Requirements Engineering in Healthcare · Siemens Healthcare and Vector Consulting Services Motivation Business trends in the healthcare industry Industrial RE challenges Project

Copyright © Siemens AG 2009. All rights reserved.

Requirements Engineering in Healthcare:Challenges, Solution Approaches and Best Practices

MedConf 2009 Munich, October 13-15,2009

Page 2 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.

Siemens Healthcare, Vector Consulting Services

Table of Contents

Siemens Healthcare and Vector Consulting ServicesMotivationBusiness trends in the healthcare industryIndustrial RE challengesProject case study 1: Healthcare information system product prototypeProject case study 2: System for public entity somewhere in the worldBest practices from industry projectsContact details



Siemens HealthcareTHE Integrated Healthcare Company

Immunodiagnostics Clinical ChemistryNucleid AcidTesting

Hematology Lab AutomationUrinAnalysis

Near PatientTesting

in-vitro diagnostics (laboratory systems)

X-Ray ComputedTomography

MagneticResonance

MolecularImaging

Ultrasound

in-vivo diagnostics (imaging)

Healthcare IT

Oncology



Asia17%

Americas43%

Germany9%

Sales according to region

Employees according to region1)

Siemens HealthcareDevelopment of sales and employee numbers

Europe(without Germany)

17%

Asia17%

Americas43%

Germany23%

Europe (without Germany)

31%

1) Employees worldwide as of Sept. 30, 2008

~49,000 employees worldwide



IKM: syngo



Vector Consulting Services

Proven consulting solutionsEfficiency improvementRequirements engineeringFunctional safetyEngineering methods and toolsProject and Product managementCMMI and SPICEOrganizational change management

Your Partner in Achieving Engineering Excellence.

Business performance

Engineering Excellence

What?

Strategy Products

Technology

Who?

CompetencesSkills

Knowledge

How?

ProcessesInterfaces

Tools

Where?

MarketsLocationsSuppliers

Part of the Vector GroupInternational presence900 employees worldwideAn international client base fromdifferent industries

www.vector.com/consulting



Goals of this Talk

Show typical RE challenges in Healthcare industry

Share lessons learned to effectively mitigate RE challenges

Highlight best practices for RE



Business Trends and Challenges in Healthcare …

• Rate of innovation is increasing

• Pressure for efficiency improvement due to increasing competition

• Increasingly global engineeringwith regulatory approval for market entry required (e.g. FDA)

• Software is crucial enabler for end-to-end medical workflows

• Solution development mainly fails due to insufficient requirements engineering

0%

2%

4%

6%

8%

10%

12%

14%

16%

18%

20%

RE as a strategic key success factor

Deg

ree

of Im

port

ance

* [%

] User Involvement (16%)

Minimized Scope (10%)

Clear Business Objectives (12%)

Firm Basic Requirements (6%)

Executive Support (18%)

Experienced Project Manager (14%)

Standard Software Infrastructure (8%)

Formal Methodology (6%)

Reliable Estimates (4%)

Other Criteria (4%)

Rate of innovation increasing for Healthcare products (*)

0

10

20

30

40

50

60

70

80

1 2 3

Shar

e of

sal

es w

ith p

rodu

cts

[%]

Less then 5 years5 to 10 yearsmore than 10 years

1980 1995 2005



High amount of rework and overhead for variantsRequirements not mapped towards platforms, product linesNo reuse of architectural, testing and coding artifacts

Benefits of reuse not realized

High likelihood of project failureQuality requirements not sufficiently understood e.g. user acceptance by clinicians; performance, scalabilityIncreased rework (>50% project effort)

Insufficient requirements engineering

Business ImpactObservations

Communicate product requirements in a global context and to/ between stakeholdersDistributed working not supported by an integrated toolInefficiencies in development approach, expected lower quality

Distributed teams interact inefficiently

Clinical workflow requirements difficult to capture (due to complexity, stakeholder variety and interdependency)Risk of implementing inadequate product featuresRoadblock for automating development tasks

Inadequate process and modeling techniques

Mismatch with market needsDifficult to manage system development from a portfolio perspective; difficult to react to market changesTracing is labor intensive and difficult to manage (e.g. FDA compliance)

Lack of end-to-end upstream and downstream integration

Solution Development Mainly Fails due to Insufficient Requirements Engineering …



Major Root Cause: Requirements EngineeringRE Challenges in Health Care Projects

C1 High complexity of customer requirements

C2 Unclear and fuzzy stakeholder expectations

C3 Insufficient requirements qualityC4 Uncertainties and rapidly changing

technologiesC5 Distributed teamsC6 Ad-hoc change management and lack

of traceabilityC7 Scope change and creep



Project Case Study 1: Development of Healthcare Information System Product Prototype (1/3)

Project description:

~40 staff, 6 Scrum teams (Requirements

Engineer, UI Designer, Architect, Developer,

Product Manager, Clinician)

Duration:> 1 a

Project objectives:To deliver end-to-end high quality workflows

To redesign user interface to achieve

optimized usability

Deliverables:15 end-to-end workflows implemented

160.000 LOC in Java Technology

Novel user interface for administrative

workflows elaborated

Unique Value Add:Every milestone in project met to support

customers’ business development activities

Rapid prototyping for just-in-time

requirements development to allow delivering

what the customer expected



Project Case Study 1: Rapid Prototyping Approach(2/3)

Challenges Addressed:Medical workflow capture & visualizationCommunicate product requirements in a global context

Benefits realized:Quick capture of medical workflowSupport business development activitiesReduction of time-to-market



Project Case Study 1: Rapid Prototyping Approach (3/3)

Electronic flow-sheet product prototype

Bed management system prototype



Result 1: Use Storyboards to Systematically Capture Clinical Workflows

Challenges:C1. High complexity of customer requirementsC2. Unclear and fuzzy stakeholder expectationsC4. Uncertainties and rapidly changing technologies

Lessons learned:Establish storyboards as a unique artifact fit to serve as a requirement,UI and test artifact

It allows to describe the happy path, but also failure pathsWill be iteratively refined along the time-box of the sprintUse of MS Powerpoint enables to overcome tool barrier

Review requirements with different stakeholdersChallenge evolution and uncertainty scenarios



Sample Storyboard



Project Case Study 2: System for a Public Entity Somewhere in the World

Project description:Project value: > 100 million $Large staff project team, 4 full-time requirements engineers to deal with > 5,000 requirementsProject work in different locations

TimeDate 1

Specification set#1 approved

Date 2

Specification set #2 approved

Project objectives:To develop high quality system requirements specificationsDefine requirements engineering approach (process, methods, tools, skills)

Deliverables:System requirements specificationsRE Management Plan

Unique Value Add:Approved specifications enable development team to streamline system developmentDramatic business risk reduction of not delivering the project on time

Date 3

Specification set #3 approved

Note: Data of project have been sanitized



Result 2: Define Appropriate Feature Hierarchy and Dependency Relationships

Challenges:C1. High complexity of customer requirementsC5. Distributed teamsC6. Ad-hoc change management and lack of traceability

Lessons learned:Changes late in the development lifecycle are expensiveUse the same feature hierarchy for planning, budgeting, staffing, traceability, documentation, etc.Foresee sufficient time and effort to create a well-structured feature hierarchy

Understanding the feature complexities and interdependencies is keySeveral iterations lead to stable structure Features should be arranged in a domain-logical hierarchy



Result 3: Obtain a Good Understanding of Customer/Market Requirements

Challenges:C1. High complexity of customer requirementsC2. Unclear and fuzzy stakeholder expectationsC3. Insufficient requirements qualityC4. Uncertainties and rapidly changing technologiesC7. Scope change and creep

Lessons learned:Customers often do not have complete understanding of requirementsRefine customer requirements as early as possible

Domain glossaryPrototyping to visualize concepts of operation

Review customer requirements with different stakeholders – individually Manage customer expectations – under-promise and over-deliver



Result 4: Develop Specifications for Problem and Solution Space

Challenge:C1. High complexity of customer requirementsC4. Uncertainties and rapidly changing technologiesC7. Scope change and creep

Lessons learned:Requirements engineering is a wicked problem: Solution affects perception on problemRequirements change as solutions are prototyped and shown to customer

Identify requirements change risks during analysis and mitigateMinimize cost of change to requirements

Reduce number of avoidable changes to requirementsTechnology of solutions is changingTradeoff between abstraction and detail



Result 5: Consistently Implement and Maintain Traceability

Challenges:C6. Ad-hoc change management and lack of traceabilityC7. Scope change and creep

Lessons learned:Ad-hoc tracing causes defects and substantial rework and thus increases cost of ownership

Traceability is an activity across the entire product life-cycle It needs effort and budget – in order to reduce overall costMaintained traceability, specifically in safety-critical systems, yields an ROI of over 5

Establish feasible traceability model from the beginningSupport project members to understand the traceability strategy and their respective responsibilitiesInsist on systematic impact analysis, progress tracking, testing



Result 6: Establish Effective RE standards and Review Processes

Challenges:C3. Insufficient requirements qualityC5. Distributed teamsC6. Ad-hoc change management and lack of traceabilityC7. Scope change and creep

Lessons learned:Establish and enforce documentation standards

Enable consistency of work productsIndustrial standards, e.g., IEEE 830, can be used as a starting point; customize as necessary

Provide document templates to enforce documentation standardsHomogeneous contents and easier review of work products

Budget the necessary effort for reviews and traceability



Best Practices from Industry Projects

1. Use Storyboards to Systematically Capture Clinical Workflows

2. Define Appropriate Feature Hierarchy and Dependency Relationships

3. Obtain a Good Understanding of Customer/Market Requirements

4. Develop Specifications for Problem and Solution Space

5. Consistently Implement and Maintain Traceability

6. Establish Effective RE standards and Review Processes



Documented Experiences and Best Practices from Many Years of Industry Projects

Link to web site McGrawHill

English language:

Software & Systems Requirements Engineering: In Practice

2009

McGrawHill

German language:

Systematisches Requirements Engineering

Second edition, 2008

Dpunkt.verlag Link to web site Dpunkt



Contact Details Arnold Rudorfer

Siemens Healthcare Imaging&ITImage and Knowledge Management

Head Software Engineering Process Group

Tel.: +49 -9131 -84 22 99Cell: +49 -174 -1537-825

E-Mail: [email protected]



Contact Details Dr. Christof Ebert

Vector Consulting Services

Partner and Managing Director

Tel.: +49 -711- 80670-175

E-Mail: [email protected]

URL:www.vector.com/consulting



Questions, Answers, Suggestions

Documents

Requirements Engineering in Healthcare · Siemens Healthcare and Vector Consulting Services Motivation Business trends in the healthcare industry Industrial RE challenges Project