Parallel Medical Device Testing With Profile-Based Pass Criteria
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Solution Overview
Problem
Manual testing of medical devices is time-consuming and prone to errors, and the testing requirements vary based on whether the device will have contact with a patient or not.
Innovation Solution
A system comprising a test device and a user computing device that facilitates parallel testing of medical devices by receiving an ID, selecting a profile with preset simulation parameter values, initiating testing, and determining a test result based on pass criteria through comparison with simulation parameter values.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If manual testing is used for medical devices, then testing can be performed with simple equipment, but the testing process is time-consuming and prone to errors
Solution Approach 1:
The testing system performs self-testing by automatically comparing measured parameter values against stored simulation parameter values and pass/fail criteria, eliminating the need for manual operator intervention in the comparison and determination processes, thereby reducing errors and improving efficiency
Solution Approach 2:
The patent replaces manual mechanical testing operations with an automated electronic system that uses processors to control test execution, compare parameters, and determine pass/fail results, substituting human operators with automated computing devices to improve both speed and accuracy
2Reliability
If comprehensive testing profiles are used to ensure safety, then testing coverage is improved, but the complexity of the testing process increases
Solution Approach 1:
The testing system is divided into distinct functional modules: a test device for performing measurements, a user computing device for controlling the test and storing criteria, and an automated comparison process, allowing each component to handle specific aspects of the complex testing process independently
Solution Approach 2:
The user computing device acts as an intermediary between the test device and the pass/fail criteria database, managing the storage, retrieval, and comparison of parameter values, thereby simplifying the overall system architecture while maintaining comprehensive testing capabilities
3Loss of time
If parallel testing of multiple parameters is implemented, then wait time is reduced, but the system complexity increases
Solution Approach 1:
The patent combines multiple parameter measurements and comparisons into a single integrated testing process, where the processor simultaneously manages multiple test parameters, simulation values, and pass/fail criteria comparisons, reducing total testing time while consolidating system complexity into a unified architecture
Data Source
AI summary
Systems, devices, and methods for testing medical devices comprising: a test device configured for testing a medical device; and a user computing device in communication with the test device, where the user computing device comprises a processor having addressable memory, where the processor is configured to: receive an ID of the medical device to be tested; select a profile associated with the received ID of the medical device; select a preset associated with the selected profile; initiate testing of the medical device by the test device; receive one or more parameter values from based on test information results from the test device; determine a test result based on pass criteria from a comparison of the received one or more parameter values to the one or more simulation parameter values of the preset.