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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
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
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
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
17.
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
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.
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