Key characteristics and role of lead users in medical device innovations: An exploratory study

Abstract

Developing medical device innovations is a lengthy and costly endeavor, so engaging the right participants early in the process is crucial. While much of the existing literature focuses on procedural aspects of innovation, the human factors that influence success are often overlooked. The Lead User Method is designed to identify key contributors based on their ability to stay ahead of market trends and realize significant benefits. However, it has been criticized for inadequacies in its identification process. To address this gap, our study distinguishes seven key personal characteristics of medical lead users that are essential for successful co-created new product development. Through case studies and semi-structured interviews, we demonstrate that engaging lead users throughout the new product development process—regardless of product complexity—enhances product-market fit and profitability. Their involvement becomes increasingly critical as the process advances, particularly during the market diffusion phase. Our research refines the Lead User Method's identification process and provides actionable insights for decision-makers, reducing uncertainty in medical device innovation while lowering development costs and time and increasing product-market fit and profitability.