2Behavioural Dynamics of AdoptionBarriers• Resistance to change/ Inherent conservativism• Infrastructure malaiseFacilitators• Institutional and professional profiling• Public expectation• Patent laws and limited market exclusivity for non-drugtechnologies
3Barriers to AdoptionPoor pre-market quality clinical trial produceuncertainty• Accuracy versus clinical utility for diagnostic tests• No prospective economic analysis• Research failed to address health system perspectives• Me-too technologies• Lack of generalisability• Inadequate trial design e.g. randomization,concealment, ITT – leading to low quality evidencePolicy including non-affordability,competing pressures
Health Technology Life-Cycle Diffusion CurveUTIMER&D Diﬀusion Steady State Inﬂec4on Point abcUncondional Yes Uncertainty Uncondional No Field Study Evidence& Uncertainty4
5>110 Single Technology Analyses by MAS, PATH &THETA92% Conversion to Policy
GRADE(Quality of EvidenceFollowing SystematicReview)Will Further ResearchChange Confidence inthe Estimate?Level of UncertaintyUncertainty Drove Field Evaluation StudiesRecognizing Uncertainty – Effect of GRADE6UncertaintyHighModerateLowVery LowVery unlikelyLikelyVery LikelyAny estimate of effectis very uncertainCertainty
7“Something is Rotten in the State of Denmark”– Hamlet Act 1, Scene 4• Does HTA cover the full spectrum ofevidence required to inform decisionmaking?• RCTs assess efficacy within a“perfect world.” How do we dealwith generalizability/externalvalidity?• How to deal with low quality evidencefrom pre-market evaluation?
9Investment RegulationLife-Cycle Diffusion Curve(Pre-Market Evidence Based Analysis)1TIMEDiffusionUnconditional YesUncertaintyR&DUnconditional NoObsolescenceHORIZONDEVELOPTESTUPre-Market Post-MarketSystematic reviewCost-Effectiveness (CE)Effectiveness• EfficacySafety• Value (CE)Affordability• Ethical &societal• Post marketconditionsSystematic reviewCost-Effectiveness (CE)E f f e c t i v e n e s s
MaRS: Urban Innovation HubLinking Creative and Business Assets of Toronto!Discovery District Financial District Creative & Arts DistrictGardiner Museum of Ceramic ArtRoyal Ontario MuseumWomen’s CollegeThe MaRS CentreUHN Toronto GeneralHospital for Sick childrenEntertainment DistrictFour Seasons CentreUniversity of TorontoUHN Princess MargaretMount SinaiArt Gallery of OntarioRoyal Conservatory of MusicTIFF & OCADFinancial DistrictToronto RehabRyersonUniversityPg 10
Memory at WorkSME and MNE"Technologies"Prioritizationand Selection"by EXCITE "Board "Apply"Review by"OHTACsubcommittee"- Relevance- Disruptive potential- Identify obsolescence- Magnitude of effect onpatient outcomes andsystem efficiencies- Stage of readiness- OHTAC recommendations- Potential economic benefit- Feasibility- Capacity
Memory at WorkSME and MNE"Industry"Prioritizationand Selection"by EXCITE "Board "Apply"*Evaluation"by EXCITEMethodologicalCentres"Review by"OHTACsubcommittee"Communication re - accrual, safety,and recommendations forimprovement"MOHLTC andBroaderHealthSystem"
Pg 14!• Assess usability/human factors• Develop education system for trainingend users• Investigate patient preferences• Analyze factors influencing of uptake• Develop a registry for tracking post-adoption effectiveness + long-termssafety• Knowledge transfer• Safety + Effectiveness• Systematic Review• Economic AnalysisCompleted by:Methodological CentresCompleted by:Specialized Methodological CentresCore Evidentiary Bundle: Optional Additional Analyses:14
ü Increased likelihood of adoptionü Access to a coordinated network of world-class expertise in evaluation of health technologiesü Early feedback provides insight during formative stageü Single, harmonized pre-market process• Duration and cost depends on complexity and protocol design"• Evaluations typically require 12-30 months to complete"• Company pays the cost which range from C$1-3 million "• Consideration for deﬁning conditions of adoption pre-market"!Pg 15
EXCITE - Progress in Year One§ Endovascular renal nerve ablation§ Home based apnoea diagnostic§ RNA disruption to predict chemotherapy response§ IV delivery not gravity/ electricity/ battery dependent§ Rapid recovery from stroke in hand/upper limb§ MRI-guided RTMS for treatment refractory depression§ Hand held device to detect pneumothorax and fluid§ IT system to track hospital acquired infections§ Remote ischemic conditioning§ Point of care diagnosis of infection in wounds
Memory at WorkPg 17 Pg 17Represented Group Members!MaRS Board Richard Ivey (Chair) "Ilse Treurnicht, "EXCITE"Chief Scientiﬁc Ofﬁcer Dr Leslie Levin"Industry: MEDEC (MNEs) "HTX (SMEs) " Brian Lewis, Peter Robertson "John Soloninka, Peter Goodhand"Government: MOHLTC, "MEDI ADM Vasanthi Srinivasan "ADM Bill Mantell Health System: OHTAC Dr Charles Wright"Academia: Council of Academic Hospitalsof Ontario (CAHO) Karen Michell, Catherine Zahn"