Problem Statement:
A challenge in production and maintenance of medtech HTA is that devices undergo iterative development throughout their lifecycle. Changes range from trivial name changes (no functional implication) to changes in mode of action. Digital devices, including digital therapeutics, AI or data-driven technologies pose similar challenges on a greater scale. Examples of challenges and learnings in NICE’s Medtech Evaluation Programme are explored.

Description (case study 1; software iterations):
During development of guidance for MyCOPD (NICE MTG68 2022) a patient expert reflected on experiences to committee about use of an older device and described problems that had since been rectified or improved regarding the user interface and experience.

Lessons Learned:
Need for companies to provide detailed product version history with key dates that can be mapped to dates of user feedback.
Greater awareness of the speed of product development for software-based devices and importance different iterations can play on user engagement.

Description (case study 2; OEMs):
During guidance review of NICE MTG3 (2011), a professional body expressed concern in consultation that the latest version of CardioQ had additional functionality with a different mode of action (arterial pulse pressure waveform) that had not been assessed in the original guidance, and was out of its scope. The additional functionality meant that it could be used in different ways to the original device. The guidance was withdrawn and incorporated into a clinical guideline (NICE NG180, 2020).

Lessons Learned:
Need to monitor changes to technologies: understand impacts of different versions/packages. In particular, whether changes impact how it is used, how much it costs, and whether it remains within the remit of the original scope.

Stakeholder Perspective:
National HTA of medtech