configuration engineering for invitro-diagnostic product development

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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



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



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



Siemens Healthcare Laboratory DiagnosticsA Global Leader in Key Market Segments




► Key takeaways

► Appendix

Largest Installed Base of Analytical Automation

Chemistry

Diagnostics ITLab Automation Molecular Point of Care

Hematology Hemostasis Immunoassay



Business Pressures for IVD Product Development




► Key takeaways

► AppendixNeed to

industrializeproduct

development

Costsdown

Productvariety

Cycle timedown

Complexitygrowth

ConfigurationEngineering

Platform-baseddevelopment

Focus of this talk

ALM

PLM



Configuration Management Defined




► 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

§ …



Impact of Variety in IVD Product Development

Externalvariety

Addressmarketsegment

Internal variety Cost-effectiveproductdevelopment




► 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)



Concept End-to-End Configuration Engineering Workflow (1)




► 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)







► Key takeaways

► Appendix

(per PDP phase gates)

§ gBOM

eBOM

mBOM

Feature 1 Feature 2 Feature 3 Feature N




eBOM

§ gBOM




► Key takeaways

► Appendix

Feature 1 Feature 2 Feature 3 Feature N







► Key takeaways

► Appendix



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?




► Key takeaways

► Appendix







► 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



Structure of Selected Challenges, Approach & Engineering Practices




► Key takeaways

► Appendix

Challenge Approach EngineeringPractice

Challenge, define a solution strategyFor each solution strategy, share ideas onengineering practicesIllustrate benefits with supporting data



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




► Key takeaways

► Appendix



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).




► 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



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




► 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



Structure Efficient & Reliable Change Management Workflow (2)

§ Workflow supported changemanagement integrated for hardware,software and firmware.




► 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



Managing Change Across Disciplines

§ Integrated ALM/PLM tool providesaccess to product data by engineeringdisciplines, changes are synchronizedquickly across disciplines.




► 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



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.




► 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



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.




► Key takeaways

► Appendix

What you need to consider when developing CE



Appendix

§ Reference documents§ Contact details Arnold Rudorfer




► Key takeaways

► Appendix



Reference Documents

§ Arnold Rudorfer, Alexander Evers: Configuration Engineeringworkflow, August 2015

§ Siemens Healthcare Laboratory Diagnostics: Companyoverview, 2016




► Key takeaways

► Appendix



Contact Details Arnold Rudorfer




► 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]