Julie Fraser presented at the AdvaMed 2012

1. Beyond Tradeoffs:
Information Flow to Improve
Medical Device Outcomes
Julie Fraser,
Lead Researcher
Beyond Tradeoffs
In Medical Device Manufacturing
© 2011 Cambashi Limited 1 Industry Knowledge for Business Advantage

2. Beyond Tradeoffs in Medical
Device Manufacturing: New Study
 Published this summer
 Two reports:
 Summary
 Comprehensive
 Methodology:
 Research conducted 1H 2012
 Industry council & sponsors
guided topics
 On-line survey
 Telephone interviews
© 2011 Cambashi Limited 2 Industry Knowledge for Business Advantage

3. Product design and quality matter
Most Important Issues for Success (select top 3)
Product innovation or design
Product quality
Cost reductions
Manufacturing consistency
Time to market
Supplier reliability
International distribution
0% 10% 20% 30% 40% 50% 60% 70%
Source: Beyond Tradeoffs in Medical Device Manufacturing: Balancing Innovation, Quality and Compliance While Improving Profit
© 2012 Cambashi Inc. and UBM Canon
© 2011 Cambashi Limited 3 Industry Knowledge for Business Advantage

4. Innovation as avenue for
improvement
Largest opportunities to improve in next three years
New products and new product lines
Faster new product introduction
Product development efficiency
Additions to existing product lines
Lowering cost of quality
Improving product quality
0% 5% 10% 15% 20% 25% 30% 35% 40% 45%
Source: Beyond Tradeoffs in Medical Device Manufacturing: Balancing Innovation, Quality and Compliance While Improving Profit
© 2012 Cambashi Inc. and UBM Canon
© 2011 Cambashi Limited 4 Industry Knowledge for Business Advantage

5. Change makes quality difficult:
especially regulatory and product
Challenges to maintaining quality
Regulatory changes
Product changes
Supply chain challenges
Staff skills issues
Innovation rate challenges
Geographic sales challenges
Technology transfer issues
0% 10% 20% 30% 40% 50% 60% 70% 80%
Significant Moderate
Source: Beyond Tradeoffs in Medical Device Manufacturing: Balancing Innovation, Quality and Compliance While Improving Profit
© 2012 Cambashi Inc. and UBM Canon
© 2011 Cambashi Limited 5 Industry Knowledge for Business Advantage

6. Traditional New Product
Introduction (NPI) process
Quality Assurance & Management
NPI Design Regula-
Require- Systems Product Service
Project Sourcing Transfer tory
ments Eng. Design Transfer
Launch to Mfg. Filings
Field Project Math. Simula- MES/ Doc. Field
Analysis CAD SCM
data Mgmt. Models tion QMS Mgmt Service
Paper Paper Paper Paper Paper
doc files doc files doc files doc files doc files
Traditional New Product Time to Market
Quality
Focus
Starts
© 2011 Cambashi Limited 6 Industry Knowledge for Business Advantage

7. Total Product Lifecycle (TPLC):
Concurrent & collaborative
NPI
Systems
Project Product
Eng.
Launch Design
Require-
ments
Service
PLM System Transfer
Quality
Design
Regula-
Transfer
Sourcing tory
to Mfg.
Filings
TPLC New Product Time to Market
Quality
focus
starts
© 2011 Cambashi Limited 7 Industry Knowledge for Business Advantage

8. Advancers are growing AND
improving financial performance
Advancers defined as: Advancers vs. Others
 Grew by 10% or more organic
AND
Advancers
 Improved on at least 4 of 6 , 25%
business metrics:
 Net operating profit
 Market share
 EBITDA
 ROA/RONA
 Cost of quality
 Cost of regulatory compliance
Others,
75%
Source: Beyond Tradeoffs in Medical Device Manufacturing: Balancing Innovation, Quality and Compliance While Improving Profit
© 2012 Cambashi Inc. and UBM Canon
© 2011 Cambashi Limited 8 Industry Knowledge for Business Advantage

9. Advancers use PLM software
Use PLM - Product Lifecycle Management
70%
60%
50%
40%
30%
20%
10%
0%
Advancers Others
Source: Beyond Tradeoffs in Medical Device Manufacturing: Balancing Innovation, Quality and Compliance While Improving Profit
© 2012 Cambashi Inc. and UBM Canon
© 2011 Cambashi Limited 9 Industry Knowledge for Business Advantage

10. Improving quality at the source
Major improvement on line level metrics
Process Capability
First Pass Yield
Advancers
Others
Recurrence of CAPAs
Product Quality
0% 10% 20% 30% 40% 50%
Source: Beyond Tradeoffs in Medical Device Manufacturing: Balancing Innovation, Quality and Compliance While Improving Profit
© 2012 Cambashi Inc. and UBM Canon
© 2011 Cambashi Limited 10 Industry Knowledge for Business Advantage

11. Improvements that matter
Portion who made improvements against these metrics
Reportable adverse events
Time to complete a recall Advancers
Others
Time to market
0% 20% 40% 60% 80%
Source: Beyond Tradeoffs in Medical Device Manufacturing: Balancing Innovation, Quality and Compliance While Improving Profit
© 2012 Cambashi Inc. and UBM Canon
© 2011 Cambashi Limited 11 Industry Knowledge for Business Advantage

12. Become an Advancer
 Innovate for value
 Drive for TPLC
 Simulate for QbD
 Automate information flows
Get beyond trade-offs:
improve business performance while growing…
© 2011 Cambashi Limited 12 Industry Knowledge for Business Advantage

13. Study and Contact
 Comprehensive study report
available for download
 Lead researcher:
Julie Fraser
+1 (508) 362-3480
julie@iyno.com
© 2011 Cambashi Limited 13 Industry Knowledge for Business Advantage