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Pursuing Paperless in an Medical Device Landscape - Part 2
Triumph over Testing
In part 1 of this blog series, we have established the clear benefits a transition to paperless offers for capturing medical device marketing requirements, but how does it fare under the rigors of the testing stage? Speaking from several decades of experience in this space, I can share that as development progresses, various testing is necessary to demonstrate feasibility, optimize design performance, and validate new innovative technologies.
Test protocols must be established to ensure test success and mitigate risk for ongoing or future studies. Typically, these protocols define the test objectives and outline the methods on how the testing will be performed. In addition, test protocols outline what equipment is required to perform each test and set expectations on what data is to be collected as well as how it will be measured against established performance criteria. Adherence to test protocols is critical to validate any new device and proper documentation throughout the testing phase is required to demonstrate regulatory compliance.
How can the transition to paperless help medical device companies triumph over testing? Again, it all comes down to selecting the right tool.
Here are a few stories from my experience to help illustrate how impactful the power of paperless can be in this stage:
Story 1: “No way! Now I need to reprint the entire document batch!”
Our team was diligently preparing for our upcoming testing period. This was a heavy lift for everyone as we completed the finishing touches on the software to be tested, reviewed the testing protocols, and primed the equipment involved. As the testing day approached, my colleague thought she would get “ahead of the game” by specifying the software version in the header of each page of the test documentation. Seemed like a great idea to ensure the paperwork was ready to go, right?
Well, unfortunately, our second test detected a major issue. We needed to halt testing and address the problem before we could resume. The new software version rendered our prepared documents useless. Into the recycle bin they went as more paper, ink, and time were needed to reprint new documents. So much for trying to be agile, efficient, and environmentally friendly!
Story 2: “Don’t pop that cork just yet!”
Testing is always a time intensive endeavor. To be organized and efficient, my team generally leverages an all-hands-on-deck approach, splitting the tests among all that were available to help. After a few weeks of running test protocols and documenting results, we thought we had everything wrapped up. The champagne was chilling and we were ready to celebrate this milestone when a documentation audit uncovered several gaps.
"Why isn't this test case signed?" inquired Peter, our Documentation Administrator. "Where is this test failure documented? And why were some of the steps in this test protocol completed?"
Panic set in as the team scrambled to address each apparent gap.
"Oh, I forgot to sign that test case," admitted Richard.
"The repeat test passed, so we didn't record the initial failure," confessed Paul.
"I had to run to another meeting before the test was completed and when I came back, I just started a new one," Mary explained.
The team had to work diligently to resolve these issues before we could proceed with the milestone celebration.
These examples, and many others like them, are what drove us to develop MatrixALM. It simplifies and digitizes design development, allowing teams to work efficiently and collaboratively. Members of all departments can provide inputs to the same tool. Everyone has direct access to development status, visibility to adaptations made between versions, and can receive notifications as soon as documents are ready, with changes highlighted, to keep everyone up-to-date. No requirements missed, no gaps in traceability.