Health technology assessment of medical devices: current landscape, challenges, and a way forward.

Background: Health Technology Assessment (HTA) has been widely recognized as informing healthcare decision-making, and interest in HTA of medical devices has been steadily increasing. How does the assessment of medical devices differ from that of drug therapies, and what innovations can be adopted to overcome the inherent challenges in medical device HTA?

Method: HTA Accelerator Database was used to describe the landscape of HTA reports for medical devices from HTA bodies, and a literature search was conducted to understand the growth trend of relevant HTA publications in four case studies. Another literature review was conducted for a narrative synthesis of the characteristic differences and challenges of HTA in medical devices. We further conducted a focused Internet search of guidelines and a narrative review of methodologies specific to the HTA of medical devices.

Main Body: The evidence of HTA reports and journal publications on medical devices around the world has been growing. The challenges in assessing medical devices include scarcity of well-designed randomized controlled trials, inconsistent real-world evidence data sources and methods, device-user interaction, short product lifecycles, inexplicit target population, and a lack of direct medical outcomes. Practical solutions in terms of methodological advancement of HTA for medical devices were also discussed in some HTA guidelines and literature.

Conclusion: To better conduct HTA on medical devices, we recommend considering multi-source evidence such as real-world evidence; standardizing HTA processes, methodologies, and criteria; and integrating HTA into decision-making.