Medical Devices Evaluation: Aqualitative Investigation from the Validate Viewpoint

Abstract

Goals : Our aim was to investigate the procedures and techniques employed by health technology assessment (HTA) agencies in evaluating medical devices, as well as the perspectives of HTA professionals regarding suitable methodologies to pinpoint obstacles in the implementation of new assessment methods for devices. We concentrated on the significance of normative commitments among HTA practitioners in embracing new methods.
Methods: Members of the International Network of Agencies for Health Technology Assessment received an online survey that included questions about processes, scopes, and medical device assessments. Interviews were conducted with survey respondents and HTA practitioners involved in transcatheter aortic valve implantation assessments to acquire a thorough grasp of their decision-making and perspectives on medical device evaluation. Survey and interview questions were influenced by the "values in doing assessments of health technologies" approach to HTA, which asserts that HTA deals with value-laden questions and data.
Conclusions: There is widespread understanding that medical device assessments may require revisions to HTA methodology. To do this, the HTA community may need to engage in a discussion about the function, responsibilities, and aims of HTA, as well as make changes in institutional environment to adopt new approaches.