Robotics 2012 Using Automation to improve patient safety and patient care

Can Europe grow its Medtech industry and lead the world on medical device regulation?John Wilkinson20th September 2012Safeguarding public healthSlide #20th September 2012John WilkinsonCE 20201Where do we sit?

Slide #20th September 2012John WilkinsonCE 20202There is a limited amount of information that can be understood about a device before it is placed on the marketpre-marketpost-marketTIMESAFETY & PERFORMANCE INFORMATIONSlide #20th September 2012John WilkinsonCE 20203Its all about balance

Better qualityof life for patients / usersRisk ofdamage to patients / usersSlide #20th September 2012John WilkinsonCE 20204Too free and easy?

Rapid accesslower costs / more innovation^ patient yearsof benefitLess cautious= unacceptablerisk topatients / usersSlide #20th September 2012John WilkinsonCE 20205Too cautious?

Delays in availability and high costsv patient yearsof benefitMore cautious= less adverseincidentsSlide #20th September 2012John WilkinsonCE 20206But we live in a changing world..HigherLowerTime - - - - - >Preparedness to payPreparedness to accept riskNeed for evidenceDemand for innovationWideningcost-benefitInvestment-returngaps+ improving data gathering and use (safety, outcomes and economics)+ explaining risk-benefit+ new business models+ better regulationSlide #20th September 2012John WilkinsonCE 20207More information needed by allClinical ProfessionsInform clinical choices around spectrum of interventions and outcomesRegulatorsInform decisions on safety and effectivenessHTAInform economic decisionsIndustryInform decisions on safety, portfolio management and R&DReal life information about clinical practiceSlide #20th September 2012John WilkinsonCE 20208Shift from public to private fundingIncreased focus on preventionIncreasing expectations of citizensIncrease of chronic andMultiple diseasesShift to community and homecareIncreasing role of purchasing & paying institutionsDeclining power of Healthcare ProfessionalsIncreasing e-solutionsIncreased demand of medical technology and services

AGEING POPULATIONS

Budget constraintsHealthcare worker shortages

9So.Can Europe grow its Medtech industry and lead the world on medical device regulation?Slide #20th September 2012John WilkinsonCE 20209There is ONE key driver of all trends: aging populations drives the increasing demand for healthcare and medical technology, thus driving its impact on budgets and worker shortages

9 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 #20th September 2012John WilkinsonCE 202010Strong performance information and feedback loops benefit all..

Slide #20th September 2012John WilkinsonCE 202011All need to play a role for the system to deliver

ManufacturersRegulatorsPatientsHealthcare WorkersNotified BodiesSlide #20th September 2012John WilkinsonCE 202012 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

NBs 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?Slide #20th September 2012John WilkinsonCE 202013