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Restricted © Siemens AG 2016 All rights reserved. Set the pace.
Configuration Engineering for Invitro-Diagnostic (IVD) Product DevelopmentInvited Talk, Stevens Institute of Technology
Author: Arnold Rudorfer
Date: March 29, 2016
Status: 1st draft
Restricted © Siemens AG 2016 All rights reserved.
2 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
This talk on Configuration Engineering (= ConfigurationManagement for Platform development) will discuss challenges,solution approaches and engineering experiences in invitro-diagnostic (IVD) product development. CE is an emergingdiscipline in various industries (such as medical devices,automotive, avionics/ space, …) which has developed fromConfiguration Management practices for single products. Further,examples presented will highlight the underlying CE concepts aswell as address tool issues including observed benefits over theintroduction.
Abstract of this Talk
Restricted © Siemens AG 2016 All rights reserved.
3 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Table of Contents
Business pressures, Configuration Engineering overview 6-122
Goals, Siemens Healthcare Laboratory Diagnostics 3-51
Appendix 24-273
Page
Challenges, approaches, engineering practices 13-213
Key takeaways 224
Restricted © Siemens AG 2016 All rights reserved.
4 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Goals of this Presentation
§ Provide an overview onconfiguration managementchallenges for platformsand its solutions in apractical context.
§ Share engineering practicesand benefits observed.
► Goals, SiemensLD
► Businesspressures, CEoverview
► Challenges,approaches,engineeringpractices
► Key takeaways
► Appendix
Restricted © Siemens AG 2016 All rights reserved.
5 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Siemens Healthcare Laboratory DiagnosticsA Global Leader in Key Market Segments
► Goals, SiemensLD
► Businesspressures, CEoverview
► Challenges,approaches,engineeringpractices
► Key takeaways
► Appendix
Largest Installed Base of Analytical Automation
Chemistry
Diagnostics ITLab Automation Molecular Point of Care
Hematology Hemostasis Immunoassay
Restricted © Siemens AG 2016 All rights reserved.
6 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Business Pressures for IVD Product Development
► Goals, SiemensLD
► Businesspressures, CEoverview
► Challenges,approaches,engineeringpractices
► Key takeaways
► AppendixNeed to
industrializeproduct
development
Costsdown
Productvariety
Cycle timedown
Complexitygrowth
ConfigurationEngineering
Platform-baseddevelopment
Focus of this talk
ALM
PLM
Restricted © Siemens AG 2016 All rights reserved.
7 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Configuration Management Defined
► Goals, SiemensLD
► Businesspressures, CEoverview
► Challenges,approaches,engineeringpractices
► Key takeaways
► Appendix
A disciplined, efficient workflow for evolving a product including its dataand associated procedural information from cradle to grave withincreasing precision and maturity.
Controlled
Input(s):Product Needs:§ Feature/ function§ Problem reports§ Enhancements
§ …
Product data:§ Product structure§ Product
configuration§ Product
documentation§ Design data
§ …
Output(s):New approvedproduct data:§ Product structures§ Product
configurations§ Product
documentation§ Design data
§ …
Change history:§ Audit/ traceability§ Verification
§ …
Restricted © Siemens AG 2016 All rights reserved.
8 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Impact of Variety in IVD Product Development
Externalvariety
Addressmarketsegment
Internal variety Cost-effectiveproductdevelopment
► Goals, SiemensLD
► Businesspressures, CEoverview
► Challenges,approaches,engineeringpractices
► Key takeaways
► Appendix
§ Infinite variety is not manageable (cost, timeline, quality, …)§ Variety in product development needs to be consciously
managed.
Evolving discipline: Configuration Engineering= Variant Management (what) + Configuration Management (how)
Restricted © Siemens AG 2016 All rights reserved.
9 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Concept End-to-End Configuration Engineering Workflow (1)
► Goals, SiemensLD
► Businesspressures, CEoverview
► Challenges,approaches,engineeringpractices
► Key takeaways
► Appendix
Coordinateand assess
Product DataSetup(1&2)
Establishinitial eBOM
structure(3)
Plan track,and reviewand Trackproductrelease
(4, 5, & 6)
ConfigurationBuild
Management(7)
ConfigurationChange
Management(8, 9, 10)
PrototypeModificationManagement
(11,12)
Restricted © Siemens AG 2016 All rights reserved.
10 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Concept End-to-End Configuration Engineering Workflow (2)
► Goals, SiemensLD
► Businesspressures, CEoverview
► Challenges,approaches,engineeringpractices
► Key takeaways
► Appendix
(per PDP phase gates)
§ gBOM
eBOM
mBOM
Feature 1 Feature 2 Feature 3 Feature N
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11 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Concept End-to-End Configuration Engineering Workflow (3)
eBOM
§ gBOM
► Goals, SiemensLD
► Businesspressures, CEoverview
► Challenges,approaches,engineeringpractices
► Key takeaways
► Appendix
Feature 1 Feature 2 Feature 3 Feature N
Restricted © Siemens AG 2016 All rights reserved.
12 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Concept End-to-End Configuration Engineering Workflow (4)
► Goals, SiemensLD
► Businesspressures, CEoverview
► Challenges,approaches,engineeringpractices
► Key takeaways
► Appendix
Restricted © Siemens AG 2016 All rights reserved.
13 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Structure of the Challenges, Approaches, Engineering Practices Employed
1 Managing productvariants
How do I structure, assessand control productvariability?
2 Structure an efficientand reliable changemanagement workflow
What is the best approachfor executing changemanagement?
3 Managing changesacross engineeringdisciplines
What do you do to manageand control product dataacross developmentprojects?
4 Coordinating designchanges acrossEngineering andManufacturing
How do I consistentlysynchronize Engineeringand Manufacturing tobecome faster and lesscostly?
► Goals, SiemensLD
► Businesspressures, CEoverview
► Challenges,approaches,engineeringpractices
► Key takeaways
► Appendix
Restricted © Siemens AG 2016 All rights reserved.
14 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Concept End-to-End Configuration Engineering Workflow (1)
► Goals, SiemensLD
► Businesspressures, CEoverview
► Challenges,approaches,engineeringpractices
► Key takeaways
► Appendix
Coordinateand assess
Product DataSetup(1&2)
Establishinitial eBOM
structure(3)
Plan track,and reviewand Trackproductrelease
(4, 5, & 6)
ConfigurationBuild
Management(7)
ConfigurationChange
Management(8, 9, 10)
PrototypeModificationManagement
(11,12)
ProductVariants
1
Manage change across disciplines
Efficient change management workflow2
3
Coordinate change beyondEngineering
4
Restricted © Siemens AG 2016 All rights reserved.
15 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Structure of Selected Challenges, Approach & Engineering Practices
► Goals, SiemensLD
► Businesspressures, CEoverview
► Challenges,approaches,engineeringpractices
► Key takeaways
► Appendix
Challenge Approach EngineeringPractice
Challenge, define a solution strategyFor each solution strategy, share ideas onengineering practicesIllustrate benefits with supporting data
Restricted © Siemens AG 2016 All rights reserved.
16 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Solution Strategy Map for Configuration Engineering
# Challenge Approach Engineering Practice1 Manage product
variants§ Provide transparency on variation
points in product structure§ Proactively manage variation points
in a configuration model
§ Generic platformproduct structure
§ Modular productarchitecture
§ Frontend configurationengineering
2 Structure efficientand reliable changemanagementworkflow
Deploy end-to-end changemanagement workflow to providealways accurate, actionable data (asautomated as possible)
Standardized changemanagement workflow
3 Manage changeacross engineeringdisciplines
Integration of product and configurationdata, change can be synchronizedaccurately across discipline
Integrated cross disciplinechange management
4 Coordinate changeBeyond Engineering
Enable manufacturing to obtainaccurate engineering data to plan &execute Manufacturing
Synchronized dataexchange of engineering tomanufacturing product data
► Goals, SiemensLD
► Businesspressures, CEoverview
► Challenges,approaches,engineeringpractices
► Key takeaways
► Appendix
Restricted © Siemens AG 2016 All rights reserved.
17 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Manage Product Variants (1)
§ Explicit modeling of a generic product structuredefining commonality & variability
§ Consistently manage variation points in aproduct and a configuration model for productvariants over time.
§ Automate creation and update of product &configuration model using PLM tool(s).
► Goals, SiemensLD
► Businesspressures, CEoverview
► Challenges,approaches,engineeringpractices
► Key takeaways
► Appendix
1
Approach: Frontend Configuration Engineering
Benefits
§ Explicit modeling of product variants providesprecision for product scope.
§ Improve design speed and reuse supporting amodular product architecture.
§ Enabler for a configure to order manufacturingmodel.
Customer needs driveproduct variants
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18 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Structure Efficient & Reliable Change Management Workflow (1)
§ End-to-end bill of material handling(from a generic BOM, engineeringBOM to a manufacturing BOM.
§ Handling of BOM baselines accordingto the level of design maturity andproduct lifecycle
► Goals, SiemensLD
► Businesspressures, CEoverview
► Challenges,approaches,engineeringpractices
► Key takeaways
► Appendix
2
Approach: Standardized change management workflow
Benefits
§ Accurate controlled changes in a singleproduct data repository.
§ Reduced change cycle time with lessdefects.
§ Increased engineering productivity§ Audit proof documentation needed for
medical devices.
Change management workflowneeds to cover different phases of
lifecycle.
gBOM eBOM mBOM
Restricted © Siemens AG 2016 All rights reserved.
19 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Structure Efficient & Reliable Change Management Workflow (2)
§ Workflow supported changemanagement integrated for hardware,software and firmware.
► Goals, SiemensLD
► Businesspressures, CEoverview
► Challenges,approaches,engineeringpractices
► Key takeaways
► Appendix
2
Approach: Standardized change management workflow
Benefits
§ Synchronize an emerging change withprototype configuration data.
§ Change requests are integrated withemerging problem reports and/orenhancements.
§ Automation support for processing ofchange requests (pre-defined,templated, internal quality checks).
§ Measure product quality based onchange requests (e.g. stability, …)
For use in simple to morecomplex change requests
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20 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Managing Change Across Disciplines
§ Integrated ALM/PLM tool providesaccess to product data by engineeringdisciplines, changes are synchronizedquickly across disciplines.
► Goals, SiemensLD
► Businesspressures, CEoverview
► Challenges,approaches,engineeringpractices
► Key takeaways
► Appendix
3
Approach: Cross-discipline change management workflow
Benefits
§ Open access to prototype configurationdata for all disciplines (HW, SW, FW).
§ Knowledge on design changes aresystematically captured and are maderetrievable.
§ Reduced errors, rework by having allproduct data in a single database.
Sample for an integratedchange in a sub-system
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21 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Managing Change Across Disciplines
§ Apply concept of continuous integrationof upgrades into instrument prototypes(similar to software).
§ Interface between ALM/PLM tool chainto MRP system allows synchronizationand transparency for design changes.
► Goals, SiemensLD
► Businesspressures, CEoverview
► Challenges,approaches,engineeringpractices
► Key takeaways
► Appendix
4
Approach: Collaborating on Change Beyond Engineering
Benefits
§ Instrument prototype generation maturesearlier by means of controlleddeployment of upgrades.
§ Synchronization of eBOM and mBOMstructures.
§ Consistent traceability of design changesfor Engineering & Manufacturing
Design changes are identifiedearly and are continuously
integrated
Restricted © Siemens AG 2016 All rights reserved.
22 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Key Takeaways: Establishing Configuration Engineering in Your Organization
§ Development of CE needs diverse engineering perspectivesalong the product development lifecycle (up- and down-stream).
§ Due to little prior published body of knowledge, start at a pointin a project that supports showing value to project stakeholders.
§ Lay out an end-to-end vision for where CE can add value andhas to lead the path.
§ For a multi-disciplinary domain such as IVD, select a tool-chainwhich allows as many stakeholders as possible to collaboratewithin the same workspace.
§ CE based on our own experiences needs to grow over timedelivering short-term gains to build credibility while keep thegrand vision in place.
► Goals, SiemensLD
► Businesspressures, CEoverview
► Challenges,approaches,engineeringpractices
► Key takeaways
► Appendix
What you need to consider when developing CE
Restricted © Siemens AG 2016 All rights reserved.
23 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Appendix
§ Reference documents§ Contact details Arnold Rudorfer
► Goals, SiemensLD
► Businesspressures, CEoverview
► Challenges,approaches,engineeringpractices
► Key takeaways
► Appendix
Restricted © Siemens AG 2016 All rights reserved.
24 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Reference Documents
§ Arnold Rudorfer, Alexander Evers: Configuration Engineeringworkflow, August 2015
§ Siemens Healthcare Laboratory Diagnostics: Companyoverview, 2016
► Goals, SiemensLD
► Businesspressures, CEoverview
► Challenges,approaches,engineeringpractices
► Key takeaways
► Appendix
Restricted © Siemens AG 2016 All rights reserved.
25 Laboratory DiagnosticsArnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Contact Details Arnold Rudorfer
► Goals, SiemensLD
► Businesspressures, CEoverview
► Challenges,approaches,engineeringpractices
► Key takeaways
► Appendix
Arnold Rudorfer is a Senior Engineering Leader InstrumentDevelopment at Siemens Healthcare Laboratory Diagnostics. He hasmore than twenty years systems development experience with afocus on medical devices and enterprise platforms. His researchinterests include requirements and systems engineering,organizational change management, software technologies,innovation- and business strategy. Mr. Rudorfer holds an MS insoftware engineering and business administration from the Universityof Technology Graz, Austria. Further, he is a INOCSE member andPMP/MSP certified.
Arnold Rudorfer
Senior Engineering Leader
Product Lifecycle Management
Siemens Healthcare Laboratory Diagnostics
62 Flanders Bartley Road
Flanders, NJ, 07836
Cell: +1 609 954 2384
E-Mail: [email protected]