Draft Guidance of 3D Printing Medical Devices issued by FDA on May 10, 2016
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Transcript of Draft Guidance of 3D Printing Medical Devices issued by FDA on May 10, 2016
Draft Guidance of 3D Printing Medical DevicesIssued by FDA on May 10, 2016
Christina Huang2016/05/18
Overview
To outline technical aspects of an AM device that should be considered through the phases of development, production process, process validation, and final device testing.
Scope: Design and manufacturing considerations Device testing considerations
BiologicalCellularTissue-based products
AM Classifications
Powder fusion Stereolithography Fused filament fabrication Liquid-based extrusion
Advantages: (1) using patient’s own medical imaging(2) ease in fabricating complex structures
Concerns:(1) relative lack of medical history experiences(2) challenges in characterization and assessment
Design and Manufacturing Process Considerations Standard-sized device
Compare the desired feature size to final device Document dimensional specifications and tolerances Check pixelation caused by mismatch
Design and Manufacturing Process Considerations Patient-matched device
Refer to “customized” devices not custom devices, which meet FD&C requirement: ≦5 pcs/yr of a type
Often made by altering features of the standardized Clearly identify design parameters and its range, and which of
these can be modified for patient-matching
Design and Manufacturing Process Considerations Patient-matched device
Effects of imaging (recommend): 1) note the range of deformation experience by the target location/tissue vs. reference image2) consider the potential time to produce since patient anatomy changes over time
Design and Manufacturing Process Considerations Patient-matched device
Interacting with design models (recommend): 1) design software identify the iteration of changes2) all medical devices and accessories is validated
Design and Manufacturing Process Considerations Software workflow
File format conversions:1) test all file conversion with simulated worse-case2) software changes may trigger revalidation3) final files for printing should be maintainedas AMF format in ISO/ASTM 52915 “Standard specification for additive manufacturing file format”
Design and Manufacturing Process Considerations Software workflow
Digital device design to physical device:1) build volume placement: distance between each component, orientation of each component, difference between machines affect final properties
Design and Manufacturing Process Considerations Software workflow
Digital device design to physical device:2) addition of (temporary) support material: location, type, number affect geometric accuracy and mechanical properties analyze geometry and other requirements
Design and Manufacturing Process Considerations
Design and Manufacturing Process Considerations Software workflow
Digital device design to physical device:3) slicing: layer thickness choice (depends on surface texture, bonding ability, powder sensibility)4) build paths: document building path space between each building path, path speed impact the quality of final device
Design and Manufacturing Process Considerations Software workflow
Digital device design to physical device:5) machine parameters and environmental conditions:
power of energy system and energy densitybuild/beam speed and pathfocal point or nozzle diameter, etc
use qualified machine with qualified installation
Design and Manufacturing Process Considerations Material control
Starting material: document material and chemical names, trade names, Chemical Abstracts Service (CAS) number, material supplier, and incoming material specifications
Material recycling (if applicable): describe the recycling process, and document evidence for coherent final device properties
Design and Manufacturing Process Considerations Nothing listed here depends on build methods
Design and Manufacturing Process Considerations Post-processing:
From cleaning to annealing for desired properties and Ra document all steps and include a discussion of the effects on the materials and device hard-to-reach spaces: effects assessment
Design and Manufacturing Process Considerations Process validation and acceptance activities:
Process validation: parameters, process steps, software document monitoring and control methods and dataEstablish criteria for determining successful final device
Revalidation: when changes in manufacturing process Acceptance activities: ASTM Committee F42 on AM tech. Test coupons: the worse-case for destructive tests
Design and Manufacturing Process Considerations Quality data:
Ensure the quality data (such as build volume location) can be analyzed enable proper identification of quality problems and investigation of the cause of nonconformities
Design and Manufacturing Process Considerations Device description Mechanical testing Dimensional measurements Material characterization Cleaning and sterilization Biocompatibility and Labeling
Device Testing Considerations
Device description: Dimensions, design variations, allowance, critical features, type of AM technology used (inc. a process flow chart)
Mechanical testing: Generally the same as that for a device manufactured by a traditional method+ consideration of build orientation and location
Device Testing Considerations
Dimensional measurements:Device dimensions may be affected by orientation and location of the build volume specify and measure
Material characterization: Material chemistry: e.g. chemical component Material physical properties: interlayer bonding, properties for
metal/ceramics, polymer, the absorbable
Device Testing Considerations
Cleaning and sterilization:Challenges posed by the complex geometries (consider in worse-case for destructive testing on final device)
Biocompatibility and Additional labeling ISO 10993 “Biological Evaluation of Medical Devices
Part 1: Evaluation and Testing” Labels of identification, and precaution is recommended
Comments?
FDA is open for comments and suggestions till August 8, 2016http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/3DPrintingofMedicalDevices/default.htm
THANKS