How are PCBAs Used in Medical Devices?

Why are PCBAs Critical to Medical Devices?

Printed Circuit Board Assemblies (PCBAs) play a critical role in the development and functioning of medical devices. These devices, which include everything from diagnostic equipment to surgical instruments, rely on the reliable and efficient operation of their electronic components. PCBAs connect and control these components, making them a fundamental part of any medical device.

How do PCBAs Function in the Devices?

One of the most common ways to use PCBAs in medical devices is to control and monitor patient vital signs. For example, a patient monitor may use a PCB to track a patient’s heart rate, blood pressure, and oxygen levels. The electronic assembly in this device would likely include a microcontroller or microprocessor, which would instruct the device’s operation and interpret the data collected by the sensors. The PCBA would also include the necessary circuits and connections to power the device and display the information on a screen.

Diagnostic Equipment

Manufacturers also build electronic assemblies into diagnostic equipment such as imaging systems. X-ray machines, CT scanners, and MRI machines use PCBAs to direct the movement of the imaging equipment and process the data collected. These machines require precise management of the imaging equipment and use high-powered electronic components to generate and process the images. Overall, the PCBAs in these devices must be highly dependable and able to withstand the high radiation levels generated by the imaging equipment.

Surgical Instruments

Another important use of PCBAs in medical devices is in surgical instruments. Surgical robots, for example, require precise and reliable regulation of their motions. The assemblies boards in these devices command the motors that move the robot’s arms and perform the surgery. These PCBAs must be able to withstand the rigorous conditions of the operating room and be resistant to disinfectants and sterilization procedures.

Implantable Devices

An example of a highly specialized application of PCBAs in medical devices is implantable devices such as pacemakers and cochlear implants. Doctors and surgeons implant these devices in the body, and they must function for an extended period. The PCBAs in these devices need to be highly miniaturized and able to withstand the harsh conditions of the human body. They must also consume very little power and be able to function for long periods on small batteries.

Certifications

PCBAs in medical devices have to go through a strict certification and compliance process with agencies such as FDA, to ensure that they are safe for use in medical applications. Manufacturers have to adhere to strict guidelines, such as those designated by ISO 13485:2016, for the materials used in the PCBA, the manufacturing process, and the quality control procedures to guarantee the PCBA is suitable for use in medical devices.

Summary

In conclusion, Printed Circuit Board Assemblies play a vital role in the development and functioning of medical devices, from patient monitors and diagnostic equipment to surgical instruments and implantable devices. The design and manufacturing of PCBAs for medical devices is a highly specialized field, requiring specific materials, manufacturing processes, and strict compliance with safety guidelines. With the advancement of technology, electronic assemblies will continue to be an essential component in the development of new and improved medical devices.

4 Huge Benefits of Selective Soldering

Selective soldering is an important process in the assembly of Printed Circuit Board Assemblies (PCBAs). It is a method of soldering specific areas of a PCB rather than the entire board. This process improves the accuracy and quality of the soldering process and offers several benefits over traditional soldering methods.

The Process

Selective soldering is an amazing process that allows manufacturers to precisely and efficiently connect components on a circuit board. It’s a process that many people don’t know much about, but it’s an essential part of creating high-quality electronic devices.

The process itself involves using a machine to apply molten solder to specific points on a circuit board, connecting components together, and ensuring a strong and reliable electrical connection. The machine is controlled by a computer program, which allows for a high degree of accuracy and control, ensuring that each component is soldered correctly and securely.

Top Benefits of Selective Soldering:

1. Improves the accuracy and quality of the soldering process.

By soldering only specific areas of the PCB, this process reduces the risk of mistakes and defects. This can lead to higher quality final products and fewer rework or repair costs. Additionally, selective soldering allows for more precise control of the temperature and duration of the soldering process, which can prevent overheating of components and reduce the risk of defects.

2. Handles complex boards and components.

Selective soldering equipment is capable of soldering surface-mount and through-hole components, including components with odd geometries, and different sizes and shapes. This can be beneficial for companies that manufacture complex or advanced products that require specialized assembly processes.

3. Offers improved efficiency and productivity.

The process is faster and more accurate than traditional soldering methods, which can lead to improved turnaround times and reduced labor costs. Additionally, selective soldering has the ability to handle large volumes, which is especially beneficial for high-volume production runs.

4. Offers more flexibility than traditional soldering methods.

The process adapts to changing production requirements and can integrate easily into automated assembly lines. This can be beneficial for companies that need to adapt to changes in demand or market conditions quickly.

In conclusion, selective soldering is an important process in the assembly of Printed Circuit Board Assemblies (PCBAs) and offers several benefits over traditional soldering methods. Overall, it is a fantastic process that makes it possible to manufacture high-quality, reliable electronic devices. It’s precise, efficient, and cost-effective, making it a popular choice among manufacturers worldwide. So, if you’re looking to produce top-quality electronic devices, consider using selective soldering in your manufacturing process. It’s a surefire way to create happy and satisfied customers!

6 Common Design Concerns with PCBAs

Before PGF, There’s the Design

Designing a Printed Circuit Board Assembly (PCBA) can be a complex task, and engineers must take into account many concerns to ensure that the assembly functions correctly and meets all the requirements. These concerns include everything from the layout and routing of the circuits to the selection of components and materials. Before starting with the PGF partnership, a company must first solidify its design for the assembly process. 

1. Proper Routing

One of the most important design concerns in PCB Assembly is ensuring the proper routing of the circuits. This means that the pathways for electrical current are clear and free of any obstacles that could cause a short circuit or other problems. The routing of the circuits must also take into account the power requirements of the components, as well as any potential electromagnetic interference (EMI) that could affect the functioning of the assembly.

2. Layout of Components

Another important design concern is the layout of the components on the PCBA. Engineers must carefully consider the placement of the components to ensure easy assembly and enough space for them to function properly. The layout must also take into account the thermal characteristics of the components, as some components may generate more heat than others, and the layout should dissipate this heat effectively.

3. Component Selection

Component selection is also an important design concern. Chosen components must be appropriate for the application and compatible with the PCBA. This designation includes not only electronic components but also the materials used on PCBAs such as the substrate, copper thickness, solder mask, etc. Engineers should select them based on their specifications and characteristics, such as power dissipation and operating temperature range, and should be of good quality to ensure that they function correctly and have a long service life.

4. Safety and Compliance Requirements

The PCB Assembly must meet any necessary safety and compliance requirements. PCBAs in medical devices, for example, must meet stringent safety and performance standards set by certifications such as ISO 13485:2016. This includes ensuring that the materials and components in the assembly are safe for use in a medical environment and that the assembly is properly shielded to protect against electromagnetic interference. Similarly, PCBAs used in other applications such as industrial or aerospace must meet relevant compliance and safety standards.

5. Testing and Validation

Another important design concern is testing and validation of the PCB Assembly. The functionality of the PCB Assembly must be verified through various testing methods such as visual inspection, continuity testing, in-circuit testing, and functional testing to ensure that it meets the specifications and requirements of the application. Some machines to assist with the testing process include X-ray and AOI Inspection. This testing must happen at different stages of the assembly process to ensure the early detection and correction of any problems.

6. Cost

Finally, the cost is always a concern when designing a PCB Assembly. PCBAs can be expensive to manufacture, and the cost of components and materials can add up quickly. To minimize costs, the designer must consider the most cost-effective components and materials and use them in the assembly. Additionally, the design should be optimized to minimize the number of components and the size of the PCBA, while still meeting all the requirements.

Summary

In conclusion, designing a Printed Circuit Board Assembly involves many design concerns that need to be taken into account. Proper routing and layout of circuits, component selection, safety and compliance, testing and validation, and cost are key design concerns that engineers need to address to ensure that the PCB assembly functions correctly and meets all requirements. Skilled engineers and designers with experience in PCBA design and assembly can help to confirm functionality and feasibility before starting with your contract manufacturer. At PGF, you design it, and we’ll build it! 

PCB Mounting Techniques

What is a PCB?

Printed Circuit Boards, or PCBs, hold a variety of functions, sizes, and industrial applications. To add electrical components to the board, PCB assemblers utilize either surface or through-hole mounting methods. PGF Technology Group prides itself on offering both PCB techniques, with optional combinations of  SMT or through-hole technologies. By staying on the edge of technology, PGF continues to further integrate surface-mounting techniques to all applicable assemblies, saving both time and money. However, although the surface mounting techniques take precedent, PGF continues to provide authentic through-hole processes to best suit customer specifications. The presence of both techniques widens the PGF market, thus utilizing either process based on the most efficient solution.

Surface Mounting

The surface mounting PCB assembly method involves mounting electrical components onto the top of the printed circuit board. With surface mount technology (SMT), electrical components are installed in a simple and timely manner. The surface-mounting technique allows ample use of both sides of the board. Surface mounting SMT technologies automate the assembly process, increasing production speed while maintaining high-quality products. The Fuji and MyData machines are the two main types of machinery used to process PCBs.

Benefits:

• Allows for smaller PCB design, closely placed components
• Compact and lightweight
• Cost-effective with faster production time
• More efficient designs with components aligned tighter together
• More controlled manufacturing environment from automated machine technology

Through-Hole Mounting 

Through-hole mounting involves a pre-drilled hole to install and solder the electrical component to the printed circuit board. Typically used for large components, the through-hole method may also be utilized for attaching components determined incompatible with the surface mount technologies. Before SMT advanced automating technologies, the through-hole method was the main assembly practice to attach components to the board. While through-hole mounting is not as common, particularly military and aerospace industries utilize such methods to ensure durability in irregular conditions.

Benefits:

• With components attached through the board, such PCBs offer higher strength and reliability
• Able to endure larger amounts of external physical stressors
• Easily replaceable and thus desirable for various testing endeavors or prototyping projects
• Ability to withstand higher heat capacities
• The stronger bond between the board and the electrical components allows higher power capabilities

PGF Premium Services

While offering both surface mounting and through-hole mounting techniques, PGF delivers high-quality products that meet all customer specifications promptly. Additionally, PGF offers X-Ray Evaluations and Ionograph Testing services to all customers, showcasing the company’s dedication to excellence. Learn more about the endless PGF advantages for all your PCB needs. Request a quote and experience all PGF premium services today!

A Complete Prototyping Checklist for Printed Circuit Boards (PCBs)

The pillars of quality electronic manufacturing are precision, reliability, and functionality. Each project must meet a specific performance standard, and printed circuit boards (PCBs) are critical in gauging whether a project has succeeded or failed. PCB assembly systems risk becoming unreliable, imprecise, and nonfunctional without proper manufacturing. Prototyping is an essential step to guarantee these products function as planned. In effect, this blog breaks down the prototyping checklist and the benefits of the process. 

Benefits of Prototypes

Prototypes for PCBs help prevent potential issues with the end product. Prototyping offers numerous advantages, such as:

Trained Eye Inspection

Firstly, multiple tests at every step ensure the project meets the original vision. In practice, tests involve a trained eye inspection of the product’s design, followed by specific testing methods, including automated optical inspection (AOI), solder paste inspection (SPI), and X-ray evaluations.

Supreme Time-Saver and Performance-Checker

Testing individual components enable manufacturers to pinpoint areas of failure in designs accurately. This process is critical, as a single defective piece is detrimental to a project. Simultaneously testing each feature helps optimize performance and save time.

Open-Line Discussion with Manufacturer

Prototype assemblies entail open communication with manufacturers. If certain areas require more focus than others, it’s easy to connect with the manufacturer to relay this need. Manufacturers will break down references, product life, component cost allocation, and documentation. Additionally, they can troubleshoot any problems that develop.

Early Discovery of Design Problems

Prototypes help ease the consequences of errors by providing sufficient time to fix design flaws or readjust concepts. This benefit stops issues from becoming more critical as manufacturers produce higher volumes, preventing resource waste and project delays.

Reduce Added Costs

Another benefit of prototyping is the ability to discover pitfalls on the road map instead of detecting fatal flaws at a later time. This step saves more money by ensuring successful production and replication.

Shorten Project Timeline

Prototyping helps avoid the winding roadblock and U-turns that could otherwise lengthen a project’s timeline. When developing new product designs, their impact on a given industry depends on their timing and effectiveness. 

Prototyping Checklist for Success

To help you get started on your next project, here’s a prototyping checklist that will guide you through each step to ensure your project’s success. These steps are as follows:

1. 1. Send initial documents and design specifications
2. 2. Receive feedback from PCBA manufacturers on the company and  initial machine compatibility
3. 3. Receive a review of the bill of materials with a focus on end-of-life components
4. 4. Review the visual model of the design with the manufacturer to ensure the project is feasible
5. 5. Make any necessary adjustments to the PCBA design
6. 6. Review the proof-of-concept (POC) with the manufacturer for a final check of feasibility
7. 7. Make additional adjustments to the PCBA design as needed
8. 8. Review the performance of the working prototype with the manufacturer to check functionality
9. 9. Make more adjustments to the PCBA design if required
10. 10. Review the functional prototype with the manufacturer for a final check of functionality
11. 11. Make final necessary adjustments to the PCBA design
12. 12. Greenlight the project for production

PCB Assembly and Prototyping at PGF Technology Group, Inc.

If you require reliable PCB assembly and prototyping for a project, PGF Technology Group offers complete PCB assembly services to help fully realize your vision. We have worked with many customers across many industries, including:

• Automotive
• Medical
• Industrial
• Electronic Vehicle 

We’ll work with you to determine what you need for your unique project based on your specifications. We’ll then prototype the end product to ensure it’s fully functional and features an accurate and precise design. Contact us today to get started on your next project with us or learn more about our services. 

ISO:13485 Benefits

What is ISO 13485?

ISO 13485 is a medical device manufacturing certification that ensures customers of the regulations and procedures necessary for product development. This certification applies to the medical industry manufacturing of wire and cable connectors, surface mount and through-hole printed circuit boards, cable, wire processing, wire harness, and panel wire assemblies. Accordingly, issued on October 29, 2021, PGF Technology is an ISO-certified company that provides many benefits for all medical industry customers.

What are the Medical Certification Benefits?

Manufacturing medical devices and similar services require immense precaution and regulatory action to provide customers and patients with the most efficient products. With a variety of potential processes and safety measures, medical certifications allow quality management systems to follow established appropriate measures. As a medical assembly certification, ISO 13485 benefits manufacturing plants and customers in providing transparent safety regulations. After all, customers seeking manufacturers to complete various medical projects are more inclined to work with ISO-certified companies as they are guaranteed proper processing and effective medical devices. 

Worldwide Access

The need for medical products, services, and industry manufacturers is a global and continuous market. To gain customers from all around the world, companies must provide effective products assembled from efficient processes. The medical certification provides customers the relief of knowing the necessary manufacturing assembly tactics are in place. Similarly, manufacturers gain more access to worldwide markets. With a standard certification, companies meet quality requirements to advertise their services internationally. Customer acquisition is more easily attainable, while potential customers increase with the ability of global outreach.

Process Improvement

As the manufacturing processes are standardized, companies continue improving efficiency and safety. Additionally, other services offered by the company can follow a similar assembly protocol showcasing improvement across the organization.

Increased Efficiency

Standard certification regulations help to increase efficiency within the companies while providing the ability to monitor supply chain performance. Manufacturers have clear process guidelines to follow, allowing for faster and more productive assemblies.

Safety

The ISO certification demonstrates safer and more effective medical devices due to the safety measures in place. The medical industry requires immense precautions to ensure the success of all delivered products. Additionally, manufacturers provide transparent and credible processes for each project and customer concerning medical equipment.

Regulation Requirements

To receive the ISO 13485 certification, companies must meet the regulatory requirements, as well as essentially the customer expectations. Arguably the most critical aspect of the medical certifications, the medical service requirements provides the credibility of manufacturers. All in all, the medical industry globally focuses on the safety and requirements of assembly to claim a successful manufacturing process.

PGF Medical Service Expertise

As can be seen, PGF Technology’s ISO certification demonstrates the company’s devotion to credibility, transparency, and quality products and services. Effectively, customers’ satisfaction and product functionality is the highest priority during all medical projects. To learn more about the printed circuit board medical assemblies and prototype services, PGF provides free downloadable eBooks.

Parts of a Printed Circuit Board Assembly

The “A” in PCBA

Printed Circuit Board Assemblies (PCBAs) are electronic assemblies responsible for connecting the electrical components of a system or device. Their applications range from everyday staples such as smartphones to complex custom box build assemblies. The difference between a PCB and PCBA is the A – Assembly of components to the board. Thinking about a PCB layer as a floor, the PCBA represents the completed building – all stairways and connections built to create a fully functioning operation.

What Are the Components of a PCBA?

PCBAs are flat, thin substrates covered in conductive metal and circuit components. Copper lines, called traces, allow electricity to flow into different board components. In turn, the solder mask insulates the copper traces from other metal parts that might accidentally touch them. Some traces remain exposed so manufacturers can solder components to them.

The following is a closer look at a few of these PCBA components:

Resistors regulate the electric current passing through them and indicate their resistance level through color-coding. Resistors are essential because they can guard fragile components against voltage spikes within the circuit. Additionally, if an element needs a lower voltage than the rest of the circuit, a resistor can drop the voltage to the required level.

Transistors are semiconductor devices that can control or amplify currents. Small currents applied to one of the transistor’s three terminals control these functions.

Capacitors can store electricity and release it when a different component in the circuit needs more power. If there is any fluctuation in the circuit’s exact voltage, capacitors can store excess charge and release it as required.

Inductors store energy in the form of a magnetic field. Since they have power separate from the circuit’s current, they provide current to the circuit even when the switch is off.

Transformers transfer current from one circuit to another using wire coils. Running electricity through the wire coils from one circuit produces a magnetic field that reaches the other circuit’s wire coils. The magnetic field creates a current in the new circuit’s wire coils. We can control the amount of current generated by changing the number of turns of the coils in each circuit.

Diodes / LEDs are elements that only transmit current in one direction and block current in the other direction. In most cases, diodes usually have coloring to note the end that allows flow and the one that does not. They protect fragile electronic components from receiving current from the wrong direction. LEDs, or light-emitting diodes, are a particular type of diode that emits light.

Sensors can detect a change in the environment around the board and translate that into electrical charge. For example, a light sensor can see when it’s getting dark and send current to another element in the circuit, like an LED.

Switches can only be open or closed. If the switch is open, then it allows the current to flow. The switch blocks the current from flowing through the circuit if it is off. This component enables more control of the operator.

How Do Manufacturers Attach Components to a Circuit Board?

At present, Electronic Manufacturing Service (EMS) Providers can attach these components to a printed circuit board through various forms of manual and automated assembly. Even more, two of the most popular are surface mounting and through-hole mounting.

• Surface-mount technology (SMT) is the master of all domains in PCB technology. In detail, it refrains from using drilled holes to attach PCBA components; all components are placed directly onto the circuit board. Assembling circuit boards using SMT automation is the simplest and cheapest method, and it allows full utilization of both sides of the PCB.

• Thru-hole mounting is the old reliable mainstay for secure builds. Pre-drilled holes connect components to the board. Since they are soldered in place, the components can withstand more stress. These boards cost more to manufacture and are more difficult to modify than surface-mounted PCBAs, so this method is better suited for mounting connectors and large components that need extra attention. In large part, this assembly method is behind the times, remaining useful for unique builds. 

PGF Technology’s High-Quality Printed Circuit Board Assembly

If you need expert printed circuit board assembly, PGF Technology can help. We pride ourselves on producing high-quality, cost-effective printed circuit board assemblies. Our experienced manufacturers can walk you through all the different options to find your project’s best components and assembly for your project. Contact us today or request a quote if you’re ready to get started!

Design for a Medical PCB Assembly

Playing the Game

When it comes to medical devices, no average or sub-par printed circuit board assembly (PCBA) is going to cut it! In this live-action game of Operation, the consequences are real, and the assembly is accountable.

As a premier manufacturer of printed circuit boards, PGF Technology Group fully understands the importance of proper PCBA design for medical devices and systems. However, some may find the design process challenging since many factors must be considered. These factors include safety requirements, cleanliness standards, industry/application-specific regulations, and more. That’s why our team has put together the following guide, which goes over some of the key considerations to keep in mind when designing medical PCB assemblies.

Safety First

Accuracy and precision are crucial to avoiding the buzzer. Many medical devices are designed to perform vital functions while living in or on the human body for extended periods, such as insulin pumps and pacemakers so that any malfunction can put the patient’s life at risk. That’s why manufacturers must design and build these products and their components carefully to ensure patient safety. PCBA manufacturers should consider the operational and environmental conditions (e.g., fluid exposure, temperature), their effect on the product, and the measures needed to combat those effects.

Cleanliness Is Close to Godliness

A clean workplace is a safe workplace. This saying is especially pertinent in the medical industry, where cleanliness can significantly affect the health and wellbeing of patients and the performance and lifespan of devices. That’s why PCBA manufacturers will often use materials that form surfaces that are easy to clean and disinfect and incorporate strict cleaning practices into production operations to remove any residues left behind from manufacturing processes. Additionally, according to the cleanliness of product clause in ISO 13485 Medical Devices — Quality Management Systems — Requirements for regulatory purposes, organizations need to document product cleanliness or contamination control requirements.

Read the Rule Book

To properly play the game, you have to know the rules. In the medical industry, products are subject to numerous regulations outlining how they should be designed, manufactured, used, etc. Knowing, understanding, and following them is essential to the success of a product.

ISO 13485

Firstly, one of the most critical regulations relevant to medical PCBAs and other electronics is ISO 13485, which establishes the requirements for quality management systems for companies involved in one or more of the lifecycle stages of a medical device or the supply of products. The 2016 update of the standard brought the requirements in line with those already mandated by the FDA.

Companies can be certified to this standard, meaning their quality management system has been verified to meet its strict requirements. The requirements aim to ensure the production of high-quality medical products that are safe and effective, which is why many countries require medical device companies to attain certification. In addition, ISO 13485 certified companies benefit from higher customer satisfaction, greater customer trust, and better credibility.

 

IPC Class 3 Standards

Other specifications to consider are the IPC Class 3 Standards. Companies that meet these specifications value skill, constant improvement, and intense scrutiny. They know that a buzzer in the game signals a life or death scenario, so practices must be monitored and perfected.

 

PGF Technology Group maintains the ISO 13485 compliance and IPC Class 3 Standards for any project connected to medical devices.

What’s the Use?

In addition to safety, manufacturers must keep in mind the usability of PCBAs. For example:

• Is SMT or thru-hole assembly appropriate? Manufacturers should reference the specific design requirements from the client to ensure that they utilize the best method of assembly. This process may include prototypes to review board real estate and functionality.
• How small is too small? While it can be tempting to go with the smallest PCBA design, a design that is too small can limit the complexity of your device. You need to ensure enough space to incorporate all components for a fully operational and reliable instrument.
• What is the min/max amount of energy input? Determine the circuit’s energy to run during typical and peak operation.

Making It Easy

Anyone who has built an IKEA item understands the pain caused by a hard-to-assemble project. Without clear-cut instructions and imagery to demonstrate design, the process can become prolonged. Medical PCBA designers can eliminate this pain by designing with assembly in mind; assemblers should not have trouble reaching and mating cables to connectors, soldering connections or placing other essential components. Additionally, the assembled product should be testable using various methods. Some examples include visual assessment, Solder Paste Inspection (SPI), X-ray scanning, In-Circuit Testing (ICT), and Automated Optical Inspection (AOI).

Medical Device Solutions at PGF Technology

Want to learn more about the critical design considerations for medical PCB assembly? Ask the experts at PGF Technology Group! As an ISO 13485 certified company specializing in PCBA, we can answer or address any of your questions and concerns. Importantly, you can check out our eBook, Key Considerations for Medical PCB Assembly, to overview the vital considerations to keep in mind when designing and assembling medical PCBAs.

At PGF Technology, we have the knowledge, experience, and certifications to deliver PCBA solutions that meet the most stringent specifications. Contact us or request a quote today if you want to partner with us for your medical PCBA needs.