1. © Safeguarding public health Can Europe grow its Medtech industry and lead the world on medical device regulation? John Wilkinson 20 th September 2012

2. Slide 2 20th September 2012 John Wilkinson CE 2020 © Where do we sit?

3. Slide 3 20th September 2012 John 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

4. Slide 4 20th September 2012 John Wilkinson CE 2020 © It’s all about balance Better quality of life for patients / users Risk of damage to patients / users

5. Slide 5 20th September 2012 John Wilkinson CE 2020 © Too free and easy? Rapid access lower costs / more innovation ^ patient years of benefit Less cautious = unacceptable risk to patients / users

6. Slide 6 20th September 2012 John Wilkinson CE 2020 © Too cautious? Delays in availability and high costs v patient years of benefit More cautious = less adverse incidents

7. Slide 7 20th September 2012 John Wilkinson CE 2020 © But we live in a changing world….. Higher Lower Time - - - - - > Preparedness to pay Preparedness to accept risk Need for evidence Demand for innovation Widening cost-benefit Investment-return gaps + improving data gathering and use (safety, outcomes and economics) + explaining risk-benefit + new business models + better regulation

8. Slide 8 20th September 2012 John 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

9. Slide 9 20th September 2012 John Wilkinson CE 2020 © Shift from public to private funding Increased focus on prevention Increasing expectations of citizens Increase of chronic and Multiple 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 constraints Healthcare worker shortages 9 So….Can Europe grow its Medtech industry and lead the world on medical device regulation?

10. Slide 10 20th September 2012 John Wilkinson CE 2020 © 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?

11. Slide 11 20th September 2012 John Wilkinson CE 2020 © Strong performance information and feedback loops benefit all….. Regulators Clinicians Manufacturers HTA processes Health system managers Patients and public Policy makers Product improvements Process improvements Economic decisions Policy decisions Safety management Real life data of actual performance in clinical practice

12. Slide 12 20th September 2012 John Wilkinson CE 2020 © All need to play a role for the system to deliver Manufacturers Regulators Patients Healthcare Workers Notified Bodies

13. Slide 13 20th September 2012 John Wilkinson CE 2020 © 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?