Self-Certification System for Medical Device Third-Party Software
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Solution Overview
Problem
Medical devices face challenges in managing post-market cybersecurity vulnerabilities and supporting diverse customer security strategies, especially when third-party software is integrated, as existing methods are often reactive and do not effectively certify third-party software products for safe use without manufacturer intervention.
Innovation Solution
A system and method for self-certification of third-party software products on medical devices, allowing customers to test and qualify software independently, using a certification system with an analysis engine and risk management database to ensure safe and effective operation, and generate cryptographic certificates for compliance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If third-party software is integrated into medical devices to address functionality needs and security concerns, then the adaptability and versatility of the device is improved, but the device complexity and difficulty of managing cybersecurity vulnerabilities increases
Solution Approach 1:
The patent segments the certification process into distinct components: a certification engine that executes test cases, a database storing test cases and results, and a certification authority that issues certificates. This segmentation allows the complex task of third-party software certification to be broken down into manageable, automated steps, reducing the perceived complexity for users while maintaining comprehensive security validation.
Solution Approach 2:
The patent introduces a certification engine as an intermediary component that acts as a bridge between third-party software and the medical device system. This intermediary automatically executes predefined test cases and generates certification results, mediating the complex interaction between external software and the regulated medical device environment without requiring direct user involvement in the complex testing process.
2Reliability
If manufacturer testing and certification of all third-party software is performed to ensure safety and compliance, then the reliability of the medical device is improved, but the loss of time and productivity decreases due to extensive testing requirements
Solution Approach 1:
The patent implements preliminary action by pre-defining a comprehensive set of test cases in the database that cover all necessary safety and compliance requirements. These test cases are prepared in advance based on regulatory standards and device-specific requirements. When third-party software needs certification, the pre-prepared test cases are automatically executed, eliminating the need to create and validate test protocols from scratch for each software integration, thus significantly reducing certification time while maintaining thoroughness.
Solution Approach 2:
The patent enables self-service certification by allowing the certification engine to autonomously execute test cases and generate certification results without requiring continuous manufacturer intervention. The system automatically compares test results against predefined criteria and issues certificates when requirements are met, enabling rapid certification of third-party software while maintaining reliability standards through automated validation.
3Measurement precision
If comprehensive test cases are executed by the certification engine to validate third-party software, then the measurement precision of software compatibility is improved, but the use of energy and computational resources increases
Solution Approach 1:
The patent applies partial action by selectively executing only the relevant subset of test cases from the comprehensive database based on the specific third-party software being certified and its intended functionality. Rather than running all possible test cases for every software integration, the system identifies and executes only the necessary tests, achieving sufficient measurement precision for compatibility verification while minimizing unnecessary computational resource consumption.
Data Source
AI summary
In the present invention, a system and method is provided for the self-certification of third party software products for use on medical products by the customer. The system enables the customer to test, qualify, and certify a third party software product for use on a controlled medical device independent of any testing or other intervention by the manufacturer. The system can be located on the particular medical device and provides internal testing and certification mechanisms to promote/authorize third party software products onto to the device/software authorization catalog, as well as notification to the manufacturer of the customer approved addition to the device certified third party software product catalog.