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Addressing Gaps in HTA Methods for Medical Devices: IFMBE Perspective

This study examines gaps in HTA MD guidelines, proposes recommendations, and compares guidelines with IFMBE suggestions. Methods include focus groups, a modified Delphi survey, and consensus discussions. Results highlight the importance of considering product lifecycle, clinical evaluation, issues in use, and costs. The discussion covers challenges like interoperability and risk assessment. The study concludes with recommendations for future research.

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Addressing Gaps in HTA Methods for Medical Devices: IFMBE Perspective

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  1. HTA Methods Guidelines for Medical Devices: How can We Address the Gaps?The International Federation of Medical and Biological Engineering Perspective Presented by: Julie Polisena, PhD

  2. Disclosure • IFMBE and the University of Warwick provided financial support for this study. • Authors declare no COI.

  3. IFMBE The International Federation for Medical and Biological Engineering (IFMBE) is primarily a federation of national and transnational societies. These professional organizations represent interests in medical and biological engineering. The IFMBE is also a Non-Governmental Organization (NGO) for the United Nations and the World Health Organization (WHO).

  4. Introduction Drug Therapies Medical Devices

  5. Introduction

  6. Study Objectives • Review and identify gaps in HTA MD guidelines • Propose recommendations • Comparison between guidelines and recommendations • Reach consensus among clinical and biomedical engineers

  7. Methods • Focus groups • Narrative summary of HTA MD guidelines • Discussions with IFMBE-HTA Division • Differences between drugs and MDs • Impact on HTA methods • Recommendations for MD assessment

  8. Methods • Modified Delphi survey • Survey design • Online • Delphi process • Agreement level on 30 recommendations • 5-point Likert scale

  9. Results • Focus Group • Product lifecycle • Clinical evaluation • Issues in use • Costs and economic evaluation

  10. Results: Product Lifecycle

  11. Results: Clinical Evaluation

  12. Results: Issues in Use

  13. Results: Costs and Economic Evaluation

  14. Results • Delphi survey

  15. Results • Delphi survey • Consensus on recommendations • Consensus with strong agreement reached in 90% recommendations • Consensus with agreement reached in 10% recommendations

  16. Discussion • Comments: • Feasibility of accurate assessment throughout product lifecycle • Interoperability of medical device with other devices or within hospital systems • Availability of data or evidence • Adoption of medical device in organization • New methods may be required • Risk assessment

  17. Limitations • Uncertain about interpretation of recommendations and descriptions in survey • Not all perspectives were represented

  18. Directions for Future Research

  19. Reference • Polisena J, Castaldo R, Ciani O, Federici C, Borsci S, Ritrovato M, Clark D, and Pecchia L. “HTA Methods Guidelines for Medical Devices: How can We Address the Gaps?” The International Federation of Medical and Biological Engineering Perspective. 2018. (International Journal of Technology Assessment in Health Care, 34:3 (2018), 276–289))

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