Lean Six Sigma, 3rd Edition

Chapter 20 Lean Six Sigma and the Medical Device Industry

DOI: 10.4324/9781003397649-24

The medical device industry is one of the fastest-growing industries internationally with an estimated worth of $400 billion. A medical device is a product used for medical purposes in patients, diagnosis, therapy, or surgery. This industry has become a sound and reliable career choice for the International Lean Six Sigma (ILSS) practitioner.

The U.S. Food and Drug Administration (FDA) has recognized three classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device:

• Class I—General Controls
• Class II—General Controls with Special Controls
• Class III—General Controls with Premarket Approval

• Class ...