Your average traceability matrix is a complex document that gets little use or attention during the typical research and development process of a device. Then, at the end of the R&D cycle, you can spend days or even weeks1 compiling data to create a matrix as part of the FDA submission process — only to file it away in your document management system after submission. If this scenario sounds familiar, you probably regard the traceability matrix as a burdensome requirement, not a useful tool.

Did you know that you limit the potential uses of a trace matrix by waiting to create it until after most of the R&D work is completed? However, when created early in the development cycle, the matrix becomes a highly useful tool, delivering five benefits that can help you make informed decisions and maximize constrained resources.

1. Save Time Now — and Later
Early planning of verification activities can save large amounts of time on the back end of the project — potentially making the difference between meeting your deadline and managing last-minute schedule surprises. When a complete, updated trace matrix is available early in the development cycle, the verification and validation (V&V) team can plan their activities while requirements and specs are being defined.

Involving V&V earlier in the design process provides three additional benefits:

  1. Saves testing time and reduces project risk by helping the team identify and re-work ambiguous or complex requirements that might be hard to verify.
  2. Lowers the chance of last-minute schedule changes by enabling verification efforts to be estimated and staffed during design rather than later in the development and testing cycle.
  3. Improves visibility and communication about the entire project schedule early in the development process, to ensure management is on board with decisions being made and their possible schedule impact.

Figure 1: Gain a single source of truth2. Ensure Requirements Are Implemented
Monitoring the implementation progress of requirements is a challenge without a centralized and updated trace matrix in place. It’s just too easy for requirements to get lost in the shuffle of documents and emails — sometimes for weeks or even months.

By creating and maintaining an accurate trace matrix during early design work, your team has a single source of truth for marketing requirements and product and system specs. There’s no confusion over which requirements are part of the project, nor what the status of each requirement is within the design and development process.

3. Get ‘Free’ Requirement Verification
Ensuring requirements are verified is something you can’t skip or complete at the last minute, especially if you’re doing it manually. Updating documents and tracking down test results is incredibly time consuming and error-prone.

If your team is already using a trace matrix, you have real-time insight into the verification process essentially for free. With an updated trace matrix in place, monitoring verification efforts is just a matter of viewing the matrix and checking test results.

4. Improve Change Management
Change is inevitable. The real concern is how effectively you can evaluate and implement change requests. Your team can waste time manually compiling information to identify the impact and effort of making a particular change. In fact, this is how many teams currently operate.

Teams that can automatically update their matrix, however, can dedicate their time to making an informed decision on whether to proceed with a change. This ensures that decision-making is based on real data about the impact and risk of making the change, rather than a gut feeling.

5. Provide Evidence of Risk Mitigation
An increasing number of organizations are integrating risk management and mitigation activities into their ongoing development processes, but they still face the critical task of proving risk mitigation. Providing evidence that all hazards have been mitigated often requires extreme effort, and results often must be double- or even triple-checked.

An updated trace matrix makes this entire process almost seamless. All of the necessary information about requirements, risk artifacts, test cases, and verification results are compiled as part of the development process and integrated into the trace matrix. The only step left is to zoom in on the risk and hazard mitigation artifacts, and produce a report specifically tailored to present that evidence.

Figure 2: Provide evidence of risk mitigation

Don’t Wait
Waiting to create a trace matrix after most of the R&D work is completed is a waste of both time and effort. By creating your matrix early in the development cycle, and maintaining it throughout, it will no longer be a time-consuming task completed only to meet regulatory requirements. Transform your trace matrix into a highly useful tool that will you save time, improve product quality, and maximize your team’s resources.

1 Seapine Software’s 2013 State of Medical Device Survey found that almost 50% of respondents spend more than a day creating their trace matrix;