Abstract

MEDICAL DEVICES FORM ECONOMIC VIEW-CHALLENGES AND OPPORTUNITIES FOR HEALTH MANAGEMENT

Hussain Mahdi Aljawad* and Fouad Hamed Alamri

ABSTRACT

Background: Medical devices are integral to modern healthcare, with over 200,000 products registered in key markets like the U.S. and Europe. As the demand for economic evaluations of these devices rises, numerous challenges arise in assessing their clinical and economic value. Aim: This study aims to analyze the complexities involved in the economic evaluation of medical devices, identifying practical challenges and proposing strategies to address them. Methods: A qualitative, non-systematic review of existing literature was conducted to identify external factors (regulatory frameworks, industry structure, product life-cycle, and market diffusion) and device-specific factors (study design constraints, proceduralintegration, cost calculations, and utilities in evaluations) affecting economic evaluations. Results: The findings reveal significant obstacles, including insufficient clinical data from randomized controlled trials (RCTs), the fragmented nature of the industry, short product life-cycles, and challenges in integrating devices into clinical procedures. These factors limit the ability to conduct comprehensive economic evaluations. Conclusion: The economic evaluation of medical devices is hindered by a variety of external and device-specific challenges. Addressing these issues through improved regulatory standards, enhanced clinical evidence requirements, and more robust economic evaluation methodologies can lead to better-informed decision-making in health management.

Keywords: Medical devices, economic evaluation, regulatory challenges, clinical evidence, health management.