Proving experience speeds medical device time to market

Experience is important for developing medical devices. This seems like a straightforward statement, yet it has been difficult to prove. In this paper, several medical device projects are compared to demonstrate how experience improves both overall development time and user interface design time. To prove that experience counts, actual data was assessed over a number of development projects. All projects were completed by a single organization. Data was collected over a period of several years. Time to market was measured along several dimensions including complexity, technological invention, and uniqueness of clinical application. Experience can improve time to market by as much as 50% whereas inexperience will slow development. This can be demonstrated even for a portion of the development. The user interface design times were studied in more detail and the effect of experience was similar to the overall product development time improvement.