requirements engineering in healthcare · siemens healthcare and vector consulting services...
TRANSCRIPT
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
Page 3 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.
Siemens Healthcare, Vector Consulting Services
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
Page 4 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.
Siemens Healthcare, Vector Consulting Services
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
Page 5 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.
Siemens Healthcare, Vector Consulting Services
IKM: syngo
Page 6 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.
Siemens Healthcare, Vector Consulting Services
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
Page 7 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.
Siemens Healthcare, Vector Consulting Services
Goals of this Talk
Show typical RE challenges in Healthcare industry
Share lessons learned to effectively mitigate RE challenges
Highlight best practices for RE
Page 8 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.
Siemens Healthcare, Vector Consulting Services
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
Page 9 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.
Siemens Healthcare, Vector Consulting Services
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 …
Page 10 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.
Siemens Healthcare, Vector Consulting Services
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
Page 11 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.
Siemens Healthcare, Vector Consulting Services
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
Page 12 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.
Siemens Healthcare, Vector Consulting Services
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
Page 13 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.
Siemens Healthcare, Vector Consulting Services
Project Case Study 1: Rapid Prototyping Approach (3/3)
Electronic flow-sheet product prototype
Bed management system prototype
Page 14 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.
Siemens Healthcare, Vector Consulting Services
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
Page 15 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.
Siemens Healthcare, Vector Consulting Services
Sample Storyboard
Page 16 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.
Siemens Healthcare, Vector Consulting Services
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
Page 17 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.
Siemens Healthcare, Vector Consulting Services
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
Page 18 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.
Siemens Healthcare, Vector Consulting Services
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
Page 19 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.
Siemens Healthcare, Vector Consulting Services
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
Page 20 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.
Siemens Healthcare, Vector Consulting Services
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
Page 21 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.
Siemens Healthcare, Vector Consulting Services
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
Page 22 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.
Siemens Healthcare, Vector Consulting Services
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
Page 23 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.
Siemens Healthcare, Vector Consulting Services
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
Page 24 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.
Siemens Healthcare, Vector Consulting Services
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]
Page 25 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009Copyright © Siemens AG 2009. All rights reserved.
Siemens Healthcare, Vector Consulting Services
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