Innovation in medical devices : a case study of the coronary stent

Abstract

This thesis presents a case study of introduction of the coronary stent into the percutaneous transluminal coronary angioplasty (PTCA) industry. The industry evolution is analyzed within the industrial life cycle framework developed by Utterback, Tushman and others. The coronary stent was first introduced in 1994, and has passed through all of the industry cycle stages: from a technology disruption stage to an incremental improvement. The interactions of the organization with the exterior environment and the technical development expertise, in combination, prove to be determining elements in an the stent manufacturer's likelihood for success. Relationships with the clinical personnel and practitioner are needed for design validation ( data for regulatory filings), design feedback, clinical acceptance of their products and to promote awareness of their products. Relations with clinical institutions and purchasing groups form distribution channels. This case study of the coronary stent industry provides an additional data point to compare actual industry practice against theory.