December 3, 2013

State of Medical Device Development in 2013: Quality Control

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.

Top 7 FDA Compliance Difficulties

Specific to quality control and verification practices, we asked a few questions that are highlighted below along with response data. The first question centered around the ability to prove compliance to the FDA and other agencies. Risk is something we've been talking about with customers a lot recently. It is the top challenge for folks in working with the FDA, so it's good to see that our customers are starting to move their risk assets out of Excel and into TestTrack where they live live along side of requirements. We've got a white paper on how to better expose risk throughout your product development cycle, as well as a short 2-minute video from David Vogel of Intertech Engineering on using traceability to identify safety-related requirements. Top 7 FDA Compliance Challenges Not surprising at all to see Validation near the top of the list either. We've done a lot of webinars with various industry consultants, and they all talk about validation being a big hurdle for their clients. Rounding out the top 3, audit trails are built into TestTrack, so that's an easy one to knock off your list if you're not already using a solution like TestTrack. Regarding the Design History File (DHF), we asked a question about what goes into that in the survey but it was an open-ended response and we haven't had time to review those yet. In a future blog post, I'll aggregate that data and provide some insight into what is typically included in the DHF.

Managing Test Cases

How are your peers managing test cases right now? More and more of them are moving to completely electronic solutions, which isn't surprising given that the number of organizations using completely electronic tools, like TestTrack, to manage their product development cycle doubled. (Download the full report to read more about the move to electronic solutions). Test case management

Providing Objective Evidence

At the bottom of the top 7 FDA compliance challenges was providing objective evidence. More than half of respondents are using text alone to build that objective evidence for auditors. They say a picture is worth a thousand words. That's why we added the ability to incorporate screenshots and other images into test case steps back in 2011. A large number of customers within the medical device space told us that text alone wasn't meeting their needs. To see how incorporating screenshots and images into test case steps works, watch this short demo on providing objective evidence during testing with TestTrack.

Providing Objective Evidence