Due to the COVID-19 pandemic, the global Medical Electronics market size is estimated to be worth USD 4506.3 million in 2022 and is forecast to a readjusted size of USD 5256.6 million by 2028 with a CAGR of 2.6% during the review period. Accordingly, the demand for medical PCBs is also increasingly growing. We can find PCBs in many medical devices such as diagnostic equipment, blood glucose monitors, ultrasonic devices, body temperature devices, fitness trackers, and so on. As a result, more and more PCB manufacturers have begun to enter the medical market, wanting a share of the pie. But unlike other PCBs, PCBs used for medical devices have very strict requirements, including extremely high precision and reliability. Hence, not every PCB manufacturer can be a good medical PCB manufacturer. In this blog, we will explain the services that medical PCB manufacturers can provide and offer workable suggestions about how to select the best medical PCB manufacturer for your projects.
Services That Medical PCB Manufacturers Provide
Generally speaking, medical PCB manufacturers can provide a full-scale of services, ranging from medical PCB designing, manufacturing to assembly and testing. There are many benefits of working with them including lower costs, logistical alignment, and rationalized supply chain management. They are well-versed in each step involved, making sure medical PCBs can play just the right role and help medical devices perform as expected.
Medical PCB Design and Manufacturing
Medical PCB manufacturers need to ensure a deep understanding of the needs of the project when designing, from function, material selection to product lifespan. The design must follow the standards and regulations of the medical industry, in addition, they also need to grasp the design trends of medical PCBs:
- Smaller and Denser
The component placement density for medical devices has increased as their circuit boards have become smaller. Subsequently, the board’s margin error has also decreased, imposing adaptability when manufacturing and designing these PCBs.
Smaller boards that have advanced functionality cause paths with tighter interconnectivity and a small area for traces. Due to this, HDI is applied on many medical boards.
- Non-standard Form Factors
A non-standard PCB form factor designs have been brought by the latest trends that focus on self-monitoring health obligations for medical conditions, wellness, and exercises.
- Rigid-Flex Structures
Flexible electronics that must be incorporated with special manufacturing requirements while designing have continued to gain momentum.
To manufacture high-precision and high-quality medical PCBs, the production process must meet international regulations, and manufacturers should constantly optimize the fabrication process. For example, they can optimize the medical PCBs by right-first-time (RFT) manufacturing, and utilize the digital twin technology for PCB development that can identify potential errors before rolling the first board. By using these manufacturing methods, the fabrication cost would be reduced and the production efficiency would be improved significantly.
Medical PCB Assembly
The medical PCBA is made by bonding electric components to a medical PCB. Several electric components must be assembled on a PCB for it to be effective in a device. Some of the factors the assembly process primarily relies on are:
The type that makes the circuit board classification
Features of the electric components assembled on the board.
Reasons for utilizing the circuit board
Below are popular assembly technologies used for medical PCB assembly:
- HDI / via-in-pad technology
Via-in-pad technology helps to reduce about 50% space and improve component density on the PCB, so it is widely used for small medical devices. In addition, this assembly technology is suitable for PCBs that require high speed and high dissipation.
- Surface Mount Technology
Surface mount technology, also known as SMT, is an assembly technology that is used for almost all medical devices. It allows us to assemble more components even in a small space as the small size of SMT components. In addition, this assembly technology supports automated soldering and assembly that improve reliability and productivity.
- Through-Hole Technology
Through Hole technology is a method that produces the electronic circuits in which the pin-through hole (PTH) components are installed through leads. It is actually a mounting process that inserts the leads into the drilled holes and solders the electronic components on the printed circuit boards.
Key Considerations When Selecting Medical PCB Manufacturers
It is not easy to find the best medical PCB manufacturer as there are a host of manufacturers in the market for your choice. Working with reliable manufacturers can shorten the project turnaround time and save costs, conversely, unqualified PCB manufacturers cannot catch up with the project schedule, and are hard to guarantee the quality of products. Then, here comes the question: How to select the best medical PCB manufacturer? Below are key considerations:
Quality and Manufacturing Standards in Medical Industry
FDA
The food and Drug Administration (FDA) classified the medical devices into 3 classes, each class refers to different types of medical equipment:
Class I Devices: General Controls
Class I medical devices consist of essential equipment like gloves, bedpans, and bandages that need sanitary, medical, and safety contemplations. Although these devices pose less to no safety hazards as they are not highly sophisticated, they still serve essential ends.
Class II Devices: Special Controls
These devices are a bit more complex than Class I devices, although they pose a higher hazard to users and patients. Class II devices include surgical needles, suture materials, and x-ray machines.
Class III Devices: Premarket Approval
Class III devices require approval from the FDA as they are more intricate than Class I or II devices. When manufactured inappropriately, these Class II devices can be more dangerous to users and patients. They include; heart valves, bone implants, and pacemakers.
At MOKO, all our finished medical devices that use our medical PCBA service are of Class II.
ISO
International Organization for Standardization (ISO) certifications are critical for medical PCB manufacturers.
ISO 9001: It refers to quality and reliability standards, manufacturers who get this certification can meet high standards in kinds of aspects including the design, fabrication, and testing processes.
ISO13485: This certification specifies requirements for manufacturers in the medical industry. It has strict requirements regarding the quality management system for the design and manufacturing of medical equipment.
Medical PCB Expertise
Good medical PCB manufacturers have rich experience and are capable of identifying the manufacturability problem of your projects. They can offer workable suggestions to optimize the design, manufacturing, and assembly processes, which can also guarantee the smooth progress of each step involved.
Strict Testing Process
Reliable medical PCB manufacturers have strict quality control systems, they would perform testing at each step, and there are kinds of testing methods applied such as manual inspection, x-ray inspection automated optical inspection. Such strict testing processes can ensure that each piece of printed circuit board delivered to customers are of high quality.
Supply Chain Management
Good medical PCB manufacturers can offer supply chain management services, their quality management system makes it easy to trace and track each product, meanwhile, they have a stable relationship with suppliers that can shorten the lead time and reduce the cost significantly.
The Best Medical PCB Manufacturers List in Global
Advanced Circuits/4PCB
Advanced Circuits, also known as 4PCB, was established in 1989, it is the leading PCB manufacturer in North America. It has branch offices in different cities such as Aurora, Chandler, Maple Grove, etc. It is featured with quick turn capabilities for both small quantity PCBs and high-volume production runs.
Sunstone Circuits
With about 50 years of experience, Sunstone Circuits has accumulated rich experience in the PCB industry. It offers full-scale services from prototype design, fabrication, to assembly and testing. Sunstone Circuits is committed to providing the best customer service and leads the industry with premium quality.
MOKO Technology
Established in 2006, MOKO brings 16 years of experience in PCB manufacturing and assembly to help each client. It offers turnkey medical PCB services ranging from New Product Introduction, engineering to PCB manufacturing, assembly and after-market services. They can handle prototypes, low to high volume production runs, and everything in between.
Bay Area Circuits
Bay Area Circuits provides end-to-end PCB solutions, their excellent design, manufacturing, and assembly services can always exceed customers’ expectations. With over 45 years of experience, they are capable of bringing printed circuit boards into the market in quick turnaround, while guaranteeing superior quality at the same time.
RushPCB
RUSH PCB Inc. specializes in manufacturing higher layer count printed circuit boards, laser drill micro-vias, and handling exotic materials. Found in 1997, they leverage their expertise and experience to provide quick turn consigned and full turn-key assembly services to meet customers’ requirements well.
Millennium Circuits Limited
Millennium Circuits Limited (MCL) has been offering medical printed circuit boards for many years. Their services are featured with quick response, short lead times, and a high price-to-value ratio. They provide a variety of materials for medical PCBs including but not limited to flex, rigid-flex, rigid, aluminum, heavy copper, ceramic, and HDI.
Bittele Electronics Inc.
Bittele Electronics Inc. has established in 2003 and offers turnkey PCB services including PCB manufacturing, components procurement and medical PCB assembly. It has a factory in Toronto and its head office is located in Canada, they provide low-cost and premium PCB services for prototypes, low and medium-volume production runs.
JLCPCB
Founded in 2006, JLCPCB has continuously innovated and improved itself in the past 15 years. Now, it has been a global leading medical PCB manufacturer, offering the rapid production of high-reliability and cost-effective printed circuit boards that can always make customers satisfied and create an unparalleled customer experience.
Partnering with MOKO to Bring Life-saving Medical PCBs to Market
MOKO has 16-year experience in offering medical PCBs to customers, we have a good understanding of all aspects of medical printed circuit boards and we are well known for our commitment to excellence.
We offer one-stop medical PCB services by working with you closely throughout the project, from PCB designing, manufacturing, assembly, testing, to supply chain management, and after-market service. Whether you need medical PCBs in HDI, copper, aluminum, or ceramic materials, MOKO can always meet your requirements and guarantee that the medical PCBs manufactured by us are top-tier. We are certified with ISO9001:2015, ISO14001, ISO13485, which means that our quality system and manufacturing process can achieve a high standard in the medical industry.
From personal medical devices, and patient monitoring devices to diagnostic imaging devices and laboratory medical equipment, MOKO is committed to providing the best medical PCBs manufacturing and assembly services to help our clients bring the critical medical equipment to the market as soon as possible.
