Model-based Engineering                                     in Medical Product                                     Develop...
Contents                                      Goals                                      Brief look on Siemens Healthcar...
Contents                                      Goals                                      Brief look on Siemens Healthcar...
Goals of this Talk Share the experiences using  models in engineering gained  at Siemens Healthcare Discuss challenges, ...
Contents                                      Goals                                      Brief look on Siemens Healthcar...
Siemens HealthcareIn vivo diagnostics (imaging)  X-Ray             Computed               Magnetic       Molecular        ...
Vector Consulting ServicesYour Partner in Achieving EngineeringExcellence … offers a comprehensive consulting, tools  and...
Contents                                     Goals                                     Brief look on Siemens and Vector ...
Business Challenges in Medical Device                     Industry                                                        ...
Typical Large-Scale Medical DeviceProjects               Project Context   Several thousand single    product requirement...
Disclaimer:                 The content discussed in this presentation needs                      to be considered as work...
Contents                                     Goals                                     Brief look on Siemens and Vector ...
Industry Issues and Pain PointsPain Points                             Business Impact Intransparent product             ...
Overview:               Solutions along the Life-Cycle               A) Requirements Meta-                  Model         ...
Pain point 1: Intransparent Product               Structure                                                           Solu...
Solution A:                Requirements Meta Model               Problem Space                                            ...
Solution B: Feature Model                                                          Characteristics:                     Hi...
Solution B:               Feature Model & Its Relations (1)               Stakeholder Requests                        Appl...
Solution B:               Feature Model & Its Relations (2)               Stakeholder Requests                        Appl...
Pain point 2: Ambiguity and Lack of               Accuracy of Specifications                                              ...
Solution C:               Graphical Modeling of Clinical Workflows (1)                                                    ...
Solution C:               Graphical Modeling of Clinical Workflows (2)               Stakeholder Requests                 ...
Pain point 3: Growing Architecture               Complexity               Selected issues:                            Solu...
Solution D:               Architecture Model Mapping                                 F        Feature Model        Charact...
Pain point 4: Insufficient Verification and               Validation Efficiency               Issues:                Test...
Solution E:               Model-based System Test (1)                                                          Benefits:  ...
Solution E:               Model-based System Test (2)               Stakeholder Requests                                  ...
Contents                                     Goals                                     Brief look on Siemens and Vector ...
Major Changes to Development for               Model-based Engineering               A) Requirements Meta-                ...
Benefits from Model-based EngineeringFeature models can help to reduce detail of product requirementsthrough abstraction ...
Experiences with Introducing Model-based Engineering Model-based engineering means a huge organizational change. Only  10...
Thank you for your attention!                                           © Siemens AG 2012. All rights reserved.2012 Siemen...
Contents                                     Goals                                     Brief look on Siemens and Vector ...
References1.     US Food & Drug Administration, Design Control Guidance for Medical Device Manufacturers; March 11, 19972....
Arnold Rudorfer                                           Program Manager System Platform                                 ...
Dr. Christof Ebert                                           Managing Director                                           V...
Documented Experiences and Best Practicesfrom various Industry Projects                                     English langua...
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Reconf2012 V4

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Software-intensive medizinische Systeme stehen in einem immensen Marktdruck. Während sie technologisch und hinsichtlich ihrer Sicherheit kompromisslos innovativ sein müssen, fordern die Krankenhäuser und auch Gesundheitskostenreformen eine immer kürzere Zykluszeit bei gleichzeitig angespannten Budgets. Traditionelle Entwicklungsprozesse, die Innovation und Qualität über einen schwerfälligen Prozess erreichten, sind nicht mehr zeitgemäß. Unsere Studien zeigen, dass in der Medizintechnik die Kosten für Nacharbeiten über den Produktlebenszyklus hinweg durch eine Verbesserung des Requirements Engineering um 30-50% gesenkt werden können. Requirements Engineering hat daher eine Schlüsselstelle als Erfolgsfaktor im Gesundheitswesen. Modellbasierte Vorgehensweisen unterstützt die durchgängige Entwicklung von Anforderungen bis zur Validierung. Durch den erhöhten Abstraktionsgrad zu Beginn bei der anforderungsentwicklung und Analyse sind Problembeschreibungen wesentlich klarer, einfacher und weniger redundant. Das erhöht nicht nur die Entwicklungsgeschwindigkeit, sondern sorgt innerhalb des Projektes für klar verstandende Domänenkonzepte. Modelle helfen bei der Durchgängigkeit von den systemanforderungen zu den Softwareanforderungen und dann zu Design und Validierung. Unser Beitrag zeigt Industrieerfahrungen bei Siemens Healthcare und bietet Orientierung bei der Umsetzung modellbasierter Entwicklung mit Fokus auf Requirements Engineering in medizinischen Systemen. Wir zeigen, wie Anforderungen so formalisiert werden, dass einerseits informell formulierte Anforderungen schrittweise in eine formalere Form kommen und während die Verständlichkeit der Anforderungen erhalten bleibt. Damit sind die Anforderungen präzise formuliert und werden zur Konsistenzsicherung und Vervollständigung genutzt, und sie können weiterhin von Stakeholder verschiedenem Hintergrund verstanden und validiert werden.

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Reconf2012 V4

  1. 1. Model-based Engineering in Medical Product Development ReConf 2012 March 14, 2012 Munich, Germany © 2012 Siemens Healthcare Diagnostics Inc. All rights reserved.2012 Siemens Healthcare Diagnostics Inc. Page 1
  2. 2. Contents  Goals  Brief look on Siemens Healthcare  Business challenges  Model-based Engineering: Issues & Solutions  Recommendations  Further Information2012 Siemens Healthcare Diagnostics Inc. Page 2
  3. 3. Contents  Goals  Brief look on Siemens Healthcare  Business challenges  Model-based Engineering: Issues & Solutions  Results and Summary  Further Information2012 Siemens Healthcare Diagnostics Inc. Page 3
  4. 4. Goals of this Talk Share the experiences using models in engineering gained at Siemens Healthcare Discuss challenges, needs and requirements to advance model-driven product development Show the concrete value of model-based engineering2012 Siemens Healthcare Diagnostics Inc. Page 4
  5. 5. Contents  Goals  Brief look on Siemens Healthcare  Business challenges  Model-based Engineering: Issues & Solutions  Results and Summary  Further Information2012 Siemens Healthcare Diagnostics Inc. Page 5
  6. 6. Siemens HealthcareIn vivo diagnostics (imaging) X-Ray Computed Magnetic Molecular Ultrasound Oncology Tomography Resonance Imaging IT SolutionsIn vitro diagnostics (laboratory systems) Immunoassay Molecular Clinical Chemistry Hematology Urinalysis Lab Automation Point of Care2012 Siemens Healthcare Diagnostics Inc. Page 6
  7. 7. Vector Consulting ServicesYour Partner in Achieving EngineeringExcellence … offers a comprehensive consulting, tools and training portfolio for optimizing technical Automotive product development … serves industries such as automotive, Aviation & Defense aviation, IT and telecom, energy and environment, medical and railway IT & Telecom … is supporting clients worldwide on efficiency improvement, requirements engineering, ALM/PLM, systems Energy & Environment engineering, product management, interim management, and organizational change Medical & … as a group serves companies across the Healthcare world with over 1000 employees and sales of well over 150 Mio € pa Railway & Transportation www.vector.com/consulting2012 Siemens Healthcare Diagnostics Inc. Page 7
  8. 8. Contents  Goals  Brief look on Siemens and Vector Healthcare  Project syngo.via Business Challenges  Business challenges Issues & Solutions Model Management:  Lean Requirements Engineering Results and Summary  Results Information Further and Summary  Further Information2012 Siemens Healthcare Diagnostics Inc. Page 8
  9. 9. Business Challenges in Medical Device Industry Focus of this talk PlatformsSources: [1, 2, 5] Application Life-cycle Model-based Management Tools Globally Integrated Engineering and Reuse Engineering Systems 2012 Siemens Healthcare Diagnostics Inc. Page 9
  10. 10. Typical Large-Scale Medical DeviceProjects Project Context Several thousand single product requirements Several million lines of code Several hundred developers in many locations worldwide Many fold clinical applicationsSource: H IM 2012 Siemens Healthcare Diagnostics Inc. Page 10
  11. 11. Disclaimer: The content discussed in this presentation needs to be considered as work in progress.2012 Siemens Healthcare Diagnostics Inc. Page 11
  12. 12. Contents  Goals  Brief look on Siemens and Vector  Project syngo.via Business challenges  Business challenges Model-based Engineering: Issues & Solutions  Lean Requirements Engineering Results and Summary  Results Information Further and Summary  Further Information2012 Siemens Healthcare Diagnostics Inc. Page 12
  13. 13. Industry Issues and Pain PointsPain Points Business Impact Intransparent product Technology-driven product platform, no link to business structure, domain drivers model partially incomplete  Non-transparent relationship between problem & solution space  Re-scoping sessions with customers on basis of many specs. Ambiguity and lack of Textual-based specifications are subject to interpretation accuracy in specifications  Textual use case descriptions work only for smaller projects  Natural language subject to interpretation, inconsistent, incomplete Growing architecture Redundancy of architecture components due to lack of complexity understanding of problem- and solution space  Business needs not consistently linked to features  Too much variability in software architecture Insufficient verification and Test specifications in natural language are validation efficiency executed in a manual way only  Thousands of pages of requirements to transform  Test cases manually created 2012 Siemens Healthcare Diagnostics Inc. Page 13
  14. 14. Overview: Solutions along the Life-Cycle A) Requirements Meta- Model B) Feature D) Architecture Model E) Model-based Model Mapping System Test C) Graphical Modeling of Clinical WorkflowsSource: H IM 2012 Siemens Healthcare Diagnostics Inc. Page 14
  15. 15. Pain point 1: Intransparent Product Structure Solutions: Selected issues:  Non-transparent relations A. Requirements Meta-model between problem- & solution B. Feature Model space  Re-scoping sessions w/Source: H IM customer on basis of many engineering specs. 2012 Siemens Healthcare Diagnostics Inc. Page 15
  16. 16. Solution A: Requirements Meta Model Problem Space DB Characteristics: Stakeholder  Provides needed artifacts, their Business Plan Request Market Analysis, attributes and relationships to each SW Platform Roadmap, Business Case, etc. input for other. input for  Using meta-model, it is also possible to prescribe the way how / which data are MRS SW Feature Analysis captured . Market analyzed Use Case Specifications, Requirement by Load Profiles, Benefits: Concept Papers  Lean artefact infrastructure, no redundancy SW Req. SWRS (Problem)  Guidance for engineering tasks SW Req. with structured input (Solution)  Established link between businessSource: H IM Specification/ Structural Element Content Mapping or drivers, requirements, design and Document Input test 2012 Siemens Healthcare Diagnostics Inc. Page 16
  17. 17. Solution B: Feature Model Characteristics: Highest Level of Feature Model  Hierarchical tree to describe the structure, dependencies and commonalities  Lays out the basics for variant management and impact analysis Benefits:  Higher level abstraction of grouping of requirements into sellable units: From 5,000 product requirements to 800+ features (factor ~ 6)  Visual domain model for healthcare workflows (tree & graphical) Graphical View  Reduction in time to understandSource: H IM Hierarchical View aspects of the system 2012 Siemens Healthcare Diagnostics Inc. Page 17
  18. 18. Solution B: Feature Model & Its Relations (1) Stakeholder Requests Application Use Cases How can I manage huge amounts of Requirements? How do I scope a product version efficiently? Architecture ModelSource: H IM 2012 Siemens Healthcare Diagnostics Inc. Page 18
  19. 19. Solution B: Feature Model & Its Relations (2) Stakeholder Requests Application Use Cases How do I manage Architecture Model stakeholder requests from different businesses most effectively?Source: H IM 2012 Siemens Healthcare Diagnostics Inc. Page 19
  20. 20. Pain point 2: Ambiguity and Lack of Accuracy of Specifications Level Requts. Manually Manual test Object Embedded graphs case creation Issues:  Textual use case descriptions work only Document Req. 1 Picture / diagram for smaller projects < ~ 100 (text) requirements  Natural language subject to Features Req. 2 Picture / diagram interpretation, usually inconsistent, (text) incomplete with incorrect version (and conflicting) Paragraph Req. 3 Picture / diagram (text) Root causes:  Textual requirements engineering do not scale for platform projects Solutions:  Missing versioning  No direct access to single requirements C. Graphical Modeling of  Lack of product structure Clinical Workflows  Inconsistently executed change management processSource: H IM 2012 Siemens Healthcare Diagnostics Inc. Page 20
  21. 21. Solution C: Graphical Modeling of Clinical Workflows (1) Characteristics:  Used to describe clinical workflows that consist of a collection of steps in a defined sequence together with accompanying specification of pre-/post-conditions, business rules, performance aspects, etc. Benefits:  Increase expressiveness of clinical workflows to describe dynamic behaviors of clinical workflows  Early analysis of stakeholder requests from customers  Improved impact analysis of change requests  Joint modeling sessions to describe theSource: H IM needs from the customer‘s point of view 2012 Siemens Healthcare Diagnostics Inc. Page 21
  22. 22. Solution C: Graphical Modeling of Clinical Workflows (2) Stakeholder Requests Application Use Cases How can I analyze a Model Architecture feature or a stakeholder request?Source: H IM 2012 Siemens Healthcare Diagnostics Inc. Page 22
  23. 23. Pain point 3: Growing Architecture Complexity Selected issues: Solutions:  Business needs not consistently linked to features/ requirements; D. Architecture Model Mapping dependencies between features not easily visibleSource: H IM  Too much variability in software architecture 2012 Siemens Healthcare Diagnostics Inc. Page 23
  24. 24. Solution D: Architecture Model Mapping F Feature Model Characteristics: F F F  Identifies links between features and their implementation SWF SWF SWF SWF SWF SWF SWF  Explicit modeling of variability in the architecture S Architecture Model Benefits: SS SS SS  Architectural decisions motivated by features C C C C C C and product-line variability  Enabling reduction of architectural complexity  Support impact analysis for (de-) scoping sessions  Early identification of architectural risks  Improved accuracy of early effort estimatesSource: H IM  Reduction of number of scoping sessions 2012 Siemens Healthcare Diagnostics Inc. Page 24
  25. 25. Pain point 4: Insufficient Verification and Validation Efficiency Issues:  Test cases often manually Solutions: generated from prose use cases  Cycle times for system test too E. Model-based System Test longSource: H IM 2012 Siemens Healthcare Diagnostics Inc. Page 25
  26. 26. Solution E: Model-based System Test (1) Benefits:  Early identification of requirements defects through validation by testers  Effort reduction for test (cycle time, cost ~ -30%) and increase of test coverage (*)  Decrease number of defects  Model-based testing is highly structured, reproducible and efficient  Increase reuse of development artifacts  Quicker impact analysis by parsing model for late requirements changesSource: H IM (*) Based on experience from other projects 2012 Siemens Healthcare Diagnostics Inc. Page 26
  27. 27. Solution E: Model-based System Test (2) Stakeholder Requests Application Use Cases Architecture Model Which application use case is covered by which test case?Source: H IM 2012 Siemens Healthcare Diagnostics Inc. Page 27
  28. 28. Contents  Goals  Brief look on Siemens and Vector  Project syngo.via Business challenges  Business challenges Model-based Engineering: Issues & Solutions  Lean Requirements Engineering Results and Summary  Results Information Further and Summary  Further Information2012 Siemens Healthcare Diagnostics Inc. Page 28
  29. 29. Major Changes to Development for Model-based Engineering A) Requirements Meta- Model B) Feature D) Architecture Model E) Model-based Model Mapping System Test C) Graphical Modeling of Clinical WorkflowsSource: H IM 2012 Siemens Healthcare Diagnostics Inc. Page 29
  30. 30. Benefits from Model-based EngineeringFeature models can help to reduce detail of product requirementsthrough abstraction (~ factor 6) [6]Reduction of review times by ~ 40% using graphical modeling ofproduct requirements [9]Reduction of analysis time for requirements changesModel-based testing reduces testing effort by ~ 30% throughautomationReduction in overall cycle time for development projects driving moreefficiency [3, 6]2012 Siemens Healthcare Diagnostics Inc. Page 30
  31. 31. Experiences with Introducing Model-based Engineering Model-based engineering means a huge organizational change. Only 10% of organizations in medical have moved that road so far [10] Modeling competence of product managers and requirements engineers needs to be built up step-by-step thereby facilitating acceptance Seamless model-driven engineering needs adequate tools support. Continuous assessment and verification of business benefits Processes for model-based engineering is mandatory to maintain sponsorship. Model-based Engineering Tools Persons2012 Siemens Healthcare Diagnostics Inc. Page 31
  32. 32. Thank you for your attention! © Siemens AG 2012. All rights reserved.2012 Siemens Healthcare Diagnostics Inc. Page 32
  33. 33. Contents  Goals  Brief look on Siemens and Vector  Project syngo.via Business challenges  Business challenges Model-based Engineering: Issues & Solutions  Lean Requirements Engineering Results and Summary  Results and Summary Further Information  Further Information2012 Siemens Healthcare Diagnostics Inc. Page 33
  34. 34. References1. US Food & Drug Administration, Design Control Guidance for Medical Device Manufacturers; March 11, 19972. US Food & Drug Administration, Quality System Regulation,; January 1, 1997, http://www.fda.org/cdrh/qsr/01qsreg.html3. Brian Berenbach, Daniel Paulish, Arnold Rudorfer, Juergen Kazmeier, Software Systems Requirements Engineering; Mc- Graw Hill 2009; http://www.mhprofessional.com/product.php?isbn=00716054794. Renate Loeffler: Formal Scenario-based Requirements Specification and Test Case Generation in Healthcare Applications, Diplomarbeit, Univ. Paderborn, 10/20095. Medical Device & Diagnostic Industry 101, Carey Smoak, Roche Molecular Systems Inc., Pleasonton, CA, Pharma SUG 2010, Paper 1B016. Arnold Rudorfer, Christof Ebert: Lean Requirements Engineering in Medical Systems, MedConf 2010, Munich, Germany, October 14, 2010; http://2010.medconf.de/downloads/abstracts2010/T2_T3_V1_vector_siemens.pdf7. Arnold Rudorfer, Christof Ebert: Quality Requirements Engineering in in Medical Systems, OOP11, Munich, Germany, January 27, 2011 http://www.sigs.de/download/oop_2011/downloads/files/Do2- 3_Ebert_Rudorfer_Update_QualityRE_OOP2011.pdf8. Arnold Rudorfer: Model-based Engineering in Medical Device Development – Issues & Solutions, INCOSE Workshop, Phoenix, AZ, USA, January 31, 2011, http://www.omgwiki.org/MBSE/lib/exe/fetch.php?media=mbse:2011iw_incose_modelmanagement_rudorfer.pdf9. Brian Berenbach: Comparison of UML and Text based Requirements Engineering, http://www.cs.helsinki.fi/u/vjkuusel/docs/Comparison%20of%20UML%20and%20text%20based%20requirements%20engi neering%20Brian%20Berenbach.pdf10. Christian Denger, Raimund Feldman: State of the Practice in Software Development for Medical Device Production, Fraunhofer Institute Experimentelles Software Engineering, February 2007 2012 Siemens Healthcare Diagnostics Inc. Page 34
  35. 35. Arnold Rudorfer Program Manager System Platform Siemens Healthcare Diagnostics 62 Flanders-Bartley Road Flanders, NJ, 08736 (U.S.A.) Phone: +1 973 927 28 28 ext. 4732 Cell: +1 609 954 2384 Email: arnold.rudorfer@siemens.com2012 Siemens Healthcare Diagnostics Inc. Page 35
  36. 36. Dr. Christof Ebert Managing Director Vector Consulting Services GmbH Ingersheimerstrasse 24 D-70499 Stuttgart Phone: +49 711 – 80670-1525 Fax: +49 711 – 86070-444 Email: christof.ebert@vector.com2012 Siemens Healthcare Diagnostics Inc. Page 36
  37. 37. Documented Experiences and Best Practicesfrom various Industry Projects English language: Software & Systems Requirements Engineering: In Practice 2009 McGrawHill German language: Systematisches Requirements Engineering Fourth edition, 2012 Dpunkt.verlagLink to web site McGrawHill Link to web site Dpunkt2012 Siemens Healthcare Diagnostics Inc. Page 37
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