Biomedical engineering
Overview
 
Biomedical Engineering is the application of engineering principles and design concepts to medicine and biology. This field seeks to close the gap between engineering
Engineering
Engineering is the discipline, art, skill and profession of acquiring and applying scientific, mathematical, economic, social, and practical knowledge, in order to design and build structures, machines, devices, systems, materials and processes that safely realize improvements to the lives of...

and medicine
Medicine
Medicine is the science and art of healing. It encompasses a variety of health care practices evolved to maintain and restore health by the prevention and treatment of illness....

: It combines the design and problem solving skills of engineering with medical and biological sciences to improve healthcare diagnosis
Medical diagnosis
Medical diagnosis refers both to the process of attempting to determine or identify a possible disease or disorder , and to the opinion reached by this process...

, monitoring
Medical monitor
A medical monitor or physiological monitor or display, is an electronic medical device used in medical monitoring that displays the monitored data, and may or may not have the ability to transmit the data on a monitoring network...

 and therapy
Therapy
This is a list of types of therapy .* Adventure therapy* Animal-assisted therapy* Aquatic therapy* Aromatherapy* Art and dementia* Art therapy* Authentic Movement* Behavioral therapy* Bibliotherapy* Buteyko Method* Chemotherapy...

.

Biomedical engineering has only recently emerged as its own discipline, compared to many other engineering fields.
Encyclopedia
Biomedical Engineering is the application of engineering principles and design concepts to medicine and biology. This field seeks to close the gap between engineering
Engineering
Engineering is the discipline, art, skill and profession of acquiring and applying scientific, mathematical, economic, social, and practical knowledge, in order to design and build structures, machines, devices, systems, materials and processes that safely realize improvements to the lives of...

and medicine
Medicine
Medicine is the science and art of healing. It encompasses a variety of health care practices evolved to maintain and restore health by the prevention and treatment of illness....

: It combines the design and problem solving skills of engineering with medical and biological sciences to improve healthcare diagnosis
Medical diagnosis
Medical diagnosis refers both to the process of attempting to determine or identify a possible disease or disorder , and to the opinion reached by this process...

, monitoring
Medical monitor
A medical monitor or physiological monitor or display, is an electronic medical device used in medical monitoring that displays the monitored data, and may or may not have the ability to transmit the data on a monitoring network...

 and therapy
Therapy
This is a list of types of therapy .* Adventure therapy* Animal-assisted therapy* Aquatic therapy* Aromatherapy* Art and dementia* Art therapy* Authentic Movement* Behavioral therapy* Bibliotherapy* Buteyko Method* Chemotherapy...

.

Biomedical engineering has only recently emerged as its own discipline, compared to many other engineering fields. Such an evolution is common as a new field transitions from being an interdisciplinary
Interdisciplinarity
Interdisciplinarity involves the combining of two or more academic fields into one single discipline. An interdisciplinary field crosses traditional boundaries between academic disciplines or schools of thought, as new needs and professions have emerged....

 specialization among already-established fields, to being considered a field in itself. Much of the work in biomedical engineering consists of research and development
Research and development
The phrase research and development , according to the Organization for Economic Co-operation and Development, refers to "creative work undertaken on a systematic basis in order to increase the stock of knowledge, including knowledge of man, culture and society, and the use of this stock of...

, spanning a broad array of subfields (see below). Prominent biomedical engineering applications include the development of biocompatible prostheses
Prosthesis
In medicine, a prosthesis, prosthetic, or prosthetic limb is an artificial device extension that replaces a missing body part. It is part of the field of biomechatronics, the science of using mechanical devices with human muscle, skeleton, and nervous systems to assist or enhance motor control...

, various diagnostic and therapeutic medical device
Medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...

s ranging from clinical equipment to micro-implants, common imaging equipment such as MRIs and EEG
EEG
EEG commonly refers to electroencephalography, a measurement of the electrical activity of the brain.EEG may also refer to:* Emperor Entertainment Group, a Hong Kong-based entertainment company...

s, regenerative tissue growth, pharmaceutical drugs
Medication
A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.- Classification :...

 and therapeutic biologicals.

Subdisciplines within biomedical engineering

  • Biomedical Electronics
  • Biomechatronics
    Biomechatronics
    Biomechatronics is an applied interdisciplinary science that aims to integrate mechanical elements, electronics and parts of biological organisms. Biomechatronics includes the aspects of biology, mechanics, and electronics. It also encompasses the fields of robotics and neuroscience. One example...

  • Bioinstrumentation
  • Biomaterials
  • Biomechanics
    Biomechanics
    Biomechanics is the application of mechanical principles to biological systems, such as humans, animals, plants, organs, and cells. Perhaps one of the best definitions was provided by Herbert Hatze in 1974: "Biomechanics is the study of the structure and function of biological systems by means of...

  • Bionics
    Bionics
    Bionics is the application of biological methods and systems found in nature to the study and design of engineering systems and modern technology.The word bionic was coined by Jack E...

  • Cellular, Tissue, and Genetic Engineering
  • Clinical Engineering
    Clinical engineering
    Clinical engineering is a specialty within Biomedical engineering responsible primarily for applying and implementing medical technology to optimize healthcare delivery...

  • Medical Imaging
    Medical imaging
    Medical imaging is the technique and process used to create images of the human body for clinical purposes or medical science...

  • Orthopaedic Bioengineering
  • Rehabilitation engineering
    Rehabilitation engineering
    Rehabilitation engineering is the systematic application of engineering sciences to design, develop, adapt, test, evaluate, apply, and distribute technological solutions to problems confronted by individuals with disabilities...

  • Systems Physiology
  • Bionanotechnology
  • Neural Engineering
    Neural engineering
    Neural engineering is a discipline within biomedical engineering that uses engineering techniques to understand, repair, replace, enhance, or otherwise exploit the properties of neural systems...



Sometimes, disciplines within BME are classified by their association(s) with other, more established engineering fields, which can include:
  • Chemical engineering
    Chemical engineering
    Chemical engineering is the branch of engineering that deals with physical science , and life sciences with mathematics and economics, to the process of converting raw materials or chemicals into more useful or valuable forms...

     - often associated with biochemical
    Biochemical engineering
    Biochemical engineering is a branch of chemical engineering or biological engineering that mainly deals with the design and construction of unit processes that involve biological organisms or molecules, such as bioreactors...

    , cellular, molecular
    Molecular engineering
    Molecular engineering is any means of manufacturing molecules. It may be used to create, on an extremely small scale, most typically one at a time, new molecules which may not exist in nature, or be stable beyond a very narrow range of conditions....

     and tissue engineering
    Tissue engineering
    Tissue engineering is the use of a combination of cells, engineering and materials methods, and suitable biochemical and physio-chemical factors to improve or replace biological functions...

    , biomaterials, and biotransport
    Transport Phenomena
    Transport Phenomena is the first textbook that is about transport phenomena. It is specifically designed for chemical engineering students...

    .
  • Electrical engineering
    Electrical engineering
    Electrical engineering is a field of engineering that generally deals with the study and application of electricity, electronics and electromagnetism. The field first became an identifiable occupation in the late nineteenth century after commercialization of the electric telegraph and electrical...

     - often associated with bioelectrical and neural engineering
    Neural engineering
    Neural engineering is a discipline within biomedical engineering that uses engineering techniques to understand, repair, replace, enhance, or otherwise exploit the properties of neural systems...

    , bioinstrumentation, biomedical imaging, and medical devices. This also tends to encompass Optics
    Optics
    Optics is the branch of physics which involves the behavior and properties of light, including its interactions with matter and the construction of instruments that use or detect it. Optics usually describes the behavior of visible, ultraviolet, and infrared light...

     and Optical engineering
    Optical engineering
    Optical engineering is the field of study that focuses on applications of optics. Optical engineers design components of optical instruments such as lenses, microscopes, telescopes, and other equipment that utilizes the properties of light. Other devices include optical sensors and measurement...

     - biomedical optics, imaging and related medical devices.
  • Mechanical engineering
    Mechanical engineering
    Mechanical engineering is a discipline of engineering that applies the principles of physics and materials science for analysis, design, manufacturing, and maintenance of mechanical systems. It is the branch of engineering that involves the production and usage of heat and mechanical power for the...

     - often associated with biomechanics
    Biomechanics
    Biomechanics is the application of mechanical principles to biological systems, such as humans, animals, plants, organs, and cells. Perhaps one of the best definitions was provided by Herbert Hatze in 1974: "Biomechanics is the study of the structure and function of biological systems by means of...

    , biotransport
    Transport Phenomena
    Transport Phenomena is the first textbook that is about transport phenomena. It is specifically designed for chemical engineering students...

    , medical devices, and modeling of biological systems
    Systems biology
    Systems biology is a term used to describe a number of trends in bioscience research, and a movement which draws on those trends. Proponents describe systems biology as a biology-based inter-disciplinary study field that focuses on complex interactions in biological systems, claiming that it uses...

    , like soft tissue
    Soft tissue
    In anatomy, the term soft tissue refers to tissues that connect, support, or surround other structures and organs of the body, not being bone. Soft tissue includes tendons, ligaments, fascia, skin, fibrous tissues, fat, and synovial membranes , and muscles, nerves and blood vessels .It is sometimes...

     mechanics.

Biotechnology and pharmaceuticals

Biotechnology
Biotechnology
Biotechnology is a field of applied biology that involves the use of living organisms and bioprocesses in engineering, technology, medicine and other fields requiring bioproducts. Biotechnology also utilizes these products for manufacturing purpose...

 (see also relatedly bioengineering) can be a somewhat ambiguous term, sometimes loosely used interchangeably with BME in general; however, it more typically denotes specific products which use "biological systems, living organisms, or derivatives thereof." Even some complex "medical devices" (see below) can reasonably be deemed "biotechnology" depending on the degree to which such elements are central to their principle of operation. Biologics/Biopharmaceuticals (e.g., vaccines, stored blood product), genetic engineering, and various agricultural applications are some major classes of biotechnology.

Pharmaceuticals are related to biotechnology in two indirect ways: 1) certain major types (e.g. biologics) fall under both categories, and 2) together they essentially comprise the "non-medical-device" set of BME applications. (The "Device - Bio/Chemical" spectrum is an imperfect dichotomy, but one regulators often use, at least as a starting point.)

Tissue engineering

Tissue engineering is a major segment of Biotechnology.

One of the goals of tissue engineering is to create artificial organs (via biological material) for patients that need organ transplants. Biomedical engineers are currently researching methods of creating such organs. Researchers have grown solid jawbones and trachea
Vertebrate trachea
In tetrapod anatomy the trachea, or windpipe, is a tube that connects the pharynx or larynx to the lungs, allowing the passage of air. It is lined with pseudostratified ciliated columnar epithelium cells with goblet cells that produce mucus...

s from human stem cells towards this end. Several artificial urinary bladder
Artificial urinary bladder
An artificial urinary bladder is an artificial organ to replace a urinary bladder.On April 4, 2006, it was announced that a team of biologists at the Wake Forest University School of Medicine, led by Professor Anthony Atala, had created the world's first lab-grown organ, a bladder, and transplanted...

s actually have been grown in laboratories and transplanted successfully into human patients. Bioartificial organs, which use both synthetic and biological components, are also a focus area in research, such as with hepatic assist devices that use liver cells within an artificial bioreactor construct.

Genetic engineering

Genetic engineering, recombinant DNA technology, genetic modification/manipulation (GM) and gene splicing are terms that apply to the direct manipulation of an organism's genes. Genetic engineering is different from traditional breeding, where the organism's genes are manipulated indirectly. Genetic engineering uses the techniques of molecular cloning and transformation to alter the structure and characteristics of genes directly. Genetic engineering techniques have found success in numerous applications. Some examples are in improving crop technology (not a medical application per se; see BioSystems Engineering
Biosystems engineering
The case in EUROPE:Biosystems Engineering is a field of engineering which integrates engineering science and design with applied biological, environmental and agricultural sciences. It represents an evolution of the Agricultural Engineering discipline applied to all living organisms not including...

), the manufacture of synthetic human insulin through the use of modified bacteria, the manufacture of erythropoietin in hamster ovary cells, and the production of new types of experimental mice such as the oncomouse (cancer mouse) for research.

Neural engineering

Neural engineering
Neural engineering
Neural engineering is a discipline within biomedical engineering that uses engineering techniques to understand, repair, replace, enhance, or otherwise exploit the properties of neural systems...

 (also known as Neuroengineering) is a discipline that uses engineering techniques to understand, repair, replace, or enhance neural systems. Neural engineers are uniquely qualified to solve design problems at the interface of living neural tissue and non-living constructs.

Pharmaceutical engineering

Pharmaceutical Engineering is sometimes regarded as a branch of biomedical engineering, and sometimes a branch of chemical engineering
Chemical engineering
Chemical engineering is the branch of engineering that deals with physical science , and life sciences with mathematics and economics, to the process of converting raw materials or chemicals into more useful or valuable forms...

; in practice, it is very much a hybrid sub-discipline (as many BME fields are). Aside from those pharmaceutical products directly incorporating biological agents or materials, even developing chemical drugs is considered to require substantial BME knowledge due to the physiological interactions inherent to such products' usage. With the increasing prevalence of "combination products," the lines are now blurring among healthcare products such as drugs, biologics, and various types of devices.

Medical devices

This is an extremely broad category -- essentially covering all health care products that do not achieve their intended results through predominantly chemical (e.g., pharmaceuticals) or biological (e.g., vaccines) means, and do not involve metabolism.

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,


Some examples include pacemaker
Artificial pacemaker
A pacemaker is a medical device that uses electrical impulses, delivered by electrodes contacting the heart muscles, to regulate the beating of the heart...

s, infusion pump
Infusion pump
An infusion pump infuses fluids, medication or nutrients into a patient's circulatory system. It is generally used intravenously, although subcutaneous, arterial and epidural infusions are occasionally used....

s, the heart-lung machine
Heart-lung machine
Cardiopulmonary bypass is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body. The CPB pump itself is often referred to as a heart–lung machine or "the pump"...

, dialysis
Dialysis
In medicine, dialysis is a process for removing waste and excess water from the blood, and is primarily used to provide an artificial replacement for lost kidney function in people with renal failure...

 machines, artificial organs
Tissue engineering
Tissue engineering is the use of a combination of cells, engineering and materials methods, and suitable biochemical and physio-chemical factors to improve or replace biological functions...

, implants
Implant (medicine)
An implant is a medical device manufactured to replace a missing biological structure, support a damaged biological structure, or enhance an existing biological structure. Medical implants are man-made devices, in contrast to a transplant, which is a transplanted biomedical tissue...

, artificial limbs, corrective lenses, cochlear implant
Cochlear implant
A cochlear implant is a surgically implanted electronic device that provides a sense of sound to a person who is profoundly deaf or severely hard of hearing...

s, ocular prosthetics, facial prosthetics, somato prosthetics, and dental implant
Dental implant
A dental implant is a "root" device, usually made of titanium, used in dentistry to support restorations that resemble a tooth or group of teeth to replace missing teeth....

s.
Stereolithography
Stereolithography
Stereolithography is an additive manufacturing technology for producing models, prototypes, patterns, and in some cases, production parts.-Technology description:...

 is a practical example of medical modeling being 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 are regulated and classified (in the US) as follows (see also Regulation):
  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
    Postmarketing surveillance
    Postmarketing surveillance is the practice of monitoring the safety of a pharmaceutical drug or device after it has been released on the market and is an important part of the science of pharmacovigilance...

    . 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 generally require premarket approval (PMA) or premarket notification (510k), 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, hip and knee joint implants, silicone gel-filled breast implants, implanted cerebellar stimulators, implantable pacemaker pulse generators and endosseous (intra-bone) implants.

Medical imaging

Medical/biomedical imaging is a major segment of medical device
Medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...

s. This area deals with enabling clinicians to directly or indirectly "view" things not visible in plain sight (such as due to their size, and/or location). This can involve utilizing ultrasound, magnetism, UV, other radiology, and other means.

Imaging technologies are often essential to medical diagnosis, and are typically the most complex equipment found in a hospital including:
  • Fluoroscopy
    Fluoroscopy
    Fluoroscopy is an imaging technique commonly used by physicians to obtain real-time moving images of the internal structures of a patient through the use of a fluoroscope. In its simplest form, a fluoroscope consists of an X-ray source and fluorescent screen between which a patient is placed...

  • Magnetic resonance imaging
    Magnetic resonance imaging
    Magnetic resonance imaging , nuclear magnetic resonance imaging , or magnetic resonance tomography is a medical imaging technique used in radiology to visualize detailed internal structures...

     (MRI)
  • Nuclear medicine
    Nuclear medicine
    In nuclear medicine procedures, elemental radionuclides are combined with other elements to form chemical compounds, or else combined with existing pharmaceutical compounds, to form radiopharmaceuticals. These radiopharmaceuticals, once administered to the patient, can localize to specific organs...

  • Positron emission tomography
    Positron emission tomography
    Positron emission tomography is nuclear medicine imaging technique that produces a three-dimensional image or picture of functional processes in the body. The system detects pairs of gamma rays emitted indirectly by a positron-emitting radionuclide , which is introduced into the body on a...

     (PET) PET scans
    Positron emission tomography
    Positron emission tomography is nuclear medicine imaging technique that produces a three-dimensional image or picture of functional processes in the body. The system detects pairs of gamma rays emitted indirectly by a positron-emitting radionuclide , which is introduced into the body on a...

    PET-CT scans
  • Projection radiography such as X-ray
    X-ray
    X-radiation is a form of electromagnetic radiation. X-rays have a wavelength in the range of 0.01 to 10 nanometers, corresponding to frequencies in the range 30 petahertz to 30 exahertz and energies in the range 120 eV to 120 keV. They are shorter in wavelength than UV rays and longer than gamma...

    s and CT scans
    Computed tomography
    X-ray computed tomography or Computer tomography , is a medical imaging method employing tomography created by computer processing...

  • Tomography
    Tomography
    Tomography refers to imaging by sections or sectioning, through the use of any kind of penetrating wave. A device used in tomography is called a tomograph, while the image produced is a tomogram. The method is used in radiology, archaeology, biology, geophysics, oceanography, materials science,...

  • Ultrasound
    Ultrasound
    Ultrasound is cyclic sound pressure with a frequency greater than the upper limit of human hearing. Ultrasound is thus not separated from "normal" sound based on differences in physical properties, only the fact that humans cannot hear it. Although this limit varies from person to person, it is...

  • Optical microscopy
  • Electron microscopy

Implants

An implant is a kind of medical device made to replace and act as a missing biological structure (as compared with a transplant, which indicates transplanted biomedical tissue). The surface of implants that contact the body might be made of a biomedical material such as titanium, silicone or apatite depending on what is the most functional. In some cases implants contain electronics e.g. artificial pacemaker and cochlear implants. Some implants are bioactive, such as subcutaneous drug delivery devices in the form of implantable pills or drug-eluting stents.

Clinical engineering

Clinical engineering
Clinical engineering
Clinical engineering is a specialty within Biomedical engineering responsible primarily for applying and implementing medical technology to optimize healthcare delivery...

 is the branch of biomedical engineering dealing with the actual implementation of medical equipment
Medical equipment
Medical equipment is designed to aid in the diagnosis, monitoring or treatment of medical conditions.-Types:There are several basic types:* Diagnostic equipment includes medical imaging machines, used to aid in diagnosis...

 and technologies in hospitals or other clinical settings. Major roles of clinical engineers include training and supervising biomedical equipment technicians (BMETs)
Biomedical Equipment Technician
A Bio-Medical Equipment Technician, also referred to as a Biomed, Biomedical Engineering Technologist , Biomed Equipment Technician, a Biomedical Equipment Specialist or Electronics and Biomedical Engineer is a highly skilled electromechanical technologist that ensures that medical equipment is...

, selecting technological products/services and logistically managing their implementation, working with governmental regulators on inspections/audits, and serving as technological consultants for other hospital staff (e.g. physicians, administrators, I.T., etc.). Clinical engineers also advise and collaborate with medical device producers regarding prospective design improvements based on clinical experiences, as well as monitor the progression of the state-of-the-art so as to redirect procurement patterns accordingly.

Their inherent focus on practical implementation of technology has tended to keep them oriented more towards incremental-level redesigns and reconfigurations, as opposed to revolutionary research & development or ideas that would be many years from clinical adoption; however, there is a growing effort to expand this time-horizon over which clinical engineers can influence the trajectory of biomedical innovation. In their various roles, they form a "bridge" between the primary designers and the end-users, by combining the perspectives of being both 1) close to the point-of-use, while 2) trained in product and process engineering. Clinical Engineering departments will sometimes hire not just biomedical engineers, but also industrial/systems engineers to help address operations research/optimization, human factors, cost analysis, etc. Also see safety engineering
Safety engineering
Safety engineering is an applied science strongly related to systems engineering / industrial engineering and the subset System Safety Engineering...

 for a discussion of the procedures used to design safe systems.

A point of reference for clinical engineers would be the catalogue published by The American Society for Hospital Engineering in the Hospital Engineering Reference Series called Maintenance Management for Medical Equipment!

Regulatory issues

Regulatory issues are of particular concern to a biomedical engineer; it is among the most heavily-regulated fields of engineering, and practicing biomedical engineers must routinely consult and cooperate with regulatory law attorneys and other experts. The Food and Drug Administration (FDA) is the principal healthcare regulatory authority in the United States, having jurisdiction over medical devices, drugs, biologics, and combination products. The paramount objectives driving policy decisions by the FDA are safety and efficacy of healthcare products.

In addition, because biomedical engineers often develop devices and technologies for "consumer" use, such as physical therapy devices (which are also "medical" devices), these may also be governed in some respects by the Consumer Product Safety Commission
Consumer Product Safety Commission
The United States Consumer Product Safety Commission is an independent agency of the United States government created in 1972 through the Consumer Product Safety Act to protect "against unreasonable risks of injuries associated with consumer products." The CPSC is an independent agency that does...

. The greatest hurdles tend to be 510K "clearance" (typically for Class 2 devices) or pre-market "approval" (typically for drugs and class 3 devices).
Most countries have their own particular mechanisms for regulation, with varying formulations and degrees of restrictiveness. In most European countries, more discretion rests with the prescribing doctor, while the regulations chiefly assure that the product operates as expected. In European Union nations, the national governments license certifying agencies, which are for-profit companies. Technical committees of engineers write recommendations which incorporate public comments, and these can be adopted as regulations by the European Union
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...

. 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
CE mark
CE marking is a mandatory conformity mark for products placed on the market in the European Economic Area . With the CE marking on a product the manufacturer ensures that the product conforms with the essential requirements of the applicable EC directives...

, indicating that the device is believed to be safe and reliable when used as directed.

The different regulatory arrangements sometimes result in particular technologies being developed first for either the U.S. or in Europe depending on the more favorable form of regulation. While nations often strive for substantive harmony to facilitate cross-national distribution, philosophical differences about the optimal extent of regulation can be a hindrance; more restrictive regulations seem appealing on an intuitive level, but critics decry the tradeoff cost in terms of slowing access to life-saving developments.

Education

Biomedical engineers require considerable knowledge of both engineering and biology, and typically have a Master's (M.S., M.S.E., or M.Eng.) or a Doctoral (Ph.D.) degree in BME (Biomedical Engineering) or another branch of engineering with considerable potential for BME overlap. As interest in BME is increasing, many engineering colleges now have a Biomedical Engineering Department or Program, with offerings ranging from the undergraduate (B.S. or B.S.E.) to the doctoral levels. As noted above, biomedical engineering has only recently been emerging as its own discipline rather than a cross-disciplinary hybrid specialization of other disciplines; now, BME programs of study at all levels are becoming more widespread, including the Bachelor of Science in Biomedical Engineering
Bachelor of Science in Biomedical Engineering
A Bachelor of Science in Biomedical Engineering is a kind of bachelor's degree typically conferred after a four year undergraduate course of study in biomedical engineering . The degree itself is largely equivalent to a bachelor of science and many institutions conferring degrees in the fields of...

 which actually includes so much biological science content that many students use it as a "pre-med" major in preparation for medical school
Medical school
A medical school is a tertiary educational institution—or part of such an institution—that teaches medicine. Degree programs offered at medical schools often include Doctor of Osteopathic Medicine, Bachelor/Doctor of Medicine, Doctor of Philosophy, master's degree, or other post-secondary...

. The number of biomedical engineers is expected to rise as both a cause and effect of improvements in medical technology.

In the U.S., an increasing number of undergraduate programs are also becoming recognized by ABET
Abet
Abet may refer to:* Abet Guidaben , former Philippine Basketball Association basketball player* ABET, Inc., a non-profit organization that accredits higher education programs in applied science, computing, engineering, and technology....

 as accredited bioengineering/biomedical engineering programs. Over 65 programs are currently accredited by ABET.

In Canada, an accredited graduate program in Biomedical Engineering is common in Universities such as McMaster University
McMaster University
McMaster University is a public research university whose main campus is located in Hamilton, Ontario, Canada. The main campus is located on of land in the residential neighbourhood of Westdale, adjacent to Hamilton's Royal Botanical Gardens...

, and the first stand-alone undergraduate BME program is at Ryerson University
Ryerson University
Ryerson University is a public research university located in downtown Toronto, Ontario, Canada. Its urban campus is adjacent to Yonge-Dundas Square located at the busiest intersection in Downtown Toronto. The majority of its buildings are in the blocks northeast of the square in Toronto's Garden...

  offering a four year B.Eng program.

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. With BME specifically, the ranking of a university's hospital and medical school can also be a significant factor in the perceived prestige of its BME department/program.

Graduate education
Graduate school
A graduate school is a school that awards advanced academic degrees with the general requirement that students must have earned a previous undergraduate degree...

 is a particularly important aspect in BME. While many engineering fields (such as mechanical or electrical engineering) do not need graduate-level training to obtain an entry-level job in their field, the majority of BME positions do prefer or even require them. Since most BME-related professions involve scientific research, such as in pharmaceutical and medical device
Medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...

 development, graduate education is almost a requirement (as undergraduate degrees typically do not involve sufficient research training and experience). This can be either a Masters or Doctoral level degree; while in certain specialties a Ph.D. is notably more common than in others, it is hardly ever the majority (except in academia). In fact, the perceived need for some kind of graduate credential is so strong that some undergraduate BME programs will actively discourage students from majoring in BME without an expressed intention to also obtain a masters degree or apply to medical school afterwards.

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 (such as the University's Medical School or other engineering divisions), owing again to the interdisciplinary nature of BME. M.S. and Ph.D. programs will typically require applicants to have an undergraduate degree in BME, or another engineering discipline (plus certain life science coursework), or life science (plus certain engineering coursework).

Education in BME also varies greatly around the world. By virtue of its extensive biotechnology sector, its numerous major universities, and relatively few internal barriers, the U.S. has progressed a great deal in its development of BME education and training opportunities. 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 supplant some of the national jurisdictional barriers that still exist. Recently, initiatives such as BIOMEDEA have sprung up to develop BME-related education and professional standards. Other countries, such as Australia, are recognizing and moving to correct deficiencies in their BME education. 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.

BME lectures with theory, tasks and solutions for teaching.

Licensure/certification

Engineering licensure in the US is largely optional, and rarely specified by branch/discipline. As with other learned professions, each state has certain (fairly similar) requirements for becoming licensed as a registered Professional Engineer
Professional Engineer
Regulation of the engineering profession is established by various jurisdictions of the world to protect the safety, well-being and other interests of the general public, and to define the licensure process through which an engineer becomes authorized to provide professional services to the...

 (PE), but in practice such a license is not required to practice in the majority of situations (due to an exception known as the private industry exemption, which effectively applies to the vast majority of American engineers). This is notably not the case in many other countries, where a license is as legally necessary to practice engineering as it is for law or medicine.

Biomedical engineering is regulated in some countries, such as Australia, but registration is typically only recommended and not required.

In the UK, mechanical engineers working in the areas of Medical Engineering, Bioengineering or Biomedical engineering can gain Chartered Engineer
Chartered Engineer (UK)
In the United Kingdom, a Chartered Engineer is an engineer registered with Engineering Council UK . Contemporary Chartered Engineers are master's degree-qualified and have gained professional competencies through training and experience...

 status through the Institution of Mechanical Engineers
Institution of Mechanical Engineers
The Institution of Mechanical Engineers is the British engineering society based in central London, representing mechanical engineering. It is licensed by the Engineering Council UK to assess candidates for inclusion on ECUK's Register of professional Engineers...

. The Institution also runs the Engineering in Medicine and Health Division.

The Fundamentals of Engineering exam
Fundamentals of Engineering exam
The Fundamentals of Engineering exam, also referred to as the Engineer in Training exam, and formerly in some states as the Engineering Intern exam, is the first of two examinations that engineers must pass in order to be licensed as a Professional Engineer in the United States...

 - the first (and more general) of two licensure examinations for most U.S. jurisdictions—does now cover biology (although technically not BME). For the second exam, called the Principles and Practices, Part 2, or the Professional Engineering exam, candidates may select a particular engineering discipline's content to be tested on; there is currently not an option for BME with this, meaning that any biomedical engineers seeking a license must prepare to take this examination in another category (which does not affect the actual license, since most jurisdictions do not recognize discipline specialties anyway). However, the Biomedical Engineering Society (BMES) is, as of 2009, exploring the possibility of seeking to implement a BME-specific version of this exam to facilitate biomedical engineers pursuing licensure.

Beyond governmental registration, certain private-sector professional/industrial organizations also offer certifications with varying degrees of prominence. One such example is the Certified Clinical Engineer (CCE) certification for Clinical engineers.

Founding figures

  • Leslie Geddes (deceased)- Professor Emeritus at Purdue University
    Purdue University
    Purdue University, located in West Lafayette, Indiana, U.S., is the flagship university of the six-campus Purdue University system. Purdue was founded on May 6, 1869, as a land-grant university when the Indiana General Assembly, taking advantage of the Morrill Act, accepted a donation of land and...

    , electrical engineer, inventor and educator of over 2000 biomedical engineers, received a National Medal of Technology
    National Medal of Technology
    The National Medal of Technology and Innovation is an honor granted by the President of the United States to American inventors and innovators who have made significant contributions to the development of new and important technology...

     in 2006 from President George Bush 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
    Cardiopulmonary resuscitation
    Cardiopulmonary resuscitation is an emergency procedure which is performed in an effort to manually preserve intact brain function until further measures are taken to restore spontaneous blood circulation and breathing in a person in cardiac arrest. It is indicated in those who are unresponsive...

     (CPR).
  • Y. C. Fung
    Yuan-Cheng Fung
    Yuan-Cheng "Bert" Fung is a scientist regarded as a founding figure of bioengineering, tissue engineering, and the "Founder of Modern Biomechanics".-Biography:Fung was born in Jiangsu Province, China in 1919...

     - professor emeritus at the University of California, San Diego
    University of California, San Diego
    The University of California, San Diego, commonly known as UCSD or UC San Diego, is a public research university located in the La Jolla neighborhood of San Diego, California, United States...

    , considered by many to be the founder of modern Biomechanics
    Biomechanics
    Biomechanics is the application of mechanical principles to biological systems, such as humans, animals, plants, organs, and cells. Perhaps one of the best definitions was provided by Herbert Hatze in 1974: "Biomechanics is the study of the structure and function of biological systems by means of...

  • Robert Langer - Institute Professor
    Institute Professor
    Institute Professor is the highest title that can be awarded to a faculty member at the Massachusetts Institute of Technology, a research university located in Cambridge, Massachusetts, United States...

     at MIT, runs the largest BME laboratory in the world, pioneer in drug delivery
    Drug delivery
    Drug delivery is the method or process of administering a pharmaceutical compound to achieve a therapeutic effect in humans or animals. Drug delivery technologies modify drug release profile, absorption, distribution and elimination for the benefit of improving product efficacy and safety, as well...

     and tissue engineering
    Tissue engineering
    Tissue engineering is the use of a combination of cells, engineering and materials methods, and suitable biochemical and physio-chemical factors to improve or replace biological functions...

  • Herbert Lissner (deceased) - Professor of Engineering Mechanics at Wayne State University
    Wayne State University
    Wayne State University is a public research university located in Detroit, Michigan, United States, in the city's Midtown Cultural Center Historic District. Founded in 1868, WSU consists of 13 schools and colleges offering more than 400 major subject areas to over 32,000 graduate and...

    . Initiated studies on blunt head trauma and injury thresholds beginning in 1939 in collaboration with Dr. E.S. Gurdjian, a neurosurgeon at Wayne State's School of Medicine. Individual for whom the American Society of Mechanical Engineers
    American Society of Mechanical Engineers
    The American Society of Mechanical Engineers is a professional body, specifically an engineering society, focused on mechanical engineering....

    ' top award in Biomedical Engineering, the Herbert R. Lissner Medal, is named.
  • Nicholas A. Peppas
    Nicholas A. Peppas
    Nicholas A. Peppas is a chemical and biomedical engineer whose leadership in biomaterials science and engineering, drug delivery, bionanotechnology, pharmaceutical sciences, chemical and polymer engineering has led to numerous biomedical products or devices.-Education and work:He was educated in...

     - Chaired Professor in Engineering
    Engineering
    Engineering is the discipline, art, skill and profession of acquiring and applying scientific, mathematical, economic, social, and practical knowledge, in order to design and build structures, machines, devices, systems, materials and processes that safely realize improvements to the lives of...

    , University of Texas at Austin
    University of Texas at Austin
    The University of Texas at Austin is a state research university located in Austin, Texas, USA, and is the flagship institution of the The University of Texas System. Founded in 1883, its campus is located approximately from the Texas State Capitol in Austin...

    , pioneer in drug delivery
    Drug delivery
    Drug delivery is the method or process of administering a pharmaceutical compound to achieve a therapeutic effect in humans or animals. Drug delivery technologies modify drug release profile, absorption, distribution and elimination for the benefit of improving product efficacy and safety, as well...

    , biomaterials, hydrogels and nanobiotechnology
    Nanobiotechnology
    Bionanotechnology, nanobiotechnology, and nanobiology are terms that refer to the intersection of nanotechnology and biology. Given that the subject is one that has only emerged very recently, bionanotechnology and nanobiotechnology serve as blanket terms for various related technologies.This...

    .
  • Otto Schmitt
    Otto Schmitt
    Otto Herbert Schmitt was an American inventor, engineer, and biophysicist known for his scientific contributions to biophysics and for establishing the field of biomedical engineering...

     (deceased) - biophysicist with significant contributions to BME, working with biomimetics
    Biomimetics
    Biomimetics is the study of the structure and function of biological systems as models for the design and engineering of materials and machines. It is widely regarded as being synonymous with biomimicry, biomimesis, biognosis and similar to biologically inspired design.-History:The term biomimetics...

  • Ascher Shapiro (deceased) - Institute Professor
    Institute Professor
    Institute Professor is the highest title that can be awarded to a faculty member at the Massachusetts Institute of Technology, a research university located in Cambridge, Massachusetts, United States...

     at MIT, contributed to the development of the BME field, medical devices (e.g. intra-aortic balloons)
  • John G. Webster
    John G. Webster
    John G. Webster is an American electrical engineer and a founding pioneer in the field of biomedical engineering.Webster attained his Ph.D. from the University of Rochester in 1967....

     - Professor Emeritus at the University of Wisconsin–Madison
    University of Wisconsin–Madison
    The University of Wisconsin–Madison is a public research university located in Madison, Wisconsin, United States. Founded in 1848, UW–Madison is the flagship campus of the University of Wisconsin System. It became a land-grant institution in 1866...

    , a pioneer in the field of instrumentation amplifier
    Instrumentation amplifier
    An instrumentation amplifier is a type of differential amplifier that has been outfitted with input buffers, which eliminate the need for input impedance matching and thus make the amplifier particularly suitable for use in measurement and test equipment...

    s for the recording of electrophysiological signals
    Electrophysiology
    Electrophysiology is the study of the electrical properties of biological cells and tissues. It involves measurements of voltage change or electric current on a wide variety of scales from single ion channel proteins to whole organs like the heart...

  • Robert Plonsey
    Robert Plonsey
    Robert Plonsey is currently the Pfizer-Pratt University Professor Emeritus of Biomedical Engineering at Duke University. He is noted for his work on bioelectricty.-Education:Plonsey was born in New York City in 1924. He received the B.E.E...

     - Professor Emeritus at Duke University
    Duke University
    Duke University is a private research university located in Durham, North Carolina, United States. Founded by Methodists and Quakers in the present day town of Trinity in 1838, the school moved to Durham in 1892. In 1924, tobacco industrialist James B...

    , pioneer of electrophysiology
  • U. A. Whitaker
    U. A. Whitaker
    Uncas Aeneas Whitaker was raised in Missouri. He was a prominent mechanical engineer, electrical engineer, lawyer, entrepreneur, and philanthropist...

     (deceased) - provider of The Whitaker Foundation
    Whitaker Foundation
    The Whitaker Foundation was based in Arlington, Virginia and was an organization that primarily supported biomedical engineering education and research, but also supported other forms of medical research. It was founded and funded by U. A. Whitaker in 1975 upon his death with additional support...

    , 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
  • Frederick Thurstone (deceased) - Professor Emeritus at Duke University
    Duke University
    Duke University is a private research university located in Durham, North Carolina, United States. Founded by Methodists and Quakers in the present day town of Trinity in 1838, the school moved to Durham in 1892. In 1924, tobacco industrialist James B...

    , pioneer of diagnostic ultrasound
  • Kenneth R. Diller - Chaired and Endowed Professor in Engineering
    Engineering
    Engineering is the discipline, art, skill and profession of acquiring and applying scientific, mathematical, economic, social, and practical knowledge, in order to design and build structures, machines, devices, systems, materials and processes that safely realize improvements to the lives of...

    , University of Texas at Austin
    University of Texas at Austin
    The University of Texas at Austin is a state research university located in Austin, Texas, USA, and is the flagship institution of the The University of Texas System. Founded in 1883, its campus is located approximately from the Texas State Capitol in Austin...

    . Founded the BME department at UT Austin. Pioneer in bioheat transfer, mass transfer, and biotransport
  • Alfred E. Mann
    Alfred E. Mann
    Alfred E. Mann , who is also known as Al Mann, is an American entrepreneur and philanthropist. According to Forbes magazine, his estimated net worth exceeded $2.2 billion as of 2007, ranking him the 204th richest man in America and the 390th richest man in the world.Born and raised in Portland, his...

     - Physicist, entrepreneur and philanthropist. A pioneer in the field of Biomedical Engineering.
  • Forrest Bird
    Forrest Bird
    Forrest M. Bird is an American aviator, inventor and biomedical engineer. He is best known for creating some of the first reliable mass-produced mechanical ventilators for acute and chronic cardiopulmonary care.-Biography:...

     - aviator and pioneer in the invention of mechanical ventilators
  • Willem Johan Kolff
    Willem Johan Kolff
    Willem Johan "Pim" Kolff was a pioneer of hemodialysis as well as in the field of artificial organs. Willem is a member of the Kolff family, an old Dutch patrician family. He made his major discoveries in the field of dialysis for kidney failure during the Second World War...

     (deceased) - pioneer of hemodialysis
    Hemodialysis
    In medicine, hemodialysis is a method for removing waste products such as creatinine and urea, as well as free water from the blood when the kidneys are in renal failure. Hemodialysis is one of three renal replacement therapies .Hemodialysis can be an outpatient or inpatient therapy...

     as well as in the field of artificial organs
  • John James Rickard Macleod(deceased) - one of the co-discoverers of insulin at Case Western Reserve University
    Case Western Reserve University
    Case Western Reserve University is a private research university located in Cleveland, Ohio, USA...

    .
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