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A manufacturer of surgical products had developed a new surgical mesh that provided various advancements in clinical outcomes, but also came with necessary adjustments to implantation procedure.
The manufacturer needed to assess the impacts of these adjustments to surgical teams’ ability to implant the mesh safely and effectively. They also needed to tailor the packaging and labeling to clearly communicate the need for the adjustments.
We recruited representative members of surgical teams to conduct simulated implantations in porcine subjects at a simulation lab managed by a local hospital.
Our researchers observed the simulated implantations to capture the surgical team dynamics and interactions with the revised implantation procedures.
We provided the manufacturer with redesigned packaging and labeling for their surgical mesh product that clearly communicated the necessary procedural adjustments.
With the revised packaging and labeling, residual use-related risks were reduced to acceptable levels.