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Adaptive Mechanical Models for Realistic Radiation Sterilization Simulations

Award Information
Agency: Department of Health and Human Services
Branch: Food and Drug Administration
Contract: 1R43FD007805-01
Agency Tracking Number: R43FD007805
Amount: $199,443.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: FDA
Solicitation Number: PA22-176
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-09-29
Award End Date (Contract End Date): 2024-09-28
Small Business Information
39655 Eureka Drive
Newark, CA 94560-4806
United States
DUNS: 184609621
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (510) 592-3000
Business Contact
Phone: (650) 906-7829
Research Institution

Project Summary
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.
While simulations are a key ingredient to address sterilization early in the design process, we find that a single
representation of the device might not be sufficient to tell the whole story. Sterile packaging is another
important factor that needs to be considered. The package determines how the device is presented to the
radiation beam, but within the package the device can move to a certain degree with separate parts of the
device also can move against each other. Thus, there is a range of possible orientations and positions of the
device that will influence the overall radiation dose that the device will receive.
In this project we propose to develop a software tool that can generate a family of CAD models that spans the
realistic range of device orientations and positions expected from packaging constraints and device
configuration. The tool will account for gravity and other forces to realistically describe the range of possible
We also will develop a custom phantom that can be used in simulations and in measurements to explore the
range of dose received. The comparative study of measured and simulated dose will be used to overall
validate our approach.
The new tool developed under this project will improve the utility of radiation sterilization simulations and pave
the path for Design for Sterilization.

* Information listed above is at the time of submission. *

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