Transforming Medical Device Development Using Simulation

TRANSFORMING MEDICAL DEVICE PRODUCT
DEVELOPMENT – VIAS EXPERIENCE
September 2017
1400 Broadfield Blvd. Suite 325, Houston TX 77084
Phone : +1 (832) 301-0881
www.viascorp.com
1
Arindam Chakraborty, Ph.D., P.E.
VP- Advanced Engineering, VIAS

Outline
© 2017 Virtual Integrated Analytics Solutions Inc. 2
• VIAS Overview
• Realistic Simulation with SIMULIA
▪ What is Realistic Simulation
▪ What can Simulation Convey?
▪ Simulation vs Physical Testing
▪ SIMULIA Capabilities for Life Sciences
• Medical Device Development with Simulation
▪ Abaqus Knee Simulator (AKS)
• Case Studies
▪ Knee Implant Simulation using AKS
▪ Simulation of Joint Forces due to Exoskeleton Structure
▪ Simulation of Device Collapse under Pressure
▪ Heart Valve- Weld Parameter Optimization
• Conclusion

VIAS Overview
Engineering
Consultancy
Training
Automation &
Customization
Software
© 2017 Virtual Integrated Analytics Solutions Inc.
• Multiple Industry Experience
• Presence in Houston, Chicago, Cincinnati, San
Francisco, Detroit
• Team consists of Ph.D. and Masters in Solid Mechanics,
Fluid Mechanics, Materials and Corrosion, Numerical
Analysis, Statistics; Optimization and Reliability
• Solution partner of Dassault Systèmes SIMULIA products
– Abaqus, Isight, fe-safe, Tosca
• Provides Virtual Design Experience through Collaboration
and Data Analytics – Provides Automation and
Customization
• Provide 3D Printing and AM Simulation Services
3

Our Technical Capabilities
Design Analysis and
Virtual Testing using
Simulation
Fatigue / Fracture /
Damage
Optimization and
Reliability
Multi-physics
Simulations (CFD,
EMAG, FSI)
Composite and
Elastomer Modelling
Additive
Manufacturing
Simulation
Simulation Automation
Patient Specific
Simulation
4

REALISTIC SIMULATION WITH SIMULIA
5

“Realistic Simulation” is a simulation that is physically realistic and “life like” in every way
6
What is Realistic Simulation
• Reduces Physical Testing
• Save Time and Money
• Improve Quality

Know your products and processes… and improve them!
Is my product
safe?
How long will my
product last? How
can I make it last
longer?
Will my product
work as I intended
it to?
Will it break if I
drop if from 1m?
From 2m? From
10m?
How can I make it
lighter without
sacrificing
performance?
Is my
development
process efficient?
How can I
accelerate the
process and get to
market faster?
Can I use a
different material
and still get good
results?
What type of
packaging will
work best for my
device?
7
What can Realistic Simulation Convey?

Physical Testing
• Very expensive (often $100Ks/test)
• Time consuming (weeks or months)
• Can only be done in an expensive lab
• Requires sophisticated equipment
• Can only be done at certain times
• Says what happened (“pass/fail”), but not
why
Realistic Simulation
• Cheap
• Quick (minutes or hours)
• Can be done anywhere
• Uses only a computer and software
• Can be done 24/7/365
• Says what happened AND why
Realistic simulation allows validation of products and processes that simply can’t be tested
physically!
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Realistic Simulation vs Physical Testing

SIMULIA Capabilities

Simulation Process and Data Management
Predict and Analyze
Product Life
• Fatigue Analysis
• Durability Prediction
fe-safe
Process Automation &
Design Optimization
Isight
• Design/Runtime Gateway
• Application Components
• Process Drivers
Continued Technology
Leadership & Innovation
More Physics,
Open Co-Simulation
Abaqus
• Abaqus/CAE
• Abaqus/Standard
• Abaqus/Explicit
• Abaqus/CFD
• CEL, FSI, SPH, EMAG
Non-parametric
Design Optimization
Tosca
• Structural & Fluid Flow Optimization
• Conceptual & Detailed Design
• Topology, Sizing, Shape, Bead Optimization
10
SIMULIA Portfolio for Life Sciences

SIMULIA for Life Science Industry
Design Exploration
Material Choices
and Geometries
Manufacturing
Tolerances
Fatigue and Failure
Stress
Concentration
Cyclic loading
Patient Specific
Realistic Patient
Geometries
Realistic Loading
Conditions
Understand
Device Effectiveness
Device Safety
Predict
Device Durability,
Reliability and
Potential Failure
Mitigate
Reduce Risk of
Device Failure in
Patients
Why?What?How?
Realistic Simulation and Durability Evaluation
Optimize Device Effectiveness and Safety
RoleofRealisticSimulation
Faster
Better
Cheaper

MEDICAL DEVICE DEVELOPMENT WITH
SIMULATION
12

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/ucm242067.htm
Current usage of modeling
and simulation
13
Medical Device Development Process

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/ucm242067.htm
Where modeling and simulation will
eventually be used
14
Medical Device Development Process

Developing Medical Devices and Processes with
Simulation
Devices and Processes
Joint Replacements and
Implants (Knee, Dental,
Eye)
Stents and Catheters
Heart Valves and
Pacemakers
Surgical Planning
Simulation Value
Realistic and virtual model
development and analysis
using
▪ Advanced Material Models
▪ Non-linear large
deformations
▪ Robust contact algorithms
▪ Wear Analysis
▪ Fracture and failure
analysis

Virtual implant testing with patient-specific
bone geometry from scan data
Patient-specific load data
considering personal activity level
Forecasting patient-specific long-term
behavior (bone remodeling)
16
Simulation of Personalized Implants

Abaqus Knee Simulator (AKS)
Automated modeling
tool to easily build
advanced knee
implant simulations
Based on well-known
implant evaluation
workflows
17

Abaqus Knee Simulator (AKS)
18
Designer
Analyst Switch between
the two modes

AKS Workflows
Contact Mechanics
Implant Constraint
Tibiofemoral Constraint
Wear Simulator
Basic TKR Loading
AKS accepted by FDA as
Non-clinical Assessment
Model (NAM) for Implant
Design Analysis
19

Why Now?
20
Technology
Regulatory
Support
Market
forces
Patient Specific
simulations
Automation, optimization,
and variational studies
Greater fidelity HPC
Imaging to Simulation

Knee Implant Simulation using AKS
22
Motion
Capture
Data
Kinematics
Inverse
Dynamic
Model
Joint forces
Patient-
specific load
data
considering
personal
activity level

Knee Implant Simulation - Material Modelling
23
• Bone modelled as isotropic and linear elastic material
• Cartilage generally modelled as isotropic, hyper-elastic
material
• Shear modulus/Young’s modulus generally obtained
from empirical relationships
• Soft-tissue material properties depend on factors, such
as synovial fluid, age and level of activity, and vary
among individuals
• Neo-Hookean hyper-elastic material properties are
generally used to represent ligaments
• Muscles/ soft tissue generally modeled as a
homogenous, isotropic, quasi-incompressible or hyper-
elastic material

Knee Implant Simulation using AKS- Simulation
Results
24
• Stresses induced within the knee
implants
• Joint Contact Area and Contact forces
for daily activities like
• Gait
• Deep Squat
• Step-Down

Simulation of Joint Forces Due to Exoskeleton
Structure
• FE model of entire limb developed with simplified axial
connectors (simulates muscles / muscle contractions)
and detailed bone geometry.
• Knee joint simulated as a modified hinge joint with 3
DOFs.
• Ligaments modelled as 3D structures that allows
wrapping over bone surfaces.
• Exoskeleton structure modeled around knee joint.
• Musculoskeletal kinematics applied to the entire model.
• Stresses induced at knee joint as a result studied and
exoskeleton knee device design modified to fit patient
specific requirements.
Upper
Brace
Lower
Brace
Flexible
Linking
Structure

Collapse under Pressure - Design using Virtual
Test
• Simulate collapsing of the device using non-
linear FEA simulation due to elevated external
pressure.
• From FEA results, determine the required
pressure to collapse the device.
• Validate FEA model with observed pressures
in testing.
• Use validated model to optimize the geometry
of the device to allow closure at different
external pressure values.
• Minimize prototype testing.

Heart Valve – Weld Parameter Optimization
• Simulate laser welding process of the impeller
cap welds that subsequently distorts the impeller
within the HVAD heart pump.
• Analyze
• Heat distribution due to welding process
• Residual stress field within welds
• Validate model and predicted results with actual
physical data.
• Numerical exploration of various welding process
parameters to minimize the distortions at the
critical regions of the impeller.
Residual Stresses

Heart Valve – Weld Parameter Optimization
• Stress and strain field at the end of cooling after
completion of welding gives an idea of distortion
within the impeller geometry.
• Welding parameters controlled to minimize
residual stresses and thereby distortion. The
parameters include:
▪ Energy input per pulse
▪ Pulse frequency
▪ Duration of single pulse
▪ Torch speed
▪ Weld spot diameter
▪ Pulse shape
▪ Cooling rate

Accelerate innovation
Design and
develop
more
effective
products –
better
performing
and more
durable
Improved
comfort
levels for
users or
patients –
more than
would be
otherwise
possible
Evaluate
scenarios
that would
be difficult if
not
impossible
to assess
Accelerate
progress
towards
personalized
solutions
30
Why Simulate Product-Life Interactions?

How can we help you?
31

Thank you
32

Transforming Medical Device Development Using Simulation

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