Does assessing the value for money of therapeutic medical devices require a flexible approach?

TY - JOUR

T1 - Does assessing the value for money of therapeutic medical devices require a flexible approach?

AU - Iglesias Urrutia, Cynthia Paola

PY - 2015/2

Y1 - 2015/2

N2 - Regulation criteria for licensing pharmaceuticals and medical devices (MDs) are asymmetric. This has affected the type, quantity and quality of the evidence produced in support of MDs. This paper has three objectives: to examine the reasons behind the current licensing criteria for MDs; to identify key methodological challenges associated with pre- and post-market evaluation of MDs and to assess the extent to which existing methods for the economic evaluation of pharmaceuticals can be applied to the evaluation of MDs. The belief that MDs cannot be properly evaluated stems from a combination of historical events and complexities in implementing rigorous RCTs in this field. Existing challenges to conduct sound economic evaluation of MDs have begun to be addressed in medical research using mixed research methods. While more challenging to implement, robust evaluations of therapeutic MDs can and need to be carried out to safeguard individual's wellbeing.

AB - Regulation criteria for licensing pharmaceuticals and medical devices (MDs) are asymmetric. This has affected the type, quantity and quality of the evidence produced in support of MDs. This paper has three objectives: to examine the reasons behind the current licensing criteria for MDs; to identify key methodological challenges associated with pre- and post-market evaluation of MDs and to assess the extent to which existing methods for the economic evaluation of pharmaceuticals can be applied to the evaluation of MDs. The belief that MDs cannot be properly evaluated stems from a combination of historical events and complexities in implementing rigorous RCTs in this field. Existing challenges to conduct sound economic evaluation of MDs have begun to be addressed in medical research using mixed research methods. While more challenging to implement, robust evaluations of therapeutic MDs can and need to be carried out to safeguard individual's wellbeing.

KW - Costs and Cost Analysis

KW - Device Approval

KW - Equipment and Supplies

KW - Humans

KW - Randomized Controlled Trials as Topic

KW - Research Design

U2 - 10.1586/14737167.2015.982098

DO - 10.1586/14737167.2015.982098

M3 - Article

C2 - 25583537

SN - 1473-7167

VL - 15

SP - 21

EP - 32

JO - Expert Review of Pharmacoeconomics and Outcomes Research

JF - Expert Review of Pharmacoeconomics and Outcomes Research

IS - 1

ER -