Refsq 2011 03 29 V3
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Refsq 2011 03 29 V3

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Medical device development is increasingly under market pressure to reduce deployment in critical care facilities. Further, budget cuts in critical care facilities drive process innovation mostly ...

Medical device development is increasingly under market pressure to reduce deployment in critical care facilities. Further, budget cuts in critical care facilities drive process innovation mostly realized through a holistic integration of IT systems (hospital information systems, PACS and modalities). One important leverage to reduce development cycle time is to introduce learn/ agile requirements engineering approaches. Traditional V-model based development processes cannot cope with the pressure from the market. Given that the content of software in medical device has risen bigger than 60% (compared to 30% by end of the ‘90s), lean/agile RE is becoming a paramount discipline for a development organization to remain competitive. 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. A comparison of traditional to learn/ agile requirements engineering rounds up the picture including key takeaways.

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Refsq 2011 03 29 V3 Refsq 2011 03 29 V3 Presentation Transcript

  • Agile Requirements Engineeringin a Large Platform Project: g jChallenges, Solutionsand Best Practices dB tP tiREFSQ 2011EssenMarch 29, 2011 © Siemens AG 2011. All rights reserved.
  • Contents  Goals  Brief look on Siemens Healthcare  Business challenges  Lean Requirements Engineering  Business case and key take-aways  Further Information © Siemens AG 2011. All rights reserved.Page 2 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • Contents  Goals  Brief look on Siemens Healthcare  Business challenges  Lean Requirements Engineering  Business case and key take-aways  Further Information © Siemens AG 2011. All rights reserved.Page 3 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • GoalsG l Disc ss an agile / lean RE Discuss approach for medical device development Present challenges, solutions, benefits using agile / lean in RE © Siemens AG 2011. All rights reserved.Page 4 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • Contents  Goals  Brief look on Siemens Healthcare  Business challenges  Lean Requirements Engineering  Business case and key take-aways  Further Information © Siemens AG 2011. All rights reserved.Page 5 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • 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 I&T SYNGO
  • syngoThe C t l ITh Central Image Hub In Healthcare W kfl H b I H lth WorkflowsMore patient exams Sound diagnosesin less time* in less time*Efficient iEffi i t image Smooth and fast S th d f tcreation, usage, collaborationarchiving,and sharing*Results may vary. Data on file. syngo. It s all about you. It’s © Siemens AG 2011. All rights reserved.Page 7 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • 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 Page 8 Arnold U.S. with syngo.PET&CT Oncology. I&T SYNGO
  • Siemens Healthcare Development of S l and Employee Numbers D l t f Sales d E l N b Sales according to region1) Germany 9% Asia & Australia 17% Europe (without Germany) 31% 0.90.7 0.9 1.0 1.1 Americas Employees according to region2) p y g g 43% Germany 23% Europe Asia & Australia (without Germany) 17% 19% 9.7 11.4 11.31) 2) Americas Basis: FY 2009 acc. To customer locations. Figures worldwide as of Sept. 30, 2009 41% © Siemens AG 2011. All rights reserved. Page 9 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • Contents  Goals  Brief look on Siemens and Vector Healthcare  Project syngo.via Business challenges  Business challengesEngineering Lean Requirements  Lean Requirementskey take-aways Business case and Engineering  Results Information Further and Summary  Further Information © Siemens AG 2011. All rights reserved.Page 10 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • Business Ch llB i ChallengesEnvironment:En ironment  Shorten time-to-market  Cuts in healthcare budgets  Continuous product innovationProduct development: Value-orientation Flexibility Risk Orientation © Siemens AG 2011. All rights reserved.Page 11 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • Contents  Goals  Brief look on Siemens and Vector Healthcare  Project syngo.via Business challenges  Business challenges Agile / Lean Requirements Engineering  Lean Requirements Engineering  Business case and key take-aways y y  Results and Summary  Further Information  Further Information © Siemens AG 2011. All rights reserved.Page 12 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • Disclaimer: The content discussed in this presentation needs to be considered as work in progress progress. © Siemens AG 2011. All rights reserved.Page 13 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • Project:P j t syngo.via Product i P d t Project O P j t Overview isyngo.via: Next generationimaging software for the entire g greading processProject data: > 5,000 single product requirements Several million lines of code C++/C# Several hundred developers in many locations Clinical applications for Radiology, PACS, X-Ray, CT, PET/SPECT, Oncology, Particle Therapy and MR can be developed © Siemens AG 2011. All rights reserved.Page 14 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • RE Issues in the ProjectPressing Pain-Points to look at …P i P i P i t t l k t V-model life-cycle does not allow for  Ambiguity and Lack of Accuracy of flexible adaptations Specifications Engineering artifact structure does  High manual effort for traceabilitynot facilitate market valuation and auditability © Siemens AG 2011. All rights reserved.Page 15 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • Pain point 1 + 2: V-model & Engineering ArtifactStructureSt t Solutions:Selected issues to deal with: Domain model for imaging A. Feature model software partially complete Scope for release planning difficult B. Value-based ranking of to define features Need to short development C. Incremental requirements lifecycle – outdated requirements engineering © Siemens AG 2011. All rights reserved. Page 16 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • Solution A F tS l ti A: Feature Model M d l Highest Level 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)  Reduction of (re-) scoping effort by ~ Graphical View 30% (*)  Reduction in time to understand aspects of the system  Hierarchical relationships enable mapping of stakeholder requests and visualize dependencies Hierarchical View © Siemens AG 2011. All rights reserved.Page 17 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • Solution B V l bS l ti B: Value-based Ranking of Features d R ki fF t Characteristics:  Ranking is used to determine the release backlog  Main criteria for ranking are business value, technical risk and effort Benefits:  Only features with the highest business value (and feasibility) are implemented  Feature independence assures parallelization of development  Simulation of optimal release plan (what- if analysis) © Siemens AG 2011. All rights reserved.Page 18 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • Solution C: Incremental RequirementsEngineeringE i i From Feature ModelCharacteristics: Benefits: High-level features are elaborated  Min 25% reduction of upfront Min. when needed – just enough requirement engineering work, just-in- specification before time (*) implementation  Elimination of unnecessary hand-offs hand offs Top-ranked features will be refined between development roles & assigned for implementation  ~ 20% reduction of life-cycle time(*) Source: MS Team Foundation Server Business Case, May 2010 through concurrent engineering (**) ( )(**) Source: Experience of agile clinical/ financial information systems projects © Siemens AG 2011. All rights reserved.Page 19 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • Agile / Lean Requirements EngineeringEmbedded i th E ti DE b dd d in the Entire Development Life-cycle l t Lif l © Siemens AG 2011. All rights reserved.Page 20 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • Process-Adaption:From V-Model to Agile DevelopmentF V M d l t A il D l t „Old“ V M d l Process Old“ V-Model P D2 D3 D4 Specification Implementation Test System- + Plan + Repair test Design Input „New“ A il / Lean P N “ Agile L Process IT IT Start Accept End D2 D3 Commit D4 Plan Implementation Test System- + Test + Repair p + Repair test Feasibility F ibilit Design Input Readiness Doneness D © Siemens AG 2011. All rights reserved.Page 21 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • Pain point 3: 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 D. D Application Use Cases Lack of product structure Inconsistently executed change management process © Siemens AG 2011. All rights reserved. Page 22 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • Solution D: Graphical Modeling of ClinicalWorkflowsW kfl C a acte st cs 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 t describe d kfl to d ib dynamic b h i i behaviors  Early analysis of stakeholder requests from customers; joint modeling sessions to describe th needs f d ib the d from th customer‘s the t ‘ point of view  Reduction of review times due to visual approach (~ -40%) 40%) © Siemens AG 2011. All rights reserved.Page 23 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • Major Changes - RecapLean Requirements EngineeringL R i t E i i Feature Model Value-based Ranking of Features Incremental Requirements Engineering Graphical Modeling of Clinical Workflows © Siemens AG 2011. All rights reserved.Page 24 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • Some Key Differences: Traditional- and Agile/ Lean R L Requirements E i i t Engineering i Traditonal Agile “Lean” Traditional RE Agile / Lean RESpecifications are developed upfront Value-based approach; only the top-most requirments are specified; reduce wasteText-based requirements specification Comination of user stories and requirementsapproach (> 90% of development models (to depict dynamic behaviors of clinicalorganization) workflows)Longer development cycles possible Concurrent engineering for development (Scrum and feature orientation combined)Requirements engineering activities only till End-to-end End to end requirements engineering„Design Input Complete“ (D3)Engineering teams detached from clinical Close working relationship of engineering team,end user product managers and clinical user © Siemens AG 2011. All rights reserved. Page 25 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • Contents  Goals  Brief look on Siemens and Vector Healthcare  Project syngo.via Business challenges  Business challenges Agile / Lean Requirements Engineering  Lean Requirements Engineering Business Case and Key Takeaways  Results Information Further and Summary  Further Information © Siemens AG 2011. All rights reserved.Page 26 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • 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 g ( 25%Planning Defnition Product t feature model‘s nature, no verticals) More effective stakeholder management (less scoping sessions, reduction in review times and effort) Transparency and easy overview on product functionality 23% Project PP 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 © Siemens AG 2011. All rights reserved. Page 27 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • Business C B i Case – NPV P j ti Projection  Benefits are realized across engineering workflows: Product Definition, Project NPV Projection Planning, Design and Test  Break even reached in 2nd year Break-even  Hints for other RE practitioners:  Business case can only be conducted with a complete technical concept  Sensitivity analysis on implementation risks shows that the effort is worthwhile even if everything goes wrong.  Business case will vary depending on y p g lccal circumstancesSource: OREA Business Case, February 2011 © Siemens AG 2011. All rights reserved. Page 28 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • Key Take-AwaysK T k A To mo e from traditional to agile / lean RE approach needs a step move step- wise, value-based approach Feature orientation brings a focus on what is relevant for the customer and the pre-condition for concurrent engineering The introduction of agile / lean Requirements Engineering is a huge organizational change management endeavor Continuous assessment and verification of business benefits is necessary t judge what i working and what not to j d h t is ki d h t t © Siemens AG 2011. All rights reserved.Page 29 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • ThankTh k you for your attention! f tt ti ! © Siemens AG 2011. All rights reserved.Page 30 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • Contents  Goals  Brief look on Siemens and Vector Healthcare  Project syngo.via Business challenges  Business challenges Agile / Lean Requirements Engineering  Lean Requirements Engineering Business Case and Key Takeaways  Results Information Further and Summary  Further Information © Siemens AG 2011. All rights reserved.Page 31 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • References R f US Food & Drug Administration, Design Control Guidance for Medical Device Manufacturers; March 11, 1997 US Food & Drug Administration, Quality System Regulation,; January 1, 1997, http://www.fda.org/cdrh/qsr/01qsreg.html Beatrice Hwong, Grace Tai, Rajanikanth Tanikella, Gergana Nikolova, Gilberto Matos, Christopher Nelson, Bradley Wehrwein, Arnold Rudorfer, Xiping Song, Monica McKenna: Quality Improvements from Using Agile Development Methods: Lessons Learned, e e op e t et ods esso s ea ed, http://www.51testing.com/ddimg/uploadsoft/20090120/Agile QualityAssurance.pdf, April 2007 Brian Berenbach, Daniel Paulish, Arnold Rudorfer, Juergen Kazmeier, Software Systems Requirements Engineering; M G E i i Mc-Graw Hill 2009; 2009 http://www.mhprofessional.com/product.php?isbn=0071605 479 Arnold Rudorfer, Christof Ebert: Lean Requirements Engineering in Medical Systems, MedConf 2010 Munich Systems 2010, Munich, Germany, October 14, 2010; http://2010.medconf.de/downloads/abstracts2010/T2_T3_V 1_vector_siemens.pdf Arnold Rudorfer, Christof Ebert: Systematisches Requirements Engineering, QZ, March 2011 © Siemens AG 2011. All rights reserved. Page 32 Arnold Rudorfer, Siemens Healthcare I&T SYNGO
  • Arnold Rudorfer Director Software Initiative and Process Improvement Siemens AG Healthcare Sector Hartmannstrasse 16 D-91052 Erlangen Phone: +49 9131 – 82 2299 Fax: +49 9131 – 84 8691 Mobile: +49 174 1537825 E-Mail: arnold.rudorfer@siemens.com © Siemens AG 2011. All rights reserved.Page 33 Arnold Rudorfer, Siemens Healthcare I&T SYNGO