Additive Manufacturing Discussion Panel – Developing a Roadmap for Regulatory Guidance and Standards - OMTEC 2018

PANEL DISCUSSION
Developing a Roadmap for Regulatory
Guidance and Standards
Moderated by
Lauralyn McDaniel
SME

www.sme.org/am3dp 2
Carl Dekker
President
Met-L-Flo
• ASTMF42
• SME Medical AM3DP Workgroup

www.sme.org/am3dp 3
Dan Fritzinger
Manager, Global Instrument Innovation
DePuy Synthes
• AMSC Medical Co-chair
• SME Medical AM3DP Workgroup

www.sme.org/am3dp 4
David Hwang
Biomedical Engineer
CDRH, Office of Device Evaluation
Division of Orthopedics
US Food & Drug Administration

www.sme.org/am3dp
Let’s get to know a little about you…
5

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• Standards
• 2009: ASTM F42
• 2016: Launch of AMSC
• Regulations—FDA
• 2014: Public Workshop
• 2016: Draft Guidance
• 2017: Technical Guidance
A little history…
6

www.sme.org/am3dp
Additive Manufacturing Standardization
Collaborative (AMSC)
• America Makes and ANSI
• Coordinate and accelerate the
development of standards
• Roadmap Version1.0—February 28, 2017
• Several SDOs are involved (ASTM, ASME, SAE,
AWS, MITA, AAMI, etc.)
• More than 200 volunteers
• www.ansi.org/amsc

www.sme.org/am3dp
AMSC Roadmap
• Identified 89 gaps across all applications and industries
• Priority
• Related standards
• In development work
• Potential SDOs
• Gap summary table

www.sme.org/am3dp
 D4: Application-Specific Design Guidelines
 D14: Designing to be Cleaned
 D18: New Dimensioning and Tolerancing
Requirements
 PM5: Feedstock Sampling
 PC2: Machine Calibration and Preventive
Maintenance
 PC7: Recycle & Re-use of Materials
 PC9: Environmental Conditions: Effects on Materials
 PC14: Environmental Health and Safety: Protection
of Machine Operators
High Priority Gaps – Version 1.0

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 FMP3: Cleanliness of Medical AM Parts
 QC1: Harmonization of AM Q&C Terminology
 QC2: Qualification Standards by Part Categories
 QC9: Personnel Training for Image Data Set Processing
 QC10: Verification of 3D Model
 NDE1: Terminology for the Identification of AM Flaws
Detectable by NDE Methods
 NDE3: Standard Guide for the Application of NDE to
Objects Produced by AM Processes
High Priority Gaps – Version 1.0

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Additional Gaps Specific to Medical
 Gap D12: Imaging Consistency
 Gap D13: Image Processing and 2D to 3D Conversion
 Gap QC6: Importing Ultrasound Data
 Gap QC7: Protocols for Image Accuracy
 Gap QC8: Phantoms
 Gap QC14: Segmentation
 Gap QC15: Sterilization of Anatomical Models

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Published Standards—
Some of the published most relevant to orthopedic implants
 ISO / ASTM52921: Terminology for Additive Manufacturing
 ISO / ASTM52910 – 17: Design for AM
 ASTM F3001: Powder bed fusion of Ti-6Al-4V ELI
 ASTM F3049: Characterizing properties of metal powders
 F3122-14: Evaluating mechanical properties
or metal materials
 ASTM F3184-16: Powder bed fusion of UNS S31603
 ASTM F3213: Powder bed fusion of Co-Cr-Mo
 DICOM Supplement 205-Encapsulation of STL

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In Development
 DICOM Update—Encapsulation of additional formats
 ASTM WK60265: Removal of Additive Manufacturing Residues in
Medical Devices Fabricated by Powder-bed Fusion
 ISO/ASTM NP 52916: Optimized medical image data

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More to come…
 AMSC Development Roadmap 2.0: June 2018

www.sme.org/am3dp
Finding Standards & Work Items
www.sme.org/am3dp

www.sme.org/am3dp
Questions
16

Additive Manufacturing Discussion Panel – Developing a Roadmap for Regulatory Guidance and Standards - OMTEC 2018

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