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

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1 Requirements Engineering in Healthcare: Challenges, Solution Approaches and Best Practices MedConf 2009 Munich, October 13-15,2009

2 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

3 Siemens Healthcare THE Integrated Healthcare Company in-vivo diagnostics (imaging) X-Ray Computed Tomography Magnetic Resonance Molecular Imaging Ultrasound Oncology Healthcare IT in-vitro diagnostics (laboratory systems) Immunodiagnostics Nucleid Acid Testing Clinical Chemistry Hematology Urin Analysis Lab Automation Near Patient Testing Page 3 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

4 Siemens Healthcare Development of sales and employee numbers Sales according to region Germany 9% Asia 17% Europe (without Germany) 31% Employees according to region 1) Americas 43% Germany 23% Europe (without Germany) 17% ~49,000 employees worldwide Asia 17% Americas 43% 1) Employees worldwide as of Sept. 30, 2008 Page 4 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

5 IKM: syngo Page 5 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

6 Vector Consulting Services Proven consulting solutions Efficiency improvement Requirements engineering Functional safety Engineering methods and tools Project and Product management CMMI and SPICE Organizational change management Part of the Vector Group International presence 900 employees worldwide An international client base from different industries What? Strategy Products Technology Business performance Engineering Excellence How? Processes Interfaces Tools Who? Competences Skills Knowledge Where? Markets Locations Suppliers Your Partner in Achieving Engineering Excellence. Page 6 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

7 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 7 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

8 Business Trends and Challenges in Healthcare Rate of innovation is increasing Pressure for efficiency improvement due to increasing competition Increasingly global engineering with regulatory approval for market entry required (e.g. FDA) Share of sales with products [%] % 18% Rate of innovation increasing for Healthcare products (*) Less then 5 years 5 to 10 years more than 10 years Software is crucial enabler for end-to-end medical workflows Solution development mainly fails due to insufficient requirements engineering Degree of Importance* [%] 16% 14% 12% 10% 8% 6% 4% 2% 0% 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%) RE as a strategic key success factor Page 8 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

9 Solution Development Mainly Fails due to Insufficient Requirements Engineering Observations Insufficient requirements engineering Lack of end-to-end upstream and downstream integration Inadequate process and modeling techniques Distributed teams interact inefficiently Benefits of reuse not realized Business Impact High likelihood of project failure Quality requirements not sufficiently understood e.g. user acceptance by clinicians; performance, scalability Increased rework (>50% project effort) Mismatch with market needs Difficult to manage system development from a portfolio perspective; difficult to react to market changes Tracing is labor intensive and difficult to manage (e.g. FDA compliance) Clinical workflow requirements difficult to capture (due to complexity, stakeholder variety and interdependency) Risk of implementing inadequate product features Roadblock for automating development tasks Communicate product requirements in a global context and to/ between stakeholders Distributed working not supported by an integrated tool Inefficiencies in development approach, expected lower quality High amount of rework and overhead for variants Requirements not mapped towards platforms, product lines No reuse of architectural, testing and coding artifacts Page 9 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

10 Major Root Cause: Requirements Engineering RE Challenges in Health Care Projects C1 C2 C3 C4 C5 C6 C7 High complexity of customer requirements Unclear and fuzzy stakeholder expectations Insufficient requirements quality Uncertainties and rapidly changing technologies Distributed teams Ad-hoc change management and lack of traceability Scope change and creep Page 10 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

11 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 Deliverables: 15 end-to-end workflows implemented LOC in Java Technology Novel user interface for administrative workflows elaborated Project objectives: To deliver end-to-end high quality workflows To redesign user interface to achieve optimized usability 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 11 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

12 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-tomarket Page 12 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

13 Project Case Study 1: Rapid Prototyping Approach (3/3) Bed management system prototype Electronic flow-sheet product prototype Page 13 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

14 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 Page 14 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

15 Sample Storyboard Page 15 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

16 Project Case Study 2: System for a Public Entity Somewhere in the World Date 1 Date 2 Date 3 Time Specification set #1 approved Specification set #2 approved Specification set #3 approved Project description: Project value: > 100 million $ Large staff project team, 4 full-time requirements engineers to deal with > 5,000 requirements Project work in different locations Deliverables: System requirements specifications RE Management Plan Project objectives: To develop high quality system requirements specifications Define requirements engineering approach (process, methods, tools, skills) Unique Value Add: Approved specifications enable development team to streamline system development Dramatic business risk reduction of not delivering the project on time Note: Data of project have been sanitized Page 16 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

17 Result 2: Define Appropriate Feature Hierarchy and Dependency Relationships Challenges: C1. High complexity of customer requirements 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 Page 17 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

18 Result 3: Obtain a Good Understanding of Customer/Market Requirements Challenges: C1. High complexity of customer requirements C2. Unclear and fuzzy stakeholder expectations C3. Insufficient requirements quality C4. Uncertainties and rapidly changing technologies 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 Page 18 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

19 Result 4: Develop Specifications for Problem and Solution Space Challenge: C1. High complexity of customer requirements C4. Uncertainties and rapidly changing technologies C7. Scope change and creep 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 Page 19 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

20 Result 5: Consistently Implement and Maintain Traceability Challenges: C6. Ad-hoc change management and lack of traceability C7. 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 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 Page 20 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

21 Result 6: Establish Effective RE standards and Review Processes Challenges: C3. Insufficient requirements quality C5. Distributed teams C6. Ad-hoc change management and lack of traceability C7. Scope change and creep 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 Page 21 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

22 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 22 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

23 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 Link to web site McGrawHill Second edition, 2008 Dpunkt.verlag Link to web site Dpunkt Page 23 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

24 Contact Details Arnold Rudorfer Siemens Healthcare Imaging&IT Image and Knowledge Management Head Software Engineering Process Group Tel.: Cell: Page 24 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

25 Contact Details Dr. Christof Ebert Vector Consulting Services Partner and Managing Director Tel.: URL: Page 25 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

26 Questions, Answers, Suggestions Page 26 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009

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