November 14, 2013

State of Medical Device Development in 2013: Design History File

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. If you're interested in how your processes compare to our industry benchmarks, download the full report. One piece of insight that's not in the full report is how folks are working with Design History Files (DHF). We asked respondents to briefly describe the most difficult items to manage and report in their DHFs. Here's what we found.

Top 5 Challenges Within the Design History File

Top 5 Design History File Challenges#1 Change - The biggest challenge respondents have within their DHF is tracking and managing all of the change requests that come through the development process. This includes changes to software, changes to firmware, and the reasons those changes were made. One respondent said, "Manually making and controlling changes in distributed locations and spreadsheet formats." That really captures the challenge of working with documents—they just don't scale as your team grows! #2 Verification - Are you struggling to keep track of all of the testing documents your team produces? Survey respondents are—they reported difficulties with tracking quality reports, bulky test plan documents, test cases and results, and the objective evidence that goes along with those test results. #3 Design - Another challenge related to managing documents is tracking all the decisions and approvals made during design. A lot of folks reported struggling to capture and maintain the data that comes out of the design review process. If you're looking for help in this area, check out how TestTrack handles requirement reviews. #4 Risk - This challenge might transcend the tools used, and really goes to the challenges of risk analysis and mitigation in general. If you look at all of the various methods that medical device companies are using to mitigate risk, it's daunting! Not surprising, then, that respondents  struggle to manage that data within the DHF. One area where risk management and mitigation can be made easier is with traceability. That leads us to the last of our top 5. #5 Trace Matrix - This is a big deal in medical device development if you're working on Class II or Class III devices. It's also incredibly difficult to link individual assets and work items if they're all packed into documents. Almost half of survey respondents told us that it takes them a day or more to update their trace matrix!