A JARVIK-7 artificial heart, an example of a biomedical engineering application of mechanical engineering with biocompatible materials for cardiothoracic surgery using an artificial organ.

Biomedical engineering (BME) also known as Pharmaceutical engineering is the application of engineering principles and techniques to the medical field. It combines the design and problem solving skills of engineering with medical and biological sciences to help improve patient health care and the quality of life of individuals.

As a relatively new discipline, much of the work in biomedical engineering consists of research and development, covering an array of fields: bioinformatics, medical imaging, image processing, physiological signal processing, biomechanics, biomaterials and bioengineering, systems analysis, 3-D modeling, etc. Examples of concrete applications of biomedical engineering are the development and manufacture of biocompatible prostheses, medical devices, diagnostic devices and imaging equipment such as MRIs and EEGs, and pharmaceutical drugs.

Disciplines in biomedical engineering

Biomedical instrumentation amplifier schematic used in monitoring low voltage biological signals, an example of a biomedical engineering application of electronic engineering to electrophysiology.

Biomedical engineering is an interdisciplinary field, influenced by various fields and sources. Due to the extreme diversity, it is typical for a biomedical engineer to focus on a particular emphasis within this field. There are many different taxonomic breakdowns of BME, one such listing defines the aspects of the field as such:^[1]

• Bioelectrical and neural engineering
• Biomedical imaging and biomedical optics
• Biomaterials
• Biomechanics and biotransport
• Biomedical devices and instrumentation
• Molecular, cellular and tissue engineering
• Systems and integrative engineering

In other cases, disciplines within BME are broken down based on the closest association to another, more established engineering field, which typically include:

• Chemical engineering - often associated with biochemical, cellular, molecular and tissue engineering, biomaterials, and biotransport.
• Electrical engineering - often associated with bioelectrical and neural engineering, bioinstrumentation, biomedical imaging, and medical devices.
• Mechanical engineering - often associated with biomechanics, biotransport, medical devices, and modeling of biological systems.
• Optics and Optical engineering - biomedical optics, imaging and medical devices.

Clinical engineering

Breast implants, an example of a biomedical engineering application of biocompatible materials to cosmetic surgery.

Clinical engineering is a branch of biomedical engineering related to the operation of medical equipment in a hospital setting. The tasks of a clinical engineer are typically the acquisition and management of medical device inventory, supervising biomedical engineering technicians (BMETs), ensuring that safety and regulatory issues are taken into consideration and serving as a technological consultant for any issues in a hospital where medical devices are concerned. Clinical engineers work closely with the IT department and medical physicists.

Schematic representation of normal ECG trace showing sinus rhythm, an example of a biomedical engineering application of electronic engineering to electrophysiology and medical diagnosis.

Medical devices

A medical device is intended for use in:

• the diagnosis of disease or other conditions, or
• in the cure, mitigation, treatment, or prevention of disease,
• intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

A pump for continuous subcutaneous insulin infusion, an example of a biomedical engineering application of electrical engineering to medical equipment.

Stereolithography is a practical example on how medical modeling can be used to create physical objects. Beyond modeling organs and the human body, emerging engineering techniques are also currently used in the research and development of new devices for innovative therapies, treatments, patient monitoring, and early diagnosis of complex diseases.

Medical devices can be regulated and classified (in the US) as shown below:

1. Class I devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Devices in this category include tongue depressors, bedpans, elastic bandages, examination gloves, and hand-held surgical instruments and other similar types of common equipment.
2. Class II devices are subject to special controls in addition to the general controls of Class I devices. Special controls may include special labeling requirements, mandatory performance standards, and postmarket surveillance. Devices in this class are typically non-invasive and include x-ray machines, PACS, powered wheelchairs, infusion pumps, and surgical drapes.
3. Class III devices require premarket approval, a scientific review to ensure the device's safety and effectiveness, in addition to the general controls of Class I. Examples include replacement heart valves, silicone gel-filled breast implants, implanted cerebellar stimulators, implantable pacemaker pulse generators and endosseous (intra-bone) implants.

Medical imaging

An MRI scan of a human head, an example of a biomedical engineering application of electrical engineering to diagnostic imaging. Click here to view an animated sequence of slices.

• Fluoroscopy
• Magnetic resonance imaging (MRI)
• Nuclear Medicine
• Positron Emission Tomography (PET) PET scansPET-CT scans
• Projection Radiography such as X-rays and CT scans
• Tomography
• Ultrasound
• Electron Microscopy

Tissue engineering

One of the goals of tissue engineering is to create artificial organs for patients that need organ transplants. Biomedical engineers are currently researching methods of creating such organs. In one case bladders have been grown in lab and transplanted successfully into patients.^[2] Bioartificial organs, which utilize both synthetic and biological components, are also a focus area in research, such as with hepatic assist devices that utilize liver cells within an artificial bioreactor construct.^[3]

Regulatory issues

Artificial limbs: The right arm is an example of a prosthesis, and the left arm is an example of myoelectric control.

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.

Implants, such as artificial hip joints, are generally extensively regulated due to the invasive nature of such devices.

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. Frequently, once one such system is satisfied, satisfying the other requires only paperwork.

Biomedical engineering training

Education

A prosthetic eye, an example of a biomedical engineering application of mechanical engineering and biocompatible materials to ophthalmology.

In the U.S., an increasing number of undergraduate programs are also becoming recognized by ABET as accredited bioengineering/biomedical engineering programs. Over 40 programs are currently accredited by ABET.^[5][6]

As with many degrees, the reputation and ranking of a program may factor into the desirability of a degree holder for either employment or graduate admission. The reputation of many undergraduate degrees are also linked to the institution's graduate or research programs, which have some tangible factors for rating, such as research funding and volume, publications and citations.

Graduate education is also an important aspect in BME. Although many engineering professions do not require graduate level training, BME professions often recommend or require them.^[7] Since many BME professions often involve scientific research, such as in the pharmaceutical and medical device industries, graduate education may be highly desirable as undergraduate degrees typically do not provide substantial research training and experience.

Graduate programs in BME, like in other scientific fields, are highly varied and particular programs may emphasize certain aspects within the field. They may also feature extensive collaborative efforts with programs in other fields, owing again to the interdisciplinary nature of BME.

Education in BME also varies greatly around the world. By virtue of its extensive biotechnology sector, numerous major universities, and few internal barriers, the U.S. has progressed a great deal in the development of BME education and training. Europe, which also has a large biotechnology sector and an impressive education system, has encountered trouble in creating uniform standards as the European community attempts to bring down some of the national barriers that exist. Recently, initiatives such as BIOMEDEA have sprung up to develop BME-related education and professional standards.^[8] Other countries, such as Australia, are recognizing and moving to correct deficiencies in their BME education.^[9] Also, as high technology endeavors are usually marks of developed nations, some areas of the world are prone to slower development in education, including in BME.

Professional certification

Engineers typically require a type of professional certification, such as satisfying certain education requirements and passing an examination to become a professional engineer. These certifications are usually nationally regulated and registered, but there are also cases of self-governing bodies, such as the Canadian Association of Professional Engineers. In many cases, carrying the title of "Professional Engineer" is legally protected.

As BME is an emerging field, professional certifications are not as standard and uniform as they are for other engineering fields. For example, the Fundamentals of Engineering exam in the U.S. does not include a biomedical engineering section, though it does cover biology. Biomedical engineers often simply possess a university degree as their qualification. However, some countries, such as Australia, do regulate biomedical engineers, however registration is typically only recommended and not required.^[10]

Founding figures

• Leslie Geddes - Professor Emeritus at Purdue University, electrical engineer, inventor and educator of over 2000 biomedical engineers, received a National Medal of Technology in 2006 from President George Bush^[11] for his more than 50 years of contributions that have spawned innovations ranging from burn treatments to miniature defibrillators, ligament repair to tiny blood pressure monitors for premature infants, as well as a new method for performing cardiopulmonary resuscitation (CPR).
• Y. C. Fung - professor emeritus at the University of California, San Diego, considered by many to be the founder of modern Biomechanics^[12]
• Robert Langer - Institute Professor at MIT, runs the largest BME laboratory in the world, pioneer in drug delivery and tissue engineering^[13]
• Otto Schmitt (deceased) - biophysicist with significant contributions to BME, working with biomimetics
• Ascher Shapiro (deceased) - Institute Professor at MIT, contributed to the development of the BME field, medical devices (e.g. intra-aortic balloons)
• John G. Webster - Professor Emeritus at the University of Wisconsin-Madison, a pioneer in the field of instrumentation amplifiers for the recording of electrophysiological signals
• U. A. Whitaker (deceased) - provider of The Whitaker Foundation, which supported research and education in BME by providing over $700 million to various universities, helping to create 30 BME programs and helping finance the construction of 13 buildings^[14]
• Alfred E. Mann - Physicist, entrepreneur and philanthropist.^[15] A pioneer in the field of Biomedical Engineering. ^[16]

See also

• List of biomedical engineering topics
• Bioengineering

Notes

Further reading

• Bronzino, Joseph D. (2000). The Biomedical Engineering Handbook - Second Edition. CRC Press.
  • Volume 1. ISBN 0-8493-0461-X.
  • Volume 2. ISBN 0-8493-0462-8.

External links

Organizations

• American College of Clinical Engineering (ACCE)
• Association of Institutions concerned with Medical Engineering (UK)
• IEEE Engineering in Medicine and Biology Society
• Biomedical Engineering Career Alliance
• Biomedical engineering at the NIH
• Biomedical Engineering website
• Danish Society for Biomedical Engineering
• EBME - Biomedical and Clinical Engineering
• The Whitaker Foundation
• The Biomedical Engineering Network
• The Biomedical Engineering Society (US)
• The Canadian Medical and Biological Engineering Society
• Thai Biomedical Engineering Research Society (ThaiBME)
• The Turkey Biomedical Engineering (Turkey)
• the Arabic biomedical engineering source (arabic BME)
• Malaysian Society of Medical and Biological Engineering (MSMBE)
• Australian Biomedical Engineering Community
• Imperial College London, Institute of Biomedical Engineering (IBE)

Job finders

• Biomedical Engineering Jobs
• Biomedical and Clinical Engineering Jobs
• Biomedical Engineering Internships, Co-op's and entry level positions

Other sites

• List of Biomedical Engineering Companies and Organizations at the Open Directory Project

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