MedConf 2009 Requirements Engineeering Rudorfer-Ebert

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

MedConf 2009
Munich, October 13-15,2009

Copyright © Siemens AG 2009. All rights reserved.

Table of Contents

Siemens Healthcare and Vector Consulting Services
Motivation
Business trends in the healthcare industry
Industrial RE challenges
Project case study 1:
Healthcare information system product prototype
Project case study 2:
System for public entity somewhere in the world
Best practices from industry projects
Contact details

Page 2 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009 Siemens Healthcare, Vector Consulting Services

Siemens Healthcare
THE Integrated Healthcare Company

in-vivo diagnostics (imaging)

X-Ray Computed Magnetic Molecular Ultrasound Oncology
Tomography Resonance Imaging

Healthcare IT
in-vitro diagnostics (laboratory systems)

Immunodiagnostics Nucleid Acid Clinical Chemistry Hematology Urin Lab Automation Near Patient
Testing Analysis Testing


Siemens Healthcare
Development of sales and employee numbers

Sales according to region
Germany
9%

Europe
Asia (without Germany)
17% 31%

Employees according to region1)

Americas Germany Europe
43% 23% (without Germany)
17%

Asia Americas
17% 43%

~49,000 employees worldwide
1) Employees worldwide as of Sept. 30, 2008


IKM: syngo


Vector Consulting Services

Proven consulting solutions Part of the Vector Group
Efficiency improvement International presence
Requirements engineering 900 employees worldwide
Functional safety An international client base from
Engineering methods and different industries
tools
Business performance
Project and Product
management
CMMI and SPICE Engineering Excellence
Organizational change
management What? How? Who? Where?
Strategy Processes Competences Markets
Products Interfaces Skills Locations
www.vector.com/consulting Technology Tools Knowledge Suppliers

Your Partner in Achieving Engineering Excellence.

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 increasing for Healthcare products
(*)
• Rate of innovation is increasing 80

70

Share of sales with products [%]
• Pressure for efficiency
60

50
Less then 5 years

improvement due to increasing 40 5 to 10 years
more than 10 years

competition
30

20

10

0

• Increasingly global engineering 1980
1 1995
2 2005
3

with regulatory approval for 20%

market entry required (e.g. FDA) 18%
User Involvement (16%)
16%

Degree of Importance* [%]
Minimized Scope (10%)

• Software is crucial enabler for 14% Clear Business Objectives (12%
Firm Basic Requirements (6%)
)

12%
end-to-end medical workflows 10%
Executive Support (18%)
Experienced Project Manager (14%)
Standard Software Infrastructure (8%)
Formal Methodology (6%)
8%

• Solution development mainly fails
Reliable Estimates (4%)
6% Other Criteria (4%)

due to insufficient requirements 4%

engineering 2%

0%
RE as a strategic key success factor


Solution Development Mainly Fails due to
Insufficient Requirements Engineering …

Observations Business Impact
Insufficient requirements High likelihood of project failure
engineering Quality requirements not sufficiently understood e.g. user acceptance by
clinicians; performance, scalability
Increased rework (>50% project effort)
Lack of end-to-end Mismatch with market needs
upstream and downstream Difficult to manage system development from a portfolio perspective;
difficult to react to market changes
integration
Tracing is labor intensive and difficult to manage (e.g. FDA compliance)
Inadequate process and Clinical workflow requirements difficult to capture (due to
modeling techniques complexity, stakeholder variety and interdependency)
Risk of implementing inadequate product features
Roadblock for automating development tasks
Distributed teams interact Communicate product requirements in a global context and to/
inefficiently between stakeholders
Distributed working not supported by an integrated tool
Inefficiencies in development approach, expected lower quality
Benefits of reuse not High amount of rework and overhead for variants
realized Requirements not mapped towards platforms, product lines
No reuse of architectural, testing and coding artifacts


Major Root Cause: Requirements Engineering
RE Challenges in Health Care Projects

C1 High complexity of customer
requirements
C2 Unclear and fuzzy stakeholder
expectations
C3 Insufficient requirements quality
C4 Uncertainties and rapidly changing
technologies
C5 Distributed teams
C6 Ad-hoc change management and lack
of traceability
C7 Scope change and creep


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

Project description: Deliverables:
~40 staff, 6 Scrum teams (Requirements 15 end-to-end workflows implemented
Engineer, UI Designer, Architect, Developer, 160.000 LOC in Java Technology
Product Manager, Clinician) Novel user interface for administrative
Duration:> 1 a workflows elaborated

Unique Value Add:
Project objectives:
Every milestone in project met to support
To deliver end-to-end high quality workflows
customers’ business development activities
To redesign user interface to achieve
Rapid prototyping for just-in-time
optimized usability
requirements development to allow delivering
what the customer expected


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

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

Benefits realized:
Quick capture of
medical workflow
Support business
development activities
Reduction of time-to-
market


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

Bed management system prototype

Electronic flow-sheet product prototype


Result 1: Use Storyboards to Systematically
Capture Clinical Workflows

Challenges:
C1. High complexity of customer requirements
C2. Unclear and fuzzy stakeholder expectations
C4. 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 paths
Will be iteratively refined along the time-box of the sprint
Use of MS Powerpoint enables to overcome tool barrier
Review requirements with different stakeholders
Challenge evolution and uncertainty scenarios


Sample Storyboard


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

Date 1 Date 2 Date 3 Time

Specification set Specification set Specification set
#1 approved #2 approved #3 approved

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

Project objectives: Unique Value Add:
To develop high quality system requirements Approved specifications enable development
specifications team to streamline system development
Define requirements engineering approach Dramatic business risk reduction of not
(process, methods, tools, skills) delivering the project on time

Note: Data of project have been sanitized

Result 2: Define Appropriate Feature Hierarchy
and Dependency Relationships

Challenges:
C5. Distributed teams
C6. Ad-hoc change management and lack of traceability

Lessons learned:
Changes late in the development lifecycle are expensive
Use 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 key
Several 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:
C2. Unclear and fuzzy stakeholder expectations
C3. Insufficient requirements quality
C7. Scope change and creep

Lessons learned:
Customers often do not have complete understanding of requirements
Refine customer requirements as early as possible
Domain glossary
Prototyping 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:

Lessons learned:
Requirements engineering is a wicked problem: Solution affects
perception on problem
Requirements change as solutions are prototyped and shown to
customer
Identify requirements change risks during analysis and mitigate
Minimize cost of change to requirements
Reduce number of avoidable changes to requirements
Technology of solutions is changing
Tradeoff between abstraction and detail

Result 5: Consistently Implement and Maintain
Traceability

Challenges:

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 cost
Maintained traceability, specifically in safety-critical systems, yields
an ROI of over 5
Establish feasible traceability model from the beginning
Support project members to understand the traceability strategy and
their respective responsibilities
Insist on systematic impact analysis, progress tracking, testing

Result 6: Establish Effective RE standards and
Review Processes

Challenges:
C3. Insufficient requirements quality
C5. Distributed teams

Lessons learned:
Establish and enforce documentation standards
Enable consistency of work products
Industrial standards, e.g., IEEE 830, can be used as a starting
point; customize as necessary
Provide document templates to enforce documentation standards
Homogeneous 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

English language:
Software & Systems
Requirements
Engineering: In Practice
2009
McGrawHill

German language:
Systematisches
Requirements
Engineering
Second edition, 2008
Link to web site Dpunkt
Link to web site McGrawHill Dpunkt.verlag


Contact Details Arnold Rudorfer

Siemens Healthcare Imaging&IT
Image and Knowledge Management

Head Software Engineering Process
Group

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

E-Mail:
arnold.rudorfer@siemens.com


Contact Details Dr. Christof Ebert

Vector Consulting Services

Partner and Managing Director

Tel.: +49 -711- 80670-175

E-Mail:
christof.ebert@vector.com

URL:
www.vector.com/consulting


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