A View of the Cardiovascular Device Industry

Abstract

This record of study details the experience and the knowledge applied by an engineering doctoral candidate during two internships with two separate organizations in the cardiovascular device industry. The first internship was with an early startup company with a large focus in early research and design. The second was in a more mature organization with a focus in process control and increasing efficiencies.

The startup company provided the appropriate dynamic for applying engineering design methods such as generating customer requirements, generating product functional requirements, building a quality function deployment, and proposing a basic high level design approach. With the mature company the focus was on investigating procedural inefficiencies through root cause analysis and mitigating the inefficiencies through integrated software solutions.

The detailed accounts of these experiences provide a broad overview of the many challenges facing the cardiovascular device industry and the organizations involved. These accounts also illustrate the importance and value of engineering design principles and systems based engineering management in the industry.