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How Medical Electronics Is Contributing to

Development in the Medical Industry
Electronic devices play crucial roles in medical procedures. The advancement in
technology has led to the increase in the demand for advanced medical devices.
Medical electronics are crucial for carrying out treatments, diagnosing health
problems, and performing surgeries. Medicine is one of the best growing fields in
today’s world where people prefer the best health service.

Medical electronics contribute to the successful operations of the medical industry.

Also, they are the pieces of equipment without which surgeons or doctors are helpless.
Medical electronics are specially designed to detect health-related problems and solve
them. Furthermore, artificial devices are examples of medical electronics. Medical
electronics are suitable for use in different medical procedures and imaging systems
like MRI (magnetic resonance insulin).

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What is Medical Electronics?

Medical Electronics pcba

Medical electronics are a core part of health systems. They are electronics specifically
designed to serve medical purposes. These electronic devices help health practitioners
to diagnose medical issues and treat patients. Also, medical electronics help in
improving quality of life. They help to prevent, diagnose, and treat health issues.

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According to the US Food and Drug Administration (FDA), medical electronics are
reviewed based on the risk to patients. High risk products demand for more clinical
proof than lower risk medical products. Also, the FDA only permits products that
have met its requirements to be available on the US market.

Medical electronic devices also include in vitro diagnostic devices. Also, these
devices help to carry out test samples like blood, tissue, and bodily fluids taken from
the body. Examples of medical electronic devices are defibrillators, hearing aids, and
diagnostic equipment for monitoring, recording, and measuring body functions like
brain waves and heartbeat.

Medical electronics require high reliability and high performance printed circuit
boards to function. Also, it is crucial to integrate high quality board in the
manufacturing of medical electronics since these devices are mainly used for life
saving purpose. Therefore, there is much emphasis on the quality and functionality of
the circuit boards used for these electronics.

Types of Medical Electronic Devices

There are different types of medical electronic devices. These devices help to treat
health conditions within the human body.

Monitoring devices

Medical monitoring devices are widely used in various diagnostic and treatment
procedures. Furthermore, they help to ensure these procedures are carefully and
successfully carried out. Examples of medical monitoring devices include heart
monitors, blood pressure monitors, EMG activity systems, flew rate and dispensing
systems, X-ray computed tomography, and body temperature monitors.

Medical diagnostic devices

These medical electronics are widely used in displaying, detecting, and acquiring
medical images. Also, they provide vital information as regards the human
body. Examples of medical diagnostic devices include magnetic resonance imaging
(MRI), CT scanner, and ultrasound equipment. A CT scanner utilizes X-rays, special
lenses, and computer algorithms to create images of the internal body parts of a
patient.

Ultrasound equipment generates sound waves that bounce off the human body. Also,
this machine displays the picture of a structure and transforms it into an image.

Implantable medical devices

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Implantable devices help to replace defective organs in the human body. Also, they
are directly implanted in the body of a patient. They serve as a substitute to any
defective organ. Heart pacemakers, cochlear, and artificial kidneys are the most
common implantable devices. Medical PCBs are a core part of these devices.

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Classification of Medical Devices Based On Risks

Medical electronics are majorly classified into three classes based on risks. Most
industry-leading medical device manufacturers now integrate electronic quality
management systems instead of paper-based systems. Also, it is important to
understand the three risk based classifications for medical electronics.

Class I

Class 1 medical devices are not designed for sustaining or supporting life. According
to the Food and Drug Administration, these devices may not have unreasonable injury
risk. More than 47% of medical devices available on the market are Class I. Also,
Class I devices are subject to few restrictions and regulatory requirements. However,
these devices need to adhere to some general regulations like branding, adulteration,
and device registration.

Class II

This category of medical devices has a higher risk than Class I. According to the FDA,
general controls for class II devices aren’t enough to offer reasonable guarantee for
the effectiveness and safety of the device. Also, controls differ based on the device
when it comes to class II devices. However, post-market surveillance, special labeling
requirements, and device performance are examples of common controls.

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Most times, the 510(k) process or premarket notification approves class II devices.
Also, the 510(k) verifies that a device is effective and safe for use.

Class III

Class III devices are medical devices that support or sustain life. Also, they are
usually implanted and have possible unreasonable risk of injury or illness. Break
implants and heart pacemakers are examples of Class II devices. About 10% of
medical electronic devices belong to class III.

Therefore, these devices are highly regulated. Class III devices are usually reserved
for cutting edge medical purposes. Also, Class III devices have the highest risk.

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PCBs as a Core Part of Medical Electronics

Medical Devices PCBA

Printed circuit board (PCB) is an integral part of medical electronics. This board is
responsible for the performance of medical devices. Also, PCB is very critical in the
healthcare and medicine field. With recent advancement in technology, diagnostic,
research, and treatment strategies are also becoming automated. Therefore, PCBs
have a great role in the production of medical electronics.

Implantable devices, diagnostic devices , and monitoring devices comprise printed

circuit boards. Medical PCBs are the ideal circuit board for manufacturing printed
circuit boards. Also, these PCBs are primarily designed to offer accuracy, precision,
and quality. This is because these devices save lives and as such, they are very critical

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A medical PCB integrates electronic components. Also, this PCB offers electrical
connection and mechanical support to electronic components in medical devices. This
PCB encompasses the electronic components and as such, these medical devices are
safe for humans.

Medical equipment should offer a good level of durability. However, they may
require replacement due to wear and tear or obsolescence. The increasing demand for
new medical equipment has resulted in more dependency on more recent technologies
like rigid-flex PCBs.

Furthermore, medical PCBs play crucial roles in the medical industry. These boards
are majorly designed to function in varying temperatures from -40oC to 140oC. Also,
the medical use of PCBs keeps growing as electronics advance to be better and more
efficient.

Consideration for Medical Electronics Manufacturing

Medical electronic manufacturing requires carefulness, precision, accuracy, and

quality. Also, medical device manufacturers must put quality and precision in mind
when producing these devices. These devices are specially developed to save lives.
Therefore, there are considerations for medical device manufacturing.

Safety

This is very important. It is the number one factor a medical device manufacturer
must put into consideration. Medical devices need to be safe for use. Also, they
should be safe for both humans and their environment. Furthermore, manufacturers
must design these devices to prevent any form of shock. For instance, medical
implantable devices need a high level of accuracy.

Compliance

Medical device manufacturing should comply with certain standards. Also, medical
device should meet strict standards. There are specific standards specially set for
medical devices. These standards evaluate the quality and precision of medical
devices.

Precision

Precision is very important when it comes to medical electronic manufacturing.

Medical device manufacturers need to determine the level of accuracy of their devices.
Also, precision is of high importance since medical devices are primarily designed to
save lives. Furthermore, these devices should be able to withstand dangerous
environments.

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Lifespan

When manufacturing medical devices, it is crucial to consider their lifespan. One of

the factors that determine the lifespan of medical devices is medical PCB. The
lifetime of medial electronic devices is crucial in ensuring durability and quality.

Marginal cases

Medical device manufacturers need to consider the marginal cases of a medical

device’s application environment. You should know the temperature at which the
device will optimally perform.

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Challenges in Medical Electronic Device Manufacturing

The manufacturing of medical electronics can be a complex process. The medical

electronics industry is a complicated one. Also, these technologies are always in high
demand. Therefore, this gives a positive outlook for the future. However, medical
device manufacturers face some challenges in the industry. Manufacturers need to
overcome these challenges to achieve success and improve public health.

Below are major challenges the medical manufacturing industry face today.

High healthcare costs

High healthcare costs are a challenge in the medical industry. A good number of
people across the world can’t afford quality care. Medical device manufacturers are
being pressurized to reduce the cost of their products. As a result of this,
manufacturers are opting for disposable products instead of long-lasting products.

Counterfeit

As the demand for medical electronic devices increases, counterfeits products will
become more in the market. Fake medical products can cause revenue diversion for
legal device manufacturers. Also, they could cause harm to patients who utilize
them. The best way to eliminate counterfeits is to integrate a system to confirm the
authenticity of their products.

Slow, expensive research and development

Through research and development is critical in medical device manufacturing.

However, carrying out necessary clinical trials is expensive. Also, this process could
be very slow and as such, delaying time to market. This could hinder profitability in
the long run. One solution to this challenge is integrating technology such as clod
and robotic process automation.
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Fragile supply chain

There were more challenges in the medical device manufacturing industry during the
COVID-19 pandemic. During the pandemic, different countries adopted various
lockdown restrictions. This caused disruption in supply chains. Also, this further
caused delay in deliveries and increasing cost of materials.
Integrating IoT technologies in medical supply chain can solve this.

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Application of Electronics in the Medical Field

Medical Surgery

Electronic devices make it easy for healthcare providers to connect and communicate
with their patients. Medical electronics have become a core part of the health industry
as health providers look for ways to improve patient’s health. There are several
applications of electronics in medical field which include:

Brain wave machine

Brain wave machine is a crucial medical electronics used in recording the scalp’s
electrical activity. It works by discharging neurons within the brain. Also, this
machine processes the data acquired from the electrodes which are then positioned on
the scalp. The brain wave machine has a screen in which it displays results. Also, this
machine helps in treating brain disorders like brain death, mental unhealthiness, and
sleeping disorder. Furthermore, it is useful in emergency units.

Defibrillator

Defibrillator is very crucial in emergency situations. It is mostly used in emergency

conditions such as heart attack. Also, this medical electronic device affects the heat

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rhythm like pulseless ventricular tachycardia, ventricular fibrillation, and cardiac

arrhythmia. The defibrillator works by delivering electric shock to the heart. This then
causes the heart muscles to depolarize and reproduces normal conduction of the heat’s
electrical pulse.

Magnetic resonance imaging (MRI)

The MRI machine reviews the inner elements of the human body. This machine is
widely used in radiology. Also, MRI machine work by using a strong magnetic field
to create images of the body. MRI machines are diagnostic devices which have effect
on identifying and treating several specialties. Also, MRI doesn’t integrate radiation.
Therefore, it is highly preferred to CT scanner.

Blood gas analyzer

The blood gas analyzer is the best application of electronics in the medical industry. It
calculates the pressure of chemical substances like oxygen and carbon monoxide in
blood. Health care providers can detect any disorder in blood by analyzing results.
This machine has a chemical device strip in which it collects blood. The chemical
device strip features particle selective electrodes.

Electronic cardiac monitor

This medical electronic device helps to display the cardiac system’s pressure
waveforms. Health care providers insert specific electrodes on the body to obtain
ECG of the cardiac system. Also, this monitor checks for any irregular activity in the
cardiac system. It is widely used in medical treatment, especially during surgery.

Sphygmomanometer

Sphygmomanometer measures blood pressure. It is an inflatable cuff that regulates the

flow of blood. Also, this medical device has mercury used to measure the pressure of
blood.

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Stages of Medical Device Manufacturing Process

Ideation and conceptualization

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This stage involves identifying a user need in the market. To develop a successful
product, one must reduce the gap between the needs of the user and the perception of
the designer. What is the function of the device? When is it ideal for use? How will
the device be used?

At the ideation and conceptualization stage, medical device manufacturers should lay
the groundwork for the design, development, and manufacturing process. This
includes calculating possible revenue, assessing risk, and coming up with timelines
for the project.

Regulation and compliance

This stage of medical device manufacturing is critical in ensuring the safest products
are available in the market. All medical devices must adhere to international and
regional compliance standards. This helps to ensure the usability of these devices. For
instance, the IEC standard 60601-1 establishes general requirements for medical
devices and guidelines to maintain safety.

A medical device might be compliant with the ISO and IEC standards, but that
doesn’t mean the FDA will approve it. Food and Drug Administration (FDA) has its
requirements for compliance gotten from international and regional standards. Also,
medical device manufacturers need to consider the FDA regulations for design control.
Design controls refer to the parameters used by an engineer to prove the safety and
effectiveness of their products.

Product development and design

Design is crucial in medical device manufacturing. A poorly designed device won’t

deliver the required functionality. Also, design inputs refer to physical characteristics
that serve as the fundamental of a device’s design. On the other hand, design outputs
are manufacturing instructions and specifications of the device.

Engineers need to keep the copies of design outputs and inputs. Also, they should
have a copy of a design plan. This describes all development activities of the project
and who is in charge of these activities. The technical performance of the device
would show up in laboratory settings. Once engineers get the result, they can start
developing the device’s form.

Testing

This stage involves verifying and validating the product. Verification evaluates if the
device meets certain requirements and verifies if design outputs meet inputs. On the

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other hand, validation evaluates if the device offers its required benefits. It is an
internal-external process.

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Benefits of Medical Electronics

medical-PCB Assembly

Remote monitoring

Medical electronic devices enable remote monitoring of chronic health conditions like
high blood pressure and diabetes. Also, these devices can transfer data from the home
of a patient to care givers. Also, medical electronics make it easy for healthcare
providers to communicate and connect with patients.

Improve health quality

This is one of the ways medical electronics is changing lives and the world at
large. Also, medical devices monitor, diagnose, and treat illnesses in humans.
Therefore, these devices are usually considered as a core aspect of health systems.
They improve health quality by preventing, diagnosing, and treating diseases and
illness in a safe way.

Cost savings

Medical devices reduce healthcare costs in various ways. For instance, the integration
of electronic health records has helped to keep a check on healthcare cost. Also,
medical devices can reduce healthcare costs when healthcare providers have access to
quickly and accurately diagnose illnesses.

Time savings

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Medical devices can help to save the time spent on diagnosing and treating illnesses.
Most time, these devices provide results quickly. Also, medical devices enable
healthcare providers to focus more on important things. Furthermore, these devices
streamline workflow in hospitals. Medical devices enhance timely intervention and
as well improve outcomes.

Contribute to sustainable healthcare

Medical electronics improve health and save lives. Also, these electronics contribute
to sustainable healthcare. The medical industry can deliver value to patients and the
healthcare systems at large. Accurate diagnostic information helps health practitioners
to make good clinical decisions.

Regulation and Standards for Medical Electronics

There are certain standards that regulate the manufacturing, design, and development
of medical electronics. Quality management standards are usually established to
prevent product failures and enhance efficiencies. Many countries rely on the
International Organization for Standardization (ISO) and Food and Drug
Administration in regulating medical devices.

Does the ISO have standards for medical devices? What is the role of FDA in medical
device compliance and regulation? We have answers to these questions.

What is FDA?

FDA simply stands for Food and Drug Administration. It is a U.S government
organization in charge of protecting public health. This organization ensures the
safety, security, and efficiency of medical devices and as well as food supply for
humans and animals. Also, this organization is the regulatory body for the production
of medical devices.

The FDA requires that medical device manufacturers follow quality management
systems to ensure medical products meet certain specifications and requirements.

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What is ISO?

ISO stands for International Organization for Standardization. About 162 national
standard bodies are members of this non-governmental international organization.
Also, this organization sets guidelines and specifications for services and products to
ensure safety. Examples of ISO standards in the medical industry include:

 ISO 9001

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The ISO 9001is widely integrated by companies that produce, manufacture, label, and
deliver medical devices. Also, medical device manufacturers should comply with this
ISO standard. A good number of medical device manufacturers have the ISO 9001
certification.

 ISO 13485

This ISO standard is specially designed for organizations that design, produce, install,
and service medical devices. Also, the ISO 13485 doesn’t meet the requirements of
ISO 9001. The ISO reviews its standards every five years. Therefore, the ISO
13845:2016 is the most recent version. Revision helps to keep the ISO standards
current and relevant.

Conclusion

Medical electronics play a crucial role in the medical industry. Also, these electronics
have contributed to the development of the medical industry. Designing and
producing medical devices isn’t a straightforward process. One major concern is
reducing time-to-market. Also, medical electronics are specifically designed for
life-saving purposes. Therefore manufacturers should pay attention to important
details during medical device design and production.

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1. Top 9 Electronics Design Companies for Development

2. The future and applications of Medical Electronics Engineering

3. The Impact of PCBs in Medical Electronics Manufacturing

4. Raspberry Pi Zero, The Tiny Pi that is Changing the Electronics Industry

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