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

Restricted © Siemens AG 2016 All rights reserved.

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



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



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



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

industrialize product

development

Cost down

Product variety

Cycle time down

Complexity growth

Configuration Engineering

Platform-based development

Focus of this talk

ALM

PLM



Providing Context “An Invitro-Diagnostic Instrument” …

A lab instrument is a highly complex mechatronics-based system: hardware, software, firmware producing test results.




► Key takeaways

► Appendix



Configuration Management Defined




► 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 …



Impact of Variety in IVD Product Development

External variety

Address market segment

Internal variety Cost-effective product development




► 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

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)







► 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 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?




► Key takeaways

► Appendix



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




► 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



Structure of Selected Challenges, Approach & 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



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




► Key takeaways

► Appendix



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).




► 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



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




► 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



Structure Efficient & Reliable Change Management Workflow (2)

Workflow supported change management integrated for hardware, software and firmware.




► 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



Managing Change Across Disciplines

Integrated ALM/PLM tool provides access to product data by engineering disciplines, changes are synchronized quickly across disciplines.




► 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



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.




► 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



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.




► 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 Engineering workflow, August 2015

Siemens Healthcare Laboratory Diagnostics: Company overview, 2016




► Key takeaways

► Appendix



Contact Details Arnold Rudorfer




► 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]

mailto:[email protected]

Configuration Engineering for Invitro-Diagnostic (IVD) Product Development

Technology

Transcript of Configuration Engineering for Invitro-Diagnostic (IVD) Product Development