Medical Device Control Module Multi-Regulatory Booting
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Solution Overview
Problem
Current medical device control systems require separate, costly equipment for each regulatory class, leading to unnecessary duplication and increased expenses due to strict regulatory requirements for Class III devices, which restrict hardware and software changes without FDA approval.
Innovation Solution
A medical device control module that selects between controlled and non-controlled binary images based on indicators, allowing operation within multiple regulatory classes, including FDA Class III and Class I/II, to reduce equipment duplication and streamline regulatory compliance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate equipment is purchased for each regulatory class to ensure compliance, then regulatory compliance is guaranteed, but equipment duplication and expenses increase
Solution Approach 1:
The control module is designed to perform multiple functions by supporting operation in both controlled and non-controlled modes, allowing a single device to serve multiple regulatory classes (FDA Class III and Class I/II) without requiring separate dedicated equipment for each class
Solution Approach 2:
The system dynamically switches between controlled and non-controlled binary images based on the operational context and regulatory requirements, allowing the control module to adapt its behavior and compliance level rather than being fixed in a single state
2Reliability
If strict regulatory control is implemented for Class III devices, then patient safety is ensured, but device flexibility and update capability are reduced
Solution Approach 1:
The control module can dynamically switch between controlled mode (for patient safety-critical operations) and non-controlled mode (for flexibility and updates), allowing the system to adapt its regulatory strictness based on the specific operational context
Solution Approach 2:
The binary image is segmented into controlled and non-controlled portions, allowing the system to apply strict regulatory control only where necessary for patient safety while permitting flexibility in other areas
3Adaptability or versatility
If multiple binary images are stored in the control module, then operation across regulatory classes is enabled, but memory requirements and system complexity increase
Solution Approach 1:
Instead of adding horizontal complexity through multiple separate control modules, the solution adds a vertical dimension by storing multiple binary images within the same control module memory space, allowing multi-class operation without increasing overall system complexity
Data Source
AI summary
Systems, devices, methods, and program products are provided for operating a medical system that is operable within at least two different medical device regulatory classes. A device control module receives an indicator for performing at least one procedure with a medical device. Based on the indicator, it selects a binary image for booting the control module from among multiple images including a controlled-type and a non-controlled type, which operate in different regulatory classes. A controlled-type image, which may be FDA PMA or other regulatory classes, is verified to be unaltered, and is then used to operate as a regulated medical device. The indicator can be automatic or manual. The indicator may result from connection of a specific medical device or peripheral device or may be user input.