November 4, 2013

State of Medical Device Development in 2013: Risk Management

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Seapine's recently completed 2013 State of Medical Device Development Survey gathered insight and feedback from more than 400 individuals working in the medical device industry, covering all organizational levels and roles within the medical device field. In addition to general questions about the way folks are developing medical devices, we drilled down into their practices and challenges in three key areas; risk control, design control, and quality control. If you're interested in how your processes compare to our industry benchmarks, download the full report. Related to risk management and mitigation specifically, we asked how teams are managing risk, the kinds of risk analysis methods they're using, as well as several questions about traceability.

Identifying and Mitigating Risk

Most teams still manage risk analysis and mitigation requirements in a document, siloed from the rest of their development assets. If you're interested in some best practices around managing risk hierarchies, check out this great video by David Vogel of Intertech Engineering.

Tools for Risk Identification and Mitigation

Risk Analysis Methods

We also asked participants what methods of risk analysis they practiced. The results were pretty varied, as you might expect.

Risk Analysis Methods Practiced

Tracing to Risk

There's a lot more data on traceability in general, in the full report, but one interesting piece of information we captured related to tracing risk is where in the development process teams are starting to trace risk. The majority of folks start linking risk artifacts back to the PRD, somewhere around the middle of the development process you might say. But even if you trace to the MRD or SRS, you've got plenty of company!

Where Does Risk Traceability Start