November 24, 2014
Working with Documents: A Key Challenge for Medical Device Development
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.Email sign up
Document-Centric Processes Waste TimeIf 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. 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 TraceabilityPossibly 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. 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.
TestTrack Is Artifact-CentricTestTrack allows you to focus on working with individual project assets or artifacts:
- User stories
- Release planning
- Work items
- Test cases
- Defect resolutions
- Risk controls and analyses