An E-beam sterilization dose map simulation tool
Ended Project Grant Awarded Last action
- Award ID
- R43FD007313
- Recipient
-
Triple Ring Technologies Inc. UEI GBBDL263ADH5
- Awarding agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Obligated
- $504,261
Award facts
- Assistance listing
- 93.103 Food and Drug Administration Research
- Completion date
- Funding
-
- $336,173.99 Federal
- $168,087.00 Non-federal
- Funding agency
- Office of the Commissioner Food and Drug Administration, Department of Health and Human Services
- Place of performance
- California, USA
Award details come from USAspending.gov.
Description
- Abstract
- 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.
Transactions
| Action | Federal | Non-federal | Date |
|---|---|---|---|
| Amendment | -$0 | $0 | |
| Amendment | $168,087 | $0 | |
| Original award | $168,087 | $168,087 |
Quick answers
Who received award R43FD007313?
R43FD007313 was awarded to Triple Ring Technologies Inc. by FDA Office of Acquisition and Grant Services (Food and Drug Administration) on September 20, 2021.
How much is award R43FD007313 worth?
$504,261 has been obligated on R43FD007313: $336,174 in federal funding and $168,087 in non-federal funding.
Which agency awarded R43FD007313?
FDA Office of Acquisition and Grant Services (Food and Drug Administration) awarded R43FD007313, with funding from Office of the Commissioner (Food and Drug Administration).
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