Medical Device Secure Element for Open Source Software Integrity

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Solution Overview

Problem

Connected medical devices face challenges in ensuring software integrity and security, particularly in managing updates and distributing responsibility among vendors, prescribers, and patients, due to the risks of security breaches and unintended behaviors associated with IoT connectivity.

Innovation Solution

A medical device with a processor, field-upgradable code storage, and a secure element that calculates code digests and verifies signatures using multiple public key certificates, allowing for secure updates managed by a combination of vendor, prescriber, and patient certificates, enabling distributed responsibility and tamper detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If open source software is used in medical devices, then peer review and community support are improved, but security and trust concerns worsen due to shifted responsibility

Engineering Contradiction:

Improvesoftware customizationVSAvoidsoftware integrity

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The patent segments the trust model by distributing signature verification responsibilities across multiple independent parties (vendor, prescriber, patient) rather than relying on a single entity. Each party can sign software updates independently, and the device verifies signatures from any authorized party, enabling open source customization while maintaining security through distributed verification.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent introduces a cryptographic signature verification mechanism as an intermediary between software updates and device execution. Before running updated software, the device verifies digital signatures from authorized parties, acting as a mediator that ensures software integrity even when sourced from community contributions rather than centralized vendor control.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If centralized vendor control is used for device updates, then security is improved, but flexibility and innovation are reduced

Engineering Contradiction:

Improvedevice securityVSAvoidsoftware modification

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent divides the update authorization authority into multiple independent signature sources (vendor, prescriber, patient) rather than requiring centralized vendor control. This segmentation allows any authorized party to initiate updates, enabling flexibility and community innovation while maintaining security through cryptographic verification of each signature.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Instead of requiring centralized approval before updates (traditional model), the patent inverts the approach by allowing updates from any authorized source and then verifying signatures decentralizedly. This reversal enables open source contributions and community-driven innovation while maintaining security through the verification mechanism.

Inventive Principle:

Principle #13The other way round (Inversion)

3Adaptability or versatility

If multiple signature verification is implemented, then distributed responsibility is achieved, but device complexity increases

Engineering Contradiction:

Improvetrust distributionVSAvoidverification system

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent replaces complex mechanical or procedural verification systems with cryptographic signature verification. Instead of multiple physical approvals or complex authorization workflows, the system uses digital signatures that can be automatically verified by the device, achieving distributed responsibility through a computationally simple process rather than organizational complexity.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

4Adaptability or versatility

If IoT connectivity is added to medical devices, then device functionality is improved, but security breach risks worsen

Engineering Contradiction:

Improvedevice connectivityVSAvoidsecurity breach risk

Core Design Contradiction:

Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The patent implements preliminary action by requiring cryptographic signature verification before executing any software updates received through IoT connectivity. This pre-verification step ensures that even if connectivity introduces security risks, unauthorized or malicious updates cannot execute, as they would fail signature verification before being installed or run on the device.

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS11601415B2Apparatus and method for a managed open source medical device

Publication Date: 2023.03.07 GROPPER ADRIAN

AI summary

This document discusses designing and managing medical devices that are equipped with software, including a variety of ways of managing the public interest in safety and effectiveness of medical devices that are preferably implemented with open-source software. In one general aspect, a method of updating a medical device is disclosed. The method includes storing a vendor certificate in the device, and receiving and storing a licensed prescriber certificate in the device. A signed request to update code in the medical device can then be received and this request can be authenticated with one of the certificates, and the code can be updated in the medical device with code from the authenticated update request.