Virtual dose mapping is a reliable method to predict the dose delivered during radiation sterilization. Since CAD is used as an input, one concern is that modelling only captures the dose distribution of an idealistic device configuration, which misses the true variations of devices within their packaging. To address this, Dose Insight has developed a new tool that generates realistic configurations by algorithmically moving the devices in their packaging. Families of such configurations can be easily made and used as input for virtual dose mapping to evaluate the realistic range of dose observed in real devices.

To capture realistic movement of devices, we simulate the handling, vibrations, and impacts that occur during transportation, as defined by ASTM D4169, commonly used in regulatory testing of sterile medical devices. We employ a real-time, multibody physics engine that implements rigid and soft body dynamics, gravity, and collision detection in order to model the restriction of the device within its packaging.

We used this tool to study the effect of transportation on a packaged device consisting of a set of syringes. We modelled two packaging designs, one of which offered little constraint, and the other restricting motion to be mostly along a single axis. For both packaging designs, we produced a family of configurations, which were analyzed to study the deviation of the final configurations from the ideal starting configuration.

In conclusion, Dose Insight has developed a new tool capable of generating realistic configurations of devices within their packaging. By using these configurations as an input into virtual dose mapping, the variations in the dose that result from realistic device movement during transportation can be studied.