I th fI th fIs there room for Is there room for innovation in today’sinnovation in today’sinnovation in today s innovation in today s medical device industry?medical device industry?Stanton J. RoweStanton J. RoweChief Scientific OfficerChief Scientific OfficerChief Scientific Officer, Chief Scientific Officer, Edwards LifesciencesEdwards Lifesciences

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, cost Physicians, payors under stress

Regulations around the world

Evidence requirements –clinical, cost effectiveness

PMAPMA

PMA, the Rest!PMA, the Rest!

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

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 longer iterate “in the middle”

Innovation is Still the AnswerInnovation is Still the Answer

Fundamentally improve patient

Impact health economics

outcomes

If truly innovative: BOTHIf truly innovative: BOTH

Adapt, SucceedAdapt, Succeed

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

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

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 pericardial valveSuccessful trans septal placement of a 23mm equine pericardial valve.Things begin to move very quickly from here.

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 for sta ted 0 yea s ago, a d o t as used ohumans, 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.”

The Environment Has ChangedThe Environment Has Changed

Approximately 15% of SalesApproximately 15% of Sales ––Approximately 15% of Sales Approximately 15% of Sales ––Edwards is Committed to Extending Edwards is Committed to Extending its Leadership Through Innovationits Leadership Through Innovation

Those Who Adapt Will ThriveThose Who Adapt Will Thrive

Success: Helping Patients WorldwideSuccess: Helping Patients Worldwide