Association of British Healthcare Industries...Organised UK Pavilions at exhibitions including Arab...

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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Andy Taylor Director

Inflation in the costs of goods and services, which range from beds and syringes to scanners and beds, rose at barely a third of the rate in the economy as a whole.

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November2009

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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).


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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.

LifeSciencesBlueprintJuly2009

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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.



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

MedtechBusinessFebruary2010

Oliver Wells Consultant,ResearchandInnovation

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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

Mike Kreuzer, OBEDirector

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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


Laura Collister, Director

22 23

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

2726

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

CMSCameronMcKenna

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

28

AssociationofBritishHealthcareIndustries111WestminsterBridgeRoad

LondonSE17HR

T(020)79604360F(020)79604361

[email protected]*www.abhi.org.uk

*ABHIstaffcanbecontactedonemailusingfirstname.lastname@abhi.org.uk

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