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Virtual dose mapping for radiation sterilization

Award Information
Agency: Department of Health and Human Services
Branch: Food and Drug Administration
Contract: 1R43FD007584-01
Agency Tracking Number: R43FD007584
Amount: $198,918.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: FDA
Solicitation Number: PA21-259
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-09-27
Award End Date (Contract End Date): 2023-08-31
Small Business Information
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
Because sterilization is often only considered after a medical device has been fully engineered and
manufactured, the costs associated with failing to meet regulatory sterilization requirements are astronomical.
In the best case, the sterilization configuration can be iteratively modified until the regulatory requirements are
met. This is an expensive and time-consuming endeavor. However, it is still preferable to the worst cases of
having to redesign parts of the device or abandoning the device all together.
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.
As such, the medical device industry needs a tool that will allow them to consider sterilization requirements
early in the product development process, in the same way they would consider other engineering concerns
such as thermal management, stress distributions, and environmental sensitivity. The incorporation of such a
tool into the product development process will allow for a first-class consideration of medical device safety as it
relates to sterilization, which has a positive impact on public health.
This project proposes to fill this gap in the computer-aided engineering market by developing a simulation tool
capable of predicting the outcome of radiation sterilization without having a fully engineered or manufactured
product. From only the Computer Aided Design (CAD) model of the device, the proposed software will be able
to calculate the full three-dimensional dose distribution that would be delivered during radiation sterilization. By
leveraging the validated Monte Carlo library Geant4, and the scalability and flexibility of cloud computing, the
simulation tool will be fast, accurate, and user-friendly.
Developing such a simulation tool involves architecting and implementing a flexible cloud computing
infrastructure and user-friendly web interface. Through both a series of internal verification tests and usability
testing, this project will result in an accurate and verified cloud-based simulation tool for the medical device
sterilization market.

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

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