MedConf 2009 Requirements Engineeering Rudorfer-Ebert

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 Copyright © Siemens AG 2009. All rights reserved. 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 Copyright © Siemens AG 2009. All rights reserved. Page 3 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009 Siemens Healthcare, Vector Consulting Services

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 Copyright © Siemens AG 2009. All rights reserved. Page 4 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009 Siemens Healthcare, Vector Consulting Services

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. Copyright © Siemens AG 2009. All rights reserved. Page 6 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009 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 Copyright © Siemens AG 2009. All rights reserved. Page 7 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009 Siemens Healthcare, Vector Consulting Services

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 Copyright © Siemens AG 2009. All rights reserved. Page 8 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009 Siemens Healthcare, Vector Consulting Services

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 Copyright © Siemens AG 2009. All rights reserved. Page 9 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009 Siemens Healthcare, Vector Consulting Services

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 Copyright © Siemens AG 2009. All rights reserved. Page 10 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009 Siemens Healthcare, Vector Consulting Services

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 Copyright © Siemens AG 2009. All rights reserved. Page 11 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009 Siemens Healthcare, Vector Consulting Services

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 Copyright © Siemens AG 2009. All rights reserved. Page 12 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009 Siemens Healthcare, Vector Consulting Services

Project Case Study 1: Rapid Prototyping Approach (3/3) Bed management system prototype Electronic flow-sheet product prototype Copyright © Siemens AG 2009. All rights reserved. Page 13 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009 Siemens Healthcare, Vector Consulting Services

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 Copyright © Siemens AG 2009. All rights reserved. Page 14 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009 Siemens Healthcare, Vector Consulting Services

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 Copyright © Siemens AG 2009. All rights reserved. Page 16 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009 Siemens Healthcare, Vector Consulting Services

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 Copyright © Siemens AG 2009. All rights reserved. Page 17 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009 Siemens Healthcare, Vector Consulting Services

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 Copyright © Siemens AG 2009. All rights reserved. Page 18 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009 Siemens Healthcare, Vector Consulting Services

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 Copyright © Siemens AG 2009. All rights reserved. Page 19 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009 Siemens Healthcare, Vector Consulting Services

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 Copyright © Siemens AG 2009. All rights reserved. Page 20 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009 Siemens Healthcare, Vector Consulting Services

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 Copyright © Siemens AG 2009. All rights reserved. Page 21 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009 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 Copyright © Siemens AG 2009. All rights reserved. Page 22 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009 Siemens Healthcare, Vector Consulting Services

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 Copyright © Siemens AG 2009. All rights reserved. Page 23 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009 Siemens Healthcare, Vector Consulting Services

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 Copyright © Siemens AG 2009. All rights reserved. Page 24 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009 Siemens Healthcare, Vector Consulting Services

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 Copyright © Siemens AG 2009. All rights reserved. Page 25 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009 Siemens Healthcare, Vector Consulting Services

Questions, Answers, Suggestions Copyright © Siemens AG 2009. All rights reserved. Page 26 Arnold Rudorfer, Siemens and Christof Ebert, Vector, MedConf 2009 Siemens Healthcare, Vector Consulting Services

MedConf 2009 Requirements Engineeering Rudorfer-Ebert

by Arnold Rudorfer

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