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Safeguarding public health

Can Europe grow its Medtech industry and lead the world on medical device regulation?

John Wilkinson20th September 2012

Slide 220th September 2012John Wilkinson

CE 2020

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Where do we sit?

Slide 320th September 2012John Wilkinson

CE 2020

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There is a limited amount of information that can be understood about a device before it is placed on the market

pre-market post-market

TIME

SAFETY & PERFORMANCE INFORMATION

Slide 420th September 2012John Wilkinson

CE 2020

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It’s all about balance

Better qualityof life for

patients / users

Risk ofdamage to

patients / users

Slide 520th September 2012John Wilkinson

CE 2020

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Too free and easy?

Rapid accesslower costs /

more innovation^ patient years

of benefit

Less cautious= unacceptable

risk topatients / users

Slide 620th September 2012John Wilkinson

CE 2020

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Too cautious?

Delays in availability and

high costsv patient years

of benefitMore cautious= less adverse

incidents

Slide 720th September 2012John Wilkinson

CE 2020

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But we live in a changing world…..

Higher

Lower

Time - - - - - >

Preparedness to pay

Preparedness to accept risk

Need

for e

viden

ce

Deman

d fo

r inn

ovat

ion

Wideningcost-benefit

Investment-returngaps

+ improving data gathering and use (safety, outcomes and economics)

+ explaining risk-benefit

+ new business models

+ better regulation

Slide 820th September 2012John Wilkinson

CE 2020

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More information needed by all

Clinical Professions

Inform clinical choices around spectrum of interventions and outcomes

Regulators

Inform decisions on safety and effectiveness

HTA

Inform economic decisions

Industry

Inform decisions on safety, portfolio management and R&D

Real life information about clinical practice

Slide 920th September 2012John Wilkinson

CE 2020

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Shift from public to private funding

Increased focus on prevention

Increasing expectations of citizens

Increase of chronic andMultiple diseases

Shift to community and homecare

Increasing role of purchasing & paying institutions

Declining power of Healthcare Professionals

Increasing e-solutions

Increased demand of medical technology and services

AGEING POPULATIONS

Budget constraintsHealthcare worker shortages

9

So….Can Europe grow its Medtech industry and lead the world on medical device regulation?

Slide 1020th September 2012John Wilkinson

CE 2020

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• We have lead so far….

• We cannot deliver societal needs if we get the balance wrong

• Health challenges first…. Industry needs second

So….Can Europe grow its Medtech industry and lead the world on medical device regulation?

Slide 1120th September 2012John Wilkinson

CE 2020

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Strong performance information and feedback loops benefit all…..

Slide 1220th September 2012John Wilkinson

CE 2020

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All need to play a role for the system to deliver

Manufacturers Regulators

PatientsHealthcare Workers

Notified Bodies

Slide 1320th September 2012John Wilkinson

CE 2020

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• Model is sound

• Model is 20 years old and world has moved on

• It has delivered but now we need to be much more transparent and engage emerging stakeholders

• NB’s and clinical data are key to underpinning reputation of system

• If we get this right we can continue to lead the world

• If we get it wrong we will put up costs and deprive patients of the opportunity for better lives…….and research and industry will suffer.

So….Can Europe grow its Medtech industry and lead the world on medical device regulation?