ABSTRACT
The medical device industry (MDI) has grown tremendously over the past few years. Many new and complex devices have been released to the market, and this is just the beginning of a new era of innovation in the healthcare industry. It is becoming common knowledge that the complexity of applications and technologies in the medical device industry is enormous. Today’s medical devices range from simple hand-held tools to complex computer-controlled surgical instruments, from implantable screws to artificial organs, from blood-glucose test strips to diagnostic imaging systems and laboratory test equipment. Now we even see hybrid devices or combination products such as combinations of device and pharmaceuticals (e.g., coated stents), products aimed at drug delivery (e.g., photodynamic therapy, which uses a light source to activate a photosensitive drug), and others requiring embedded software to function correctly (e.g., the “camera-in-a-pill” for use in diagnosing bleeding in hard-to-image sections of the intestines). Energy sources such as lasers and high-intensity ultrasound can pass safely through the body, affecting only targeted tissue.
