Ireland has developed a highly successful medical device cluster. The cluster experience accelerated growth during the 1990s when many USA multinationals established manufacturing sites. Manufacturing is the driving force that created the cluster with linkages between, universities, venture capital, entrepreneurs, suppliers, and supporting industry. Using Lean tools and principles the sites have established a reputation for excellence. A generation since the sites have been established changes outside of the cluster are impacting its competitiveness. Lean tools and systems may no longer be enough to sustain the cluster. This paper examines the key changes affecting the cluster and highlights the reasons lean principles may not be enough for the cluster to continue to thrive for another generation. The paper provides valuable insights into a strategy for individual firms, and the medical device cluster in Ireland and has lessons for any other industrial cluster.