agile medical device development

© Zühlke 2015

Agile Medical Device Development

Agile Medical Device Development | Erik Steiner, Thomas Weber 15. October 2015 Slide 1

© Zühlke 2015Agile Medical Device Development | Erik Steiner, Thomas Weber

Erik SteinerDipl.-Ing. (FH)

[email protected]

Senior Project Manager

> 17 yrs. professional experience Project management

agile and regulated Focus on development of

medical devices Located at Eschborn

15. October 2015 Slide 3

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Facts & Figures

• Over 8000 projects to our credit

• Turnover 119 Mio. CHF (2014)

• 700 Employees (end 2014)

• In Austria, Germany, Serbia,Switzerland and in the United Kingdom

• Foundation 1968, now owned by a group of managing partners

• ISO 9001 and 13485 certified


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Product Development & Software Solutions

• Creating innovative products all the way from the concept phase, through development and into mass production.

• Developing bespoke software solutions which combine innovation with stability and link business with software.

• Bringing experiences gained in many different industry sectors and disciplines.

• Using tried and tested development processes


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Agile device development – in feasibility and system design phases –

with a cross-functional team – electronics, mechanics, software,

microfluidics, optics, simulation, etc. –

based on SCRUM


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Time to market

Moving target

Undocumented requirements

etc.

Agile Medical Device Development | Erik Steiner, Thomas Weber

Device underdevelopment

EE/ME/SW

Not an end to itself!



The Method

Daily ScrumTime Boxed

Frequent Releases

ReviewsRetrospectivesPlanning



The Mindset

Act pragmatically!

Fail early!

Think and act in system context!

Talk, discuss, and ask!

Learn and adapt!

Think positive!

Don’t make assumptions!

Drive team success!

Define System-DoD!

Draw a common picture!

Act proactively!



The Realization

Where does the backlog come from?

How to use automated

testing?

How to integrate

continuously?

How to organize the

team?

How to realize the flow of

work?

…?


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Mindset!


Integration Strategy


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Product

Integr.Model

Integr.Model


Lab Model

Lab Model

Integr.Model

Integr.Model

Integr.Model


Fail early!

Learn and adapt!


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Product

Integr.Model

Integr.Model

Lab Model

Lab Model

Integr.Model

Integr.Model

Integr.Model


4 weeks

Continuous System Integration



Draw a common picture!

Talk, discuss, and ask!


Act pragmatically!

How to realize the integration

strategy???


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Mindset!


User Scenarios

System Architecture


Interfaces


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System Architecture


Technical Function m

Technical Function 5


UserSzenario n

UserSzenario 2

UserScenario 1

Technical Function x



Subsystem

User Interface

Subsystem

MicroController

Subsystem

Motion

Subsystem

SensingSubsystem

Stimulation


UserScenario 1

TF2

Test Scenario

1Test

Scenario 2

TF5

TFm



User Scenarios

System Architecture

Technical Risk Matrix


Interfaces

Mindset!



TechnicalRisk Matrix

Low< 30%

Medium30% … 70%

High> 70%

Criticalpotential

project killer

Majorsignificant

project delay

Moderateacceptable

project delay

Minornegligible

project impact

Sensing Motion

Stimulation

Microcontr.

User Interface

…

Probability of technical failure

Proj

ect i

mpa

ct in

cas

e of

tech

nica

l fai

lure

Risk eval. of scenarios and

functions

Results in subsystem

risk evaluation

Defines order of subsystem

integration


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Mindset!


User Szenarios

System Architecture


Degree-of-maturity-table


Interfaces



Laboratory ModelLabMo_1

Integration ModelIMo_1

Integr.Model

Integr.Model

Lab Model

Lab Model

Integr.Model

Integr.Model

Integr.Model


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Integration Step LabMo_1 LabMo_2 IMo_1 IMo_2 IMo_3 IMo_4 IMo_5

Scenario(s) coveredMotor movesreliable and

exact

Stimulationand sensing

works basicallyas designed

Motorintegrates withcontroller and

evaluationboard

Sensor System integrates with

Microcontr.

Motion andSensing

integrate withdevelopedmainboard

User Scenario1

User Scenario2

Release Date tbd tbd tbd tbd tbd tbd tbd

TestCheck

OscillogrammeCheck

OscillogrammeCheck

OscillogrammeCheck sniffed

DataCheck

regression, …Test Scenario

1, 2Test Scenario

1, 2, 3, 5

Deg

ree

ofm

atur

ityof

subs

yste

ms

Motion TF8 (70%)TF8 (100%)

TF9 (40%)TF9 (100%) TF8 (change)

Sensing TF2 (10%) TF2 (80%) TF2 (100%)

Stimulation TF5 (50%) TF5 (80%) TF5 (90%) TF5 (100%)

Microcontroller Evalboard Evalboard MainboardV0.8

MainboardV0.9

User Interface TF12 (15%)TF12 (85%)

TF15 (20%)

… TF… TF … TF …

Equipment & DeliveriesOTS-ControllerOscilloscope Oscilloscope Oscilloscope Oscilloscope,

Sniffer … Delivery bycustomer, …

Delivery bycustomer, …


Integration Steps

Scenarios to be provided by integration step

Subsystems

Integr.Model

Integr.Model

Lab Model

Lab Model

Integr.Model

Integr.Model

Integr.Model

Detailed description of degree of maturity and acceptance criteria

per integration step and subsystem





exact




evaluationboard


Microcontr.

Motion andSensing


User Scenario1

User Scenario2

Release Date tbd tbd tbd tbd tbd tbd tbd

TestCheck

OscillogrammeCheck

OscillogrammeCheck

OscillogrammeCheck sniffed

DataCheck

regression, …Test Scenario

1, 2Test Scenario

1, 2, 3, 5

Deg

ree

ofm

atur

ityof

subs

yste

ms

Motion TF8 (70%)TF8 (100%)

TF9 (40%)TF9 (100%) TF8 (change)

Sensing TF2 (10%) TF2 (80%) TF2 (100%)



MainboardV0.9


TF15 (20%)


Equipment & DeliveriesOTS-ControllerOscilloscope Oscilloscope Oscilloscope Oscilloscope,




© Zühlke 2015

Mindset!


User Szenarios

System Architecture




Interfaces

Integrationsteps

Backlog &Estimation



Technical PBI

Technical PBI

Technical PBI

Technical PBI

Backlog Items

LabMo_1Technical PBI

Technical PBI

Backlog Items

LabMo_2Technical PBI

Technical PBI

Technical PBI

Backlog Items

IMo_1Technical PBI

Technical PBI

User Story PBI

Technical PBI

Backlog Items

IMo_2User Story PBI

Technical PBI

User Story PBI

User Story PBI

Technical PBI

Backlog Items

IMo_3User Story PBI

User Story PBI

Technical PBI

User Story PBI

User Story PBI

Backlog Items

IMo_4User Story PBI

User Story PBI

User Story PBI

Backlog Items

IMo_5


Risk-driven technical focus Value-driven feature focus

Subsystem-Teams Functional-Teams Feature-Teams

Learn and adapt

Learn and adapt



Product Backlog

Technical PBI

Technical PBITechnical PBI


Technical PBI

Technical PBI

Technical PBI

Technical PBI

Technical PBI

Technical PBI

Technical PBIUser Story PBI


Technical PBI

User Story PBI

User Story PBI

User Story PBIUser Story PBITechnical PBI

User Story PBIUser Story PBI


User Story PBI


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Mindset!


User Szenarios

System Architecture




Interfaces

Integrationsteps

Backlog &Estimation

Team staffing

Deliveries

Integration step plan



LabMo_2

IMo_1

IMo_2

IMo_3

IMo_4

IMo_5

LabMo_1

Del

iver

y fo

r Lab

Mo_

1

TimeProduct

Backlog

Technical PBI



Technical PBI

Technical PBI

Technical PBI

Technical PBI

Technical PBI

Technical PBI



Technical PBI

User Story PBI

User Story PBI

User Story PBIUser Story PBITechnical PBI



User Story PBI



Effort per Integration Step [PD] LabMo_1 Lab_Mo2 IMo_1 IMo_2 IMo_3 IMo_4 IMo_5Electrical Engineering 46 8 11 4 55 9 16Mechanical Engineering 45 39 16 6 3 38 0Software Engineering 187 22 0 22 31 54 21Test Engineering 8 38 0 7 6 16 4

Expected Delivery Time [weeks] LabMo_1 Lab_Mo2 IMo_1 IMo_2 IMo_3 IMo_4 IMo_5Electrical Engineering 7 4 3 0 4 4 4Mechanical Engineering 12 4 2 0 0 4 0Software EngineeringTest Engineering

Expected Readiness LabMo_1 Lab_Mo2 IMo_1 IMo_2 IMo_3 IMo_4 IMo_5Electrical Engineering CW11/15 CW10/15 CW11/15 CW9/15 CW24/15 CW26/15 CW29/15Mechanical Engineering CW14/15 CW11/15 CW12/15 CW10/15 CW14/15 CW16/15 CW13/15Software Engineering CW09/15 CW12/15 CW15/15 CW15/15 CW19/15 CW24/15 CW32/15Test Engineering CW10/15 CW11/15 CW12/15 CW16/15 CW18/15 CW20/15 CW25/15

Estimated backlog

Delivery times from suppliers

Calculated readiness

times

Excel magic incl. staffing


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exact




evaluationboard


Microcontr.

Motion andSensing


User Scenario1

User Scenario2

Release Date CW 14/2015 CW 12/2015 CW 15/2015 CW 16/2015 CW 24/2015 CW 26/2015 CW 32/2015

Equipment & Deliveries

CheckOscillogramme

CheckOscillogramme

CheckOscillogramme

Check sniffedData

Checkregression, …

Test Scenario 1, 2

Test Scenario 1, 2, 3, 5

Deg

ree

ofm

atur

ityof

subs

yste

ms

Motion TF8 (70%)TF8 (100%)

TF9 (40%)TF9 (100%) TF8 (change)

Sensing TF2 (10%) TF2 (80%) TF2 (100%)



MainboardV0.9


TF15 (20%)


TestOTS-ControllerOscilloscope Oscilloscope Oscilloscope Oscilloscope,




© Zühlke 2015


Scenario(s) covered



Motor movesreliable and

exact


evaluationboard


Microcontr.

Motion andSensing


User Scenario1

User Scenario2

Release Date CW 12/2015 CW 14/2015 CW 15/2015 CW 16/2015 CW 24/2015 CW 26/2015 CW 32/2015

Equipment & Deliveries

CheckOscillogramme

CheckOscillogramme

CheckOscillogramme

Check sniffedData

Checkregression, …

Test Scenario 1, 2

Test Scenario 1, 2, 3, 5

Deg

ree

ofm

atur

ityof

subs

yste

ms

Motion TF8 (70%)TF8 (100%)

TF9 (40%)TF9 (100%) TF8 (change)

Sensing TF2 (10%) TF2 (80%) TF2 (100%)



MainboardV0.9


TF15 (20%)


Test Oscilloscope OTS-ControllerOscilloscope Oscilloscope Oscilloscope,




© Zühlke 2015

Mindset!


User Szenarios

System Architecture




Interfaces

Integrationsteps

Backlog &Estimation

Team staffing

Deliveries

Integration step plan



Much more aspects!

Iteration Metaphor

Estimation Method

Planning Poker

Earned Value Analysis

Self-organization

Team skill Composition

Meeting Structure

Planning & Reviews with

Customer

Team Retrospectives

Office Organisation

…!

Technical Infrastructure

Customer’s mindset for deliveries



Conclusions

Degree-of-Maturity Tableas Core of Agile Device

Development Communication with customer

Team communication Learn and adapt

Continuous work and improvement of team mindset

Continuous assessment and

adaption of planning



Zühlke. Empowering Ideas.
