3D Printing Workflow Tracking for Medical Device Compliance
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Solution Overview
Problem
Current three-dimensional printing processes face challenges in managing and tracking the development of medical devices at point-of-care manufacturing operations under good manufacturing practices and HIPAA compliance, with teams struggling to understand and visualize the design and manufacturing phases effectively.
Innovation Solution
A workflow management tool is developed to provide additive manufacturing operations with the capability to produce medical devices at the point of care, featuring a request scheme with parameters like Model Purpose, Imaging Type, and Model Definition for end-to-end traceability, and a user interface that visualizes job phases and stages, allowing teams to track and manage jobs efficiently.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional three-dimensional printing processes are used, then manufacturing flexibility is maintained, but traceability and compliance tracking become difficult
Solution Approach 1:
The patent introduces a workflow management tool as an intermediary system between the three-dimensional printing process and compliance requirements. This tool acts as a mediator that automatically tracks and records manufacturing steps, material usage, and device information, thereby achieving reliable compliance tracking without directly complicating the core printing process.
Solution Approach 2:
The workflow management tool implements feedback mechanisms by continuously monitoring and recording various parameters throughout the printing process. It provides real-time tracking of job phases, stages, and compliance metrics, enabling automatic verification and reporting without requiring manual intervention at each step.
2Reliability
If detailed tracking of all printing phases is implemented, then compliance and traceability improve, but ease of operation decreases
Solution Approach 1:
The workflow management tool is designed to automatically perform tracking and recording functions without requiring manual data entry or intervention. The system self-services by automatically capturing job information, tracking phases and stages, and maintaining compliance records, thereby achieving detailed traceability while maintaining ease of operation.
Solution Approach 2:
The patent replaces manual tracking methods with an automated computer-based workflow management system. This substitution eliminates the need for manual recording and monitoring of printing phases, automatically generating comprehensive traceability data without increasing operational complexity for users.
3Productivity
If manual tracking of printing jobs is used, then system complexity remains low, but productivity and resource allocation efficiency decrease
Solution Approach 1:
The workflow management tool performs preliminary actions by pre-configuring tracking parameters, job templates, and compliance requirements before the printing process begins. This preparation enables automatic tracking and efficient resource allocation throughout the manufacturing process, improving productivity without requiring complex manual interventions during operation.
Data Source
AI summary
A computer-based workflow management method is provided for use in connection with a process for printing an object with a three-dimensional printer. The method includes executing a request queue phase comprising receiving instructions for defining a request for printing the object; executing an anatomic modeling phase comprising generating an anatomic three-dimensional model representing the object; and executing a build phase comprising printing an object in response to the generated anatomic model. The method includes generating and displaying various user interface screens programmed for visualizing different aspects of phases or stages of the three-dimensional printing process.