Dynamic Medical Device Configuration via Jurisdictional Algorithm Selection
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Solution Overview
Problem
Medical systems face challenges in ensuring compliance with jurisdictional requirements for medical devices and algorithms, leading to disparities in medical care access and quality across different geographic regions.
Innovation Solution
A computing service-based solution that dynamically configures medical devices by accessing a data structure containing algorithms for health event detection, ensuring compliance with jurisdictional requirements through automatic configuration and verification of patient data.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a medical device is approved for use in one geographic region, then the device can provide medical care in that region, but the same device may be unlawful in different geographic regions
Solution Approach 1:
The patent implements dynamic configuration of medical devices by allowing the algorithm selection to change based on the patient's current geographic location. The system continuously determines the applicable jurisdiction and automatically selects the appropriate algorithm configuration, making the device adaptable to different geographic regions without requiring manual reconfiguration or physical modification of the device hardware.
Solution Approach 2:
The patent changes the operational parameters of the medical device by selecting different algorithms based on jurisdictional requirements. Instead of modifying the physical device structure, the system changes the software algorithm parameters dynamically according to the patient's location, allowing the same hardware to comply with different regulatory frameworks across various geographic regions.
2Adaptability or versatility
If a manufacturer builds different configurations of a medical device for different jurisdictions, then the device can be used in multiple regions, but it takes time for those configurations to be ready and incurs extra costs
Solution Approach 1:
The patent creates a universal medical device platform that can operate in multiple jurisdictions by incorporating a single algorithm selection mechanism that adapts to different geographic requirements. Instead of maintaining separate device configurations for each jurisdiction, the system uses one unified device with the capability to automatically select the appropriate algorithm based on location, thereby eliminating the time and cost associated with building multiple specialized configurations.
Solution Approach 2:
The patent introduces an intermediary algorithm selection mechanism that mediates between the medical device and the jurisdictional requirements. This intermediary layer determines the applicable jurisdiction based on patient location and selects the appropriate algorithm, allowing the device to access multiple jurisdictions without the manufacturer needing to pre-configure and prepare multiple distinct device versions.
3Reliability
If a medical algorithm is approved in one jurisdiction but not in another, then the device can operate in the first jurisdiction, but access is lost in the second jurisdiction
Solution Approach 1:
The patent implements dynamic algorithm selection where the system continuously monitors the patient's geographic location and automatically switches to the appropriate algorithm based on the applicable jurisdiction. This dynamic adaptation ensures that the medical device maintains reliability by using only approved algorithms in each region while preserving access to multiple jurisdictions through automatic, location-based algorithm switching.
Solution Approach 2:
The patent incorporates feedback mechanisms where the system determines the patient's location and uses this information to select the appropriate algorithm. The location determination provides feedback that triggers the algorithm selection process, ensuring that the device always operates with the correct algorithm for the current jurisdiction while maintaining the ability to access multiple jurisdictions through continuous location-based adaptation.
Data Source
AI summary
This disclosure is directed to medical systems and techniques for dynamic configuration of medical devices. In one example, a method is configured to access a data structure comprising an algorithm for health event detection in patient data generated by at least one of a medical device of the patient or a personal device of the patient based on a usage scenario. An association of the algorithm and the usage scenario in the data structure indicates that use of the algorithm for the usage scenario complies with one or more jurisdictional requirements.