Review on Biomedical Engineering and Engineering Technology in Bio- Medical Devices

Abstract

Biomedical engineering and engineering technology in medical devices is very important as the rapid development of technology, the increase in diseases, and the presence of many medical and technical problems for some medical devices that need engineering solutions for medical devices, which leads to an increasing demand for medical engineers in order to deal with the increasingly complex biological problems. The need for a medical engineer is increasing every day. The research also deals with solving engineering problems in medical and life devices. In medical companies specialized in the manufacture of medical devices, or those specialized in the maintenance and sale of medical devices, or research centers such as universities which research the development of medical devices and analyze, understand and solve engineering problems and develop and invent new engineering devices.

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Review on Biomedical Engineering and Engineering Technology in Bio-
Medical Devices
Dr. Nagham Mahmood Aljamali1* , Widad Hashim Yahya Almuhana2
1Professor, Ph.D, Organic Chemistry, Synthetic Chemistry Field, Iraq
2Lecturer, Department of Biology, College of Education for Girls, University of Kufa, Iraq
*Corresponding Author: dr.nagham_mj@yahoo.com
ABSTRACT
Biomedical engineering and engineering
technology in medical devices is very
important as the rapid development of
technology, the increase in diseases, and the
presence of many medical and technical
problems for some medical devices that need
engineering solutions for medical devices,
which leads to an increasing demand for
medical engineers in order to deal with the
increasingly complex biological problems.
The need for a medical engineer is increasing
every day. The research also deals with
solving engineering problems in medical and
life devices. In medical companies specialized
in the manufacture of medical devices, or
those specialized in the maintenance and sale
of medical devices, or research centers such
as universities which research the
development of medical devices and analyze,
understand and solve engineering problems
and develop and invent new engineering
devices.
Keywords-- Biomedical engineering, Medical
system, Medical devices, Technology devices,
Bio medical devices
INTRODUCTION
Medical engineering is concerned with
applying engineering principles to medical
problems including replacement of damaged
organs, medical devices, health care systems,
and computer applications for patient diagnosis.
Medical engineering also includes the invention,
manufacture, design, and development of new
technology in academic fields, by conducting
research on possible medical options, diagnostic
procedures, and medical devices, medical
engineering includes examining medical
equipment to ensure that it is working safely and
soundly [1,2]. It also studies tissues and stem
cells, and the industrial interactions that include
them, which have an important role in organ
transplants, which improves the quality of life
for millions of people, as well as the
development of internal and external assistance
devices such as Pacemakers, coronary arterial
stents, prosthetics, prosthetics, dental devices
and products, and it is worth noting that most
medical engineers work within the scope of
modern companies, or by opening their own
projects[3, 4].
THE HISTORY OF BIOMEDICAL
ENGINEERING
The origin of medical engineering goes
back to ancient a civilization, that is since the
time of the philosopher Alcaion, the philosopher
Plato, and the Greek doctor Galen, who studied
the world around them including the human
body, through an organized scientific
methodology 1200 years, specifically until the
time of Maimonides, Leonardo da Vinci was
also called the greatest engineer in history, as he
applied physical, experimental, and analytical
principles to the study of physiology. Medicine
in 1838 AD, and contributed surprisingly to
physiology and psychology, as he discovered the
ophthalmoscope based on the same methodology
where engineers, inventors, and scientists knew,
the scientific methodology adopted in the study
of physics, mathematics, science, and
engineering, applies to medical engineering in
which technology, knowledge, practical and
theoretical aspects are shared in improving the
life of the individual at the health level.
Biomedical Engineering is one of the important
branches of engineering, also known by another

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Volume-6, Issue-2 (May-August, 2021)
term known as "Medical Technology
Engineering", whatever the name, that discipline
focuses on one goal, which is the design and
maintenance of devices that are used to treat
patients, and engineering is considered medical
devices serve as a link between the fields of
engineering and medicine, and we are now
seeing what medical devices, with their various
classifications, perform in terms of tasks, to help
doctors reach an accurate diagnosis of
pathological conditions, and then find
appropriate treatment methods that help speed
recovery and achieve positive results. In this
article, we will learn about adequate information
related to the specialization of Biomedical
Engineering [5-8].
DEVELOPMENT OF ENGINEERING
DEVICES – MEDICAL LIFE
Engineering companies can develop
devices and maintain damaged ones.
Engineering companies work in the general
medical and medical technical fields.
Accordingly, his responsibilities include the
following Designing, testing and implementing
new medical procedures such as computer
programs and techniques for surgical and tissue
engineering. Design and development of medical
products and devices as well as their testing and
modification. Maintenance of medical devices,
before medical machines are sold to laboratories
and hospitals, these devices must meet certain
conditions. For example, these devices have to
prove that they are both safe and effective. It is
considered safe if patients or physicians who use
it are not harmed or harmed when using it. So,
precautionary measures must be taken. Many
accidents occurred in recent years because of
these machines, which led to an increase in the
stringent tests that these machines must go
through before they are approved. These
machines are considered effective if they
achieve their desired goal within a reasonable
period of time. Medical engineering is a science
that combines engineering sciences (mechanical,
electrical, electronic and computer) with
biomedical and physiological sciences, applying
advanced engineering theories and techniques to
deal with, analyze and solve biomedical
problems. This is done by designing appropriate
tools and devices to measure and understand
physiological and biological systems and to
develop devices capable of treating and dealing
with diseases, which requires studying the way
these devices work, maintain and model them.
Medical engineering greatly allows for
creativity, development and invention, due to the
diversity of medical fields and the enormity of
the physiological systems (the human body) that
this field of engineering deals with, knowing that
the most sophisticated, advanced and most
expensive techniques are used in two fields, one
of which is medical engineering [9-11]., many
companies and universities invest millions of
dollars in scientific research. Researchers are
developing medical machines and artificial
organs. Machines produced from scientific
research projects are carefully checked to ensure
that they comply with the laws and regulations
in place in the country. Machines have to pass
many tests and analyzes before their safety can
be confirmed. After ensuring the safety of these
machines, they are sold to hospitals and
laboratories. Some countries like America and
Germany are exporting machines to be sold in
other countries. Among the most important
areas of scientific research like biomaterials,
medical imaging, medical mechanics, nano
biotechnology, tissue engineering, and many
others. The rapid development of technology,
the increase in diseases, and the presence of
many medical and technical problems that need
solutions lead to an increasing demand for
medical engineers in order to deal with
increasingly complex biological problems,
develop the work of previous devices to obtain
better results, and invent new devices that help
the doctor perform his task in a better manner.
Better and faster, the need for a medical engineer
is increasing every day [ 12-14].
FIELD OF BIOMEDICAL ENGINEERING
At the present time there is nothing
wrong with it, as there is a comprehensive
renaissance in this field. There are liposuction
devices, laser devices for treating long and short-
sightedness, sonar devices of all kinds, magnetic,
x-ray, tomography devices, electron
microscopes, endoscopes and catheters for
treating vascular blockages and installing stents.
Modernity is still ongoing, and there is new
every day [14], shown in below Fig. 1, 2 and 3.

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Figure 1: Prosthetics and pressure devices engineering.
Figure 2: Some of medical eengineering devices.
Figure 3: Medical engineering device for dialysis.

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SYSTEMS & INTEGRATIVE
ENGINEERING
 Engineering of Biological Materials:
Biological materials are materials that
interact with living systems, and many
international companies invest millions to
manufacture these biological materials
either naturally or produced in laboratories
by various chemical methods. These
materials can be placed anywhere in the
body, such as the heart, and are widely used
in surgical operations and in delivering
medication or anesthetics to tissues. Other
use of this material includes joint
replacements, bone plates, artificial heart
valves and blood vessels, tissue, molecular
etc.
 Cell Engineering: It is considered an
important part of biotechnology that
overlaps with medical engineering. One of
its goals is to create artificial organs with
biomaterials in patients who need organ
transplants. Medical engineers are
currently looking for ways to invent such
organs, and some of them have been able to
reach this end through stem cells. For
example, some artificial bladders were built
in laboratories and transferred to some
patients.
 Genetic Engineering: Genetic engineers
alter the genetic content of some organisms.
The goal of this manipulation is to stimulate
these organisms to produce certain
hormones and chemicals. For example,
scientists modify the genes of a special type
of bacteria to produce the necessary insulin
for the human body, and then doctors inject
insulin into patients with diabetes. The
engineers were also able to transfer the
genes responsible for the production of
bioluminescent materials from the flies to
the tobacco plants. Medical engineering is
closely related to genetic engineering
because it aims to improve the performance
of vital organs. To achieve their goals,
genetic engineers clone molecules and
transfer genes from one organism to another
[12].
 Neural Engineering: Neural engineering is
a field of biomedical engineering that uses
engineering techniques to repair or replace
nervous systems. Neuro-engineering is
related to cybernetics, computer
engineering, and neural tissue engineering
as well as materials science and
nanotechnology. Neuro engineers are
qualified to solve problems in both living
and non-living tissues. The goal of neural
engineering is to install devices that can
produce nerve signals to achieve purposeful
responses such as controlling a limb or
interacting with nervous systems to
improve their performance. and that neuro-
engineering is a new field, the engineering
of medical devices that use magnetic
resonance magnetic fields to show the
internal organs in the body, the (PET)
device uses radioactive materials injected
into the body to take pictures. Radioactive
materials, such as Oxygen-15, which breaks
down over a short period of time and
releases radiation, are attached to molecules
bound for the organ to be imaged. For
example, when imaging the brain, these
radioactive materials are attached to
glucose molecules. The goal of PET
imaging is to see how active certain areas of
the organ are being imaged. Although this
imaging method may be more expensive
than others, it has many characteristics that
distinguish it from other imaging methods.
CLASSIFICATION OF MEDICAL
ENGINEERING DEVICES
Biomedical Engineering devices are
classified according to the physical classification
into three basic categories i.e. electronic medical
equipment, radiation equipment group, and
radiation equipment group. This technique is
used in imaging many vital organs such as the
brain, heart, kidneys and others. Computerized
medical imaging is based on X-rays. Using this
imaging, the skeleton can be seen in high
resolution. Before starting the imaging process,
the patient is injected with a contrast material in
order to increase the resolution of the image. The
first tomography machine was built in England.
The first filming took place in 1971 in London.
This type of imaging has side effects and may
affect the nucleic acids in the patient's body.
The resolution of the resulting image is directly
proportional to the amount of radiation emitted
by this device. Computerized tomography is
used to diagnose malignant and benign tumors in
different areas of the body. One of the newest

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medical diagnostic devices is the camera the size
of a pill, this camera can be swallowed like any
pill. This pill can take about 15 color images as
it passes through the pharynx and esophagus.
The goal of this camera is the early detection of
gastrointestinal cancer, which increases the
chance of a cure. This camera sends the captured
images to a device in the doctor's office, which
reviews these images and assesses the patient's
condition based on them. The width of this bead
is approximately 9 millimeters. This tool will
make a big difference in the field of medical
diagnostic devices. This device was developed at
the University of Washington. It is the science
that combines biomedical sciences, as well as
physiological and engineering sciences, such as
computer engineering, electrical engineering,
and mechanical engineering, with the aim of
which is the design of medical and prosthetic
devices. To understand the nature of diseases in
all aspects and to deal with them, and it is one of
the most prestigious departments of engineering
colleges, and students are more interested in it
than all other departments, so whoever engages
in that specialization in many of the prestigious
engineering colleges must obtain excellent
grades in the first preparatory year.
ENGINEERING MAINTENANCE OF
MEDICAL DEVICES
The purpose of maintenance of
engineering devices such as electrical,
mechanical, helps doctors to do their work to the
fullest, helps patients to recover better, provides
complete comfort, and helps greatly in
diagnosing diseases, especially tumors inside the
body that cannot be predictable existence
without these devices. BME is also traditionally
known as "bioengineering", but this term has
also come to refer to biological engineering.
This field seeks to bridge the gap between
engineering and medicine, combining design and
problem solving engineering skills with the
biomedical sciences of pre-medical treatment,
including diagnosis, monitoring, and treatment
while adhering to relevant industry standards.
This includes making recommendations for
equipment, procurement, routine testing, and
preventive maintenance, a role also known as a
Biomedical Equipment Technician (BMET) or
clinical engineering. Such a development is as
common as new field shifts from being an
interdisciplinary major among already
established fields to being considered a field in
its own right. Much of the work in biomedical
engineering consists of research and
development, and spans a wide range of
subfields. Notable applications of biomedical
engineering include the development of
biocompatible synthetics, various diagnostic and
therapeutic medical devices ranging from
medical equipment to micro implants, common
imaging equipment such as magnetic resonance
and ECG/EKG, regenerative tissue growth, and
pharmaceutical drugs and therapeutic biological.
It is an umbrella term for the group of biological
studies that use computer programming as part
of their methodology, particularly in the field of
genomics. Common uses of bioinformatics
include identification of candidate genes and
nucleotides (SNPs). This determination is made
with the aim of better understanding the genetic
basis of disease, unique adaptations, or desirable
characteristics (particularly in agricultural
species), bioinformatics also attempts to
understand the regulatory principles within DNA
and protein sequences.
CLINICAL ENGINEERING
Clinical engineering is the branch of
biomedical engineering that deals with the actual
implementation of medical equipment and
technologies in hospitals or other clinical
settings. The main roles of Clinical Engineers
include training and supervising Biomedical
Equipment Technicians (BMETs), selecting
technology products/services and managing their
logistical implementation, working with
government regulators on inspections/reviews,
and acting as technical advisors to other hospital
staff e.g. doctors, administrators, IT, etc.
Clinical engineers also advise and collaborate
with medical device manufacturers regarding
prospective design improvements based on
clinical experiences. In addition to monitoring
the progress of the latest technology to redirect
purchasing patterns accordingly. Their inherent
focus on the practical implementation of
technology tends to keep them geared more
towards incremental level redesigns and retro
fittings, as opposed to revolutionary research and
development or ideas that will be many years
after clinical adoption. However, there is a
growing effort to expand this time horizon
within which clinical engineers can influence the
path of biomedical innovation. In their various

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roles, they form a "bridge” between primary
designers and end users, by combining the
perspectives of being close to the point of use,
while also being trained in product and process
engineering. But also industry/systems engineers
to help address process/optimization research,
human factors, cost analysis, etc. See also
Safety Engineering for a discussion of the
procedures used to design safe systems. Clinical
Engineering Department has been set up with a
Director, Supervisor, Engineer and Technician.
One engineer for every eighty beds in the
hospital is the ratio. Clinical engineers are also
authorized to audit pharmaceuticals and
associated stores to monitor FDA recalls of
gaseous items. Select the Medical Devices
Directive detailed procedures for obtaining
certification. In general, these procedures
include testing and verification that must be
included in specific deliverables such as risk
management file, technical file and quality
system deliverables. The risk management file is
the first product to stipulate the following design
and manufacturing steps. The risk management
phase should lead the product so that the
product's risk is reduced to an acceptable level in
relation to the expected benefits to patients from
using the device. In the technical file contains all
the data documents and records supporting the
certification of the medical device. The FDA
technical file contains similar content although it
is organized in a different structure. Quality
system outputs usually include actions that
ensure quality throughout the product life cycle.
CONCLUSION
Biomedical engineering is the most
common name, and there are two other names
i.e. the first is medical engineering, and the
second is bio engineering. For example, the
manufacture of a rubber valve for the heart to
control blood flow is a joint work between the
biomechanical engineer who knows the
mechanism of the heart's work, and the medical
materials engineer who can choose the best
materials suitable for the human body. The
human heart performs an involuntary mechanical
action by stimulating an electrical impulse of
approximately six volts, so the right ventricle
pumps blood into the right atrium with an
involuntary movement that is not controlled by
the human being, the occurrence of circulatory
failure.
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