Biomedical devices represent a wide variety of implements that are beneficial for human health and welfare. According to the Medical Device, Food, Drug and Cosmetics Act, Section 201 (h), a "device" is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or related article including any component, part or accessory, which is:
Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
Intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes
This definition provides a clear distinction between "devices" and drugs. In short, devices are not drugs.
What are some examples of Biomedical Devices?
There are numerous biomedical devices that are in current use, all aimed at improving human health and welfare. Some examples are contact lenses, hip implants, pace makers, artificial heart valves, stents, catheters, and breast implants, to name just a few. Surgical instruments are also biomedical devices. With the development of minimally invasive surgery, trauma to the patient and health care costs have been minimized while speeding up the time period required for recovery. Other devices, such as blood glucose monitors or apnea monitors, help to improve the quality of life of individuals.
Who designs and builds Biomedical Devices?
First Ð just about anybody can conceive of a biomedical device that can be helpful to patients. However, the actual design, development and ultimate market release of a product will involve a multi-disciplinary team that will include scientists, engineers, technologists, machinists, technicians, legal professionals, business and financial professionals, regulatory affairs professionals, and physicians.
Other unique aspects of Biomedical Devices
All biomedical devices are regulated by the United States Food and Drug Administration. This includes regulation of the design and development process, the manufacturing process and ultimately the use of the devices. The FDA regulates all aspects in order to ensure maximum safety for the end user of the product.
Another unique aspect of Biomedical Devices is the fact that the primary customer is usually the physician rather than the consumer. In most cases manufacturers of biomedical devices sell their products to the physician. Only when medical devices are approved for over-the-counter sale are they sold directly to the consumer. An example of medical devices that are sold directly to the consumer are some types of wound dressings, such as adhesive bandages.
What Skill sets should a Biomedical Device Engineer have?
A good command of engineering fundamentals and a sound understanding of the various engineering disciplines is essential. In addition to excellent engineering capabilities, a professional involved in the design, development and manufacture of biomedical devices should also have a good knowledge of human anatomy and physiology, at the very least. Knowledge of other biology-related fields such as immunology and neurology, among others, will also be very useful, depending upon the specific application.