Additive Manufacturing: Industry Addresses Standards, Quality,

Evidence Building Lauralyn McDaniel

SME Dan Fritzinger

DePuy Synthes Laura Gilmour

EOS of North America

• 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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• 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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• 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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• 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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• 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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PROJECT: Professional Outreach

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• 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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• 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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• 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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• 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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• Search by: • Process • Material & form • Topic • Application • Status • More

www.sme.org/am3dp

PROJECT: Standards Database

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• 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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• 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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• 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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• 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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• Can be used to build to curriculums, certifications, and more: • Metals • Medical applications

• Built on job descriptions

PROJECT: Competency Model

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• Combination of engineering and medicine • Device manufacturers • Point-of-care (clinical) manufacturers • Researchers

PROJECT: Job Description Template

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• Degree programs • Research

www.sme.org/am3dpuniversity

PROJECT: University Database

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• 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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• High school student competition • SME and Stratasys sponsor AM Competition • Medical Workgroup developing medical

AM competition for 2018

PROJECT: SkillsUSA

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• Anatomical models and cutting guides • Needs to become standard of care

CHALLENGE: Reimbursement

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• 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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• Continue to identify challenges • Gathering resources: www.sme.org/medical-additive

Moving Forward

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Thank you!

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