A new trend has been spotted in medical device companies, giving them improved visibility into project progress, simplifying the transfer of design assets between teams, and reducing the time spent on manual documentation. Results from Seapine Software’s 2013 State of Medical Device Development Survey indicate that more and more medical device makers are moving from a document-centric approach to an artifact-centric approach for managing their product development processes. What does this mean exactly, and how can this help to simplify project management and design transfers?

Figure 1: Use of artifact-centric vs. document-centric approachesHistorically, medical device development has been based on working with documents that typically contain numerous artifacts, work items, and tasks. It’s still common for teams to use Microsoft Word documents to manage the various requirements that go into building a device. There might be a product requirements document (PRD), another document that outlines system specifications, and yet another document for the Software Requirements Specification (SRS). These documents are then manually linked to other assets in the project, including CAD drawings, risk analysis results, and test plans. While sometimes easy to use for individual contributors, documents limit traceability and visibility, and hinder team-based work. Some common challenges in a document-centric process are:

  • Only one person can work on a document at any given time
  • Linking individual design assets (e.g., a CAD drawing) to product requirements or other work items is a manual process
  • Transferring designs and other assets between teams is tedious and error-prone

There’s a Better Way to Manage Project Assets
The 2013 survey results, when compared to a similar survey Seapine Software conducted in 2011, show that the number of teams using an artifact-centric approach to product development has doubled. Why the big shift in just two years? Because an artifact-centric approach is focused on working with individual artifacts and work items integrated across various teams. Instead of passing around and updating documents, teams using an artifact-centric approach focus on managing the change, versioning, reviews, and approvals of individual work items (e.g., risk, requirements, test cases, CAD drawings, etc.). This enables each artifact to be changed, reviewed, and verified separately while automatic linking maintains the relationships between artifacts.

Figure 2: Most time-consuming tasksWith this level of granularity, tracing project assets is easier and less time consuming. Rather than having to manually associate a CAD drawing with relevant requirements, for example, each artifact is linked separately and automatically. The impact of change is more obvious when artifacts are directly linked. A change to one artifact can result in all linked artifacts immediately being flagged for review. Imagine a product requirement changing, which then causes one member of the team to get an email asking for a review of the half-dozen system specs linked to that product requirement. Linking at the artifact level is faster, which results in a more complete and up-to-date view of project assets and their relationships. This greatly simplifies transferring project assets between groups by eliminating the need to manually collect and associate documents before sending them off to the next team.

Time Savings Could be Significant
As a project progresses under a document-centric approach, documenting and communicating work starts to consume more and more of a team’s time. Many teams get mired in clerical work that provides no value to the development of the actual device. The survey asked respondents, “What are the most time-consuming tasks in your role?” Not surprisingly, given that over half of respondents are still working with documents, updating, reviewing, and communicating about documents were the top three time-consuming tasks. These teams could save quite a bit of time if they moved to an artifact-centric approach within their product development processes.

These teams could save quite a bit of time if they moved to an artifact-centric approach within their product development processes.

Get the 2013 State of Medical Device Development Survey Report
This year’s survey gathered feedback from more than 400 respondents within the medical device field. The survey reports includes information about how medical device companies are improving their design control processes, managing risk and requirements, tracking testing and verification activities, as well as benchmarks for maintaining traceability across all of their product development assets.