nih ce-presentation-05272016(for approval)

Unrestricted © Siemens Healthcare GmbH, 2016

Configuration Engineering for Invitro-Diagnostic (IVD) Product DevelopmentPrepared for National Institute of HealthAuthor: Arnold Rudorfer

Date: May 27, 2016

Status: 1st draft

2016-02-20 HC xxx – xxx

Unrestricted © Siemens Healthcare GmbH, 2016 HOOD05162002380020

Abstract of this Talk

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.

2016-02-20 HC xxx – xxx


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

2016-02-20 HC xxx – xxx


Goals of this Presentation

Goals,

Siemens LD

Business

pressures,

CE overview

Challenges,

approaches,

engineering

practices

Key

takeaways

Appendix

Provide an overview

on configuration

management

challenges for

platforms and its

solutions in a practical

context.

Share engineering

practices and

benefits observed.

2016-02-20 HC xxx – xxx


Siemens Healthcare Laboratory DiagnosticsA Global Leader in Key Market Segments

Largest Installed Base of Analytical Automation

Chemistry

Diagnostics ITLab Automation Molecular Point of Care

Hematology Hemostasis Immunoassay Goals,

Siemens LD

Business

pressures,

CE overview

Challenges,

approaches,

engineering

practices

Key

takeaways

Appendix

2016-02-20 HC xxx – xxx


Business Pressures for IVD Product Development

Need toindustrialize

productdevelopment

Cost down

Product variety

Cycle time down

Complexitygrowth

Configuration

Engineering

Platform-based

development

Focus of this talk

ALM

PLM

Goals,

Siemens LD

Business

pressures,

CE overview

Challenges,

approaches,

engineering

practices

Key

takeaways

Appendix

2016-02-20 HC xxx – xxx


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

2016-02-20 HC xxx – xxx


Configuration Management Defined

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

…

Goals,

Siemens LD

Business

pressures,

CE overview

Challenges,

approaches,

engineering

practices

Key

takeaways

Appendix

2016-02-20 HC xxx – xxx


Impact of Variety in IVD Product Development

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)

Goals,

Siemens LD

Business

pressures,

CE overview

Challenges,

approaches,

engineering

practices

Key

takeaways

Appendix

2016-02-20 HC xxx – xxx


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)

2016-02-20 HC xxx – xxx



(per PDP phase gates)

gBOM

eBOM

mBOM

Feature 1 Feature 2 Feature 3 Feature N

Goals,

Siemens LD

Business

pressures,

CE overview

Challenges,

approaches,

engineering

practices

Key

takeaways

Appendix

2016-02-20 HC xxx – xxx



eBOM

gBOM

Feature 1 Feature 2 Feature 3 Feature N

Goals,

Siemens LD

Business

pressures,

CE overview

Challenges,

approaches,

engineering

practices

Key

takeaways

Appendix

2016-02-20 HC xxx – xxx



Goals,

Siemens LD

Business

pressures,

CE overview

Challenges,

approaches,

engineering

practices

Key

takeaways

Appendix

2016-02-20 HC xxx – xxx


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

2016-02-20 HC xxx – xxx


Structure of the Challenges, Approaches, Engineering Practices Employed (2)

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 workflow2

3

Coordinate change beyond

Engineering

4

Goals,

Siemens LD

Business

pressures,

CE overview

Challenges,

approaches,

engineering

practices

Key

takeaways

Appendix

2016-02-20 HC xxx – xxx


Structure of Selected Challenges, Approach & Engineering Practices

Challenge, define a solution strategy

For each solution strategy, share ideas on

engineering practices

Illustrate benefits with supporting data

Challenge ApproachEngineering

Practice

Goals,

Siemens LD

Business

pressures,

CE overview

Challenges,

approaches,

engineering

practices

Key

takeaways

Appendix

2016-02-20 HC xxx – xxx


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

2016-02-20 HC xxx – xxx


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).

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

Goals,

Siemens LD

Business

pressures,

CE overview

Challenges,

approaches,

engineering

practices

Key

takeaways

Appendix

2016-02-20 HC xxx – xxx


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

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

Goals,

Siemens LD

Business

pressures,

CE overview

Challenges,

approaches,

engineering

practices

Key

takeaways

Appendix

2016-02-20 HC xxx – xxx


Structure Efficient & Reliable Change Management Workflow (2)

Workflow supported change management

integrated for hardware, software and

firmware.

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).

For use in simple to more

complex change requests

Goals,

Siemens LD

Business

pressures,

CE overview

Challenges,

approaches,

engineering

practices

Key

takeaways

Appendix

2016-02-20 HC xxx – xxx


Managing Change Across Disciplines

Integrated ALM/PLM tool provides

access to product data by engineering

disciplines, changes are synchronized

quickly across disciplines.

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

Goals,

Siemens LD

Business

pressures,

CE overview

Challenges,

approaches,

engineering

practices

Key

takeaways

Appendix

2016-02-20 HC xxx – xxx


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.

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, traceability.

Design changes are identified early

and are continuously integrated

Goals,

Siemens LD

Business

pressures,

CE overview

Challenges,

approaches,

engineering

practices

Key

takeaways

Appendix

2016-02-20 HC xxx – xxx


Key Takeaways: Establishing Configuration Engineering in Your Organization

Lay out an end-to-end vision for where CE can add value and

has to lead the path.

Development of CE needs diverse engineering perspectives

along the product development lifecycle (up- and down-stream).

For a multi-disciplinary domain such as IVD, select a ALM/ PLM

tool-chain which allows as many stakeholders as possible to

collaborate within the same workspace.

CE based on my own experiences needs to grow over time

delivering short-term gains to build credibility while keeping the

grand vision in place.

What you need to consider when developing CE

Goals,

Siemens LD

Business

pressures,

CE overview

Challenges,

approaches,

engineering

practices

Key

takeaways

Appendix

2016-02-20 HC xxx – xxx


Appendix

Reference documents

Contact details Arnold Rudorfer

Goals,

Siemens LD

Business

pressures,

CE overview

Challenges,

approaches,

engineering

practices

Key

takeaways

Appendix

2016-02-20 HC xxx – xxx


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

2016-02-20 HC xxx – xxx


Contact Details Arnold Rudorfer

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.

Siemens Healthcare Laboratory Diagnostics

62 Flanders Bartley Road

Flanders, NJ, 07836

Cell: +1 609 954 2384

E-Mail: [email protected]

mailto:[email protected]

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