Poor quality medical devices may lead to dire financial and reputational consequences for an organization. Food and Drug Administration (FDA) warning letters are indicators of the challenges the medical device industry has to overcome the deficiencies . . .

A major problem in the field of continuous improvement is that approximately 60% of continuous improvement programs fail to deliver the desired results (McLean & Anthony, 2014). This problem exists in manufacturing industries around the world (Lodgaar . . .