Challenges & Approaches to Implementing Structured … · • Management of traceability between...

Sumit Gupta, HC LD ENG EPS

Challenges & Approaches to Implementing Structured System architecture in the Medical Device Industry

Sumit Gupta, May 2018

Unrestricted © Siemens Healthcare GmbH, 2018


About Siemens Healthineers



Imaging Diagnostics Advanced Therapies

Services

About Siemens Healthineers



Diagnostics


• 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


• 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



DigitalizationApproach


Documents Structured and integrateddata model

Common Tool Landscape

mBOM ERPPLMNX

Mentor Microsoft

Simcenter …


Structured System architecture Approach


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


Structured System architecture V- Model


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


Benefits


• 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


• 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



Structured System architectureKey Aspects of the Transformation


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


Q&A?


?

This Photo by Unknown Author is licensed under CC BY

Sumit GuptaDirector, Global EngineeringHead of PLM Systems, Tools, & InfrastructureSiemens [email protected]

http://justintarte.blogspot.com/2011/12/top-10-questions-to-ask-yourself-in.html?m=0

https://creativecommons.org/licenses/by/4.0/

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