Patient-Specific Device Workflow With Interactive Model Feedback
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Solution Overview
Problem
The manufacturing of user-specific devices, such as medical devices, is challenging due to the need for unique characteristics that vary from patient to patient, making it difficult to implement a standardized mass manufacturing process while ensuring quality and regulatory compliance.
Innovation Solution
A system that integrates cloud-based servers and databases to facilitate secure data exchange and control the end-to-end design and manufacturing process, allowing for dynamic generation and manipulation of user-specific device designs, feedback incorporation, and resource allocation based on user-specific requirements, ensuring devices are tailored to individual anatomy and regulatory specifications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If mass manufacturing process is used, then productivity is improved, but adaptability deteriorates
Solution Approach 1:
The system performs preliminary actions by creating interactive digital models and obtaining user feedback before final manufacturing. This allows customization decisions to be made upfront, enabling efficient mass manufacturing of finalized designs while maintaining adaptability to individual user requirements.
Solution Approach 2:
The system uses interactive digital models as virtual copies of the final product, allowing users to review and provide feedback on the digital representation before physical manufacturing. This copying approach enables customization without requiring multiple physical prototypes, thus maintaining productivity while achieving adaptability.
2Ease of manufacture
If standardized design process is used, then ease of manufacture is improved, but adaptability deteriorates
Solution Approach 1:
The system implements a dynamic design process where the sequence of tasks can be modified based on user feedback. The workflow adapts iteratively through digital model revisions while maintaining an organized, standardized framework that ensures ease of manufacture for the final approved design.
Solution Approach 2:
The system incorporates feedback mechanisms where users can review interactive digital models and provide input on design characteristics. This feedback loop allows the standardized manufacturing process to adapt to specific user requirements while maintaining process efficiency through structured iterations.
3Adaptability or versatility
If individual design for each device is performed, then adaptability is improved, but productivity deteriorates
Solution Approach 1:
The system creates interactive digital models as virtual copies that can be reviewed, modified, and approved before physical manufacturing. This digital copying approach allows individual customization to be performed efficiently in the virtual domain, preventing productivity loss while achieving necessary adaptability.
Solution Approach 2:
The system replaces physical prototyping and manual design iterations with automated digital modeling and computer-based workflow management. This substitution of mechanical processes with digital systems enables individualized device design to be performed efficiently without compromising productivity.
4Manufacturing precision
If complex control mechanisms are implemented, then manufacturing precision is improved, but device complexity increases
Solution Approach 1:
The system implements a universal technology platform that handles multiple functions including digital model creation, feedback collection, sequence management, and manufacturing control within a single integrated framework. This multi-functionality reduces overall system complexity while maintaining manufacturing precision through centralized control.
Solution Approach 2:
The system uses interactive digital models as intermediaries between design specifications and physical manufacturing. This intermediary approach simplifies control mechanisms by providing a clear, manipulable representation that bridges the gap between complex manufacturing requirements and quality control objectives.
Data Source
AI summary
Described herein are systems and methods for controlling a design and manufacturing process of a user-specific device (e.g., a patient-specific medical device). A method involves receiving, from the requesting entity user-specific information related to a requested device. Based on the information, a list of devices matching user-specific information is determined and displayed for selection by the requesting entity. Based on the information and the selection, a sequence of tasks for design and manufacturing of the user-specific device is generated. Based on the received information and the tasks, a designing entity can generate an interactive digital model of the user-specific device. Based on the interactive model, feedback is received from the requesting entity. Based on the feedback, the interactive digital model and sequence of tasks may be updated. Depending on a location of the requesting entity, the sequence of tasks or devices can be configured to satisfy regulatory compliance.