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Beyond Tradeoffs:                          Information Flow to Improve                           Medical Device Outcomes  ...
Beyond Tradeoffs in Medical   Device Manufacturing: New Study       Published this summer       Two reports:            ...
Product design and quality matter                           Most Important Issues for Success (select top 3)              ...
Innovation as avenue for   improvement                           Largest opportunities to improve in next three years     ...
Change makes quality difficult:   especially regulatory and product                                            Challenges ...
Traditional New Product   Introduction (NPI) process                                                                      ...
Total Product Lifecycle (TPLC):   Concurrent & collaborative                                               NPI            ...
Advancers are growing AND   improving financial performance      Advancers defined as:                                    ...
Advancers use PLM software                               Use PLM - Product Lifecycle Management          70%          60% ...
Improving quality at the source                                 Major improvement on line level metrics             Proces...
Improvements that matter                     Portion who made improvements against these metrics        Reportable adverse...
Become an Advancer       Innovate for value       Drive for TPLC       Simulate for QbD       Automate information flo...
Study and Contact       Comprehensive study report        available for download       Lead researcher:        Julie Fra...
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AdvaMed Panel J Fraser Beyond Tradeoffs

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Julie Fraser presented at the AdvaMed 2012

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AdvaMed Panel J Fraser Beyond Tradeoffs

  1. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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

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