Model-basedModel based Engineering inMedical Device Development –                     pIssues & SolutionsINCOSE SwedenLink...
Contents                                  Goals                                  Brief look on Siemens Healthcare       ...
Contents                                  Goals                                  Brief look on Siemens Healthcare       ...
Goals f thi T lkG l of this Talk Disc ss the e periences  Discuss      experiences  using engineering models (in  differe...
Contents                                  Goals                                  Brief look on Siemens Healthcare       ...
Siemens HealthcareTHE Integrated Healthcare Company    I t    t d H lth      Cin-vivo diagnostics (imaging)   X-Ray       ...
Example: syngo.mCT Oncology:      Oncology Workflow: Tumor Detection, Staging      O   l    W kfl     T     D t ti     St ...
Contents                                  Goals                                  Brief look on Siemens and Vector       ...
Business Challenges in Medical Device IndustryB i      Ch ll      i M di l D i I d t                           Industry   ...
Disclaimer:              The content discussed in this presentation needs                       to be considered as work i...
Contents                                   Goals                                   Brief look on Siemens and Vector     ...
syngo.via Product       i P d t          Project Summarysyngo.via: Next generationimaging software covering the    g g    ...
Industry I  I d t Issues and Pain Points                 dP i P i tPain Points                          Business Impact P...
Pain point 1: Product Structure Intransparent, Domain M d l Partially Incomplete D     i Model P ti ll I        l t       ...
Solution A: Requirements Engineering Meta Model –B  Benefits & T l Requirements (1)        fit   Tool R  i      tProblem S...
Solution A: Requirements Engineering Meta Model –C  Concepts (2)          tStakeholder                                    ...
Solution A: Requirements Engineering Meta Model–C Concepts (3)         t Problem Space                                    ...
Solution A: Requirements Engineering Meta Model–C Concepts (4)         t Problem Space                                    ...
Solution A: Requirements Engineering Meta Model–C Concepts (5)         t Problem Space                                    ...
Solution B F tS l ti B: Feature Model                  M d l          Highest Level                                       ...
Solution B F t S l ti B: Feature Model & Its Relations (1)                   M d l It R l tiStakeholder Requests          ...
Solution B F t S l ti B: Feature Model & Its Relations (2)                   M d l It R l tiStakeholder Requests          ...
Pain point 2: Ambiguity and Lack of Accuracy of  Specifications  S    ifi ti                                              ...
Solution C: Graphical Modeling of ClinicalWorkflows (1)W kfl                                                  Characterist...
Solution C: Graphical Modeling of Clinical Workflows (2) W kflStakeholder Requests                                        ...
Pain i t 3 C t lli A hit t P i point 3: Controlling Architectural Complexity                                      lC    l ...
Solution D: Architecture M d l MappingS l ti D A hit t         Model M   i                    F        Feature Model      ...
Solution D: Architecture M d l Mapping  S l ti D A hit t         Model M   iStakeholder Requests                          ...
Pain i t 4 N d to Increase V&V Efficiency P i point 4: Need t I          Effi iIssues: Test cases partially manually     ...
Solution E: Model-based System Test (2)S l ti E M d l b      dS t     T t                                                 ...
Solution E: Model-based System Test S l ti E M d l b      dS t     T tStakeholder Requests                                ...
Focus o Requirements Engineering …F       R   i     t E i      i                                                          ...
Contents                                   Goals                                   Brief look on Siemens and Vector     ...
Major Changes to Development ApproachModel-based EngineeringM d lb    dE i      i Requirements Engineering Meta          ...
Benefits fB   fit from M d l b             Model-based Engineering                       dE i      i                      ...
Results     Business C     B i      Case – C t ib ti                     Contribution of Levers                           ...
Results  Business C  B i      Case – NPV P j ti                      Projection  B   Benefits are realized across        ...
Key Take-Aways f M d l bK T k A        for Model-based Engineering                             dE i      i Modeling compe...
ThankTh k you for your attention!         f         tt ti !                                                               ...
Contents                                   Goals                                   Brief look on Siemens and Vector     ...
References  R f US Food & Drug Administration, Design Control Guidance for Medical Device Manufacturers; March 11 1997   ...
syngo    The C t l I    Th Central Image Hub In H lth                     H b I Healthcare W kfl                          ...
Arnold Rudorfer                                                         Director Software Initiative and                  ...
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Incose Sweden Model Management01292011 V8

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Medical device development is increasingly under market pressure to reduce deployment time in critical care facilities. Further, budget cuts in critical care facilities drive process innovation mostly realized through a holistic integration of IT systems across departments (hospital information systems, PACS and modalities). One important leverage to reduce development cycle time and to control complexities of software along the life-cycle is to use model-based engineering approaches. Such new technology adoption is still in its early adoption phase. Less than 10 percent of organizations (in the medical device industry) use such approaches. As more and more clinical workflows start to be IT-supported > 60% (end of the ’90 only ~ 30%), model-based engineering brings viable solutions to large software development efforts (> 5000 requirements) in multi product lines. This talk will discuss implemented model-based engineering in Requirements Engineering, Architecture Design as well as outline what is planned for the system test by means of an imaging platform project carried out in Siemens Healthcare. Our own experience and an underlying business case show concrete cost savings in the project planning, testing and complexity reduction of the imaging platform architecture using a model-based requirements engineering approach. Further, the current status and requirements of engineering tools will be discussed. The talk ends with best practices developed as well as key take aways.

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Incose Sweden Model Management01292011 V8

  1. 1. Model-basedModel based Engineering inMedical Device Development – pIssues & SolutionsINCOSE SwedenLinkoepingApril 4 2011 4, © Siemens AG 2011. All rights reserved.
  2. 2. Contents  Goals  Brief look on Siemens Healthcare  Business challenges  Model-based Engineering: Issues & Solutions Model based  Recommendations  Further Information © Siemens AG 2011. All rights reserved.Page 2 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  3. 3. Contents  Goals  Brief look on Siemens Healthcare  Business challenges  Model-based Engineering: Issues & Solutions Model based  Results and Summary  Further Information © Siemens AG 2011. All rights reserved.Page 3 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  4. 4. Goals f thi T lkG l of this Talk Disc ss the e periences Discuss experiences using engineering models (in different phases of product development of a next generation imaging platform) Identify and share needs and requirements with colleagues from diverse industries to advance product d d t development tooling © Siemens AG 2011. All rights reserved.Page 4 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  5. 5. Contents  Goals  Brief look on Siemens Healthcare  Business challenges  Model-based Engineering: Issues & Model based Solutions  Results and Summary y  Further Information © Siemens AG 2011. All rights reserved.Page 5 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  6. 6. Siemens HealthcareTHE Integrated Healthcare Company I t t d H lth Cin-vivo diagnostics (imaging) X-Ray Computed Magnetic Molecular Ultrasound Oncology Tomography Resonance Imaging syngo.viain-vitroin vitro diagnostics (laboratory systems)Immunodiagnostics Nucleid Acid Clinical Chemistry Hematology Urin Lab Automation Near Patient Testing Analysis Testing © Siemens AG 2011. All rights reserved.Page 6 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  7. 7. Example: syngo.mCT Oncology: Oncology Workflow: Tumor Detection, Staging O l W kfl T D t ti St i Automated Case Preparation Disease Oriented Disease-Oriented Reading Multi Modality Multi-Modality Access Automated bone and bloodpool  Preferred layout applied  Image fusion for CT, PET, and removal  Automated lesion segmentation MR images, etc. Automated sorting of images, etc.  Automatic loading of prior exams, etc.Courtesy of University Hospital of Munich-Grosshadern/ Munich, Germany © Siemens AG 2011. All rights reserved.syngo.mCT Oncology is cleared in theRudorfer, Siemens Healthcare Imaging & Therapy SYNGO Page 7 Arnold U.S. with syngo.PET&CT Oncology.
  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 Information © Siemens AG 2011. All rights reserved.Page 8 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  9. 9. Business Challenges in Medical Device IndustryB i Ch ll i M di l D i I d t Industry Cycle time regulations down Complexity Costs down growth Need to industrialize product development Focus of this talk PlatformsApplication Life-cycle Model-based Management Tools Engineering Globally Integrated Clinical Workflows © Siemens AG 2011. All rights reserved.Page 9 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  10. 10. Disclaimer: The content discussed in this presentation needs to be considered as work in progress progress. © Siemens AG 2011. All rights reserved.Page 10 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  11. 11. Contents  Goals  Brief look on Siemens and Vector  Project syngo.via SYNGO products  Business challenges  Lean Requirements Engineering Model-based Engineering: Issues & Solutions  Results and Summary  Further Information © Siemens AG 2011. All rights reserved.Page 11 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  12. 12. syngo.via Product i P d t Project Summarysyngo.via: Next generationimaging software covering the g g gentire reading processProject data:> 5,000 single productrequirementsSeveral million lines of codeC++/C#Several hundred developers inmany locationsClinical applications f Cli i l li ti forRadiology, PACS, X-Ray, CT,PET/SPECT, Oncology, ParticleTherapy and MRMR. © Siemens AG 2011. All rights reserved.Page 12 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  13. 13. Industry I I d t Issues and Pain Points dP i P i tPain Points Business Impact Product structure Technology-driven product platform, no link to business intransparent, domain drivers model partially incomplete  Opaque relationship between problem & solution space  Re-scoping sessions w/ customers on basis of many specs. Ambiguity and lack of Textual-based specifications are subject to interpretation accuracy of specifications y p  Textual use case descriptions work only for smaller p j p y projects  Natural language subject to interpretation, inconsistent, incomplete Controlling architectural 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 Lack of V&V efficiency Test specifications in natural language are mostly executed in a manual way only  Test cases manually created  Thousands of pages of requirements © Siemens AG 2011. All rights reserved. Page 13 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  14. 14. Pain point 1: Product Structure Intransparent, Domain M d l Partially Incomplete D i Model P ti ll I l t Solutions: S l tiSelected issues: Opaque relations between A. Requirements Engineering problem problem- & solution space Meta-model Re-scoping sessions w/ B. Feature Model customer on basis of many engineering specs. g g p © Siemens AG 2011. All rights reserved. Page 14 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  15. 15. Solution A: Requirements Engineering Meta Model –B Benefits & T l Requirements (1) fit Tool R i tProblem Space DB Characteristics: Stakeholder  Provides needed artifacts, their Business Plan Request attributes and relationships to each Market Analysis, SW Platform Roadmap, other. other input for Business Case, etc.  Using meta-model, it is also possible to input for prescribe the way how / which data are captured . MRS SW Feature Analysis Benefits: Market analyzed Use Case Specifications, Requirement by Load Profiles,  Lean artefact infrastructure, no Concept Papers redundancy SWRS  Guidance for engineering tasks SW Req. (Problem) with structured input SW Req.  Established link between business (Solution) drivers, requirements, design and Specification/ Structural Element Content Mapping or pp g test Document Input © Siemens AG 2011. All rights reserved. Page 15 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  16. 16. Solution A: Requirements Engineering Meta Model –C Concepts (2) tStakeholder A Feature represents a characteristic of a product which Feature Request provides a business value and supports purchase decisions […]. A Feature structure requirements in a meaningful way and is no specification in itself (only “container”). Feature Feature A Feature Model is a hierarchical "tree" to describe the structure, dependencies, commonalities and variabilities of Features within a product or product line (e.g. SW Platform, Finished Medical Device). SW Feature SW Feature Requirements specify the Feature. They represent the functionality already implemented within the product and Market functionality that is planned for future versions. Depending on the Requirement project phase requirements are less or more detailed (e g (e.g. Market Req., SW Req.). SW Requirement Stakeholder Requests are wishes towards an existing or future product. Stakeholder Requests (SR) are gathered from various sources (e.g. end customer, business units) and may have an impact on different levels and phases of the product lifecycle . © Siemens AG 2011. All rights reserved. Page 16 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  17. 17. Solution A: Requirements Engineering Meta Model–C Concepts (3) t Problem Space Solution Sol tion Space DB Business Plan Stakeholder Market Analysis, Request Roadmap, Roadmap Business Case Case, Version Goal input for input for MRS SW Feature Analysis Market analyzed Use Case Specifications, Requirement R i t by Load Profiles, Concept Papers, etc. Architecture SWRS Architectural CDS SW Req. (Problem) Build. Block realizes SW Req. Design (Solution) Description © Siemens AG 2011. All rights reserved.Page 17 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  18. 18. Solution A: Requirements Engineering Meta Model–C Concepts (4) t Problem Space Solution Sol tion Space DB Business Plan Stakeholder Market Analysis, Request Roadmap, Roadmap Business Case Case, Version Goal Example: Feature - „Demo of Images“ input for input for Market Requirement: As a Clinician, I want to mark images to support MRS presentations for a medical conference. SW Feature Analysis Market analyzed Use Case Specifications, Requirement R i t by Load Profiles, Concept Papers, etc. Architecture SWRS Architectural CDS SW Req. (Problem) Build. Block realizes SW Req. Design (Solution) Description © Siemens AG 2011. All rights reserved.Page 18 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  19. 19. Solution A: Requirements Engineering Meta Model–C Concepts (5) t Problem Space Solution Sol tion Space DB Business Plan Stakeholder Market Analysis, Request Roadmap, Roadmap Business Case Case, Version Goal input for input for Use Case: „Demo of Images“ with activity diagram to derive software requirements. i t MRS SW Feature Analysis Market analyzed Use Case Specifications, Requirement R i t by Load Profiles, Concept Papers, etc. Architecture SWRS Architectural CDS SW Req. (Problem) Build. Block realizes SW Req. Design (Solution) Description © Siemens AG 2011. All rights reserved.Page 19 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  20. 20. Solution B F tS l ti B: Feature Model M d l Highest Level Characteristics:  Hierarchical tree to describe the structure, dependencies and commonalities liti  Lays out the basics for variant management and impact analysis Benefits:  Higher level abstraction of grouping Graphical View of requirements into sellable units: From 5,000 product requirements to 800+ features (factor ~ 6)  Visual domain model for healthcare workflows (tree & graphical)  Reduction in time to understand aspects of the system Hierarchical View Hi hi l Vi © Siemens AG 2011. All rights reserved.Page 20 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  21. 21. Solution B F t S l ti B: Feature Model & Its Relations (1) M d l It R l tiStakeholder Requests Application Use CasesHow can I manageHhuge amounts ofRequirements?How do I scope aproduct versionefficiently? Architecture Model © Siemens AG 2011. All rights reserved. Page 21 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  22. 22. Solution B F t S l ti B: Feature Model & Its Relations (2) M d l It R l tiStakeholder Requests Application Use Cases How do I manage Architecture Model stakeholder requests from different businesses most effectively? © Siemens AG 2011. All rights reserved. Page 22 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  23. 23. Pain point 2: Ambiguity and Lack of Accuracy of Specifications S ifi ti Level Requts. Manually Manual test Object Embedded graphs case creationIssues: Textual use case descriptions work only for smaller projects < ~ 100 Document Requt. 1 Picture / diagram (text) requirements Natural language subject to Features Requt. 2 Picture / diagram interpretation, usually inconsistent, (text) incomplete with inccorrect version (and p ( conflicting) Paragraph Requt. 3 Picture / diagram (text)Root causes: T t l requirements engineering d not Textual i t i i do t scale for platform projects Solutions: Missing versioning No direct access to single requirements C. C Application Use Cases Lack of product structure Inconsistently executed change management process © Siemens AG 2011. All rights reserved. Page 23 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  24. 24. Solution C: Graphical Modeling of ClinicalWorkflows (1)W kfl 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: B fit  Increase expressiveness of clinical workflows to describe dynamic behaviors of clinical workflows f li i l kfl  Early analysis of stakeholder requests from customers  Improved impact analysis of change requests  Joint modeling sessions to describe the needs from the customer s point of view customer‘s © Siemens AG 2011. All rights reserved.Page 24 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  25. 25. Solution C: Graphical Modeling of Clinical Workflows (2) W kflStakeholder Requests Application Use Cases How can I analyze a Model Architecture feature or a stakeholder request? © Siemens AG 2011. All rights reserved. Page 25 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  26. 26. Pain i t 3 C t lli A hit t P i point 3: Controlling Architectural Complexity lC l itSelected issues: Solutions: Business needs not consistently linked to features/ requirements; D. D Architecture Model Mapping dependencies between features not easily visible Too much variability in software architecture © Siemens AG 2011. All rights reserved. Page 26 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  27. 27. Solution D: Architecture M d l MappingS l ti D A hit t Model M i F Feature Model Characteristics:  Identifies links between features and their F F F implementation  Explicit modeling of variability in the architecture SWF SWF SWF SWF SWF SWF SWF S Architecture Model Benefits: SS SS SS  Architectural decisions motivated by features and product-line variability C C C C C C  Enabling reduction of architectural complexity  Support impact analysis for (de-) scoping sessions  Early identification of architectural risks  Improved accuracy of early effort estimates  Reduction of number of scoping sessions © Siemens AG 2011. All rights reserved.Page 27 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  28. 28. Solution D: Architecture M d l Mapping S l ti D A hit t Model M iStakeholder Requests Application Use Cases Architecture Model Which component p implements which feature? © Siemens AG 2011. All rights reserved. Page 28 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  29. 29. Pain i t 4 N d to Increase V&V Efficiency P i point 4: Need t I Effi iIssues: Test cases partially manually Solutions: generated from prose use cases C l ti Cycle times f system t t too long for t test t l E. Model-based S E M d lb d System T Test Compliance requirements QSR 21 CFR 820, ISO 13485:2003, EU MDD 93/ and other ed ca device 93/42 a d ot e medical de ce software regulations. © Siemens AG 2011. All rights reserved. Page 29 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  30. 30. Solution E: Model-based System Test (2)S l ti E M d l b dS t T t Benefits: B fit  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 p  Increase reuse of development artifacts  Quicker impact analysis by parsing model for late requirements changes (*) Based on experience from other projects © Siemens AG 2011. All rights reserved.Page 30 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  31. 31. Solution E: Model-based System Test S l ti E M d l b dS t T tStakeholder Requests Application Use Cases Architecture Model Which application use case is covered by which test case? © Siemens AG 2011. All rights reserved. Page 31 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  32. 32. Focus o Requirements Engineering …F R i t E i i Sync between tools Problem Space Master M t Slave Sl Solution Space (Features & Requirements) (Architectural Building Blocks) MRS Architectural Enterprise SW Feature Build. Block Enterprise realizes Architect Architect Market Requirement SWRS CDS Caliber RM SW Feature Architectural Build. Block SW Req. Req realizes* Design (Problem) Description SW Req. (Solution) Caliber RM Together © Siemens AG 2011. All rights reserved.Page 32 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  33. 33. Contents  Goals  Brief look on Siemens and Vector  Project syngo.via SYNGO products  Business challenges  Lean Requirements Engineering & Solutions Model-based Engineering: Issues  Results and Summary Results and Summary  Further Information © Siemens AG 2011. All rights reserved.Page 33 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  34. 34. Major Changes to Development ApproachModel-based EngineeringM d lb dE i i Requirements Engineering Meta Meta- Model Feature Model Graphical Modeling of Clinical Workflows Architecture Model Mapping Model-based System Test Note: syngo.via © Siemens AG 2011. All rights reserved.Page 34 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  35. 35. Benefits fB fit from M d l b Model-based Engineering dE i i © Siemens AG 2011. All rights reserved.Page 35 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  36. 36. Results Business C B i Case – C t ib ti Contribution of Levers fL Description of Benefit Distribution of Benefits  Tracing with less effort (based on 25%Defnition uct feature model‘s nature no verticals) model s nature,Produ  More effective stakeholder management (less scoping sessions, reduction in review times and effort)  Transparency and easy overview on product functionality 23%Planning Project  Reduction of product complexity (transparent modeling of 7%Design product lines and product variability)D More effective Testing 45%Test Easier bug-fixingSource: OREA Business Case, February 2011 (to be expected) © Siemens AG 2011. All rights reserved. Page 36 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  37. 37. Results Business C B i Case – NPV P j ti Projection B Benefits are realized across fit li d engineering workflows: Product Definition, Project Planning, Design and Test  Break-even reached in 2nd year  Hints for other RE practitioners:  Business case can only be carried out with a complete technical concept  Sensitivity analysis done on risks shows that the effort is worthwhile even when everything goes wrong.  Business case will vary depending on lccal circumstancesSource: OREA Business Case, February 2011 (to be expcetd) © Siemens AG 2011. All rights reserved. Page 37 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  38. 38. Key Take-Aways f M d l bK T k A for Model-based Engineering dE i i Modeling competence of prod ct managers needs to be b ilt up step product built p step- by-step thereby facilitating acceptance of new approach Seamless model-driven engineering is only partially tool-supported; model driven tool supported; the biggest gap remains in requirements engineering. Tool vendors need to stronger leverage the experience of leading development organizations and uptake it into technology roadmaps. Acceptance of model-based engineering is a huge organizational change management endeavor, only 10% of organizations have h t d l f i ti h already gained practical experience. Continuous assessment and verification of business benefits for model-based engineering is a must to maintain sponsorship from management. © Siemens AG 2011. All rights reserved.Page 38 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  39. 39. ThankTh k you for your attention! f tt ti ! © Siemens AG 2011. All rights reserved.Page 39 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  40. 40. Contents  Goals  Brief look on Siemens and Vector  Project syngo.via SYNGO products  Business challenges  Lean Requirements Engineering & Solutions Model-based Engineering: Issues  Results and Summary  Further Information Further Information © Siemens AG 2011. All rights reserved.Page 40 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  41. 41. References R f US Food & Drug Administration, Design Control Guidance for Medical Device Manufacturers; March 11 1997 Administration 11, US Food & Drug Administration, Quality System Regulation,; January 1, 1997, http://www.fda.org/cdrh/qsr/01qsreg.html Brian Berenbach, Daniel Paulish, Arnold Rudorfer, Juergen Kazmeier, Software Systems Requirements Engineering; Mc-Graw Hill 2009; http://www.mhprofessional.com/product.php?isbn=0071605479 Renate Loeffler: Formal Scenario-based Requirements Specification and Test Case Generation in Healthcare Applications, Diplomarbeit, Univ. Paderborn, 10/2009 Siemens Healthcare Imaging & Therapy SYNGO: Optimized Requirements Engineering Approach, Siemens Healthcare, 2010 Siemens Healthcare Imaging & Therapy SYNGO: Microsoft Team Foundation Server Business Case May 2010 Case, Medical Device & Diagnostic Industry 101, Carey Smoak, Roche Molecular Systems Inc., Pleasonton, CA, Pharma SUG 2010, Paper 1B01 Arnold Rudorfer, Christof Ebert: Lean Requirements Engineering in Medical Systems, MedConf 2010, Munich, Germany, October 14, 14 2010; http://2010 medconf de/downloads/abstracts2010/T2 T3 V1 vector siemens pdf http://2010.medconf.de/downloads/abstracts2010/T2_T3_V1_vector_siemens.pdf 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.pdf 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.pdf Siemens Healthcare Imaging & Therapy SYNGO: Optimized Requirements Engineering Approach Business Case, February 2011 © Siemens AG 2011. All rights reserved. Page 41 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  42. 42. syngo The C t l I Th Central Image Hub In H lth H b I Healthcare W kfl Workflows More patient exams Sound diagnoses in less time* in less time* Efficient i Effi i t image Smooth and fast S th d f t creation, usage, collaboration archiving, and sharing syngo. It s all about you. It’s*Results may vary. Data on file. © Siemens AG 2011. All rights reserved. Page 42 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
  43. 43. Arnold Rudorfer Director Software Initiative and Process Improvement Siemens AG Healthcare Sector Hartmannstrasse 16 D-91052 Erlangen Phone: +49 9131 – 84 2299 Fax: +49 9131 – 84 8691 Mobile: +49 174 1537825 Email: arnold.rudorfer@siemens.com © Siemens AG 2011. All rights reserved.Page 43 Arnold Rudorfer, Siemens Healthcare Imaging & Therapy SYNGO
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