Opportunities, Challenges and Applications of Advanced Manufacturing ( Additive manufacturing) and Medical Devices Technologies

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1 Opportunities, Challenges and Applications of Advanced Manufacturing ( Additive manufacturing) and Medical Devices Technologies presented by Yeong Wai Yee Assistant Professor School of Mechanical and Aerospace Engineering Programme Director Singapore Centre for 3D Printing World Metrology Day May 2016

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3 3 What is 3D Printing? Construct physical models directly from Computer-Aided Design (CAD) data. Other names: 3D printing, Additive Manufacturing, Rapid Prototyping, layered manufacturing, solid freeform fabrication

4 Different Technologies ASTM F2792

5 3D Printing machines 5

6 What can you print: Materials Wood Plastic Metal plastic and carbon composite Biomaterials Glass Cells Chocolate Ceramics 6

7 What can you print: Applications Medical Automotive Sports Wearables Aerospace Furniture, even a house! Fashion Food 7

8 Advantages of AM Prototypes are made faster and cheaper, variable in same batch. ( without tooling) Create objects with complicated internal features that cannot be manufactured by other means. Built-in porosity Design for specific function ( lightweight design) Produce personalized, customized part. Medical devices and pharmaceutical 8 Dentistry Implants

9 AM in Biomedical and Healthcare Biomodel Medical Devices Scaffold for tissue engineering Implant Bioprinting Cells, bacteria, food, pharma, bioelectronics

10 To-date More than 85 AM/3D printed devices approved largely been through the 510(k) pathway. Substantially equivalent in terms of safety and effectiveness to predicates devices cleared by the FDA. 3D printing/ additive manufacturing being viewed as another form of advanced manufacturing. Reed Smith white paper, titled 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles,

11 Commercial 3D Printed Products HeartPrint Bio-models : class 1 device Devices Porous load bearing implant Intervertebral body fusion device(credit: Joimax) Surgical guide Porous degradable implant Solid load bearing implant 3D printed polymer, spinal load-bearing device (Credit: OPM) TRS Scaffold Technology

12 CE-certified classified in accordance with the medical device directive 93/42/EEC Digital dentistry

13 3D Printed Drug- Spritam FDA Approves Spritam (levetiracetam) as the First 3D Printed Drug Product by Aprecia Pharmaceuticals to be available in the first quarter of 2016 pill can be made more porous than typical pills, rapidly disintegrate, Support dose loading up to 1,000 mg

14 New Opportunities New design New materials New combination medical devices Emerging technologies bioprinting, lab on chip. Hybrid manufacturing bioelectronics.

15 New Device Design : Customized Lattice Metal Implants for Enhanced Osteointegration Sing, S. L., An, J., Yeong, W. Y. and Wiria, F. E. (2015). Laser and electron-beam powder-bed additive manufacturing of metallic implants: A review on processes, materials and designs. Journal of Orthopaedic Research, Accepted, doi: /jor SL Sing, WY Yeong, FE Wiria. (2016). Selective laser melting of titanium alloy with 50 wt% tantalum: Microstructure and mechanical properties. Journal of Alloys and Compounds, 660, SL Sing, WY Yeong, FE Wiria, BY Tay. (2015). Characterization of Titanium Lattice Structures Fabricated by Selective Laser Melting using an Adapted Compressive Test Method. Experimental Mechanics,, /s y

16 New Materials :

17 New combination medical device: 3D Printed Biodegradable Scaffold for Tissue Engineering Yeong WY, et al: Porous polycaprolactone scaffold for cardiac tissue engineering fabricated by selective laser sintering. Acta Biomater; 2010 Jun;6(6):

18 Emerging technologies: Bioprinting Multi-material bioprinting Controlled cellular de per droplet Patterning and printing W.L Ng, S.Wang, W.Y.Yeong, M.W. Naing (2016) SKIN BIOPRINTING: IMPENDING REALITY OR FANTASY, Trends in Biotechnology, Accepted

19 Emerging technologies: 3D Printed Microfluidics Chip 3D printing provides design freedom in micro-to-macro fluidics chip designs. Enable new capabilities in cells processing, and cellencapsulated droplets production. Jia Min LEE, Meng ZHANG, Wai Yee YEONG. (2016). Characterization and evaluation of 3D printed microfluidic chip for cell processing. Microfluidics and Nanofluidics, 20(1), 1-15

20 Hybrid technologies: Bio-integrated electronic and nanomaterial printing New sensors enabled by Nanomaterials + printing + new biointerface

21 Interlinked-Process Materials Process Part + = Considerations of critical steps in AM: Feedstock material Processability by the machine ( + any post processing) Part performance 21

22 Challenges of AM in Medical Technologies The current regulatory philosophy A quality framework for AM process Standards and Measurement Sciences

23 Current AM Standards ASTM International Committee F42 on Additive Manufacturing Technologies, formed in 2009 and ISO Technical Committee 261 on Additive Manufacturing, formed in

24 Standards: ASTM Committee F42 Formed in 2009 Standards under the jurisdiction of F42 Subcommittees will address specific segments within AM covered by the F42 committee F42.01 Test methods F42.04 Design F42.05 Materials and processes F42.90 Executive F42.91 Terminology F42.94 Strategic planning F42.95 US TAG to ISO TC

25 Standards: ASTM Committee F42 Standards under F42.01 Test Methods Standards Description Stage F Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing F Standard Guide for Evaluating Mechanical Properties of Metal Materials Made via Additive Manufacturing Processes ISO/ASTM WK49798 WK49229 WK49272 Standard Terminology for Additive Manufacturing-Coordinate Systems and Test Methodologies New Guide for Intentionally Seeding Flaws in Additively Manufactured (AM) Parts New Guide for Orientation and Location Dependence Mechanical Properties for Metal Additive Manufacturing New Test Methods for Characterization of Powder Flow Properties for AM Applications Published Published Published Proposed new standard Proposed new standard Proposed new standard 25

26 Standards: ASTM Committee F42 Standards under F42.05 Materials and Processes Standards Description Stage F Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion Published F Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion F Standard Guide for Characterizing Properties of Metal Powders Used for Additive Manufacturing Processes F a F e1 F3091/F3091M Standard Specification for Additive Manufacturing Nickel Alloy (UNS N07718) with Powder Bed Fusion Standard Specification for Additive Manufacturing Nickel Alloy (UNS N06625) with Powder Bed Fusion Standard Specification for Powder Bed Fusion of Plastic Materials Published Published Published Published Published

27 Standards: ASTM Committee F42 Standards under F42.05 Materials and Processes Standards Description Stage WK51282 Additive Manufacturing, General Principles, Requirements for Purchased AM Parts Proposed new standard WK51329 WK37654 WK46188 WK48732 New Specification for Additive Manufacturing Cobalt-28 Chromium-6 Molybdenum Alloy (UNS R30075) with Powder Bed Fusion1 New Guide for Standard Guide for Directed Energy Deposition of Metals New Practice for Metal Powder Bed Fusion to Meet Rigid Quality Requirements New Specification for Additive Manufacturing Stainless Steel Alloy (UNS S31603) with Powder Bed Fusion Proposed new standard Proposed new standard Proposed new standard Proposed new standard 27

28 Opportunities: A Need for AM Measurement Sciences & Metrology Materials & management Process understanding Product measurement and quality assurance Virtual prototyping and measurement digital nature of AM 28

29 Measurement Sciences for Materials 29

30 Process Understanding and Control Xing, J., W. Sun, and R.S. Rana, 3D modeling and testing of transient temperature in selective laser sintering (SLS) process. Optik, (4): p Bayle, F. and M. Doubenskaia. Selective laser melting process monitoring with high speed infra-red camera and pyrometer Berumen, S., et al., Quality control of laser- and powder bed-based Additive Manufacturing (AM) technologies. Physics Procedia, , Part B(0): p Transient and dynamic temperature field Energy, mass and momentum transformation at the same time Highly resolved pictures at high scanning speed Reflectivity of metal powder Prediction and models are unique to combination of system, material, scanning strategy, part orientation etc Difficulty in developing a generalized model 30

31 Metrology in Design Verification & Validation FEA virtual model simulation 3D printing of a tracheobronchial splint Mechanical testing, material testing

32 AM in Medical Device Framework Metrology plays an important role to support each consideration Yeong, W.Y., Implementing Additive Manufacturing for medical devices: A quality perspective High Value Manufacturing: Advanced Research in Virtual and Rapid Prototyping - Proceedings of the 6th International Conference on Advanced Research and Rapid Prototyping, VR@P 2013pp

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34 Design verification Material Controls Process Validation Device Testing ( QA)

35 Summary Quality Management System is critical for implementation of AM in manufacturing of medical device. Metrology plays an important role to enable new opportunities in AM to produce scientific evidence to support and establish Quality Management System

36 Thank you