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. 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. LifeLife--Saving, LifeSaving, Life--Enhancing InnovationsEnhancing Innovations
- 3. Everyone Wants to HelpEveryone Wants to Help
- 4. Who We AreWho We Are
- 5. Who We AreWho We Are
- 6. Early Days of MedEarly Days of Med--Tech InnovationTech Innovation Time from design to successful FIM: 2 years!
- 7. “Only” 50 Years Later!“Only” 50 Years Later!
- 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. PMAPMA
- 10. PMA, the Rest!PMA, the Rest!
- 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. What Do Hospitals Want?What Do Hospitals Want?
- 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. Innovation is Still the AnswerInnovation is Still the Answer Fundamentally improve patient Impact health economics outcomes If truly innovative: BOTHIf truly innovative: BOTH
- 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
- 18. 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
- 19. European Society of Cardiology 1992European Society of Cardiology 1992
- 22. 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.
- 23. Inspiration is Never Far AwayInspiration is Never Far Away
- 24. 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.”
- 25. 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
- 26. Those Who Adapt Will ThriveThose Who Adapt Will Thrive
- 27. Success: Helping Patients WorldwideSuccess: Helping Patients Worldwide