Advanced Design & Re-use Harness the complexity of integrated, multi-disciplinary product designfor optimized devices with Siemens Design Excellence.

Siemens Digital Industries Software

Trends

Intelligent Platforming

FDA has defined “data integrity” as the completeness, consistency and accuracy of data.Complete, consistent and accurate data have the following attributes using the acronym ALCOA:

How can you challenge the focus on documentation and re-focus on the power of data control,rather than document control to enable advanced design and re-use?

Model Based Systems Engineering

Customer Realized Value

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RequirementsDefinition

Massive amounts of mixed data and documentation without context

ImplicationsContext may be trapped in the heads of the developers and it may be captured in some of the documentation, but traditional approaches have major challenges to reliably capture this

Data sets that are fully contextualized across design control requirements not only offer robust compliance but can be developed as intelligent platforms for true re-use across products and programs.

This will improve development efficiency andlower the total cost of ownership.

As medical device complexity continues to increase, many companies are turning to systems engineering principles to architect solutions for re-use

Reduces cost of traditional prosthetics by 90 percent, improves quality and expedites delivery

Reduce cost of typical prosthetic by 90%

Reduce number testsockets required

Deliver prosthetic 5times faster

Targets & regulatoryconstrains

Requirements

Feasibility& details

Feasibility& details

Feasibility& details

FDA: Data Integrity and Compliance with CGMP Guidance for Industry

Digitize core processes to create greater levels of efficiency and effectiveness.Leaders have captured 20 to 50 percent improvements in cost and efficiency.

Mckensey – How Medical Device CEOs can navigate digital disruption in healthcare

The NX driven socket development process really caused a ripple effect throughout the company. We're expanding the ways the software can further automate and enhance

our operation.

Easton LaChappelle, Founder and CEO Unlimited Tomorrow

With Advanced Design and Re-use, data sets are fully contextualized across design control requirements and not only offer robust compliance but can be developed as intelligent platforms for true re-use across products and programs.

Improve development efficiency and lower the total cost of ownership by collaborating through the cloud with design tools to plan, develop, and deliver devices faster with a complete Design Excellence solution.

Static documentation& isolated systems

ImplicationsData generated throughout the product

design cycle is not connected or related – and cannot be maintained that way

Limited Re-use

Advanced Design and Re-use is just part of our Design Excellence Solution.Design Excellence combines multi-disciplinary design collaboration with advanced design tools and

multi-physics simulations to achieve competitively differentiated, premium-value devices.

ImplicationsDecreases productivity and efficiency

Difficult maintenance and human reliance

ImplicationsDocument and data decay

Learn more about the additional parts of Design Excellenceand unlock your design potential to a distinct competitive advantage.

Product planning

System Functional andArchitectural Design

R&D

Clinical

Regulatory

Attributable

Legible

Contemporaneouslyrecorded

Original ora true copy

Accurate

PLATFORM

ALCO

A Visibility &Digital continuity

across theproduct lifecycle

90% x5

CxO

Post Market

Real World

Patient Outcomes

Other

Quality

Supplie&Partner

Manufacturing