Refsq 2011 03 29 V3

Agile Requirements EngineeringAgile Requirements Engineering in a Large Platform Project: g jChallenges, Solutions

d B t P tiand Best PracticesREFSQ 2011REFSQ 2011EssenMarch 29, 2011

© Siemens AG 2011. All rights reserved.

Contents

Goals Goals

Brief look on Siemens Healthcare

Business challenges

Lean Requirements EngineeringLean Requirements Engineering

Business case and key take-aways

Further Information

Page 2 Arnold Rudorfer, Siemens Healthcare I&T SYNGO© Siemens AG 2011. All rights reserved.

Contents

Goals Goals


Business challenges



Further Information


G lGoals

Disc ss an agile / lean RE Discuss an agile / lean RE approach for medical device development

Present challenges, solutions, benefits using agile / lean in REagile / lean in RE


Contents

Goals Goals


Business challenges



Further Information


Siemens HealthcareTHE I t t d H lth CTHE Integrated Healthcare Company

in-vivo diagnostics (imaging)

X-Ray ComputedTomography

MagneticResonance

MolecularImaging

Ultrasound Oncology

in vitro diagnostics (laboratory systems)

Tomography Resonance Imaging

syngo.via

in-vitro diagnostics (laboratory systems)

Immunodiagnostics Clinical ChemistryNucleid AcidTesting

Hematology Lab AutomationUrinAnalysis

Near PatientTesting


syngoTh C t l I H b I H lth W kflThe Central Image Hub In Healthcare Workflows

More patient exams in less time*

Sound diagnosesin less time*

Effi i t i S th d f tEfficient image creation, usage, archiving, and sharing

Smooth and fast collaboration

syngo. It’s all about you.


syngo. It s all about you.*Results may vary. Data on file.

Example: syngo.mCT OncologyO l W kfl T D t ti St i

Automated Case Preparation Multi-Modality AccessDisease-Oriented Reading

Oncology Workflow: Tumor Detection, Staging

Automated Case Preparation Multi Modality AccessDisease Oriented Reading

Automated bone and bloodpoolremoval

Automated sorting of images, etc.

Image fusion for CT, PET, and MR images, etc.

Preferred layout applied Automated lesion segmentation Automatic loading of prior exams, etc.

Page 8 Arnold Rudorfer, Siemens Healthcare I&T SYNGO© Siemens AG 2011. All rights reserved.Courtesy of University Hospital of Munich-Grosshadern/ Munich, Germany © Siemens AG 2011. All rights reserved.

syngo.mCT Oncology is cleared in the U.S. with syngo.PET&CT Oncology.

Siemens HealthcareD l t f S l d E l N b

Sales according to region1)

Development of Sales and Employee Numbers

Germany9%

Sales according to region

0.7 0.9

Europe (without Germany)

31%

Asia & Australia17%

0.9 1.0 1.1

Americas Employees according to region2)Americas

43%p y g g

Asia & Australia17%

Europe(without Germany)

Germany23%

17%19%11.49.7 11.3


1) Basis: FY 2009 acc. To customer locations. 2) Figures worldwide as of Sept. 30, 2009Americas

41%

Contents

Goals

Contents

Goals Goals

Brief look on Siemens and Vector

Goals


Project syngo.via

Business challenges

Business challenges

Lean Requirements EngineeringBusiness challenges

Lean Requirements Engineering



Results and Summary

Further Information

Further Information


B i Ch llBusiness Challenges

En ironmentEnvironment: Shorten time-to-market

Cuts in healthcare budgets Cuts in healthcare budgets

Continuous product innovation

Product development:Value-orientation

Flexibility

Risk Orientation


Contents

Goals

Contents

Goals Goals


Goals


Project syngo.via

Business challenges

Business challenges

Agile / Lean RequirementsBusiness challenges


Agile / Lean Requirements Engineering

Business case and key take-aways Results and Summary

Further Information

y y

Further Information


Disclaimer:Disclaimer:

The content discussed in this presentation needs

to be considered as work in progressto be considered as work in progress.


P j t i P d t

P j t O i

Project: syngo.via Product

Project Overviewsyngo.via: Next generation imaging software for the entire g greading process

Project data: > 5,000 single product requirements Several million lines of code

C++/C# Several hundred developers in Several hundred developers in

many locations Clinical applications for Radiology,

PACS, X-Ray, CT, PET/SPECT, Oncology, Particle Therapy and MR can be developed


RE Issues in the ProjectP i P i P i t t l k tPressing Pain-Points to look at …

Ambiguity and Lack of Accuracy of Specifications

V-model life-cycle does not allow for flexible adaptations

High manual effort for traceability and auditability

Engineering artifact structure does not facilitate market valuation


Pain point 1 + 2: V-model & Engineering Artifact St tStructure

Solutions:Selected issues to deal with:A. Feature model

B. Value-based ranking of

Selected issues to deal with: Domain model for imaging

software partially complete Scope for release planning difficult

featuresC. Incremental requirements

engineering

Scope for release planning difficult to define

Need to short development lifecycle – outdated requirements


engineeringlifecycle outdated requirements

S l ti A F t M d lSolution A: Feature Model

Highest Level Benefits:Highest Level Benefits: Higher level abstraction of grouping of

requirements into sellable units: From

5,000 product requirements to 800+

features (factor ~ 6)

Visual domain model for healthcare

Graphical View

workflows (tree & graphical)

Reduction of (re-) scoping effort by ~ 30% (*)

Reduction in time to understand

aspects of the system

Hierarchical relationships enableHierarchical relationships enable

mapping of stakeholder requests and

visualize dependencies


Hierarchical View

S l ti B V l b d R ki f F tSolution B: Value-based Ranking of Features

Characteristics:Characteristics: Ranking is used to determine the release

backlog Main criteria for ranking are business value,Main criteria for ranking are business value,

technical risk and effort

Benefits: Only features with the highest business

value (and feasibility) are implemented Feature independence assures

parallelization of development Simulation of optimal release plan (what-

if analysis)if analysis)


Solution C: Incremental Requirements E i iEngineering

From Feature ModelFrom Feature Model

Characteristics: High-level features are elaborated

Benefits:

Min 25% reduction of upfront High-level features are elaborated when needed – just enough specification before implementation

Min. 25% reduction of upfront requirement engineering work, just-in-time (*) Elimination of unnecessary hand-offsimplementation

Top-ranked features will be refined & assigned for implementation

Elimination of unnecessary hand offs between development roles ~ 20% reduction of life-cycle time

through concurrent engineering (**)


through concurrent engineering ( )(**) Source: Experience of agile clinical/ financial information systems projects(*) Source: MS Team Foundation Server Business Case, May 2010

Agile / Lean Requirements EngineeringE b dd d i th E ti D l t Lif lEmbedded in the Entire Development Life-cycle


Process-Adaption: F V M d l t A il D l tFrom V-Model to Agile Development

Old“ V M d l P„Old“ V-Model ProcessD2 D3 D4

Implementation

N “ A il / L P

Specification+ Plan

Design Input

Test+ Repair

System-test

ITStart Commit Accept

ITEndD2 D3 D4

„New“ Agile / Lean Process

Commit AcceptD2 D3 D4

F ibilit

Plan Implementation+ Test + Repair

Test+ Repair

System-test

DesignInput

Feasibility

D

p Repair test


DonenessReadiness

Pain point 3: Ambiguity and Lack of Accuracy of S ifi tiSpecifications

Level Requts. Manually Manual test

Issues: Textual use case descriptions work only

for smaller projects < ~ 100

Level Requts.Object

Manually Embedded graphs

Manual testcase creation

Document Requt. 1(text)

Picture / diagram

requirements Natural language subject to

interpretation, usually inconsistent, incomplete with inccorrect version (and

Features

(text)

Requt. 2(text)

Picture / diagram

p (conflicting)

Root causes:T t l i t i i d t

Paragraph Requt. 3(text)

Picture / diagram

Textual requirements engineering do not scale for platform projects

Missing versioning No direct access to single requirements

Solutions:

D Application Use Cases Lack of product structure Inconsistently executed change

management process

D. Application Use Cases


Solution D: Graphical Modeling of Clinical W kfl

Characteristics:

Workflows

C a acte st cs Used to describe clinical workflows that

consist of a collection of steps in a defined sequence together with accompanying specification of pre-/post-conditions, business rules, performance aspects, etc.

Benefits:

Increase expressiveness of clinical kfl t d ib d i b h iworkflows to describe dynamic behaviors

Early analysis of stakeholder requests from customers; joint modeling sessions to d ib th d f th t ‘describe the needs from the customer‘s point of view Reduction of review times due to visual

approach (~ 40%)


approach (~ -40%)

Major Changes - RecapL R i t E i iLean Requirements Engineering

Feature Model Feature Model

Value-based Ranking of Features

Incremental Requirements Incremental Requirements Engineering

Graphical Modeling of Clinical Workflows


Some Key Differences: Traditional- and Agile/ L R i t E i iLean Requirements Engineering

Traditonal Agile“Lean”

Traditional RE Agile / Lean RESpecifications are developed upfront Value-based approach; only the top-most

requirments are specified; reduce waste

Text-based requirements specificationapproach (> 90% of developmentorganization)

Comination of user stories and requirementsmodels (to depict dynamic behaviors of clinicalworkflows)

Longer development cycles possible Concurrent engineering for development (Scrumand feature orientation combined)

Requirements engineering activities only till End to end requirements engineeringRequirements engineering activities only till„Design Input Complete“ (D3)

End-to-end requirements engineering

Engineering teams detached from clinicalend user

Close working relationship of engineering team, product managers and clinical user


end user product managers and clinical user

Contents

Goals

Contents

Goals Goals


Goals


Project syngo.via

Business challenges

Business challenges

Agile / Lean Requirements EngineeringBusiness challenges



Business Case and Key Takeaways

Results and Summary

Further Information

Further Information


B i C C t ib ti f LBusiness Case – Contribution of Levers

Description of Benefit Distribution ofBenefits

t n Tracing with less effort (based on 25%

Prod

uct

Def

nitio

g (feature model‘s nature, no verticals)More effective stakeholder management (less scopingsessions, reduction in review times and effort)

Proj

ect

Plan

ning Transparency and easy overview on product functionality 23%

P PD

esig

n Reduction of product complexity (transparent modeling ofproduct lines and product variability)

7%

DTe

st

More effective Testing 45%

Easier bug-fixing


Source: OREA Business Case, February 2011

B i C NPV P j tiBusiness Case – NPV Projection

Benefits are realized across engineering Benefits are realized across engineering workflows: Product Definition, Project Planning, Design and Test

Break even reached in 2nd year

NPV Projection

Break-even reached in 2nd year

Hints for other RE practitioners:

Business case can only be conducted with a complete technical concept

Sensitivity analysis on implementationrisks shows that the effort isworthwhile even if everything goeswrong.

Business case will vary depending on y p glccal circumstances


Source: OREA Business Case, February 2011

K T k AKey Take-Aways

To mo e from traditional to agile / lean RE approach needs a step To move from traditional to agile / lean RE approach needs a step-wise, value-based approach

Feature orientation brings a focus on what is relevant for the customerFeature orientation brings a focus on what is relevant for the customerand the pre-condition for concurrent engineering

The introduction of agile / lean Requirements Engineering is a huge organizational change management endeavor

Continuous assessment and verification of business benefits is t j d h t i ki d h t tnecessary to judge what is working and what not


Th k f tt ti !Thank you for your attention!

Page 30 Arnold Rudorfer, Siemens Healthcare I&T SYNGO© Siemens AG 2011. All rights reserved.© Siemens AG 2011. All rights reserved.

Contents

Goals

Contents

Goals Goals


Goals


Project syngo.via

Business challenges

Business challenges

Agile / Lean Requirements EngineeringBusiness challenges



Business Case and Key Takeaways

Results and Summary

Further Information

Further Information


R fReferences

US Food & Drug Administration, Design Control Guidancefor Medical Device Manufacturers; March 11, 1997

US Food & Drug Administration, Quality System Regulation,; January 1, 1997, http://www.fda.org/cdrh/qsr/01qsreg.html

Beatrice Hwong, Grace Tai, Rajanikanth Tanikella, Gergana Nikolova, Gilberto Matos, Christopher Nelson, Bradley Wehrwein, Arnold Rudorfer, Xiping Song, Monica McKenna: Quality Improvements from Using Agile Development Methods: Lessons Learned, e e op e t et ods esso s ea ed,http://www.51testing.com/ddimg/uploadsoft/20090120/AgileQualityAssurance.pdf, April 2007

Brian Berenbach, Daniel Paulish, Arnold Rudorfer, Juergen Kazmeier, Software Systems RequirementsE i i M G Hill 2009Engineering; Mc-Graw Hill 2009; http://www.mhprofessional.com/product.php?isbn=0071605479

Arnold Rudorfer, Christof Ebert: Lean RequirementsEngineering in Medical Systems MedConf 2010 MunichEngineering in Medical Systems, MedConf 2010, Munich, Germany, October 14, 2010; http://2010.medconf.de/downloads/abstracts2010/T2_T3_V1_vector_siemens.pdf

Arnold Rudorfer, Christof Ebert: Systematisches


Requirements Engineering, QZ, March 2011

Arnold RudorferDirector Software Initiative and Process ImprovementProcess ImprovementSiemens AG Healthcare Sector

Hartmannstrasse 16D-91052 Erlangen

Phone: +49 9131 – 82 2299Fax: +49 9131 – 84 8691Mobile: +49 174 1537825

E-Mail:[email protected]


[email protected]

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Refsq 2011 03 29 V3