Post on 29-Jul-2018
Page 1 Sumit Gupta, HC LD ENG EPS
Challenges & Approaches to Implementing Structured System architecture in the Medical Device Industry
Sumit Gupta, May 2018
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About Siemens Healthineers
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Page 3 Sumit Gupta, HC LD ENG EPS
About Siemens Healthineers
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Imaging Diagnostics Advanced Therapies
Services
About Siemens Healthineers
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Diagnostics
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• 14,000 employees • 30,000 customers in 120 countries• Broad spectrum of testing systems to
cover 900 different tests:• immunoassay• chemistry• hematology• molecular• urinalysis• blood gas
• Automation and Informatics solutions• Services
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• Process• Platform-based development
• Structured System Architecture
• Design to Shelf
• Multi-BOM Management
• Change Management
• Closed loop manufacturing
• Design controls
• Set-based design
• Agile Development
• Integrated Test Management
• …
• People (aligned to process)
• Digitalization (to connect people and process)
Transformation
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DigitalizationApproach
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Documents Structured and integrateddata model
Common Tool Landscape
mBOM ERPPLMNX
Mentor Microsoft
Simcenter …
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Structured System architecture Approach
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System Architecture Template (Structured Data Model)
Requirements& Architecture
Features Functions Logical Physical
Customer Feature 1
Customer Feature 2
Customer Feature 3
Customer Feature …
Technical Feature 1
Technical Feature 2
Technical Feature 3
Technical Feature …
Functional Decomposition
Logical Decomposition
Interfaces
Physical Design
PLM
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Structured System architecture V- Model
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Customer Feature 1
Customer Feature 2
Customer Feature 3
Customer Feature …
Physical Design
Technical Feature 1
Technical Feature 2
Technical Feature 3
Technical Feature …
Functional Decomposition
Logical Decomposition
Interfaces
Sub-SystemsAssemblyPart
PlatformProduct
Solution
Integ
ration
Valid
ation
Verif
icatio
n
Arch
itect
ure
Desig
n
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Benefits
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• Rapid development to respond to fast evolving market needs• Re-use of proven design assets• Accurate impact analysis of design changes• Improved test coverage via comprehensive system interface characterization• Features provide a vehicle for communication with marketing• Trade-offs based on cost and value of a feature• Visual architecture facilitates communication within engineering• Collaboration between configuration management and architecture• Improve accuracy and planning of new development project• Optimize modularity of system to resolve complex architectural dependencies
Quality
Cost
Accuracy
Time to market
Competition
Customer
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• Organization:
• Need for continuous and repetitive education at all levels (user, manager, executive)
• Functional divide between architecture (SW, HW) and requirements
• Need a collaborative approach between departments versus transactional
• Increased level of complexity of:
• Product information organization
• Management of traceability between design inputs and design outputs
• Regulatory standards and risks definition are requirements oriented
• Impact analysis during development is partial due to missing relationship
• Inefficient configuration management during development
• Lack of standards - architecture views and artifacts that are important for PLM
• Lack of architecture tools integrated with PLM system
• Definition of MVP is continuously challenged during adoption of the PLM processes and tools
Challenges
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Structured System architectureKey Aspects of the Transformation
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Before: After:Document Centric Knowledge Centric
Project Based Platform Based
Requirement Driven Feature Driven
Physical Architecture (HOW?) Functional Architecture (WHAT?)
New Product for New Customer Needs or New Market New configuration for New Customer Needs or New Market
Difficult to identify Re-use opportunities Facilitates Re-use
Feasibility testing in every project Minimal feasibility which is based on added technical risks
Difficult to plan accurately Fast and accurate development iteration planning
Functional silos Facilitate cross-team collaboration
Relatively simpler document management Increased complexity of product information management
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Q&A?
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This Photo by Unknown Author is licensed under CC BY
Sumit GuptaDirector, Global EngineeringHead of PLM Systems, Tools, & InfrastructureSiemens Healthineerssumitgupta@siemens-healthineers.com