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

Different Technologies ASTM F2792

3D Printing machines

5

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

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•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 Materials :

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

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+ =

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

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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

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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

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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

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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-

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Standard Specification for Powder Bed Fusion of

Plastic Materials

Published

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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

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• Materials & management

• Process understanding

• Product measurement and quality

assurance

• Virtual prototyping and measurement –

digital nature of AM

Measurement Sciences for Materials

29

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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

Material Controls

Process Validation

Device Testing ( QA)

Design verification

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

Thank you