closing the loop on medical device systems simulation
TRANSCRIPT
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
Closing the Loop on Medical Device Systems Simulation
Marc Horner, Ph.D.
Technical Lead, Healthcare
ANSYS, Inc.
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
A. Healthcare Industry Overview• Systems Engineering for Medical Devices
• Digital Systems Prototyping
• Regulatory Update
B. Insulin Pump Example• Background
• Drug Delivery Sub-system Model• Kink Detection Modeling
• Virtual Patient Modeling
C. Conclude
Outline
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
Healthcare Industry Overview
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Electric Smarter Connected
* Cogizant, How the IOT is Transformng Medical Devices, May 2016
Today’s Medical Devices are Increasingly
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
Electronic Control
Embedded Software
Sensors
Actuators
Components
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
Electronic Control
Embedded Software
Sensors Operating Conditions
Safety Requirements
Operational Profiles
Actuators
…are ultimately part of a system
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
Electronic Control
Embedded Software
Sensors Operating Conditions
Safety Requirements
Operational Profiles
Actuators
…with complex interactions.
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
Challenge: System Complexity
• Understand and optimize performance
• Eliminate late-stage integration failures
• Improve collaboration among design disciplines
• Enhance or reduce physical testing
• Accelerate innovation
Digital System Prototyping
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
Design Still Happens in Silos
Each discipline has its’ own set of tools, processes, and expertise.
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
Systems Engineering: A Unifying Approach
Reduced Order
Model Creation
System Model
Interoperability Embedded Software
IntegrationCo-simulation
with 3D Physics
Language-Based
Modeling
Multi-Domain
Model Libraries
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
Reduced Order
Model Creation
System Model
Interoperability Embedded Software
IntegrationCo-simulation
with 3D Physics
Language-Based
Modeling
Multi-Domain
Model Libraries
Thousands of Built-in
Component Models
Industry Standards
for System Modeling
Interfaces with all ANSYS 3D Physics 3rd Party System
Modeling Tools
ANSYS SCADE
and More
Systems Modeling– Model Flexibility, Reusability, and Interoperability
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
System Simulation & Digital Twins
Simplorer
Model-Based Software Engineering
Model-Based Systems Engineering
System/SW Architecture
System Safety Analysis
System Architecture
The ANSYS Portfolio
3D Physics Simulation
RO
M
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
FDA Analyses of Product Recalls
“failures in product design and manufacturing process control caused more than half of all product recalls”
1. from FDA Report “Understanding Barriers to Medical Device Quality” (2011)
“The most frequent causes for recalls are related to device design,software, and non-conforming material or component issues.”
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsechttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm209042.htm
“many of the reported problems appear to be related to
deficiencies in device design and engineering”
Infusion Pump Safety
http://diyabetimben.com/diyabet-muzesi/
1963
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
Insulin Pump Model
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
What is Diabetes?
diabetes image from https://i.ytimg.com/vi/SCCb5GqhnrI/maxresdefault.jpgPump image from http://www.medtronicdiabetes.com/products/minimed-530g-diabetes-system-with-enlite
• Insulin is a hormone created by the pancreas. It is required for sugar molecules (from the food you eat) to move inside cells. Patients with diabetes either do not produce insulin (Type 1) or do not use insulin the right way (Type 2).
• Insulin pumps replace the function of the pancreas by injecting insulin under the skin throughout the day.
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
HBM EM
Catheter
Manufacture
Antenna
Design/Optimization
Electro-
Mechanical
Design
Drug
Delivery
Catheter Kink
Testing
Catheter Pressure
TestingCatheter
Occlusion ROM
Embedded Software -
Display
Drop Test
Embedded Software
- Controller
Components, Components, Components
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
Drug Delivery Sub-System
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
EMBEDDED SOFTWARE
ELECTRICAL
FLUIDIC+MECHANICAL
Drug Delivery Sub-SystemM
OD
EL D
OM
AIN
S
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
display controller
power
electronicshydraulics
kin
k d
ete
ctio
n
volu
me
de
live
red
INFO
RM
ATI
ON
FLO
WDrug Delivery Sub-System
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
Pressure-Flow Analysis of Tube Bending
ROM
Family of Structural Fluid Simulations
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Q
bend
DPkink
REQUIREMENT:if Psensor > Pthreshold
then (imotor = 0;warn patient; )
Psensor = DPcath + DPcannula + DPkink
Insulin Pump – ROM Behavior
DPcath = 𝟏𝟐𝟖𝝁𝑸𝑳𝒄𝒂𝒕𝒉
𝝅𝑫𝒄𝒂𝒕𝒉𝟒
DPcann = 𝟏𝟐𝟖𝝁𝑸𝑳𝒄𝒂𝒏𝒏
𝝅𝑫𝒄𝒂𝒏𝒏𝟒
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
Drug Delivery Sub-SystemV
IRTU
AL
PATI
ENT
Couple the device model to a patient predictive model
of glucose metabolism.
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
Virtual Patient ModelTwo-compartment insulin model
Two-compartment glucose model
Insulin effectiveness
• The patient model requires a mathematical representation of the relevant physics.
• The model should capture insulin metabolism as well as the ability of insulin to effect glucose uptake into cells.
• Researchers and industry typically rely on pharmacokinetic/pharmacodynamics (PK/PD) modeling to represent these processes.
*Kanderian et al., Identification of Intraday Metabolic Profiles during Closed-Loop Glucose Control in Individuals with Type 1 Diabetes, J Diabetes Sci and Tech , Vol. 3 (2009).
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
Virtual Patient ModelTwo-compartment insulin model
Two-compartment glucose model
Insulin effectiveness
*Kanderian et al., Identification of Intraday Metabolic Profiles during Closed-Loop Glucose Control in Individuals with Type 1 Diabetes, J Diabetes Sci and Tech , Vol. 3 (2009).
CLINICAL DATA
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
Dig
ital
Tw
in
Execution Layer
S
Monitor & Visualization
Ph
ysic
al A
sse
tDigital Twin Predictive Platform
MIoT Connector
S
ROM Builder Data Layer - Device
Simulation DataReal Test DataPLM/ERP/etc.S
ROM Builder Data Layer - Patient
Simulation DataElectronic Medical RecordPatient Physiology
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
▪Chronic diseases and the aging population are placing significant strain on healthcare systems, motivating the need for more effective medical technologies.
▪ The risk (and failure) of medical devices has increased since incorporating new technologies and functionality, much of which is related to embedded software.
▪Systems modeling can improve the robustness and safety of today’s medical devices.
▪Digital twins for implanted devices that include models of human physiology (enabled by computer modeling) can improve treatment outcomes.
Conclusions
19-20 April, 2018 Twin Cities, MinnesotaHow Systems Engineering Can Reduce Cost & Improve Quality #hwgsec
Thank you for attending!Share your experiences at #HWGSEC
Copyright © 2018 by Marc Horner. Permission granted to INCOSE to publish and use.