Medical Device Simulation Using Predictive Creep Modulus

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Solution Overview

Problem

Existing methods for testing medical devices like auto-injectors are costly and time-consuming, and existing simulation techniques do not adequately account for parameters such as creep, making it difficult to determine if a device meets quality or use criteria.

Innovation Solution

A method involving the use of creep modulus data to generate predictive modulus through 3D interpolation, allowing for accelerated testing by determining variables like temperature, time, and stress to simulate creep strain, and a linear device model to simulate device performance efficiently.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If multiple iterations of medical device design are tested physically to meet quality criteria, then device reliability is improved, but time and cost increase significantly

Engineering Contradiction:
Improvedevice reliabilityVSAvoidtesting time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent creates a digital twin (virtual model) of the medical device that replicates physical behavior including creep strain characteristics. This virtual copy allows unlimited testing iterations without physical manufacturing, resolving the contradiction by enabling comprehensive reliability validation while eliminating repeated physical testing time and cost.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent performs preliminary virtual testing and validation before physical prototyping. By using the digital twin to predict device behavior under various conditions including accelerated aging, designers can identify and correct issues virtually, reducing the need for multiple physical iteration cycles and significantly cutting development time.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If multiple iterations of medical device design are tested physically to meet quality criteria, then device reliability is improved, but cost increases significantly

Engineering Contradiction:
Improvedevice reliabilityVSAvoidtesting cost
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent replaces expensive physical testing with virtual testing using a digital twin model. Once the model is created, unlimited testing scenarios can be run at minimal computational cost, eliminating the need to repeatedly manufacture physical prototypes for each test iteration and dramatically reducing overall validation costs.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent uses parameter-based virtual modeling where device geometry, material properties, and loading conditions can be modified digitally without physical re-manufacturing. This allows comprehensive testing of design variations at minimal cost, maintaining reliability validation while eliminating the high costs associated with physical iterative manufacturing and testing.

Inventive Principle:
Principle #35Parameter changes

3Productivity

If accelerated testing is conducted to reduce validation time, then productivity is improved, but measurement precision of creep strain may deteriorate

Engineering Contradiction:
Improvevalidation speedVSAvoidcreep strain measurement
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The patent introduces a computational model as an intermediary between accelerated physical testing and long-term performance prediction. The model captures the relationship between accelerated test conditions and actual service conditions, allowing rapid validation while maintaining measurement precision through mathematical correction rather than direct physical measurement alone.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent uses parameter transformation to convert accelerated test results into predictions for normal service conditions. By modeling the relationship between temperature, time, and creep strain parameters, the system can run accelerated tests for quick validation while using parameter transformations to maintain accurate predictions of long-term device behavior.

Inventive Principle:
Principle #35Parameter changes

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Enables efficient simulation-based testing that reduces time and resources while ensuring medical devices meet quality criteria by accurately predicting creep strain and device performance.

Implementation Method 1

receiving raw creep modulus data relating creep strains to durations of stress and amounts of stress, as a factor of a range of temperatures

Methodology Applied
Scientific EffectCreep: Creep

Data Source

PatentUS12619799B2System and methods for simulation of medical devices
Publication Date: 2026.05.05 REGENERON PHARMACEUTICALS INC
  • US12619799B2 patent drawing
  • US12619799B2 patent drawing
  • US12619799B2 patent drawing

AI summary

Disclosed herein are devices and methods for generating and/or verifying a predictive temperature stress and time creep modulus, approving or rejecting a medical device, verifying a medical device design using a linear device model, and generating coefficients using thermal analysis.