Medical Device Software Updates Through a Firewall Gateway

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Solution Overview

Problem

Internet-connected medical devices face security risks during software updates and potential interference with patient care when updated while in operation, necessitating inefficient manual updates to avoid these issues.

Innovation Solution

A system comprising a medical device, a firewall device, and an Internet-connected device that isolates the medical device from networks, checks for updates, verifies data integrity, and performs secure software updates only when the device is not in patient use, using a bidirectional data transfer communication link.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual software updates are used to avoid security risks, then device security is improved, but update efficiency and user convenience deteriorate

Engineering Contradiction:
Improvedevice securityVSAvoidupdate efficiency
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The patent introduces a firewall device as an intermediary component between the medical device and the network. The firewall manually downloads and verifies software updates, then transfers them to the medical device through a secure channel. This intermediary approach allows automated update retrieval while maintaining security controls, resolving the contradiction between security and update efficiency.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system performs preliminary actions by having the firewall device download and verify software updates before they are installed on the medical device. The firewall checks for updates, validates their integrity, and prepares them for secure transfer. This preliminary verification process ensures security while enabling automated update distribution, improving both security and update efficiency.

Inventive Principle:
Principle #10Preliminary action

2Speed

If software updates are performed while the device is in operation, then update speed is improved, but patient safety and operational stability deteriorate

Engineering Contradiction:
Improveupdate speedVSAvoidpatient safety
Core Design Contradiction:
SpeedVSReliability

Solution Approach 1:

The patent implements dynamic control of the update process by monitoring the operational state of the medical device. The system determines whether the device is in a patient-use state and dynamically decides whether to allow updates. Updates are only permitted when the device is not actively serving patients, ensuring safety while enabling timely updates when conditions are safe.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system applies preliminary anti-action by preventing updates during critical operational periods when patients are being served. The firewall device checks the operational status before allowing updates, and blocks update attempts during patient-use states. This preventive measure ensures patient safety while allowing updates to proceed when the device is idle, maintaining both safety and update speed.

Inventive Principle:
Principle #9Preliminary anti-action

3Ease of operation

If the medical device is connected to the network for updates, then update accessibility is improved, but security vulnerabilities and interference risks worsen

Engineering Contradiction:
Improveupdate accessibilityVSAvoidsecurity vulnerabilities
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent segments the network connection by introducing a dedicated firewall device that acts as a separate security boundary. The medical device does not directly connect to the general network but instead communicates through the firewall, which segments the network traffic and provides controlled access. This segmentation maintains update accessibility while filtering out security vulnerabilities and interference risks.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The firewall device serves as an intermediary between the medical device and the network, providing a secure bridge. It handles all network communications, verifies update integrity, and transfers updates through encrypted channels. This intermediary approach maintains ease of operation for updates while blocking harmful factors such as security vulnerabilities and network interference.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentUS12511399B2Secure software update for internet-connected medical devices
Publication Date: 2025.12.30 ABIOMED INC
  • US12511399B2 patent drawing
  • US12511399B2 patent drawing
  • US12511399B2 patent drawing

AI summary

Methods and apparatus for securely updating software for a medical device are described. The method comprises receiving, by the medical device from a firewall device, an indication that a software update for the medical device is available, determining whether the medical device is in a patient use state, and sending a request to the firewall device to establish a bidirectional data transfer communication link between the medical device and an Internet-connected device when it is determined that the medical device is not in a patient use state.