Single-use diagnostic test device with electronic reader
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Solution Overview
Problem
Existing diagnostic test devices are complex, require medical interpretation, and cannot easily record data in electronic medical records outside of laboratory or hospital settings, limiting their use and accuracy.
Innovation Solution
A single-use handheld diagnostic test device system that includes an electronic device with a processor, sensor, and presentation element, capable of reacting with biological or environmental samples, generating accurate quantitative results, and transmitting data for remote recording, with integrated identification and billing features, and compatible with various electronic devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If sophisticated and accurate rapid point-of-care tests are implemented, then measurement precision is improved, but device complexity increases and requires hospital or core laboratory settings
Solution Approach 1:
The system is divided into separate components: a disposable test device containing the biological reagents and sample processing elements, and a reusable electronic device containing the sensor, processor, and display. This segmentation allows the complex electronic functionality to be consolidated in one unit while the disposable portion remains simple and replaceable.
Solution Approach 2:
The electronic device is designed to work with multiple different disposable test devices through a standardized interface, allowing one electronic unit to perform multiple diagnostic functions by simply changing the disposable test cartridge.
2Productivity
If automated data recording and electronic medical record integration are added to simple tests, then productivity is improved, but device complexity increases
Solution Approach 1:
The test device automatically performs data recording and transmission functions without requiring manual intervention. The sensor automatically detects test results, the processor automatically analyzes the data, and the system automatically transmits results to electronic medical records, eliminating the need for manual data entry by healthcare providers.
Solution Approach 2:
The system combines the testing function, data acquisition function, data processing function, and data transmission function into a single integrated device, eliminating the need for separate equipment for each function and reducing overall system complexity.
3Measurement precision
If professional medical interpretation is required for test results, then measurement precision is improved, but ease of operation deteriorates
Solution Approach 1:
The system provides immediate visual feedback through the display element showing the test result in a clearly interpreted format. The processor analyzes the raw sensor data and presents the results in an easily understandable form, providing feedback to the user about the test outcome without requiring professional interpretation skills.
Solution Approach 2:
The system replaces the need for human medical professionals to interpret test results with an automated electronic processor that applies algorithms to analyze sensor data and generate diagnostic conclusions, substituting mechanical/electronic processing for human expert analysis.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables highly sensitive and accurate diagnostic testing outside traditional laboratory settings, reducing the need for IT infrastructure and professional interpretation, allowing for user-friendly, portable, and automated data recording and analysis.
Implementation Method 1
The sensor may be optical, electrical, or otherwise suitable for detecting test data from the sample
Implementation Method 2
The sensor may be optical, electrical, or otherwise suitable for detecting test data from the sample
Data Source
AI summary
In a single-use handheld diagnostic test device and an associated system and method, a biological and/or environmental test sample is received and reacted with reagents. The test device tests a single sample and includes a sensor to detect test data. The test device mates with, and transmits the test data to, an electronic device. A processor of the electronic device applies algorithms to the test data to generate highly sensitive and accurate quantitative test results. A presentation element of the electronic device presents the test results to a user. The test device is adapted for disposal, or for sterilization and re-use, after the electronic device receives the test data. The electronic device may be, for example, a mobile communications device, a personal digital assistant, a laptop computer, a navigation device, a digital audio player, a camera, or a gaming device.