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Post-Market Observation
Inaccurate or
Incomplete
determination
of VOC or VOB.
Increase in raw
materials costs.
Insufficient
post-production
monitoring.
Insufficient exploration
of concepts and
prototypes.
Multiple iterations in
design and testing.
Inadequate attention
to DFx requirements.
Lack of focus on
cost/value aspect
of design.
Initiating V&V efforts
after design is nearly
complete.
Manual approval/wet
signature for design and
test artifact approvals.
Test all for CSV/COTS
validation.
Enable
knowledge-based
engineering to reduce
iterations.
Adopt DFx checklist
for analysis.
Risk-based CSV/COTS
validation.
Early involvement
of V&V to identify
requirements defects
early.
Adoption of electronic
document management
systems and test
management systems.
Integrated quality
management system
that stresses active
vigilance.
Use analytics to
preempt failures.
Thorough root-cause
analysis before
re-releasing the product
to the field after
a recall.
Complete requirements
analysis before
proceeding to design.
Latest
Thinking
Social Media
PLM Integration
Figure 1
Poor
Neglecting
authority at an earlier stage of product development such as with the Federal Drug Administration (FDA) in cases concerning medical
device development.
Sourcing &
Manufacturing
Interface
Performance
Product &
Data Security
Service &
Installation
Labelling
Documentation
Packaging &
Shipping
Usability
Regulatory
Figure 2
to
Improve
Inadequate
Consideration
is on time to market.
Design/Verify/Prototype Stage
Design is another critical phase in the product
realization value chain. Approximately 70% of
the product costs are fixed during its design.3
Quick Take
Integrated Requirements Management for a Global Automotive Major
was using legacy systems to manage requirements. As a result, its engineers were spending
an inordinate amount of time fetching data and
managing requirements.
Benefits:
>> Conduct
Create
>> Improve
>> Reduce
Design Outputs
Design Inputs
KnowledgeBased Design
Aid
Design Outputs
Design Verify,
Validate & Launch
Source of
Knowledge
Design Verify,
Validate & Launch
Production
Redesign
Loops
Production
Post-Production
Maintenance
Post-Production
Maintenance
Figure 3
Quick Take
Automated Design Verification and Validation at a Global
Automotive Major
>> Increased
>> Effectively
ing manpower.
Solution:
making activity.
Knowledge
Formalization
Capture of
Engineering Knowledge
Knowledge
acquisition through
reports, design,
manufacturing,
performance and
maintenance
functions.
Captured knowledge
from business to
maintenance
activities & modeling
techniques.
Use of spreadsheet
for capturing
knowledge by
implementing
equations or rules
that enable
knowledge recycling
Output
Reports
Drawings
Costs
BOM
Manufacturing Plans
CAD Models/Assemblies
External Data
Catalogues
Tables
Materials
Analysis
Product Model
Geometry
Configuration
Product Knowledge
Engineering
Knowledge
Automation of
Engineering Activities
Interpretation of
acquired knowledge
into rules and
formalization to a
computer-implementation-friendly format.
Implementation
captured process,
rules & activities to
develop a KBE tool.
Follow iterative
process between the
capturing of
engineering
knowledge and the
automation of
engineering
activities.
Formalization using
a partner-company
approach. During
this activity the
implementation
structure i.e., a
hierarchical class
structure takes
shape.
Testing of tool
and/or application by
allowing engineers
to design the
lifecycle properties
of the product.
Packaging &
deployment of
the tool.
Figure 4
Problem
Statement
Measure
Understand
customer needs.
Define as is and
to be condition in
measurable terms.
Gather baseline
information.
Project charter.
Critical to quality
customer
requirements.
Process map.
Analyze
Reengineer
Analyze info/data
collected for
evaluation.
Develop
concepts/ideas for
better design.
Identify top
contributors for
defects or issues.
Perform cost
analysis.
Figure 5
Test &
Validate
Validate design
using CAE analysis.
Build functional
prototypes.
Measure
performance of
new design.
Manufacture
Manufacture and launch is another critical phase
in the device lifecycle. While requirements and
design set the foundation for a successful product
launch, costs incurred on manufacturing and the
supply chain can make or break a product launch.
Hence, cost optimization in manufacturing is of
prime importance. The factors that contribute to
cost overruns in this phase inclde:
Control:
Produce:
Optimize
Control
Six Sigma
Poka Yoke
Lean
SPC
Produce
Contract
Manufacturing
Figure 6
Post-Market Stage
Product development companies spend billions
of dollars5,6 on product recalls (warranty- or
compliance-based). The cost of poor quality
affects the image of companies and erases profit
Aging
Tr
ain
ing
Audit
Suppor
t
EA
tu
re
c
ufa
Man
Recall
FM
n, V&V
sig
De
ts
in
pla
au
nc
h
Com
Product
Realization
Value Chain
Aspects
Nonc
ent
om
e Ev
pli
ers
an
v
d
c
A
Ideate
PA
CA
Figure 7
Going Beyond
Any cost optimization inititiative without the
ability to view cost metrics is of little use. Enterprises typically do not visualize the benefits and
ROI of a cost optimization drive in a holistic way.
A single source of truth is necessary for analyzing
or viewing product costs, which can be obtained
through a cost analytics and reporting tool that
can communicate insights holistically across the
organization or enterprise.
An enterprise cost reporting system should be
ableto:
Interact
Quick Take
Product Cost Management at a Global Automotive Major
Business
>> CAD data moved between various departments such as design, sourcing and costing
through e-mails.
>> Delays in design changes due to cost overruns led to product rollout delays.
parts costs.
Post-Market-Activity Categories
Reactive Vigilance
Regulator-Initiated Recall
Quality Incidents
Adverse Event
Figure 8
Track
Looking Forward
Any effective product cost optimization program
is an amalgamation of effective people using
efficient tools to drive effective processes.
Product cost optimization is a by-product of
efficiency and a never-say-die attitude embedded
in an organizations culture.
Product Lifecycle
Management (PLM)
ENGINEERING
Enterprise Resource
Planning (ERP)
RESEARCH &
DEVELOPMENT
PRODUCT COST
MANAGEMENT
SOURCING
Supply Chain
Management (SCM)
MANUFACTURING
Material Requirements
Planning (MRP)
COST ANALYSIS
Source: http://resources.apriori.com/h/
Figure 9
COST TRACKING
COST REPORTING
Quick Take
Proactive Vigilance in Medical Device Quality Management Systems
A working QMS is part of reactive vigilance which
triggers a chain of events back to the PDLC only
when quality issues are discovered in the product.
Medical device companies should be encouraged
to go a step further and be proactive in following
Footnotes
1
http://www.cognizant.com/InsightsWhitepapers/a-PLM-accelerator-for-socio-interactive-automotiveproduct-development-codex1204.pdf.
http://www.plm.automation.siemens.com/en_us/products/teamcenter/systems-engineering-software/.
Design determines 70% of cost? A review of implications for design evaluation. J.A. Barton, D.M.
Love and G.D. Taylor.
http://www.plm.automation.siemens.com/en_us/products/open/geolus/.
http://www.catlin.com/flipbook/product-recall/files/inc/382055422.pdf.
The Business Case for Medical Device Quality, by Ted Fuhr, Katy George, Janice Pai,
www.mckinsey.com.
Reference
Requirements
About Cognizant
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