Monitoring Software for Secure Medical Device Programming

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Solution Overview

Problem

Electronic medical devices (EMDs) require secure and reliable programming, but dedicated programming devices are costly and limited in functionality, while off-the-shelf computers lack the necessary security and performance for safe operation.

Innovation Solution

A software platform on a general-purpose computer that invokes monitoring software to ensure the host computer meets criteria for safe operation, allowing it to function as a reliable programming device for EMDs, similar to dedicated devices, by monitoring processing bandwidth, data storage, compatibility, and security, and insulating against system faults.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a dedicated programming device is used to program an EMD, then security and reliability are improved, but device cost and functionality limitations worsen

Engineering Contradiction:
ImprovesecurityVSAvoidfunctionality
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent applies universality by enabling a general-purpose computer to perform multiple functions: it can be used for programming EMDs through the software platform, accessing electronic medical records, and other clinical applications. This eliminates the need for separate dedicated devices while maintaining security through the monitoring software layer.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Adaptability or versatility

If a general-purpose computer is used to program an EMD, then functionality and cost efficiency are improved, but security and reliability worsen

Engineering Contradiction:
ImprovefunctionalityVSAvoidsecurity
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The patent applies the intermediary principle by introducing a software platform with monitoring software as a mediator between the general-purpose computer and the EMD. This intermediary layer enforces security protocols, monitors system state, and ensures reliable operation while allowing the general-purpose computer to maintain its versatility.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If dedicated programming devices are used, then security is improved, but device cost worsens

Engineering Contradiction:
ImprovesecurityVSAvoiddevice cost
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The patent applies this principle by replacing expensive dedicated programming devices with a software-based solution running on existing general-purpose computers. The software platform acts as a virtual programming device that can be deployed across multiple computers, eliminating the need for expensive hardware purchases while maintaining security through software enforcement.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

4Reliability

If monitoring software is added to ensure safe operation, then security is improved, but software complexity worsens

Engineering Contradiction:
ImprovesecurityVSAvoidsoftware complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies segmentation by dividing the software system into distinct modular components: the operating system, the software platform, the programming application, and the monitoring software. Each component has a specific function and operates independently, which manages complexity while enabling comprehensive security monitoring through the dedicated monitoring layer.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentUS9471752B2Operating environment monitor for medical device programming
Publication Date: 2016.10.18 MEDTRONIC INC
  • US9471752B2 patent drawing
  • US9471752B2 patent drawing
  • US9471752B2 patent drawing

AI summary

A programming system for an electronic medical device (EMD) is described. The programming system, as described in this disclosure, comprises a host computer, such as a general purpose computer in an in-clinic computer network, executing a software platform that provides an operating environment with which a user can interact to program an EMD. The software platform invokes monitoring software that ensures that the host computer satisfies criteria for safe operation of the operating environment, e.g., ensures that the host computer meets the minimum operating conditions required for reliable operation of the operating environment. In particular, the monitoring software may monitor system faults that occur during operation, as well as ensure that criteria for safe operation are satisfied prior to initiating the operating environment.