Role of Modeling and Virtualization In Medical Device Development
• White Paper
solutions overview
Abstract
The medical devices and diagnostics industry is
increasingly adapting advances in information
technologies and systems for better diagnosis,
delivery of treatment, product lifecycle
management, new functionalities and features,
enhanced usability and product innovations to
reduce time-to-market. Software is playing a
major role in new features and functionalities
of devices, introducing an additional dimension
to the product development process. With an
increasing focus on regulatory compliance in light
of adverse incidents, these challenges can be more
effectively tackled by leveraging information
technologies. Modeling and simulation is one such
Advances in technology have enabled the
integration of mathematical models and
virtualization on a single platform. This platform
can be seen as a key enabler to reduce time
and cost while prototyping medical devices
and systems. Mathematical models that mimic
the functional behavior of a system have
found applications in various domains such as
process control and automotive, where these
models have been successfully deployed for
design, operational control and optimization
and diagnostic solutions. Recently, the medical
device industry has begun exploring the use of
models for new product introductions, improving
performance or reliability of existing designs
and overall re-engineering. Virtualization allows
the simulation of hardware components with
concurrent operating systems before actually
building the hardware prototype. Mathematical
models in conjunction with the simulated
hardware and applications forms the complete
system simulation.
This paper provides an overview of systems
modeling and its relevance to virtualized,
platform-based solution development. Such a
virtual platform allows device manufacturers
to use a range of simulation technologies with
which to test products for feasibility, design
sensitivity, performance, reliability, endurance,
safety and any other issues. A typical infusion
pump provides a good example to illustrate the
modeling paradigm and its applicability.
Overview
Medical device manufacturers make devices that
range from implants, to analyzer equipment,
pumps and dosing devices, sedation systems,
intelligent scanners and disposables used as
surgical aids. The challenge for medical device
manufacturers is to accelerate time-to-market
and stay lean on cost, without compromising
quality and regulatory norms. Their lifeline
depends on continuous improvisations and
innovations, leading to a stream of products
across segments. Additionally, there is a growing
need for adding electronics and intelligence
solutions overview 2
into devices. Such “electronic” medical devices
are becoming intricate due to multiple boards,
processors, operating systems and complex
decision making processes.
The typical product life cycle for a medical device
is shown in Figure 1.
The design phase covers stages such as ideation
and research, product design or prototyping, 1
2. The design phase, especially prototyping,
goes through various iterations, adding to both
cost and time. Functionality changes or design
alternatives means re-testing and validation,
hardware iterations. The absence of an interacting
environment limits the ability to achieve the
required functionality, which can be validated
during clinical trials only after the prototype
is developed. Compliance with regulatory
and effort, since the product and development
process itself is subject to scrutiny. Thus, to
perform hardware prototype testing for every
new product development cycle -- or to conduct
systematic analysis during re-engineering -- is
both costly and time consuming.
Modeling and Virtualization Paradigm
in addressing the needs of faster development
can be incorporated within model and software
simulations. Simulations comprise both the
functional behavior of the device or system and
the hardware components. The virtual platform-
based approach has three main elements.
Modeling that mimics the behavioral
functionality of the device and the interacting
systems.
Embedded hardware device simulation that
mimics the behavior of the target board
(CPU, memory, battery, etc.), enabling quick
The ability for models running on the
Windows platform to coexist and interact
with embedded target hardware simulators
and the functionality of the device running
on an embedded operating system on a
single PC.
The role of a virtualized platform in medical device
development is depicted in Figure 2.
Modeling involves the use of a mathematical
representation to describe a system. This can
be in the form of equations, data-driven models
or representations developed from domain
experts’ knowledge. Various techniques can be
used, such as CFD, parametric techniques, black-
box methods such as neural networks and other
A virtualized platform consists of a mix of virtualized
systems development (VSD) and virtualization.
VSD is product development without the use of,
or need of, the target hardware platform on which
the software will eventually run. With VSD, the
target hardware is simulated and runs on each
developer’s development workstation. For the
target software, the virtualized target hardware
Medical Devices Product Lifecycle
Ideation & Research Product
Design
Sustenance
PMA &510 (k)
Support
Testing &
Medical Device Product Life Cycle
Figure 1
Figure 2
SW – HMI, Hardware Model
Test Plan, Environment
Environment Model
Program
Quick design
savings
Virtual
thus fewer trials,
Environment Model
MonitorHardware
Model
Design
Develop
Run
Prototype Device
Clinical Trials
Hardware
industry-standard techniques
Develop the systems with the applicable IDE
Manufacture prototypes
Find only usability issues as
previous phase
Prepare for Study Environment
disparate OS, data sharing
behaves exactly the same as the physical target
hardware. The schematic representation of VSD
is shown in Figure 3.
Schematic VSD
Virtualization is a technology that allows the
concurrent running of two or more operating
systems on a single PC or embedded system, and
is being rapidly adopted in the engineering world.
It is enabled by a hypervisor, which is a software
layer that abstracts the hardware from the
operating system, permitting multiple operating
systems to run. A candidate representation of
virtualization is shown in Figure 4.
Representation of Virtualization
A virtualized platform allows for configurability
of design, enabling designers to iterate designs
quickly and develop a robust solution architecture
after considering all the possible alternatives in a
virtual manner. The simulations on a virtualized
platform help designers conduct what-if
analysis on various design aspects instead of
experimenting on developed hardware that could
be limited, underachieving and expensive.
Modeling medical devices or equipment can
be done mainly for new product development,
re-engineering or re-design. Such models can
learn from expert information or from an
experimental database. Models can be developed,
with appropriate fidelity, using tools such as
Matlab, Scilab, Mathematica, etc. The VSD
allows developers to define, develop, deploy and
integrate target-specific firmware, operating
system kernel and device drivers, and application
and communication stacks, even while the
hardware design and production progresses in
parallel, while virtualization allows them to save
costs, reduce footprint and consolidate systems.
The following section illustrates the use of
mathematical model and virtualization technology
for the design of a typical infusion pump. The
infusion pump is designed to provide a measured
flow of infusion fluid, medication or nutrients
to the patient. It has three major components:
the fluid reservoir, a mechanism such as a tube
for transferring the fluid to the patient and a
mechatronic system to generate and regulate flow.
The regulation of the drug concentration in the
body to achieve and maintain the desired result is
highly critical. An under-dosage may not provide
sufficient treatment, while an overdose can
produce dangerous side effects. The industry is
currently experiencing an increase in the number
and severity of infusion pump product recalls1.
solutions overview 3
Figure 3
Virtualized Target System with
Application
Application program and interfaces
Target operating system
Target hardware drivers and boot code
PC
Processors Memory Devices Network I/O
Figure 4
App1
Embedded OS
Hypervisor/Virtual Machine Monitor
Shared hardware
Another OS(Windows)
App1App1 App1
Advantages of VSD
• What-if analysis of various architectures and design• Identify problems early • Quicker detection and resolution of bugs• Highest quality assurance, early validation and
automated testing• Optimize hardware and software co-development to
produce higher quality systems in less time• Improve on time to market and overall saving in
development and deployment costs
On a broad level, Modeling serves as
• Enabler for new product development,• Platform for re-engineering and re-design. • Catalyst in choosing right-fit technology
alternative,• Tool to perform sensitivity analysis on various
design
Benefits of Virtualization
• Save Hardware cost and footprint• Make use of multi-core processors• Test beta systems and maintain legacy ap-
plications• Increase system security• Reduce time to market
This underlines the necessity of a platform to
experiment with and accelerate development.
Use of Modeling and Virtualization for Designing Infusion Pumps
The infusion pump is designed to provide
measured flow of infusion fluid, medication
or nutrients to the patient. It has three major
components, fluid reservoir, mechanism such as
tube for transferring the fluid to the patient and
mechatronic system to generate and regulate
flow. The regulation of the drug concentration
in the body to achieve and maintain a desired
result is highly critical. Underdose may not
provide sufficient treatment, while overdose can
produce side effects. Infusion pump in current
scenario is going through a phase where there
is rise in number and severity of product recalls
[1]. This underlines the necessity of a platform;
to experiment and accelerate the development.
The infusion pump is an intricate system
comprising mechanical, electrical and software
systems. A high-level schematic of a typical pump
is shown in Figure 5. The pump motor drives the
mechanism, including the gearbox and cam, to
achieve the required reciprocating action, such
as valves and/or shuttle mechanisms, that results
in the squeezing and unsqueezing of the tube.
This operation provides a positive displacement
of fluid, thus delivering the requisite fluid flow to
the patient. The accuracy of the output flow is
a critical performance parameter, and typically
there is no feedback available for it. The motor
controller is a hardware platform to which all the
sensors are interfaced, and it generates a control
signal for the motor operation. The power and
battery module manages the power supply for
the set-up.
High-Level Schematic of an Infusion Pump
The motor, and the associated drive mechanism
along with the tube, can be modeled using
tools such as Matlab. This detailed, high-fidelity
mathematical model helps in understanding the
interaction of the various subsystems, as well
as with optimizing overall system performance.
The motor controller and power and battery
target hardware are simulated on the virtualized
platform. The strategy and functionality code for
both is developed using a standard integrated
development environment and is integrated
into the virtual platform. The user interface
is developed on a platform for configuring
hardware and functionality parameters. Various
design alternatives can be tested by varying
these parameters. The mathematical model
developed in the Matlab environment runs on the
Windows OS and interfaces with the simulated
motor controller and power module through the
virtualized platform.
Virtualized Infusion Pump
Figure 6 shows the virtualized platform for
designing the infusion pump.
This virtualized platform offers the following
advantages.
� The opportunity to test different components
of the power module and motor controller.
� Mathematical models that enable design
sensitivity analysis, in the form of technology
change, material changes, etc.
� Testing of the end-to-end functionality of
the power module and motor controller.
� Minimal performance degradation from the
simulated hardware to the actual hardware.
� Ability to host various operating systems
that could be crucial from a functionality
perspective. For example, models can
solutions overview 4
Patient
Motor Controller
Power and Battery Module
Sensors(Temp, Pressure, Position etc.)
Drive Mechanism
Comprises gearbox, cam, valves, shuttle etc.
TubeAdministered
flow
Motor
Simulated hardware and functionalityMathematical model
Figure 5
Figure 6
Virtualized platform
User Interface
Data exchangeacross OS components
Configurator Display
Power module functionality
Power module Embedded OS
Power module hardware
Motor controllerfunctionality
Motor controller Embedded OS
Motor controller hardware
Behavioral functionality using
modeling tools
Windows OS
PC / Hardware
be executed on the Windows OS, as the
numerical methods or solvers are best
suited for such an operating system,
whereas hardware functionality needs a
real-time operating system.
Ability to perform data exchange between
disparate operating system applications.
Facilitation of experimentation, such as
Ability to more easily develop performance
analysis and test automation tools.
The Road Ahead
A number of things need to be addressed when
using a development platform for design at this
time.
Supporting various types of hardware
devices from different manufacturers.
time performance.
tested in real time.
Handling complexity issues due to
hierarchical scheduling as part of
virtualization.
Developing life cycle development tools for
analyzing performance, timing, memory,
code coverage and enabling test automation
for the virtual platform.
Conclusion
Modeling and virtualization together provide a
systematic integrated platform to accelerate the
can be expected across the ideation and research,
prototyping and sustenance stages, where models
can be exploited for system representations,
enhancements and re-engineering, while the
iterations in system prototyping can be reduced
through virtualization principles.
References
1. Total Product Life Cycle. FDA. www.fda.gov
2. National Instruments. www.ni.com
3. AJ5800 Volumetric Infusion Pump
operation manual.
4.
Baxter.
5. Wind River Systems Inc. www.windriver.com
6. Virtutech. www.virtutech.com
7. Eureka Infusion Pump operator’s manual by
Universal Medical Technologies.
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