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


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FDA published guidance on additive manufacturing technical considerations in late 2017, outlining the Agency’s long-awaited position on use of the technology for medical devices. At the time, FDA said that the 31-page document was considered “leapfrog” guidance, a term reserved for the Agency’s anticipation that its initial thoughts on an emerging technology will change over time. In short, more questions and answers have arisen — and will continue to do so as the technology is adopted. This FDA guidance is critical to the additive manufacturing narrative. However, standards and best practices surrounding the technology are being discussed globally on a daily basis. This discussion puts representatives from ASTM, FDA, SME and DePuy Synthes in one room, for one conversation, that will provide attendees with practical, actual guidance not only for current times, but also for what is on the horizon.

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

  1. 1. PANEL DISCUSSION Developing a Roadmap for Regulatory Guidance and Standards Moderated by Lauralyn McDaniel SME
  2. 2. 2 Carl Dekker President Met-L-Flo • ASTMF42 • SME Medical AM3DP Workgroup
  3. 3. 3 Dan Fritzinger Manager, Global Instrument Innovation DePuy Synthes • AMSC Medical Co-chair • SME Medical AM3DP Workgroup
  4. 4. 4 David Hwang Biomedical Engineer CDRH, Office of Device Evaluation Division of Orthopedics US Food & Drug Administration
  5. 5. Let’s get to know a little about you… 5
  6. 6. • Standards • 2009: ASTM F42 • 2016: Launch of AMSC • Regulations—FDA • 2014: Public Workshop • 2016: Draft Guidance • 2017: Technical Guidance A little history… 6
  7. 7. 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 •
  8. 8. AMSC Roadmap • Identified 89 gaps across all applications and industries • Priority • Related standards • In development work • Potential SDOs • Gap summary table
  9. 9.  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
  10. 10.  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
  11. 11. 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
  12. 12. 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
  13. 13. 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
  14. 14. More to come…  AMSC Development Roadmap 2.0: June 2018
  15. 15. Finding Standards & Work Items
  16. 16. Questions 16