Unique Device Identification Platform for Medical Supply Chain Tracking

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Solution Overview

Problem

Medical device manufacturers face challenges in ensuring patient safety and product compliance due to counterfeiting and device tracking issues, particularly with the upcoming Unique Device Identification (UDI) compliance timelines set by regulatory organizations like the FDA and EC.

Innovation Solution

A system and method for generating a unique device identifier (UDI) based on article number, serial number, manufacturing batch number, and shelf-life expiry date, which tracks devices in their supply chain and provides real-time production, component, and supply chain attributes, using a processor and a Unique Device Identification platform, capable of generating UDIs in real-time or serially, and printing them on labels in formats like barcodes or Braille.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If real-time UDI generation and tracking is implemented, then device traceability and patient safety are improved, but system complexity and implementation cost increase

Engineering Contradiction:

Improvedevice traceabilityVSAvoidsystem complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The UDI system is segmented into distinct components: device identifier generation module, supply chain tracking module, and data retrieval module. Each component handles specific tasks independently, reducing overall system complexity while maintaining comprehensive traceability functionality.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A centralized UDI database acts as an intermediary between device manufacturers, supply chain participants, and regulatory bodies. This mediator stores and manages UDI data, simplifying interactions and reducing the complexity of direct peer-to-peer tracking systems.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If comprehensive device tracking through supply chain is implemented, then counterfeiting risks are reduced, but data management complexity increases

Engineering Contradiction:

Improvecounterfeiting risksVSAvoiddata management complexity

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The UDI system is designed to serve multiple functions: identification, tracking, authentication, and recall management. This universal approach reduces the need for separate systems for each function, simplifying data management while comprehensively addressing counterfeiting risks.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The system incorporates feedback mechanisms where UDI data is continuously verified and updated throughout the supply chain. This feedback loop ensures data integrity and enables real-time detection of counterfeit devices, reducing risks while maintaining manageable data complexity through automated verification.

Inventive Principle:

Principle #23Feedback

3Productivity

If real-time UDI generation is implemented, then product recall effectiveness is improved, but processing time requirements increase

Engineering Contradiction:

Improveproduct recall effectivenessVSAvoidprocessing time

Core Design Contradiction:

ProductivityVSLoss of time

Solution Approach 1:

UDI identifiers are generated and registered in advance during device manufacturing and before products enter the supply chain. This preliminary action ensures that all necessary identification data is already in place, enabling immediate and effective product recalls without time-consuming processing during emergency situations.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The system replaces manual tracking and recall processes with automated electronic UDI tracking. Digital data processing and electronic database queries substitute for physical inventory checks and manual record-keeping, significantly reducing processing time while improving recall effectiveness.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentUS12197978B2Unique device identification for devices

Publication Date: 2025.01.14 ACCENTURE GLOBAL SOLUTIONS LTD

AI summary

Systems and methods for unique device identification for devices are disclosed. An example system comprises a processor causing a Unique Device Identification Platform (UDIP) to generate, in real-time, for a first device, a unique device identifier (UDI), based on at least one of an article number associated with a category of devices that first device forms part of, serial number of first device, manufacturing batch number of first device, and a shelf-life expiry date. The processor may cause the UDIP to track, based on the generated UDI, a first device in its respective supply chain to trace a current location of first device. Further, the processor may cause the UDIP to render, in response to a request message from a user at a first-time instance, based on a trace of first device using UDI at the time instance, an output indicative of production attributes, component attributes, and supply chain attributes of the first device.