November 24, 2014

Working with Documents: A Key Challenge for Medical Device Development

Helix ALM
After analyzing the results of this year’s State of Medical Device Development Survey, we identified three key challenge areas within the industry: managing risk, working with documents, and overcoming barriers to improvement. In a previous blog post, we looked at what the survey revealed about managing risk, and how TestTrack can help with that important facet of medical device development. In this post, we’re going to look at the challenges of working with documents. When asked to identify their most time-consuming tasks, respondents put “documenting work” and “reviewing documentation” at the top of the list. top-time-consuming-tasks 600

Document-Centric Processes Waste Time

If you had a choice between spending your time on refining the product and getting it to market faster, or managing compliance documentation, which would you choose? You’d choose to work on the product, right? The problem is, getting new devices to market depends on proving that you’ve complied with all applicable regulations. In order to do that, you have to have your documentation in order. Many companies attempt to meet this challenge by sharing the reports, traceability matrices, and other necessary documentation on a network or in a document control system. As we previously pointed out, this is bad for risk management. It’s also a major productivity killer. Development teams lose valuable time as they struggle to manually manage these documents. That’s why many companies are moving away from document-centric systems. The industry made a huge leap forward in this area from 2011 to 2013. artifact-vs-document-centric 600 Although that progress seemed to stagnate this year, we’re confident the industry will continue to move toward artifact-centric systems as the productivity benefits become more widely recognized.

Improving Traceability

Possibly the biggest timesaver delivered by an artifact-centric solution like TestTrack is in leveraging traceability. Teams using a document-centric approach spend an inordinate amount of time digging through documents to ensure accurate traceability from design through code and testing. Hours, days, or even weeks can be lost to maintaining the trace matrix. time update trace matrix 600 Nearly half of survey respondents reported wasting nearly a day or more each time they need to update the traceability matrix. When maintaining traceability takes that much time, you’re forced to chose between creating the trace matrix early and adding massive time to the schedule, or creating it late in the process and wasting less time—but also losing valuable traceability data. Only 19% said they create the traceability matrix at the very beginning of the development process; 13% said they wait until right before submission. when-is-trace-matrix-created 600 2

TestTrack Is Artifact-Centric

TestTrack allows you to focus on working with individual project assets or artifacts:
  • Requirements
  • User stories
  • Release planning
  • Sprints
  • Assignments
  • Work items
  • Test cases
  • Defect resolutions
  • Releases
  • Specifications
  • Risk controls and analyses
These artifacts can be sent out for review to only the people responsible for each piece, with TestTrack centralizing their changes. User A will see user B’s changes in real time and can adjust their updates and feedback accordingly, eliminating the need to merge changes. An artifact-centric approach can also easily support various development methodologies—spiral, iterative, parallel, Agile, Waterfall, and other hybrid alternatives. To regain the lost productivity, medical device development teams need to get out from under the burden of document-centric systems. Migrating to an artifact-centric approach with TestTrack allows for much better data, risk, gap, and impact analyses. With TestTrack, users can focus on tasks instead of constantly reviewing and updating documents. Learn more about TestTrack and our other solutions for the medical device industry.