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Presented by: Julie Polisena, PhD

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. Disclosure. IFMBE and the University of Warwick provided financial support for this study.

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Presented by: Julie Polisena, PhD

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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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