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Additive Manufacturing: Industry Addresses Standards, Quality, Evidence Building - OMTEC 2017

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The SME Medical Additive Manufacturing/3D Printing Workgroup collaborates to identify challenges, develop resources and facilitate changes to support anyone using the technologies for medical/biomedical applications. Ms. McDaniel shares the group's progress and the headwinds that remain with non-technology barriers to adoption.

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Additive Manufacturing: Industry Addresses Standards, Quality, Evidence Building - OMTEC 2017

  1. 1. Additive Manufacturing: Industry Addresses Standards, Quality, Evidence Building Lauralyn McDaniel SME Dan Fritzinger DePuy Synthes Laura Gilmour EOS of North America
  2. 2. • Professional society • Dedicated to advancing technology and workforce development • Inspire, prepare and support • Attract future generations www.sme.org About SME 6/23/2017 2
  3. 3. • 1990: First conference • 1993: Rapid Prototyping Association (RPA) • 2003: RPA became Rapid Technologies and Additive Manufacturing (RTAM) community • 2003: Medical Tech Group joins RTAM • 2003: First Additive Manufacturing Certification program • 2003: Medical applications fill half- day session • 2008: Medical applications fill full- day session • 2014: SME Medical AM/3DP Workgroup • 2015: Medical Manufacturing Innovations (MMI) at RAPID becomes 2.5 day program SUPPORTING AM/3DP 6/23/2017 3
  4. 4. • Researchers, clinicians, device manufacturers, technology developers, technology users • Identify challenges • Identify resources • Develop tools • Make resources available www.sme.org/medical-am3dp-workgroup Medical AM/3DP Workgroup 6/23/2017 4
  5. 5. • 3D Systems • DePuy Synthes • Direct Dimensions • EOS • FDA • Johnson & Johnson • Materialise • Mayo Clinic • Medivators • Met-L-Flo • Monash University • New York University School of Medicine • Nicklaus Children's Hospital • NIH • North Carolina State University • Northwestern University • nScrypt • NYU Langone • Orthopaedic Innovation Centre • Orthopaedic Research Laboratories • Penn State University • Phoenix Children's Hospital • Rush University Medical Center • Smith & Nephew • Stryker Orthopaedics • UNC/NCSU Joint Department of Biomedical Engineering • University of Michigan Hospitals • University of Toronto • Wake Forest Institute for Regenerative Medicine • Walter Reed National Military Medical Center • Zimmer Biomet Medical AM/3DP Workgroup 6/23/2017 5
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  7. 7. • Wake Forrest University • University of Michigan • Facilitating discussions and working together • Very different types of manufacturers • Traditional device manufacturers • Clinical organizations and others CHALLENGE: Combining Engineering & Biology 6/23/2017 7
  8. 8. PROJECT: Professional Outreach 6/23/2017 8
  9. 9. 6/23/2017 9
  10. 10. • Need for meta data, patient information • Patient confidentiality, HIPAA • DICOM (Digital Imaging and Communications in Medicine); ISO 12052 -- medical images and related information CHALLENGE: File Format 6/23/2017 10
  11. 11. • Needs analysis • Proposal to DICOM Steering Committee • Unanimously approved December 1, 2016 • APPROACH: Encapsulation of G-code and other “objects” within DICOM file PROJECT: DICOM WG-17 6/23/2017 11
  12. 12. • None specific to medical applications of AM • Awareness of existing AM standards • Understanding existing medical device standards can be used for AM CHALLENGE: Additive Manufacturing Standards 6/23/2017 12
  13. 13. • Searchable database of standards, specs, regulations, and guides that are: • Developed for AM • Applicable to AM • Relevant to AM PROJECT: Standards Database 6/23/2017 13
  14. 14. • Search by: • Process • Material & form • Topic • Application • Status • More www.sme.org/am3dp PROJECT: Standards Database 6/23/2017 14
  15. 15. • America Makes and ANSI • Coordinate and accelerate the development of standards • Roadmap published February 28 • Several SDOs are involved (ASTM, ASME, SAE, AWS, MITA, AAMI, etc.) • More than 200 volunteers www.ansi.org/amsc PROJECT: Standards Roadmap 6/23/2017 15
  16. 16. • Design • Process and Materials • 4 subgroups: Precursor Materials, Process Control, Post- Processing, Finished Material Properties • Qualification & Certification • Non-Destructive Evaluation • Maintenance PROJECT: Standards Roadmap 6/23/2017 16
  17. 17. • Nearly 200 pages • Identified 89 gaps across all applications and industries • Priority • Related standards • In development work • Potential SDOs • 17 gaps specific to medical applications PROJECT: Standards Roadmap 6/23/2017 17
  18. 18. • Understand the entire process • Which technologies and materials are best for each application • Patient-matched devices: medical imaging segmentation • and processing • Interest and knowledge for the next generation CHALLENGE: Qualified Workforce 6/23/2017 18
  19. 19. • Can be used to build to curriculums, certifications, and more: • Metals • Medical applications • Built on job descriptions PROJECT: Competency Model 6/23/2017 19
  20. 20. • Combination of engineering and medicine • Device manufacturers • Point-of-care (clinical) manufacturers • Researchers PROJECT: Job Description Template 6/23/2017 20
  21. 21. • Degree programs • Research www.sme.org/am3dpuniversity PROJECT: University Database 6/23/2017 21
  22. 22. • Apprenticeship Acceleration Framework • Developed by ToolingU/SME with funding from Robert C. Byrd Institute and DOL • Combines on-the-job training with instruction • Competency-based approach http://www.toolingu.com/training/apprenticeship PROJECT: AM Apprenticeships 6/23/2017 22
  23. 23. • High school student competition • SME and Stratasys sponsor AM Competition • Medical Workgroup developing medical AM competition for 2018 PROJECT: SkillsUSA 6/23/2017 23
  24. 24. • Anatomical models and cutting guides • Needs to become standard of care CHALLENGE: Reimbursement 6/23/2017 24
  25. 25. • May 2016 program • Identified key comparators for common study reporting • Need for appropriateness guidelines • RSNA 3D Printing SIG: Anatomical Models • AAOS: Cutting guides • Technical information, studies database www.sme.org/am3dptech PROJECT: Building Evidence 6/23/2017 25
  26. 26. • Continue to identify challenges • Gathering resources: www.sme.org/medical-additive Moving Forward 6/23/2017 26
  27. 27. Thank you! 6/23/2017 27

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