Overview

Due to the nature of the products they develop, all sectors of the healthcare industry are subject to a great deal of regulation. Administering the regulations is the responsibility of the Food and Drug Administration (FDA), which has oversight throughout the product development process, as well as a mandate to review the manufacturing and QA process on an ongoing basis.

Developing safe and effective new drugs and medical devices is a long, intricate, and multi-phase process and there is a tremendous investment of time and personnel involved in moving a drug from R&D to the marketplace. Engineers are involved throughout the process, so its critical that they understand FDA regulations and take them into consideration.

The approval process for drugs and medical devices differ considerably, due to the more physical interaction with the human body of devices, as opposed to the more chemical interaction of drugs. For medical devices, the first step involves determining the class of the device and that decision will determine the process from that point on. The FDA classifications of medical devices are assigned by the risk the medical device presents to the patient and the level of regulatory control the FDA determines is needed to legally market the device. As the classification level increases, so too does the risk and regulatory control.

The drug development and approval process, like the medical devices approval process, is overseen by the FDA but the process for drugs involves many more phases and can take considerably longer. A full drug development and approval process can take up to 12-15 years, though in special circumstances, the FDA has used an abbreviated process for drug testing and approval called "fast-tracking". The “fast track” designation is applied to products that demonstrate the potential to treat or answer unmet medical needs of a serious or life-threatening condition. For example, a number of treatments for AIDS and various forms of cancer have been fast-tracked in recent years in the hope that this will bring these valuable treatments to market more quickly.

Naturally, over the course of a process cycle as long as that, many, many people are involved. Bringing a drug to market involves the work of countless professionals with a variety of skill sets and interests, including a variety of those in the engineering fields. At every phase, engineering excellence and attention to detail ensure the process is consistent, safe, and effective.

To give you an idea of what is involved, we'll next go through a typical phase-by-phase description of the FDA drug-approval process.