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Saturday, January 11, 2025

Biomechanics

From Wikipedia, the free encyclopedia
https://en.wikipedia.org/wiki/Biomechanics
Page of one of the first works of Biomechanics (De Motu Animalium of Giovanni Alfonso Borelli) in the 17th century

Biomechanics is the study of the structure, function and motion of the mechanical aspects of biological systems, at any level from whole organisms to organs, cells and cell organelles, using the methods of mechanics. Biomechanics is a branch of biophysics.

Today, computational mechanics extends well beyond traditional mechanics, encompassing a wide range of physical processes such as chemistry, heat and mass transfer, electrical and magnetic interactions, and more.

Etymology

The word "biomechanics" (1899) and the related "biomechanical" (1856) come from the Ancient Greek βίος bios "life" and μηχανική, mēchanikē "mechanics", to refer to the study of the mechanical principles of living organisms, particularly their movement and structure.

Subfields

Biofluid mechanics

Red blood cells

Biological fluid mechanics, or biofluid mechanics, is the study of both gas and liquid fluid flows in or around biological organisms. An often studied liquid biofluid problem is that of blood flow in the human cardiovascular system. Under certain mathematical circumstances, blood flow can be modeled by the Navier–Stokes equations. In vivo whole blood is assumed to be an incompressible Newtonian fluid. However, this assumption fails when considering forward flow within arterioles. At the microscopic scale, the effects of individual red blood cells become significant, and whole blood can no longer be modeled as a continuum. When the diameter of the blood vessel is just slightly larger than the diameter of the red blood cell the Fahraeus–Lindquist effect occurs and there is a decrease in wall shear stress. However, as the diameter of the blood vessel decreases further, the red blood cells have to squeeze through the vessel and often can only pass in a single file. In this case, the inverse Fahraeus–Lindquist effect occurs and the wall shear stress increases.

An example of a gaseous biofluids problem is that of human respiration. Recently, respiratory systems in insects have been studied for bioinspiration for designing improved microfluidic devices.

Biotribology

Biotribology is the study of friction, wear and lubrication of biological systems, especially human joints such as hips and knees. In general, these processes are studied in the context of contact mechanics and tribology.

Additional aspects of biotribology include analysis of subsurface damage resulting from two surfaces coming in contact during motion, i.e. rubbing against each other, such as in the evaluation of tissue-engineered cartilage.

Comparative biomechanics

Chinstrap penguin leaping over water

Comparative biomechanics is the application of biomechanics to non-human organisms, whether used to gain greater insights into humans (as in physical anthropology) or into the functions, ecology and adaptations of the organisms themselves. Common areas of investigation are Animal locomotion and feeding, as these have strong connections to the organism's fitness and impose high mechanical demands. Animal locomotion, has many manifestations, including running, jumping and flying. Locomotion requires energy to overcome friction, drag, inertia, and gravity, though which factor predominates varies with environment.

Comparative biomechanics overlaps strongly with many other fields, including ecology, neurobiology, developmental biology, ethology, and paleontology, to the extent of commonly publishing papers in the journals of these other fields. Comparative biomechanics is often applied in medicine (with regards to common model organisms such as mice and rats) as well as in biomimetics, which looks to nature for solutions to engineering problems.

Computational biomechanics

Computational biomechanics is the application of engineering computational tools, such as the Finite element method to study the mechanics of biological systems. Computational models and simulations are used to predict the relationship between parameters that are otherwise challenging to test experimentally, or used to design more relevant experiments reducing the time and costs of experiments. Mechanical modeling using finite element analysis has been used to interpret the experimental observation of plant cell growth to understand how they differentiate, for instance. In medicine, over the past decade, the Finite element method has become an established alternative to in vivo surgical assessment. One of the main advantages of computational biomechanics lies in its ability to determine the endo-anatomical response of an anatomy, without being subject to ethical restrictions. This has led FE modeling (or other discretization techniques) to the point of becoming ubiquitous in several fields of Biomechanics while several projects have even adopted an open source philosophy (e.g., BioSpine) and SOniCS, as well as the SOFA, FEniCS frameworks and FEBio.

Computational biomechanics is an essential ingredient in surgical simulation, which is used for surgical planning, assistance, and training. In this case, numerical (discretization) methods are used to compute, as fast as possible, a system's response to boundary conditions such as forces, heat and mass transfer, and electrical and magnetic stimuli.

Continuum biomechanics

The mechanical analysis of biomaterials and biofluids is usually carried forth with the concepts of continuum mechanics. This assumption breaks down when the length scales of interest approach the order of the microstructural details of the material. One of the most remarkable characteristics of biomaterials is their hierarchical structure. In other words, the mechanical characteristics of these materials rely on physical phenomena occurring in multiple levels, from the molecular all the way up to the tissue and organ levels.

Biomaterials are classified into two groups: hard and soft tissues. Mechanical deformation of hard tissues (like wood, shell and bone) may be analysed with the theory of linear elasticity. On the other hand, soft tissues (like skin, tendon, muscle, and cartilage) usually undergo large deformations, and thus, their analysis relies on the finite strain theory and computer simulations. The interest in continuum biomechanics is spurred by the need for realism in the development of medical simulation.

Neuromechanics

Neuromechanics uses a biomechanical approach to better understand how the brain and nervous system interact to control the body. During motor tasks, motor units activate a set of muscles to perform a specific movement, which can be modified via motor adaptation and learning. In recent years, neuromechanical experiments have been enabled by combining motion capture tools with neural recordings.

Plant biomechanics

The application of biomechanical principles to plants, plant organs and cells has developed into the subfield of plant biomechanics. Application of biomechanics for plants ranges from studying the resilience of crops to environmental stress to development and morphogenesis at cell and tissue scale, overlapping with mechanobiology.

Sports biomechanics

In sports biomechanics, the laws of mechanics are applied to human movement in order to gain a greater understanding of athletic performance and to reduce sport injuries as well. It focuses on the application of the scientific principles of mechanical physics to understand movements of action of human bodies and sports implements such as cricket bat, hockey stick and javelin etc. Elements of mechanical engineering (e.g., strain gauges), electrical engineering (e.g., digital filtering), computer science (e.g., numerical methods), gait analysis (e.g., force platforms), and clinical neurophysiology (e.g., surface EMG) are common methods used in sports biomechanics.

Biomechanics in sports can be stated as the body's muscular, joint, and skeletal actions while executing a given task, skill, or technique. Understanding biomechanics relating to sports skills has the greatest implications on sports performance, rehabilitation and injury prevention, and sports mastery. As noted by Doctor Michael Yessis, one could say that best athlete is the one that executes his or her skill the best.

Vascular biomechanics

The main topics of the vascular biomechanics is the description of the mechanical behaviour of vascular tissues.

It is well known that cardiovascular disease is the leading cause of death worldwide. Vascular system in the human body is the main component that is supposed to maintain pressure and allow for blood flow and chemical exchanges. Studying the mechanical properties of these complex tissues improves the possibility of better understanding cardiovascular diseases and drastically improves personalized medicine.

Vascular tissues are inhomogeneous with a strongly non linear behaviour. Generally this study involves complex geometry with intricate load conditions and material properties. The correct description of these mechanisms is based on the study of physiology and biological interaction. Therefore, is necessary to study wall mechanics and hemodynamics with their interaction.

It is also necessary to premise that the vascular wall is a dynamic structure in continuous evolution. This evolution directly follows the chemical and mechanical environment in which the tissues are immersed like Wall Shear Stress or biochemical signaling.

Immunomechanics

The emerging field of immunomechanics focuses on characterising mechanical properties of the immune cells and their functional relevance. Mechanics of immune cells can be characterised using various force spectroscopy approaches such as acoustic force spectroscopy and optical tweezers, and these measurements can be performed at physiological conditions (e.g. temperature). Furthermore, one can study the link between immune cell mechanics and immunometabolism and immune signalling. The term "immunomechanics" is some times interchangeably used with immune cell mechanobiology or cell mechanoimmunology.

Other applied subfields of biomechanics include

History

Antiquity

Aristotle, a student of Plato, can be considered the first bio-mechanic because of his work with animal anatomy. Aristotle wrote the first book on the motion of animals, De Motu Animalium, or On the Movement of Animals. He saw animal's bodies as mechanical systems, pursued questions such as the physiological difference between imagining performing an action and actual performance. In another work, On the Parts of Animals, he provided an accurate description of how the ureter uses peristalsis to carry urine from the kidneys to the bladder.

With the rise of the Roman Empire, technology became more popular than philosophy and the next bio-mechanic arose. Galen (129 AD-210 AD), physician to Marcus Aurelius, wrote his famous work, On the Function of the Parts (about the human body). This would be the world's standard medical book for the next 1,400 years.

Renaissance

The next major biomechanic would not be around until the 1490s, with the studies of human anatomy and biomechanics by Leonardo da Vinci. He had a great understanding of science and mechanics and studied anatomy in a mechanics context. He analyzed muscle forces and movements and studied joint functions. These studies could be considered studies in the realm of biomechanics. Leonardo da Vinci studied anatomy in the context of mechanics. He analyzed muscle forces as acting along lines connecting origins and insertions, and studied joint function. Da Vinci is also known for mimicking some animal features in his machines. For example, he studied the flight of birds to find means by which humans could fly; and because horses were the principal source of mechanical power in that time, he studied their muscular systems to design machines that would better benefit from the forces applied by this animal.

In 1543, Galen's work, On the Function of the Parts was challenged by Andreas Vesalius at the age of 29. Vesalius published his own work called, On the Structure of the Human Body. In this work, Vesalius corrected many errors made by Galen, which would not be globally accepted for many centuries. With the death of Copernicus came a new desire to understand and learn about the world around people and how it works. On his deathbed, he published his work, On the Revolutions of the Heavenly Spheres. This work not only revolutionized science and physics, but also the development of mechanics and later bio-mechanics.

Galileo Galilei, the father of mechanics and part time biomechanic was born 21 years after the death of Copernicus. Over his years of science, Galileo made a lot of biomechanical aspects known. For example, he discovered that  "animals' masses increase disproportionately to their size, and their bones must consequently also disproportionately increase in girth, adapting to loadbearing rather than mere size. The bending strength of a tubular structure such as a bone is increased relative to its weight by making it hollow and increasing its diameter. Marine animals can be larger than terrestrial animals because the water's buoyancy relieves their tissues of weight."

Galileo Galilei was interested in the strength of bones and suggested that bones are hollow because this affords maximum strength with minimum weight. He noted that animals' bone masses increased disproportionately to their size. Consequently, bones must also increase disproportionately in girth rather than mere size. This is because the bending strength of a tubular structure (such as a bone) is much more efficient relative to its weight. Mason suggests that this insight was one of the first grasps of the principles of biological optimization.

In the 17th century, Descartes suggested a philosophic system whereby all living systems, including the human body (but not the soul), are simply machines ruled by the same mechanical laws, an idea that did much to promote and sustain biomechanical study.

Industrial era

The next major bio-mechanic, Giovanni Alfonso Borelli, embraced Descartes' mechanical philosophy and studied walking, running, jumping, the flight of birds, the swimming of fish, and even the piston action of the heart within a mechanical framework. He could determine the position of the human center of gravity, calculate and measure inspired and expired air volumes, and he showed that inspiration is muscle-driven and expiration is due to tissue elasticity.

Borelli was the first to understand that "the levers of the musculature system magnify motion rather than force, so that muscles must produce much larger forces than those resisting the motion". Influenced by the work of Galileo, whom he personally knew, he had an intuitive understanding of static equilibrium in various joints of the human body well before Newton published the laws of motion. His work is often considered the most important in the history of bio-mechanics because he made so many new discoveries that opened the way for the future generations to continue his work and studies.

It was many years after Borelli before the field of bio-mechanics made any major leaps. After that time, more and more scientists took to learning about the human body and its functions. There are not many notable scientists from the 19th or 20th century in bio-mechanics because the field is far too vast now to attribute one thing to one person. However, the field is continuing to grow every year and continues to make advances in discovering more about the human body. Because the field became so popular, many institutions and labs have opened over the last century and people continue doing research. With the Creation of the American Society of Bio-mechanics in 1977, the field continues to grow and make many new discoveries.

In the 19th century Étienne-Jules Marey used cinematography to scientifically investigate locomotion. He opened the field of modern 'motion analysis' by being the first to correlate ground reaction forces with movement. In Germany, the brothers Ernst Heinrich Weber and Wilhelm Eduard Weber hypothesized a great deal about human gait, but it was Christian Wilhelm Braune who significantly advanced the science using recent advances in engineering mechanics. During the same period, the engineering mechanics of materials began to flourish in France and Germany under the demands of the Industrial Revolution. This led to the rebirth of bone biomechanics when the railroad engineer Karl Culmann and the anatomist Hermann von Meyer compared the stress patterns in a human femur with those in a similarly shaped crane. Inspired by this finding Julius Wolff proposed the famous Wolff's law of bone remodeling.

Applications

The study of biomechanics ranges from the inner workings of a cell to the movement and development of limbs, to the mechanical properties of soft tissue, and bones. Some simple examples of biomechanics research include the investigation of the forces that act on limbs, the aerodynamics of bird and insect flight, the hydrodynamics of swimming in fish, and locomotion in general across all forms of life, from individual cells to whole organisms. With growing understanding of the physiological behavior of living tissues, researchers are able to advance the field of tissue engineering, as well as develop improved treatments for a wide array of pathologies including cancer.

Biomechanics is also applied to studying human musculoskeletal systems. Such research utilizes force platforms to study human ground reaction forces and infrared videography to capture the trajectories of markers attached to the human body to study human 3D motion. Research also applies electromyography to study muscle activation, investigating muscle responses to external forces and perturbations.

Biomechanics is widely used in orthopedic industry to design orthopedic implants for human joints, dental parts, external fixations and other medical purposes. Biotribology is a very important part of it. It is a study of the performance and function of biomaterials used for orthopedic implants. It plays a vital role to improve the design and produce successful biomaterials for medical and clinical purposes. One such example is in tissue engineered cartilage. The dynamic loading of joints considered as impact is discussed in detail by Emanuel Willert.

It is also tied to the field of engineering, because it often uses traditional engineering sciences to analyze biological systems. Some simple applications of Newtonian mechanics and/or materials sciences can supply correct approximations to the mechanics of many biological systems. Applied mechanics, most notably mechanical engineering disciplines such as continuum mechanics, mechanism analysis, structural analysis, kinematics and dynamics play prominent roles in the study of biomechanics.

A ribosome is a biological machine that utilizes protein dynamics

Usually biological systems are much more complex than man-built systems. Numerical methods are hence applied in almost every biomechanical study. Research is done in an iterative process of hypothesis and verification, including several steps of modeling, computer simulation and experimental measurements.

Biomedical engineering

 

From Wikipedia, the free encyclopedia
Telemedicine system. Federal Center of Neurosurgery in Tyumen, 2013
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 applications (e.g., diagnostic or therapeutic purposes). BME is also traditionally logical 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 procurement, routine testing, preventive maintenance, and making equipment recommendations, a role also known as a Biomedical Equipment Technician (BMET) or as a clinical engineer.

Biomedical engineering has recently emerged as its own field of 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 biocompatible prostheses, various diagnostic and therapeutic medical devices ranging from clinical equipment to micro-implants, imaging technologies such as MRI and EKG/ECG, regenerative tissue growth, and the development of pharmaceutical drugs including biopharmaceuticals.

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 organizational principles within nucleic acid and protein sequences.

Biomechanics

Data obtained from crash test dummy impacts are integral to the field of biomechanics.

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,[4] using the methods of mechanics.[5]

Biomaterials

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 combines the principles of physics, engineering, and biology to study the interaction of biological tissue and light, and how this can be exploited for sensing, imaging, and treatment. It has a wide range of applications, including optical imaging, microscopy, ophthalmoscopy, spectroscopy, and therapy. Examples of biomedical optics techniques and technologies include optical coherence tomography (OCT), fluorescence microscopy, confocal microscopy, and photodynamic therapy (PDT). OCT, for example, uses light to create high-resolution, three-dimensional images of internal structures, such as the retina in the eye or the coronary arteries in the heart. Fluorescence microscopy involves labeling specific molecules with fluorescent dyes and visualizing them using light, providing insights into biological processes and disease mechanisms. More recently, adaptive optics is helping imaging by correcting aberrations in biological tissue, enabling higher resolution imaging and improved accuracy in procedures such as laser surgery and retinal imaging.

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. Neural engineering can assist with numerous things, including the future development of prosthetics. For example, cognitive neural prosthetics (CNP) are being heavily researched and would allow for a chip implant to assist people who have prosthetics by providing signals to operate assistive devices.

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.

Hospital and medical devices

Schematic of silicone membrane oxygenator

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.

Some examples include pacemakers, infusion pumps, the heart-lung machine, dialysis machines, artificial organs, implants, artificial limbs, corrective lenses, cochlear implants, ocular prosthetics, facial prosthetics, somato prosthetics, and dental implants.

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

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.

Alternatively, navigation-guided equipment utilizes electromagnetic tracking technology, such as catheter placement into the brain or feeding tube placement systems. For example, ENvizion Medical's ENvue, an electromagnetic navigation system for enteral feeding tube placement. The system uses an external field generator and several EM passive sensors enabling scaling of the display to the patient's body contour, and a real-time view of the feeding tube tip location and direction, which helps the medical staff ensure the correct placement in the GI tract.

A T1-weighted MRI scan of a human head, an example of a biomedical engineering application of electrical engineering to diagnostic imaging. Click here to view an animated sequence of slices.

Imaging technologies are often essential to medical diagnosis, and are typically the most complex equipment found in a hospital including: fluoroscopy, magnetic resonance imaging (MRI), nuclear medicine, positron emission tomography (PET), PET-CT scans, projection radiography such as X-rays and CT scans, tomography, ultrasound, optical microscopy, and electron microscopy.

Medical 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 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 limbs: The right arm is an example of a prosthesis, and the left arm is an example of myoelectric control.
A prosthetic eye, an example of a biomedical engineering application of mechanical engineering and biocompatible materials to ophthalmology

Bionics

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 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 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. The 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 are also authorized to audit pharmaceutical and associated stores to monitor FDA recalls of invasive items.

Rehabilitation engineering

Ultrasound representation of urinary bladder (black butterfly-like shape) a hyperplastic prostate. An example of practical science and medical science working together.

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.

Schematic representation of a normal ECG trace showing sinus rhythm; an example of widely used clinical medical equipment (operates by applying electronic engineering to electrophysiology and medical diagnosis).

Regulatory issues

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"

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 an 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" which 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. The 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 a different structure. The Quality System deliverables usually include procedures that ensure quality throughout all product life cycles. The same standard (ISO EN 13485) is usually applied for quality management systems in the 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 complies 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., or MD-PhD) 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 includes enough 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. As of 2023, 155 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 University of Guelph 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 5% (faster than average) from 2012 to 2022. Biomedical engineering has the highest percentage of female engineers compared to other common engineering professions. Now as of 2023, there are 19,700 jobs for this degree, the average pay for a person in this field is around $100,730.00 and making around $48.43 an hour. There is also expected to be a 7% increase in jobs from here 2023 to 2033 (even faster than the last average).

Notable figures

Human extinction

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