The global healthcare market for medical technologies has become more challenging. Demand for high-quality evidence demonstrating that our science and technologies benefit patients has become crucial for approval. Objective measures showing differentiation and value against important unmet patient needs are required for provider (hospital) acceptance, physician adoption, and successful reimbursement by payers. Intense competition and a higher burden for innovation creates a risk vs. return profile that increasingly marginalizes iteration while rewarding only the most differentiated technologies. Meanwhile, changes in the healthcare landscape such as personalized medicine, targeted treatments, and shared decision-making drive an increased need for timely, expert evidence, and information not just for traditional audiences but also for patients and caregivers.

This article draws on the expertise of 10 senior Medical Affairs leaders across diverse global organizations to describe the role of Medical Affairs in ensuring the MedTech industry meets these demands. The authors hope that readers from within and beyond Medical Affairs will use this article to establish a baseline understanding of the profession within their organizations, as well as the aspirational north star when evaluating Medical Affairs actions, structure, and strategy. In short, this paper provides a concise answer to critically defining Medical Affairs questions of who we are, why we are, and what we do within the MedTech industry.