This document discusses how simulation can be used in healthcare product design. It begins by introducing ANSYS and its role in simulation. It then discusses how simulation allows for virtual prototyping of medical devices to evaluate designs without physical testing. Specific applications mentioned include modeling electromagnetic implants, drug delivery systems, and modeling biomechanics of implants and natural tissues. The benefits of simulation highlighted are reducing risk through virtual testing, accelerating innovation, improving accuracy over physical testing, and saving time and costs compared to repeated physical prototyping.

1. Simulation by Design
A healthcare focus
Dr. Mike Slack
ANSYS Technical Services
1 © 2011 ANSYS, Inc. October 10, 2011

2. 2 © 2011 ANSYS, Inc. October 10, 2011

3. What does simulation promise?
3 © 2011 ANSYS, Inc. October 10, 2011

4. ANSYS
• ANSYS have been around for 40 years.
• Has the biggest and most diverse customer base in
simulation.
• A simulation company succeeds by evolving the way
our products work to meet the needs of our
customers.
4 © 2011 ANSYS, Inc. October 10, 2011

5. Presentation objectives
Why simulation
– Business drivers for simulation.
– How ANSYS simulation fits a healthcare business
– How it enables virtual prototyping
– The Future
5 © 2011 ANSYS, Inc. October 10, 2011

6. But First ...
Conservation of Mass
The Navier-Stokes Equation for
 
   V  0 fluid flow
t
Conservation of Momentum
 u u u u  p    u 2      u v     u w 

 u v w         2    V            
     Bx
 t x y z  x x   x 3  y   y x  z   z x 
 v v v v  p    v 2      u v     v w 

  u  v  w        2    V            
 x  y x  z  z y   B y
 t x y z 
 y y   y 3
      


 w w w w  p    w 2      w u     v w 
 u v  w       2    V               Bz

 t x y z 
 z z   z 3  x   x z  y   z y 
  
6 © 2011 ANSYS, Inc. October 10, 2011

7. Using a computer to solve flow eqns.
• Eqn. is complex so lets make things easier
• You can either simplify the equation or the shape of the domain.
• We discretise our domain into simple shapes - a computational mesh.
• We now need a computer to calculate how each shape
interacts with its neighbours.
control volume
CFD - Computational Fluid Dynamics
7 © 2011 ANSYS, Inc. October 10, 2011

8. So now we can model a race car
8 © 2011 ANSYS, Inc. October 10, 2011

9. Business Drivers for simulation
9 © 2011 ANSYS, Inc. October 10, 2011

10. The healthcare sector
• A high value growth sector
– Increased spending on Health
– Aging more active presentation
– Customised patient specific treatment
• Regulatory and technological demands have seen simulation
tools playing an increasingly vital role.
– Design, development and understanding of medical devices, effective
drug delivery and bio processing
10 © 2011 ANSYS, Inc. October 10, 2011

11. The importance of Innovation
• It is critical to not only maintain but to accelerate and
innovate.
• Innovation brings game changing technology.
Joseph Lister's reduced death rate from 45.7%. To 15% Ipad tablet. A brand new concept. Sweeps
with the introduction of his new antiseptic treatment. into the market
11 © 2011 ANSYS, Inc. October 10, 2011

12. Top Health Care Companies
Rely on ANSYS Simulation
12 © 2011 ANSYS, Inc. October 10, 2011

13. Business Driver - Risk
“The cost of getting it wrong and the value of
getting in right have never been greater.”
Admired companies, known for their good products,
experience trouble because a lack of product Integrity!
13 © 2011 ANSYS, Inc. October 10, 2011

14. Innovation
“ I’m not in the business of predicting, I’m in the business
of innovating. We need the tools to predict with
confidence so our product is right the first time. ”
David Stanbridge, CEO at Swift Technology Group
14 © 2011 ANSYS, Inc. October 10, 2011

15. Accuracy
“By using an anisotropic hyperelastic material model in
ANSYS Mechanical we are able to accurately predict the
quality of motion of the natural and the implanted spine.
Using ANSYS software allows us to perform hundreds of
design iterations in the same amount of time it would take
to run a single cadaveric test.”
Jorge A. Ochoa, Ph.D., P.E., CTO - Archus Orthopedics
15 © 2011 ANSYS, Inc. October 10, 2011

16. Time
"The ability to evaluate different designs with CFD
without building prototypes drastically reduced
the amount of time needed to bring the glucose
monitor to market.“
Dr. Ron Kurnik - Cygnus Therapeutic Systems
16 © 2011 ANSYS, Inc. October 10, 2011

17. Top Product Design Challenges
Top Product Design Challenges
Workforce reductions / lack of technical
24%
experts
Predicitng product behavior in a real
28%
world environment
Frequent design changes 36%
Making trade-offs for cost, performance
41%
and quality
Problems/errors found too late 47%
Source: Aberdeen Group. April 2010
Percentage of Respondants; n=157 0% 10% 20% 30% 40% 50%
17 © 2011 ANSYS, Inc. October 10, 2011

18. The process of testing Ideas
18 © 2011 ANSYS, Inc. October 10, 2011

19. Its better to make mistakes early
Cost of
change
Concept Design Prototype Production Operation
Review
19 © 2011 ANSYS, Inc. October 10, 2011

20. History of simulation in design
1990’s
Today
20 © 2011 ANSYS, Inc. October 10, 2011

21. Test Your Concepts
Evaluate the current
– Develop your knowledge and experience in new
technology areas.
Try out your ideas
– Establish what works and understand why
– Understand the impact of scale
– Review your best concepts
21 © 2011 ANSYS, Inc. October 10, 2011

22. Testing and healthcare
• Why?
– Biomechanical testing is required before implanting in the human body
– Preclinical tests help protect patients from ineffective devices
– Experimental and computational models provide insight about what
happens in the real system, provide focus and therefore reduce more
costly tests
Preclinical Testing
Animal
Increasing
Relevance
Biological
Experiments
Physical
Models
Simulation
Increasing Cost
* Prendergrast and Maher J Mat Proc Tech (2001)
22 © 2011 ANSYS, Inc. October 10, 2011

23. Have Confidence in your design
Provide evidence to back up your concept.
Communication
3D visualisation and numerical data will demonstrate
and provide confidence to your internal and external
customers.
Simulation provides evidence to differentiate your
design.
23 © 2011 ANSYS, Inc. October 10, 2011

24. Range of Healthcare Applications
26 © 2011 ANSYS, Inc. October 10, 2011

25. Electromagnetic implants
Far Field of Implant Antenna
E field produced by Implant
Antenna
The FCC ruled in February, 2011 that the finite element method (FEM) is a
valid technique to simulate a medical device that must communicate with
other similar devices.
27 © 2011 ANSYS, Inc. October 10, 2011

26. ANSYS Solutions for Process and
manufacture
28 © 2011 ANSYS, Inc. October 10, 2011

27. Virtual prototyping
29 © 2011 ANSYS, Inc. October 10, 2011

28. Virtual prototyping
• Refine the design - establish the most sensitive
parameters.
• Satisfy regulatory demands by demonstration and
explanation, simulation can support and document
compliance.
• Investigate the robustness of your product ensuring
it achieves all of its promise.
30 © 2011 ANSYS, Inc. October 10, 2011

29. Go Beyond the Single Design Point…
Central to Simulation Driven Product Development
• Move from a single design point solution to understanding the design
space so simulation can guide design
• Design exploration answers the big questions
?
?
?
Response
Single point What if? surface
31 © 2011 ANSYS, Inc. October 10, 2011

30. Dyson Reinvents the Fan
• Explored 10x design variations per day.
• Improved performance 250% over original
design
• Continuous airflow!
• Safe device...
33 © 2011 ANSYS, Inc. October 10, 2011

31. New Technology and R&D Activities
34 © 2011 ANSYS, Inc. October 10, 2011

32. ANSYS Vision for Healthcare Industry
Old Paradigms New Paradigms
Single Physics Multiphysics Simulation
(flow, thermal, structural,
Single Component Simulation electromagnetic, acoustic, etc.)
by a Single Person
Collaborative Multidomain
Idealized geometries Simulation (component and
system)
Few Design Points
Studied Patient-Specific Testing on
Large Patient Database
Long Pre-Clinical/
Clinical Testing Extensive Design Exploration
In Silico Testing Validated
through Few (pre-)Clinical Checks
35 © 2011 ANSYS, Inc. October 10, 2011

33. Assess your design in a multiple physics
environment
Flow and Cooling
Power loss distribution
Radio Frequency
Vibration stress
36 © 2011 ANSYS, Inc. October 10, 2011

34. System Design - ANSYS Simplorer
Custom Simulation
Model, C IcePak
Simulink
Maxwell
Fluent Q3D ANSYS
Mechanical
37 © 2011 ANSYS, Inc. October 10, 2011

35. HBM full physics
CARDIOVASCULAR MUSCULOSKELETAL DRUG DELIVERY ELECTROMAGNETICS
Application areas: Application areas: Application areas: Application areas:
• Coronary stents • Orthopaedic implants • Transdermal • Medical imaging
• Peripheral stents • Exercise equipment • Inhalers • Cardiology products
• Artificial organs • Oral • Drug delivery
• Intrathecal
38 © 2011 ANSYS, Inc. October 10, 2011

36. Summary
39 © 2011 ANSYS, Inc. October 10, 2011

37. Summary
Simulation
• Do the what if’s
• Refine through virtual Prototyping
• Have confidence in your design
• Compliments regulatory approval
40 © 2011 ANSYS, Inc. October 10, 2011