ISSUE: The level of evidence required to demonstrate value for reimbursement is subject to debate due to its potential impact on patient access, healthcare cost, and future medical device innovation. Value-driven care will represent a paradigm shift for the medical device industry. Regulators, payers, and manufacturers often find themselves at an impasse on solutions to these challenges leading to the question - if the current methodological pathways are not adequate, what are the alternatives? Each stakeholder will present different perspectives, highlighting the device industry's most significant challenges and whether the current pathway can address those challenges or whether there needs to be an alternative path for devices. Specific focus will be given to evidence requirements to prove the safety and efficacy of medical devices and the adequacy of such data for reimbursement decisions, and the most appropriate time at which to undertake economic evaluations. OVERVIEW: Methods of economic evaluation can be applicable to all health technologies; however, its practical use for device industries presents several challenges. Much of this is due to the unique characteristics of medical devices and that of ‘pharma-precedence’ - evaluating medical devices the same as drugs: can this be equally applied to devices? The process and expectation for demonstrating value for drugs places greater emphasis on randomized control studies (RCT) and ignores the complex nature and diverse categories of medical devices. Furthermore, RCTs are not required for regulatory approval and conducting RCT’s can present an economic burden for device companies, especially in a system that confers incremental benefit ‘relative’ to an existing device. With a growing number of HTA assessments for devices undertaken annually, and the reimbursement landscape shifting to a more value-based payment system, there is a need for stakeholders to align on a clear framework for the clinical and economic assessment for medical devices.