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Connecting the Value Chain from Idea to Market · 2020-03-04 · Connecting the Value Chain from...

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This presentation and all information contained herein is the confidential and proprietary information of Kalypso L.P. and its affiliates and subsidiaries (collectively, “Kalypso”) and is intended solely for the person(s) to whom it is transmitted by or on behalf of Kalypso. As such, no information contained herein shall be reproduced, copied, quoted, circulated, relied upon, or disclosed without the express written consent of Kalypso. With receipt of the information contained herein, the recipient acknowledges and agrees to at all times abide by the aforementioned non-use and non-disclosure obligations and any applicable written non-disclosure agreement(s). Connecting the Value Chain from Idea to Market
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This presentation and all information contained herein is the confidential and proprietary information of Kalypso L.P. and its affiliates and subsidiaries (collectively,

“Kalypso”) and is intended solely for the person(s) to whom it is transmitted by or on behalf of Kalypso. As such, no information contained herein shall be reproduced,

copied, quoted, circulated, relied upon, or disclosed without the express written consent of Kalypso. With receipt of the information contained herein, the recipient

acknowledges and agrees to at all times abide by the aforementioned non-use and non-disclosure obligations and any applicable written non-disclosure agreement(s).

Connecting the Value Chainfrom Idea to Market

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PLM has provided efficiency and productivity benefits helping manufacturers shorten design cycles,

but now, coupled with advanced digital solutions such as AI and ML, it has the capacity to deliver more innovation and improve the design to manufacturing integration

ERP

Establishing a digital platform can enable the transformation of product design and development, production management, and customer service models

The Digital Value Chain

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Product Service and Work Management

Health & Condition

Design/Engineering/ Manufacturing Documentation(P-BOM, E-BOM, M-BOM)

Engineering

Traditional/ Additive Manufacture

Prototype & Collaboration

Engineering Simulation& FEA

Ideation

Supply Chain Optimization

Analytics & Prediction

Generative Design

Augmented Reality (AR)

Virtual Reality (VR)

3DPrinting

Internet of Things (IoT)

ConceptPDM

PLMProductRecord

MES

Digital Twin

In Market

Productivity

Create MakeDiscover Sell

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The availability of intelligent data and providing it to the right functions at the right time creates new opportunities to reduce risk, improve quality, and accelerate innovation

Market Insights

ProductRequirements

Concept Setup

Item Setup

BoM/Formulation

Release New Product & Equipment Design

Setup New Item for Manufacturing

Equipment Configuration

Innovation Mngmt.

Product Development & Formulation

Product Data Record

Manufacturing / Production Line

IoT AI

Monitor Color Accuracy, Temperature, Humidity

Analyze Accuracy Deviations and Correlate to Environmental Conditions, Shifts, Resources, Suppliers and others.

Project Management: Manage new product and equipment project

Product QualityCapture Audit Results Create CAPA

InMarket

Smart Connected Value Chain

Product Lifecycle Intelligence – Predict cost of change, time to implement change, resource by region etc.

How about…?

Requirements and Digital content management

Virtual/Digital clones and digital verification and validation

Virtual/Digital models

Systems Engineering approach to product development adapted by industry is achieved through the utilization of the digital tools aligned with the process below

Digital product creation and validation

N E E D S S Y S T E M

Requirements

System Architecting

SubsystemDesign

ComponentDesign

ComponentTest

SubsystemIntegration

System Integration

System Validation

Process, Manufacture,

Assembly

M E S MES

Definition &Decomposition

Integration& Verification

Simulation& Verification

User Needs

Design Input

Design Process

Design Output

MedicalDevice

VERIFICATION

VALIDATION

REVIEW

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Digital opportunity is built upon a solid product record foundation

PLM

Product PackagingProcessing

Finished Product

PR

The Connected Product Record

through

Systems and Data

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But there is one common theme that spans across industries: for all digital efforts, data is the underlying raw material. And it’s time to get your data under control.

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We work with our clients to lay the right foundation, set the course and take the first steps.

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We think of Digital as both strategic and practical.

Visit www.kalypso.comto experience Smart Connected Discover to Make in real-life

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Appendix

Medical Device Capability Accelerators

Part / BOM ManagementCAD Data Management and

Model Based Enterprise (MBE)Document Management

Design Control & Design

Review (DHF/DMR)

Change Management Nonconformance Complaints CAPA & SCAR

New Product Introduction (NPI)

Project Management

Regulatory Information

Management (RIM)

Electronic Records

Management (ERM)

Product Lifecycle Intelligence

(PLI) - Machine Learning,

Artificial Intelligence (AI), &

Predictive Analytics

Roles / Groups & Access

ControlElectronic Signatures Automated Testing Validation Documentation

Pre-configured, leading practice business processes using Windchill PLM and QMS for the following capabilities:

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CAD Management for a Model Based Enterprise (MBE)

Leading Practice• Enforce use of a standard set of CAD Management practices (templates, CAD

behavior configuration files, numbering & revision sequences, and approvals)

to ensure support of the expectations of a Digital Model-Based Enterprise.

Capabilities• Supported CAD Tools (Creo 4, Solidworks 2019, later versions and other tool

suites coming soon)

• Example templates (start parts and drawings with linked parameters,

restricted parameter files, application behaviors, etc.)

• Coherent Naming, Numbering, and Parameter mapping to Windchill Attributes

based on Windchill Behavioral Preferences

• Common Numbering & Revision Sequences, Roles and ACLs, Lifecycle

with Maturity-based Data, Approvals Rules, Attribute Assignment,

default Behavioral Preferences shared with Parts and BOMs

• Supports both Bottom-Up (CAD first) and Top-Down (Part first) approaches

• Simplified drawing initiation – naming, numbering, and parameter value rules

• Customized Check-In enforces cascading parameter and attributes rules

• Supports CAD-Driven Product Structure in Part and BOM Management

Value• CAD usage aligned with integrated Master Data and Digital Model-Based

Enterprise vision

• CAD created to be enterprise ready

Data Set Automation

The ASME Y14.41 Data Set Concepts are supported by a series of small CAD-side automations

and Windchill-side configurations. Product definition can start with any Data Set element using

either “Top Down” and “Bottom Up” design approaches.

• Honor the “create data once and propagate it” paradigms.

Part

CAD Drawing (2D Data)

CAD Model (3D Data)

Referenced By

Owner

ContentMetadataMaterials,

Finishes,

ProcessesNotes

Analytical Data,

Test RequirementsAssociated

Lists

Model Drawing

Part

ASME Y14.41 Data Set Concepts supported by light automation

• Data required for complete definition may be

integral to, or referenced by, the product

definition data set

• Data not integral product definition data set, but

describing the product, may be revised

independently

• Related data may be manually set or computer

generated


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