title: Health technology assessment of medical devices: a survey of non-European union agencies.
abstract: OBJECTIVE
  The aim of this study was to review and compare current health technology assessment (HTA) activities for medical devices across non-European Union HTA agencies.
  
  
  METHODS
  HTA activities for medical devices were evaluated from three perspectives: organizational structure, processes, and methods. Agencies were primarily selected upon membership of existing HTA networks. The data collection was performed in two stages: stage 1-agency Web-site assessment using a standardized questionnaire, followed by review and validation of the collected data by a representative of the agency; and stage 2-semi-structured telephone interviews with key informants of a sub-sample of agencies.
  
  
  RESULTS
  In total, thirty-six HTA agencies across twenty non-EU countries assessing medical devices were included. Twenty-seven of thirty-six (75 percent) agencies were judged at stage 1 to have adopted HTA-specific approaches for medical devices (MD-specific agencies) that were largely organizational or procedural. There appeared to be few differences in the organization, process and methods between MD-specific and non-MD-specific agencies. Although the majority (69 percent) of both categories of agency had specific methods guidance or policy for evidence submission, only one MD-specific agency had developed methodological guidelines specific to medical devices. In stage 2, many MD-specific agencies cited insufficient resources (budget, skilled employees), lack of coordination (between regulator and reimbursement bodies), and the inability to generalize findings from evidence synthesis to be key challenges in the HTA of medical devices.
  
  
  CONCLUSIONS
  The lack of evidence for differentiation in scientific methods for HTA of devices raises the question of whether HTA needs to develop new methods for medical devices but rather adapt existing methodological approaches. In contrast, organizational and/or procedural adaptation of existing HTA agency frameworks to accommodate medical devices appear relatively commonplace.
authors.affiliation: Evidence Synthesis & Modelling for Health Improvement,Institute of Health Research,University of Exeter Medical School;Centre for Research on Health and Social Care Management (CERGAS),Bocconi Universityo.ciani@exeter.ac.uk.
authors.forename: Oriana
authors.initials: O
authors.lastname: Ciani
authors.affiliation: Institute of Health Research,University of Exeter Medical School.
authors.forename: Britni
authors.initials: B
authors.lastname: Wilcher
authors.affiliation: Hamburg Center for Health Economics,University of Hamburg.
authors.forename: Carl Rudolf
authors.initials: CR
authors.lastname: Blankart
authors.affiliation: Hamburg Center for Health Economics,University of Hamburg.
authors.forename: Maximilian
authors.initials: M
authors.lastname: Hatz
authors.affiliation: Institute for Economic Research (IER).
authors.forename: Valentina Prevolnik
authors.initials: VP
authors.lastname: Rupel
authors.affiliation: Institute for Economic Research (IER).
authors.forename: Renata Slabe
authors.initials: RS
authors.lastname: Erker
authors.affiliation: Hamburg Center for Health Economics,University of Hamburg.
authors.forename: Yauheniya
authors.initials: Y
authors.lastname: Varabyova
authors.affiliation: Evidence Synthesis & Modelling for Health Improvement,Institute of Health Research,University of Exeter Medical School.
authors.forename: Rod S
authors.initials: RS
authors.lastname: Taylor
mesh_terms: D003657:Decision Making; D004864:Equipment and Supplies; D006291:Health Policy; D006801:Humans; D013673:Technology Assessment, Biomedical / Q000191:economics / Q000379:methods* / Q000458:organization & administration*
keywords: Health technology assessment; Medical devices; Reimbursement