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).
What is Medical Electronics?
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.
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
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.
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.
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.
PCBs as a Core Part of Medical Electronics
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
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.
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.
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.
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.
Application of Electronics in the Medical Field
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 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.
Stages of Medical Device Manufacturing Process
Ideation and conceptualization
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 other hand, validation evaluates if the device offers its required benefits. It is an internal-external process.
Benefits of Medical Electronics
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
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.
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
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.
