I th fI th fIs there room forIs there room for
innovation in today’sinnovation in today’sinnovation in today sinnovation i...
LifeLife--Saving, LifeSaving, Life--Enhancing InnovationsEnhancing Innovations
Everyone Wants to HelpEveryone Wants to Help
Who We AreWho We Are
Who We AreWho We Are
Early Days of MedEarly Days of Med--Tech InnovationTech Innovation
Time from design to
successful FIM:
2 years!
“Only” 50 Years Later!“Only” 50 Years Later!
Why So Challenging?Why So Challenging?
Tax impact Innovation time cost Physicians, payors –Tax impact Innovation time, cos...
PMAPMA
PMA, the Rest!PMA, the Rest!
Today: Two Ways to Develop ProductsToday: Two Ways to Develop Products
High quality High quality• High-quality
• Reasonabl...
What Do Hospitals Want?What Do Hospitals Want?
The Innovation SpectrumThe Innovation Spectrum
Status
quo
Iterating for
innovation’s sake
Changing
the norm
We can no long...
Innovation is Still the AnswerInnovation is Still the Answer
 Fundamentally
improve patient
 Impact health
economics
out...
Adapt, SucceedAdapt, Succeed
Be ProactiveBe Proactive
• Invest in R&D
• Prioritize development carefully
• Improve/invest in quality systems serviceImp...
Andersen & Colleagues: BalloonAndersen & Colleagues: Balloon--
Expandable Aortic Heart ValveExpandable Aortic Heart Valve
...
European Society of Cardiology 1992European Society of Cardiology 1992
2002: Cribier Goes to First In Man2002: Cribier Goes to First In Man
Successful trans-septal placement of a 23mm equine pe...
Inspiration is Never Far AwayInspiration is Never Far Away
Inspiration is Never Far AwayInspiration is Never Far Away
“I started 20 years ago, and now it was used forsta ted 0 yea s...
The Environment Has ChangedThe Environment Has Changed
Approximately 15% of SalesApproximately 15% of Sales ––Approximatel...
Those Who Adapt Will ThriveThose Who Adapt Will Thrive
Success: Helping Patients WorldwideSuccess: Helping Patients Worldwide
Is there room for innovation in today’s medical device industry?
Is there room for innovation in today’s medical device industry?
Is there room for innovation in today’s medical device industry?
Is there room for innovation in today’s medical device industry?
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Is there room for innovation in today’s medical device industry?

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Stanton J. Rowe, Chief Scientific Officer, Edwards Lifesciences

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Is there room for innovation in today’s medical device industry?

  1. 1. I th fI th fIs there room forIs there room for innovation in today’sinnovation in today’sinnovation in today sinnovation in today s medical device industry?medical device industry? Stanton J. RoweStanton J. Rowe Chief Scientific OfficerChief Scientific OfficerChief Scientific Officer,Chief Scientific Officer, Edwards LifesciencesEdwards Lifesciences
  2. 2. LifeLife--Saving, LifeSaving, Life--Enhancing InnovationsEnhancing Innovations
  3. 3. Everyone Wants to HelpEveryone Wants to Help
  4. 4. Who We AreWho We Are
  5. 5. Who We AreWho We Are
  6. 6. Early Days of MedEarly Days of Med--Tech InnovationTech Innovation Time from design to successful FIM: 2 years!
  7. 7. “Only” 50 Years Later!“Only” 50 Years Later!
  8. 8. Why So Challenging?Why So Challenging? Tax impact Innovation time cost Physicians, payors –Tax impact Innovation time, cost Physicians, payors under stress Regulations around the world Evidence requirements – clinical, cost effectiveness
  9. 9. PMAPMA
  10. 10. PMA, the Rest!PMA, the Rest!
  11. 11. Today: Two Ways to Develop ProductsToday: Two Ways to Develop Products High quality High quality• High-quality • Reasonable cost • Serviceable, practical • High-quality • High cost • ExclusiveSe ceab e, p act ca • Feature-rich • Variety within the category Exclusive • Flashy • Limited portfolio
  12. 12. What Do Hospitals Want?What Do Hospitals Want?
  13. 13. The Innovation SpectrumThe Innovation Spectrum Status quo Iterating for innovation’s sake Changing the norm We can no longer iterate “in the middle”
  14. 14. Innovation is Still the AnswerInnovation is Still the Answer  Fundamentally improve patient  Impact health economics outcomes If truly innovative: BOTHIf truly innovative: BOTH
  15. 15. Adapt, SucceedAdapt, Succeed
  16. 16. Be ProactiveBe Proactive • Invest in R&D • Prioritize development carefully • Improve/invest in quality systems serviceImprove/invest in quality systems, service • Generate evidence beyond safety Effi– Efficacy – Cost effectiveness – Quality of life • Be innovative in all facets of the device – procedure, distribution, emerging markets
  17. 17. Andersen & Colleagues: BalloonAndersen & Colleagues: Balloon-- Expandable Aortic Heart ValveExpandable Aortic Heart Valve • Porcine aortic valve sutured to a stainless Expandable Aortic Heart ValveExpandable Aortic Heart Valve sutured to a stainless steel frame • Crimped on a triple balloon catheter: 41F • IP acquired by Heartportp • No further development
  18. 18. European Society of Cardiology 1992European Society of Cardiology 1992
  19. 19. 2002: Cribier Goes to First In Man2002: Cribier Goes to First In Man Successful trans-septal placement of a 23mm equine pericardial valveSuccessful trans septal placement of a 23mm equine pericardial valve. Things begin to move very quickly from here.
  20. 20. Inspiration is Never Far AwayInspiration is Never Far Away
  21. 21. Inspiration is Never Far AwayInspiration is Never Far Away “I started 20 years ago, and now it was used forsta ted 0 yea s ago, a d o t as used o humans, treating patients. Now there is an extra dimension – and that’s my father. Because now it’s going from son to fatherBecause now it s going from son to father, into my own family.”
  22. 22. The Environment Has ChangedThe Environment Has Changed Approximately 15% of SalesApproximately 15% of Sales ––Approximately 15% of SalesApproximately 15% of Sales –– Edwards is Committed to ExtendingEdwards is Committed to Extending its Leadership Through Innovationits Leadership Through Innovation
  23. 23. Those Who Adapt Will ThriveThose Who Adapt Will Thrive
  24. 24. Success: Helping Patients WorldwideSuccess: Helping Patients Worldwide

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