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

Can Europe grow its Medtech industry and lead the world on medical device regulation?. John Wilkinson 20 th September 2012. Where do we sit?. There is a limited amount of information that can be understood about a device before it is placed on the market. SAFETY & PERFORMANCE INFORMATION.

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

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

  2. Where do we sit?

  3. There is a limited amount of information that can be understood about a device before it is placed on the market SAFETY & PERFORMANCE INFORMATION pre-market post-market TIME

  4. It’s all about balance Risk ofdamage to patients / users Better qualityof life for patients / users

  5. Too free and easy? Less cautious= unacceptablerisk topatients / users Rapid accesslower costs / more innovation^ patient yearsof benefit

  6. Too cautious? Delays in availability and high costsv patient yearsof benefit More cautious= less adverseincidents

  7. But we live in a changing world….. Higher Need for evidence Demand for innovation + improving data gathering and use (safety, outcomes and economics) + explaining risk-benefit + new business models + better regulation Wideningcost-benefit Investment-returngaps Preparedness to accept risk Preparedness to pay Lower Time - - - - - >

  8. More information needed by all Clinical Professions Inform clinical choices around spectrum of interventions and outcomes Industry Inform decisions on safety, portfolio management and R&D Real life information about clinical practice HTA Inform economic decisions Regulators Inform decisions on safety and effectiveness

  9. So….Can Europe grow its Medtech industry and lead the world on medical device regulation? Increase of chronic and Multiple diseases Increasing expectations of citizens Increased focus on prevention • AGEING POPULATIONS • Budget constraints • Healthcare worker shortages Increasing e-solutions Shift from public to private funding Increased demand of medical technology and services Shift to community and homecare Increasing role of purchasing & paying institutions Declining power of Healthcare Professionals 9

  10. So….Can Europe grow its Medtech industry and lead the world on medical device regulation? • We have lead so far…. • We cannot deliver societal needs if we get the balance wrong • Health challenges first…. Industry needs second

  11. Strong performance information and feedback loops benefit all…..

  12. All need to play a role for the system to deliver Notified Bodies Manufacturers Regulators Patients Healthcare Workers

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

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