Assessing medical devices: a qualitative study from the validate perspective.

Area of Science:

• Health Technology Assessment (HTA)
• Medical Device Evaluation
• Methodology Development

Background:

• Current health technology assessment (HTA) practices for medical devices largely rely on methodologies originally developed for pharmaceuticals.
• This reliance presents challenges in adapting to the unique characteristics of medical devices.

Purpose of the Study:

• To explore current health technology assessment (HTA) procedures and methods for medical devices.
• To understand HTA practitioners' views on appropriate methodologies and challenges in adopting new approaches.
• To examine the influence of normative commitments on the adoption of new HTA methods for devices.

Main Methods:

• An online survey distributed to members of the International Network of Agencies for Health Technology Assessment.
• In-depth interviews with survey respondents and practitioners involved in transcatheter aortic valve implantation assessments.
• Methodology informed by the 'values in doing assessments of health technologies' approach, acknowledging HTA's value-laden nature.

Main Results:

• HTA agencies predominantly utilize drug-centric assessment procedures and methods for medical devices.
• Practical constraints such as time, decision-maker demands, legal frameworks, and guidelines impede the adoption of novel methodologies.
• Practitioner commitments to evidence-based medicine principles also pose a barrier to methodological innovation.

Conclusions:

• There is a recognized need to adapt HTA methodologies for medical device assessments.
• Implementing methodological changes requires a community-wide discussion on the role, responsibilities, and objectives of HTA.
• Institutional context and policy adjustments are necessary to facilitate the adoption of new HTA methodologies for medical devices.