Health technology assessment of medical devices

Health technologyassessment ofmedical devicesWHO Medical device technical series

PrefaceHealth technologies are essential for a functioning health system. Medical devices inparticular are crucial in the prevention, diagnosis, and treatment of illness and disease,as well as patient rehabilitation. Recognizing this important role of health technologies,the World Health Assembly adopted resolution WHA60.29 in May 2007. The resolutioncovers issues arising from the inappropriate deployment and use of health technologies,and the need to establish priorities in the selection and management of healthtechnologies, specifically medical devices. By adopting this resolution, delegationsfrom Member States acknowledged the importance of health technologies for achievinghealth-related development goals; urged expansion of expertise in the field of healthtechnologies, in particular medical devices; and requested that the World HealthOrganization (WHO) take specific actions to support Member States.One of WHO’s strategic objectives is to “ensure improved access, quality and use ofmedical products and technologies.” This objective, together with the World HealthAssembly resolution, formed the basis for establishing the Global Initiative on HealthTechnologies (GIHT), with funding from the Bill & Melinda Gates Foundation. GIHTaims to make core health technologies available at an affordable price, particularlyto communities in resource-limited settings, to effectively control important healthproblems. It has two specific objectives:• to challenge the international community to establish a framework for thedevelopment of national essential health technology programmes that will have apositive impact on the burden of disease and ensure effective use of resources;• to challenge the business and scientific communities to identify and adaptinnovative technologies that can have a significant impact on public health.To meet these objectives, WHO and partners have been working towards devising anagenda, an action plan, tools and guidelines to increase access to appropriate medicaldevices. This document is part of a series of reference documents being developed foruse at the country level. The series will include the following subject areas:• policy framework for health technology• medical device regulations• health technology assessment• health technology management››needs assessment of medical devices››medical device procurement››medical equipment donations››medical equipment inventory management››medical equipment maintenance››computerized maintenance management systems• medical device data››medical device nomenclature››medical devices by health-care setting››medical devices by clinical procedures• medical device innovation, research and development.WHO Medical device technical series3

These documents are intended for use by biomedical engineers, health managers,donors, nongovernmental organizations and academic institutions involved in healthtechnology at the district, national, regional or global levels.MethodologyThe documents in this series were written by international experts in their respectivefields, and reviewed by members of the Technical Advisory Group on Health Technology(TAGHT). The TAGHT was established in 2009 to provide a forum for both experiencedprofessionals and country representatives to develop and implement the appropriatetools and documents to meet the objectives of the GIHT. The group has met on threeoccasions. The first meeting was held in Geneva in April 2009 to prioritize which toolsand topics most required updating or developing. A second meeting was held in Rio deJaneiro in November 2009 to share progress on the health technology management toolsunder development since April 2009, to review the current challenges and strategiesfacing the pilot countries, and to hold an interactive session for the group to presentproposals for new tools, based on information gathered from the earlier presentationsand discussions. The last meeting was held in Cairo in June 2010 to finalize thedocuments and to help countries develop action plans for their implementation. Inaddition to these meetings, experts and advisers have collaborated through an onlinecommunity to provide feedback on the development of the documents. The conceptswere discussed further during the First WHO Global Forum on Medical Devices inSeptember 2010. Stakeholders from 106 countries made recommendations on howto implement the information covered in this series of documents at the country level. 1All meeting participants and persons involved in the development of these documentswere asked to complete a declaration of interest form, and no conflicts were identified.1 First WHO Global Forum on Medical Devices: context, outcomes, and future actions is available at: http://www.who.int/medical_devices/gfmd_report_final.pdf (accessed March 2011)4Health technology assessment of medical devices

DefinitionsRecognizing that there are multiple interpretations for the terms listed below, they aredefined as follows for the purposes of this technical series.Health technology: The application of organized knowledge and skills in the form ofdevices, medicines, vaccines, procedures and systems developed to solve a healthproblem and improve quality of life. 2 It is used interchangeably with health-caretechnology.Medical device: An article, instrument, apparatus or machine that is used in theprevention, diagnosis or treatment of illness or disease, or for detecting, measuring,restoring, correcting or modifying the structure or function of the body for some healthpurpose. Typically, the purpose of a medical device is not achieved by pharmacological,immunological or metabolic means. 3Medical equipment: Medical devices requiring calibration, maintenance, repair, usertraining, and decommissioning – activities usually managed by clinical engineers.Medical equipment is used for the specific purposes of diagnosis and treatment ofdisease or rehabilitation following disease or injury; it can be used either alone or incombination with any accessory, consumable, or other piece of medical equipment.Medical equipment excludes implantable, disposable or single-use medical devices.2 World Health Assembly resolution WHA60.29, May 2007 (http://www.who.int/medical_devices/resolution_wha60_29-en1.pdf, accessed March 2011).3 Information document concerning the definition of the term “medical device”. Global Harmonization Task Force, 2005 (http://www.ghtf.org/documents/sg1/sg1n29r162005.pdf, accessed March 2011).WHO Medical device technical series5

AcknowledgementsHealth technology assessment of medical devices was developed under the primaryauthorship of Reiner Banken, Institut national d’excellence en santé et en servicessociaux (INESSS), Montréal, Canada, and Donald Juzwishin, Alberta Health Services,Edmonton, Canada, and produced under the overall direction of Adriana Velazquez-Berumen, World Health Organization, Geneva, Switzerland as part of the Global Initiativeon Health Technologies (GIHT) project funded by the Bill & Melinda Gates Foundation.The draft was reviewed by Jennifer Barragan, Maria Benkhalti, Stephen Bornstein,Lisa Farrell, Janet Hatcher-Roberts , Janet Hiller, Mira Johri, Egon Jonsson, ArmineeKazanjian, Guy Maddern, Logan Mardhani-Bayne, Joseph L Mathew, Craig Mitton,Laura Sampietro-Colom, Dima Samaha, Julian Stedman, and edited by Cathy Needham.We would like to thank Aditi A Sharma for assistance in proofreading and Karina Reyes-Moya and Gudrun Ingolfsdottir for administrative support throughout the developmentof this document.Declarations of interestsConflict of interest statements were collected from all contributors to and reviewers of thedocument. Donald Juzwishin declared his employment at the Alberta Health Servicesand as a consultant with McMaster University as remuneration from an organizationwith an interest related to the subject. Maria Benkhalti declared her position withKnowledge Transition and Health Technology Assessment in Health Equity, Universityof Ottawa as representation of interests related to the subject. Janet Hatcher-Robertsdeclared receipt of funding for a global conference on health equity which was unrelatedto health technology assessment. Joseph L Mathew declared the Health TechnologyAssessment International (HTAi) travel grant award to participate in the annual meetingof the scientific society as well as his interest in the publication of the report in questionto benefit health care professionals and people in developing countries with whom hehas substantial professional interests. None of these declared conflicts influenced thecontent of the document.6Health technology assessment of medical devices

Acronyms and abbreviationsTAGHTCOHREDCSIHDALYEUnetHTAEVIPNetGIHTHTAHTAiHTMHTRINAHTAISGQALYSIGWHOTechnical Advisory Group on Health TechnologyCouncil on Health Research for DevelopmentCanadian Society for International Healthdisability-adjusted life yearEuropean network for Health Technology AssessmentEvidence-Informed Policy NetworkGlobal Initiative on Health Technologieshealth technology assessmentHealth Technology Assessment internationalhealth/health-care technology managementhealth technology regulationInternational Network of Agencies for Health Technology Assessmentinterest sub-groupquality-adjusted life yearspecial interest groupWorld Health OrganizationWHO Medical device technical series7

Executive summaryHealth technology assessment (HTA) has emerged as an important tool for supportingthe core functions of an effective global health system. 1 Actions by the World HealthOrganization (WHO) and other global health organizations are necessary to supportregional and national initiatives for the advancement of HTA in developing and emergingcountries (i.e. nations in the process of rapid growth and industrialization). Thisdocument describes an approach for how the multiple players in the global communitycan come together to advance the knowledge and effective uptake of health technologyassessment in local settings.HTA is the systematic evaluation of properties, effects, and/or impacts of healthtechnology. Its main purpose is to inform technology-related policy-making in healthcare, and thus improve the uptake of cost-effective new technologies and preventthe uptake of technologies that are of doubtful value for the health system. It is oneof three complementary functions to ensure the appropriate introduction and use ofhealth technology. The other two components are regulation, which is concerned withsafety and efficacy, and assessment of all significant intended as well as unintendedconsequences of technology use, including clinical and cost-effectiveness; andmanagement, which is concerned with the procurement and maintenance of thetechnology during its life-cycle. The performance of health systems is strengthenedwhen the linkages and exchange among these elements are clearly differentiated butmutually supportive.This document integrates health technology assessment into the WHO framework forevidence-informed policy-making (2). Health systems are strengthened when HTA isintegrated into the human and material resources, data, transparent decision- andpolicy-making, and linked to the overall vision of equity and accountability. Goodgovernance can rely on health technology assessment to provide a policy approachthat is accountable for its decisions to the population.Organizations specializing in health technology assessment are becoming institutionalizedelements of health systems, not only to help identify health-care interventions that maynot be effective, but also to identify promising technologies that can stimulate innovation.There are several international agencies supporting the advancement of HTA on theglobal stage. Health Technology Assessment international (HTAi) and the InternationalNetwork of Agencies in Health Technology Assessment (INAHTA) have a demonstratedcommitment to advance and collaborate on health technology assessment with WHOand any country or community that is interested. WHO collaborating centres and theirglobal network – specifically the Global Network of WHO Collaborating Centres forHTA – have made a commitment to promote international dialogue, collaboration andstrengthen existing projects.1 The global health system has been defined as the constellation of actors (individuals and/or organizations) “whose primary purpose is to promote, restore or maintain health” and “the persistent andconnected sets of rules (formal or informal), that prescribe behavioral roles, constrain activity, and shape expectations” among them. Such actors may operate at the community, national or globallevels, and may include governmental, intergovernmental, private for-profit, and/or non-profit entities (1).8Health technology assessment of medical devices

There are several strategies for overcoming challenges and advancing health technologyassessment in developing and emerging countries. In all, sensitivity for contextualizingto the resource capacity and capability is encouraged. One approach for advancing HTAis to build on the 1990 report of the Commission on Health Research for Developmentand the 2003 commentary by the Council on Health Research for Development, both ofwhich encourage the strengthening of national institutions supported through regionaland international networking.The strategy of introducing focal points for health technology assessment in a developingor emerging country will be dependent on many factors – appropriate location, humanresource capability, and organization capacity to name a few. Good governance, funding,and effective collaboration with partners will be essential ingredients for building HTAcapacity. This document demonstrates that there are many international organizationsand professionals willing to work with WHO and developing and emerging countries toadvance HTA to strengthen health systems. Alignment of HTA capacity building initiativeswith the WHO strategy on research for health will create synergies for promotingevidence-informed decision-making to improve health systems and population health.WHO Medical device technical series9

1 IntroductionHealth systems throughout the world,whether in developed or developingcountries, are struggling with the challengeof how to manage health-care delivery inconditions of resource constraint. Healthcarepolicy, practice and decisions areneeded to maximize the positive impactof health-care interventions on populationhealth, while maximizing the value fromthe cost of providing the interventions.This document explores how healthtechnology assessment can be adoptedand adapted in developing and emergingcountries in an attempt to foster healthequity.2 PurposeHealth technology assessment of medicaldevices provides a background to theconcept and programme of healthtechnology assessment (HTA) aroundthe world, and highlights the contributionthat HTA can make to informed policyanddecision-making, particularly fordeveloping and emerging countries. Itaims to describe strategic actions foradvancing HTA into developing andemerging countries, and to support informeddecision-making on the introductionof HTA into the health systems of thesecountries.This document was commissioned byWHO for the advancement of health technologyassessment in developing andemerging countries.3 ApproachThis document builds on the work of theWHO Department of Essential HealthTechnologies, the Global Initiative onHealth Technologies (GIHT), the GlobalNetwork of WHO Collaborating Centres forHealth Technology Assessment, HealthTechnology Assessment international(HTAi), the International Networkof Agencies for Health TechnologyAssessment (INAHTA), and otherscommitted to the use of high-qualityevidence to inform health-care policy anddecision-making. The authors have basedtheir work on a personal knowledge of theinternational literature on the conceptsand practice of health technologyassessment (HTA) as well as on theavailable literature and past experiencesof introducing HTA into developing andemerging countries. Consultations withkey groups and international experts inHTA have contributed to the text.10Health technology assessment of medical devices

4 Definition of health technology assessmentThe paradigm of HTA emerged as aresponse to decision-makers’ questionsabout the uncontrolled diffusion of costlymedical equipment. HTA began in theearly 1970s, when the rapid demandfor computer-assisted tomography (CTscans)became a public policy issue dueto the very high cost per unit, often inexcess of US$ 300 000 (3).In February 1975 the US SenateCommittee on Labor and Public Welfare(on behalf of its Subcommittee on Health)invited the recently established Officeof Technology Assessment to conducta study of the justifications requiredbefore the implementation of costly newmedical technologies and procedures.The concepts of health technologies andHTA have developed very broadly since.A health technology is “any interventionthat may be used to promote health, toprevent, diagnose or treat disease or forrehabilitation or long-term care” (4). It thusencompasses medical devices rangingfrom simple wooden tongue depressorsand assistive devices, to the mostsophisticated implants, medical imagingsystems, drugs, medical and surgicalprocedures, and the organizational andsupportive systems within which suchcare is provided.HTA is “the systematic evaluation ofproperties, effects, and/or impacts ofhealth-care technology. It may addressthe direct, intended consequences oftechnologies as well as their indirect,unintended consequences. Its mainpurpose is to inform technology-relatedpolicy-making in health care. HTA isconducted by interdisciplinary groupsusing explicit analytical frameworksdrawing from a variety of methods”(4).Depending on the issues involved, thetime frame of decision-making, and theavailability of resources, HTAs can takedifferent forms such as a full-scale HTAreport, contextualization of HTA reportsproduced elsewhere, rapid reviews,health technology information services orhorizon scanning reports. HTA is alwayspolicy-oriented, context-embedded andmethodologically sound (5).As outlined in a document from theOrganisation for Economic Co-operationand Development (6), countries cansuccessfully manage the opportunitiesand challenges arising from healthrelatedtechnology by optimizing decisionmakingprocesses, recognizing the valueof innovation, dealing with uncertainty,and producing and coordinating HTA.WHO Medical device technical series11

5 Methods in health technology assessmentAs stated in a policy brief by the EuropeanObservatory on Health Systems and Policies,“in order to give an evidence-basedsolution to the problems outlined in thepolicy question, the researchers undertakingthe assessment will need to specifythe policy question in terms of safety, efficacy,effectiveness, psychological, social,ethical, organizational, professional andeconomic aspects. These research questionsdetermine how the rest of the assessmentwill be conducted, the aspectsthat will be evaluated and those that willnot ... Formulating research questions is acrucial part of the assessment, since theytranspose the original decision-makingproblem, the policy question, into questionsthat can be answered by evaluatingscientific evidence”(5). Depending on thespecific context of the decision-making,the dimensions needed by the decisionmakermay vary. For example, hospitalbasedHTA tends to focus much moreon specific organizational dimensions,compared with HTA for decision-makingby a ministry of health.The Health technology assessmenthandbook by the Danish Centre forHealth Technology Assessment providesan excellent overview of most of themethods needed and used internationallyin HTA (7). It is important to note thatan economic analysis is often, but notalways, part of an HTA. The economicdimensions may include cost-benefitanalysis, cost-utility analysis, costeffectivenessanalysis, cost-minimizationanalysis, and also budget impactanalysis and other forms of economicassessments. As always in HTA, themethod must be appropriate for thedecision-making process to be informedby the HTA. Quality-adjusted life years(QALYs) and disability-adjusted life years(DALYs), as used in cost-utility analyses,are often seen as the hallmarks of HTA,but in many situations budget impactis much more important and useful fordecision-makers.Formal methods for using HTAs producedin one setting and putting them into thecontext of another setting are receivingincreasing attention. One example isthe HTA adaptation toolkit developed aspart of the European Network for HTA(EUnetHTA) collaboration (8).12Health technology assessment of medical devices

6 Links between health technology regulation,health technology management and healthtechnology assessmentHealth technology regulation (HTR),health technology assessment (HTA) andhealth technology management (HTM)are complementary functions to ensurethe appropriate introduction and use ofmedical devices.While the regulatory processes concernall medical devices and drugs to somedegree, HTA is usually reserved for complexproblems. Table 1 summarizes someof the differences and complementaryroles of health technology regulationand HTA.Table 1. Comparison of health technology regulationand health technology assessmentCharacteristicsPerspectiveHealthtechnologyregulationSafety andefficacyHealthtechnologyassessmentEfficacy,effectiveness andappropriatenessRequirement Mandatory Recommendationon complextechnologiesRole Prevent harm Maximizeclinical and costeffectivenessPractitioners from HTM and HTA have hadonly very limited interactions in the past.However, as requested in the World HealthAssembly resolution WHA60.29 on healthtechnologies, Member States are urged“to formulate as appropriate nationalstrategies and plans for the establishmentof systems for the assessment, planning,procurement and management of healthtechnologies in particular medicaldevices, in collaboration with personnelinvolved in health-technology assessmentand biomedical engineering”(9).It is useful to compare the dimensionsof HTM and HTA to gain an appreciationof their respective contribution to policydecisions that ensure the most appropriatediffusion of health-care technologies,such as medical devices. Table 2compares HTM and HTA along severalvery broad dimensions. Understandingand supporting the synergy between HTMand HTA will be a major factor for thesuccess of national health technologypolicies.Table 2. Comparison of health technologymanagement and health technology assessmentDimensionHealthtechnologymanagementHealthtechnologyassessmentPerspective Health facility SocietalOrientation Community served Population healthMethodCriteriaProjectmanagement,technology lifecycleNeeds analysis,alternatives,specificationsSystematic criticalreview, metaanalysisClinicaleffectiveness, costeffectiveness,appropriatenessOutcome Decision Policy/decision/practiceHTR, HTA and HTM are distinctactions for enabling the best use ofhealth technologies, especially medicaldevices, for better health care and betterpopulation health. Close links need tobe established between the three, butit is essential to keep these activitiesseparate. For example, in order to supportdecision-making for complex problems,HTA examines all significant intendedas well as unintended consequences ofWHO Medical device technical series13

technology use through multidisciplinaryanalysis, whereas the regulation processfocuses on safety and effectiveness.Therefore, the timing, procedures,objectives and resources needed aredifferent for each of them. Regardless, itis important that the outcome from eachis considered as part of decision-makingin national health technology policies.Very close links between regulation andHTA on a country level will lead to a verysuperficial use of HTA not conduciveto evidence-informed decision-making.Furthermore, as described on page 21,HTA cannot support innovation if it isamalgamated with regulation. HTR, HTA,clinical engineering and surveillance areall essential, but have specific roles in thislife-cycle of technologies (10). Figure 1illustrates the distinction of the regulatoryand management of health technologiesfor drugs and devices, and the position ofHTA being independent of both.The complementary function of HTRand HTA is related to a set of questionsthat must be answered for the coherentintroduction of technologies, especiallymedical devices, into health systems(Figure 2).Figure 1. Domains of health technology regulation, assessment and management for drugs and devicesHealth technologyregulationSafetyPerformance(devices)Efficacy (drugs)Health technologyassessmentClinical effectivenessEthicsSocial issuesOrganizationalHealth technologymanagementProcurementSelectionTrainingUseFigure 2. From performance to use in health care: layers of questionsHow should the technology beimplemented in this setting?Should the technology beimplemented in this setting?Can the technology workin this setting?ImplementationAppropriatenessEffectivenessEfficacyHealth technology assessmentCan the technology work?TechnicalperformanceRegulation14Health technology assessment of medical devices

7 Health technology assessment for evidenceinformedcontext-based decision-makingDifferent concepts and processes havebeen promoted to increase the contributionof science to decision-making.Over the last 20 years, the concept ofevidence-based and evidence-informeddecision-making has received ever increasingattention.The technical rigour of the evidence mustbe matched to the policy relevance asillustrated in Figure 3.Figure 3 underscores the importance ofthe need for those who create informationand knowledge to be accessible, reliableand effective in the communication anddissemination of the facts. On the otherhand, those who use the information anddata must demonstrate a commitmentto use the evidence and create policyframeworks that incentivize appropriatebehaviour and practice (11).Figure 3. Good quality evidence. Matching technical rigour to policy relevanceData providers(statisticians, evaluators,researchers)Data users(policy-makers)Need to improve dialogueHow?What?Why?WhenReliable andtrustworthyevidenceImproving‘usability’ ofevidenceEffectivedisseminationWide accessGettingappropriatebuy-inIncentive touse evidenceSource: (11)WHO Medical device technical series15

Figure 4. Framework for evidence-informed policy-makingWider enabling environmentNational contextEvidence-informed (national) policy-makingInfluencesOrganizations FunctionsOrganizationalcapacityResearchpriority-settingFundingbodiesLeadership andgovernanceKnowledgegeneration anddisseminationResearchinstitutionsMediaAdvocacyorganizationsResourcesEvidencefiltering andamplificationThink tanksPolicy messagesCommunicationand networksPolicy-makingprocessesGovernmentbodiesDecision and research culture, regulations and legislationExternal fundersExternal researchinstitutionsExternal advocacyorganizationsTechnical capacity forHealth Policy andSystems ResearchSource: (2)The WHO Alliance for Health Policy andSystems Research proposes a modelthat takes into account the multipleinteracting dimensions for enhancingcapacity for evidence-informed healthpolicy (Figure 4).As depicted in Figure 4, the nationalcontext plays an important role inpatterning the overall conditions forevidence-informed policy. For example,“the policy environment may vary froma closed and corrupted society to anopen, accountable and transparent one.Political and social systems influenceuse of evidence. Issues such as thetiming of evidence and availability ofresources; values, beliefs and ideologyaffect its use”(2). Many countries arelabelled as “vicious circle countries”where “evidence is weak and policymakersmake little use of it. Evidencebasedpolicy-making is not practiced,which results in poor policy decisionsand poor development outcomes. In thiscase, it is necessary to adopt measureswhich will simultaneously increase boththe demand and supply of evidence, aswell as improve the dialogue betweenproducers and users of evidence” (2).If a “knowledge pull” from decisionmakersis present, HTA has shown thepotential of informing decision-makingunder a great variety of conditions.Introducing HTA into a health systemcan change the decision-makingdynamics over time. For example, inThailand, HTA has developed from beinga provider of technical information tohaving a transforming role in decisionmakingwhere “experience gained amongacademics, health officials, and civilsociety organizations [was] helpful notonly in sustaining the momentum butalso in improving formal HTA systems inthe future” (12).16Health technology assessment of medical devices

8 Health technology assessment in healthsystems8.1 Decision-making andgovernanceThe policy-oriented nature of HTA callsfor a close integration into the functioningand governance of health systems.Strengthening the health systems ofthe global health community is one ofthe prime objectives of the CanadianSociety for International Health (CSIH).The health system model of the CSIHemphasizes the central role of evidencebaseddecision-making, both on the levelof service delivery/community interventionas well as for planning and policy-making.The CSIH framework is reproduced inFigure 5.The best practice of HTA draws upon anumber of elements of this model.• HTA contextualizes global knowledgeinto the different elements of thehealth system such as human andmaterial resources, as well as relevantdata from the health system setting.• HTA supports transparent decisionmaking,and therefore participationfrom all stakeholders including civilsociety.• Equity and needs-based HTA enablesdecisions to be linked to the overallvision of equity and accountability.Figure 5. Canadian Society for International Health (CSIH) framework for strengthening health systemsVision: equity and accountabilitySocial determinants of health frameworkHealth human resourcesStewardship and leadershipHealth financing andresource allocationResource for development(evidence-based planning and policy-making)Health information systemsdata for decision-makingEvidence-based decision-making(clinical and community-based)Service delivery –treatments and programmesCommunity interventionsand health promotion“Health in all policies”Strong and vibrant civil societyTransparent and accountable public/private sectorSource: (13©JHR/CSIH 2004WHO Medical device technical series17

Decision-making in health systems ispatterned by governance. For example,in health systems with hospital autonomy,an important part of new technologiesare introduced at the hospital level onthe basis of decision-making by hospitalauthorities. In such health systems, itcan be valuable for some form of HTAto be used not only at the national level,but also at the hospital level. The samereasoning applies to regionalized healthsystems. If HTA is to maximize populationhealth impact, it must take into accountthe governance structure of the specifichealth system.8.2 Institutionalized healthtechnology assessmentHTA agencies have emerged in responseto the need for a formal organizationto structure and undertake reviews ofthe safety, efficacy and effectiveness ofhealth technologies. The agencies areoften established with a mission, andprovided with financial and human resourcesto undertake systematic assessmentsof public policy questions witha defined set of objectives. Most HTAactivity in high-income countries is linkedto such agencies – most being membersof the International Network of Agenciesin Health Technology Assessment(INAHTA). This non-profit organizationhas grown to 46 member agencies from26 countries including Australia, NewZealand, and countries in North and LatinAmerica, and Europe. All members arenon-profit organizations producing HTAs,and are linked to regional or nationalgovernments. HTA agencies are, however,not limited to non-profit organizations;there are also HTA agencies that operatein the for-profit sectors.Over the last few years, other modelsof institutionalized HTA have emerged,such as hospital-based HTA (14) or HTAin regional health authorities. These morelocalized forms of HTA are following theprinciple of a close linkage of HTA to thelevels of decision-making as patternedby the governance mechanisms of thehealth system.One of the authors of this documenthas developed a framework for thedevelopment and introduction of HTAto inform practice and governancedecisions in local health authorities (15).In addition to a framework, the authorhas developed a screening procedurefor determining which technologies areworthy of consideration for a HTA (16).HTA institutions are often linked touniversities. For instance, in Canada,the Newfoundland and Labrador Centrefor Applied Health Research is linked tothe Memorial University of Newfoundlandand is an innovative example of explicitlycontextualizing existing researchsynthesis from HTA or other sources. As adirect result of the ever increasing role ofHTA in health decision-making, industryalso harbours an increasing number ofHTA-related activities.8.3 Health technologyassessment and innovationThe processes of HTA and innovation areintertwined. HTA started as a responseto the technological breakthrough ofcomputer-assisted tomography (CTscans)in the early 1970s. HTA is still verymuch used to inform the decision-makingprocess concerning the introduction ofnew technologies to a health system.Figure 6 captures the natural life-cycleof technologies in health care.HTA is aimed at improving the uptakeof cost-effective new technologies,preventing the uptake of technologiesthat are of doubtful value for the health18Health technology assessment of medical devices

Figure 6. Health technology assessment and diffusion of health technologiesUseHTAMedical devicelicensingHTAHTATimeResearch anddevelopmentExperimentaltechnologyInnovativetechnologyGeneral useObsolescence/replacementsystem, and slowing the uptake oftechnologies that seem promising buthave persistent uncertainties.For some, especially industry, HTA isperceived as a hurdle to the introductionof innovative technologies into thehealth system. In this perspective, HTAis sometimes classified as the “fourthhurdle”, after the assessment of safety,efficacy and quality that are part ofthe regulatory requirements in manycountries (17). This view of HTA as anadditional hurdle is sometimes used asa synonym for an additional requirementof demonstrating cost-effectivenessfor coverage decisions (18). The term“fourth hurdle” is most commonly usedin relation to the coverage of new drugs,where it becomes increasingly evidentthat not only cost-effectiveness, but alsobudget impact is an important dimensionin decision-making (19). However, it isbecoming increasingly clear that HTA canbe a highly beneficial additional step formoving technologies from the laboratoryto the bedside (20).There is general concern among medicaldevice manufacturers about the timingof HTAs in relation to the innovationprocess. The 2008 Eucomed positionpaper on HTA states that:Policy makers should considerthe implications of HTA on theenvironment needed to fosterinnovation of medical devices. IfHTA introduces significant newchallenges to market entry then thereis a potential that this may impact onthe rate of innovation in the devicesector which already faces a numberof challenges. Intellectual propertyassociated with medical devicesis less well protected than patentson new medical compounds. Inaddition to this, medical devicedevelopment is characterized byiterative improvement of technologiesresulting in a more rapid life-cycleand increased competition (21).Indeed, industry is one of the maincontributors to innovation in healthtechnology. However, the innovationprocess goes beyond the developmentof a new device for regulatory approval.Innovation comprises both invention andexploitation, meaning an invention onlyWHO Medical device technical series19

ecomes an innovation if it is somehowadapted by the market and integrated intoa technology, process or organizationallandscape. Any innovation comprisesthree dimensions.1. Kind of innovation: What is new?Product, process, input, organizational,social.2. Subjectivity of innovation: New forwhom? Individual, group, organization,industry, society.3. Degree of innovation: How new?Market, technology, organization,environment.The Global Forum for Health Researchproposes this very short working definitionof innovation: “Innovation encompassesthe entire process from the generationof new ideas to the transformationof those ideas into useful things(health services, products, methods,management practices and policies) totheir implementation” (22). In accordancewith this concept of innovation, HTA playsa major role in innovation by shaping theconditions of successful implementationin health systems.Overall, the use of HTA to inform nationalcoverage policies leads to a more explicitand transparent resource-allocationprocess, improving not only technical orallocative efficiency, but also health equity.A case study of Argentina illustratesthe importance of HTA for transparentresource allocation in countries withfragmented health systems (23). Acontext-oriented concept of innovationmay also explain the increasing useof HTA in different levels of decisionmakingwithin health systems, includinghospitals. In order to support innovation,HTA must support decision-making notonly on what to implement, but also onhow to implement a new technology.It is valuable for any discussion ofinnovation to take into account theoverall objective of the use of healthtechnologies for a population. In a casestudy of the Israeli health system, theinvestigators state, “Innovation playsa key role in medical progress, andcontributes significantly to public health.Reimbursement provides a significantincentive for innovation, with the twoforming a feedback cycle. Nevertheless,it should be kept in mind that it is healththat people desire, and health technologyutilization is merely the means to achieveit” (24).8.4 Health technologyassessment as part of goodhealth governanceIn their 2008 book Access: how dogood health technologies get to poorpeople in poor countries? Laura Frostand Michael Reich from the HarvardCentre for Population and DevelopmentStudies illustrate a number of barriersto an equitable access to beneficialhealth technologies. Their case studies“highlight the importance of expertconsensus, both within the directlyinvolved international technical agenciesand the broader international publichealth community” (25). The vision ofHTA as an interdisciplinary, contextinformedapproach for evidence-basedconsensus building should be promoted.This will help build a stronger communityof practice and discourse between theproducers of HTA and the policy anddecision-makers who use the information.This sets the stage for the need for goodgovernance and leadership.Arminee Kazanjian and Carolyn Green,from the University of British Columbia,Canada, pointed out that healthtechnology assessment is a necessarypart of the public accountabilityframework in a health system (26). TheWorld Bank recently released a reportstating that “good governance as an entrypoint can help to focus on performance in20Health technology assessment of medical devices

health care delivery, and in turn, providepolicymakers and program managerswith a basis upon which to raiseperformance” (27). The report goes onto describe the importance of standards,incentives, information and accountabilityto ensure strong system governance andperformance (27). HTA is a standardsbasedpractice built on the foundationof the highest quality evidence and canbe held up to and be accountable for itsclaims. HTA is an essential ingredientin any health system that is seeking apolicy approach that is accountable for itsdecisions to the population of the country.WHO’s Good Governance for Medicinesprogramme has identified that theft,extortion and abuse contribute to a hugeloss of value in health services worldwide.Corruption has been identified as thesingle greatest obstacle to economic andsocial development. The programmeis raising awareness of abuse in thepharmaceutical sector and promotinggood governance. Its ultimate aim is toensure that essential medicines reachpeople – not the black market. Buildingon the momentum of WHO’s GoodGovernance for Medicines programme,HTA can become an effective processand tool for helping prevent such abuses.HTA takes a practical approach, free ofbias, to objectively identifying the clinicalor economic effectiveness of a healthtechnology (28).WHO Medical device technical series21

9 International collaboration in healthtechnology assessmentThere are several international agenciessupporting the advancement of HTA onthe global stage. The following sectionreviews each of these agencies in turn toprovide an appreciation of their mission,goals and activities.9.1 Health TechnologyAssessment international(HTAi)HTAi is the global scientific and professionalsociety for all those who produce, use,or encounter HTA. HTAi embraces allstakeholders, including researchers,agencies, policy-makers, industry,academia, health service providers, andpatients/consumers, and acts as a neutralforum for collaboration and the sharing ofinformation and expertise. HTAi has over1200 members from 59 countries.The mission of HTAi is to support andpromote the development, communication,understanding and use of HTAaround the world, as a scientifically-basedand multidisciplinary means of informingdecision-making regarding the introductionof effective innovations and theefficient use of resources in health care.HTAi serves as a hub for a range ofcollaborative work. Its major activitiesinclude:• annual international meetings, whichserve as a major gathering pointfor global networking, informationsharing, and dissemination of latestadvances in policy, methods, andother areas of HTA research;• the HTAi Policy Forum, whichprovides a venue for open discussionbetween global leaders from HTAbodies and industry in areas ofshared strategic interest;• in a number of interest sub-groups(ISGs), acting as international networksfor information exchange inspecific focus areas;• active collaborations with WHO andrelated international societies;• maintenance of a web site (www.htai.org) to share information andresources and to act as an onlinework platform for ISGs and othercollaborations;• publication of regular onlineresources, including a newsletter andwebcasts;• publication of the InternationalJournal of Technology Assessment inHealth Care, HTAi’s official academicjournal.Through its ISG on HTA in developingcountries, and through collaborationwith INAHTA, HTAi has made a clearcommitment to explore and promotestrategies and tools to advance accessto, and application of, HTA in developingcountries. In 2005, the HTAi specialinterest group (SIG) of experts in HTAproduced a report with INAHTA, whichwas presented to WHO as an expressionof support. In the report, the authorsstate:One of the most importantchallenges to improving the qualityof health systems worldwide is theneed to establish mechanisms fortransferring knowledge to action,(i.e. for bridging the “know-do”gap). Such mechanisms require22Health technology assessment of medical devices

the involvement of many differentconstituencies, all of whom arecommitted to achieving evidencebasedhealth policy and practice.The HTA community, with itsagencies, associations, andresearchers, has developed its rolearound contributing to this effort (29).This statement of commitment has beenoffered to WHO and other agencieswishing to extend HTA into theirjurisdictions. The authors of the reportalso recognized the need for respectinglocal contextual settings and advancingthe field of HTA at a pace that is mostappropriate for the recipient country,stating:HTA aims to “globalize the evidence,localize the decision”, and, therefore,involves 2 steps. The first comprisesa systematic synthesis of the globalevidence base (i.e. systematicreviews). The second involves anappraisal of this evidence withina local or jurisdictional context,engaging local experts and decisionmakerswho play important roles inthe dissemination and utilization ofthe intervention. It may also includean examination of the intervention’spotential impact on the higherpopulation and policy levels (29).The authors provided a graphicalrepresentation of how HTA can be usedto inform different levels of practice,policy and decisions (Figure 7), whichshows how the chain of evidence can beoperationalized along an iterative loop ofcontinual learning.9.2 International Networkof Agencies in HealthTechnology Assessment(INAHTA)The International Network of Agencies inHealth Technology Assessment (INAH-TA), established in 1993, is a non-profitorganization that in 2010 had grown to52 member agencies from 26 countries.Figure 7. Knowledge chains and learning loops: health technology assessment as a toolPolicyinterventionsResearchSynthesisAppraisalDisseminationUtilizationEvaluationPopulationinterventions(public health)ResearchSynthesisAppraisalDisseminationUtilizationEvaluationIndividualinterventions(clinical practice)ResearchSynthesisAppraisalDisseminationUtilizationEvaluationTechnologies(drugs, devices, etc.)ResearchSynthesisAppraisalDisseminationUtilizationEvaluation(Primary)researchinnovationSynthesis/assessment(global)Impact andapplicabilityappraisal(local)Dissemination Utilization EvaluationmonitoringSource: (29)WHO Medical device technical series23

All members are non-profit making organizationsproducing HTAs, and are linkedto regional or national governments. MostINAHTA activities are coordinated by asecretariat. The membership meets yearlyand participates in various workinggroups throughout the year. The annualmeeting is held in conjunction with theHTAi conference. The Executive Committeeand Board are elected for two-yearterms.INAHTA’s key communication forum isthe Internet. The INAHTA web site atwww.inahta.org includes informationabout ongoing activities and HTA reports.INAHTA Briefs are published regularly onthe site, and are intended as a forum formember agencies to present overviewsof recently published reports. Also onthe web site are HTA checklists, whichare an aid to furthering a consistent andtransparent approach to HTA.The web site also has information on jointprojects that involve member agencies incollaborative efforts to evaluate medicaltechnologies of mutual interest. As anexample, the INAHTA report on positronemission tomography (PET) was updatedand published in the International Journalof Technology Assessment in HealthCare in 2006 (30, 31). A synthesis reportwas published in 2000 and contains asummary and analysis of five reports onpreoperative evaluation from INAHTAagencies (32). A members-only sectionof the site provides a platform for ongoingwork of the membership.INAHTA also produces a newsletter,which includes news on current initiativesand activities among member agencies,new projects within the Network, recentdevelopments and trends in healthpolicy research, publications in the field,and upcoming events. Other means ofdissemination include participation ininternational conferences, workshops,exhibitions, and educational activities andseminars.9.3 WHO collaborating centresand their global networkWHO collaborating centres areinstitutions such as units in ministries ofhealth, research institutes, universitiesor academies, which are designatedby the WHO Director-General to carryout activities in support of WHO’sprogrammes. In 2010, there were over800 WHO collaborating centres in 90Member States working with WHO onareas such as nursing, occupationalhealth, communicable diseases, nutrition,mental health, chronic diseases andhealth technologies.In 2009, the Global Network of WHOCollaborating Centres for HTA waslaunched during the HTAi annual meetingin Singapore. This is a network of WHOcollaborating centres involved in researchand implementation of HTA worldwide.The aim of the network is to connect thevarious collaborating centres across theworld involved directly or indirectly inHTA to promote international dialogueand collaboration and to strengthenexisting projects. This networking willlead to increased capacity for using HTAas a key tool in decision-making andpolicy-making processes, especially indeveloping and emerging countries.The network holds annual meetings ofmembers in conjunction with the HTAiannual meetings. It also facilitatescommunication between its membersvia its web site hosted by the Universityof Ottawa (http://www.cgh.uottawa.ca/htanet/) and newsletters. In addition,it actively seeks opportunities forcollaboration between its members viaprojects and internships.24Health technology assessment of medical devices

There are currently 14 WHO collaboratingcentres with full membership to thenetwork whose work is either directly orindirectly linked to HTA.• National Center for Health TechnologyExcellence (CENETEC), Ministry ofHealth – WHO Collaborating Centrein Health Technology in Mexico.• Fudan University Shanghai – WHOCollaborating Centre for Health TechnologyAssessment and Managementin China.• Catalan Agency for Health TechnologyAssessment and Research (CAHTA)– WHO Collaborating Centre forHealth Technology Assessment inSpain.• Swedish Council on TechnologyAssessment in Health Care (SBU) –WHO Collaborating Centre for HealthTechnology Assessment in Sweden.• Fundação Oswaldo Cruz InstitutoOswaldo Cruz (FIOCRUZ) – WHOCollaborating Centre for Education ofHealth Technicians in Brazil.• Institute of Population Health – WHOCollaborating Centre for KnowledgeTranslation and Health TechnologyAssessment in Health Equity inCanada.• WHO Collaborating Centre for OralHealth Research in Ireland.• WHO Collaborating Centre for MentalHealth Research and Training inEgypt.• Emergency Care Research Institute –WHO Collaborating Centre for PatientSafety, Risk Management and HealthCare Technology in the United Statesof America.• College of Nursing at Ribeirao PretoUniversity of São Paulo – WHOCollaborating Centre for NursingResearch Development in Brazil.• DHI Water and Environment andHealth – WHO Collaborating Centrefor Water and Health in Denmark.• Norwegian Centre for Telemedicine(NST), University Hospital of NorthNorway – WHO Collaborating Centrefor Telemedicine in Norway.• Curtin University of Technology –WHO Collaborating Centre for EnvironmentalHealth Impact Assessmentin Australia.• CES University – WHO CollaboratingCentre for Health Technology inColombia.The network also aims to work in synergywith other existing HTA networks,including HTAi and INAHTA, in orderto galvanize the international HTAcommunity as a whole.9.4 European network for HealthTechnology Assessment(EUnetHTA)EUnetHTA is a European collaborationlaunched in November 2008 with 25founding partners from 15 Europeancountries. Focusing on HTA collaborationin Europe, EUnetHTA:• facilitates efficient use of resourcesavailable for HTA;• creates sustainable systems of HTAknowledge sharing;• promotes good practices in HTAmethods and processes.In addition, EUnetHTA implementsproject tools and processes, exploresrelative effectiveness principles andmethodology, and develops transparentand broad balanced engagement withidentified HTA stakeholder groups. In2009, the EUnetHTA collaboration joinedforces with European Union MemberStates and the European Commission toimplement the results of the EUnetHTAproject through a Joint Action on HTA2010–2012 (33).WHO Medical device technical series25

10 Challenges for using health technologyassessment in developing and emergingcountriesThe institutional dimensions are essentialfor enhancing the use of knowledge bydecision-makers. A multi-method casestudy by Lavis et al. examined theseinstitutional dimensions of evidenceinformedhealth policy in developingcountries. The authors point out:Seven recommendations emergedfor those involved in establishingor leading organizations thatsupport the use of researchevidence in developing healthpolicy: 1) collaborate with otherorganizations; 2) establish stronglinks with policymakers and involvestakeholders in the work; 3) beindependent and manage conflictsof interest among those involved inthe work; 4) build capacity amongthose working in the organization;5) use good methods and betransparent in the work; 6) startsmall, have a clear audience andscope, and address importantquestions; and 7) be attentive toimplementation considerations, evenif implementation is not a remit (34).The Health Technology Assessmentinternational interest sub-group (HTAiISG) on the use of HTA in developingcountries highlighted in their 2005 paperthe special challenges of advancing HTAfor policy, decision-making and practicein developing countries (29). The authorsof the paper state:Whether within or among countries,HTA should be context-specific.Although it originated in and hasbeen used mostly in the wealthiernations, HTA is increasingly usedin low- and high-resource nationsto provide findings to inform healthcarepolicies and decisions. Further,there is increasing internationalsharing of HTA expertise,information, methods, and findings.It is also an aim among HTA agenciesand scientists in the developedcountries to assist low-incomecountries by “adopting” future localHTA activities and helping to buildup local expertise (29).For many health-care interventions,the medical evidence on safety andefficacy is applicable across populationsin different communities or countries.Indeed, evidence used in HTA can berapidly and easily shared around muchof the world. However, the desirable oracceptable levels of safety, effectiveness,cost-effectiveness, and other attributesof a technology, as well as acceptabletrade-offs among these, may vary indifferent communities, countries, or othercircumstances. As such, in HTA, it can beuseful to “globalize the evidence, localizethe decision” (35).In a presentation at the 2009 HTAiconference in Singapore, entitledNational planning and regulation underpressure, Akiko Maeda from the WorldBank presented the following conclusionsconcerning the challenges for applyingHTA in developing countries.• HTA offers critical information ontechnology solutions but to date,most HTA applications have been26Health technology assessment of medical devices

developed for high-income countrieswith relatively well-establishedplanning and regulatory systems inplace.• To be useful for developing countries,there is a need to:››find ways to lower the cost ofestablishing and maintaining HTAfunctions and capacities;››better link HTA with governanceand organizational reforms indeveloping countries to generateappropriate demand (36).At the opening ceremony of the HTAi2009 meeting, the Minister of Health ofSingapore, Khaw Boon Wan, stressed theimportance for developing countries toadapt global knowledge to local contexts.He urged participants to “not re-inventthe wheel’ and reaffirmed that:Asians welcome such objective,authoritative assessments ofhealth technology. Many do nothave as many resources for suchresearch, but this is where theglobal collaborative approach canbenefit us. We can adapt yourtechnology assessments for our localcontext. And some Asian countriesin a position to do so, should alsocontribute to this body of knowledge.I hope that this conference will be auseful forum for mutual learning indeveloping and enhancing decisionmakingsystems which integrateevidence from HTA, and that aresensitive to local factors (37).The HTAi ISG on HTA in developingcountries was aware of the sensitivityand different challenges of advancingthe application of HTA in developingcountries. The authors of the paperrecognized this challenge by observingthat:Certainly, implementing healthinterventions in developing countriesthat have been proven in wealthiernations has been difficult and oftendisappointing. In the completion ofHTA and the transfer of findings fromone country to another, there can besubstantial differences in:• epidemiological environments (e.g.relative prevalence of communicablevs. noncommunicabledisease; acute vs. chronic disease);• physical environments;• financial resources;• health-care financing anddistribution mechanisms;• cultural acceptance of healthcareinterventions;• values for personal choice,efficiency, and equity;• technology maintenancecapacity;• civil and health-care infrastructure;• skilled human resources;• training and education;• regulatory environment;• health professional standards;profitability of health-caremarkets (e.g. for technologycompanies) (29).HTAi has made an explicit commitmentto collaborate on advancing HTA aroundthe globe. In the paper from the HTAiISG on developing countries, the authorsstate, “Partnership – HTAi welcomes theopportunity to work in partnership withother agencies to develop resources forpromot(ing) the use of HTA around theworld” (29). The challenge is now for theglobal community to work with HTAi toadvance scientific evidence to informhealth practice, and to facilitate policyanddecision-making for the benefitof people in developing and emergingcountries.WHO Medical device technical series27

The Global Network of WHO CollaboratingCentres for HTA also recognizes many ofthese challenges and has come forwardwith approaches and next steps toaddress them. In addition, some WHOcollaborating centres have developedtoolkits that will assist in capacity buildingto incorporate HTA into decision-makingand allocate resources within local healthsystems. One such example is the Equityorientedtoolkit for HTA (38) developedby the WHO Collaborating Centre forKnowledge Translation and HTA in HealthEquity, which assesses existing HTA toolsby their capability to detect differencesin impact by taking into considerationvulnerable populations.28Health technology assessment of medical devices

11 Strategies for developing healthtechnology assessment11.1 Adapting the strategy to thespecific contextHealth technology assessment can beused and introduced in countries basedon their capability, capacity and need.Any country can access HTA knowledgethrough the international HTA database(39), but networking is essential forfinding ongoing HTA research. Thebiggest challenge however is not tofind information, but rather to developthe capacity to use HTA information.Institutional capacity for assessing theneed for HTA, finding the information,analysing this information in relationto the specific context, and supportingdecision-makers to use the informationwill be described in this section.The appropriate use of health technologyassessment in a country matched againstits resource capacity can be thought ofas being located along a continuum ofdevelopment:i. researchers, scientists and policymakersbecome familiar with theinternational scientific literature;ii. researchers, scientists and policymakersbecome familiar with theappraisal, interpretation and potentialapplication(s) of scientific literature inthe local settings;iii. a critical mass of professionals isdeveloped so that the country hasthe capacity and capability to createnew knowledge in HTA;iv. formalized mechanisms areestablished for linking the creationof knowledge to decision-makingprocesses, eventually leading toformal organizations.The foundation for advancing healthtechnology assessment to developingcountries can be signalled with the 1990report of the Commission on HealthResearch for Development, entitledHealth research: essential link to equity indevelopment (40). The report states, “Forthe health field, international functionscan be better achieved by strengtheningnational institutions within developingcountries to play both national andinternational roles, buttressed by regionaland international networking, rather thanby creating new autonomous internationalhealth research centres”(40). Whendeveloping HTA in a specific country orregion it is important to identify existingreputable and autonomous nationalresearch organizations in the country todevelop the HTA capacity.Health research systems should beconsidered as part of the country’shealth system and take into account thelarge variety of stakeholders within thecountry’s national context. A commentaryby the Council on Health Research forDevelopment (COHRED) reflects thissentiment in their statement:Furthermore, by defining a healthresearch system as “the people,institutions and activities whose aimis to generate detailed and reliableknowledge”, its boundaries arerestricted to research producers.This retrogressive definition iscontrary to the broad thrust forinclusiveness that has characterizedthe movement for health researchfor development during the lasttwo decades: by moving towardsa demand-driven model of healthresearch, decision-makers, users ofWHO Medical device technical series29

esearch, civil society and mediatorshave been acknowledged as equallyimportant actors (41).The most current and importantcontribution to the advancement ofhealth research on the internationalstage is the WHO strategy on researchfor health, which was approved by theWorld Health Assembly in May 2010.The strategy focuses on the managementand organization of research activitieswithin WHO and on support provided tocountries in organizing health researchwhen required (42). Since this is such animportant piece of work it is being usedto inform the structure and approach fordeveloping country HTA capacity.11.2 Priority setting for healthtechnology assessmentMaking choices of resource allocationin health care is a complex andcontested matter. Approaches usingcost-effectiveness, QALYs, programmebudgeting marginal analysis, anddeliberative discourse are recommended.The optimal approach for priority settingin health care however is far from clear,as each technique has its own strengthsand weaknesses. A deliberative approachusing summaries of costs and benefits ofoptions as a basis for discussion may bepreferable as it is inclusive of a wide arrayof participants.A balance sheet approach has beenshown to be very promising in study ofa low-income setting. The authors of thepaper Combining evidence and valuesin priority setting: testing the balancesheet method in a low-income country(43) concluded that evidence-based anddeliberative decision-making does changepriorities significantly in an experimentalsetting. Their use of the balance sheetmethod was meant as a demonstrationproject but could, if properly developed,be feasible for health planners, expertsand health workers; although morework is needed before it can be used bylaypersons (43, 44).11.3 A strategy of healthtechnology assessment focalpointsHTA could be introduced gradually byidentifying individuals with a capacityfor accessing and understanding HTAsand making these individuals the “focalpoints” of HTA and scientific evidence ofeffectiveness of health-care interventions.Focal points could be located in anational research organization, a nationalgovernment department, a university orother non-profit agencies concernedwith advancing the use of HTA for goodgovernance in policy- and decisionmaking.These individuals – hereafterreferred to as “HTA focal points” –would serve as knowledge mobilizers orambassadors of the relevant informationthat they would bring to the attention ofpolicy- or decision-makers.The basic role of the HTA focal pointwould be to develop awareness of healthtechnology assessment and increasethe uptake and use of HTA within adesignated country by:• developing and supporting a networkof HTA stakeholders within thecountry that find HTA useful in thepolicy- and decision-making;• facilitating the flow of HTAinformation from the internationalHTA community to the country;• acting as the primary contact inthe country for HTA resources andinformation;• organizing or facilitating meetings,providing presentations andconducting workshops to helppotential users of HTA to interpretand disseminate HTA information;30Health technology assessment of medical devices

• identifying and articulating the HTAneeds and priorities of key audiences;• facilitating interaction betweenHTA producers and HTA users todevelop an ongoing relationship,and maintaining linkages to theinternational HTA community.The HTA focal point can also takehealth technology assessments from theinternational literature and customizethem for appropriate utilization in theircommunities. They would work withthe data and information in the HTAsand with the country-specific data andinformation, and then merge the two sothat they provide a credible source ofinformation to inform the policy question.Another strategy would be to introduceand develop HTA capacity within an existingorganization, such as a university orgovernment, or to establish an independentagency with the capacity to undertakehealth technology assessments. The elementsthat contribute to an independenthigh functioning HTA agency have beenidentified and described elsewhere in theliterature (45).11.4 Building on synergisticlinkagesOn page 24, synergies were identifiedbetween and among HTAi and INAHTAinitiatives in advancing the internationalcommunity’s advancement of HTA. Thesewill be important partners and linkagesavailable to WHO at all levels as wellas the national research organizations,which function in support of the countryhealth systems.The WHO strategy on research for health(42) focuses on the management andorganization of research activities withinWHO and on support provided to countriesin organizing health research whenrequired. A fundamental componentof the strategy is that WHO becomesmore familiar with using evidencebaseddecision-making methods suchas health technology assessment, at itsheadquarters, and in its regional andcountry offices. This demonstrates asubstantive committment to HTA andevidence-based policy-making, andincreases the likelihood of HTA gainingtraction in the lower-income countries.The commitment of WHO to healthresearch and to HTA will support capacitybuilding in health research and healthtechnology assessment, and strengthenthe advocacy for these fields. It willalso provide an improved platform forcommunicating its involvement in thecommitment to health research andhealth technology assessment.For the HTA projects to be successfuland for the WHO infrastructure to beappropriately aligned and supportive,four ingredients are necessary.Figure 9 illustrates the importance ofthese ingredients – good governance,funding, adequate staffing and goodcollaboration with partners – for asuccessful implementation of HTAprojects at the country level.Disseminating knowledge and skills inHTA should be based on a progressivestrategy, starting with raising awarenessby attending workshops to becomefamiliar with the concept, methods andresults of HTA, and participating in HTAand policy networks. As experience andunderstanding is gained, the next stepwill be toward improving individuals’capability in accessing, assessing,applying and contextualizing the HTA forthe country setting. The next stage wouldbe an attempt to build self-sufficiencyin the knowledge and skills by capacitybuilding with individuals in the countrythrough mentorships, distance education,in situ graduate study or post-doctoralwork. Implementation involves gainingWHO Medical device technical series31

Figure 8. Building health technology assessment awareness and capacity in WHO and in countriesEvidence-informedpolicy-makingWHOregionalofficeWHOcountryofficeCountryexploringHTA as apolicy toolWHOheadquartersFigure 9. Ingredients for successful implementation of health technology assessment projectsGoodgovernanceFundingSuccessfulHTA projectsGoodcollaborationand partnersAdequatestaffing32Health technology assessment of medical devices

the experience, knowledge and skillsthat would permit countries to beginconsidering the introduction of agenciesto undertake HTAs to solve local healthcareissues. Significant experiencehas been gained by INAHTA memberagencies on mentoring individuals fromdeveloping countries who are interestedin learning HTA. One study demonstratedthat success in implementing an HTApresence in a country setting depends onfactors such as local political, economic,and educational support (46).Health technology assessment works inconcert with, and relies on, many scientificdisciplines to advance its work– epidemiology, biomedical sciences, behaviouralsciences, clinical effectivenessstudies, health economics, implementationscience, health impact analysis andevaluation are a few of many. The multidisciplinaryand interdisciplinary natureof HTA is what gives it its strength in beinga valuable tool to inform health-caredecisions and policy about what worksand what does not. This character andstrength is commensurate with the call toaction that the WHO research for healthstrategy has articulated (42). Figure 10shows how health research spans fivegeneric areas of activity, all of which aresupported by HTA.The WHO research strategy (42) has fiveinterrelated goals.1. Organization – strengthening theresearch culture across WHO.2. Priorities – reinforcing research asessential (at national, regional andglobal levels, and within WHO) inresponse to priority health needs.Figure 10. WHO call to action on health research: the five generic areas of activityImplement ordeliver solutionsthrough policiesand programmesEvaluate impacton level anddistribution of theproblemWHOresearchfor healthstrategyUnderstandcauses-biological,behavioral, social,environmentalSource: (42)Solutions forinterventions toprevent or mitigatethe problemMeasure themagnitude anddistribution of thehealth problemWHO Medical device technical series33

3. Capacity – providing support to thestrengthening of national systems forhealth research.4. Standards – promoting good practicein research, drawing on WHO’score function of setting norms andstandards.5. Translation – strengthening the linksbetween the policy, practice andproducts of research.Figure 11 illustrates the relationshipbetween the five goals of the researchfor health strategy and how they convergewith HTA to support WHO’s objectives inhealth research.The actions identified in the WHO researchfor health strategy are commensurate andsupported by the approach of HTA toinform practice, policy and decisions.HTA can help to achieve the goals andobjectives of WHO’s research for healthstrategy through specific initiativesestablished within the country projects.Regional WHO-supported networkssupporting evidence-informed decisionmaking,such as the Evidence-InformedPolicy Network (EVIPN: http://www.who.int/rpc/evipnet/) should be linked to HTAprojects.Figure 11. Convergence of the goals of WHO’s research for health strategy and the goals of health technologyassessmentSource: adapted from (42)34Health technology assessment of medical devices

12 Concluding remarksOver the last decades, HTA has emerged asa powerful paradigm for institutionalizingevidence-based and evidence-informeddecision-making for health policies.Appropriate HTA strategies enabledeveloping and emerging countries tocontextualize global knowledge, supporttransparent and accountable decisionmaking,and promote health equity.Linking knowledge with action is one ofthe greatest challenges of the global healthsystem. This linkage is often achievedthrough innovations, which commonlystart with basic research that is translatedinto new health technologies. Thesetechnologies must be delivered to thosein need of them (47). HTA is an importanttool for supporting these core functionsof an effective global health system.Actions by WHO and other global healthorganizations are needed to support theeffective development of HTA.WHO Medical device technical series35

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