Biomedical engineering is a discipline concerned with the development and manufacture of prostheses, medical devices, diagnostic devices, drugs and other therapies as well as the application of engineering principles to basic biological science problems. It combines the expertise of engineering with medical needs to improve healthcare. It is more concerned with biological, safety and regulatory issues than other forms of engineering. It may be defined as "The application of engineering principles and techniques to the medical field."
Biomedical engineers usually require degrees from recognized universities, and sound knowledge engineering, and human anatomy and physiology. Their jobs often pay well (ranging from US $50,000 to $100,000 per year in 2005). Though the number of biomedical engineers are currently low (under 10,000), the number is expected to rise as modern medicine improves. Universities are now improving their undergraduate biomedical engineering courses because interest in the field is increasing.
It was not until the late 1930s when researchers began to understand the effects of X-rays on tissues and the electrical properties of tissues. These discoveries permitted doctors to use X-rays to get images of most organ systems. These techniques encouraged manufacturers to develop the modern array of medical imaging technologies. These technologies nearly eliminated the need for exploratory surgery.
Imaging technologies were the first modern applications of scientific engineering to medical needs. Earlier devices were built as a craft by instrument-makers. These earlier devices included crutches, platform shoes, wooden teeth, and the ever-changing instruments in the doctor’s bag. Some of the modern devices that followed medical imaging include pacemakers, infusion pumps, the heart-lung machine, dialysis machines, diagnostic equipment, imaging technologies of every kind, and artificial organs, implants, and advanced prosthetics.
Most biomedical devices are either inherently safe, or have added devices and systems so that they can sense their failure and shut down into an unusable, thus very safe state. A typical, basic requirement is that no single failure should cause the therapy to become unsafe at any point during its life-cycle. See safety engineering for a discussion of the procedures used to design safe systems.
Many biomedical devices need to be sterilized. This creates a unique set of problems, since most sterilization techniques can cause damage to machinery and materials.
Most biomedical devices are completely tested. That is, every line of software is executed, or every possible setting is exercised and verified. Most devices are intentionally simplified in some way to make the testing process less expensive, yet accurate.
Regulatory issues are never far from the mind of a biomedical engineer. To satisfy safety regulations, most biomedical systems must have documentation to show that they were managed, designed, built, tested, delivered and used using a planned, approved process. This is thought to increase the quality and safety of the therapy by reducing the likelihood that needed steps can be accidentally omitted.
In the United States, biomedical engineers may operate under two different regulatory frameworks. Clinical devices and technologies are generally governed by the Food and Drug Administration (FDA) in a similar fashion to pharmaceuticals. Biomedical engineers may also develop devices and technologies for consumer use, such as physical therapy devices, which may be governed by the Consumer Product Safety Commission. See US FDA 510(k) documentation process for the US government registry of biomedical devices.
Other countries typically have their own mechanisms for regulation. For example, in Europe the actual decision about whether a device is suitable is made by the prescribing doctor, and the regulations are to assure that the device operates as expected. Thus in Europe, the governments license certifying agencies, which are for-profit. Technical committees of leading engineers write recommendations which incorporate public comments and are adopted as regulations by the European Union. These recommendations vary by the type of device, and specify tests for safety and efficacy. Once a prototype has passed the tests at a certification lab, and that model is being constructed under the control of a certified quality system, the device is entitled to bear a "CE mark." The CE mark indicates that the device is believed to be safe and reliable when used as directed.
The different regulatory arrangements sometimes result in technologies being developed first for either the U.S. or in Europe depending on the more favorable form of regulation. Most safety-certification systems give equivalent results when applied diligently. Usually, once one such system is satisfied, satisfying the other requires only paperwork.
In general, FDA certification is seen as more strict, and more time-consuming, but not necessarily more safe. Obtaining a CE mark can be easier, because the certifying agencies have convenient branch offices, and provide technical assistance for fees. Obtaining such assistance early in the design process can save a manufacturer large amounts of money and time.
- Bioengineering, also referred to as biological engineering
- Tissue engineering
- Medical imaging
- safety engineering
- Biomedical equipment technician
- Biomedical informatics
- Biomedical technology
- Department of Biomedical Engineering, UC Irvine
- Department of Bioengineering, UC Berkeley
- Biomedical engineering at the University of Iowa
- Weldon School of Biomedical Engineering
- The Biomedical Engineering Society
- Biomedical Engineering website
- The Biomedical Engineering Network
- Foundation supporting biomedical engineering research