digital transformation in the medical device...

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Digital Transformation in the

Medical Device Business

Maik Auricht

Solution Architect

Dassault Systèmes

Ital Bolliger

Client Executive

Dassault Systèmes

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Accelerated Development In Emerging Countries

Increased Regulatory

Scrutiny

Accelerate New Product Introduction cycle time

Medical Devices | Examples of Key Challenges

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Innovation Spendings

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Connecting the Dots along the cycle

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Generation changes

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Process Transformation Initiatives

Impact analysis

Traceability

Collaboration

Document centric

Departments in silos

Time-consuming iterations

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Why Digital Transformation?

Secure Framework for

Single Source of the Truth

From document based and siloed designs to data-

driven and model based approach

Foster Innovation From Product to Experience, through multi-scale & multi-

discipline support

Maximize Ecosystem Engagement

From siloed organizations to Flexibility in a Global

Company

Increase visibility & speed

From process execution to real time business impact

analysis

From Capacity Maximization to

Cycle Time Optimization Excel in Business Operations

Improve product consistency & regulatory filling efficiency

From Transactional to more

standardized regulatory

dossiers & quality

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Requirements Functional description Logical description 3D Structures

Project Management

Simulation

Mastering complexity: Connect the dots between all disciplines

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A systematic approach to mechatronics

Machine / end-product behavior

Electrical Schematics and 3D Design

Motion System Modeling and Simulation

Multi-discipline System Engineering

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5

6

2

4

Production Line Modeling and Simulation

Machine / Equipment Control Modeling

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Fluid Schematics and 3D Design

3

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Systems Engineering Overview

Tools

Methods

Processes

How to do?

With what?

supported by

Define activities to achieve a

particular objective

Defines techniques to perform

processes activities

Improve the efficiency of activities

through methodology

What to do?

support

supported by support

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The RFLP (*) Data Model | Principle

Function 2

Function 1

Function 3

Requirement

Functional

System 2 Logical

System 1

System 3

Physical

Product Tree Product

Functions

Logical

Physical

Requirements

Function 1

Function 2

Function 3

System 1

System 2

System 3

Part 1

Part 2

Part 1 Part 2

Req 1

Req2

Reg3

R1 : requirement 1

R2 : requirement 3

R3 : requirement 3 Allocate to

• Each RFLP objects support : Configuration, Traceability,

and Versioning

• Enable to maintain the models consistency

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Mastering System Complexity

Context

Intrinsic complexity of systems

Complexity of interactions with other systems

Many stakeholders requirements to consider

and balance

Point of views

Necessity to consider several point of views

to manage the complexity

Point of view

View and concern

Real

world

Stakeholder

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Implementation of the Modeling Methodology for Systems (MMS)

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Requirements Engineering Behavior Modeling

KPIs Validation/ Dashboarding

System Architecture Design

3D Modeling

Simulations Processes Optimization and DOE

Dynamic & Static Simulations

Mechatronics Engineering Synergies

Test Management

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Software in-the-loop

Hardware in-the-loop

Design in configured Context

3D Configurator

Virtual Validation for

Manufacturability and Maintainability

Virtual Prototyping Behaviour Simulation

Multi-Discipline Consistency

Virtual validation

Quality

Change Control

Summary: Facettes of Systems Engineering

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Value of a Multi-discipline System Engineering approach

Boost product reliability and performance • Validate holistic system behavior and performance

• Leverage amazing possibilities offered by automation to drive and maintain equipment performance throughout life cycle

Accelerate Smarter Components Development • Develop complex mechatronic products matching customer needs • Synchronize all engineering disciplines - both schematics and 3D - in a unique environment

Master Product Architecture • Intuitive view of machine architecture / system • Full traceability all the way, from needs identification to product validation • IP re-use

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In Cooperation with Fraunhofer IPK / TU Berlin

Engineer

Experience

User, Engineer,

Manager, …

Motion Plattform,

360° Active Stereo

Primary Environment

Secondary Environment

Systems Engineering to Experience

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Outlook Systems Engineering to Experience 2.0

Realtime Coupling

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