2013 Medical Device Development Report

Medical device manufacturers have made significant changes to their product development processes over the past two years in an effort to improve quality, safety, and time to market according to the recently released 2013 Medical Device Development survey report. Conducted by Seapine Software, the survey polled over 400 medical device development professionals between June and August 2013 and compared the results to a similar survey Seapine conducted in 2011.

This year’s results show the number of respondents using artifact-centric approaches has doubled over the past two years, indicating a trend away from document-centric methods. However, a majority of medical device companies still rely on documents for traceability, risk mitigation, and other key processes, which clouds visibility into project status, complicate design transfers between teams, and hinders accountability.

Other key findings include significant changes in the way medical device developers manage risk, requirements, and core artifacts. The changes allow them to better focus on the artifacts they need to track to assure product quality and more effectively mitigate risk. For risk management alone, survey results show a 500% increase in the use of commercial software tools since 2011.

Participants also identified where their product development processes are weak, and the barriers that keep them from improving those processes. Nearly 60% indicated the same non-productive chore – documenting work – as one of their most time-consuming tasks, taking valuable hours or even days away from more productive work.

After analyzing data from both the 2011 and this year’s surveys, Seapine’s industry experts estimate between 60% to 80% of medical device companies will adopt artifact-centric processes by 2015. 

The 2013 Medical Device Development report is available now, and can be downloaded at www.seapine.com/MedDevReport2013.

Source: Seapine Software