Medical Device Usage Data Encryption Key Elimination

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Solution Overview

Problem

Medical devices face challenges in protecting usage data integrity from tampering, as existing solutions require expensive hardware-based write-once memory protection devices that are limited in application.

Innovation Solution

A medical device with a memory component that uses a data structure with encryption keys, where usage data is encrypted and the encryption key is eliminated after use, providing a cost-effective and versatile write-once capability without the need for special hardware.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If hardware-based write-once memory protection devices are used, then usage data integrity is protected, but device cost increases and application versatility is limited

Engineering Contradiction:

Improveusage data integrityVSAvoidhardware protection requirements

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent replaces hardware-based write-once memory protection with a software-based cryptographic system. Instead of using specialized hardware memory devices, the invention uses encryption/decryption keys stored in standard memory to protect usage data. The control unit encrypts usage data with a key before writing to memory, and eliminates the key afterward, achieving write-once protection through cryptographic means rather than mechanical hardware restrictions.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Ease of operation

If encryption keys are stored permanently in memory, then data can be decrypted and accessed, but unauthorized modification and tampering become possible

Engineering Contradiction:

Improvedata accessibilityVSAvoiddata authenticity

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent applies preliminary action by eliminating the encryption key from memory immediately after the usage data is encrypted and written. The control unit reads the key, uses it to encrypt the usage data, writes the encrypted data to memory, and then eliminates the key so it is no longer present in the medical device. This preliminary elimination of the key prevents any future unauthorized modification while maintaining data accessibility during the encryption process.

Inventive Principle:

Principle #10Preliminary action

3Ease of manufacture

If standard unprotected memory hardware is used, then device cost is reduced and application versatility is improved, but write-once protection capability is lost

Engineering Contradiction:

Improvememory component costVSAvoidwrite-once protection

Core Design Contradiction:

Ease of manufactureVSReliability

Solution Approach 1:

The patent introduces an intermediary cryptographic mechanism between the control unit and the standard memory hardware. The encryption key acts as an intermediary that enables the control unit to encrypt usage data before writing to the memory component. This intermediary cryptographic layer provides write-once protection using standard, unprotected memory hardware, eliminating the need for specialized hardware while maintaining security.

Inventive Principle:

Principle #24Intermediary (Mediator)

Data Source

PatentUS10089439B2Medical device with cryptosystem and method of implementing the same

Publication Date: 2018.10.02 STRYKER SUSTAINABILITY SOLUTIONS

AI summary

A medical device and a method of implementing a cryptosystem on the medical device include storing a data structure on a memory component of the medical device. An encryption key is stored in the data structure. Usage data related to usage of the medical device is provided. The encryption key is read from the data structure. The usage data is encrypted with the read encryption key. The encryption key is eliminated such that the encryption key is no longer present in the medical device.