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.

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Configuration Engineering for Invitro-
Diagnostic (IVD) Product Development
Invited Talk, Stevens Institute of Technology
Author: Arnold Rudorfer
Date: March 29, 2016
Status: 1st draft

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2 Laboratory Diagnostics
Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
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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3 Laboratory Diagnostics
Arnold 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

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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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Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Siemens Healthcare Laboratory Diagnostics
A 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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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
► Appendix
Need to
industrialize
product
development
Costs
down
Product
variety
Cycle time
down
Complexity
growth
Configuration
Engineering
Platform-based
development
Focus of this talk
ALM
PLM

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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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8 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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Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
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
Management
(11,12)

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10 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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11 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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12 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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13 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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14 Laboratory Diagnostics
Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
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
Management
(11,12)
Product
Variants
1
Manage change across disciplines
Efficient change management workflow
2
3
Coordinate change beyond
Engineering
4

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15 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
Engineering
Practice
Challenge, define a solution strategy
For each solution strategy, share ideas on
engineering practices
Illustrate benefits with supporting data

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16 Laboratory Diagnostics
Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Solution Strategy Map for Configuration Engineering
# Challenge Approach Engineering Practice
1 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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17 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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18 Laboratory Diagnostics
Arnold 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, 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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19 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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20 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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21 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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22 Laboratory Diagnostics
Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
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, 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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23 Laboratory Diagnostics
Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
Appendix
§ Reference documents
§ Contact details Arnold Rudorfer
► Goals, Siemens
LD
► Business
pressures, CE
overview
► Challenges,
approaches,
engineering
practices
► Key takeaways
► Appendix

24. Restricted © Siemens AG 2016 All rights reserved.
24 Laboratory Diagnostics
Arnold Rudorfer, Technical Talk @ Stevens Institute of Technology
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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25 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: arnold.rudorfer@siemens.com