Configuration Engineering for Invitro-Diagnostic Product Development
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The document presents a technical talk by Arnold Rudorfer at Stevens Institute of Technology, focusing on configuration engineering (CE) for in vitro diagnostic (IVD) product development. It outlines the challenges, approaches, and engineering practices related to managing product variants and change management workflows in IVD products. Key takeaways emphasize developing a collaborative approach across engineering disciplines and integrating tools to enhance product development efficiency and effectiveness.
Configuration Engineering for Invitro-Diagnostic Product Development
- 1. Restricted © Siemens AG 2016 All rights reserved. Set the pace. Configuration Engineering for Invitro- Diagnostic (IVD) Product Development Invited Talk, Stevens Institute of Technology Author: Arnold Rudorfer Date: March 29, 2016 Status: 1st draft
- 2. 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
- 3. Restricted © Siemens AG 2016 All rights reserved. 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
- 4. Restricted © Siemens AG 2016 All rights reserved. 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
- 5. Restricted © Siemens AG 2016 All rights reserved. 5 Laboratory Diagnostics 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
- 6. Restricted © Siemens AG 2016 All rights reserved. 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 ► 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
- 7. Restricted © Siemens AG 2016 All rights reserved. 7 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 § …
- 8. Restricted © Siemens AG 2016 All rights reserved. 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)
- 9. Restricted © Siemens AG 2016 All rights reserved. 9 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)
- 10. Restricted © Siemens AG 2016 All rights reserved. 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
- 11. Restricted © Siemens AG 2016 All rights reserved. 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
- 12. Restricted © Siemens AG 2016 All rights reserved. 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
- 13. Restricted © Siemens AG 2016 All rights reserved. 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
- 14. Restricted © Siemens AG 2016 All rights reserved. 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
- 15. Restricted © Siemens AG 2016 All rights reserved. 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
- 16. Restricted © Siemens AG 2016 All rights reserved. 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
- 17. Restricted © Siemens AG 2016 All rights reserved. 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
- 18. Restricted © Siemens AG 2016 All rights reserved. 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
- 19. Restricted © Siemens AG 2016 All rights reserved. 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
- 20. Restricted © Siemens AG 2016 All rights reserved. 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
- 21. Restricted © Siemens AG 2016 All rights reserved. 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
- 22. Restricted © Siemens AG 2016 All rights reserved. 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
- 23. Restricted © Siemens AG 2016 All rights reserved. 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
- 25. Restricted © Siemens AG 2016 All rights reserved. 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