Dose Insight

Medical Device development has an underlying paradigm to reduce risk early in the development cycle. Developers are using computational tools such as finite element analysis to mitigate risks from thermal loads, mechanical stresses etc. There is one exception to this paradigm: sterilization validation. Sterilization validation is addressed late in the development cycle as an actual physical device is needed to perform these activities. Sterilization configurations (e.g., packaging design, radiation beam direction, etc.) are iteratively modified until the regulatory requirements are met. This “trial-and-error” approach is prevalent throughout all aspects of sterilization. As another example, when choosing between sterilization modalities, medical device companies often rely on rules-of-thumb which may lead to a suboptimal choice for their device. However, use of simulations to model the radiation sterilization process is an emerging field that has the promise to address sterilization validation early in the development process and thereby allow for a Design for Sterilization approach. That means as soon as a Computer Aided Design (CAD) model of the device exists, simulation can be performed to analyze whether the device will pass sterilization validation or mitigations will be needed.