configuration engineering for invitro-diagnostic (ivd) 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
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This talk on Configuration Engineering (= Configuration Management for Platform development) will discuss challenges, solution approaches and engineering experiences in invitro-diagnostic (IVD) product development. CE is an emerging discipline in various industries (such as medical devices, automotive, avionics/ space, …) which has developed from Configuration Management practices for single products. Further, examples presented will highlight the underlying CE concepts as well as address tool issues including observed benefits over the introduction.
Abstract of this Talk
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Table of Contents
Business pressures, Configuration Engineering overview 6-122
Goals, Siemens Healthcare Laboratory Diagnostics 3-51
Appendix 24-275
Page
Challenges, approaches, engineering practices 13-213
Key takeaways 224
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4 Laboratory Diagnostics Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Goals of this Presentation
Provide an overview on configuration management challenges for platforms and its solutions in a practical context.
Share engineering practices and benefits observed.
► Goals, Siemens LD
► Business pressures, CE overview
► Challenges, approaches, engineering practices
► Key takeaways
► Appendix
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5 Laboratory Diagnostics Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Siemens Healthcare Laboratory DiagnosticsA Global Leader in Key Market Segments
► Goals, Siemens LD
► Business pressures, CE overview
► Challenges, approaches, engineering practices
► Key takeaways
► Appendix
Largest Installed Base of Analytical Automation
Chemistry
Diagnostics ITLab Automation Molecular Point of Care
Hematology Hemostasis Immunoassay
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6 Laboratory Diagnostics Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Business Pressures for IVD Product Development
► Goals, Siemens LD
► Business pressures, CE overview
► Challenges, approaches, engineering practices
► Key takeaways
► AppendixNeed to
industrialize product
development
Cost down
Product variety
Cycle time down
Complexity growth
Configuration Engineering
Platform-based development
Focus of this talk
ALM
PLM
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7 Laboratory Diagnostics Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Providing Context “An Invitro-Diagnostic Instrument” …
A lab instrument is a highly complex mechatronics-based system: hardware, software, firmware producing test results.
► Goals, Siemens LD
► Business pressures, CE overview
► Challenges, approaches, engineering practices
► Key takeaways
► Appendix
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8 Laboratory Diagnostics Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Configuration Management Defined
► Goals, Siemens LD
► Business pressures, CE overview
► Challenges, approaches, engineering practices
► Key takeaways
► Appendix
A disciplined, efficient workflow for evolving a product including its data and associated procedural information from cradle to grave with increasing 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 approved product data: Product structures Product
configurations Product
documentation Design data …
Change history: Audit/ traceability Verification …
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9 Laboratory Diagnostics Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Impact of Variety in IVD Product Development
External variety
Address market segment
Internal variety Cost-effective product development
► Goals, Siemens LD
► Business pressures, CE overview
► Challenges, approaches, engineering practices
► 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)
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Concept End-to-End Configuration Engineering Workflow (1)
► Goals, Siemens LD
► Business pressures, CE overview
► Challenges, approaches, engineering practices
► Key takeaways
► Appendix
Coordinate and assess
Product Data Setup
(1&2)
Establish initial eBOM
structure(3)
Plan track, and review and Track product release
(4, 5, & 6)
Configuration Build
Management
(7)
Configuration Change
Management
(8, 9, 10)
Prototype Modification Managemen
t(11,12)
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11 Laboratory Diagnostics Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Concept End-to-End Configuration Engineering Workflow (2)
► Goals, Siemens LD
► Business pressures, CE overview
► Challenges, approaches, engineering practices
► Key takeaways
► Appendix
(per PDP phase gates)
gBOM
eBOM
mBOM
Feature 1 Feature 2 Feature 3 Feature N
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12 Laboratory Diagnostics Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Concept End-to-End Configuration Engineering Workflow (3)
eBOM
gBOM
► Goals, Siemens LD
► Business pressures, CE overview
► Challenges, approaches, engineering practices
► Key takeaways
► Appendix
Feature 1 Feature 2 Feature 3 Feature N
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13 Laboratory Diagnostics Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Concept End-to-End Configuration Engineering Workflow (4)
► Goals, Siemens LD
► Business pressures, CE overview
► Challenges, approaches, engineering practices
► Key takeaways
► Appendix
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14 Laboratory Diagnostics Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Structure of the Challenges, Approaches, Engineering Practices Employed
1 Managing product variants
How do I structure, assess and control product variability?
2 Structure an efficient and reliable change management workflow
What is the best approach for executing change management?
3 Managing changes across engineering disciplines
What do you do to manage and control product data across development projects?
4 Coordinating design changes across Engineering and Manufacturing
How do I consistently synchronize Engineering and Manufacturing to become faster and less costly?
► Goals, Siemens LD
► Business pressures, CE overview
► Challenges, approaches, engineering practices
► Key takeaways
► Appendix
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15 Laboratory Diagnostics Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Structure of the Challenges, Approaches, Engineering Practices Employed (2)
► Goals, Siemens LD
► Business pressures, CE overview
► Challenges, approaches, engineering practices
► Key takeaways
► Appendix
Coordinate and assess
Product Data Setup
(1&2)
Establish initial eBOM
structure(3)
Plan track, and review and Track product release
(4, 5, & 6)
Configuration Build
Management
(7)
Configuration Change
Management
(8, 9, 10)
Prototype Modification Managemen
t(11,12)
Product Variants
1
Manage change across disciplines
Efficient change management workflow2
3
Coordinate change beyond Engineering
4
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16 Laboratory Diagnostics Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Structure of Selected Challenges, Approach & Engineering Practices
► Goals, Siemens LD
► Business pressures, CE overview
► Challenges, approaches, engineering practices
► Key takeaways
► Appendix
Challenge Approach EngineeringPractice
Challenge, define a solution strategy
For each solution strategy, share ideas on engineering practices
Illustrate benefits with supporting data
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17 Laboratory Diagnostics Arnold 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 platform product structure
Modular product architecture
Frontend configuration engineering
2 Structure efficient and reliable change management workflow
Deploy end-to-end change management workflow to provide always accurate, actionable data (as automated as possible)
Standardized change management workflow
3 Manage change across engineering disciplines
Integration of product and configuration data, change can be synchronized accurately across discipline
Integrated cross discipline change management
4 Coordinate change Beyond Engineering
Enable manufacturing to obtain accurate engineering data to plan & execute Manufacturing
Synchronized data exchange of engineering to manufacturing product data
► Goals, Siemens LD
► Business pressures, CE overview
► Challenges, approaches, engineering practices
► Key takeaways
► Appendix
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18 Laboratory Diagnostics Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Manage Product Variants (1)
Explicit modeling of a generic product structure defining commonality & variability
Consistently manage variation points in a product and a configuration model for product variants over time.
Automate creation and update of product & configuration model using PLM tool(s).
► Goals, Siemens LD
► Business pressures, CE overview
► Challenges, approaches, engineering practices
► Key takeaways
► Appendix
1
Approach: Frontend Configuration Engineering
Benefits
Explicit modeling of product variants provides precision for product scope.
Improve design speed and reuse supporting a modular product architecture.
Enabler for a configure to order manufacturing model.
Customer needs drive product variants
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Structure Efficient & Reliable Change Management Workflow (1)
End-to-end bill of material handling (from a generic BOM, engineering BOM to a manufacturing BOM.
Handling of BOM baselines according to the level of design maturity and product lifecycle
► Goals, Siemens LD
► Business pressures, CE overview
► Challenges, approaches, engineering practices
► Key takeaways
► Appendix
2
Approach: Standardized change management workflow
Benefits
Accurate controlled changes in a single product data repository.
Reduced change cycle time with less defects.
Increased engineering productivity Audit proof documentation needed for
medical devices.
Change management workflow needs to cover different phases of
lifecycle.
gBOM eBOM mBOM
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20 Laboratory Diagnostics Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Structure Efficient & Reliable Change Management Workflow (2)
Workflow supported change management integrated for hardware, software and firmware.
► Goals, Siemens LD
► Business pressures, CE overview
► Challenges, approaches, engineering practices
► Key takeaways
► Appendix
2
Approach: Standardized change management workflow
Benefits
Synchronize an emerging change with prototype configuration data.
Change requests are integrated with emerging problem reports and/or enhancements.
Automation support for processing of change requests (pre-defined, templated, internal quality checks).
Measure product quality based on change requests (e.g. stability, …)
For use in simple to more complex change requests
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21 Laboratory Diagnostics Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Managing Change Across Disciplines
Integrated ALM/PLM tool provides access to product data by engineering disciplines, changes are synchronized quickly across disciplines.
► Goals, Siemens LD
► Business pressures, CE overview
► Challenges, approaches, engineering practices
► Key takeaways
► Appendix
3
Approach: Cross-discipline change management workflow
Benefits
Open access to prototype configuration data for all disciplines (HW, SW, FW).
Knowledge on design changes are systematically captured and are made retrievable.
Reduced errors, rework by having all product data in a single database.
Sample for an integrated change in a sub-system
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22 Laboratory Diagnostics Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Managing Change Across Disciplines
Apply concept of continuous integration of upgrades into instrument prototypes (similar to software).
Interface between ALM/PLM tool chain to MRP system allows synchronization and transparency for design changes.
► Goals, Siemens LD
► Business pressures, CE overview
► Challenges, approaches, engineering practices
► Key takeaways
► Appendix
4
Approach: Collaborating on Change Beyond Engineering
Benefits
Instrument prototype generation matures earlier by means of controlled deployment of upgrades.
Synchronization of eBOM and mBOM structures.
Consistent traceability of design changes for Engineering & Manufacturing
Design changes are identified early and are continuously
integrated
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Key Takeaways: Establishing Configuration Engineering in Your Organization
Development of CE needs diverse engineering perspectives along the product development lifecycle (up- and down-stream).
Due to little prior published body of knowledge on CE, start at a point in a project that supports showing value to project stakeholders.
Lay out an end-to-end vision for where CE can add value and has to lead the path.
For a multi-disciplinary domain such as IVD, select a tool-chain which allows as many stakeholders as possible to collaborate within the same workspace.
CE based on our own experiences needs to grow over time delivering short-term gains to build credibility while keep the grand vision in place.
► Goals, Siemens LD
► Business pressures, CE overview
► Challenges, approaches, engineering practices
► Key takeaways► Appendix
What you need to consider when developing CE
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Appendix
Reference documents Contact details Arnold Rudorfer
► Goals, Siemens LD
► Business pressures, CE overview
► Challenges, approaches, engineering practices
► Key takeaways
► Appendix
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Reference Documents
Arnold Rudorfer, Alexander Evers: Configuration Engineering workflow, August 2015
Siemens Healthcare Laboratory Diagnostics: Company overview, 2016
► Goals, Siemens LD
► Business pressures, CE overview
► Challenges, approaches, engineering practices
► Key takeaways
► Appendix
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26 Laboratory Diagnostics Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Contact Details Arnold Rudorfer
► Goals, Siemens LD
► Business pressures, CE overview
► Challenges, approaches, engineering practices
► Key takeaways
► Appendix
Arnold Rudorfer is a Senior Engineering Leader Instrument Development at Siemens Healthcare Laboratory Diagnostics. He has more than twenty years systems development experience with a focus on medical devices and enterprise platforms. His research interests include requirements and systems engineering, organizational change management, software technologies, innovation- and business strategy. Mr. Rudorfer holds an MS in software engineering and business administration from the University of Technology Graz, Austria. Further, he is a INOCSE member and PMP/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]