host publication | DS 58-1 |
| Subtitle of host publication | Proceedings of ICED 09, the 17th International Conference on Engineering Design |
| Pages | 85-96 |
| Number of pages | 12 |
| Volume | 1 |
| State | Published - Dec 1 2009 |
| Event | 17th International Conference on Engineering Design, ICED 09 - Palo Alto, CA, United States Duration: Aug 24 2009 → Aug 27 2009 |
Other
| Other | 17th International Conference on Engineering Design, ICED 09 |
|---|---|
| Country/Territory | United States |
| City | Palo Alto, CA |
| Period | 8/24/09 → 8/27/09 |
Keywords
- Iterative design
- Medical device design
- Medical device development process
ASJC Scopus subject areas
- Engineering (miscellaneous)
- Modeling and Simulation