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Key Recommendations from the MedtecHTA Project.

Rosanna Tarricone1,2, Aleksandra Torbica1,2, Michael Drummond1,3

  • 1Cergas, Bocconi University, Milan, Italy.

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Summary

Health technology assessment (HTA) for medical devices (MDs) requires tailored methods. Recommendations focus on aligning regulatory processes, harmonizing frameworks, and treating MDs as complex interventions to improve HTA and device diffusion.

Keywords:
MedtecHTAeconomic evaluationhealth technology assessmentmedical devicesmethodsrecommendations

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Area of Science:

  • Health Technology Assessment
  • Medical Device Innovation
  • Health Economics

Background:

  • Medical devices (MDs) present unique challenges for health technology assessment (HTA) due to device-user interaction, incremental innovation, and organizational impact.
  • Existing HTA processes and methods may not fully address the complexities of evaluating MDs.
  • Optimizing the diffusion of beneficial MDs requires effective assessment and integration into healthcare systems.

Purpose of the Study:

  • To explore key aspects of conducting and improving HTA for MDs.
  • To identify methods that enhance HTA processes and optimize the diffusion of MDs.
  • To provide recommendations for better HTA of MDs.

Main Methods:

  • Conducted systematic reviews and original research studies.
  • Analyzed regulatory processes and HTA evaluative frameworks.
  • Examined methods for evaluating complex interventions and comparative effectiveness.

Main Results:

  • Recommended closer alignment of regulatory processes for MDs.
  • Advocated for harmonization of HTA evaluative frameworks and use of conditional coverage.
  • Suggested treating MDs as complex interventions, establishing registries, and using iterative evaluation.
  • Highlighted the need for a common classification for international comparisons and understanding diffusion drivers.

Conclusions:

  • The MedtecHTA project provides key recommendations to enhance the conduct and utilization of HTA for MDs.
  • Implementing these recommendations can improve the evaluation and adoption of medical technologies.
  • Addressing the specific characteristics of MDs is crucial for effective HTA and healthcare innovation.