Model-Based Design with MATLAB and Simulink to shorten the ... · prototyping Hardware In the Loop Rapid control prototyping System requirements Model refinement MATLAB Simulink Stateflow

APPLICATION

DEVICES

Model-Based Design

with MATLAB and Simulink

to shorten the design of a new

infusion pump

Fresenius Approach

Claude VITTORIA, Fresenius Kabi

Model-Based Design to shorten the design of a new infusion pump

About Fresenius Kabi

Medical market issues to guide Fresenius decisions

Model-Based Design in the product development

Lessons learned and perspectives

MATLAB EXPO – October 2nd 2014 © Copyright Fresenius Kabi AG 2






© Copyright Fresenius Kabi AG 3MATLAB EXPO – October 2nd 2014

Fresenius organization

© Copyright Fresenius Kabi AG 4

• Infusion devices• Dialysis• Equipments• Services

• Employees: 86 000

• Infusion therapies• Nutrition therapies• Medical Devices• Transfusion


• Hospital Operations


• Engineering & Services• Healthcare facilities

• Employees: 4400

• Sites in over 100 countries• Turnover: 19 200 M€• Employees: 170 000

MATLAB EXPO – October 2nd 2014

FRESENIUS KABI AG Medical Devices : A global solution














Stakes & ChallengesWhy Model Based Design ?

Improve design process

– Scenario validation

– Increase collaboration

– Knowledge sustainability

– Code validation for verification

Reduce time to market

– Speed up algorithm validation

– Automatic code generation

Prepare Medical Certification

– Refine requirements & traceability

– Model verification & validation

11© Copyright Fresenius Kabi AGMATLAB EXPO – October 2nd 2014

How to get started ?

– Blank page syndrome

– Which Process and Methodology ?

Which tools to achieve our objectives ?

– Combination of physical model and control algorithm

– Simulation, rapid prototyping and production code generation

– Certification

Mathworks solution

– Tools (Simulink, Simscape, Stateflow)

– Services (training, follow-up)

– Proven in use in other industries

Stakes & ChallengesSimulink to address MBD for Medical devices


Simulink or Simscape ?

Why Simscape ?

– knows I.S. units, simulation faster, rigor

– Simulink assists to define and to tune the equations

Physical Model


)()()()( tFtkxtxbtxm

Simulink or Stateflow ?

– No continuous regulation (PI, PID) in our products

Why Stateflow ?

– FSM theory (Moore, Mealy, actions, events)

– Lifecycle representation

– Debug tools

– Easy time segregation for code generation

Control algorithms





Model-Based Design at Fresenius



Model-Based Design at FreseniusOverview

16

System requirements

Modelrefinement

Processor In the Loop

On-target prototyping

Hardware In the Loop

Rapid control prototyping

© Copyright Fresenius Kabi AGMATLAB EXPO – October 2nd 2014

New product shall be compliant with

Medical Devices 60601-1 3th edition

and60601-2-24 2th edition

Make a simple physic

– Stay dynamic, let’s use parameters

– Simulate and validate the model without physical constraints

Make the first iteration of the algorithms

– Validate hypothesis and refine the requirements

Model-Based Design at FreseniusModeling






System requirements

Modelrefinement

MATLAB

Simulink

Stateflow

Simscape

MATLAB Coder

Simulink Coder

Simulink Verification & Validation

MATLAB Report Generator

Simulink Report Generator

17

04/2013 Licenses purchase

06/2013First Simulink

models


models

Simulation

– Try...Mine...Try again

– Quickly & Faster

– Improve targeted performance

Cost reducing conception

– Validate requirements

– Track non reasonable requirements

– Refine requirements to help the choice of technologic solutions

Model-Based Design at FreseniusHypothesis & simulation






System requirements

Modelrefinement

18

MATLAB

Simulink

Stateflow

Simscape

MATLAB Coder

Simulink Coder






models

11/2013Validate

requirements


models

02/2014Validate

requirements

Use your conception and your algorithms

– Stop to modify existing to get a mechanic animated

– Break the existing limitations

– Validate technologic solutions

– Confirm model and simulation

Develop validation plan earlier

– Better maturity of plan and team

Model-Based Design at FreseniusRapid prototyping






System requirements

Modelrefinement

MATLAB

Simulink

Stateflow

Simscape

MATLAB Coder

Simulink Coder




19



models

08/2013Rapid

Prototyping

11/2013Validate

requirements


models

02/2014Validate

requirements

04/2014Rapid

Prototyping

Validate algorithms and their precisions

– Keep advance, choose a compatible target (Texas Instruments toolbox)

– Code coverage tests

– Valid calibration process

Create functional tests for the product integration

– HW filters fit to the mechanical behavior

– Push the limits of HW

Model-Based Design at FreseniusProcessor-in the-Loop and on-target






System requirements

Modelrefinement

MATLAB

Simulink

Stateflow

Simscape

MATLAB Coder

Simulink Coder




20



models

07/2014Tests on

HW

08/2013Rapid

Prototyping

11/2013Validate

requirements


models

02/2014Validate

requirements

04/2014Rapid

Prototyping

05/2014Tests on

HW

Repeatability of the validation plan

– No regression, play the same tests again, again and again

Complex tests

– Hypothetic failures, unlikely use

– Push the limits of Sw/Hw

Model-Based Design at FreseniusHIL based on Simscape model






System requirements

Modelrefinement

MATLAB

Simulink

Stateflow

Simscape

MATLAB Coder

Simulink Coder




21



models

07/2014Tests on

HW

08/2013Rapid

Prototyping

11/2013Validate

requirements


models

02/2014Validate

requirements

04/2014Rapid

Prototyping

05/2014Tests on

HW

Document in the model

– Requirements and justifications

Verification & Validation

– Referenced requirements from external documents in the model

– Create tests and reference for validation plan

– Create automatic regression test suits

Report generator

– Generate conform documents to the quality assurance

Model-Based Design at FreseniusRequirements & Traceability






System requirements

Modelrefinement

MATLAB

Simulink

Stateflow

Simscape

MATLAB Coder

Simulink Coder




22



models

07/2014Tests on

HW

06/2014Generate

documentation

08/2013Rapid

Prototyping

11/2013Validate

requirements


models

02/2014Validate

requirements

04/2014Rapid

Prototyping

05/2014Tests on

HW

06/2014Generate

documentation







Achieving technology together

– How to integrate in the existing ?

– Which perimeter ?

Try to meet any type of interrogations

– Theory vs Practice

Take care to be compatible with our solution choices

– Technical and tooling

Tools are skill-less but helpful

– Find the Know-how

Warned about


BenefitsExplore technical solutions


Validate technical choices early

– Simulation

– Rapid prototyping

Get a specification faster with a better confidence

– Explore more solutions through simulation

– Justify choices

BenefitsTeam work


Provide solutions to help the teams

– Rapid prototyping

– SIL/PIL

– Code generation

Greater interaction between the teams

– Model

– Prototypes

– Tools

– Specifications

MATLAB EXPO – October 2nd 2014 © Copyright Fresenius Kabi AG 27

BenefitsTests & Validation

Think tests and validation earlier

– Document

– Trace requirements

– Create tests

Quality of tests

– Exhaustively

– Define the exact behavior of the product

Time and effort

– Better vision

– Better control

– Good practice in place

Next step

© Copyright Fresenius Kabi AGMATLAB EXPO – October 2nd 2014 28

Run more tests on Simulink models

– Formal proof

Production code generation

– Embed algorithm into microcontroller (volumetric pump and syringe pump)

Develop new ranges of pumps

– Reusability



Thanks for your attention

Documents

Model-Based Design with MATLAB and Simulink to shorten the ... · prototyping Hardware In the Loop Rapid control prototyping System requirements Model refinement MATLAB Simulink Stateflow