Data-Driven R&D Module Updates for In Vitro Diagnostic Reagents

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Solution Overview

Problem

Existing in vitro diagnostic reagent products face challenges in being developed for various diseases, requiring multiple testing equipment and hindering early-stage disease diagnosis in primary and secondary hospitals, leading to delayed medical examinations and treatments.

Innovation Solution

A research and development management device and method that enables standardized development and production of in vitro diagnostic reagent products using a unified research and development module, allowing external user accounts to use the same equipment and evolve their research and development processes through data-driven updates.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If multiple testing equipment are provided for different reagent products, then each external user account can test their dedicated reagent products, but the device complexity and cost increase significantly

Engineering Contradiction:
Improvecompatibility with different reagent productsVSAvoidnumber of testing equipment
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent implements a universal testing equipment platform that can accommodate multiple types of reagent products through standardized interfaces and modular configurations. The system uses a common testing equipment with adaptable software and hardware modules that can be configured to test different reagent products from various external user accounts, eliminating the need for dedicated equipment for each product type.

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

Solution Approach 2:

The system changes operational parameters and configuration settings of the testing equipment to accommodate different reagent products. By adjusting software parameters, testing protocols, and hardware configurations rather than requiring physical hardware changes, the system maintains versatility while controlling complexity.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If multiple dedicated testing equipment are required for different external user accounts, then each account can use optimized equipment, but it becomes difficult to perform tests in primary and secondary hospitals

Engineering Contradiction:
Improvetesting accuracyVSAvoidaccessibility in primary and secondary hospitals
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent creates a universal testing platform that can be deployed in various healthcare settings including primary and secondary hospitals. The system maintains testing reliability through standardized protocols and quality control mechanisms while being accessible in resource-limited environments by reducing equipment requirements to a single multi-functional platform.

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

Solution Approach 2:

The system uses software-based testing protocols and digital configurations that can be replicated across different locations. By copying standardized testing methods and procedures through software rather than requiring custom hardware for each location, the system ensures consistent testing quality across different hospital levels.

Inventive Principle:
Principle #26Copying

3Manufacturing precision

If each reagent product uses dedicated testing equipment, then product-specific optimization is achieved, but the productivity and efficiency of diagnostic testing decrease

Engineering Contradiction:
Improveproduct testing precisionVSAvoiddiagnostic testing efficiency
Core Design Contradiction:
Manufacturing precisionVSProductivity

Solution Approach 1:

The patent implements a universal testing equipment that maintains product-specific testing precision through modular software configurations and standardized testing protocols. The system can switch between different reagent product testing modes efficiently, combining the benefits of dedicated equipment optimization with the productivity advantages of shared resources.

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

Solution Approach 2:

The system dynamically adjusts its configuration and parameters based on the specific reagent product being tested. By changing software settings, testing protocols, and operational parameters in real-time rather than requiring static dedicated equipment, the system maintains precision while improving overall productivity through resource sharing.

Inventive Principle:
Principle #15Dynamics

Data Source

PatentEP4632760A1Method for updating research and development module of in vitro diagnostic reagent product and research and development management device
Publication Date: 2025.10.15 SEEGENE INC
  • EP4632760A1 patent drawingFigure 1
  • EP4632760A1 patent drawingFigure 2
  • EP4632760A1 patent drawingFigure 3

AI summary

A method and a device for updating a research and development module are provided. The method for updating a research and development module according to one embodiment may include the steps of: obtaining research and development data of an in vitro diagnostic reagent product generated by the research and development module used by an external user account and/or clinical data of the in vitro diagnostic reagent product; obtaining update candidate content for the research and development module determined on the basis of at least a portion of the obtained research and development data and the clinical data; obtaining a result generated by performing change impact assessment of the update candidate content on the research and development module; and controlling the research and development module to be updated in response to the result generated by performing the change impact assessment.