3D Anatomical Model Certification for Diagnostic Use Selection
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Solution Overview
Problem
Creating and obtaining 3D anatomical models is a time-consuming and expensive process, especially for complex objects, and existing solutions lack flexibility to accommodate varying degrees of accuracy and precision required for different use cases.
Innovation Solution
A 3D print portal that interacts with existing image file viewing systems via APIs, allowing healthcare professionals to easily order and manage the printing of 3D anatomical models, with features for certification and use case differentiation between diagnostic and non-diagnostic purposes, enabling flexible printing options and improved workflow efficiency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If 3D anatomical models are created with high precision and accuracy for diagnostic purposes, then the quality and reliability of surgical planning improves, but the time and cost required for production increases significantly
Solution Approach 1:
The patent segments the certification process into two distinct pathways: diagnostic certification (requiring high precision and FDA clearance) and non-diagnostic certification (allowing faster production with reduced precision requirements). This segmentation enables users to select appropriate precision levels based on their specific needs, thereby reducing unnecessary time and cost for non-diagnostic applications while maintaining high precision for diagnostic purposes.
Solution Approach 2:
The patent applies partial action by implementing a non-diagnostic certification pathway that requires only essential quality controls without the full suite of diagnostic-level validations. This partial certification approach produces models sufficient for educational and planning purposes without the time-consuming and expensive complete diagnostic certification process, thus resolving the contradiction between precision and production time.
2Manufacturing precision
If 3D anatomical models are created with high precision and accuracy for diagnostic purposes, then the quality and reliability of surgical planning improves, but the cost of production increases significantly
Solution Approach 1:
The patent segments the certification process into two distinct pathways: diagnostic certification (requiring high precision and FDA clearance) and non-diagnostic certification (allowing faster production with reduced precision requirements). This segmentation enables users to select appropriate precision levels based on their specific needs, thereby reducing unnecessary time and cost for non-diagnostic applications while maintaining high precision for diagnostic purposes.
Solution Approach 2:
The patent changes the certification parameter from a single uniform standard to a dual-standard system (diagnostic vs. non-diagnostic). This parameter change allows the system to adjust precision and cost characteristics based on the intended use, enabling cost-effective production for non-diagnostic applications while preserving the ability to produce high-precision models when diagnostically required.
3Reliability
If a single certification standard is applied to all 3D anatomical models, then consistency and reliability are maintained, but flexibility to accommodate varying use case requirements is lost
Solution Approach 1:
The patent segments the certification system into two distinct certification types: diagnostic certification for high-precision surgical planning applications and non-diagnostic certification for educational and preliminary planning uses. This segmentation maintains reliability within each category while providing adaptability across different use cases, resolving the contradiction between consistency and flexibility.
Solution Approach 2:
The patent creates a universal certification framework that serves multiple functions through its dual-pathway design. The system can accommodate both diagnostic and non-diagnostic applications under a single integrated platform, allowing healthcare institutions to select the appropriate certification level based on their specific needs while maintaining overall system consistency and reliability.
4Reliability
If full diagnostic certification processes are applied to all 3D printing orders, then the accuracy and safety of medical applications is ensured, but resource efficiency and productivity are reduced
Solution Approach 1:
The patent segments the certification process into two distinct pathways: diagnostic certification (requiring high precision and FDA clearance) and non-diagnostic certification (allowing faster production with reduced precision requirements). This segmentation enables users to select appropriate precision levels based on their specific needs, thereby reducing unnecessary time and cost for non-diagnostic applications while maintaining high precision for diagnostic purposes.
Solution Approach 2:
The patent applies partial action by implementing a non-diagnostic certification pathway that requires only essential quality controls without the full suite of diagnostic-level validations. This partial certification approach produces models sufficient for educational and planning purposes without the time-consuming and expensive complete diagnostic certification process, thus resolving the contradiction between precision and production time.
Data Source
AI summary
Techniques for providing clearance, notification, and selection of use related to certification of 3D anatomical models for pre-surgical planning are provided. In one technique, a collection of sets of one or more files for generating a 3D anatomical model is stored. First input to print a 3D anatomical model based on a set of one or more files in the collection is received from a requester computer. In response to determining that the to-be-printed 3D anatomical model is not associated with a predetermined certification, a user interface is updated to indicate that the 3D anatomical model cannot be used for a diagnostic purpose. Second input that indicates that a user of the requester computer accepts using the 3D anatomical model for only non-diagnostic purposes is received. After receiving the second input, the 3D anatomical model is generated.