This course is designed for those with an intermediate knowledge of medical devices and their market access pathways. The focus will be on understanding the areas of United States (US) and European Union (EU) healthcare systems relevant to medical devices (eg, diagnosis-related groups (DRG’s), inpatient versus outpatient), implicit value drivers of medical devices, the stakeholder organizations necessary to engage in order to obtain medical device funding/reimbursement and adoption, and the healthcare system pathways through which medical devices can be implemented. The course will conclude with a primer on performance-based risk-sharing agreements. Market access for medical devices is an evolving, multi-faceted, and multi-stakeholder journey that requires dedicated knowledge. Experience in launching pharmaceutical products can present both challenges and opportunities for medical device companies, as the pathways, evidence requirements, and value domains are materially different. This course will attempt to demystify the medical device landscape and help all stakeholders ensure that appropriate patients benefit from innovation in the medical device space through improving participants’ awareness of marketplace trends and needs to demonstrate clinical and economic value.