October 29, 2013

State of Medical Device Development in 2013: Design Control Processes

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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.

Better Visibility

Specific to design control processes, we asked a few questions that are highlighted below along with response data. The first question centered around visibility into project assets. Sadly, survey results indicate most teams don’t have real-time visibility into their data, and must track down and dig through multiple documents to get that information. Not only is this time-consuming, but it often results in incomplete or outdated information being used to make decisions.

Top 3 Visibility Challenges During Design Control

Requirements Management

The next question focused on how teams manage their requirements under design control. Again, we see that many medical device teams don't have the tools necessary to really increase efficiencies and reduce time to market. We've seen three stages of evolution in this area. Initially, product design is done in electronic documents that are passed around via email and typically stored on a shared network drive. This works fine during the concept phase when the design is very fluid and a smaller number of people are working on an idea, but breaks down pretty quickly once other teams get involved. A team will usually start to investigate a document control tool when the pain of updating, merging, and tracking documents becomes unbearable. What we see with our customers though, is that document control tools only take you so far. These tools are fine for achieving compliance, but they don't address the efficiency challenge that electronic documents present. Tracing and linking to individual artifacts within a document is a manual, time-consuming process.  (You can read about the most time-consuming tasks for medical device professionals in the full report.) The third step in a team's evolution is to adopt an integrated toolset that gives them the ability to manage, link, and trace at the artifact level. Instead of managing an entire PRD in a Word document, for example, a tool like TestTrack can break the PRD down into individual requirements. TestTrack also allows the team to update, review, and trace against each requirement separately.

Managing Requirements Under Design Control

Verifying Requirements

The last data point I'll share with you today is a look into how people are verifying changed and approved requirements. The following chart compares results from our 2011 survey, showing that teams are slowly moving away from manual signatures to electronic signatures for requirements verification. Based on comments from some survey participants, it appears that regulatory is the group most likely to hold up adoption of electronic signatures.

Verifying Changed Requirements with Electronic Signatures

Download the full report to learn how other medical device companies are managing their design control activities, and benchmark your processes against your peers.