Biomedical engineering

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Telemedicine system. Federal Center of Neurosurgery in Tyumen, 2013 Operatsionnaia. FTsN (Tiumen') 01.JPG
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 Hemodialysismachine.jpg
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. [1] [2] 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.

Contents

Biomedical engineering has recently emerged as its own field of study, as compared to many other engineering fields.[ citation needed ] 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 Microarray2.gif
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. B09685P005 (1).jpg
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, [3] using the methods of mechanics. [4]

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. [5] 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 [6] and tracheas [7] from human stem cells towards this end. Several artificial urinary bladders have been grown in laboratories and transplanted successfully into human patients. [8] 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. [9]

Micromass cultures of C3H-10T1/2 cells at varied oxygen tensions stained with Alcian blue Alcian stain micromass.jpg
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.[ citation needed ]

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.

Hospital and medical devices

Schematic of silicone membrane oxygenator Schematic of silicone membrane oxygenator.jpg
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:

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 Opampinstrumentation.svg
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, [10] treatments, [11] patient monitoring, [12] of complex diseases.

Medical devices are regulated and classified (in the US) as follows (see also Regulation):

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. [13]

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. Brain chrischan.jpg
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. Army prosthetic.jpg
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 Prosthetic eye.png
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. [14] 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. UltrasoundBPH.jpg
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. [1]

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. [6] [8] 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. [9]

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). SinusRhythmLabels.svg
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" [15]

Regardless of the country-specific legislation, the main regulatory objectives coincide worldwide. [16] For example, in the medical device regulations, a product must be: 1) safe and 2) effective and 3) for all the manufactured devices (why is this part deleted?)

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. Hip replacement Image 3684-PH.jpg
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). [17] 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 [18] [19] [20] ) 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. [21]

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. [22]

In Canada and Australia, accredited graduate programs in biomedical engineering are common. [23] For example, McMaster University offers an M.A.Sc, an MD/PhD, and a PhD in Biomedical engineering. [24] The first Canadian undergraduate BME program was offered at Ryerson University as a four-year B.Eng. program. [25] [26] The Polytechnique in Montreal is also offering a bachelors's degree in biomedical engineering [27] as is Flinders University. [28]

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. [29] 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. [30] Other countries, such as Australia, are recognizing and moving to correct deficiencies in their BME education. [31] 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. [32]

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. [33] 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. [34] Biomedical engineering has the highest percentage of female engineers compared to other common engineering professions.

Notable figures

See also

Related Research Articles

<span class="mw-page-title-main">Medical device</span> Device to be used for medical purposes

A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.

<span class="mw-page-title-main">Biocompatibility</span> Biologically compatible substance

Biocompatibility is related to the behavior of biomaterials in various contexts. The term refers to the ability of a material to perform with an appropriate host response in a specific situation. The ambiguity of the term reflects the ongoing development of insights into how biomaterials interact with the human body and eventually how those interactions determine the clinical success of a medical device. Modern medical devices and prostheses are often made of more than one material so it might not always be sufficient to talk about the biocompatibility of a specific material. Even the same materials, such as diamond-like carbon coatings, may show different levels of biocompatibility based on the manufacturing conditions and characteristics.

<span class="mw-page-title-main">Organ printing</span> Method of creating artificial organs

Organ printing utilizes techniques similar to conventional 3D printing where a computer model is fed into a printer that lays down successive layers of plastics or wax until a 3D object is produced. In the case of organ printing, the material being used by the printer is a biocompatible plastic. The biocompatible plastic forms a scaffold that acts as the skeleton for the organ that is being printed. As the plastic is being laid down, it is also seeded with human cells from the patient's organ that is being printed for. After printing, the organ is transferred to an incubation chamber to give the cells time to grow. After a sufficient amount of time, the organ is implanted into the patient.

A biomedical engineering/equipment technician/technologist or biomedical engineering/equipment specialist is typically an electro-mechanical technician or technologist who ensures that medical equipment is well-maintained, properly configured, and safely functional. In healthcare environments, BMETs often work with or officiate as a biomedical and/or clinical engineer, since the career field has no legal distinction between engineers and engineering technicians/technologists.

<span class="mw-page-title-main">Clinical engineering</span> Modern medical technologies

Clinical engineering is a specialty within biomedical engineering responsible for using medical technology to optimize healthcare delivery.

A Bachelor of Science in Biomedical Engineering is a kind of bachelor's degree typically conferred after a four-year undergraduate course of study in biomedical engineering (BME). The degree itself is largely equivalent to a Bachelor of Science and many institutions conferring degrees in the fields of biomedical engineering and bioengineering do not append the field to the degree itself. Courses of study in BME are also extremely diverse as the field itself is relatively new and developing. In general, an undergraduate course of study in BME is likened to a cross between engineering and biological science with varying degrees of proportionality between the two.

<span class="mw-page-title-main">Biological engineering</span> Application of biology and engineering to create useful products

Biological engineering or bioengineering is the application of principles of biology and the tools of engineering to create usable, tangible, economically viable products. Biological engineering employs knowledge and expertise from a number of pure and applied sciences, such as mass and heat transfer, kinetics, biocatalysts, biomechanics, bioinformatics, separation and purification processes, bioreactor design, surface science, fluid mechanics, thermodynamics, and polymer science. It is used in the design of medical devices, diagnostic equipment, biocompatible materials, renewable energy, ecological engineering, agricultural engineering, process engineering and catalysis, and other areas that improve the living standards of societies.

<span class="mw-page-title-main">Biomaterial</span> Any substance that has been engineered to interact with biological systems for a medical purpose

A biomaterial is a substance that has been engineered to interact with biological systems for a medical purpose – either a therapeutic or a diagnostic one. The corresponding field of study, called biomaterials science or biomaterials engineering, is about fifty years old. It has experienced steady 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.

Biomechanical engineering, also considered a subfield of mechanical engineering and biomedical engineering, combines principles of physics, biology, and engineering. Topics of interest in this field include biomechanics, computational mechanics, continuum mechanics, bioinstrumentation, design of implants and prostheses, etc. This is a highly multidisciplinary field, and engineers with such a background may enter related niche careers, e.g., as an ergonomics consultant, rehabilitation engineer, biomechanics researcher, and biomedical device engineer.

Medical equipment management is a term for the professionals who manage operations, analyze and improve utilization and safety, and support servicing healthcare technology. These healthcare technology managers are, much like other healthcare professionals referred to by various specialty or organizational hierarchy names.

<span class="mw-page-title-main">Nicholas A. Peppas</span> Greek chemical and biomedical engineer (b. 1948)

Nicholas (Nikolaos) A. Peppas is a chemical and biomedical engineer whose leadership in biomaterials science and engineering, drug delivery, bionanotechnology, pharmaceutical sciences, chemical and polymer engineering has provided seminal foundations based on the physics and mathematical theories of nanoscale, macromolecular processes and drug/protein transport and has led to numerous biomedical products or devices.

<span class="mw-page-title-main">American Institute for Medical and Biological Engineering</span> Non-profit organization

The American Institute for Medical and Biological Engineering (AIMBE) is a non-profit organization founded in 1991, and headquartered in Washington, D.C. It represents 50,000 medical and biomedical engineers, and academic institutions, private industry, and professional engineering societies.

<span class="mw-page-title-main">Linda Griffith</span> American biological engineer

Linda Gay Griffith is an American biological engineer, and Professor of Biological Engineering and Mechanical Engineering at Massachusetts Institute of Technology, where she also directs the Center for Gynepathology Research.

Buddy Ratner is an American professor of chemical engineering and bioengineering. He is the director of the Research Center for Biomaterials at the University of Washington. He is also the faculty member for the Program for Technology Commercialization at the University of Washington.

<span class="mw-page-title-main">George Truskey</span>

George Alexander Truskey is an American biomedical engineer noted for his research on transport phenomena in biological systems, cardiovascular tissue engineering, and cell adhesion to natural and synthetic surfaces.

<span class="mw-page-title-main">Ravi V. Bellamkonda</span>

Ravi V. Bellamkonda is an Indian-American biomedical engineer and academic administrator. Since 2021, he has served as Provost and Executive Vice President for Academic Affairs at Emory University in Atlanta, Georgia. Bellamkonda was previously Vinik Dean of the Pratt School of Engineering at Duke University.

Thomas J. Webster is an American biomedical engineer, researcher, and entrepreneur. Throughout his over 25-year academic career, his research group has produced several books and book chapters. He has over 1350 publications and has an H-index of 118. This high H-index places him amongst the top 1% of researchers in his field.

Christine E. Schmidt is an American biomedical engineer. As a professor at the University of Florida, Schmidt was inducted into the Florida Inventors Hall of Fame for her creation of the Avance Nerve Graft which has "improved the lives of numerous patients suffering from peripheral nerve damage."

Elizabeth Cosgriff-Hernandez is an American biomedical engineer who is a professor at the University of Texas at Austin. Her work involves the development of polymeric biomaterials for medical devices and tissue regeneration. She also serves on the scientific advisory board of ECM Biosurgery and as a consultant to several companies on biostability evaluation of medical devices. Cosgriff-Hernandez is an associate editor of the Journal of Materials Chemistry B and Fellow of the International Union of Societies for Biomaterials Science and Engineering, Biomedical Engineering Society, Royal Society of Chemistry, and the American Institute for Medical and Biological Engineering.

Melissa Ann Grunlan is an American scientist and academic. She is Professor and Holder of the Charles H. and Bettye Barclay Professorship in the Department of Biomedical Engineering at Texas A&M University. She holds courtesy appointments in the Departments of Chemistry and Materials Science & Engineering. Her research focuses on the development of polymeric biomaterials for regenerative engineering and medical devices.

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Further reading