Biomedicine (also referred to as Western medicine, mainstream medicine or conventional medicine) is a branch of medical science that applies biological and physiological principles to clinical practice.
Biomedicine stresses standardized, evidence-based treatment validated
through biological research, with treatment administered via formally
trained doctors, nurses, and other such licensed practitioners.
Biomedicine also can relate to many other categories in health and biological related fields. It has been the dominant system of medicine in the Western world for more than a century.
Biomedicine is based on molecular biology and combines all issues of developing molecular medicine into large-scale structural and functional relationships of the human genome, transcriptome, proteome, physiome and metabolome with the particular point of view of devising new technologies for prediction, diagnosis and therapy
Biomedicine involves the study of (patho-) physiological processes with methods from biology and physiology. Approaches range from understanding molecular interactions to the study of the consequences at the in vivo level. These processes are studied with the particular point of view of devising new strategies for diagnosis and therapy.
Depending on the severity of the disease, biomedicine pinpoints a
problem within a patient and fixes the problem through medical
intervention. Medicine focuses on curing diseases rather than improving
one's health.
In social sciences biomedicine is described somewhat differently.
Through an anthropological lens biomedicine extends beyond the realm of
biology and scientific facts; it is a socio-cultural
system which collectively represents reality. While biomedicine is
traditionally thought to have no bias due to the evidence-based
practices, Gaines & Davis-Floyd (2004) highlight that biomedicine
itself has a cultural basis and this is because biomedicine reflects the
norms and values of its creators.
Molecular biology
Molecular biology is the process of synthesis and regulation of a
cell's DNA, RNA, and protein. Molecular biology consists of different
techniques including Polymerase chain reaction, Gel electrophoresis, and
macromolecule blotting to manipulate DNA.
Polymerase chain reaction is done by placing a mixture of the desired DNA, DNA polymerase, primers, and nucleotide bases
into a machine. The machine heats up and cools down at various
temperatures to break the hydrogen bonds binding the DNA and allows the
nucleotide bases to be added onto the two DNA templates after it has
been separated.
Gel electrophoresis
is a technique used to identify similar DNA between two unknown samples
of DNA. This process is done by first preparing an agarose gel. This
jelly-like sheet will have wells for DNA to be poured into. An electric
current is applied so that the DNA, which is negatively charged due to
its phosphate
groups is attracted to the positive electrode. Different rows of DNA
will move at different speeds because some DNA pieces are larger than
others. Thus if two DNA samples show a similar pattern on the gel
electrophoresis, one can tell that these DNA samples match.
Macromolecule blotting
is a process performed after gel electrophoresis. An alkaline solution
is prepared in a container. A sponge is placed into the solution and an
agaros gel is placed on top of the sponge. Next, nitrocellulose paper is
placed on top of the agarose gel and a paper towels are added on top of
the nitrocellulose paper to apply pressure. The alkaline solution is
drawn upwards towards the paper towel. During this process, the DNA
denatures in the alkaline solution and is carried upwards to the
nitrocellulose paper. The paper is then placed into a plastic bag and
filled with a solution full of the DNA fragments, called the probe,
found in the desired sample of DNA. The probes anneal to the
complementary DNA of the bands already found on the nitrocellulose
sample. Afterwards, probes are washed off and the only ones present are
the ones that have annealed to complementary DNA on the paper. Next the
paper is stuck onto an x ray film. The radioactivity of the probes
creates black bands on the film, called an autoradiograph. As a result,
only similar patterns of DNA to that of the probe are present on the
film. This allows us the compare similar DNA sequences of multiple DNA
samples. The overall process results in a precise reading of
similarities in both similar and different DNA sample.
Biochemistry
Biochemistry is the science of the chemical processes which takes
place within living organisms. Living organisms need essential elements
to survive, among which are carbon, hydrogen, nitrogen, oxygen, calcium,
and phosphorus. These elements make up the four macromolecules that
living organisms need to survive: carbohydrates, lipids, proteins, and
nucleic acids.
Carbohydrates, made up of carbon, hydrogen, and oxygen, are energy-storing molecules. The simplest carbohydrate is glucose,
C6H12O6, is used in cellular respiration to produce ATP, adenosine triphosphate, which supplies cells with energy.
Proteins
are chains of amino acids that function, among other things, to
contract skeletal muscle, as catalysts, as transport molecules, and as
storage molecules. Protein catalysts can facilitate biochemical
processes by lowering the activation energy of a reaction. Hemoglobins
are also proteins, carrying oxygen to an organism's cells.
Lipids, also known as fats, are small molecules derived from biochemical subunits from either the ketoacyl or isoprene groups. Creating eight distinct categories: fatty acids, glycerolipids, glycerophospholipids, sphingolipids, saccharolipids, and polyketides (derived from condensation of ketoacyl subunits); and sterol lipids and prenol lipids (derived from condensation of isoprene
subunits). Their primary purpose is to store energy over the long
term. Due to their unique structure, lipids provide more than twice the
amount of energy that carbohydrates
do. Lipids can also be used as insulation. Moreover, lipids can be used
in hormone production to maintain a healthy hormonal balance and
provide structure to cell membranes.
Nucleic acids
are a key component of DNA, the main genetic information-storing
substance, found oftentimes in the cell nucleus, and controls the
metabolic processes of the cell. DNA consists of two complementary
antiparallel strands consisting of varying patterns of nucleotides. RNA
is a single strand of DNA, which is transcribed from DNA and used for
DNA translation, which is the process for making proteins out of RNA
sequences.
Hemodialysis a process of purifying the blood of a person whose kidneys are not working normally.
Biomedical engineering (BME) or medical engineering
is the application of engineering principles and design concepts to
medicine and biology for healthcare purposes (e.g., diagnostic or
therapeutic). BME is also traditionally known as "bioengineering", but
this term has come to also refer to biological engineering. This field seeks to close the gap between engineering and medicine,
combining the design and problem-solving skills of engineering with
medical biological sciences to advance health care treatment, including diagnosis, monitoring, and therapy.
Also included under the scope of a biomedical engineer is the
management of current medical equipment in hospitals while adhering to
relevant industry standards. This involves making equipment
recommendations, procurement, routine testing, and preventive
maintenance, a role also known as a Biomedical Equipment Technician
(BMET) or as clinical engineering.
Biomedical engineering has recently emerged as its own study, as
compared to many other engineering fields. Such an evolution is common
as a new field transitions from being an interdisciplinary
specialization among already-established fields to being considered a
field in itself. Much of the work in biomedical engineering consists of research and development, spanning a broad array of subfields (see below). Prominent biomedical engineering applications include the development of biocompatibleprostheses, various diagnostic and therapeutic medical devices ranging from clinical equipment to micro-implants, common imaging equipment such as MRIs and EKG/ECGs, regenerative tissue growth, pharmaceutical drugs and therapeutic biologicals.
Bioinformatics
Example of an approximately 40,000 probe spotted oligo microarray with enlarged inset to show detail.
Bioinformatics is an interdisciplinary field that develops
methods and software tools for understanding biological data. As an
interdisciplinary field of science, bioinformatics combines computer
science, statistics, mathematics, and engineering to analyze and
interpret biological data.
Bioinformatics is considered both an umbrella term for the body
of biological studies that use computer programming as part of their
methodology, as well as a reference to specific analysis "pipelines"
that are repeatedly used, particularly in the field of genomics. Common
uses of bioinformatics include the identification of candidate genes and
nucleotides (SNPs). Often, such identification is made with the aim of
better understanding the genetic basis of disease, unique adaptations,
desirable properties (esp. in agricultural species), or differences
between populations. In a less formal way, bioinformatics also tries to
understand the organisational principles within nucleic acid and protein
sequences.
Biomechanics is the study of the structure and function of the
mechanical aspects of biological systems, at any level from whole organisms to organs, cells and cell organelles, using the methods of mechanics.
Biomaterial
A biomaterial is any matter, surface, or construct that interacts with living systems. As a science, biomaterials is about fifty years old. The study of biomaterials is called biomaterials science or biomaterials engineering.
It has experienced steady and strong growth over its history, with many
companies investing large amounts of money into the development of new
products. Biomaterials science encompasses elements of medicine,
biology, chemistry, tissue engineering and materials science.
Biomedical optics
Biomedical
optics refers to the interaction of biological tissue and light, and
how this can be exploited for sensing, imaging, and treatment.
Tissue engineering
Tissue engineering, like genetic engineering (see below), is a major segment of biotechnology – which overlaps significantly with BME.
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 tracheas from human stem cells towards this end. Several artificial urinary bladders have been grown in laboratories and transplanted successfully into human patients.
Bioartificial organs, which use both synthetic and biological
component, are also a focus area in research, such as with hepatic
assist devices that use liver cells within an artificial bioreactor
construct.
Micromass cultures of C3H-10T1/2 cells at varied oxygen tensions stained with Alcian blue.
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. Unlike traditional
breeding, an indirect method of genetic manipulation, genetic
engineering utilizes modern tools such as molecular cloning and
transformation to directly alter the structure and characteristics of
target genes. Genetic engineering techniques have found success in
numerous applications. Some examples include the improvement of crop
technology (not a medical application, but see biological systems engineering),
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
(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 an interdisciplinary science that includes drug engineering, novel
drug delivery and targeting, pharmaceutical technology, unit operations
of Chemical Engineering, and Pharmaceutical Analysis. It may be deemed as a part of pharmacy due to its focus on the use of technology on chemical agents in providing better medicinal treatment.
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
in the cure, mitigation, treatment, or prevention of disease.
Stereolithography 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, of complex diseases.
Medical devices are regulated and classified (in the US) as follows (see also Regulation):
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.
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.
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 devices.
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,
radiology, and other means.
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 pacemakers
and cochlear implants. Some implants are bioactive, such as subcutaneous
drug delivery devices in the form of implantable pills or drug-eluting stents.
Artificial body part replacements are one of the many applications of
bionics. Concerned with the intricate and thorough study of the
properties and function of human body systems, bionics may be applied to
solve some engineering problems. Careful study of the different
functions and processes of the eyes, ears, and other organs paved the
way for improved cameras, television, radio transmitters and receivers,
and many other tools.
Biomedical sensors
In
recent years biomedical sensors based in microwave technology have
gained more attention. Different sensors can be manufactured for
specific uses in both diagnosing and monitoring disease conditions, for
example microwave sensors can be used as a complementary technique to
X-ray to monitor lower extremity trauma.
The sensor monitor the dielectric properties and can thus notice change
in tissue (bone, muscle, fat etc.) under the skin so when measuring at
different times during the healing process the response from the sensor
will change as the trauma heals.
Clinical engineering
Clinical engineering is the branch of biomedical engineering dealing with the actual implementation of medical equipment and technologies in hospitals or other clinical settings. Major roles of clinical engineers include training and supervising biomedical equipment technicians (BMETs),
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 re configurations, 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 close to the point-of-use, while also 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
for a discussion of the procedures used to design safe systems.
Clinical engineering department is constructed with a manager,
supervisor, engineer and technician. One engineer per eighty beds in the
hospital is the ratio. Clinical engineers is also authorized audit
pharmaceutical and associated stores to monitor FDA recalls of invasive
items.
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. Functional areas addressed through
rehabilitation engineering may include mobility, communications,
hearing, vision, and cognition, and activities associated with
employment, independent living, education, and integration into the
community.
While some rehabilitation engineers have master's degrees in
rehabilitation engineering, usually a subspecialty of Biomedical
engineering, most rehabilitation engineers have an undergraduate or
graduate degrees in biomedical engineering, mechanical engineering, or
electrical engineering. A Portuguese university provides an
undergraduate degree and a master's degree in Rehabilitation Engineering
and Accessibility.
Qualification to become a Rehab' Engineer in the UK is possible via a
University BSc Honours Degree course such as Health Design &
Technology Institute, Coventry University.
The rehabilitation process for people with disabilities often
entails the design of assistive devices such as Walking aids intended to
promote the inclusion of their users into the mainstream of society,
commerce, and recreation.
Regulatory issues have been constantly increased in the last decades
to respond to the many incidents caused by devices to patients. For
example, from 2008 to 2011, in US, there were 119 FDA recalls of medical
devices classified as class I. According to U.S. Food and Drug
Administration (FDA), Class I recall
is associated to "a situation in which there is a reasonable
probability that the use of, or exposure to, a product will cause
serious adverse health consequences or death"
Regardless of the country-specific legislation, the main regulatory objectives coincide worldwide. For example, in the medical device regulations, a product must be: 1) safe and 2) effective and 3) for all the manufactured devices
A product is safe if patients, users and third parties do not run
unacceptable risks of physical hazards (death, injuries, ...) in its
intended use. Protective measures have to be introduced on the devices
to reduce residual risks at acceptable level if compared with the
benefit derived from the use of it.
A product is effective if it performs as specified by the
manufacturer in the intended use. Effectiveness is achieved through
clinical evaluation, compliance to performance standards or
demonstrations of substantial equivalence with an already marketed
device.
The previous features have to be ensured for all the manufactured
items of the medical device. This requires that a quality system shall
be in place for all the relevant entities and processes that may impact
safety and effectiveness over the whole medical device lifecycle.
The medical device engineering area 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 effectiveness of healthcare products that have to be
assured through a quality system in place as specified under 21 CFR 829 regulation.
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.
The greatest hurdles tend to be 510K "clearance" (typically for Class 2
devices) or pre-market "approval" (typically for drugs and class 3
devices).
In the European context, safety effectiveness and quality is
ensured through the "Conformity Assessment" that is defined as "the
method by which a manufacturer demonstrates that its device complies
with the requirements of the European Medical Device Directive".
The directive specifies different procedures according to the class of
the device ranging from the simple Declaration of Conformity (Annex VII)
for Class I devices to EC verification (Annex IV), Production quality
assurance (Annex V), Product quality assurance (Annex VI) and Full
quality assurance (Annex II). The Medical Device Directive specifies
detailed procedures for Certification. In general terms, these
procedures include tests and verifications that are to be contained in
specific deliveries such as the risk management file, the technical file
and the quality system deliveries. The risk management file is the
first deliverable that conditions the following design and manufacturing
steps. Risk management stage shall drive the product so that product
risks are reduced at an acceptable level with respect to the benefits
expected for the patients for the use of the device. The technical file
contains all the documentation data and records supporting medical
device certification. FDA technical file has similar content although
organized in different structure. The Quality System deliverables
usually includes procedures that ensure quality throughout all product
life cycle. The same standard (ISO EN 13485) is usually applied for
quality management systems in US and worldwide.
Implants, such as artificial hip joints, are generally extensively regulated due to the invasive nature of such devices.
In the European Union, there are certifying entities named "Notified Bodies",
accredited by the European Member States. The Notified Bodies must
ensure the effectiveness of the certification process for all medical
devices apart from the class I devices where a declaration of conformity
produced by the manufacturer is sufficient for marketing. Once a
product has passed all the steps required by the Medical Device
Directive, the device is entitled to bear a CE marking,
indicating that the device is believed to be safe and effective when
used as intended, and, therefore, it can be marketed within the European
Union area.
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.
RoHS II
Directive
2011/65/EU, better known as RoHS 2 is a recast of legislation
originally introduced in 2002. The original EU legislation "Restrictions
of Certain Hazardous Substances in Electrical and Electronics Devices"
(RoHS Directive 2002/95/EC) was replaced and superseded by 2011/65/EU
published in July 2011 and commonly known as RoHS 2.
RoHS
seeks to limit the dangerous substances in circulation in electronics
products, in particular toxins and heavy metals, which are subsequently
released into the environment when such devices are recycled.
The scope of RoHS 2 is widened to include products previously
excluded, such as medical devices and industrial equipment. In addition,
manufacturers are now obliged to provide conformity risk assessments
and test reports – or explain why they are lacking. For the first time,
not only manufacturers but also importers and distributors share a
responsibility to ensure Electrical and Electronic Equipment within the
scope of RoHS comply with the hazardous substances limits and have a CE
mark on their products.
IEC 60601
The new International Standard IEC 60601
for home healthcare electro-medical devices defining the requirements
for devices used in the home healthcare environment. IEC 60601-1-11
(2010) must now be incorporated into the design and verification of a
wide range of home use and point of care medical devices along with
other applicable standards in the IEC 60601 3rd edition series.
The mandatory date for implementation of the EN European version
of the standard is June 1, 2013. The US FDA requires the use of the
standard on June 30, 2013, while Health Canada recently extended the
required date from June 2012 to April 2013. The North American agencies
will only require these standards for new device submissions, while the
EU will take the more severe approach of requiring all applicable
devices being placed on the market to consider the home healthcare
standard.
AS/NZS 3551:2012
AS/ANS 3551:2012
is the Australian and New Zealand standards for the management of
medical devices. The standard specifies the procedures required to
maintain a wide range of medical assets in a clinical setting (e.g.
Hospital). The standards are based on the IEC 606101 standards.
The standard covers a wide range of medical equipment management
elements including, procurement, acceptance testing, maintenance
(electrical safety and preventive maintenance testing) and
decommissioning.
Training and certification
Education
Biomedical
engineers require considerable knowledge of both engineering and
biology, and typically have a Bachelor's (B.Sc., B.S., B.Eng. or B.S.E.)
or Master's (M.S., M.Sc., 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
increases, many engineering colleges now have a Biomedical Engineering
Department or Program, with offerings ranging from the undergraduate
(B.Sc., B.S., B.Eng. or B.S.E.) to doctoral levels. Biomedical
engineering has only recently been emerging as its own discipline
rather than a cross-disciplinary hybrid specialization of other
disciplines; and BME programs at all levels are becoming more
widespread, including the Bachelor of Science in Biomedical Engineering which actually includes so much biological science content that many students use it as a "pre-med" major in preparation for medical school. 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 as accredited bioengineering/biomedical engineering programs. Over 65 programs are currently accredited by ABET.
In Canada and Australia, accredited graduate programs in biomedical engineering are common. For example, McMaster University offers an M.A.Sc, an MD/PhD, and a PhD in Biomedical engineering. The first Canadian undergraduate BME program was offered at Ryerson University as a four-year B.Eng. program. The Polytechnique in Montreal is also offering a bachelors's degree in biomedical engineering as is Flinders University.
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 is
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
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
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 master's 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.
Licensure/certification
As with other learned professions, each state has certain (fairly similar) requirements for becoming licensed as a registered Professional Engineer
(PE), but, in US, in industry such a license is not required to be an
employee as an engineer in the majority of situations (due to an
exception known as the industrial exemption, which effectively applies
to the vast majority of American engineers). The US model has generally
been only to require the practicing engineers offering engineering
services that impact the public welfare, safety, safeguarding of life,
health, or property to be licensed, while engineers working in private
industry without a direct offering of engineering services to the public
or other businesses, education, and government need not be licensed.
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 status through the Institution of Mechanical Engineers. The Institution also runs the Engineering in Medicine and Health Division.
The Institute of Physics and Engineering in Medicine (IPEM) has a panel
for the accreditation of MSc courses in Biomedical Engineering and
Chartered Engineering status can also be sought through IPEM.
The Fundamentals of Engineering exam
– 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.
Career prospects
In
2012 there were about 19,400 biomedical engineers employed in the US,
and the field was predicted to grow by 27% (much faster than average)
from 2012 to 2022. Biomedical engineering has the highest percentage of female engineers compared to other common engineering professions.
Notable figures
Earl Bakken - Invented the first transistorised pacemaker, co-founder of Medtronic.
Leslie Geddes (deceased) – 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
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).
Alfred E. Mann – Physicist, entrepreneur and philanthropist. A pioneer in the field of Biomedical Engineering.
J. Thomas Mortimer – Emeritus professor of biomedical engineering at
Case Western Reserve University. Pioneer in Functional Electrical
Stimulation (FES)
Robert M. Nerem – professor emeritus at Georgia Institute of Technology.
Pioneer in regenerative tissue, biomechanics, and author of over 300
published works. His works have been cited more than 20,000 times
cumulatively.
P. Hunter Peckham – Donnell Professor of Biomedical Engineering and
Orthopaedics at Case Western Reserve University. Pioneer in Functional
Electrical Stimulation (FES)
Fred Weibell, coauthor of Biomedical Instrumentation and Measurements
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
"Cyborg" is not the same thing as bionic, biorobot, or android; it applies to an organism that has restored function or enhanced abilities due to the integration of some artificial component or technology that relies on some sort of feedback. While cyborgs are commonly thought of as mammals, including humans, they might also conceivably be any kind of organism.
D. S. Halacy's Cyborg: Evolution of the Superman (1965)
featured an introduction which spoke of a "new frontier" that was "not
merely space, but more profoundly the relationship between 'inner space'
to 'outer space' – a bridge...between mind and matter."
Biosocial definition
According to some definitions of the term, the physical attachments that humans have with even the most basic technologies have already made them cyborgs. In a typical example, a human with an artificial cardiac pacemaker or implantable cardioverter-defibrillator would be considered a cyborg, since these devices measure voltage potentials in the body, perform signal processing, and can deliver electrical stimuli, using this synthetic feedback mechanism to keep that person alive. Implants, especially cochlear implants, that combine mechanical modification with any kind of feedback response are also cyborg enhancements. Some theorists cite such modifications as contact lenses, hearing aids, smartphones, or intraocular lenses as examples of fitting humans with technology to enhance their biological capabilities.
As cyborgs currently are on the rise, some theorists argue there is a need to develop new definitions of aging. (For instance, a bio-techno-social definition of aging has been suggested.)
The term is also used to address human-technology
mixtures in the abstract. This includes not only commonly-used pieces
of technology such as phones, computers, the Internet, and so on, but
also artifacts that may not popularly be considered technology; for
example, pen and paper, and speech and language.
When augmented with these technologies and connected in communication
with people in other times and places, a person becomes capable of much
more than they were before. An example is a computer, which gains power
by using Internet protocols to connect with other computers. Another example are social-media bots—either bot-assisted humans or human-assisted-bots—used to target social media with likes and shares. Cybernetic
technologies include highways, pipes, electrical wiring, buildings,
electrical plants, libraries, and other infrastructure that people
hardly notice, but which are critical parts of the cybernetics that
humans work within.
Bruce Sterling, in his Shaper/Mechanist universe,
suggested an idea of alternative cyborg called 'Lobster', which is made
not by using internal implants, but by using an external shell (e.g. a powered exoskeleton). Unlike human cyborgs, who appear human externally but are synthetic internally (e.g., the Bishop type in the Alien franchise), Lobster looks inhuman externally but contains a human internally (such as in Elysium and RoboCop). The computer game Deus Ex: Invisible War
prominently featured cyborgs called Omar, which is a Russian
translation of the word 'Lobster' (as the Omar are of Russian origin in
the game).
Visual appearance of fictional cyborgs
In science fiction,
the most stereotypical portrayal of a cyborg is a person (or, more
rarely, an animal) with visible added mechanical parts. These include
superhero Cyborg (DC Comics) and the Borg (Star Trek).
However, cyborgs can also be portrayed as looking more robotic or more organic. They may appear as humanoid robots, such as Robotman (from DC's Doom Patrol) or most varieties of the Cybermen (Doctor Who); they can appear as non-humanoid robots such as the Daleks (again, from Doctor Who) or like the majority of the motorball players in Battle Angel Alita.
More human-appearing cyborgs may cover up their mechanical parts with armor or clothing, such as Darth Vader (Star Wars) or Misty Knight (Marvel Comics). Cyborgs may have mechanical parts or bodies that appear human. For example, the eponymous Six Million Dollar Man and the Bionic Woman (from their respective television series) have prostheses externally identical to the body parts that they replace; while Motoko Kusanagi (Ghost in the Shell) is a full-body cyborg whose body appears human. In these examples, among others, it is common for cyborgs to have superhuman (physical or mental) abilities, including great strength, enhanced senses, computer-assisted brains, or built-in weaponry.
Origins
The concept of a man-machine mixture was widespread in science fiction before World War II. As early as 1843, Edgar Allan Poe described a man with extensive prostheses in the short story "The Man That Was Used Up". In 1911, Jean de La Hire introduced the Nyctalope, a science fiction hero who was perhaps the first literary cyborg, in Le Mystère des XV (later translated as The Nyctalope on Mars). Nearly two decades later, Edmond Hamilton presented space explorers with a mixture of organic and machine parts in his 1928 novel The Comet Doom.
He later featured the talking, living brain of an old scientist, Simon
Wright, floating around in a transparent case, in all the adventures of
his famous hero, Captain Future. In 1944, in the short story "No Woman Born", C. L. Moore
wrote of Deirdre, a dancer, whose body was burned completely and whose
brain was placed in a faceless but beautiful and supple mechanical body.
For the exogenously extended
organizational complex functioning as an integrated homeostatic system
unconsciously, we propose the term 'Cyborg'.
Their concept was the outcome of thinking about the need for an
intimate relationship between human and machine as the new frontier of space exploration was beginning to open up. A designer of physiological
instrumentation and electronic data-processing systems, Clynes was the
chief research scientist in the Dynamic Simulation Laboratory at Rockland State Hospital in New York.
The term first appears in print 5 months earlier when The New York Times reported on the "Psychophysiological Aspects of Space Flight Symposium" where Clynes and Kline first presented their paper:
A cyborg is essentially a
man-machine system in which the control mechanisms of the human portion
are modified externally by drugs or regulatory devices so that the being
can live in an environment different from the normal one.
Thereafter, Hamilton would first use the term cyborg
explicitly in the 1962 short story, "After a Judgment Day", to describe
the "mechanical analogs" called "Charlies," explaining that "[c]yborgs,
they had been called from the first one in the 1960s...cybernetic
organisms."
In 2001, a book titled Cyborg: Digital Destiny and Human Possibility in the Age of the Wearable Computer was published by Doubleday. Some of the ideas in the book were incorporated into the 35-mm motion picture film Cyberman that same year.
Cyborg tissues in engineering
Cyborg tissues structured with carbon nanotubes and plant or fungal cells have been used in artificial tissue engineering to produce new materials for mechanical and electrical uses.
Such work was presented by Raffaele Di Giacomo, Bruno Maresca, and others, at the Materials Research Society's spring conference on 3 April 2013.
The cyborg obtained was inexpensive, light and had unique mechanical
properties. It could also be shaped in the desired forms. Cells combined
with multi-walled nanotubes (MWCNTs) co-precipitated as a specific aggregate of cells and nanotubes that formed a viscous material. Likewise, dried cells still acted as a stable matrix for the MWCNT network. When observed by optical microscopy,
the material resembled an artificial "tissue" composed of highly-packed
cells. The effect of cell drying was manifested by their "ghost cell" appearance. A rather specific physical interaction between MWCNTs and cells was observed by electron microscopy, suggesting that the cell wall (the most outer part of fungal and plant cells) may play a major active role in establishing a carbon nanotube's
network and its stabilization. This novel material can be used in a
wide range of electronic applications, from heating to sensing. For
instance, using Candida albicans cells cyborg tissue materials with temperature sensing properties have been reported.
In current prosthetic applications, the C-Leg system developed by Otto Bock HealthCare is used to replace a human leg
that has been amputated because of injury or illness. The use of
sensors in the artificial C-Leg aids in walking significantly by
attempting to replicate the user's natural gait, as it would be prior to
amputation.
Prostheses like the C-Leg and the more advanced iLimb are considered by
some to be the first real steps towards the next generation of
real-world cyborg applications. Additionally cochlear implants and magnetic implants which provide people with a sense that they would not otherwise have had can additionally be thought of as creating cyborgs.
In vision science, direct brain implants have been used to treat non-congenital
(acquired) blindness. One of the first scientists to come up with a
working brain interface to restore sight was a private researcher William Dobelle.
Dobelle's first prototype was implanted into "Jerry", a man blinded in
adulthood, in 1978. A single-array BCI containing 68 electrodes was
implanted onto Jerry's visual cortex and succeeded in producing phosphenes,
the sensation of seeing light. The system included cameras mounted on
glasses to send signals to the implant. Initially, the implant allowed
Jerry to see shades of grey in a limited field of vision at a low
frame-rate. This also required him to be hooked up to a two-ton
mainframe, but shrinking electronics and faster computers made his
artificial eye more portable and now enable him to perform simple tasks
unassisted.
In 1997, Philip Kennedy, a scientist and physician, created the
world's first human cyborg from Johnny Ray, a Vietnam veteran who
suffered a stroke. Ray's body, as doctors called it, was "locked in".
Ray wanted his old life back so he agreed to Kennedy's experiment.
Kennedy embedded an implant he designed (and named "neurotrophic
electrode") near the part of Ray's brain so that Ray would be able to
have some movement back in his body. The surgery went successfully, but
in 2002, Johnny Ray died.
In 2002, Canadian Jens Naumann, also blinded in adulthood, became
the first in a series of 16 paying patients to receive Dobelle's second
generation implant, marking one of the earliest commercial uses of
BCIs. The second-generation device used a more sophisticated implant
enabling better mapping of phosphenes into a coherent vision. Phosphenes
are spread out across the visual field in what researchers call the
starry-night effect. Immediately after his implant, Naumann was able to
use his imperfectly restored vision to drive slowly around the parking
area of the research institute.
In contrast to replacement technologies, in 2002, under the heading Project Cyborg, a British scientist, Kevin Warwick,
had an array of 100 electrodes fired into his nervous system in order
to link his nervous system into the internet to investigate enhancement
possibilities. With this in place, Warwick successfully carried out a
series of experiments including extending his nervous system over the
internet to control a robotic hand, also receiving feedback from the
fingertips in order to control the hand's grip. This was a form of
extended sensory input. Subsequently, he investigated ultrasonic input
in order to remotely detect the distance to objects. Finally, with
electrodes also implanted into his wife's nervous system, they conducted
the first direct electronic communication experiment between the
nervous systems of two humans.
Since 2004, British artist Neil Harbisson has had a cyborg antenna
implanted in his head that allows him to extend his perception of
colors beyond the human visual spectrum through vibrations in his skull. His antenna was included within his 2004 passport photograph which has been claimed to confirm his cyborg status. In 2012 at TEDGlobal,
Harbisson explained that he started to feel cyborg when he noticed that
the software and his brain had united and given him an extra sense. Neil Harbisson is a co-founder of the Cyborg Foundation (2004)
and cofounded the Transpecies Society in 2017, which is an association
that empowers the individuals with non-human identities and supports
them in their decisions to develop unique senses and new organs. Neil Harbisson is a global advocate for the rights of cyborgs.
Rob Spence, a Toronto-based film-maker, who titles himself a
real-life "Eyeborg," severely damaged his right eye in a shooting
accident on his grandfather's farm as a child.
Many years later, in 2005, he decided to have his ever-deteriorating and now technically blind eye surgically removed,
whereafter he wore an eye patch for some time before he later, after
having played for some time with the idea of installing a camera
instead, contacted professor Steve Mann at the Massachusetts Institute of Technology, an expert in wearable computing and cyborg technology.
Under Mann's guidance, Spence, at age 36, created a prototype in
the form of the miniature camera which could be fitted inside his
prosthetic eye; an invention would come to be named by Time magazine
as one of the best inventions of 2009. The bionic eye records
everything he sees and contains a 1.5 mm-square, low-resolution video
camera, a small round printed circuit board, a wireless video
transmitter, which allows him to transmit what he is seeing in real-time
to a computer, and a 3-voltage rechargeable Varta microbattery. The eye
is not connected to his brain and has not restored his sense of vision.
Additionally, Spence has also installed a laser-like LED light in one
version of the prototype.
Furthermore, many cyborgs with multifunctional microchips
injected into their hand are known to exist. With the chips they are
able to swipe cards, open or unlock doors, operate devices such as
printers or, with some using a cryptocurrency, buy products, such as drinks, with a wave of the hand.
bodyNET
bodyNET is an application of human-electronic interaction currently in development by researchers from Stanford University. The technology is based on stretchable semiconductor materials (Elastronic). According to their article in Nature,
the technology is composed of smart devices, screens, and a network of
sensors that can be implanted into the body, woven into the skin or worn
as clothes. It has been suggested, that this platform can potentially
replace the smartphone in the future.
Animal cyborgs
The US-based company Backyard Brains released what they refer to as the "world's first commercially available cyborg" called the RoboRoach. The project started as a senior design project for a University of Michigan biomedical engineering student in 2010, and was launched as an available beta product on 25 February 2011.
The RoboRoach was officially released into production via a TED talk at the TED Global conference; and via the crowdsourcing website Kickstarter in 2013, the kit allows students to use microstimulation to momentarily control the movements of a walking cockroach (left and right) using a bluetooth-enabled smartphone as the controller.
In the late 2010s, scientists created cyborg jellyfish
using a microelectronic prosthetic that propels the animal to swim
almost three times faster while using just twice the metabolic energy of
their unmodified peers. The prosthetics can be removed without harming
the jellyfish.
