<p>This paper reviews the academic literature on including lead users in developing new healthcare products. It underscores their pivotal role in fostering co-creation and innovation in the healthcare sector. Through a structured review following the PRISMA protocol, we identify and explore various dimensions of lead user engagement, including identification, role delineation, engagement methods, and the stages of new product development (NPD) in which they are involved. We also examine strategies for lead user recruitment and techniques for tracking and evaluating their contributions. Our findings have been synthesised into a framework for lead user involvement across different NPD stages. This framework is designed to enhance theoretical understanding and guide practical applications in healthcare innovation, offering a clear pathway for integrating lead user insights into product development processes. Additionally, based on our review, we extracted detailed guidelines on managing and leveraging lead user contributions to maximise the impact of healthcare innovation. This study advances theoretical knowledge and provides a practical tool that healthcare practitioners and innovators can directly apply. By bridging the gap between theoretical research and practical application, this paper offers a novel perspective that enriches our understanding of lead user dynamics and their essential role in healthcare NPD. The practical implications of our findings provide a clear pathway for integrating lead user insights into product development processes and detailed guidelines on managing and leveraging lead user contributions to maximise the impact of healthcare innovation.</p>