Biochemical Sensor Calibration Using Manufacturing Parameter Correlation
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Solution Overview
Problem
Biochemical sensors exhibit performance variations due to manufacturing process and material inconsistencies, leading to inaccuracies in chemical measurement.
Innovation Solution
Determine individualized calibration information for each sensor by correlating manufacturing parameters with in vitro testing results of a subset, allowing prediction of performance without destructive testing on the entire batch.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If in vitro testing is performed on all sensors to ensure performance accuracy, then measurement precision is improved, but productivity deteriorates due to destructive testing rendering sensors unsuitable for distribution
Solution Approach 1:
The patent applies preliminary action by performing in vitro testing on a subset of sensors during the manufacturing process to obtain test data before the sensors are distributed. This early testing allows the system to build a predictive model that can later estimate performance of undistributed sensors without requiring destructive testing on all units, thus maintaining both measurement precision and productivity
2Reliability
If in vitro testing is performed on all sensors, then reliability is improved through direct performance verification, but loss of substance worsens as tested sensors become contaminated and unsuitable for distribution
Solution Approach 1:
The patent applies copying by using test data from a subset of sensors to create a predictive model that estimates performance of the broader sensor population. Instead of testing all sensors directly, the system creates a virtual representation of sensor performance through the predictive model, allowing reliability verification without consuming all physical sensors through destructive testing
3Manufacturing precision
If manufacturing process variations are reduced to improve sensor consistency, then manufacturing precision is improved, but device complexity worsens due to need for tighter process control
Solution Approach 1:
The patent applies parameter changes by measuring specific manufacturing parameters (such as electrode dimensions, material composition, or fabrication conditions) and using these parameters as inputs to a predictive model. By focusing on key parameters that most influence sensor performance, the system can predict and compensate for manufacturing variations without requiring complete process control, thus improving manufacturing precision while managing device complexity
Data Source
AI summary
Systems, devices, kits, and methods are provided herein in the form of example embodiments that relate to calibration of medical devices. The medical devices can be sensors adapted to sense a biochemical attribute. The embodiments can be used to determine calibration information specific to an individual medical device. The embodiments can determine the calibration information by reference to one or more parameters obtained during manufacturing of the medical device. The embodiments can also determine the calibration information by reference to in vitro testing of the medical devices. The embodiments also apply to systems incorporating those medical devices in their use in the field. Also described are embodiments of modifications to surfaces of sensor substrates, such as through applied radiation and/or the creation of a well, to aid in the placement and/or sizing of a sensor element on the substrate.