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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 2016
20 May 2016
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
3
What can you print: Materials
6
Plastic
Ceramics
Biomaterials
Glass
Metal
Wood
Chocolate Cells
plastic and carbon composite
What can you print: Applications
7
Medical
Furniture, even a house!
Automotive
Fashion
Sports
Aerospace
Food
Wearables
Advantages of AM
8
•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.
Dentistry Implants
Medical devices and pharmaceutical
AM in Biomedical and Healthcare
Scaffold for tissue
engineering
Bioprinting
Biomodel
Medical
Devices
Implant
Cells, bacteria,
food, pharma,
bioelectronics
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,”
Commercial 3D Printed Products
Intervertebral body fusion device(Credit: Joimax)
3D printed polymer, spinal load-bearing device
(Credit: OPM)
http://tissuesys.com/technology
TRS Scaffold Technology
Surgical guide
Devices
Porous load
bearing implant
Solid load bearing implant
Porous
degradable
implant
HeartPrint Bio-models :
class 1 device
CE-certified
• classified in accordance
with the medical device
directive 93/42/EEC
Digital dentistry
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
https://www.aprecia.com/zipdose-platform/zipdose-technology.php
New Opportunities
• New design
• New materials
• New combination medical devices
• Emerging technologies – bioprinting, lab
on chip.
• Hybrid manufacturing – bioelectronics.
New Device Design :
Customized Lattice Metal Implants for
Enhanced Osteointegration
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, 461–470
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, ,
10.1007/s11340-015-0117-y
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: 10.1002/jor.23075.
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):2028-34
W.L Ng, S.Wang, W.Y.Yeong, M.W. Naing (2016) SKIN BIOPRINTING: IMPENDING REALITY OR
FANTASY, Trends in Biotechnology, Accepted
Emerging technologies: Bioprinting
Multi-material
bioprinting
Controlled cellular density
per droplet
Patterning
and printing
Emerging technologies: 3D Printed
Microfluidics Chip
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
• 3D printing provides design freedom in micro-to-macro fluidics
chip designs.
• Enable new capabilities in cells processing, and cell-
encapsulated droplets production.
Hybrid technologies: Bio-integrated
electronic and nanomaterial printing
Nanomaterials + printing + new biointerface
New sensors enabled by
Interlinked-Process
21
+ =
Materials Process Part
Considerations of critical steps in AM: • Feedstock material • Processability by the machine ( + any post
processing) • Part performance
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
2011
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 261
25
Standards: ASTM Committee F42
Standards under F42.01 Test Methods
Standards Description Stage
F2971-13 Standard Practice for Reporting Data for Test
Specimens Prepared by Additive Manufacturing
Published
F3122-14 Standard Guide for Evaluating Mechanical
Properties of Metal Materials Made via Additive
Manufacturing Processes
Published
ISO/ASTM5292
1-13
Standard Terminology for Additive
Manufacturing-Coordinate Systems and Test
Methodologies
Published
WK49798 New Guide for Intentionally Seeding Flaws in
Additively Manufactured (AM) Parts
Proposed new
standard
WK49229 New Guide for Orientation and Location
Dependence Mechanical Properties for Metal
Additive Manufacturing
Proposed new
standard
WK49272 New Test Methods for Characterization of
Powder Flow Properties for AM Applications
Proposed new
standard
26
Standards: ASTM Committee F42
Standards under F42.05 Materials and Processes
Standards Description Stage
F2924-14 Standard Specification for Additive
Manufacturing Titanium-6 Aluminum-4 Vanadium
with Powder Bed Fusion
Published
F3001-14 Standard Specification for Additive
Manufacturing Titanium-6 Aluminum-4 Vanadium
ELI (Extra Low Interstitial) with Powder Bed
Fusion
Published
F3049-14 Standard Guide for Characterizing Properties of
Metal Powders Used for Additive Manufacturing
Processes
Published
F3055-14a Standard Specification for Additive
Manufacturing Nickel Alloy (UNS N07718) with
Powder Bed Fusion
Published
F3056-14e1 Standard Specification for Additive
Manufacturing Nickel Alloy (UNS N06625) with
Powder Bed Fusion
Published
F3091/F3091M-
14
Standard Specification for Powder Bed Fusion of
Plastic Materials
Published
27
Standards: ASTM Committee F42
Standards Description Stage
WK51282 Additive Manufacturing, General Principles, Requirements
for Purchased AM Parts
Proposed new
standard
WK51329 New Specification for Additive Manufacturing Cobalt-28
Chromium-6 Molybdenum Alloy (UNS R30075) with
Powder Bed Fusion1
Proposed new
standard
WK37654 New Guide for Standard Guide for Directed Energy
Deposition of Metals
Proposed new
standard
WK46188 New Practice for Metal Powder Bed Fusion to Meet Rigid
Quality Requirements
Proposed new
standard
WK48732 New Specification for Additive Manufacturing Stainless
Steel Alloy (UNS S31603) with Powder Bed Fusion
Proposed new
standard
Standards under F42.05 Materials and Processes
Opportunities: A Need for AM
Measurement Sciences & Metrology
28
• Materials & management
• Process understanding
• Product measurement and quality
assurance
• Virtual prototyping and measurement –
digital nature of AM
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, 2013. 124(4): p. 301-304
Bayle, F. and M. Doubenskaia. Selective laser melting
process monitoring with high speed infra-red camera and
pyrometer. 2008
Berumen, S., et al., Quality control of laser- and powder
bed-based Additive Manufacturing (AM) technologies.
Physics Procedia, 2010. 5, Part B(0): p. 617-622
• 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
Metrology in Design Verification & Validation
Mechanical
testing ,
material
testing
FEA virtual
model
simulation
3D printing of a tracheobronchial splint
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. 115-120
AM in Medical Device Framework
Metrology plays an important role to support each consideration
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