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Medical PCB Assembly Service - Instant Quote - NextPCB

Posted:01:50 PM January 03, 2023 writer: NextPCB

The medical industry requests the highest precision, quality, and reliability of the circuit board. NextPCB is in constant work of providing our service in the healthcare market. We provide documentation to our customer, ensuring that the PCB assembly satisfy the manufacturing requirements. This article provides the reader about Medical PCB Assembly, their use cases, and the type of materials used in medical PCB.

What is Medical PCB Assembly?

Medical PCB assembly is the process of constructing a printed circuit board (PCB) for use in medical devices. The process involves mounting and soldering electrical components onto the board, such as capacitors, resistors, transistors, and integrated circuits. The assembly process is critical for ensuring the accuracy and reliability of medical devices, as the boards are responsible for controlling the operation of the device, transmitting data, and providing power to components. Proper assembly of the boards is essential for the safe operation of medical devices, as any errors in assembly can lead to malfunctions or even patient harm. Medical PCB assembly is a highly specialized process and should only be performed by experienced technicians or engineers. Additionally, the boards must be tested to make sure that they meet the required standards and specifications.

Application of PCB Assemblies in the Medical Device Industry

The safety and well-being of patients are guaranteed by engineering electronic devices and diagnostic tools for exceptional precision, long lifespans, and reliable performance. High-quality PCBAs are integrated into medical products to meet these requirements. In recent years, PCBAs have been designed, manufactured, and tested in ways that have enabled PCB manufacturers to increase the accuracy of measuring instruments, the flexibility of treatment design, and the speed at which medical personnel exchange information. Some examples of medical technologies or equipment that have PCB include:

  • Handheld monitors
  • Pacemakers
  • Blood Pressure Monitors
  • Drug Delivery Systems
  • Imaging and Diagnostic Equipment
  • Body Temperature Devices
  • Infusion Fluid Control
  • Heart Monitors and Implants
  • Flow Rate Dispension Systems
  • Dental Equipment
  • Digital X-ray Equipment

Medical technologies are critical and should meet extremely strict quality standards. Further, PCB assembly is often performed by tightly packing multiple connections onto a small surface to ensure the final assembly will fit within compact spaces, as medical devices are becoming lighter and smaller. This small and dense layout requires many considerations during design and assembly. You can use your PCB assembly partner's expertise to navigate some of the factors listed below. 

Medical PCB Assembly

PCB Materials Used in Medical PCB

You'll have a wide range of choices regarding PCB materials and specifications for your medical devices and equipment. You can optimize the performance of your medical device by selecting the right PCB specifications. Some of the most commonly used PCBs in the medical field, along with some key factors that make individual PCBs suitable for specific applications are as follows:

Flexible PCBs

Flex PCB is the first choice for medical equipment. Flex PCBs are a great option for medical devices since they are malleable and can often be placed in places that require flexibility. 

Flexible aluminum PCBs

Some high-power medical devices require harder PCBs, which are unsuitable for flex PBCs. Due to their heat transfer abilities, flexible aluminum PCBs are ideal for high-power applications. Surgical lighting and scanning are some of the most popular applications for these boards. 

PCB microcircuits: 

A flexible PCB microcircuit might also be an option to consider. Moreover, PCB microcircuits offer greater performance than flex PCBs, which is what makes them so unique. Microcircuits on PCBs are commonly present in small medical devices, such as wearable technology, industrial sensor, etc.

Polyimide PCB material

The polyimide base material is often one of the best choices when designing PCBs. The tensile strength and flexibility of polyimide PCB materials are excellent. Medical devices, such as prosthetics and implants, can also benefit from these materials because they are highly durable, thermally stable, and chemically resistant.

Ceramic PCBs

Ceramic PCBs have lower thermal expansion coefficient and high thermal conductivity, making them an excellent choice for medical device manufacturers. In addition to being able to work in extremely high temperatures, these PCBs contribute to incredible performance at high frequencies, are easy to implement high-density tracing, and are chemically resistant.

Rigid-flex PCBs

A flex circuit and rigid-flex PCB can make the PCB durable and strong. The conductors sit between rigid and flexible materials to connect the flexible materials with other layers. In addition to their durability, rigid boards offer greater design versatility since they are lighter and smaller than flex boards. 

Medical PCB

Basic Considerations for Medical PCB Assembly

Medical PCBs are designed and assembled by following some strict guidelines. For any devices or equipment used in the medical domain, designers should consider the following factors:

  • Safety

Safety is one of the important considerations when it comes to the design and manufacturing of PCBs. Patients use medical devices directly. Thus, any circuitry malfunctions are extremely dangerous and can be life-threatening. Therefore, designers make well-engineered medical devices and their components even when exposed to harsh environmental conditions. 

Knowing how important high-reliability PCB design is, a PCB fabricator can work with you to minimize safety risks and address specific concerns.

  • Regulatory Compliance

Medical devices must comply with strict standards depending on their function and environment. Ensuring your device complies with all regulatory requirements requires working with a PCB manufacturer familiar with these standards. The medical industry places a high standard on component tracking, so a qualified PCB manufacturer can provide detailed records of the various testing and inspection procedures. 

  • Usability

For medical practitioners and other users to enjoy your product, you must balance functionality and usability. Several physical attributes and specialized designs make medical devices practical and easy to use. Your device can deliver maximum value and utility when you choose a PCB manufacturer that incorporates these design considerations.

  • Cleanliness

Electronic devices cannot function without PCBs, which is why they must be able to work without fault. A PCB assembly may become highly susceptible to corrosion when residues like inorganic salts, acids, and other inorganic acids leave behind during manufacturing and soldering. As a result, your electrical device may end its useful life without warning due to corrosion. 

  • Quality

In addition to improving PCB assembly reliability, contaminant removal enhances the reliability of medical devices. PCB manufacturers need to ensure that their products are clean.

Basic Considerations for Medical PCB Assembly

PCB Assembly Challenges in Medical Device Industry

Medical devices can face various challenges while constructing and designing products. Some of the common challenges faced in the medical industry include the following:

  • Standard and Regulation

Manufacturing tools and equipment are subject to many regulations in the medical industry. Complying with these standards protects staff and patients from unsafe, unreliable, and untraceable products. Companies also have difficulty getting their products approved for marketing because of stringent regulations. Complying with the relevant standards is mandatory for all components, including PCBs.

  • Performance Requirements

Medical devices offer reliable performance. It ensures that equipment and devices consistently perform according to their design and specifications. 

  • Production Cost

Medical device development and production are similar to other manufacturing projects in that they must adhere to a budget. To maintain performance and regulatory compliance at a reasonable cost, manufacturers must find a way to balance the two. 

  • Size

Size is one of the challenges in medical PCB. Medical PCB should be smaller in size to fit medical devices. This trend is increasing with the more advanced technologies and electronics. A good PCB manufacturer can easily craft their talent to build any smaller-size PCB that provides top-notch performance. 

  • Reliability

Since PCB-equipped medical equipment is often lifesaving, it must be reliable. Medical devices should work in extreme conditions like liquid, shocks, temperature, etc. Although working in such a harsh environment, these PCBs should provide reliable and effective results. 

PCB Assembly Challenges in Medical Device Industry

Technologies for Medical PCB Assembly

  • Flex and Rigid-Flex
  • Multi-layer/High-Density Interconnect PCBs
  • SMT and SMT 
  • Flip-Chip (FC)
  • Chip on Board (CoB)
  • Chip on Chip (CoC)
  • Through-Hole Technology (THT)
  • Reflow Soldering
  • Selective Soldering
  • Conformal Coating

Types of Medical Devices PCB

Wearable Technology

NextPCB designs and manufactures flexible PCB for smart wearable devices. By using a flexible PCB, this device combines user-friendliness, connectivity, and a high level of functionality. The ergonomic design of the device met the expectation of users. 

Characteristics

  • Flex PCB has the bending property that reduces the size and cost of manufacturing. 
  • With the flex PCB, you can easily mold the device into various shapes. 
  • The designing and working with flex PCB is user-friendly.
  • Diagnostic Device Technology

Instant testing kits for blood tests and diabetes are demanding in the market. Optimal portability, compactness, lightweight, and high-speed functionality are all enabled by compact-sized PCBs, flexible PCBs, or multilayer PCBs.  Thus, we provide you with a durable PCB for wireless Diagnostic devices. They ensures signal integrity with less heat and power consumption. 

Wireless device PCB

Electrotherapy Equipment

Some medical devices, like electrotherapy, deal with human life. Thus, it's very important to keep their design priority. These devices are of various formats and therefore require various types of PCBs. Moreover, some may use single layered while others may use multilayer PCBs. At, NextPCB, we designed single to multi-layered PCBs. Our expertise can help you with any challenges in PCB design.

Single Layered PCB

Single-Layered PCB is easy to design and consider. Besides, they are cost-effective and don't require any complex components. 

Characteristics 

  • Provide resistance against bending and breaking of the circuit
  • Perfect to use in sensor devices
  • Cost efficient design
  • Time for troubleshooting the fault is less.
  • They are perfect for simple analog and digital circuits.

Multi-layer PCB

It consists of 3 layers of conductive materials. The PCB reduces the size of the device and finally optimizes power consumption. 

Characteristics of Multi-layer PCB

  • High-quality product
  • Improve durability
  • Small laser drilling, hole drilling
  • Greater capacity due to high-density assemblies
  • Minimal impedance that results to high quality

Multilayer PCB

Design and Fabricate the Medical PCB

Schematic Diagram

The schematic design is the foremost step in the design and manufacturing process. All the required information is collected from the user. Some of the reports include PCB types, application of PCB, materials, and power requirements of PCB. With these accurate designs, the initial design of medical PCB is made.

Layout

A PCB layout is followed by a schematic design. The required details of the project are considered, and further work is done. 

Crucial factors

The design process of a Medical PCB requires consideration of several critical factors. Several essential elements go into selecting pins, including the split planes, the sequencing, and the number of pins.

Split Power Properly

This stage of the design process involves splitting power to reduce noise and crosstalk on the board. It is important to diversify power properly to achieve effective results.

Allow Multiple Layers

It is necessary to layer the PCB base multiple times to reduce noise and SNR. Medical PCBs with multiple layers are also more reliable and perform better. 

Review BOM (BOM) List

The next step is to review the medical PCB bill of material BOM. Medical PCB Bills of Material contain all the parts and materials.

Check Components

In this stage, manufacturers check the Medical PCB parts thoroughly to ensure they meet design requirements.

Prepare and Verify Alternative Component Lists

Occasionally, certain PCB components fail to meet design requirements or fail to function properly. An additional list of components is prepared beforehand to deal with this issue. By doing this, the designing process can be speed up.

Make a Drawing for the Assembly

Assembling medical PCBs is a complex process. Additionally, Medical PCBs need to be extremely accurate since they are used in a sensitive medical field. PCB design and assembly should be error-free. An assembly process drawing is created and followed diligently to ensure PCB assembly accuracy.

Show Test Points in the Design

The human body requires precision and accuracy when it comes to medical devices. It also requires accurate, error-free Medical PCBs to manufacture these devices. A PCB should include all possible test points to achieve this.

PCB desing and manufacturing

Assembling Medical PCB

PCB assembling requires consideration of several important factors. Circuit boards, PCB parts, and their functions are all vital factors to consider. Before assembly, you need some essential tools to help you. Testing equipment, soldering machines, and SMT equipment are some of the critical assembling tools. Some other materials include solder wire and paste. 

The medical field is extremely sensitive, so conducting a design for manufacturability test prior to assembly is essential. During the design for manufacture test, any design challenges are identified and corrected before starting actual assembly. After the assembly of the medical board, DFM's primary objective is to ensure that it functions properly. Some of the assembling processes for the medical PCB are as follows: 

Solder Paste Stencilling

Assembly begins with stenciling the solder paste. This board is covered with a stencil, so it is only left with the part where a component would be mounted. Solder paste can then only be applied where components will be mounted. 

A mechanical fixture holds the board and solder stencil. A solder paste applicator is then used to apply the paste at designated locations. All exposed areas are coated uniformly with solder paste. The solder past remains at the desired place after removing the stencil.

Pick and Place

A medical PCB is mounted accurately here with its various electronic components. An assembly robot is used to manufacture medical PCBs due to the high accuracy required. Robots pick up and place surface-mounted devices on boards. Solder paste is precisely placed on the components by the mounting device.  

Soldering Reflow

Solder overflow ensures that the joints between components and boards are strong. The conveyer belt moves the board through the large reflow oven. Then, with the heat of 2500℃, the solder paste melts. Then, the medical PCB passes through the cooler, solidifying the paste and forming the joints between the board and the parts.  

Inspection and Quality Control

The assembled Medical PCB then examines to find and fix any flaws and connectivity problems that might have emerged due to movements during the reflow. The board performs manual checks, automatic optical inspections, and X-ray inspections, among other inspections. 

Last Inspection and Functionality Test

Medical PCB assembly ends with the inspection and testing of the manufactured board. The board is put through a rigorous functionality test in this instance to ensure it performs as needed and complies with the high standards of the medical industry. Cleaning the board then eliminates oil, flux, and other debris after it has been examined and approved. This makes the medical board sterile and suitable for producing medical devices. The Medical PCB can be subjected to specialized tests depending on the kind of medical apparatus that will use it.

PCB Assembly

Tips to Choose the Right Medical PCB Assembler

In the medical field, well-designed PCBs play an essential role in enabling critical medical procedures and improving patients' quality of life. These PCBs are designed and assembled utilizing specialized skills that require a high level of expertise and strict adherence to quality, safety, and cleanliness standards. PCBA assembler who understand the unique challenges of the medical field can assist medical device manufacturers in meeting these requirements. Some of the qualities to check for PCB assembler includes the following:

  • Experience Expertise

It is vital to know that your manufacturer should have the expertise and knowledge to meet the standard of the project. Your manufacturer should have experience in manufacturing and designing PCBs similar to your project applications. The knowledge gained from the experience and the expertise can help to avoid mistakes during the execution and planning stages. 

  • Turnkey Solutions

Turnkey PCB assembly solutions from PCB assembly manufacturers are beneficial in many ways. Since you only have to keep in contact with one company throughout the entire process, from prototype to production to delivery, answering your questions and addressing your concerns is considerably easier. Besides having better control over the project, you also have a greater chance of getting a quality product, and the fulfillment and delivery process is usually much faster.

  • Sufficient Resources and Capacities

Your PCB manufacturer and assembler should have the necessary equipment to accommodate your production requirements, including volume, design, and materials. 

PCB Assembler

Why NextPCB for Your Medical PCB Needs?

NextPCB is a Contract Manufacturer of PCB and PCB-related services. We can produce reliable and durable PCB solutions that meet technical specifications and quality standards. We have listed some of the certifications that demonstrate our ability to provide PCB assemblies and services for the medical field and other applications:

  • ISO 9001:2015 quality certification
  • ISO 14001:2015 Environmental Management System (EMS)
  • IATF 16949:2016 International Standard for Automotive Quality Management System
  • REACH, Regulation concerning the Registration, Evaluation, Authorization, and Restriction of Chemicals
  • RoHS, Restriction of Harza Substances
  • UL E469747

NextPCB is the PCB manufacturer and assembler that offers full turnkey product assembly capabilities, board fabrication, testing, serialization, component sourcing, etc.

Conclusion

Medical PCBs are becoming popular in diagnostic devices, bioanalysis equipment, and laboratory devices. In the medical industry, it plays a vital role. Thus, the assembled process of medical PCB is of high standards. Almost all medical devices use this PCB, and the manufacturer's design and assembly follow separate medical rules and standards. 

Tag: Medical PCB assembly
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