association of british healthcare industries...organised uk pavilions at exhibitions including arab...
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Association of British Healthcare IndustriesA n n u A l R e p o Rt 2 0 0 9
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4 A personal message from our Chairman
5 Introduction from the Chief Executive
6–21 Performance against objectives
6 Realimpactonpolicy
8 Highlightingthepotentialoftechnology
9 Empoweringourmembers
10 Biddingforbetterprocurement
12 Proportionateregulation
14 Championingtechnologytake-up
16 Pavingthewayforinnovation
17 Focusoninternationalwork
18 Settingstandards:ourCodeofBusinessPractice
20 Exhibitions
21 Events
22 Our people
22–23 Members
Contents Mission Statement
ABHI is the industry association for the UK medical technology sector. Our purpose is to promote the rapid adoption of medical technologies to ensure optimum patient outcomes throughout the UK and in key global markets.
Delivery
• Policy:Focusonthedevelopmentofpolicywhichtakesintoaccountthecontinuingneedforclinicalinnovation;ensuringclearpathwaystomarketforsupplierswhilepayingattentiontothecontributionofSMEs.
• Regulation:Ensurethatmedicaldeviceregulationremainsappropriate,proportionateandsustainablebyinfluencingtheUKregulatorsandtheEuropeanUnionlegislativeprocess.
• Reputation:ReinforceindustryintegrityandhighethicalstandardsthroughtheoperationandenforcementoftheABHICodeofBusinessPractice.
• Membership:Proactivelyengagewithmemberstounderstandtheirneedsandaspirations.ABHIstructuresenableeffectiverepresentationandareabletorespondtothechangingmarketenvironment.
• Resources:ABHIemployeesincludeindustry,regulatory,policyandcommunicationsexpertswiththeknowledgeandinsighttodeliverrealvalueformembers.
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Key Achievements
Achievements 2009In 2009 ABHI focused on the delivery of key activities to demonstrate value to members. Activity is targeted at the core ABHI values of policy, regulation, reputation and membership.
PolicyOffice for Life Sciences.ABHIledthemedicaltechnologyindustryengagementduringthedevelopmentbyGovernmentofthenewOfficeforLifeSciencesandits‘LifeSciencesBlueprint’whichsetinplacenewworkingarrangementsforindustrywiththeNHS.TheMinisterforScienceandInnovationdescribedOLSas“drivinganewwayofcollaborativeworkingbetweenGovernmentandindustry”.NHSLifeSciencesInnovationDeliveryBoardwaslaunchedwithindustryrepresentationandanagendatoimmediatelyaddressestechnologyadoptionanduptake.
Developmentof‘singleevaluationpathway’formedicaldevicetechnologyassetoutinLordDarzi’s2008‘NextStageReview’report.AjointinitiativewithNICE,co-chairedbychairofABHI’sHTAworkinggroup.
Procurement.ThenewDH/NHScommercialstrategyrespondedtocriticismsintheOfficeforGovernmentCommerce(OGC)reviewin2008andrecognises:theroleofSMEs;significanceofinnovationasadriverforprocurement;andproblemsoffragmentationinthelandscape.
Innovation Expo.TheExposawstrongindustryrepresentation.NHSChiefExecutiveDavidNicholsonhighlightedfivethingstheNHSshouldnotdoduringthefinancialcrisis,oneofwhichistocutinvestmentsintechnology,andstatedthat“ifweinvestnow,adecreaseincostswillcomelater”.
Industry Recommendations.EnhancingPatientCareintheNHS:TheRoleofMedicalDevicestargetedstakeholdersandoutlinesthekeyrequirementsforfullbenefitsoftechnologytoberealised.
Scotland.Toaddressmembers’procurementanduptakeissuesinScotlandABHIestablishedScotlandMedicalTechnologyIndustryGroup.
Innovation.ABHIhelpedestablishthenewHealthTechnologyandMedicinesKnowledgeTransferNetwork(KTN)andworkedwiththenetworkandtheMedilinkstoagreeanewstrategyforresearchandinnovationsupportwhichisbeingusedwithGovernment.
International Policy.ABHIgainedsupportfromUKGovernmentoverBrazilianregulatoryissuesandgeneratedaGovernmentrequesttotheEUforaction.
RegulationMedical Devices Directives.FollowingpostponementoftheRecast,ABHIhasdevelopedalternativeproposalstoaddressshortcomingsinthedirectiveswhilemaintainingaregulatoryframeworkthatwillallowEuropeanindustrytoremaininnovativeandcompetitive.
Unique Device Identification.ABHIhashelpedtoleadthedevelopmentofanindustryprogrammeinEucomed.ThishasensuredcloseinvolvementintheworkwhichislikelytoleadtoEUlegislationin2010.
Environment.ABHIsuccessfullyarguedthatthetimescaleforbringingdeviceswithinthescopeoftheRestrictiononuseofHazardousSubstances(RoHS)Directiveshouldallowforsafetyissuestobeaddressedandalsothatexemptionsshouldapplywherethesearedulyjustified.CommencedworktoensurethatundertheRegistration,Evaluation&AuthorisationofChemicals(REACH)legislation,DEHPplasticisedPVCmaycontinuetobeusedformedicaldevices.
ReputationCode of Business Practice.DevelopedcomplianceprogrammeswhichincludeinternalandexternalcommunicationandtrainingandalignedthisactivitywithEucomed.
MembershipMembership.Recruited43newmembers,inparticularexpandingmembershipamongstSMEs.
Communications.ProvidedindepthbriefingsformembersoneventsincludingtheBudget,Pre-BudgetReportandOfficeforLifeSciences.Expandedmembercommunicationstoincludeamonthlypublicaffairsupdate,anoverviewofactivitiesandChiefExecutivesUpdate.LaunchednewABHIwebsite.
Events.Organisedover20eventsincluding:LegalandRegulatoryconference;PaymentbyResultsseminar;monthlyExportClubmeetingsonmarkets;andUKmarketconference.
Exhibitions.OrganisedUKPavilionsatexhibitionsincludingArabHealth,ChinaMedicalEquipmentFairandMedica.Providedassistanceforover250companiestoparticipate.Achievements2009
In 2009 ABHI focused on the delivery of key activities to demonstrate value to members. Activity is targeted at the core ABHI values of policy, regulation, reputation and membership.
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A personal message from our Chairman
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Introduction from the Chief Executive
Geoff CoxChairman
Peter Ellingworth ChiefExecutive
The active engagement and work of our members with ABHI Secretariat has been critical to our ability to deliver against our objectives.
As the Joint Secretariat to the MMTSG, we keep in close and regular contact with key officials and ministers across Government…
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Since1April2008,allABHImembershavebeenrequiredtocomplywiththehighethicalstandardssetoutinourCodeofBusinessPractice(CoBP),
TheCoBPComplianceWorkingGroupmetfourtimesin2009.ThepurposeofthisgroupistoconsiderallissuesrelatingtocompliancewiththeCoBP.Areasofworkincludeddevelopmentofa‘businessplan’fortheCoBP,communicationwithmembers,promotionoftheCoBPtothirdpartyorganisations,relationshipwithEucomed,andpublicationofareviseddocument.
HavingestablishedaCoBPComplaintsPaneltowardstheendof2008,ABHIreceivednocomplaintsraisedundertheCodein2009thatnecessitatedthepanelmeeting.Anumberofminorissueswereraisedwiththesecretariatduringtheyear,butitwaspossibletoresolvethesethroughmediation.Thisdemonstratesthatthesystemworksinsofarasithasbeentested.
TofacilitatecommunicationwithmembersABHIhasidentifiedaCoBPcontactatallmembercompanies.ThisallowsustoquicklydisseminateinformationtothemembershiponkeyCoBPissues.Moregeneralinformationformembersisincludedinregularmembercommunications.arestillmadethroughothermeanssuchasPrimed,ourelectronicweeklynewsletter.
Anumberofmeetingswereheldduringtheyearwithorganisationsrepresentinghealthcareprofessionals,suchastheRoyalCollegeofSurgeons,theRoyalCollegeofNursingandtheRoyalCollegeofPhysicians.ABHIalsocommunicatedwithstakeholdersinparticularspecialityareas.ThisworkisvitaltoensuretheacceptanceoftheCoBPinthewidercommunityandABHIislookingatwaystoassistmembers’staffintheirdealingswithcustomersinrelationtotheCode.
GiventhattheCoBPderivesfromtheEucomeddocument,itisextremelyimportantthatABHIalignsitselfasfaraspossiblewiththem.TothisendABHIisinvolvedwithEucomedinanumberofareas.ThereareseveralmembersoftheABHICoBPComplianceWorkingGroupwhoarealsoinvolvedintheequivalentforuminEucomedandthisassistsgreatlyinkeepingtheorganisationinstep.AdditionallyABHIsecretariathasparticipatedinanumberofmeetingsintheareasoftrainingandcompliance.Membersshouldkeepaneyeoutforannouncementsonthisduring2010.
Intermsoftraining,ABHIhasengagedwithfourthird-partyorganisationsthatcandelivertrainingandcertificationtomembersanditishopedthiswillbeusefulinhelpingcompaniesaddresstheimplicationsoftheCoBPfortheirorganisations.TherearecommercialarrangementsbetweenABHIandtheseorganisationssothatmembershavetheopportunitytoassesstheirownneedsandengageastheyseefit.
Late2009sawpublicationofarevisedversionoftheCoBP.Thisincludedsomeadditionstothequestionandanswersectiontoprovideclarificationonarrangementsbetweenhealthcareprofessionalsandcompanies.Themajorchange,however,wastospecifyinsomedetailhowtheComplaintsPanelprocesswouldoperate.
Setting Standards: ABHI Code of Business Practice
Laura Collister Director
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This is a great example from the medical technology sector of industry responding proactively to the need for effective self regulation. We applaud ABHI’s initiative and commend it as a precedent for other suppliers to the NHS. The NHS will respond strongly by respecting the Code in its dealings with the device industry.
ProfessorSirBruceKeoghNHSMedicalDirector
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ItwasaneventfulyearforABHIintermsofUKmarketactivities.AnumberofdevelopmentscontributedtoachangeinrelationshipsbetweentheindustryandtheNHSaswellaswithwiderGovernment.ThisculminatedwiththefirstmeetingofanNHS-ledgroupwitharemittosupportuptakeoftechnologiesintheNHS,accountabletotheNHSOperationsBoard.ThisisthefirsttimethattheNHSitselfhastakenaleadinrelationshipswithindustryandABHIwelcomedthecreationofthisnewNHSLifeSciencesInnovationDeliveryBoard,onwhichthesectorisrepresented.
Oneofthekeydevelopmentsin2009wastheannouncementearlyintheyearofthecreationoftheOfficeforLifeSciences(OLS),toaddresstheneedsofthewiderlifesciencesindustryincludingmedicaldevicetechnologyandin-vitrodiagnosticsaswellaspharmaceuticalsandbiotechnology.TheOLShasbeenajointendeavourbetweenGovernmentandindustry,andhasfocusedonwhatisneededfortheNHStobecomeaninnovationchampion,buildamoreintegratedindustryandenableaccesstofinanceandinvestmentfortheUKlifescienceindustry.TheLifeSciencesBlueprintwaspublishedinJulyandmanyofitsaimsarewellonthewaytobeingdelivered.
UK Market Environment
AnothersignificantdevelopmentwasthepublicationofareviewofprocurementintheNHS.NecessitynotNicetywaspublishedinMay2009andtookonboardtheoutputoftheOfficeofGovernmentCommercereviewin2008.ThereviewaddressedchangesintheneedsoftheNHS,acknowledgingthesignificanceofinnovativetechnologies,anditsimplementationisunderway.However,uncertaintyremains,particularlyaroundthewidevarietyofregionalandlocalprocurementarrangementsthatcontinue,eachwiththeirowncontractualdemandsandcosts.
Alsoin2009,theindustrysawtheemergenceofNHSImprovement’sQualityandProductivityChallengeasthescaleoffinancialdifficultiesfacingtheNHSbecameapparent.TheindustrywasaskedtocontributeproposalsforreducingNHScoststhroughuptakeofinnovativetechnologies.Attheyearend,alargenumberofproposalshadbeensubmittedandassessedashavingstrongpotentialtoimproveNHSproductivity.
Takentogether,thesedevelopmentsenabledmorecomprehensivediscussionsbetweenthemedicaltechnologyindustryandGovernmentthanhavebeenpossibleforsometime.TheMinisterialMedicalTechnologyStrategyGroup(MMTSG)hasprovidedstewardshipforthesediscussions.ABHIprovidesindustrysecretariatfortheMMTSG,whichhelpedensureaconsistentdialoguewithGovernmentsinceitwaslaunchedin2007.
Aswellasthedevelopmentsdescribedabove,theMMTSG-chairedfromJanuary2009byColinMorganofJohnson&JohnsonMedical-hasalsoprovidedareportingpointforworkinitiatedearlier,attheendoftheHealthcareIndustriesTaskForcein2007.Thisincludesadatabaseprovidingforthefirsttimeaclearviewofthesizeofthemedicaltechnologyindustry,whichwaslaunchedbyGovernmentinDecember2009;andaprojecttodeterminethebestsupportforcompetitivenessofSMEs,whichwasalsocompletedduringtheyear.
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AkeyroleforMMTSGin2009wastoprovideoversightforthefourprojectsinitiatedbyLordDarziin2008withpublicationoftheNHSNextStageReview,topromoteuptakeofinnovationbytheNHS.Thishadfourdistinctworkstreams:
• ThecreationofasingleevaluationpathwaytopromotemorerapiduptakeofmedicaldevicetechnologyintheNHS,takingintofullaccountthedifferencesindevelopmentandevaluationofmedicaldevicesthatarisefromtheirengineering(asdistinctfrompharmaceutical)characteristics.ThisworkhasbeenledforGovernmentbytheNationalInstituteforClinicalExcellence(NICE),whichhascreatedaMedicalTechnologiesAdvisoryCommittee(MTAC)forthepurpose.TheABHI’sHealthTechnologyAssessmentworkinggrouphasmadeverysignificantinputtotheprocessthroughouttheyear,providingmembersfortheworkinggroupsandaforumforconsideringprogresswithinABHI.
• ThedevelopmentofmetricstobenchmarkuptakeofmedicaldeviceswithinandacrosstheNHS,intheknowledgethatNHSuptakeisinmanyrespectsslowerthanincomparableEuropeancountries.ThisworknowcomplementsworkunderwayonpharmaceuticaluptakeandwillinfuturebeoverseenbytheNHSLifeSciencesInnovationDeliveryBoard.
• Thepromotionof‘intelligentdemand’formedicaltechnologyintheNHS.Thisisakeyarea,whichhasbeentakenupbytheNHSaspartoftheQualityandProductivityChallenge.TheproposalssubmittedbyindustryattheyearendarethebestindicationyetthattheNHSwillrespondsystematicallytoinnovationifthecircumstancesareright.TheNHSInnovationExpoinJune2009,whichlookedbackovertheyearsincethepublicationofLordDarzi’sNextStageReview,alsoofferedaveryencouragingforumforengagementbetweentheNHSanditssuppliers.
• Procurementremainsascomplexasever,withapparentlycontradictory
developmentsintherolesofregionalandnationalbodies,includingNHSSupplyChainandsomeofthecollaborativeprocurementhubs.Several‘roundtable’meetingswereheldbetweentheDepartmentofHealthandindustrylaterintheyear,whichhelpedtoframeanewagendaforNHSprocurementinthenewfinancialcircumstances.Theseeventsacknowledgedthatprocurementisprimarilyameanstoanend,ratherthananendinitself.TheyfocusedonwhattheNHSwouldneedtodotoenhanceproductivity-whileindustryinvariablytakesproductivitysavings,theNHSrarelytakesthedecisionstodosoinasystematicway.Overthelastpartof2009,theindustryhasbeguntogetacrossthemessagethatthiswillbeessentialifthefinancialchallengefacedbytheNHSistobeovercome.TheyearendsubmissionsdescribedaboveofferastronghopeofthebeginningofanewkindofrelationshipbetweentheNHSandsomeofitskeysuppliers.ABHI’sconsiderationoftheseissueswassupportedthroughouttheyearbytheSupplyChainandE-BusinessWorkingGroupandbythecreationofanewgroupintheautumntofocusonlonger-termstrategicissuesinprocurement,chairedbyABHI.
• TheDepartmentofHealthpublisheditsNationalInnovationProcurementPlaninDecember,inwhichitreferredto“Aneffectivebusiness-to-businessrelationshipbetweenindustryandtheNHS.AkeyoutputfromthisworkwillbeaConcordatwithindustrythatwillseektoidentifynewcommercialmodelsanddisableundesirablebehavioursonbothsidesofthecommercialrelationship,suchthattheadoptionofinnovationcanbeencouragedandefficienciesfound.”ABHIisworkingwithmemberstoestablishhowwemightrespondtothis.
ABHI’sUKmarketworkcoversthreemainthemes,eachsupportedbyworkinggroupsaswellasbythespecialinterestsections(SISs).Thethemesarecommercialaccesstothemarket,evaluationandassessment,andreimbursement.ForEngland,thefirsttwoofthesethemesareaddressedabove.Forreimbursement,themainABHIfocusin2009wasonthecontinueddevelopmentofPaymentbyResults(PbR).
UK Market Environment
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A strong life sciences industry can drive growth and high-value job creation as well as playing a vital role in meeting future healthcare challenges.
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ABHI’sresearchandinnovationactivitiesin2009havefocusedoncreatingabetterinnovationenvironmentforthemedicaltechnologyindustry,withaparticularfocusontheneedsofSMEs.
Working with our innovation partnersThevalueofinnovationanddevelopmentofhealthtechnologytotheeconomyhasbeenrecognisedsincetheworkoftheHealthcareIndustryTaskForce(HITF)fiveyearsago.Theemphasisin2009hasbeenonthestepsneededtorealisethispotential.ABHIworkscloselywithanumberoforganisationswhoseroleistosupportthisinnovationagendaincludingMedilinks,theNHSInnovationHubsandtheDepartmentofHealthNationalInnovationCentre.
AnessentialpartofthisnetworkistheHealthTechnologyandMedicinesKnowledgeTransferNetwork(HTMKTN),fundedbytheTechnologyStrategyBoard(TSB).Recognisingconvergenceinhealthtechnologies,itsrolehasbeenexpandedtoembracediagnostics,biotechnologyandmedicinesaswellasABHI’straditionalareasofinterest.ABHIworkscloselywiththeKTN.
UK Super ClusterTheUKBioscienceSuperClusterwasannouncedaspartoftheOfficeforLifeSciences(OLS)work.ABHI’sResearchandInnovationPolicyGrouphasfocusedonthedevelopmentoftheClustertoensureitsrelevanceforourindustry.
NHS innovation initiativesABHIhasworkedwiththeDepartmentofHealthonseveralinnovationinitiatives.IntheHCAITechnologyInnovationsProgramme,theAssociationhelpedtoarrangemeetingsofindustryandNHSusers,andcontributedtotheDesignBugsOutprogramme.Nineshowcasehospitalsarenowpioneeringnewtechnologies,withanumberofnewproductsbeingtakentomarketwithinayear.ThisprogrammeisbeingtakenforwardthroughtheInnovationVillageconcept.
ABHIhasdevelopeditsroleasstakeholderduringtheyear,pressingthecaseforreviewfollowinganapparenterrorinthe2009/10tarifffortotalkneereplacement.Forthefirsttime,ABHIsupportedthe‘sensecheck’ofthetariffforthefollowingfinancialyear.OnthebasisofthecasemadefortheLifeSciencesBlueprint,ABHIhelpedtobringaboutanindustry-NHSworkshoptoestablishwhatcouldbedonetomakePbRmorepro-innovation.Aswellastheabovecross-sectoractivity,individualSISsaddressedissuesspecifictotheirsectors,forexamplethedecontaminationgroup.
Finally,ABHIbuiltonscopingworkundertakenin2008andlauncheditsScotlandMedicalTechnologyIndustryGroup,whichmetseveraltimesin2009.MembersconsideredtheparticularissuesarisingfromthedifferentapproachtakentoprocurementinScotlandandheldaproductivemeetingwithaleaddirectorfromNationalProcurement.Towardstheendoftheyear,discussionsstartedontheinvolvementoftheindustryinScottishhealthtechnologyassessmentprocedures.
ItwasaneventfulyearforABHIintermsofUKmarketactivities.AnumberofdevelopmentscontributedtoachangeinrelationshipsbetweentheindustryandtheNHSaswellaswithwiderGovernment.
ThisculminatedwiththefirstmeetingofanNHS-ledgroupwitharemittosupportuptakeoftechnologiesintheNHS,accountabletotheNHSOperationsBoard.
ThisisthefirsttimethattheNHSitselfhastakenaleadinrelationshipswithindustryandABHIwelcomedthecreationofthisnewNHSLifeSciencesInnovationDeliveryBoard,onwhichthesectorisrepresented.
UK Market Environment
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Paving the way for innovation
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In establishing the Office for Life Sciences, the Government clearly signalled the importance of the industry to building the Britain of the future
LifeSciencesBlueprintJuly2009
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Paving the way for innovation
TheSmallBusinessResearchInitiative(SBRI)hasbeenpromotedbyGovernmentasameanstouseitsprocurementpowertoencouragebetterproductsfromindustry.TheDepartmentofHealthhasbeenworkingwiththeTSBtorunaninitialprogrammefromtheDepartmentofHealthNationalInstituteforHealthResearch(NIHR)onhealthcare-associatedinfections,.ABHIwillcontinuetoworkwithNIHRandtheInventionforInnovation(i4i)programmetotrytoimprovethemomentumoftheSBRIapproach.
Thei4iprogrammehasexpandedoverthelasttwoyearswiththeprimarygoalsofacceleratingthedeliveryofgoodnewtechnologiestopatients.ABHIwelcomedtheappointmentoftheDirectorwhoiscommittedtoensuringtheimpactofthisprogrammeindeliveringbothpatientbenefitandimprovingthenationalwealth.
Delivering recommendationsABHIcontinuestoworktoimplementtherecommendationsofHITFanditssuccessorprogrammes.TheseincludethetwopilotHealthTechnologyCooperatives(D4DandEnteric),whichhaveengagedwithover120companiesandestablishedover50projects.
AnumberofinitiativeshavetakenplacetofacilitateindustryaccesstotheresearchexpertiseavailableintheNHStoundertakeessentialclinicalstudies.
WorkwithBISonthedevelopmentofadetaileddatabasetoprovideessentialinformationonthesizeandstrengthofthehealthtechnologysectorwaspublishedinDecember2009.
TheroleofSMEsinthissectorisclearlyrecognised-companieswithturnoveroflessthan£5millionaccountfor90%ofthoseinthissector.ABHIishelpingtocoordinateapolicytoprovidesupporttheSMEsworkingcloselywithbothBISandtheDepartmentofHealth,andwillinvolveafocusonbettercommunicationwithSMEsthrough2010usingthesupportofallournetworkpartners.
Working with funding organisationsInthecurrenteconomicenvironment,availabilityofgrantfundingcanbecriticallyimportanttothesuccessfuldevelopmentofaninnovativetechnology.ABHImaintainsstronglinkswiththemajorfundingorganisations(includingi4i,TSB,theEngineeringandPhysicalSciencesResearchCouncilandtheMedicalResearchCouncil)tohelpalignthesewiththeneedsofthesector,andtohelpcompaniesunderstandthescopeofthesupportavailablefromthesesources.
The research communityToinformtheaboveactivities,ABHIrecognisestheneedtobeawareoftherealresearchrequirementsofthemedicaltechnologyindustry.ABHIwillbeinstitutinganumberofcommunicationmechanismsincludingnationalmeetings,novelinformationtechnologyapproaches,anetworkoflocalclusters,anetworkofHealthcareTechnologyCooperativeapplicationsfocuspoints,andagroupofhigh-levelindustryresearchanddevelopmentpractitionerstofeedbackonthedevelopmentandappropriatenessoftheSuperCluster.Formationofanactiveresearchcommunitywillbethekeyfocusfor2010.
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The past year saw the Association for British Healthcare Industries (ABHI) gain a higher profile among health policy-makers than ever before, through its advisory role in the new Office for Life Sciences (OLS) and its function as secretariat of the Ministerial Medical Technology Strategy Group (MMTSG), which provides the strategic direction for joint working by industry and Government
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DuringthepastyearABHI’sregulatoryteamfocusedonanumberofissuesthatarecentraltothefuturewell-beingoftheindustry.
Recast of the EC Medical Devices Directive (MDD)Inearly2009welearnedthatindustryactivityontherecastoftheMDDhadbeensuccessfulinthattheEuropeanCommissionhaddecidedtopostponeanyworkonthisuntil2010.SincethenEucomed,withsupportfromABHI,hasdevelopedindustrypositionsonmanyoftheissuesraisedintheoriginalproposal.
AninformaldialoguewiththeECandtheMedicinesandHealthcareproductsRegulatoryAgency(MHRA)gavegroundsforsomeoptimisminthatoneofthemainthreats-arequirementforpremarketapprovalforhigh-riskproduct-seemedtohavereceded.AttheveryendoftheyeartheindustrylearntthattheMedicalDeviceUnitistomovefromDGEnterprise,whichhasresponsibilityfortradeandcompetitiveness,toDGSANCOwitharemitforpublichealth.Thismovehadlongbeenflaggedasafairlyremotepossibility,butfewexpectedittocomewithoutwarningandorconsultation.ThisnewsituationpotentiallyreopensthewholerangeofquestionsposedbytheoriginalrecastandcouldleadtoachallengetothebasicphilosophythathasgoverneddeviceregulationsincetheMDDwasdeveloped20yearsago.2010iskeyforthefutureofdeviceregulationandABHIwillcontinuetobevigilant.
DecontaminationDuringtheyeartheindustrysub-committeeofESACPrwaswoundupfollowingareviewoftotalESACactivity.ABHIisactivelyseekingrepresentationonthemainESACCommittee,butthishasnotyetbeenconfirmed,despiteAssociationworkondecontamination-relatedissuesbeingcentredontheactivitiesaroundESAC.
Unique device identificationWorkhascontinuedonuniquedeviceidentification(UDI),particularlyincommunicatingthemessagetoindustryintheUKaswellasacrossEurope.TheGlobalHarmonizationTaskForce(GHTF)hasproducedareportscheduledforconsultationduringthefirstquarterof2010,whichislikelytoformthebasisforlegislationultimatelyrequiringalldevicestocarryuniqueidentifiersandprobablytobeenactedthroughtherecast.
StandardsStandardsworkin2009wasdominatedbytheneedtoreviewallexistingharmonisedstandardsagainstthenewrevisionoftheMDD.ThiswassubstantiallycompletedbythebeginningofDecember2009.Theotherissuesofsignificancein2009werethedraftingofanewstandardcoveringthelabellingofphthalatesasrequiredunderthenewAnnex1Clause7.5oftheMDDandtheprogressionofENISO15223-1onlabellingtoreplaceEN980.
EnvironmentTherecastoftheWasteElectricalandElectronicEquipment(WEEE)andRestrictionofHazardousSubstances(RoHS)directiveswasthemajorenvironmentalconcernof2009,astheyaregoingthroughthepoliticalprocessintheEU.TheRoHSDirectiveisbeingwatchedespeciallycloselyastherecastproposesthatmedicaldevicesshouldfallwithinthescope.CurrentprojectionsarethatthereviseddirectiveareexpectedtobepublishedintheOfficialJournaloftheEUaroundtheendof2010,beginning2011.TheregistrationoftheplasticiserDi(2-ethylhexyl)phthalate(DEHP)undertheRegulationonRegistration,Evaluation,AuthorisationandRestrictionofChemicals(REACH)isbeingfacilitatedthroughaconsortiumofDEHPmanufacturers.
Proportionate regulation
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ABHIcommunicationsworkhastwomaintargetaudiences–membersandexternalaudiences.2009sawanemphasisonmembercommunicationwithanumberofnewpublicationslaunchedaswellasongoingactivitywitharangeofmedia.
AsanindustryassociationthetimelyandefficientcommunicationwithmembersisessentialforABHIandakeyelementrunningacrosstheorganisation.ABHImassmembercommunicationsinclude:
• Primed–thelong-runningfortnightlye-newswireremainsABHI’skeymechanismforcommunicatingwithmembers.In2009itwasrevamped,withanewstructure,designandheadings.
• DailyNews–thedailymedianewsservicefromABHIfocusesonthekeynewsstoriesforourbusinesssector.
• ChiefExecutivesUpdate–thisnewmonthlypublicationfocusesonthetopbusinessrelatedissuesofthemonth.
• ABHIOverview–thisnewmonthlypublicationprovidesaround-upofABHIactivity,achievementsandmeetings.
• PublicAffairsUpdate–anewpublicationprovidingamonthlyupdateoftopparliamentaryandpoliticalactivity.
• InternationalNewswire–focusingoninternationalbusinessandexhibitions.
• Briefings–ABHIprovidesbriefingsontopeventsformembers.In2009briefingsincludedtheBudget,Queen’sSpeechandtheOLSBlueprint.
ABHIconductedtwomembersurveysin2009.ThesurveysensurethatABHIisaddressingmembers’needsandconcerns,providesanopportunityforinputonfutureactivityaswellasprovidinganinsightintothebusinessconfidenceofmembersandtheirreactionstothepolicyandeconomicenvironment.ThesurveyreceivesahighnumberofresponsesfrommembersandABHIensuresthattheresultsareactedupon.ABHIwillcontinuetoholdmembersurveyseverysixmonths. InAutumn2009ABHIworkedwiththeSundayTelegraphonasupplementfocusingoninnovation.ThesupplementprovidedABHIwithanopportunitytoreachawideraudiencewitharangeofissuesandformemberstopromotetheirbusinessesseparately.ABHIhascontinuedtoworkwithanumberoftradepublicationsovertheyear.
ABHI’sPublicAffairsPolicyGroupoversawthelaunchofEnhancingPatientCareintheNHS:TheRoleofMedicalDevices.Thepublicationcoverstheoverarchingrecommendationsofindustryforthesector.Itwastargetedatbothpoliticalaudiencesandhealthcarestakeholdersandwaswidelydistributedamongsttheseaudiences.
ABHIcontinuestomaintainitspresenceatthePoliticalPartyConferencesthroughHealthHotelmembership.Fringemeetingswereheldatallthreemainpartyconferencesin2009inpartnershipwithBreakthroughBreastCancerCare,theBritishDentalAssociation,andtheParkinsonDiseaseSociety.Entitled‘WhitehalltoTownhall-nolongeranationalhealthservice?‘debatecoveredwhetherornotpowerdevolvedtotheNHSregionshasbeenbeneficialtotheNHSorifithasleftapatchworkofserviceswithvaryinglevelsofcareacrosstheregions.
TheMedicalTechnologyGroupperformedstronglyin2009.Thecoalitionofpatientgroups,researchorganisationsandindustryundertookanumberofcampaignsandactivities.Thegrouppublished“MedicalTechnology–CanWeAffordtoMissOut”anactionplantohighlighthowtheUKlagsbehindmanyotherEuropeancountriesinitsuptakeofproveneffectivetechnologies,andoutlinessomeofprincipalobstaclestoprovision,whichrestrictaccessandpatientchoice.Itspublicationattractednationalpressattention.OthersuccessesincludedtheannualParliamentaryShowcasewhichattractedanumberofparliamentarianstoviewtechnology.TheMTGsubmittedwrittenevidencetotheHealthSelectCommitteeenquiryintocommissioningandactivitytookplacearoundtheHealthAct2009.AnewMTGwebsite–www.mtg.org.uk–wasalsolaunched.
Communicating the value
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Focus on International Work
2009wasverysuccessfulforABHIintermsofhelpingmemberstogrowbusinessinternationally.ThechallengingeconomicclimatehasincreasinglyinfluencedUKcompaniestofocustheirattentiononforeignmarketsandinmanycasesmembershavehadconsiderablesuccessingainingnewbusinessoverseasthroughavarietyofABHIinternationalactivity.
ABHI’sInternationalPolicyGroup(IPG)hashadabusyyearengagingwithitsstakeholders,includingGovernmentDepartments,toensurethatissuesfacingUKmedicaltechnologyexportersareraisedandcommunicatedeffectively.ABHIsecretariatandmemberscontinuetoactasanindustryvoiceonanumberofinternationalhealthcaremarketworkinggroups,andtheAssociationcontinuestopromotethevalueandqualityoftheUKmedicaltechnologyindustrythroughitseventsandengagement.
Throughout2009ABHIcontinuedtoimproveandexpanditsrangeofinternationalservicesformembers,whichnowincludesmarketreports,overseasbusinessopportunities,partneringopportunitiesanddetailedUKcompanydirectories-aswellasprovidingadedicatedteamtoanswermembers’exportenquiriesandsupportmembers’internationalbusinessdevelopment.
Internationalactivitiesin2009havecontinuedtogofromstrengthtostrength.ABHIhasimprovedandexpandedopportunitiesforindustrytomeetcustomersandaccessmarketinformationandexpertise.TheyearsawABHItakeover250companiesawaytointernationalexhibitions-thelargestnumbertodate.Over400delegatesattendedtheAssociation’smonthlyExportClubs,whichprovidevaluablemarketinformationandcasestudiesonkeymarketsandexportissues.Thiswasamarkedincreaseonthepreviousyear.
ABHI’sinternationale-newsletterhascontinuedtodevelopandnowprovidesacomprehensiverangeofnewsectionscontainingvaluableinternationalnews,articles,marketupdates,businessopportunitiesandGovernmentupdates,aswellasup-to–the-minuteinformationonallforthcominginternationaleventsandactivity.
ABHIhasworkedcloselywithUKTradeandInvestmenttohelpcompaniesaccessvitalgrantassistance.In2009theAssociationaccessedover150grantsforUKexporterstoassistwiththecostofattendingtradeshows,andprovidedadviceandguidanceformanymore.
2010willprovideopportunityandchallengeinequalmeasureforUKexporters.ABHIwillagainbeworkinghardforindustrytoensurethatthequalityandvalueofUKmedicaltechnologyiscommunicatedin2010andthatmembershaveopportunitiestodeveloptheirbusinessoverseas.
RENASYS™ GO © Smith & Nephew
Paul Benton Director,Commercial&International
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InOctober2009ABHIlauncheditsnewwebsite–www.abhi.org.uk.Thepublicpartofthewebsiteprovidesasnapshotintothemedicaltechnologyindustryandkeyissues.Keyissuebriefingsandpressreleasesareincluded,aswellasanexpandedeventssection.Newelementsincludeadetailedeventscalendar.
Formembersthemembersectionhasbeengreatlyexpanded.Accesstothemembersectionisopentoallemployeesofmembercompanies–thereisnorestrictiontothenumberthatmayhaveaccess.Valueaddedinformation,knowledgeandintelligenceisincludedinthesection.EachABHIgrouphasaseparatepagecontaininginformationabouteachgroup’sremit,meetingminutesandupcomingmeetingdates.Theaimofthemembersectionistoprovidea“community”formembers.
Picturesofmedicaltechnologyweresubmittedbymembersforthesite.Thesewillberegularlychangedandmembersareencouragedtosubmitproductimages.
InitsfirstfullyearABHI’seventsfunctionsuccessfullydeliveredover25eventsacrossalltheassociation’smajorpolicyareas-andbroughtclosecollaborationandengagementwithmanyofourkeystakeholders.
The2009eventsprogrammeconsistedofseverallargeconferencesaswellasarangeofseminars,educationalworkshopsandpartneringevents.TheAssociation’seventsactivityprovidedmemberswiththeopportunitytogainvaluableknowledge,communicatedkeydevelopmentsandprovidedalookatwhatthefuturemayholdacrosstheABHI’sbroadspectrumofpolicyareas.
ABHI’sannualdinnerinFebruarysuccessfullybroughttogetherover300oftheindustry’sleadingfiguresanddecisionmakersaswellasalargenumberofkeystakeholdersandseniorpolicymakers.The‘HCAIinternationalsummit’,heldatChelseaFCandorganisedbyABHIlaterthatmonth,sawover350delegatesattendafull-dayconferenceandexhibitionfollowedbyaverysuccessfulawardsdinnerforover200delegates.
ABHILegalandRegulatoryConferenceandABHIDecontaminationConference,bothofwhichattractedsignificantdelegatenumbers,broughttogetheranexpertlineupofspeakers.SmallerseminareventscoveringkeytopicssuchasREACH,PaymentbyResultsandhealthtechnologyassessmentprovidedmemberswithup-to-dateinformationandguidance.InadditionABHIlaunchedmonthlyExportClubmeetingsfocusingonkeyinternationalmarketsandissues,whichhasgrowndramaticallyandnowactsasavitalsourceofinformationforexporters.
Theeventsteamalsoorganisedandworkedoncollaborativeinitiativeswithstakeholders,whichincludeddeliveringanindustryexhibitionstandandseminarattheNHSInnovationExpothatattractedseveralthousandNHSdelegates.
Theyearendedverysuccessfullywithover300industrydelegatesattendingtheABHIUKMarketConferenceandexhibition.ThisbroughtmanyoftheUK’sleadinghealthcaredecisionmakerstogethertotalktoindustryabouttheprogressmade,currentlandscapeandfuturedirectionoftheNHSandhealthcareintheUK.
2010willseeabusyprogrammeofactivitybuildingonthesuccessof2009,withmanysignificanteventsandopportunities.
Paul Benton Director,Commercial&International
Events Website
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Laura Collister, Director
ABHI website
DDCDolphinLtd
DeconSciencesLtd
DeltexMedical
DentonWildeSapte
DePuyInternational
DePuyUK
DixonsSurgicalInstrumentsLtd
DonawaLifescienceConsulting
DTRMedicalLtd
Durbinplc
EdwardsLifesciencesLtd
EschmannEquipment
ev3Ltd
ExmoorInnovations
ExmoorPlasticsLtd
ExomedicaLtd
FanninUKLtd,SurgicalDivision
FertilityFocusLtd
FieldFisherWaterhouseLLP
Finsbury(Instruments)Ltd
GalbraithWightLtd
GalilMedicalUKLtd
GAMAHealthcareLtd
Griffiths&NielsenMedicalDivision,t/aG&NMedical
GS1UK
GuerbetLaboratoriesLtd
HaagStreitUKLtd
HammondsLLP
hanover
HealthEdgeSolutionsLtd
HealthTechnologySolutionsSpains.l.
Healthlogistics.co.ukLtd
HeraeusMedical
HologicUKLtd
HospiraUKLtd
HullAssociates
HuntleighHealthcareLtd
HuntleighTechnologyLtd
HygienicsBiosecurityLtd
HygienicsLtd
IntertekTestingLtd
IsotronLtd
JohnWeiss&SonLtd
Johnson&JohnsonMedicalLtd
JointReplacementInstrumentationLtd
JuzoUKLtd
K2MedicalSystemsLtd
KapitexHealthcareLtd
KarlStorzEndoscopy(UK)Ltd
KimalPlc
LifecareHospitalSuppliesLtd
Limbs&ThingsLtd
LloydsRegisterQualityAssuranceLtd
LombardMedicalTechnologiesPlc,CardiovascularDivision
LyallWillis&CoLtd
MalaysianRubberExportPromotionCouncil
ManagementForumLtd
MathysOrthopaedicsLtd
MatrixMarkingLtd
MDMMedicalLtd
MedactaUKLimited
MediUKLtd
MedibrandLtd
MedicalDeviceConsultantsInternationalLtd
MedicalPlanning&DesignConsultancy
MediplusLtd
MeditecInternationalEnglandLtd
MeditechSystemsLtd
Meditrax(AltraxGroupLtd)
MedtronicLtd
MercuriUrvalLimited
MerrillBrinkInternational
Mi3Ltd
MirageHealthGroupLtd
MolnlyckeHealthCareLtd
MorganLewis
MoviantoUKLtd
NewCo-OrdinatesLtd(t/aNEWCO®Surgical)
NorginePharmaceuticalsLtd
NuVasiveUKLtd
OlympusKeymed
OPTIC(UK)
OrthovitaUKLtd
OsteotecLtd
OwenMumfordLtd
P3MedicalLtd
PajunkUKMedicalProductsLtd
PallMedical
ParburchMedicalDevelopmentsLtd
PDIEurope
PennineHealthcare
PraxisHighIntegritySystemsLtd
Procter&GambleTechnicalCentresLtd
ProplinkMedical(Europe)Ltd
PuricoreSteriloxEndoscopy
QuantaFluidSolutionsLtd
QuintilesConsulting
QuotecLtd
RaynerIntraocularLensesLtd
ReamSurgicalLtd
RenfrewGroupInternationalLtd
RenishawPlc
RichardWolfUKLtd
RobertsSurgicalHealthcare
RustonPooleInternationalPlc
SMurray&CoLtd
SaharanTradingCompanyLtd
SarstedtLimited
ScanTrackHealthcareSystems(UK)Ltd
SchulkeandMayrUKLtd
ScotmedLtd
SDMA
SewardThackray
SGSUnitedKingdomLtd
Shotwell&Carr,Inc.
Simmons&Simmons
Smith&Nephew
SmithsMedical
SMSTechnologiesLtd
SorinGroup(UK)Ltd
SouthWesternSurgicalLtd
StJudeMedical
StarSyringeLtd
SterigenicsUKLtd
SterilinLtd
STERISLtd
STOKUKLtd
StrykerUKLtd
SurgicalInstrumentGroupHoldingsLtd
SurginsSurgicalLtd
Swann-MortonLtd
SymmetryMedicalCheltenhamLtd
SynthesLtd
SystagenixWoundManagementInternationalLtd
TangramMedicalTechnologyConsultingLtd
TaylorWessing
TeleflexMedicalUK
TerumoUKLtd
TimescoofLondon
TissueRegenixLtd
TSLplc
TÜVProductServiceLtd
UKHealthEnvironmentResearchInstitute(PERA)
UKMAMLtd
UKSurgicalLtd
UnderwritersLaboratoriesLtd
UnimedicLtd
UniroseMedicalLtd
UrgoLtd
VerathonMedical
WLGore&Associates(UK)Ltd
WelchAllyn(UK)Ltd
Wellards/SGCPartnership
WrightMedicalUKLtd
XirosLtd
ZimmerUKLtd
Our people Members
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3MHealthCare
AAlgeoLtd
AbbottMedicalOptics
AbbottVascular
AccentusMedical
AdvancedBionicsUKLtd
AIMConsultingLtd
AlbertBrowneLtd
AlconLaboratories(UK)Limited
AltomedLtd
AmericanMedicalSystemsUKLtd
AndersenProducts
AneticAidLtd
AngioDynamicsUKLtd
Ansell(UK)Ltd
ApaTechLtd
Arnold&Porter(UK)LLP
AventalLtd
B.BraunMedicalLtd
BaileyInstrumentsLtd
Baker&McKenzieSolicitors
BardLtd
Barema
BarlowLyde&Gilbert
Bausch&LombUKLtd
BaxterHealthcareLtd
BD
BDTA
BedfontScientificLtd
BiocompatiblesUKLtd
BiometHealthcareUKLtd
BiotronikUKLtd
BITECICLtd
BlazeVentureTechnologiesLtd
BMPolycoLtd
Bodyguards
BoltonSurgicalLtd
BostonScientificLtd
BrowneHealthCareLtd
BSIProductServicesLtd
CarinaVTLtd
CellnovoLtd
CentreofExcellenceforLifeSciencesLtd
CeramTec
CirrusHealthcareProducts
ClementClarkeInternationalLtd
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ConsortMedicalplc
ConvaTecLtd
CookMedical
CorinLtd
Covidien(UK)CommercialLtd
CyberonicsEuropeS.A.
Peter Ellingworth ChiefExecutive
Mike Kreuzer, OBE Director,TechnicalandRegulatory
Clive Powell Manager,Technical
Andy Taylor Director,HealthcarePolicy
Judith Mellis Manager,UKMarketAffairs
Laura Collister Director,ExternalRelations
Daniel Jones PublicAffairsandMembershipOfficer
Paul Benton InternationalandEventsManager
Emma Pocock EventsExecutive
Sarah Izon ExhibitionsandEventsCo-ordinator
Theresa Ashford InternationalBusinessCo-ordinator
Linette Irons FacilitiesManager
Marion Harris Receptionist/Secretary
Angela Jeffery PAtoChiefExecutiveandMembershipCo-ordinator
Esther Mannoukas AccountsAdministrator
Ian Cranston AccountantandCompanySecretary
Andy Vaughn Consultant,Standards
Oliver Wells Consultant,ResearchandInnovation
Steve Cook Consultant,ResearchandInnovation
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