Citation for this paper:
MacNeil, M., Koch, M., Kuspinar, A., Juzwishin, D., Lehoux, P. & Stolee, P. (2019).
Enabling health technology innovation in Canada: Barriers and facilitators in policy
and regulatory processes. Health Policy, 123(2), 203-214.
https://doi.org/10.1016/j.healthpol.2018.09.018
UVicSPACE: Research & Learning Repository
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Enabling health technology innovation in Canada: Barriers and facilitators in policy
and regulatory processes
Maggie MacNeil, Melissa Koch, Ayse Kuspinar, Don Juzwishin, Pascale Lehoux, Paul
Stolee
February 2019
© 2018 The Author(s). Published by Elsevier B.V. This is an open access article
under the CC BY-NC-ND license (
http://creativecommons.org/licenses/by-nc-nd/4.0/
)
The final publication is available at:
HealthPolicy123(2019)203–214
ContentslistsavailableatScienceDirect
Health
Policy
jo u rn al h om ep a g e :w w w . e l s e v i e r . c o m / l o c a t e / h e a l t h p o l
Enabling
health
technology
innovation
in
Canada:
Barriers
and
facilitators
in
policy
and
regulatory
processes
Maggie
MacNeil
a,
Melissa
Koch
a,
Ayse
Kuspinar
b,
Don
Juzwishin
c,d,
Pascale
Lehoux
e,
Paul
Stolee
a,∗aSchoolofPublicHealthandHealthSystems,UniversityofWaterloo,Waterloo,Ontario,N2L3G1,Canada
bSchoolofRehabilitationScience,McMasterUniversity,Hamilton,Ontario,L8S1C7,Canada
cHealthTechnologyAssessment&Innovation,AlbertaHealthServices,Edmonton,Alberta,T5J3E4,Canada
dHealthInformationScience,UniversityofVictoria,Victoria,BritishColumbia,V8P5C2,Canada
eÉcoledesantépublique,UniversitédeMontréal,Montréal,Québec,H3N1X9,Canada
a
r
t
i
c
l
e
i
n
f
o
Articlehistory:
Received31July2017
Receivedinrevisedform1August2018
Accepted25September2018 Keywords: Healthtechnology Innovation Healthpolicy Canada
a
b
s
t
r
a
c
t
Objectives:Healthcareinnovationandtechnologiescanimprovepatientoutcomes,butpoliciesand reg-ulationsestablishedtoprotectthepublicinterestmaybecomebarrierstoimprovementofhealthcare delivery.Weconductedascopingreviewtoidentifypolicyandregulatorybarriersto,andfacilitatorsof, successfulinnovationandadoptionofhealthtechnologies(excludingpharmaceuticalandinformation technologies)inCanada.
Methods:ThereviewfollowedArkseyandO’Malley’smethodologytoassessthebreadthanddepthof literatureonthistopicanddrewuponpublishedandgreyliteraturefrom2000-2016.Fourreviewers independentlyscreenedcitationsforinclusion.
Results:Sixty-sevenfull-textdocumentswereextractedtocollectfacilitatorsandbarrierstohealth technologyinnovationand adoption.Theextractiontablewasthemedusingcontent analysis,and reanalyzed,resultinginfacilitatorsandbarriersundersixbroadthemes:development,assessment, implementation,Canadianpolicycontext,partnershipsandresources.
Conclusion:Thisscopingreviewidentifiedcurrentbarriersandhighlightsnumerousfacilitatorsto cre-atearesponsiveregulatoryandpolicyenvironmentthatencouragesandsupportseffectiveco-creation ofinnovationstooptimizepatientandeconomicoutcomeswhileemphasizingtheimportanceof sus-tainabilityofhealthtechnologies.
©2018TheAuthor(s).PublishedbyElsevierB.V.ThisisanopenaccessarticleundertheCC BY-NC-NDlicense(http://creativecommons.org/licenses/by-nc-nd/4.0/).
1. Introduction
Canadahasastrongreputationinclinicaltrials,healthservices research,andevidence-basedmedicine,butlesssoinsuccessfully implementingnewknowledgeinpractice.Arecentnational advi-sorypanelonhealthcareinnovationfoundthat“entrepreneurs across Canada are finding it difficult to introduce, sustain and scaleuptheirinnovationsinthehealthcaresystem”[1].Several contributing factorshave been identifiedand may include pol-icy gapssuchas jurisdictionalissues in theprovisionof health careacrossthecountry[2]andanemphasisonpilotprojectsthat donottransformpromisingandvaluablehealthcareinnovations
∗ Correspondingauthorat:SchoolofPublicHealthandHealthSystems,200
Uni-versityAvenueWest,UniversityofWaterloo,Waterloo,Ontario,N2L3G1,Canada.
E-mailaddress:stolee@uwaterloo.ca(P.Stolee).
andtechnologiesnationally[3–5].Withanagingpopulationand moreindividualsbeingdiagnosedwithfrailtyandmultiplechronic conditions,animbleandresponsiveregulatoryandpolicy environ-mentsupportingeffectiveinnovationtoensurebetteruseofscarce resourcesbecomesimperative[6].
Definitionsofinnovationarevarying,butmostemphasizenew approachesorproductsthatresultinmeaningfulimprovements; thesecanincludethegeneration,developmentorimplementation ofneworbetterideasthatproduce,policies,products,strategies, services,procedures,models,orothersolutionsthataddvalueover thestatusquo,suchassocialor economicvalue[7–10].Within thehealthcarecontext,theCanadianAdvisoryPanelonHealthcare Innovation(theNaylorPanel),definedinnovativeactivitiesasthose that“generatevalueintermsofqualityandsafetyofcare, admin-istrativeefficiency,thepatientexperienceandpatientoutcomes” [1].Thedefinitionof‘healthtechnologies’alsovaries;accordingto theWorldHealthOrganization,thesereferto“theapplicationof https://doi.org/10.1016/j.healthpol.2018.09.018
0168-8510/©2018TheAuthor(s).PublishedbyElsevierB.V.ThisisanopenaccessarticleundertheCCBY-NC-NDlicense(http://creativecommons.org/licenses/by-nc-nd/
204 M.MacNeiletal./HealthPolicy123(2019)203–214
organizedknowledgeandskillsintheformofdevices,medicines, vaccines, procedures and systems developed to solve a health problemandimprovequalityoflives,”whereastheInternational NetworkofAgenciesforHealthTechnologyAssessmentdefinesa healthtechnologyas“aninterventionthatmaybeusedtopromote health,toprevent,diagnoseortreatacuteorchronicdisease,or forrehabilitation,andmayincludepharmaceuticals,devices, pro-ceduresandorganizationalsystemsusedinhealthcare”.[11,12]. “Despitethevariousbenefitsofmanyhealthtechnologies,some innovationshavebeencriticizedasadriverofrisinghealthcare expenditures[13,14].Recent reviewshave shownthis relation-shipbetweeninnovationandexpendituresmaybecomplicatedby theuseofcost-ineffectiveinnovations[13,14].Therefore,access totechnologicalinnovationsshouldbemediatedbyconsideration ofwhich innovationsofferthebestvalue-for-money,for which patients[13,14].”
Factorsthatfostertheadoptionofhealthcareinnovationshave beenstudiedandreportedoninthecontextofarangeofcountries internationally[15]Withthispaper,weaimtoaddressa knowl-edgegapandfurthertheexistingbodyofevidencebydescribing documentedpolicyandregulatorybarriersandfacilitatorstothe adoptionofhealth technologiesand medicaldevices inCanada. Witha small market and a negative trade balance for medical devices,theCanadiancontextissimilartoanumberofother coun-tries[16].CanadaisgeographicallyadjacenttotheUnitedStates, whichrepresentsthelargestglobalmedicaldevicemarketshare, similartosmallercountriesthatborderlargermedicaldevice mar-ketssuchasthoseinGermany,France,orJapan[3,16].
2. Methods
Inthisscopingreview,weutilized afive-stage methodologi-calframeworkasoutlinedbyArkseyandO’Malleytoidentifythe breadthofkeyconceptsandthemaintypesandsourcesof
exist-ingevidence[17].Weselectedascopingreviewtoaddressabroad, complexandexploratoryresearchquestionthatspansanumber ofdiversedisciplines,andidentifiesgapsintheexistingliterature. Thisapproach alsogaveustheflexibilitytoincludeavarietyof studies,includinggreyliterature(whichisespeciallyrelevantto healthpolicyresearch),andstudiesofvaryingquality[18]. Addi-tionally,thisapproachallowedustodeterminethefeasibilityofa futuresystematicreview[18].
2.1. Stage1:identifyingtheresearchquestion
Ourreviewaimedtoanswerthequestion,Whatarethepolicy andregulatorybarriersto,andfacilitatorsof,successfulinnovation andsafeadoptionofhealthtechnologiesinCanada?
2.2. Stage2:identifyingrelevantsources
WeconductedacomprehensivesearchofallpublishedEnglish language literature using both MEDLINE and Scopus databases for the period January 2000–October 2016. Search terms were developedviaaniterativeprocess,inconsultationwithahealth sciences librarian, and included: Canada, technology, medical device,government,policy,regulatory,approvalprocess, market-ing, decision-making, and health technologyassessment (HTA). Grey literature was searched using The Canadian Agency for Drugsand TechnologiesinHealth(CADTH)GreyMattersSearch Tool,acomprehensivechecklistofnationalsearchwebsitesand databases,drugand deviceregulatoryagencies,andhealth eco-nomicsresources[19].
2.3. Stage3:studyselection
Allpublications (e.g., commentaries,editorials, and reviews) wereincluded if theyinvolved a health technologyor medical
M.MacNeiletal./HealthPolicy123(2019)203–214 205
device and discussed the barriersto and/or facilitators of pol-icy, regulation,approval processes,marketing, decisionmaking, andhealthtechnologyassessmentinCanada.Sourcesthatfocused onpharmaceuticalsorinformation–systemfocusede-health tech-nologies (such as electronic medical records or e-prescribing systems)wereexcluded.Norestrictionswereplacedonthe demo-graphicsorhealthstatusofthestudyparticipants.
SearchresultswereexportedtoRefWorks,a reference man-agementsoftware,anddividedintofourlistsforreviewbyfour researchers.Eachreviewerscreenedoutpublicationswith irrel-evanttitlesand abstracts, andindependently evaluatedthefull textsoftheremainingsources.Reasonsforexclusionwere doc-umentedforallsourcesthatdidnotmeettheinclusioncriteria. Duringthisprocess,arandomsampleof10articleswereselected toassesstheinterraterreliabilityofapplicationoftheinclusion cri-teriaamongthefourresearchersusingFleiss‘KappaFleiss’Kappa betweenthefourresearcherswas0.73,representing‘substantial’ agreement[20,21].Theaveragepercentagreement[22]between theresearcherswas95%.
Fig.1illustratesthestudyselectionprocess.
2.4. Stage4:chartingthedata
Eachresearcherrecordedtheirresultsinasummary tablein Excel,similartothatofArkseyandO’Malley[17],whichincluded theauthor(s),year,publicationtype,contextortopicofthearticle, andanylistedbarriersandfacilitatorstohealthtechnology inno-vationandoradoptionfoundineachreference.Thisprovideddata amenabletothethemingandsummarizingcharacteristicofstage five.
2.5. Stage5:collating,summarizingandreportingresults
Theresearchersadoptedadirectedapproachtocontent analy-sisasdescribedbyHsiehandShannon[22].Withinthisapproach, existingliteraturecanbeusedtoidentifykeyconceptsasinitial codingcategories[22].Basedonourknowledgeofexisting inno-vationframeworks(e.g.InnovationAdoptionJourney,TheHealth TechnologyInnovationCycle)weconsideredthatthestageof inno-vationwasrelevanttothepolicyandregulatoryissuesencountered [1,2].Withdirectcoding,wesummarizedandorganizedthe barri-ersandfacilitatorswhichwereextractedinstagefour,acrossthree stagesofinnovationcommonlyfoundintheliterature(i.e., devel-opment,assessmentand implementation)[1,2].Tworesearchers (MMandMK)readthroughtheextractiontabletofamiliarize them-selveswiththedata,andthenindependentlycategorizedfindings intooneofthethreecategories(stages);thetworesearchersthen discussedthecategorizationstoachieveconsensus.The categoriza-tionswerethenreviewedbyothermembersoftheresearchteam (includingCS,SGandPS).Datathatcouldnotbecodedwithinthe existingcategorieswereanalyzedinasecondphase;this phase generatedthree over-archingthemes (policycontext,resources, andpartnerships)usingemergentcoding[22].Literaturefindings notpreviouslycategorizedwerethencodedintothesethree cat-egoriesusingaprocesssimilartothefirstanalysisphase.Within eachofthenowsixcategories,findingswerethenre-labelledas barriersorfacilitatorsdependingonthepartoftheextractiontable fromwhichtheyweredrawn.
3. Results
Sixty-sevensourcesarecategorizedanddisplayedinTable1as identifyingfacilitatorsand/orbarriersacrosscommonstagesofthe innovationprocess,including:
• Development,e.g.researchanddeviceprototyping;
• Assessment, e.g. regulatory approval and health technology assessment(HTA);and
• Implementation,e.g.animplementationplan,adoptionand dif-fusion.
Anadditionalthree themes emergedbeyondthesestages in relationtotheCanadianpolicycontext,resources,and partner-ships.Theconceptsfoundwithinthesethemestendedtomemore overarching,spanningmultipleinnovationstages.Table1 summa-rizesthesourcesincludedinthereviewandFig.2indicatesthe distributionofpaperspertheme.Examplesofsourceexcerptsare includedinTable2.
4. Development
Development barriersoccur when innovationsinadvertently exclude groups, reinforce hierarchical social arrangements or impedesocialprogress[60].Canadianpolicymakersareoften iso-latedfromthepracticalaspectsofhealthcaredelivery,resultingin thedevelopmentofinnovationpoliciesthatarenotalways reflec-tiveof thegoalsand needsof thehealth caresystem[53]. For example,innovationsthatareprimarilyorientedtowardsreadily commercializabletechnologiesortotheinterestsofventure capi-talistsmaynotsatisfythehealthsystemorparticularusergroups [67,57].Also,developerswithouthealthcarecontacts,encounter additionalbarrierswhentheyoverestimatethevalueoftheir tech-nology;makecostlyandavoidablemistakes;formassumptionson behalfofclinicians,ornarrowlyfocusonempoweringphysicians withtheirtechnology[53,50,52,54,60].
Canadiantechnologydevelopmentsareoftenfundedbyand ori-entedtoAmericanmarketswherethetechnologiesmaybemore rapidlycommercializableandprofitable;thisorientationis poten-tially inconsistentwiththecost-containment and sustainability aimsofa publiclyfunded healthcaresystem[68]. This orienta-tionmayalsodrawtalent,technologyandtaxrevenuesawayfrom Canada[38],andleadtothecreationofinnovationswhichdonot respondtothemostpressingneedsinCanadianhealthcaresystems [57,68,38].
Severalimportantapproacheswereidentifiedtofacilitate fur-therinnovationinthedevelopmentphase,including:
• Providingadditionallocal/nationalseedfundingorventure cap-ital opportunities to spur innovation activities and decrease dependenceonforeigninvestment[73,81];
• Building awareness and understanding among developers of unmethealthsystempriorities[56];and
• Creatingopportunitiesforinnovatorstoconsultwithclientsand health careprofessionalsearlyin thedevelopmentphase and incorporatingtheirfeedbackonhowtechnologicalinnovations wouldfitwithinhealthsystemstofacilitatethedevelopmentof moreappropriateinnovations[54,57,52].
5. Assessment
Healthtechnologyassessments(HTAs)aresystematic evalua-tionsof technologiesusingevidence toconsiderthedirect and unintendedconsequencesofthetechnology[12].Themainpurpose of conductingassessments istoinform policydecision-making, howeverwhenHTAsdonotmeetpolicymakers’needs,the result-ingrecommendations maynotbeimplemented [39]. Given the timeinvolvedinproducinganHTAreport(typicallyoneyear),the resultswhenproducedmaynolongeralignwithdecision-makers’ priorities[65,39,60].Additionally,reportsmaynotbeusefulto pol-icymakersiftheyaretootechnicalanddifficulttounderstand,orif
206 M. MacNeil et al. / Health Policy 123 (2019) 203–214 Table1
SummaryofIncludedStudiesandIdentifiedThemes.
Author,Year Study/publication
Type
Context/Topic Development Assessment Implementation Canadian
Policy Context
Resources Partnerships /Communi-cation
Abelson(2013)[18] Qualitativestudy PatientandcaregiverinvolvementinHTA √ √
Abelson(2016)[19] Literaturereview PublicandpatientinvolvementinHTA √ √
Agrawal(2006)[20] Retrospectivereviewand regressionanalysis
Licensingformedicaldevices √
Akpinar(2006)[21] Review Economicevaluation √ √
Assasi(2014)[22] Review EthicalassessmentinHTA √ √
Baltussen(2006)[23] Review Multi-criteriadecisionanalysis √
Battista(2006)[24] Commentary ExpandingmethodologytypesinHTA √
Bercovitz(2007)[25] Quantitativestudy Technologytransfer √
Blomqvist(2016)[8] Greyliterature-Institutional report
TheNaylorReportandhealthpolicyinCanada √ √ √
Bombard(2011)[26] Mixed-methodsstudy EthicalandsocialvaluesinHTA √ √
Brehaut(2005)[27] Greyliterature-Institutional report
Usingresearchevidenceinpolicydevelopment √ √
Bubela(2010)[28] Commentary Technologytransfer √
Burls(2011)[29] Survey EthicalissuesinHTA √
Carbonneil(2009)[30] Review Accesswithevidencegeneration √ √
Chafe(2010)[31] Casestudy Accesswithevidencegeneration √
Challinor(2016)[32] Greyliterature-Institutional report
Recommendationstosupporthealthsciencesector innovation
√ √ √
Cuyler(2014)[33] Commentary CosteffectivenessanalysisinHTA √ √
HealthTechnologyAssessment TaskGroup(2004)[34]
Greyliterature-Institutional report
Recommendationstosupportthemanagementof healthtechnologiesacrossthelifecycle:innovation throughobsolescence
√
Holmes(2012)[35] Greyliterature-Institutional report
Stakeholderconsultationtodevelopamedical devicestrategyforCanada
√ √ √ √
Husereau(2015)[36] Greyliterature-Institutional report
EntryofnewmedicaldevicesintoCanada’s publically-fundedhealthcaresystem
√ Husereau(2011)[37] Greyliterature-Institutional
report
ChallengesandopportunitiestousingHTAto developproviderfeesinCanada
√ √ √
Khayat(2015)[38] Greyliterature-Institutional report
Onlinecommentaryonhealthtechnology innovation
√ √ √
Lavis(2008)[39] Multi-methodstudy Useofresearchevidenceinpolicymaking √ √ √
Lavis(2010)[40] Review Usingresearchevidenceinhealthsystempolicy making
√
Lee(2003)[41] Casestudy DevelopingaregionalHTAimplementationunit √ √ √
Lehoux(2012)[42] Casestudy Medicaldevices √
Lehoux(2015)[43] Qualitativestudy Venturecapitalinmedicalinnovation √
Lehoux(2016)[44] Qualitativestudy Venturecapitalinmedicalinnovation √ √
Lehoux(2000)[45] Commentary ExpandingmethodologiesinHTA √ √ √ √ √
Lehoux(2005)[46] Casestudy DisseminationofHTAreports √ √ √
Lehoux(2008)[47] Qualitativeinterviews Relationshipsbetweenevaluatorsandregulators inHTA
√ √
Lehoux(2008)[48] Commentary PolicyresearchagendaforHealthinnovation √ √ √
Lehoux(2013)[49] Practicalguidance Knowledgetransfer √ √
Lehoux(2013)[50] Commentary Healthcareinnovationpolicy √
Lehoux(2014)[51] Studyprotocol EthicalandsocialissuesinHTA √
Lehoux(2014)[52] Mixed-methodsstudy Academicspinoffcompanies √ √ √
Levin(2015)[53] Qualitativestudy Harmonizationofregulationandreimbursement √ √ √
M. MacNeil et al. / Health Policy 123 (2019) 203–214 207
Martin(2016)[55] Qualitativestudy Hospital-based/RegionalHTA √ √
McDaid(2003)[56] Interviews Economicevaluation √ √
McMillanLLP(2010)[57] Greyliterature-Institutional report
Overviewoflegislationrelatedtohealthcarein Canadaforbusinesses
√ √
MDI2(2011)[58] Greyliterature-Institutional
report
Howtoimprovedevelopmentand
commercializationofCanadianmedicaldevicesto theglobalmarket
√ √ √ √
MEDEC(2011)[59] Greyliterature-Institutional report
Stakeholderconsultation:Ontariobusinesssector strategyformedicaltechnologies
√ √
Menon(2009)[60] Commentary HTAinCanada:productionanduse,currentissues, lessonslearned
√ √ √ √ √
Menon(2008)[61] Review PatientinvolvementinHTA √ √ √
Menon(2011)[62] Survey PatientinvolvementinHTA √ √
Miller(2009)[63] EthnographicStudy Technologytransferforhealthinnovation √ √ √
MinistryofResearchand Innovation(2015)[64]
Greyliterature-Institutional report
Ontario’sinnovationagenda √
Mitton(2014)[65] Commentary Programbudgetingandmarginalanalysis √ √
Mortenson(2013)[66] Interviewanalysis Powermobilityinrehabsettings √
Naylor(2015)[1] GreyLiterature-Institutional Report
RecommendationsabouthowtosupportCanadian healthcareinnovation
√ √ √
OntarioHealthInnovation Council(2015)[2]
Greyliterature-Institutional report
Stakeholderconsultation:Recommendationsto enableperson-centredcareandgrowOntario’s Healthtechnologysector
√ √ √ √ √
Prada(2015)[7] Greyliterature-Institutional report
Researchorganization:onlinecommentary √ √ √
Prada(2016)[67] Greyliterature-Institutional report
Researchorganizationreport:Recommendations aboutapplicabilityofcompetitivedialoguein OntarioandCanada
√ √
Prada(2007)[68] Greyliterature-Institutional report
Researchorganizationreport:suggestionsto improveCanada’scapacityfortechnological innovationinhealthsystems
√ √ √
Prada(2011)[69] Greyliterature-Institutional report
Researchorganizationreport:suggestionsabout implementinginnovativeprocurementpolicies
√ √ √ √ √
Pratesi(2013)[70] Review Technologydesign,development,implementation √
Ross(2015)[71] Literaturereview Lifecyclesofmedicaldevices √ √
Scott(2015)[72] Literaturereview Systemleveladoptionanddiffusionofmedical devices
√ √
Sebastianski(2015)[73] Review Innovationinpublichealthcaresystems √ √ √ √ √
Shultz(2015)[74] Survey Willingnesstopayfortechnologies √
Snowdon(2011)[3] Greyliterature-Institutional report
Medicaldevices √ √ √ √
Tarride(2008)[75] Secondarydataanalysis Economicevaluation √
Tesfayohannes(2007)[76] Secondarydataanalysis Industrialresearchanddevelopmentinstitutions √ √ √
Tsoi(2013)[77] Literaturereview Harmonizationofregulatoryandreimbursement activities
√ √ √
Verma(2016)[78] Invitedessay Policyframeworktopromotehealthsystem transformation
√ √
Xie(2011)[79] ExpertReview SummaryofHTAsupportingdecision-makingin OntarioandCanada
208 M.MacNeiletal./HealthPolicy123(2019)203–214
Fig.2. Distributionofpaperspertheme.
Table2
Examplesofsourceexcerpts.
Focusstageortheme Articleexample Reference
Development “Encouragingly,therehavebeensomeeffortsinrecentyearstocurbcapitaldroughtthroughprogrammatic changesinboththepublicandprivatesectors.Forexample,givingspecialattentiontothose
commercializationchallengesexperiencedinthedevelopmentcycle“valleyofdeath”,thegovernmenthas launchedinitiativeslikeMaRSInnovation/MaRSDiscoveryDistrict.”
(Challinor,2016)[38]
Assessment “Thisstudyaddressesthisgapbyreportingonthedevelopmentandoutputsofacomprehensiveframework
forinvolvingthepublicandpatientsinagovernmentagency’sHTAprocess.”
(Abelson,2016)[25]
Implementation “Regionalimplementation—Whilethereisaneedforacoordinatedfederalandprovincial/territorialpolicy
frameworkforinnovationprocurement,theU.K.experiencesuggeststheneedforastrongregionalfocus.
Governmentsshouldgivehealthregionsanexplicitmandateashealth-careinnovatorsandshouldsupport
thedevelopmentofregionalinnovationhubs.”
(Prada,2011)[75]
CanadianPolicy
Context
“Decision-makersandadministratorscomplainedofpolicyandmanagerialgridlock,confidingonoccasion
thatattemptsatreforminthepublicinterestweresometimesco-optedtotheshort-termbenefitofproviders
orpoliticians.Policyexpertsemphasizedtheclumsinessofthecurrentfee-for-servicemodeofremunerating
physicians,andaskedwhyCanadahadfailedtoadoptintegrateddeliverysubsystems,exemplifiedbyleading
Americangrouphealthplans.Professionalshighlightedthewaysthatcumbersomeregulationsandperverse
incentiveswerestiflingtheircreativityandabilitytoplayabiggerroleinCanada’shealthcaresystems.”
(Naylor,2015)[1]
Resources “Thereisalackoffundingopportunitiestosupportsuccessfulregionalinitiativestobecomenational
initiatives.Whileeconomiesofscaleworkinfavourofnationalincentives,lackofstableoperatingfundingat
thenationallevelimpedetheseefficiencies.Turningasuccessfulregionalpilotintoasuccessfulnational
initiativerequiresthecommitmentofastablefunder.”
(Naylor,2015)[1]
Partnerships “Aroundtheworld,afeatureofsuccessfuljurisdictionsthathavefosteredastrongmedicaldeviceindustryis
theclosecollaborationthatventurecapitalfirms,universitiesandotheracademicinstitutionsenjoy.”
(Snowdon,2011)[3]
theytakeaglobalperspective,withoutadequatelyconsideringhow anewtechnologyimpactsbudgetsorcarepathwaysatan individ-ualhealthcareorganizationlevel[39,51,78,60].Somereportsmay notadequatelytargettheirfindingswhentheyintegratemany per-spectives(social,ethical,legal)fromawideconsultationprocess [51].SinceHTAorganizationsarenotresponsibleforwhethertheir recommendationsareappliedornot,theymaynotcollectdata onimplementationfor feartheymaylosecredibilityiftheyare perceivedtobetooclosetothepolicyprocess[51,44].
Identifiedfacilitatorsintheassessmentstageinclude:
• CollectingdataabouttheuseofHTAreportsindecision-making, thesedatacouldinformeffortsofHTAorganizationstoinclude implementationofHTArecommendationsaspartoftheirremit [51]. Such a databasewascreatedin2014,and contains HTA reportsfromCanadafrom1991onandinternationalHTAreports from1989on[96].
• EncouragingtheuseofevidencefromHTA reportscompleted inotherjurisdictionsthroughaninformation-sharingplatform accessibleto,andpopulatedby,differentregionsandcoordinated bya nationalHTAagency[85,37,60].Pre-existingHTA reports mayrequirecontextualizationiftheylackthespecificityrequired tobeusefulfordecision-makers[43,60].
• Whereexistinginformationmaynotbeavailableonanew tech-nology,fieldevaluationsandaccesswithevidencegenerationare
techniquesthatallowforpromisingtechnologiestobeadopted andassessedsimultaneously[40].
• FormalizingtheprocessforpatientinvolvementinHTAreporting byconsideringoptionssuchascitizenjuries,committee member-ship,patientreviewofHTArecommendations,orpresentationof testimonials[52,65].
• Tools such as multi-criteria decision analysis and decision-makingframeworksforhospitaltechnologyapprovalscanhelp healthcaresystemstoconsiderthemanywayshealth technolo-giesimpactopportunitycosts,organizationalissuesandbudgets [29,60].
6. Implementation
Adoptionofinnovationsismore likelyforthosethatrequire theleastamountoffinancialandinfrastructureinvestments[77], and normally occurs through a procurement procedure that is extremely risk averse, disconnected from innovation activities, and focused oncost-containment rather thanon value genera-tion[5,74].Ingeneral,procurementistreatedasanadministrative functionofthehealthcaresystemthatinvolvesblind,competitive biddingtoensurefairnessamongpotentialcandidates[72,73].An issuewiththecurrentcompetitivemodelofprocurementisthat,by definition,innovativetechnologieswillnothavecomparatorswith whichtocompete.Currentprocurementpoliciesthatfocusonthe
M.MacNeiletal./HealthPolicy123(2019)203–214 209
leastexpensiveitemintheshort-termarenotaccommodatingto innovativetechnologies,whichmayhaveresultsorvaluethatare moreapparentinthelong-term[78].Inthissense,Canadais consid-eredalaggardinprocurementpolicyinnovationandranks55thof 140countriesontheGlobalCompetitivenessIndexofGovernment ProcurementofAdvancedTechnology[72,38].Goingforward,the procurementpolicycontextmaybeslowtochangeasneedsand prioritiesforhealthprocurementsectorhavenotbeenidentified [5].
Theprocurementprocesscanalsobeabarrierforsmall innova-tioncompanieswhengrouppurchasingorganizations(GPOs)(e.g., groupsofhospitals)extendtheirbuyingpowerthroughprocuring suppliesinbulkquantities.Smallerinnovationcompaniescannot competewiththevolumethattheGPOsrequire[78].InCanada, thereareafewlargeGPOsandmanysmallerpayerssuchas hos-pitalsorclinics,creatingafragmentedmarket.Thisischallenging forlocalinnovatorstodemonstrateandvalidatetheeffectiveness ofnewproducts,selltoearlyadopters,orspreadandscalea tech-nologywidelyacrossthesystem[5,73,78].
Technologytransferoffices(TTOs)arecommonacrossacademic institutionsasvehiclestotransferresearchinnovationsintothe marketplace;however, in somecases theirprocesses may hin-derhealthtechnologyadoption.SomeTTOshavelimitedhuman andfinancialresources,andinsufficientunderstandingofhealth caredelivery. Witharewardstructure,thatvaluestangible out-putssuchasthenumberofpatents,spinoffcompaniesandroyalty incomegenerated,TTOsfocusoninnovationswiththemost com-mercialpromise.Thiscanbeproblematicinthecaseofpublichealth researchthatisnotpatentable[34,69]. Focusingoninnovations withthegreatestcommercialpotentialmayalsobedetrimental tothosedesignedforrareconditionsortargetedtoparticularuser groups,andmaylimitfundingforvalidationorproof-of-principle studies[34,73].Inothercases,TTOsmayletthepersonality charac-teristicsofinnovatorsinfluencetheirfundingdecisionsbymaking assumptionsabouthowengageddevelopersareinthe commer-cialization process and choosing not tosupport those who are perceivedtobedifficult[68].
TTOs also play a major role in negotiating challenging and time-consuming intellectual property (IP) agreements, which vary greatly within industry and across academic institutions [3,31,68,69]. Different normsregarding commercialization exist betweenresearchersandindustry,whichmayleadresearchersto shieldinnovationsfromTTOssoasnottoriskpublicationdelays thatcanaccompanythesearchforanindustrypartneror exclu-sivelicensingagreementsthatblockaccesstoresearchtoolsand methods[34,31].Inothercases,TTOscanbepressuredby unrealis-ticexpectationsregardingoutputsfromresearchersanduniversity administration[82].
Thisreviewfoundthatmanystrategiesandapproachestomore effectively facilitate implementation of innovations have been identified;theseinclude:
• Facilitatingalternativeproposalsthatenhancecollaborationand giveinnovativetechnologiesaccesstoprocurementby consid-eringreformssuchasrisk-sharing,negotiation,andvalue-based pricing[3,38].
• Moving to a value-based (as opposed to cost-focused) pro-curementprocess that isconcernedwiththelife cycleofthe technologyandintegratingbudgetsandincentivesthatsupport betterpatientoutcomes[5,1].Outcomescouldbemonitoredto supportcontinualrefinementoftheprocess.
• Developingmaterialsfor innovators,includinga procurement how-tohandbook;standardbidtemplatesandprocurementbest practices[64].
• Encouraginggovernmentstimulustooffsetthecostofamoveto value-basedprocurement,whichrequiresup-frontcostsinfavor oflong-termsavings[74].
• Developingroyalty-sharingincentivesbetweenTTOsanda fac-ultymember’slab[31].
• Developingflexibleagreementssuchasthosethatenable uni-versitiestoholdIntellectualPropertyrightsonpublicallyfunded research[69];
• Developing metrics for evaluating the effectiveness of tech-nologiesthatconsidersocietalimpactsofhealthinnovationsas opposed to using standard technology transfer office metrics suchasnumberofpatents,licensingpartnershipsandintellectual propertyagreements[34];
• EncouragingmoreresearchontherolethatTTOsplayin shap-inghowtechnologiesare/arenotpairedwithindustrypartners impactingdevelopment;and
• SupportingTTOsinbetterunderstandingandrespondingto end-userneedstobenefitthehealthcaresystem[68].
7. Canadianpolicycontext
Thereimbursementhurdlesresultingfromthethirteenunique provincialandterritorialjurisdictionscreateaconstrained Cana-dianpolicycontext.Eachhasdifferentpriorities,privacylegislation, provider organizations, centralization models, and intake and procurement systems [3]. These multiplejurisdictions create a complicatedlabyrinthofpathwaysforinnovatorstryingtoscale uptheirtechnologyadoptionanddiffusionacrossthecountry.The challengeofmultiplejurisdictionsisexacerbatedbyanabsence ofnational levelstandardsand strategicprioritiesinthehealth innovationsector[71,1,40,53].
Canadian healthcare systemfundingis directed toward the delivery of patient care – with innovation functions generally fallingoutsideofthescopeofmosthealthorganizationsotherthan selecttertiaryproviders.Withinthefederalgovernment,thehealth and innovationdepartmentsaresiloedwithdifferentand often conflictinggoals:innovationdepartmentsseekouttechnologies perceivedtobethemostprofitable,whilehealthdepartmentslook tomaximizepatientoutcomesandacquirerevenue-saving tech-nologies[53,44].Silosalsoleadtodifferenttimesforinterventionin theinnovationprocess[53].Forexample,attheprovinciallevelthe innovationdepartmentmightinterveneearlywithgrantfundingto theinnovator,withthehealthdepartmentonlyinterveninglaterin atechnology’sdevelopmentthroughregulatoryorreimbursement action.Silosbetweenthedepartmentsthatfundresearchandthose thatregulateitmeanthatnewhealthtechnologiescanbe“pushed” ontohealthsystemswithoutanunderstandingoftheirusefulness orreceptivenessfromthehealthcaresector[58].Asaresult, inno-vationsthatmightbeeffectiveinimprovinghealthcaredelivery maybeignoredwhileothertechnologiesaredevelopedthatdonot enhancehealthcareorservicedeliveryforCanadians.
Importantfacilitatorstoenablehealthtechnologyadoptionin Canadainclude:
• Removing silos between the health and innovation policy departmentsandencouragingbetterlinkagesbetweenthetwo departments’policyeffortsandtheanalystswhodevisethem willfacilitatehealthtechnologyinnovation[53]. Thisbridging andtargetedfinancingcouldextendtomobilizingand supple-mentingtheinterestandinfluenceofventurecapitalinvestorson innovationwiththatfromhealthpolicyexperts[50]andhealth careproviders.Balancinginnovationpolicywithhealth sector expertisewillensurepublicinvestmentisresponsiblyallocated totechnologieswithahighutilityforthehealthcaresector.
210 M.MacNeiletal./HealthPolicy123(2019)203–214
• Developinganinnovationecosystemwherepublicandprivate stakeholdersworktogethertoidentify,stratifyandtarget invest-mentopportunitiesinthehealthtechnologyarea[38]thatare responsiveto unmetpublic health care needs. An ecosystem approachfacilitatestechnologyinnovation,andresultsinareturn oninvestmentforinnovatorsbyhelpingtospreadandscaleup technologies[43,38].
8. Resources
Alackofresourcesconstrainstechnologyinnovationand adop-tion,particularlyduringtheearly,high-riskstagesoftechnology development,whenthereareveryfewpublicandprivateseed cap-italoptionsavailabletoinnovators[63,74].Healthsciencesector innovationsarehighlyimpactedbytheseconstrainedresources becausedevelopmentcyclesarelong,achievingproofofconcept isexpensive,andmarketaccessisregulated[38].Workinginan environmentofconstrainedfinancialand humanresources lim-itsflexibilityandavailablefundsarequicklydepletedinsituations whereprojectsstall[78,3].
Strategicresourceallocationisimportant,howeverhalfof Cana-dianhealthcaredecision-makersreporttheylackaformalprocess todo this [84]. The resultingrisk is that decision-makersmay beallocating scarceresources based onhistorical precedent or political factors, which could disadvantage investment in new technologies. Additionally, these innovationsrequiresignificant upfrontinvestment,whichisatoddswithtightlymanaged gov-ernmentfundsandafocus oncostcontainment[71,78,5]. Rigid governmentfundingstructuresdonotallowthetransferoffunds betweenandamongdepartmentsoracrossfiscalyears.This envi-ronmentmakesitdifficultfordecision-makerstoseepastthecost oftechnologytoitspotentialbenefitorvaluetopatientoutcomes, especiallyifvalueisaccruedtoanotherdepartmentorsector,or onlyrecuperatedyearsaftertheinitialinvestment[67,62,3,43].
The current allocation of resources to physicians who are compensatedon a fee-for-service basis further impedes health technologyinnovation.Thereislittleincentiveforphysiciansto participateindevelopment,testingorprocurementprocessesfor newinnovations,becauseprovidercodesarenotalignedwiththese activities[1,4].Inaddition,thereisnoincentivetoofferservices thathavegoodvalue-for-money,asfeecodesarebasedonthecosts todelivertheservice,notthevalueaserviceprovides[42].Time thatphysiciansmightspendworkingoninnovationprojectsistime takenawayfromtheirpatients,diminishingtheirincomestream.
Severalstrategieswereidentifiedtobetterfacilitatetheflowof resourcestoinnovatorsandthusimprovetheadoptionofhealth technologiesinCanada:
• Developinganationalmedicaldevicespartnershipfund(apublic privateenterprise)togenerateresourcestoinvest(byfunding prototypes,proofofconceptresearch,orpre-marketevaluations) inpromisingmedicaldevices[2].
• Creatingresearchanddevelopmenttaxcredits,andoptimizing existinginnovation-orientedtaxcreditsincentivizeandbetter accommodateinnovatorsworkinginthehealth sciencesector [38].
• Scalingupandincreasinginvestmentinexistingsuccessful fund-ingprograms, Canadian examples include:British Columbia’s AngelInvestorTax Credit, TheCouncil ofAcademic Hospitals Ontario’s ARTIC (Adopting Research to Improve Care), MaRS EXCITE(ExcellenceinClinicalInnovationandTechnology Eval-uation),theOntario Chief HealthInnovation StrategistHealth TechnologiesInnovationFund, andthe TEC EdmontonHealth AcceleratorinAlberta[3,38,86].
• AdoptingtheTripleAimphilosophytomobilizehealthresources aroundthethreegoalsof:populationhealth,improvedpatient experience,andreducedorstablepercapitacosts.SpecificTriple Aimhealthsystempaymentreformsincludevalue-based pur-chasinginprocurement,pay-for-performanceschemes,bundled paymentmechanisms,andsharedsavingsmodelsbetween pub-licandprivatestakeholderstobetteralignincentivestohealth systemgoals[82].
• Consideranalternativefundingmodelwherehealthfundingis tiedtoachievingregionalinnovationgoals[74].
• Attheconsumerlevel, programswhich combinegovernment fundingwithprivatepaytoincreaseaccessbilityoftechnologies mayfacilitatetheiradoption[80].
9. Partnerships/communication
Inthedevelopmentstage,understandingandincorporatingthe needsof patientsand health care providersis essential tothe successoftargetedinnovations, howevertechnologycompanies consultwiththesepartnersinconsistently[53].Innovators strug-gleto gain accesstoclinician insight toimprove therelevance andappropriatenessoftheirtechnologies[53,5],andhealthcare organizations’specificneedsandanyplansforinnovationarenot typicallyexternallyaccessible[74].Technologycompaniesalsolack importantpartnershipswithventurecapitalfirms,hospitals,health careprovidersanduniversitiesthatwouldprovidethementorship theyneedtobetternavigatebureaucracyandaccessseedfunding [3].Thedisconnectbetweeninnovators,healthcareproviders,and payersisproblematicwhenittranslatesintoadifferenceofopinion relatedtothevalueofatechnology[47].
Communicationattheassessmentstageisabarrierformany groupsandpartnerships.Forexample,themedicaldeviceindustry isnotwellconnectedtotheregulatorsandfundingagencieswho assesstheirdevices[50].Whenthetwogroupscommunicate,it canbechallengingasHTAassessmentrequirementsarecomplex anddifficulttotranslateintoplainlanguage[51,52].Relationships betweenHTAorganizationsandpolicymakerscanbetenseand maybeconflictedbydifferingmotivationsandpriorities[46,44]. HTAorganizationsarefurtherchallengedtosuccessfully incorpo-ratepatientandpublicperspectivesintoHTAreports.Thisrequires organizationstounderstandandapplyappropriatepatient engage-mentmethodology,andthentoincorporatetheseperspectivesin ameaningfulandrobustway[25].
Recommendationstobetterfacilitatepartnershipsand commu-nicationinclude:
• Encouraging,aligning,andmanagingpartnershipsand commu-nicationbetween stakeholders involved along theinnovation pathway–formingpartnershipsearlyandseekingpatientand clinicianinputonimportanthealthsystemneeds[75,53,78,3,58]. • Involvingpatientsandcliniciansinearlytestingofassistive tech-nologies toincrease quality, utility, effectiveness and ease of adoption[53].
• Formingpartnershipentities,suchasIndustryCanada’sNetworks CentresofExcellence(NCE)program,whichbringtogetherpublic andprivatestakeholdersinindustry,researchandhealthcare tobettertranslateresearchintohealthtechnologyinnovations [79,53,3].
• Creating an environment that considers collaboration, trust, informationsharing,time,andcost,andthatprovides commu-nicationtoolstoensurestakeholdersunderstandoneanother’s differentroles[48,86,83,33,52].
M.MacNeiletal./HealthPolicy123(2019)203–214 211
Fig.3.Graphicdepictionofinnovationstagesandcrosscuttinginfluences.
10. Discussion
Our scopingreview foundsignificant researchonthepolicy environmentaroundhealthtechnologiesandmedicaldeviceswith afocusonexistingbarriersand facilitatorstoadoptionofthese innovations. We present a graphic depiction (Fig. 3)depicting the stages along the innovation pathway and the crosscutting influenceoftheCanadianpolicycontext,resources,and partner-shipsandcommunicationontechnologydevelopment,assessment, and implementation. In additiontothese stages, weare aware ofemerging areaswithin thehealthtechnologyassessment lit-erature, which emphasize the importance of evaluating health technologiesovertheirlifecycle[87,88].Ongoingevaluationsand delayeringinnovationsplaysanimportantroleincreatingbudget flexibilitytosupportadoptionofnewtechnologies[15],anda sus-tainablesystemovertime.Ratherthanendingatimplementation, theinnovationpathwayrequiressustainability.Anotheremerging themeistherecognitionandcurrenteffortfocusedonengaging usersinco-creatingrelevanttechnologies[89–91].The meaning-fulengagementofpatientsandcaregiversinthedevelopmentand adoptionofusefulinnovationshasbeenechoedinternationally[15] andregionalinnovationecosystems[93]havebeenproposedasa mechanismthroughwhichtoengagetheseuserstoensure tech-nologiesarealignedwithhealthsystemneeds.Thoughoutsidethe scopeofoursearch,wehaveincorporatedthesefindingsintoa revisedgraphicdepictionofCanadianhealthtechnology innova-tions,andsupportanongoingemphasisofengagementofusers throughouttheinnovationprocess.
TheinfluenceoftheCanadianpolicycontextfoundinthisstudy alignswithotherinternationalfindingsthatpointtotheinfluence of macro-level factors suchas political structures and macroe-conomicand fiscal policiesonhealth innovation diffusion[15]. Althoughmicrolevelfactorsdidnotemergestronglyinthis scop-ingreview,othershavesuggestedafocusonthecultureatthefront linesofhealthcare,whichmaybemoreamenabletointervention thanmacrosystemfactors[15].
Despitethemanyhurdlesthatexist,Canadaiswellpositionedto successfullyimplementhealthtechnologies,withnumerousassets including:ahighlyeducatedworkforce;astablefinancialsystem; astableinnovationsystemwithrelative certainty,aclose prox-imitytolucrativeAmericanmedicaldevicemarkets;strengthsin informationtechnology;apublichealthcaresystemwithstrong researchcapacities;astrongtrackrecordforconductingclinical tri-als;andacapacityatthelocalhealthlevel,inhealthcaredelivery andresearch[5,49,3,40].
Ourfindingswillbeofinteresttothree audiencesthat com-posetheTripleHelixmodelofinnovation[92]includingindustry, who areaddressing health systemneedsthrough technological innovations;policy-makers,who seektounderstandbarriersto healthtechnologyinnovationdiffusion,and;researcherswhoare studyingthefactorsinfluencinghealthtechnologyinnovationsand theregulationsandpoliciessurroundingthem.Resultsmayalso beofinteresttospecificgroupssuchasAgingGracefullyacross EnvironmentsusingTechnologytoSupportWellness,Engagement andLong-Life(AGE-WELL)afederallyfundedresearchnetworkin Canada.Aspartofitswork,AGE-WELLaimstomake recommen-dationsforhowinnovationinhealthtechnologiesforseniorscan beaccommodatedandstimulatedwithinexistingpolicyand reg-ulatoryframeworks,aswellashowtheseframeworksmightbe modifiedtosupportandacceleratethesafeadoptionofpromising andeffectivetechnologies.
Our teamis partoftheAGE-WELL NCEand wehave a spe-cificinterestintechnologiesthatareparticularlyrelevantforolder adults.Wefoundfewstudiesorreportsthatdealtspecificallywith barriersto and facilitators oftechnology innovationto support healthyaging.We seethisasanareawarrantingfurther inves-tigation; in our own work, we plan to explore these topics in consultationswithresearchers,policy-makers,andindustry rep-resentatives, aswellaswitholderadultsand familycaregivers. Weanticipatethatdevelopingandimplementingtechnologiesfor olderadultsmaybeparticularlychallenging.Olderadults often experiencecomplexhealthchallengesandmultipleco-morbid con-ditions, which can make technological design problematic. For example, useof an assistive technology that supports mobility maybecompromisedbycognitiveorcommunicationimpairments. Thesehealthandcommunicationchallengescanalsomakeit diffi-culttoengageolderadultsindesignprocesses[94,95].
11. Limitations
Basedonthebroadnatureofourtopic,itwasdifficulttoidentify searchtermsthatwouldensurecomprehensiveretrievalof rele-vantsources.Asanexample,thisreviewidentifiedanumberof issuesrelevanttoreimbursement,althoughwedidnotexplicitly includereimbursementasakeywordinthesearch.Doingsomay havegeneratedamorethoroughunderstandingof reimbursement-relatedissues.Tosomeextent,limitationsofthesearchstrategy couldbeaddressedthroughtheexpertconsultationphasethathas beensuggestedasanoptionalsixthstepinthescopingreview pro-cess[17].Wearecurrentlyundertakinganextensiveconsultation
212 M.MacNeiletal./HealthPolicy123(2019)203–214
processthatwillbereportedinaseparatepaper.ThroughHealth TechnologyAssessmentinternational(HTAi),wearealsobeginning conversationswithexpertsfromothercountriesthat willallow somecomparisonofexperiencesacrossjurisdictions.
Wenotethatwhilewedidnotfeelasystematicrevieworrealist synthesiswouldbeappropriateforourpurposes,suchareviewmay beausefulapproachforfurtherstudyofwaystoaddressspecific facilitatorsorbarriersidentifiedinthispaper.
12. Conclusions
Overall,ourfindingsprovideacomprehensivesummaryof facil-itatorsandbarrierstotechnologydevelopment,assessment and implementation,andhowthosestagesarecrosscutbybarriersand facilitatorsintheCanadianpolicycontext,resourcesand partner-ships/communication.Thereisalackofliteratureonbarriersto andfacilitatorsoftechnologyinnovationprocesstosupporthealthy aging.Wesuggestfuturestudiesmayexplorethesebarriersand facilitators,particularlyastheyrelatetotechnologiestosupport healthyaging.
Conflictsofinterest None.
Acknowledgements
This work was supported by the AGE-WELL (Aging Grace-fullyacrossEnvironmentsusingtechnologytosupportWellness, EngagementandLongLife)Network,whichisfundedbythe Gov-ernment of Canada’s Networks of Centres of Excellence (NCE) Program.MelissaKochwassupportedby anAGE-WELL Gradu-ateFellowship.WearegratefultoUniversityofWaterlooHealth ScienceslibrarianJackieStapletonforherassistanceindesigning thesearchstrategy.WeacknowledgethesupportoftheGeriatric HealthSystemsResearchGroup,especiallyAneesEbrahim,Laura Brooks,AlisonKernoghan,andChiranjeevSanyal.
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