At the level of devices, participant views contrasted on whether devices were interchangeable. PE is, in part, based on a discussion of the evidence for device safety and effectiveness, however, such information is lacking for many types of devices [13, 14]. The IDEAL (Idea, Development, Exploration, Assessment and Long-term follow-up) framework, originally devised to guide the evaluation of novel surgical techniques, was recently modified to accommodate the evaluation of devices . The IDEAL framework included five stages (first in human, prospective development studies, prospective exploration studies, assessment via RCT or alternatives and long-term study). The IDEAL-D framework includes six stages (first in human, which allows confidential reporting to accommodate intellectual property rights; sequential prospective non-comparative cohort studies to generate insight on operator learning curves and iterative changes to implantation procedures; large uncontrolled prospective cohort studies or audits to build consensus on definitions, quality control and outcome expectations for subsequent trials (for first-of-kind devices, could be omitted for successor devices); assessment via RCT or alternatives (for first-of-kind devices) and long-term study or nested RCTs via device registries). If widely adopted, IDEAL-D processes may lead to greater evidence on the safety and effectiveness of medical devices .