Post on 25-Jan-2021
1 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Entering the ‘in silico’ era Simulation Driven Product Development
in the Cardiovascular Sector
2 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
The Clinical World is Changing
Engineering simulation makes it possible to Ensure a successful FDA approval
through comprehensive upfront ‘in silico’ testing
Test disruptive innovations in a humanlike environment
Equip designers and surgeons with additional knowledge
“I don’t understand why simulation is used so much in automotive and aeronautic applications and so little in the medical world, where we directly impact a patient’s life. As surgeons, we are spending years to acquire enough know-how and experience to learn how to react quickly when the patient is lying on the operating table; but simulation is giving us the luxury to examine the situation when we still have plenty of time to think through
more quietly. I trust that simulation will be used increasingly in the clinical world in the near future.” Dr. Antoine Lucas Cardiovascular Surgeon
University Hospital of Rennes
ANSYS in the operating room
Source: ANSYS Healthcare blog
3 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential Courtesy Bill Murray, CEO MDIC and Randy Schiestl, VP R&D Boston Scientific
4 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
The Medical World has Experienced Several Revolutions that Accelerated the Pace of Innovations
Ind
uce
d In
no
vati
on
Rat
e
Time
In Vivo Surgery
In Vitro Antibiotics
In Silico Preventive personalized medecine
5 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential © 2015 ANSYS, Inc.
ANSYS Confidential
5
Rising Health Care Cost
Challenges • Reduce cost of
equipment • Avoid replacement
treatment • Minimize hospital
stays • Minimize nursing
cost
Access to Health Care
Challenges • Reduce cost of
medicine • Remote Persona-
lized medicine • Facilitate sterile
storage • Participatory
medicine
Safety & Increased
Regulation
Challenges • Failure could mean
injuries, death hence bad press
• Longer approval process
• Multiplication of clinical testing
• Difficult access to target population
Aging Population
Challenges • New emerging
pathologies • Replacement of
implanted devices • Chronic diseases • Lack of nursing
resources
Human Variability
Challenges • Multiplication of
clinical testing • No 100% certainty
of product integrity • Patient specific
geometry / material properties
• Rare disease
Industry Challenges Provide Opportunities
6 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential © 2015 ANSYS, Inc.
ANSYS Confidential
6
Healthcare Companies Are Focusing On These Initiatives
Affordable & Profitable Medicine
to make health care affordable to a larger audience despite the
“medicare” impact
Effective Medical Innovation
to ensure sustainable competitive advantage through disruptive
innovations
Ensuring Extreme Product Integrity
- to fulfill patient expectations
- to prevent product recall and treatment replacement
Accelerating Globalization
- to assist the entire population
- to collaborate with relevant resources
Digitalization of Medicine (and PDP)
- to increase product throughput
- for quicker treatment to patients
P4 Medicine:
Personalized, Participatory, Preventive & Predictive
to create new opportunities and open new markets
7 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
What Motivates Healthcare Companies to Look for Alternative Solutions?
1. Strong pressure for effective innovation
2. Long & costly clinical testing
3. Compliance to regulatory authorities approvals
© 2015 ANSYS, Inc.
ANSYS Confidential
7
8 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
What Motivates Healthcare Companies to Look for Alternative Solutions?
1. Strong pressure for effective innovation
2. Long & costly clinical testing
3. Compliance to regulatory authorities approvals
© 2015 ANSYS, Inc.
ANSYS Confidential
8
Virtual Human Laboratory
In Silico Testing
Simulation Driven FDA
Approval Process
9 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Global Engineering Simulation Leader
Including 97 of the top 100 Industrial Companies on the FORTUNE Global 500
40,000 Total Customers
315,000 Commercial Seats 290,000 University Seats 200 Channel Partners 160 Industry Partners
Only software company focused solely on simulation with 44 years of simulation software experience
•Approx. 2,500 employees / 60+ sales offices on 3 continents
• Network of sales channel partners in 40+ countries
• 22 major development centers on 3 continents
2014 Target % of revenue spending on R&D: 15%
2014 Target Revenues: ~$ 1 Bn
Market Cap: ~$8.5B
http://www.gm.com/
10 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
ANSYS Created a Platform For Complete Virtual Prototyping of Medical Device and Human Body System
Tech
nical D
ep
th
Steady-State, Transient, Parameterized, Harmonic & Modal
Linear & Nonlinear
Technical Breadth
Meshing 2-way CAD interface
Simulation Project Management Design Xploration
Engineering Knowledge Management
HPC More…
Simulation Process and Data Management
Conduction
Convection
Radiation
Phase Change
Mass Transport
More…
Thermal
Ophthalmology: Laser Surgery
Structural
Large Displacements
Finite Strain
Contact
Multibody Dynamics
Random Vibration
Implicit & Explicit
More…
Orthopedic: Spinal Disorders
Compressible
Incompressible
Laminar Flow
Turbulence
Multiphase Flow
Non-Newtonian Fluids
More…
Fluids
Respiratory: Drug Delivery
Quasi static (Low Freq)
Full Wave
Joule Heating
Eddy currents Current flow Circuit Coupling
More…
Electromagnetics
Diagnosis Equipment: MRI Compatibility
Model-Based System & Architecture Design
Human Body Model
Reduced Order Model
Cardiovascular, Skeleton, PKPD
More…
System
Cardiovascular: Full System Modeling
11 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Leading Medical Device Companies Rely on Simulation
Global ANSYS Medical Device Customer Base
• 88% of top 50 largest medical device
companies including:
- 16 largest medical device companies WW
- 40 largest US medical device companies
- 96% of the Top 25
• 88% of top 20 largest cardiology companies
including:
- 10 largest cardiology companies
• Typical Best in Class CAE investment:
- 0.2% of their total R&D investment in
engineering simulation
- Target 5% of their engineering force to use
simulation
12 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
The cardiology market is expected to grow but some key players are likely to loose market share.
13 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Contents
• The On-Going Medical Revolution
• Case Studies:
- Patient Specific Modeling of LVAD and PVAD
• Biomedical Applications
• Cardiovascular Applications
• Industry Best Practices
• Wrap up: A Successful Revolution
14 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Contents
• The On-Going Medical Revolution
• Case Studies:
- Patient Specific Modeling of LVAD and PVAD
• Biomedical Applications
• Cardiovascular Applications
• Industry Best Practices
• Wrap up: A Successful Revolution
15 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Investigating the Position and Shape of the Outflow Cannula to Minimize Cerebral Embolization
By proper adjustment in this CFD study of a synthetic
model of an aortic arch bed, we found nearly a 50%
reduction of cerebral embolism could be achieved for a
configuration consisting of a shallow angle of implantation
over a baseline normal incidence of the LVAD cannula.
Department of Mechanical, Materials and Aerospace Engineering,
College of Engineering and Computer
Science, University of Central Florida, Orlando, FL, USA
16 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Tracking Where the Particles of Different Sizes (2 & 5 mm)are Flowing Minimizes the Risk of Cerebral Embolization
In the standard configuration
with an angle of β=0 (right
column), a major feature of the
flow is a large recirculation zone
and a stagnation flow region as
the jet emanates from the LVAD
cannula. Thrombi of all
diameters are trapped in that
zone and are susceptible to
ingestion at the IA take-off.
17 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
The Shape of the Inflow Cannula is Playing a Major Role to Prevent Blood Damage
Blood damage index for various inflow cannula shapes
Local vortices facilitates the formation of clots
Courtesy of Medical College, Beijing, China
18 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Miniaturization of Pediatric Implants without Compromizing with Performance is Very Valuable.
• Optimizing the structure of a PVAD impeller by minimizing volume, thereby minimizing mass. A total volume reduction of 46% was achieved.
• Combining computational analysis and optimization methods significantly reduced the cost of redesigning the impeller
• Despite the PVAD redesign, the critical speed of the PVAD was successfully increased, ultimately providing a more effective tool for assisting weak hearts in small children.
Paul Witherell, Sundar Krishnamurty, Ian Grosse, James Antaki
Department of Mechanical & Industrial Engineering
University of Massachusetts
19 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Ventricular Assist Device are Complex Product Involving Different Physics
Numerical analysis and optimization of fluid dynamics,
electromagnetics, heat transfer, and structural stresses
• Generating a clot free blood
flow with the right speed and
volume
• Minimizing the stress to limit
the risk of fatigue deterioration
• Managing the heat exchange
to avoid patient incomfort
• Inducing the proper
electromagetic field to ensure
reliable power
• Avoid noise induced vibration
Courtesy of LaunchPoint Technologies, Inc.
20 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Contents
• Adoption of simulation
• Case Studies:
- Patient Specific Modeling of LVAD and PVAD
• Biomedical Applications
• Cardiovascular Applications
• Industry Best Practices
• Wrap up: A Successful Revolution
21 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Cardiovascular
Challenges • Patient-specific geometry
• Plaque growth and rupture
• Blood recirculation and low Wall Shear Stress (WSS)
• Deforming artery wall
• Fatigue induced by large number of cycles
Solutions brought by simulation • Local evaluation of WSS, pressure and flux at
aneurysm neck
• Deterioration of blood cell in blow pump
• Parametric studies for extreme conditions
• Automatic Design exploration of geometry, material and operating conditions
• Virtual prototyping e.g. for hearth valves
Courtesy of UPF, Barcelona & LTSI, Rennes
Peak-systolic aneurismal flow pattern and wall shear stress(WSS) of the unstented aneurysm model.
after the stent 2 deployment.
Stent deployment close to an aneurysm (stress in the stent)
22 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Challenges • Patient-specific geometry
• Continuously varying material properties (porosity, density, Young’s modulus)
• Bone fragility (osteoporosis)
• Minimizing patient recovery times
• Transient loads
Benefits of Modeling • Testing different prostheses / implants
designs
• Investigation of different scenarios and impact on the bone / implant interface
• Virtual prototyping on a large number of virtual patients
• Various pathologies considered during design
Orthopedics
Pictures, courtesy of CADFEM, ANYBODY
23 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Respiratory
Challenges • Patient-specific geometry
• Continuously varying materials properties (porosity, density, Young’s Modulus)
• Size of the drugs particles (~ few mm)
• Minimizing patient recovery times
• Transient loads
Benefits of CAE • Particles tracking in the inhaler and the
upper air way
• Including patient-specific physiology and health condition
• Virtual process adjustment from new born to elderly
• Surgical planning and training
25 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Contents
• Adoption of simulation
• Case Studies:
- Patient Specific Modeling of LVAD and PVAD
• Biomedical Applications
• Cardiovascular Applications
• Industry Best Practices
• Wrap up: A Successful Revolution
26 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
EndoSize Ansys
- Navigation along centerlines of the vascular structure - Extraction of lumen contours from planes orthogonal to
the centerline - Mapping of density values and distance between aorta and
spine onto a mesh of the vascular structure - Export to Ansys DesignModeler
- Import of centerlines, planes and contours
- Reconstruction of the vascular wall by surface interpolation
- Conversion of « image data » to « mechanical data » (material properties, boundary conditions)
Geometry reconstruction from CT data
27 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Segment Patient Data
Artery wall properties (healthy, calcified, thrombotic) Aorta-spine distance
28 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Material models artery
UPPER Boundary Conditions tools
INSERTION boundary conditions tools
Boundary conditions Spine-Aorta support artery
Boundary conditions internal iliac arteries artery
Arterial pressure artery
29 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Material behavior laws
Hyperelastic anisotropic model
𝑊 = 𝐶0(𝐼1 −3)+𝑘12𝑘2
(exp 𝑘2 𝐼4 − 1) 2
− 1 +𝑘32𝑘4
(exp(𝑘4 𝐼6 − 1) 2
− 1)
Neo-Hookean model
𝑊 =𝜇
2(𝐼1 −3)+)
1
𝑑(𝐽 − 1)2
𝐶0 (MPa) 𝑘1,3(MPa) 𝑘2,4 α
AA 0,006 0,015 18 42,3°
AAA 0,001 0,045 28 37,6°
𝜇(Mpa) 𝑑(MPa-1)
calcifications 17,86 4.10-8
Arterial tissue
Calcifications
Thrombus
Need to be taken into account for the good determination of the zero-pressure geometrie and
to apply internal pressure (1st simple approach)
Wall thickness (or stiffness) increase
30 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Artery boundary conditions Aorta-Rachis support Internal iliac arteries support
𝑘 = 𝒌𝒎𝒂𝒙(1 −𝑙
𝒍𝒎𝒂𝒙)4
Distribution of stiffness decreasing with rachis-aorta distance
Two more linear springs
0 ≤ 𝑘 ≤ 5.10 −4𝑁/𝑚𝑚
𝑘~0,1 − 1𝑁/𝑚𝑚
Internal iliac arteries
31 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
1. Initial state: - Deformed artery and guidewire in equilibrium state - Delivery system : undeformed, outside the artery, insertion zone fixed
2. Delivery system initialization : - Displacement of the delivery
system into vascular lumen - Guidewire /artery contact
deactivation - Delivery system/artery contact
activation
3. Equilibrium: Relaxation of delivery system constraints until equilibrium state
Delivery system simulation process
32 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Delivery system simulation results
FRONT 30° LAO 30° RAO
33 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
@neurist Hemodynamic Toolchain
3D solver
ANSYS-CFX
Patient medical image
(3DRA) Vessel surface extraction Reduction to region of interest,
and skeleton generation
Computational mesh
Hemodynamic results Flow rates from 1D model or MRI
34 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Influence of the Stent on HemoDynamics
The stent is an important flow driver as it prevents blood to massively flow into the aneurysm.
Blood flow reduction progressively lead to filling the cavity and prevent additional flow
Courtesy of A. Frangi, CIBER-BBN
Peak-systolic flow pattern and wall shear stress(WSS) of the unstented aneurysm model
Peak-systolic flow pattern and wall shear stress(WSS) of the stented aneurysm model
35 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Maximum principal stress
distribution
Deformed Stent-Artery Configuration
• As a result of structural analysis, stress, strain and deformation in the stent are obtained as well as the position of the deformed artery, possibly the plaque and the deployed stent.
• This initial configuration may lead to important fatigue modeling as the stent is expecting to experience 400 million cycles during its lifetime.
• Finally, this provides the at rest configuration for hemodynamics applications critical to evaluate different stent model performances.
INLET
OUTLET
WALL
Velocity profile: parabolic and transient
Constant fixed
pressure
No slip
condition
Fluid mechanical perturbations induced by stent implantation: a numerical study Rossella Balossino, Francesca Gervaso, Francesco Migliavacca, Gabriele Dubini LaBS, Department of Structural Engineering, Politecnico di Milano, ITALY
36 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Influence of the Stent Geometry on Hemodynamics
A pulsatile flow analysis for hyperemic condition is performed for a freshly deployed stent in a human coronary artery having a three dimensional geometry with an axial length of 20 mm and a larger diameter (6 mm).
Following the deployment of the stent, it is assumed that half of the stent is exposed to the blood flow whereas the other half is embedded in the arterial wall.
A constant blood density of 1.05 gm/cc and an infinite-shear-rate viscosity of 3.45 cp were considered. Time-varying, uniform velocity boundary condition was imposed at inlet boundary
A close-up view of the velocity vector at time 3.14 s shows significant recirculation zones in the voids created by cross-links of stent wires.
Rupak K. Banerjee (1), John Straus (2), S. Subbiah (2), K. Bhargava (3), Lloyd H. Back (4) Developing pulsatile flow through the entrance region of a deployed stent in a coronary artery
velocity vector near the stent and artery interface at time t= 3.14 s
Cycle for post-processing (2.4-3.2 s)
Time, 100th of s
37 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Influence of Strut Shape on Restenosis
The results show that the presence of stents markedly affects the WSS distribution.
In the stent strut, the corners are the critical areas, i.e., areas with low wall shear stress (
38 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
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MRI Induced Implant Heating Simulation using ANSYS Workbench
HFSS Simulation
Transient Thermal Simulation
+ =
Temperature Profile
39 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Fluid Mechanical Systems Enables Innovative Treatments For Preventive Medicine
Business Initiative:
Increase Market Share
• Clinicians are demanding for customized solution for critical client pathologies but very cautious with new
solutions.
• Convincing a surgeon a new solution is better and safer requires lot of clinical and visual evidences
Customer Success Factors
•ANSYS Fluent is used to analyze the blood flow for a specific patient with a given stent model.
•The Cardiatis stent value is shown by comparing the blood flow for the same patient without any implant.
“Cardiatis has invested significantly in the latest simulation and analysis tools such as ANSYS and
Mimics®. These tools allow virtual simulation so clinicians may evaluate the effect of the implanted
MFM® on blood flow, velocity, wall shear stress (WSS) and peak WSS.”
Ait Brik Boubker Virtual Simualtion & Core Lab Director Cardiatis
Key Results
• Stenting solution could be customized in days for specific patient • More surgeons adopting the Cardiatis solution after
20x more patients benefiting
from simulation
Risk of complication
divided by 5
Gro
wth
Co
st
40 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Contents
• Adoption of simulation
• Case Studies:
- Patient Specific Modeling of LVAD and PVAD
• Biomedical Applications
• Cardiovascular Applications
• Industry Practice
• Wrap up: A Successful Revolution
41 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Contents
• Industry Best Practices
Comprehensive Multiphysics Solution
Simulation Assisted FDA Process
Virtual Human Environment
Systematic Use of Simulation Early
In silico Testing
Robust Design Optimization
Collaborative Simulation Environment
HPC Scale Up and HW Optimization
System Architecture Design
Embedded Software Design
Early Reliability Prediction & Simulation
42 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Fluid Structure Savvy Devices – Value Proposition
• Better performance optimization through deeper system knowledge
• Ensure product integrity through comprehensive modeling
• Accelerate product development process through virtual prototyping
• Minimize warranty cost
• Boost disruptive innovation rate
• Combine best in class software in each physics
• Provide integrate though autonomous environment for both physics
• Encompass FSI in a working env. (DoE, HPC, Custom., bidirectional CAD, optimization etc.)
• Combine multiphysics with multi scale and system level approach
• Sequential & simultaneous FSI in the same env.
• Modern complex devices involve both fluid and structure
• Optimizing product performance is getting more complex with multiphysics
• Ensuring product integrity despite FSI
• Reduction of design safety margin without compromising with safety
• FSI induces failure modes often missed during product design
Business Impact Typical Challenges ANSYS approach
43 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Fluid Structure Savvy Devices Best Practice Summary
Fluid Structure Interaction: Accounting for interactions between fluid and structural aspects to better optimize the product performance while protecting it against real life failure modes to improve its reliability.
Thermal
Structural Fluid
Electromagnetic
Fluid
Structure
Interaction
Simulation
Data Mapping
Dat
a M
app
ing
Data Mapping
Dat
a M
app
ing
Verification & Validation
• Reliable model of the complete mutliphysics system
• Optimization DoE of advanced system
Capabilities: • Couple fluid and structure
component in a single environment
• Conduct system multiphysics investigations
Benefits: Maximize product
performance through optimized combination of fluid and structure
Prevent fluid induced structure failure or erosion
Efficiently evaluate large number of FSI device in a single environment
44 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Designers want to improve cost, performance, reliability and time to market
Impact/Value Challenges ANSYS Approach
• Clinically validated model
• Coupled modeling whenever necessary (diagnosis)
• Sequential fluid structure modeling:
Advance transient structural model
Hemodynamic simulation after deployment
• Design exploration on combined system
• Customization for democratization
Product Development Time (Months)
-60%
After Before
• 60% reduction in time
Product Cost (&)
-30%
After Before
• 30% reduction in Product Cost
Induced stress during stent deployment (Abdominal Aortic Aneurysm)
Restenosis induced by local blood flow after stent deployment
Evaluation of aneurysm risk of rupture
(cerebral aneurysm)
• Intangible maximization of treatment reliability
45 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Computer Based Models Accepted in the FDA Approval Process
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• FDA approval process
long and costly
• Requested measurement
difficult
• Any approval question
leads to more experiment
• Verification and Validation
• Validate new solutions with
same simulation protocol
• Virtual FDA testing on a
large number of patients
• Decrease of warranty
cost
• Improved customers
satisfaction
• Reduction of physical
testings
Animal Bench
Computational Human
Safety/Efficacy
46 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
FDA Analysis of Product Recalls from FDA Report “Understanding Barriers to Medical Device Quality”
“failures in product design and manufacturing process control caused more than half of all product recalls”
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM277323.pdf
47 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
OSEL Regulatory Support
The FDA Speaks Our Language
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm126739.htm
48 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
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Publicly Available FDA Presentations Highlighting Computational Modeling
https://sites.google.com/site/cm4cvd/presentations/fda-presentation-on-computational-modelinghttp://www.imagwiki.nibib.nih.gov/mediawiki/images/f/f1/IMAG_&_MSM_2011_-_Morrison.pdfhttp://cstools.asme.org/csconnect/pdf/CommitteeFiles/36699.pdfhttp://xaviermedcon.com/wp-content/uploads/2012/05/Shuren - Keynote Presentation.pdf
49 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
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Will provide reporting best practices for computational modeling studies
Recent publication in J. Biomech. may provide early insight
Sections:
Guidance on Reporting Methods for M&S*
2.4 Verification
2.5 Validation
2.6 Availability
* draft expected November 2012
2.1 Model Identification
2.2 Model structure
2.3 Simulation structure
http://www.jbiomech.com/article/S0021-9290(11)00720-2/abstract
50 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
The Full Benefit of Modeling is Obtained through a Systematic Use of Simulation Early
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• Problems identified too late
in the PDP
• Persistent uncertainty for
new concepts
• Baby step innovation, no
major breakthrough
• Bring simulation upfront in
the PDP
• Quick feasibility study for all
promising new concepts
• Develop comprehensive
model through the PDP
• Run 10 to 30 times more
prototypes
• Reduce design cost by a
factor 2 to 4
• Cut time to market by a
factor 2 to 5
Complex heat exchange situation involving
• Neonate body insufficient metabolic heat versus higher energy demand
• Heat exchange with surrounding air flow
• Radiant heat loss through the wall
• Water loss through transpiration and respiration
• Radiation from electromagnetic wave
Delicate multiphysics / multiphase situation
• Providing externally heated and humidified air
• Minimizing heat loss during any intervention
• Reducing radiant heat loss with double walled devices
• Fine controlling the heat exchange through convection and evaporation
51 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Simulation Directly Impacts the Bottom Line
Problem: Optimizing the fill patterns and mixing in the Polonator gene sequencer*
Solution: Used FLUENT to understand the filling patterns, mixing, and residence times in the microfluidic circuit.
Outcome: Microfluidic circuit geometry optimized to get uniform mixing. They also scale-down the channel height without compromising efficiency.
Cost savings: Operating cost reduced by a factor 10.
“The tenfold decrease in channel height resulted in an operating cost reduction by a factor 10!”
* Desktop Engineering, August 30, 2009
“The time to get to final design would have doubled or tripled without CFD analysis.”
Channel geometry Speed contours Pressure contours
52 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Designers Create Virtual Human Laboratory to Quickly Test New Concepts Early
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• Few disruptive innovations
• Prohibitive cost to try new
creative idea
• Difficulty to get sustainable
competitive advantages
• 3D multiphysics model:
human body and solution
• Virtually test any promising
idea
• Build confidence through
What if analysis and DoE
• Increased product
throughput
• Reduced risk of failing
approval process
• Brand impact as leading
company
Courtesy of Kleinstreuer & Zhang, NCSU
Rudimentary Delivery
• More than 50% of particles do not reach the trachea; less than 5% reach any specific target
• Massive waste of expensive medicine
• Endangering patients treated with aggressive API
Target Delivery
• Patient Specific upper airflow
• Ensure Laminar flow
• Back track particles reaching target(s)
• Identify precise injection location
• Design / adjust inhaler for proper injection
53 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Designing the PediaFlowTM Ventricular Assist Device
Each year, over 35,000 children are born with congenital heart disease
• 1,000 will die before 10th birthday
PediaFlow increases pump's life span
It prevents recirculating flows
• Minimizes blood clot formation
Geometry adjustments reduce blood cell exposure to shear stress • Less damage to blood
New device delivers adequate flow rate to heart
Engineering simulation reduces design time
"CFD-based design optimization with ANSYS CFD solver reduces the design optimization cycle from years, compared to the traditional trial-and-error methods, to just several months."
J. WU, LaunchPoint Technologies, Inc.
PediaFlow Ventricular Assist Device New born virtual
cardiovascular system
54 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
A Robust Design Optimization Approach Boost Performance and Reduce Warranty Cost
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• Systematically testing every
configuration
• Identify stable optimums
• Consider routine and
extreme service conditions
• Automated Design of
Experiment
• Stability Analysis
• Reduced order Models
• Design for Six Sigma
• Extreme Reliability
• Get it Best the First Time
• Sustainable competitive
advantage
Position of the impellers has significant effect on mass transfer coefficient.
Design
point
Liquid
level
(in)
Bottom
impeller
offset
(in)
Top
impeller
offset
(in)
Gap
between
impeller
s (in)
Baffle
offset
(in)
Length
of
spargin
g area
(in)
Angula
r
velocity
(rpm)
Gas
mass
flow
rate
(kg/s)
Bubble
diamete
r (m)
Volume
average
d Kla-
hr
DP0 55 14 30 16 10 6 120 2e-3 0.003 81.96
DP1 55 14 35 21 10 6 120 2e-3 0.003 70.46
DP2 55 14 40 26 10 6 120 2e-3 0.003 70.05
DP3 55 18 30 12 10 6 120 2e-3 0.003 65.56
DP4 55 18 35 17 10 6 120 2e-3 0.003 67.13
DP5 55 18 40 22 10 6 120 2e-3 0.003 78.47
DP6 55 22 35 13 10 6 120 2e-3 0.003 75.85
DP7 55 22 40 18 10 6 120 2e-3 0.003 73.07
DP8 55 22 45 23 10 6 120 2e-3 0.003 81.80
55 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
In Silico Testing Validates New Prototypes on Large Cohort of Patients Before Clinical Testing
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• New products tested on
cohort of patients
• Major cost / unacceptable
risk of failure
• Long approval process
delays access to new care
• Working with large database
of patient specific data
• Virtually testing new concept
on virtual patients
• Enter formal approval when
all virtual tests successful
• Risk of failing approval
dramatically reduced
• Multiply submission of
disruptive solution
• Global time to market
significantly reduced
Validation on
120 + femurs
56 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
A Collaborative Simulation Environment Leverage all Available Resources Efficiently
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• Remotely located staff
• People with different
background
• Knowledge transfer btw
senior and junior engineers
• Centralized project,
remotely accessible
• Integrate platform where
various physics and multi
levels co-exist
• Customization & Automation
• Experts in each physics can
collaborate on single model
• Senior experts in modeling
coach junior analysts
• Virtual teams able to work
24h /day on a given project
57 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Increasing Productivity Through Staff Efficiency
Business Initiative: Reduce Late Stage Design Fixes Design problems caught late in the product development process are costly to address, but for most companies are a cost of doing business. As a result many companies deploy engineering resources late in the development process to help fix design and manufacturing problems prior to product rollout. Oticon sees a better way of operating. They reallocated engineering resources to the early stages of the design process to explore the design space more fully and avoid decisions that might lead to problems later.
Action Taken Oticon was successfully using ANSYS tools to properly design the most important components but engineering resources were short to optimize the entire system what led to an unacceptable design.
Using the ANSYS’ Application Customization Toolkit (ACT) Oticon was able to integrate advanced acoustic capabilities and Oticon’s best practices in a designers accessible workflows. By making complex physics such as acoustic and frequency dependent material mechanical models, accessible to non-expert simulation users in an application specific environment, ACT enables them to perform design validations with ANSYS.
Key Results By adopting ACT driven multiphysics simulation, Oticon was able to democratize the use of simulation without compromising with the reliability of results. More than 75% of simulations traditionally done by experts can now be delegated to non-expert simulation users. Specifically, Oticon freed the simulation experts to model the full system, the complete hearing aid, rather than just some of its key components. This translates in significantly better performance leading to more competitive products and eventually will eradicate costly and time consuming late stage design fixes.
Martin Larsen Simulation Specialist Oticon
“ACT and ANSYS Workbench enable Oticon A/S to achieve our objective for design engineers to successfully employ simulation. Our goal is to leverage Workbench and the ACT environment: – Flexible and open – Ease of use (easier deployment) – Captures Oticon’s business specific (expertise & know how)”
58 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Centralized HPC Scale Up and Hardware Optimization Support the SDPD* Vision
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• Some models request
parallel computing and DoE
• Distributed staff needs
access to resource
• Numerous large simulations
to be run by all facilities
• Centralized computational
resources accessible
remotely.
• Highly scalable HPC and
Access to Cloud
• Affordable DoE
• DoE across the company
even for limited local needs
• Sharing a pool of software
amongst facilities
• Democratization of
simulation towards patient
* Simulation Driven Product Development
Observed trend at ABB:
• Integration in design processes (non-expert users)
59 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Simulation is Deployed at the System Level to Ensure Complete Robust Design Optimization
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• Interacting components
• Influence of the
environment
• Multiphysics, multiscale
products
• Integrated platform
• Interacting multiphysics
• 0D to 3D modeling
• Optimized system rather
than components
• Warranty cost reduction
• Accelerate PDP
especially for complex
products
Dynamically Linked HFSS/Designer Simulation
60 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Cutting Time to Market by Three Months for Body-Worn Wireless Devices for New Applications.
Business Initiative: Amplify Engineering Productivity Designing external wireless design safe for the patient and robust in terms of reliable transmission. The radiated power of the device must be kept below levels that can create a health hazard. The device’s power consumption, size, aspect ratio and weight must be minimized to make it suitable for wearing. Yet the device must be designed to deliver a signal of sufficient power to the right location, with good reception by the target device — despite the fact that the human body may absorb a significant portion of the signal.
Action Taken Synapse uses the ANSYS HFSS 3-D full-wave electromagnetic (EM) simulator and the ANSYS human body model to evaluate the performance of various antenna designs by modeling the complete system, including the wireless device and antenna and their interactions with the human body.
Key Results Guided by simulation, electrical engineers typically can increase the range of the product by a factor of five, relative to the initial concept, while saving an estimated three months out of a traditional 12-month development cycle. The ability to evaluate designs without building physical prototypes typically helps Synapse engineers to increase the global performance of the antenna by a factor of five compared to the original design concept.
Bert Buxton, Senior Electrical Engineer Synapse Product Development
“Synapse uses ANSYS HFSS and the ANSYS human body model to evaluate performance of various antenna designs by modeling the complete system, including the wireless device and antenna and their interactions with the human body.”
Simulation output shows power
absorbed by foot and ground.
61 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Smart Product Models Combine Hardware and Embedded Software Simulation
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• Reliability of software
interacting with hardware
• Interface design
• Certification
• Integration of soft and had
component in the model
• Automatic code
generation
• Certified software
• Acceleration of process
development
• Increased system
reliability
• More complex solution
IEC 62304 Relationship to Other Standards
derived
PROTOTYPE & DESIGN
62 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Contents
• Adoption of simulation
• Case Studies:
- Patient Specific Modeling of LVAD and PVAD
• Biomedical Applications
• Cardiovascular Applications
• Industry Best Practice
• Wrap up: A Successful Revolution
63 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
Click to edit Master text styles
Market Drivers Tightening Regulation
Ageing population
Accessing Care
Key Business Initiatives Boost innovation rate
Maximize Product Reliability
Reduce Cost
Industry Best Practices: Systematic use of simulation early
Simulation Assisted FDA Approval
Collaborative Simulation Environment
These evolutions apply across medical sectors; they are progressively reaching the clinical world
Wrap up
Rising health care cost
No mercy for failure
Reduce time to market
Enable remote personalized med.
Globalize resource
In Silico Testing
Virtual Human Laboratory
Certified Embedded Software
64 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
How quickly this Medical Revolution will succeed depend upon you and us.
Ind
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In Vivo Surgery
In Vitro Antibiotics
In Silico Preventive personalized medecine
In Vitro Antibiotics
65 © 2015 ANSYS, Inc. November 12, 2015 ANSYS Confidential
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