Health Technology Assessment and Biomedical Engineering: Global trends, gaps and opportunities

L Pecchia,N Pallikarakis,R Magjarevic,E Iadanza

doi:10.1016/j.medengphy.2019.08.008

Abstract

The diffusion of medical devices is expanding at an astonishing rate. The increasing number of novel patents per year suggests this growth will continue. In contrast to drugs, medical devices are intrinsically dependent on the environment in which they are used and how they are maintained. This created an unprecedented global need for well-trained biomedical engineers who can help healthcare systems to assess them. The International Federation for Medical and Biological Engineering (IFMBE) is the global scientific society of biomedical engineers in official relations with the United Nations World Health Organisation (WHO) and has been very active in promoting the role of the biomedical engineer in Health Technology Assessment (HTA). The IFMBE Health Technology Assessment Division (HTAD) is the IFMBE operative branch in this field, promoting studies, projects and activities to foster the growth of this specific and very important science sector, including summer schools, training material, an HTA eLearning platform, HTA guidelines, awards and more. This article describes the vision, the mission and the strategy of the HTAD, with a focus on the results achieved and the impact this is having on global policymaking.

Highlights

The past 10 years has seen a remarkable diffusion of Medical Devices (MDs)
The International Federation for Medical and Biological Engineering (IFMBE) Health Technology Assessment Division (HTAD) vision is that biomedical engineers “should be constantly involved in Health Technology Assessment (HTA) studies focusing on MDs, in order to better serve the ultimate beneficiary of healthcare and biomedical engineering: the patient”
The second day was dedicated to the HTA of MD, introducing the main difference between medical devices and other healthcare technologies, and presenting methodological implications and existing tools, which could be used to assess medical devices

Summary

Introduction

The past 10 years has seen a remarkable diffusion of Medical Devices (MDs). Similar figures come from the United States of America (US), where patent filings show a significant uptrend from 2007 (about 22,000 applications) to 2018 (more than 34,000 applications). For many MDs, the time to market (TTM) has become shorter and shorter over the past years The combination of those two trends (i.e., increased number of MD patent applications and shorter TTM) has already resulted in an unprecedented increase of novel MDs introduced in the market each year: a veritable ‘tsunami’ of medical devices! (7) HTA of medical devices (a) The industry of medical devices & medical devices regulation of in the EU N Pallikarakis) (b) The industry, the regulation and the challenges in assessing medical devices

Objectives

Methods

Results

Conclusion