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An e-beam sterilization dose map simulation tool

Award Information
Agency: Department of Health and Human Services
Branch: Food and Drug Administration
Contract: 1R43FD007313-01
Agency Tracking Number: R43FD007313
Amount: $168,087.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: FDA
Solicitation Number: PA20-260
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-09-20
Award End Date (Contract End Date): 2022-08-31
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 methods, 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 is in need of 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
processing. By leveraging the massively parallel architecture of Graphical Processing Units (GPUs), the
simulations will be fast and user-friendly.
Developing such a simulation tool involves architecting a way to score the three-dimensional dose distribution
on a GPU, as well as implementing the physics of radiation sterilization. By following an incremental
development approach and benchmarking against established simulation libraries and measurements at
contract sterilizers, this project will result in an accurate and verified prototype of a simulation tool for the
medical device market.This grant aims to improve predictability and reliability of sterilization methods of medical devices by using
computer simulations. Current standard of practice is to address sterilization once the product is fully
developed potentially leading to expensive changes or failure. Our approach allows to address sterilizability
early in the development process thereby lowering development cost and risk and ultimately lowering cost of
medical devices.

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

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