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Julie Fraser presented at the AdvaMed 2012
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Industry Knowledge for Business Advantage © 2011 Cambashi Limited
Beyond Tradeoffs: Information Flow to Improve
Medical Device Outcomes
Julie Fraser,
Lead Researcher
Beyond Tradeoffs
In Medical Device Manufacturing
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Industry Knowledge for Business Advantage © 2011 Cambashi Limited
Beyond Tradeoffs in Medical
Device Manufacturing: New Study
2
Published this summer
Two reports:
Summary
Comprehensive
Methodology:
Research conducted 1H 2012
Industry council & sponsors guided topics
On-line survey
Telephone interviews
Industry Knowledge for Business Advantage © 2011 Cambashi Limited
Product design and quality matter
3
Source: Beyond Tradeoffs in Medical Device Manufacturing: Balancing Innovation, Quality and Compliance While Improving Profit © 2012 Cambashi Inc. and UBM Canon
0% 10% 20% 30% 40% 50% 60% 70%
International distribution
Supplier reliability
Time to market
Manufacturing consistency
Cost reductions
Product quality
Product innovation or design
Most Important Issues for Success (select top 3)
Industry Knowledge for Business Advantage © 2011 Cambashi Limited
0% 5% 10% 15% 20% 25% 30% 35% 40% 45%
Improving product quality
Lowering cost of quality
Additions to existing product lines
Product development efficiency
Faster new product introduction
New products and new product lines
Largest opportunities to improve in next three years
Innovation as avenue for
improvement
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Source: Beyond Tradeoffs in Medical Device Manufacturing: Balancing Innovation, Quality and Compliance While Improving Profit © 2012 Cambashi Inc. and UBM Canon
Industry Knowledge for Business Advantage © 2011 Cambashi Limited
Change makes quality difficult:
especially regulatory and product
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0% 10% 20% 30% 40% 50% 60% 70% 80%
Technology transfer issues
Geographic sales challenges
Innovation rate challenges
Staff skills issues
Supply chain challenges
Product changes
Regulatory changes
Challenges to maintaining quality
Significant Moderate
Source: Beyond Tradeoffs in Medical Device Manufacturing: Balancing Innovation, Quality and Compliance While Improving Profit © 2012 Cambashi Inc. and UBM Canon
Industry Knowledge for Business Advantage © 2011 Cambashi Limited
Traditional New Product
Introduction (NPI) process
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Traditional New Product Time to Market
Quality
Focus
Starts
Require-
ments
NPI
Project
Launch
Systems
Eng.
Product
Design Sourcing
Design
Transfer
to Mfg.
Regula-
tory
Filings
Service
Transfer
Field
data Analysis
Project
Mgmt.
Math.
Models CAD
Simula-
tion SCM
MES/
QMS
Doc.
Mgmt
Field
Service
Paper
doc files
Paper
doc files
Paper
doc files
Paper
doc files
Paper
doc files
Quality Assurance & Management
Industry Knowledge for Business Advantage © 2011 Cambashi Limited
Total Product Lifecycle (TPLC):
Concurrent & collaborative
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TPLC New Product Time to Market
PLM System
Require-
ments
NPI
Project
Launch
Systems
Eng. Product
Design
Sourcing
Design
Transfer
to Mfg.
Regula-
tory
Filings
Service
Transfer
Quality
Quality
focus
starts
Industry Knowledge for Business Advantage © 2011 Cambashi Limited
Advancers are growing AND
improving financial performance
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Advancers defined as:
Grew by 10% or more organic
AND
Improved on at least 4 of 6
business metrics:
Net operating profit
Market share
EBITDA
ROA/RONA
Cost of quality
Cost of regulatory compliance
Advancers, 25%
Others, 75%
Advancers vs. Others
Source: Beyond Tradeoffs in Medical Device Manufacturing: Balancing Innovation, Quality and Compliance While Improving Profit © 2012 Cambashi Inc. and UBM Canon
Industry Knowledge for Business Advantage © 2011 Cambashi Limited
Advancers use PLM software
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Source: Beyond Tradeoffs in Medical Device Manufacturing: Balancing Innovation, Quality and Compliance While Improving Profit © 2012 Cambashi Inc. and UBM Canon
0%
10%
20%
30%
40%
50%
60%
70%
Advancers Others
Use PLM - Product Lifecycle Management
Industry Knowledge for Business Advantage © 2011 Cambashi Limited
Improving quality at the source
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0% 10% 20% 30% 40% 50%
Product Quality
Recurrence of CAPAs
First Pass Yield
Process Capability
Major improvement on line level metrics
Advancers
Others
Source: Beyond Tradeoffs in Medical Device Manufacturing: Balancing Innovation, Quality and Compliance While Improving Profit © 2012 Cambashi Inc. and UBM Canon
Industry Knowledge for Business Advantage © 2011 Cambashi Limited
Improvements that matter
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Source: Beyond Tradeoffs in Medical Device Manufacturing: Balancing Innovation, Quality and Compliance While Improving Profit © 2012 Cambashi Inc. and UBM Canon
0% 20% 40% 60% 80%
Time to market
Time to complete a recall
Reportable adverse events
Portion who made improvements against these metrics
Advancers
Others
Industry Knowledge for Business Advantage © 2011 Cambashi Limited
Become an Advancer
Innovate for value
Drive for TPLC
Simulate for QbD
Automate information flows
Get beyond trade-offs:
improve business performance while growing…
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Industry Knowledge for Business Advantage © 2011 Cambashi Limited
Study and Contact
Comprehensive study report
available for download
Lead researcher:
Julie Fraser
+1 (508) 362-3480
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