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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
©
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
©
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
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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
©
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?