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HTA of medical devices: Challenges and ideas for the future from a European perspective

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  • Fuchs, Sabine
  • Olberg, Britta
  • Panteli, Dimitra
  • Perleth, Matthias
  • Busse, Reinhard

Abstract

Health Technology Assessment (HTA) of Medical devices (MDs) and MD-based procedures can be challenging due to the unique features and particularities of this group of technologies, such as device-operator interaction. The aim of this study was to (1) clarify, and supplement earlier findings on European HTA institutions’ structural, procedural and methodological characteristics with regard to the assessment of MDs and to (2) capture the institutions’ perceptions regarding challenges and future trends.

Suggested Citation

  • Fuchs, Sabine & Olberg, Britta & Panteli, Dimitra & Perleth, Matthias & Busse, Reinhard, 2017. "HTA of medical devices: Challenges and ideas for the future from a European perspective," Health Policy, Elsevier, vol. 121(3), pages 215-229.
    • Handle: RePEc:eee:hepoli:v:121:y:2017:i:3:p:215-229
    DOI: 10.1016/j.healthpol.2016.08.010
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    References listed on IDEAS

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    1. Joyce Craig & Louise Carr & John Hutton & Julie Glanville & Cynthia Iglesias & Andrew Sims, 2015. "A Review of the Economic Tools for Assessing New Medical Devices," Applied Health Economics and Health Policy, Springer, vol. 13(1), pages 15-27, February.
    2. Olberg, Britta & Perleth, Matthias & Busse, Reinhard, 2014. "The new regulation to investigate potentially beneficial diagnostic and therapeutic methods in Germany: Up to international standard?," Health Policy, Elsevier, vol. 117(2), pages 135-145.
    3. Campillo-Artero, Carlos, 2013. "A full-fledged overhaul is needed for a risk and value-based regulation of medical devices in Europe," Health Policy, Elsevier, vol. 113(1), pages 38-44.
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    1. Fuchs, Sabine & Olberg, Britta & Perleth, Matthias & Busse, Reinhard & Panteli, Dimitra, 2019. "Testing a new taxonomic model for the assessment of medical devices: Is it plausible and applicable? Insights from HTA reports and interviews with HTA institutions in Europe," Health Policy, Elsevier, vol. 123(2), pages 173-181.
    2. Lübbeke, A. & Silman, A.J. & Barea, C. & Prieto-Alhambra, D. & Carr, A.J., 2018. "Mapping existing hip and knee replacement registries in Europe," Health Policy, Elsevier, vol. 122(5), pages 548-557.
    3. Tarricone, Rosanna & Amatucci, Fabio & Armeni, Patrizio & Banks, Helen & Borsoi, Ludovica & Callea, Giuditta & Ciani, Oriana & Costa, Francesco & Federici, Carlo & Torbica, Aleksandra & Marletta, Marc, 2021. "Establishing a national HTA program for medical devices in Italy: Overhauling a fragmented system to ensure value and equal access to new medical technologies," Health Policy, Elsevier, vol. 125(5), pages 602-608.
    4. Zippel, Claus & Bohnet-Joschko, Sabine, 2017. "Post market surveillance in the german medical device sector – current state and future perspectives," Health Policy, Elsevier, vol. 121(8), pages 880-886.
    5. Sandor Kovács & Zoltán Kaló & Rita Daubner‐Bendes & Katarzyna Kolasa & Rok Hren & Tomas Tesar & Vivian Reckers‐Droog & Werner Brouwer & Carlo Federici & Mike Drummond & Antal Tamás Zemplényi, 2022. "Implementation of coverage with evidence development schemes for medical devices: A decision tool for late technology adopter countries," Health Economics, John Wiley & Sons, Ltd., vol. 31(S1), pages 195-206, September.
    6. Philip Klein & Hedwig Blommestein & Maiwenn Al & Benedetta Pongiglione & Aleksandra Torbica & Saskia de Groot, 2022. "Real‐world evidence in health technology assessment of high‐risk medical devices: Fit for purpose?," Health Economics, John Wiley & Sons, Ltd., vol. 31(S1), pages 10-24, September.
    7. Beck, ACC & Retèl, VP & Bhairosing, PA & van den Brekel, MWM & van Harten, WH, 2019. "Barriers and facilitators of patient access to medical devices in Europe: A systematic literature review," Health Policy, Elsevier, vol. 123(12), pages 1185-1198.
    8. Pedro Parreira & Liliana B. Sousa & Inês A. Marques & Paulo Santos-Costa & Sara Cortez & Filipa Carneiro & Arménio Cruz & Anabela Salgueiro-Oliveira, 2020. "Usability Assessment of an Innovative Device in Infusion Therapy: A Mix-Method Approach Study," IJERPH, MDPI, vol. 17(22), pages 1-13, November.
    9. Beata Kiselova Bilekova & Beata Gavurova & Vladimír Rogalewicz, 2018. "Application of the HTA Core Model for complex evaluation of the effectiveness and quality of Radium-223 treatment in patients with metastatic castration resistant prostate cancer," Health Economics Review, Springer, vol. 8(1), pages 1-13, December.
    10. Milena Vainieri & Francesca Ferrè & Stefania Manetti, 2021. "An Integrated Framework to Measure the Performance of Inter-Organizational Programme on Health Technology Assessment," Sustainability, MDPI, vol. 13(7), pages 1-17, March.
    11. Rowan Iskandar & Carlo Federici & Cassandra Berns & Carl Rudolf Blankart, 2022. "An approach to quantify parameter uncertainty in early assessment of novel health technologies," Health Economics, John Wiley & Sons, Ltd., vol. 31(S1), pages 116-134, September.

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