Health Technology Assessment for Medical Devices: Current Approaches and Challenges

Original version (Spanish)

English Version

Portuguese version

The Pan American Health Organization and the Health Technology Assessment Network of the Americas (RedETSA) organized a new edition of the RedETSA Webinar Program: “Health Technology Assessment for Medical Devices: Current Approaches and Challenges”

It was a very emotional webinar as we paid special tribute to our esteemed colleague from the WHO, Adriana Velázquez, on the occasion of her retirement. Adriana has been a key figure in strengthening medical device management, and her legacy will continue to inspire our work. 

Date: Friday, August 22, 2025

Context

Although many principles of HTA are applicable to all health technologies, the medical devices They present unique characteristics that require specific approaches. Unlike drugs, the evaluation of medical devices faces particular challenges, such as:

• Difficulty generating solid evidence in clinical studies.
• Limitations in randomization and masking, especially in implantable devices.
• Lack of adequate comparators, which complicates comparative analyses.

For these reasons, the HTA for medical devices must be adapted and differentiated from that applied to pharmaceutical products.

About the Webinar

The webinar addressed current approaches to Health Technology Assessment for medical devices. This webinar aims to provide guidance and discuss the potential use of different HTA methodologies for medical devices and the advantages they can offer to countries in our region. Methodologies that enable timely and contextualized assessments, such as rapid HTA, multicriteria decision analysis, adaptive HTA, and the use of RWE, can be particularly useful for medical device assessment.

Speakers

– Adriana Velazquez, WHO

– Blanca Novella, SERMAS-REDETS, Spain 

– Victoria Hurtado, RedETSA Working Group on Medical Devices, Chile