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A Review-Biomedical Engineering-Present and Future Prospective

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Asian J. Pharm. Res. 2013; Vol. 3: Issue 4, Pg 202-206 [AJPRes.]

ISSN- 2231–5683 (Print) www.asianpharmaonline.org

ISSN- 2231–5691 (Online)

REVIEW ARTICLE

A Review- Biomedical Engineering-Present and Future Prospective

Mohd. Yaqub Khan*, Poonam Gupta, Vikas Kumar Verma
Saroj Institute of Technology & Management, Ahimamau P.O. Arjunganj Sultanpur Road, Lucknow.
*Corresponding Author E-mail: [email protected]

ABSTRACT:
Biomedical engineering is the application of engineering principles and design concepts to medicine and biology for
healthcare purposes. This field seeks to close the gap between engineering and medicine: It combines the design and
problem solving skills of engineering with medical and biological sciences to advance healthcare treatment, including
diagnosis, monitoring, and therapy. Much of the work in biomedical engineering consists of research and development,
spanning a broad array of subfields. Prominent biomedical engineering applications include the development of
biocompatible prostheses, various diagnostic and therapeutic medical devices ranging from clinical equipment to
micro-implants, common imaging equipment such as MRIs and EEGs, regenerative tissue growth, pharmaceutical
drugs and therapeutic biological. But more often, sub-disciplines within BME are classified by their association(s) with
other more established engineering fields, which can include:
• Biochemical-BME, based on Chemical engineering - often associated with biochemical, cellular, molecular and
tissue engineering, biomaterials, and biotransport.
• Bioelectrical-BME, based on Electrical engineering and Computer Science - often associated with bioelectrical
and neural engineering, bioinstrumentation, biomedical imaging, and medical devices. This also tends to encompass
optics and optical engineering - biomedical optics, bioinformatics, imaging and related medical devices.
• Biomechanical-BME, based on Mechanical engineering - often associated with biomechanics, biotransport,
medical devices, and modeling of biological systems, like soft tissue mechanics.
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. 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.

KEYWORDS: Diagnosis, Monitoring, Therapy, Biocompatible prostheses, RoHS, IEC 60601-1-11.

INTRODUCTION:
Biomedical engineering is the application of engineering Biomedical engineering is a discipline that advances
principles and design concepts to medicine and biology for knowledge in engineering, biology and medicine, and
healthcare purposes. This field seeks to close the gap improves human health through cross-disciplinary activities
between engineering and medicine: It combines the design that integrate the engineering sciences with the biomedical
and problem solving skills of engineering with medical and sciences and clinical practice. It includes:
biological sciences to advance healthcare treatment, 1. The acquisition of new knowledge and understanding of
including diagnosis, monitoring, and therapy. living systems through the innovative and substantive
application of experimental and analytical techniques based
on the engineering sciences.
2. The development of new devices, algorithms, processes
and systems that advance biology and medicine and
improve medical practice and health care delivery.
Received on 10.10.2013 Accepted on 30.11.2013
© Asian Pharma Press All Right Reserved Biomedical engineering has only recently emerged as its
Asian J. Pharm. Res. 3(4): Oct. - Dec.2013; Page 202-206 own discipline, compared to many other engineering fields.
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Asian J. Pharm. Res. 2013; Vol. 3: Issue 4, Pg 202-206 [AJPRes.]

Such an evolution is common as a new field transitions participate in or direct research activities in collaboration
from being an interdisciplinary specialization among with other researchers with such backgrounds as medicine,
already-established fields, to being considered a field in physiology, and nursing. Some biomedical engineers are
itself. Much of the work in biomedical engineering consists technical advisors for marketing departments of companies
of research and development, spanning a broad array of and some are in management positions. Some biomedical
subfields. Prominent biomedical engineering applications engineers also have advanced training in other fields. For
include the development of biocompatible prostheses, example, many biomedical engineers also have an M.D.
various diagnostic and therapeutic medical devices ranging degree, thereby combining an understanding of advanced
from clinical equipment to micro-implants, common technology with direct patient care or clinical research.
imaging equipment such as MRIs and EEGs, regenerative
tissue growth, pharmaceutical drugs and therapeutic Notable subdisciplines within biomedical engineering:
biologicals.1 Biomedical engineering can be viewed from two angles,
from the medical applications side and from the engineering
Development of Bioengineering: side. A biomedical engineer must have some view of both
Over the last few years there has been a major paradigm sides4. As with many medical specialties (e.g. cardiology,
shift in both Europe and the United States away from neurology), some BME sub-disciplines are identified by
traditional schemes of health care towards health care their associations with particular systems of the human
systems which are much more dependent on technology. body, such as:
This is true in terms of diagnosis (eg body scanners); • Cardiovascular technology - which includes all
treatment (radiation therapy and minimal access surgery); drugs, biologics, and devices related with diagnostics and
and health care system integration (via information therapeutics of cardiovascular systems
technology). In parallel with these changes, there has been a • Neural technology - which includes all drugs,
progressive increase in the proportion of the national Gross biologics, and devices related with diagnostics and
Domestic Product spent in the medical sector. For example, therapeutics of the brain and nervous systems
in the United Kingdom it is currently between 6 and 7%, in • Orthopaedic technology - which includes all drugs,
Germany about 9%, and in the United States about 14%. biologics, and devices related with diagnostics and
This has resulted partly from demographic changes and therapeutics of skeletal systems
additionally from increasing public demand for better health • Cancer technology - which includes all drugs,
care. As medical practice becomes more technologically biologics, and devices related with diagnostics and
based, a progressive shift is occurring in industry to meet therapeutics of cancer
the demand. Developments in science and engineering are
increasingly being directed away from traditional
But more often, sub-disciplines within BME are classified
technologies towards those required for health care in its
by their association(s) with other more established
widest sense. Although in many countries there is a
engineering fields, which can include5:
problem with escalating costs in the medical sector,
• Biochemical-BME, based on Chemical engineering -
technology can contribute to economies because of falling
often associated with biochemical, cellular, molecular and
costs of electronic/physics based components relative to
tissue engineering, biomaterials, and biotransport.
those for personnel, and because of technologically based
screening programmes.2 • Bioelectrical-BME, based on Electrical engineering
and Computer Science - often associated with bioelectrical
Where do they Work? and neural engineering, bioinstrumentation, biomedical
Biomedical engineers are employed in industry, in imaging, and medical devices. This also tends to encompass
hospitals, in research facilities of educational and medical optics and optical engineering - biomedical optics,
institutions, in teaching, and in government regulatory bioinformatics, imaging and related medical devices.
agencies. They often serve a coordinating or interfacing • Biomechanical-BME, based on Mechanical
function, using their background in both the engineering engineering - often associated with biomechanics,
and medical fields. In industry, they may create designs biotransport, medical devices, and modeling of biological
where an in-depth understanding of living systems and of systems, like soft tissue mechanics.
technology is essential. They may be involved in
performance testing of new or proposed products. One more way to sub-classify the discipline is on the basis
Government positions often involve product testing and of the products created. 6
safety, as well as establishing safety standards for devices.
In the hospital, the biomedical engineer may provide advice Biologics and Biopharmaceuticals often designed using
on the selection and use of medical equipment, as well as the principles of synthetic biology (synthetic biology is an
supervising its performance testing and maintenance3. They extension of genetic engineering). The design of biologic
may also build customized devices for special health care or and biopharma products comes broadly under the BME-
research needs. In research institutions, biomedical related (and overlapping) disciplines of biotechnology and
engineers supervise laboratories and equipment, and bioengineering.

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Asian J. Pharm. Res. 2013; Vol. 3: Issue 4, Pg 202-206 [AJPRes.]

Pharmaceutical Drugs (so-called "small-molecule" or pharmaceuticals) or biological (e.g., vaccines) means, and
non-biologic) which are commonly designed using the do not involve metabolism.9
principles of synthetic chemistry and traditionally A medical device is intended for use in:
discovered using high-throughput screening methods at the • The diagnosis of disease or other conditions, or
beginning of the development process. • In the cure, mitigation, treatment, or prevention of
disease
Tissue engineering
Tissue engineering, like genetic engineering, is a major Some examples include pacemakers, infusion pumps, the
segment of Biotechnology - which overlaps significantly heart-lung machine, dialysis machines, artificial organs,
with BME .One of the goals of tissue engineering is to implants, artificial limbs, corrective lenses, cochlear
create artificial organs (via biological material) for patients implants, ocular prosthetics, facial prosthetics, somato
that need organ transplants. Biomedical engineers are prosthetics, and dental implants.
currently researching methods of creating such organs.
Researchers have grown solid jawbones and tracheas from Medical devices are regulated and classified (in the US) as
human stem cells towards this end. Several artificial urinary follows:
bladders actually have been grown in laboratories and 1. Class I devices present minimal potential for harm to
transplanted successfully into human patients. Bioartificial the user and are often simpler in design than Class II or
organs, which use both synthetic and biological Class III devices. Devices in this category include tongue
components, are also a focus area in research, such as with depressors, bedpans, elastic bandages, examination gloves,
hepatic assist devices that use liver cells within an artificial and hand-held surgical instruments and other similar types
bioreactor construct.7 of common equipment.
2. Class II devices are subject to special controls in
Genetic engineering addition to the general controls of Class I devices. Special
Genetic engineering, recombinant DNA technology, genetic controls may include special labeling requirements,
modification/manipulation (GM) and gene splicing are mandatory performance standards, and postmarket
terms that apply to the direct manipulation of an organism's surveillance. Devices in this class are typically non-invasive
genes. Genetic engineering is different from traditional and include x-ray machines, PACS, powered wheelchairs,
breeding, where the organism's genes are manipulated infusion pumps, and surgical drapes.
indirectly. Genetic engineering uses the techniques of 3. Class III devices generally require premarket approval
molecular cloning and transformation to alter the structure (PMA) or premarket notification (510k), a scientific review
and characteristics of genes directly. Genetic engineering to ensure the device's safety and effectiveness, in addition
techniques have found success in numerous applications. to the general controls of Class I. Examples include
replacement heart valves, hip and knee joint implants,
Neural engineering silicone gel-filled breast implants, implanted cerebellar
Neural engineering (also known as Neuroengineering) is a stimulators, implantable pacemaker pulse generators and
discipline that uses engineering techniques to understand, endosseous (intra-bone) implants.
repair, replace, or enhance neural systems. Neural engineers
are uniquely qualified to solve design problems at the Medical imaging
interface of living neural tissue and non-living constructs.8 Medical/biomedical imaging is a major segment of medical
devices. This area deals with enabling clinicians to directly
Pharmaceutical engineering or indirectly "view" things not visible in plain sight (such as
Pharmaceutical engineering is sometimes regarded as a due to their size, and/or location). This can involve utilizing
branch of biomedical engineering, and sometimes a branch ultrasound, magnetism, UV, other radiology, and other
of chemical engineering; in practice, it is very much a means.
hybrid sub-discipline .Aside from those pharmaceutical
products directly incorporating biological agents or Imaging technologies are often essential to medical
materials, even developing chemical drugs is considered to diagnosis, and are typically the most complex equipment
require substantial BME knowledge due to the found in a hospital including: 10
physiological interactions inherent to such products' usage. • Fluoroscopy
With the increasing prevalence of "combination products," • Magnetic resonance imaging (MRI)
the lines are now blurring among healthcare products such
• Nuclear medicine
as drugs, biologics, and various types of devices.
• Positron emission tomography (PET) scans PET
Medical devices • Projection radiography such as X-rays and CT scans
This is an extremely broad category—essentially covering • Tomography
all health care products that do not achieve their intended • Ultrasound
results through predominantly chemical (e.g., • Optical microscopy
• Electron microscopy
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Implants philosophical differences about the optimal extent of

An implant is a kind of medical device made to replace and regulation can be a hindrance; more restrictive regulations
act as a missing biological structure. The surface of seem appealing on an intuitive level, but critics decry the
implants that contact the body might be made of a tradeoff cost in terms of slowing access to life-saving
biomedical material such as titanium, silicone or apatite developments.13
depending on what is the most functional. In some cases
implants contain electronics e.g. artificial pacemaker and RoHS II
cochlear implants. Some implants are bioactive, such as Directive 2011/65/EU, better known as RoHS 2 is a recast
subcutaneous drug delivery devices in the form of of legislation originally introduced in 2002. The original
implantable pills or drug-eluting stents.11 EU legislation “Restrictions of Certain Hazardous
Substances in Electrical and Electronics Devices” (RoHS
Bionics Directive 2002/95/EC) was replaced and superseded by
Artificial body part replacement is just one of the things 2011/65/EU published in July 2011 and commonly known
that bionics can do. Concerned with the intricate and as RoHS 2. RoHS seeks to limit the dangerous substances
thorough study of the properties and function of human in circulation in electronics products, in particular toxins
body systems, bionics may be applied to solve some and heavy metals, which are subsequently released into the
engineering problems. Careful study of the different environment when such devices are recycled.
function and processes of the eyes, ears, and other organs
paved the way for improved cameras, television, radio The scope of RoHS 2 is widened to include products
transmitters and receivers, and many other useful tools. previously excluded, such as medical devices and industrial
These developments have indeed made our lives better, but equipment. In addition, manufacturers are now obliged to
the best contribution that bionics has made is in the field of provide conformity risk assessments and test reports – or
biomedical engineering. explain why they are lacking. For the first time, not only
manufacturers, but also importers and distributors share a
Clinical engineering responsibility to ensure Electrical and Electronic Equipment
Clinical engineering is the branch of biomedical within the scope of RoHS comply with the hazardous
engineering dealing with the actual implementation of substances limits and have a CE mark on their products.14
medical equipment and technologies in hospitals or other
clinical settings. Major roles of clinical engineers include IEC 60601
training and supervising biomedical equipment technicians The new International Standard IEC 60601 for home
(BMETs), selecting technological products/services and healthcare electro-medical devices defining the
logistically managing their implementation, working with requirements for devices used in the home healthcare
governmental regulators on inspections/audits, and serving environment. IEC 60601-1-11 (2010) must now be
as technological consultants for other hospital staff. Clinical incorporated into the design and verification of a wide
engineers also advise and collaborate with medical device range of home use and point of care medical devices along
producers regarding prospective design improvements with other applicable standards in the IEC 60601 3rd
based on clinical experiences, as well as monitor the edition series.
progression of the state-of-the-art so as to redirect
procurement patterns accordingly.12 The mandatory date for implementation of the EN
European version of the standard is June 1, 2013. The US
Regulatory issues FDA requires the use of the standard on June 30, 2013,
Regulatory issues are of particular concern to a biomedical while Health Canada recently extended the required date
engineer; it is among the most heavily-regulated fields of from June 2012 to April 2013. The North American
engineering, and practicing biomedical engineers must agencies will only require these standards for new device
routinely consult and cooperate with regulatory law submissions, while the EU will take the more severe
attorneys and other experts. The Food and Drug approach of requiring all applicable devices being placed on
Administration (FDA) is the principal healthcare regulatory the market to consider the home healthcare standard.15
authority in the United States, having jurisdiction over
medical devices, drugs, biologics, and combination Founding figures16
products. The paramount objectives driving policy • Leslie Geddes (deceased)- Professor Emeritus at
decisions by the FDA are safety and efficacy of healthcare Purdue University, electrical engineer, inventor, and
products. educator of over 2000 biomedical engineers, received a
National Medal of Technology in 2006 from President
The different regulatory arrangements sometimes result in George Bush for his more than 50 years of contributions
particular technologies being developed first for either the that have spawned innovations ranging from burn
U.S. or in Europe depending on the more favorable form of treatments to miniature defibrillators, ligament repair to tiny
regulation. While nations often strive for substantive blood pressure monitors for premature infants, as well as a
harmony to facilitate cross-national distribution, new method for performing cardiopulmonary resuscitation

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 Asian J. Pharm. Res. 2013; Vol. 3: Issue 4, Pg 202-206 [AJPRes.]

(CPR). 2006.
4. Trial begins for first artificial liver device using human cells,
• Y. C. Fung - professor emeritus at the University of University of Chicago, February 25, 1999
California, San Diego, considered by many to be the 5. "Accredited Biomedical Engineering Programs". Bmes.org.
founder of modern Biomechanics Retrieved 2011-09-24.
• Robert Langer - Institute Professor at MIT, runs the 6. "McMaster School of Biomedical Engineering".
largest BME laboratory in the world, pioneer in drug Msbe.mcmaster.ca. Retrieved 2011-09-24.
7. "Biomedical Engineering - Electrical and Computer Eng.
delivery and tissue engineering Ryerson". Ee.ryerson.ca. 2011-08-04. Retrieved 2011-09-24.
• Herbert Lissner (deceased) - Professor of Engineering 8. "Ryerson Biomedical Engineering Students Invent Brain-
Mechanics at Wayne State University. Initiated studies on Controlled Prosthetic Arm". STUDY Magazine. 2011-04-01.
blunt head trauma and injury thresholds beginning in 1939 Retrieved 2011-09-24.
in collaboration with Dr. E.S. Gurdjian, a neurosurgeon at 9. Biomedical Engineering Curriculum: A Comparison Between the
USA, Europe and Australia
Wayne State's School of Medicine. Individual for whom the 10. "Leslie Geddes - 2006 National Medal of Technology".
American Society of Mechanical Engineers' top award in YouTube. 2007-07-31. Retrieved 2011-09-24.
Biomedical Engineering, the Herbert R. Lissner Medal, is 11. "Biomedical Engineering Professor Emeritus Fredrick L.
named. Thurstone Dies". Pratt.duke.edu. Retrieved 2011-09-24.
12. Gallegos, Emma (2010-10-25). "Alfred E. Mann Foundation for
• Nicholas A. Peppas - Chaired Professor in Scientific Research (AMF)". Aemf.org. Retrieved 2011-09-24.
Engineering, University of Texas at Austin, pioneer in drug 13. Bronzino, Joseph D. (April 2006). The Biomedical Engineering
delivery, biomaterials, hydrogels and nanobiotechnology. Handbook, Third Edition. [CRC Press]. ISBN 978-0-8493-2124-
• Otto Schmitt (deceased) - biophysicist with significant 5.
contributions to BME, working with biomimetics 14. Villafane, Carlos, CBET. (June 2009). Biomed: From the
Student's Perspective, First Edition. [Techniciansfriend.com].
• Ascher Shapiro (deceased) - Institute Professor at MIT, ISBN 978-1-61539-663-4.
contributed to the development of the BME field, medical 15. Bioengineering Education, Journal of Clinical Engineering
devices (e.g. intra-aortic balloons) (series) Volume 11, No. 1-6 (1986) and Volume 12, No. 1 (1987)
• John G. Webster - Professor Emeritus at the University 16. Engineering High-tech Student's Handbook, D.R. Reyes-Guerra
and A.M. Fischer, Peterson's Guides (1985)
of Wisconsin–Madison, a pioneer in the field of
instrumentation amplifiers for the recording of
electrophysiological signals
• Robert Plonsey - Professor Emeritus at Duke
University, pioneer of electrophysiology
• U. A. Whitaker (deceased) - provider of The Whitaker
Foundation, which supported research and education in
BME by providing over $700 million to various
universities, helping to create 30 BME programs and
helping finance the construction of 13 buildings
• Frederick Thurstone (deceased) - Professor Emeritus at
Duke University, pioneer of diagnostic ultrasound
• Kenneth R. Diller - Chaired and Endowed Professor in
Engineering, University of Texas at Austin. Founded the
BME department at UT Austin. Pioneer in bioheat transfer,
mass transfer, and biotransport
• Alfred E. Mann - Physicist, entrepreneur and
philanthropist. A pioneer in the field of Biomedical
Engineering.
• Forrest Bird - aviator and pioneer in the invention of
mechanical ventilators
• Willem Johan Kolff (deceased) - pioneer of
hemodialysis as well as in the field of artificial organs
• John James Rickard Macleod (deceased) - one of the
co-discoverers of insulin at Case Western Reserve
University.

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