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.

2. Additive Manufacturing:
Industry Addresses Standards, Quality,
Evidence Building
Lauralyn McDaniel
SME
Dan Fritzinger
DePuy Synthes
Laura Gilmour
EOS of North America

3. • Professional society
• Dedicated to advancing technology and workforce development
• Inspire, prepare and support
• Attract future generations
www.sme.org
About SME
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4. • 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
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5. • 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
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6. • 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
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8. • 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
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9. PROJECT: Professional Outreach
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10. 6/23/2017 9

11. • 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
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12. • 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
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13. • 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
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14. • Searchable database of standards, specs,
regulations, and guides that are:
• Developed for AM
• Applicable to AM
• Relevant to AM
PROJECT: Standards Database
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15. • Search by:
• Process
• Material & form
• Topic
• Application
• Status
• More
www.sme.org/am3dp
PROJECT: Standards Database
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16. • 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
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17. • Design
• Process and Materials
• 4 subgroups: Precursor Materials, Process Control, Post-
Processing, Finished Material Properties
• Qualification & Certification
• Non-Destructive Evaluation
• Maintenance
PROJECT: Standards Roadmap
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18. • 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
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19. • 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
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20. • Can be used to build to curriculums, certifications, and more:
• Metals
• Medical applications
• Built on job descriptions
PROJECT: Competency Model
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21. • Combination of engineering and medicine
• Device manufacturers
• Point-of-care (clinical) manufacturers
• Researchers
PROJECT: Job Description Template
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22. • Degree programs
• Research
www.sme.org/am3dpuniversity
PROJECT: University Database
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23. • 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
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24. • High school student competition
• SME and Stratasys sponsor AM Competition
• Medical Workgroup developing medical
AM competition for 2018
PROJECT: SkillsUSA
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25. • Anatomical models and cutting guides
• Needs to become standard of care
CHALLENGE: Reimbursement
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26. • 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
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27. • Continue to identify challenges
• Gathering resources: www.sme.org/medical-additive
Moving Forward
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28. Thank you!
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