Pursuing Paperless in an Medical Device Landscape - Part 3

Reign in Risk Analysis

In part 1 and part 2 of this blog series, we have established the clear benefits a transition to paperless offers for capturing medical device requirements and tackling testing, but how do they translate to the rigors of risk analysis? Speaking from several decades in the medical device space, I can share that discussions around risk can be unsettling but they are critical to successfully bring disruptive innovations to market.

Throughout the development journey, teams are constantly looking to identify potential areas of risk. What the worst possible outcome might be from the most unlikely scenario? While this seems a bit “doom and gloom”, it is necessary to ensure all risks are accounted for and appropriately mitigated.

Generally, risk analysis is tackled during a collaborative brainstorming session involving key stakeholders from every department - engineering, regulatory, quality, marketing, sales - providing their unique perspective to outline and document every imaginable scenario. Quite often, this is captured in a massive spreadsheet that over time becomes increasingly challenging to manage.

How can the transition to paperless help medical device companies reign in risk analysis? 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: “Time for risk analysis on this new software version.”

Twice a year, our team blocked a significant chunk of time – a half to a full day – for risk analysis brainstorming. Everyone on the project team would gather around the large conference table proposing potential pitfalls one after another. In no time at all, this exercise translated to hundreds of lines in an Excel file! It was crazy to see the creativity in some of these scenarios my colleagues proposed!

While this exercise captured our possible risks reasonably well, with each new software release or update to our device, the team needed to revisit the established list to re-assess impact. As more changes were made, it became impossible to tease out which risks were impacted by the most recently implemented changes. Our own risk analysis process was becoming a bottleneck inhibiting innovation at our company!

Story 2: “How can you demonstrate your mitigations are well tested?"

While our bloated Excel outlined the mitigations, we were left in panicked scramble when a reviewer requested proof that a specific mitigation was effectively tested in our last product release.

"Where is that summary report?" questioned Michael.

Lisa chimed in, "I ran the test, but Ed documented the results."

"Let me dig through my notebook to find the data from that test run. Give me some time, that was three months ago!" replied Ed.

Teammates were frantically digging through data logs to track down the test cycle to show the particular feature successfully mitigated the identified risk. To compound the stressful search, the auditor had more time to ask other questions, our time wasted in expeditions to find even more documents was growing exponentially!

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. With Matrix applications in place, users have dynamic information at their fingertips. The team can focus on risks linked specifically to new design implementation to streamline analysis with full traceability from the risk to its risk controls, the tests protocol, and results of executed test cases. Matrix ensures you are always audit-ready.

So, if you want to reign in risk analysis with the power to customize your documentation and ensure compliance at every step so your disruptive technology can go-to-market faster, check out the Matrix platform. Sign up for one of our online demos or view our recorded webinar on Risk Management to see the functionality, flexibility, and power of MatrixALM.