www.grantadesign.

com
Materials Selection Methods and Information
Databases for Design of Optimised Medical
Devices
Dr Sarah Egan
Introduction to Granta
Company overview
Brief history
Rational Materials Selection
Principles of rational materials selection
Case study:
Advanced Information for Medical Device Design
Biological response to synthetic materials
Biomechanics of human tissues
Information databases in action
Outline
Company overview
Brief history
Introduction to Granta
The materials information technology experts

Selected customers

Aermacchi
Airbus
ASCO Industries
Baker Hughes
Baxter Healthcare
Boeing
Bombardier Aerospace
Bosch
Carrier
Centro Ricerche Fiat
Chengdu Aircraft
Cochlear
Constellium
Covidien
DePuy
Deutsches Zentrum fr Luft- & Raumfahrt
EADS Astrium
ESA
Eurocopter
GE - Aviation & GE - Energy
Honeywell Aerospace
Ishikawajima-Harima Heavy Industries
JLR
Lab 126 (Kindle)
LL Products
Lockheed Martin
MASCO
MBDA Group
MTU
NASA
Northrop Grumman
Novo Nordisk
Owens Corning
Parker Aerospace
Perkins Engines
Philips Technologie
Raytheon
Rheinmetall (KSPG Automotive)
Rhodia
Rolls-Royce
RUAG Space
Suzlon
Sulzer
Toshiba Corporation
The Timken Company
Thyssen Krupp Steels
TRW Automotive
Vestas
Whirlpool
The Granta team
The worlds largest concentration of materials
information technology expertise
110 engineers, scientists, developers, support staff
Locations & service partners in US, Europe, A/P
Providing software, data products, services
Consistent growth with profitability
Customers: many of the worlds leading
engineering enterprises

Grantakey facts
Cambridge team, July 2010
Granta for industry
Materials &
Processes
Materials
decision
support
Eco design &
environmental
regulations
Materials
information
management
Materials
support for
CAD, CAE
Grantas CES EduPack is used to support
teaching of materials & processes at 800
universities and colleges worldwide
Granta for education
The next generation of
engineers is familiar with
Granta and its technology
Materials Education Symposium, April 2011
Granta Designinnovating since 1994
1994: Granta Design is founded; key
UIPs:
Extensive materials data compilation
Materials property charts (Ashby
charts)
Performance index concept
1
st
Product: Cambridge Material
Selector
1995-7: Development and refinement of materials data compilation using first
implementations of Grantas unique data checking and estimation techniques
1998: 1
st
release of Cambridge Process Selector
1999: CES Selector launched 1
st
integrated material and process selector
2000: Strategic investment by ASM International, Granta now extends
expertise to management and publication of materials data
2001: Granta provides digital online version of MIL-HDBK 5
Granta Designinnovating since 1994
2002: Launch of MDMC by Granta, ASM, NASA.
New tools for plastics selection
2004: First release of GRANTA MI, later to become industry standard for
corporate materials information management
2005: New CES Edupak, building on materials data and selection tools with
content, tailored databases and resources for teaching
2006: Materials Strategy Consortium starts focus on cost optimisation
2007: New Materials for Medical Devices database
2008: Eurocopter hosts first meeting of new Environmental Materials
Information Technology (EMIT) consortium
2010: Granta opens new headquarters at Rustat House and expands team to
80 people
2011: First overseas offices (in US & Germany)
Collaboration with Autodesk to deliver a new eco design tool
New software for coatings and composite data management.
Granta Designinnovating since 1994
Principles of rational selection
Case Study: Medical Forceps
Rational Material Selection
Conventional approaches:
Use previous material, use a familiar material
Ask materials vendor
Ask colleague or consultant
Unstructured database/Web search

Rational Selection methodology:

Rational materials selection:
Exhaustive
Systematic
Auditable
Requirements:
Complete & comparable dataset for all materials
Use of Performance indices (e.g. cost per unit of stiffness)
Design Requirements

Optimal material for application All materials
5 obstacles to rational materials selection:

Lack of a rational, systematic method

Lack of relevant data

Non-comparable data

Holes in the data

Lack of information on material price
Why is it difficult?
Exhaustive
Systematic
Auditable
CES Selector
Material selection for a new product
Replacement of a material in an existing product
Evaluation of materials recommended by a vendor

Expert PC-based tool for material users and producers
that aids critical design & business decisions:
Key components
Rational Selection methodology
Data on materials & processes
Visualization & selection tools
Prediction & evaluation tools


Rational selection methodology - Ashby
All Materials
Breakdown design requirements into:
Function What does the component do?
Constraints What essential conditions must be met?
Objectives What is to be maximized or minimized?
Screen on constraints - Go / no-go criteria (usually many)
Rank on objectives - Ordering of materials that go
Supporting information Specialist databases, contact suppliers
Local conditions Preferred suppliers, process capability, location
Top Candidate Materials
Final Selection
Ranking - Performance Index Finder

Key component of Rational Selection methodology
Identifies & plots Performance index
Covers main standard load cases
(mechanical, thermal, electrical, vapour barrier)
Optimize: mass, volume, cost, eco footprint...
Trade-off multiple objectives
Mass per
unit of stiffness
Mass vs cost
trade-off
Example of resulting Ashby chart
L
o
w
e
r

C
o
s
t

Lower Permeability
Case study: Medical forceps handle
Function:
Handle of minimally-invasive electrosurgical forceps


Constraints:
Biocompatibility USP class VI or ISO 10993
Sterilizability (steam autoclave) Good or Excellent
Mechanical Stiffness & strength in bending
Mechanical toughness Impact Strength >7 kJ/m^2
Electrical Insulator
Dimensional stability Water absorption @ 24hr < 0.5%
Processing 3D complex shape; surface finish
Objectives:
Minimize cost
Minimize volume (component size)
Beam loaded in bending
Stiffness-limited design
Length, section shape specified
Section area free
Current material:
PEEK (unfilled)
Biological response to synthetic materials
Biomechanics of human tissues
Information databases in action
Advanced Information for
Medical Device Design
Information needs:
1. Properties of materials used to make devices
2. Properties of surrounding tissues:
Biological response
Mechanical properties
Materials in medical device design
Information needs:
1. Properties of materials used to make devices
2. Properties of surrounding tissues:
Biological response
Mechanical properties
Materials in medical device design
Medical Materials Database
Cardiovascular module
Orthopaedic module

In addition to mechanical/physical properties, information is
needed on:
Chemical and biological properties
Regulatory classifications
Compatibility of materials, surface treatments, coatings and drugs
Predicate devices
Historically, this information has been:
Complex and poorly structured
Sometimes of questionable quality
Widely dispersed (literature, books, suppliers, FDA, patents)
Time-consuming to find and compile
Information gap between engineers and medical personnel
Engineers often do not understand the biology and vice-versa
Medical materials information needs
An information resource & associated tools providing:
Engineering properties
AND biological response
AND coating and drug compatibility information
Application information
where materials are used in predicate devices
Covering materials used in:
Cardiovascular implantable devices, plus catheters
Orthopaedic implantable devices and trauma
Developed in conjunction with:
Guidance committee
Peer review panel
What is the Medical Materials database?
DEMONSTRATION
Information needs:
1. Properties of materials used to make device
2. Properties of surrounding tissues:
Biological response
Mechanical properties
Materials in medical device design
Human Biological Materials

Textbooks
Quickly find simple data
Limited detail concerning age, direction dependencies
Journal articles
Wide range of articles covering different tissues, testing methods,
dependencies etc.
Time consuming do exhaustive search
Difficult to analyse effects of different tissues, testing methods etc.
Animal tissue testing
Not human tissue
Costly
CT scan data
Dependent on empirical density/property relationships
Person specific
Typical data sources
Material properties of human tissues
Mechanical
Physical
Current coverage: Load bearing bones
Femur
Tibia
Vertebrae
Acetabulum
Age and direction dependence
Export directly to FEA packages
Human Biological Materials
DEMONSTRATION
1. GRANTA MI
Access from company internal servers
Combine with synthetic material databases AND
proprietary data COMPLETE RESOURCE

2. Online
As part of ASM Medical Materials database series
Availability