Automated Medical Device Interface Generation for Standards Compliance
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Solution Overview
Problem
The development of standards-compliant communication and data storage interfaces for electrical medical devices (EMDs) is costly and time-consuming, and current systems lack robust security features, making them vulnerable to unauthorized access and data breaches.
Innovation Solution
A system for automated generation of interface software that includes a medical device modeler for validating EMD properties and generating standards-compliant communication interfaces, user device interfaces, and data storage solutions, ensuring secure data transfer and storage compliant with regulatory standards.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If custom communication interfaces are manually developed for each medical device to ensure standards compliance, then reliability and security are improved, but development time and cost increase significantly
Solution Approach 1:
The system performs preliminary actions by pre-defining communication templates and interface structures that already incorporate standards compliance requirements. These templates are prepared in advance and can be automatically instantiated for specific devices, eliminating the need to manually develop interfaces from scratch while ensuring reliability and security standards are met.
Solution Approach 2:
The system creates copies of proven, standards-compliant communication interface templates and adapts them to specific device requirements. Instead of manually developing unique interfaces for each device, the system replicates and customizes pre-validated interface structures, significantly reducing development time while maintaining reliability through template validation.
2Reliability
If custom communication interfaces are manually developed for each medical device, then security and reliability are improved, but development cost increases significantly
Solution Approach 1:
The system implements universal communication templates that can serve multiple devices and purposes. A single validated template can be instantiated and adapted for different medical devices, reducing the need to develop separate secure interfaces for each device. This multi-functionality maintains security standards while significantly reducing development costs through reuse.
Solution Approach 2:
The system creates and reuses copies of security-validated communication interface templates across multiple devices. By copying proven secure interface structures and adapting them to specific device needs, the system maintains high security standards without incurring the full cost of manual development for each device.
3Manufacturing precision
If comprehensive validation testing is performed on each EMD property, then manufacturing precision is improved, but productivity decreases
Solution Approach 1:
The system performs preliminary validation of communication templates and interface structures before they are instantiated for specific devices. By pre-validating the template structures, the system ensures manufacturing precision is maintained while reducing the validation burden during actual device development, thereby improving productivity without sacrificing accuracy.
Solution Approach 2:
The system copies and reuses validated property definitions and validation rules from templates across multiple device instances. Once properties are validated in a template, the validation results are replicated and applied to derived interfaces, maintaining manufacturing precision while significantly reducing the repetitive validation work required for each new device.
Data Source
AI summary
Systems and methods for automated generation of medical device communication software, cloud-based storage of medical device data including an electronic medical device (EMD) application communication interface and a central communication interface, and user interface software to allow a user device to receive EMD data transmitted from a data storage medium (DSM) and transmit data to the DSM for transmission to the EMD, that meets one or more medical device standards set by government or industry regulatory bodies.