Medical Device Control Architecture with Switchable Network Isolation

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Solution Overview

Problem

Medical device controllers face security vulnerabilities when connected to networks, limiting data analysis capabilities and posing risks to patient safety due to potential unauthorized control of operating parameters.

Innovation Solution

A control architecture with a switchable data communication network isolates computing devices within a medical device from external networks during operation, using a processor to enable or disable communication based on device state and network connections, incorporating firewall and video conversion components for secure data transfer.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If the medical device controller is connected to external networks for data analysis and software updates, then data analysis capabilities and software update functionality are improved, but security vulnerabilities increase and patient safety is compromised

Engineering Contradiction:

Improvedata analysis capabilityVSAvoidpatient safety

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The controller is divided into two separate computing devices: a first computing device that controls the medical device and remains isolated from external networks, and a second computing device that handles network communications for data analysis and software updates. This segmentation allows the system to gain enhanced data analysis capabilities through network connectivity while the critical control functions remain protected from network-based security threats.

Inventive Principle:

Principle #1Segmentation

2Productivity

If a network connection is always enabled for data transfer, then data analysis and software update capabilities are improved, but security risks to patient safety increase

Engineering Contradiction:

Improvedata transfer efficiencyVSAvoidsecurity vulnerability

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The network connection capability is made dynamic rather than static. The second computing device can enable or disable network connectivity based on operational requirements. During critical medical procedures, the network connection can be disabled to eliminate security vulnerabilities, while during non-critical periods when data analysis or software updates are needed, the connection can be enabled to improve productivity and data transfer efficiency.

Inventive Principle:

Principle #15Dynamics

3Reliability

If the controller is isolated from external networks to ensure patient safety, then security vulnerabilities are reduced, but data analysis capabilities and software update functionality are limited

Engineering Contradiction:

Improvepatient safetyVSAvoidsoftware update capability

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The second computing device acts as an intermediary between the external network and the first computing device that controls the medical device. This intermediary handles all network communications, including software updates and data transfers, while the first computing device remains isolated from direct network exposure. This allows the system to maintain patient safety through network isolation while still enabling software updates and data analysis through the intermediary's controlled network access.

Inventive Principle:

Principle #24Intermediary (Mediator)

Data Source

PatentUS20250242147A1Control architecture for a medical device

Publication Date: 2025.07.31 ABIOMED INC

AI summary

Methods and apparatus for controlling a medical device are provided. A controller may include a first computing device configured to control the medical device, a second computing device configured to connect to at least one network device, and a processor configured to selectively enable or disable a switchable data communication network coupled between the first computing device and the second computing device.