Helen Frankenthaler PCB Circuit Board R&D Center

High TG Prototype PCB for Medical Electronics

PCB Manufacturing and Assembling for Medical Devices

Introduction

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 guide explains what medical PCB assembly is. It also covers why it is important and how we ensure high quality in medical electronics manufacturing.

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 the accuracy and reliability of medical devices. The boards control how the device works, send data, and provide power to its parts. Proper PCB assembly is crucial for the safe use of medical devices. Any mistakes in assembly can cause malfunctions or harm to patients.

Experienced technicians or engineers should perform medical PCB assembly, as it is a highly specialized process. Additionally, we must test the boards to ensure 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. Manufacturers integrate high-quality PCBAs into medical products to meet these requirements.

In recent years, designers have created and produced PCBAs in ways that help PCB manufacturers. This has improved the accuracy of measuring tools. It has also increased the flexibility of treatment design. Finally, it has sped up how quickly medical staff share 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. PCB assembly processes often involve packing many connections closely together on a small surface. This helps the final assembly fit into tight spaces, as medical devices are getting 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.

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. Here are some of the most common PCBs used in medicine. We will also look at what makes each PCB good for certain uses.

Medical PCB Material Selection Guide for High-Reliability Devices

Material TypeKey Properties & AdvantagesMedical ApplicationsBest ForCompliance/Standards
Flexible PCBs• Dynamic bending (500k+ cycles) • 0.1mm thickness • 30% weight reduction vs rigid PCBsWearable medical devices: ECG patches, glucose monitors Endoscopic tools: Camera leads Implantable leads• Flex PCB medical applications • Space-constrained devicesIPC-6013 Class 3 ISO 13485 IEC 60601
Aluminum MCPCBs• Thermal conductivity: 2-5 W/mK • Dielectric strength: 4kV • 10X heat dissipation vs FR4Surgical lighting systems Laser treatment equipment Medical scanning systems• Thermal management medical PCBA • High-power electronicsUL 94V-0 Flammability RoHS compliant medical devices
HDI Microcircuits• Microvias: 50μm diameter • 30μm trace width • 5μm line spacingNeural implants Hearing aids Nano-sensor platforms• Micro-coil PCB assembly • Miniaturization in medical electronicsIPC-2226 Standards Biocompatible PCB materials
Polyimide PCBs• Continuous temp: -269°C to 400°C • Chemical resistance: Acids, solvents • 500 MPa tensile strengthSterilization compatible PCBA: Autoclaved instruments Prosthetic controllers Deep implant electronics• High-temperature applications • Chemical exposure environmentsISO 10993 Biocompatibility NASA outgassing standards
Ceramic PCBs• CTE: 4-8 ppm/°C (matches silicon) • Thermal conductivity: 24-170 W/mK • 0.05% moisture absorptionMRI & CT imaging systems RF ablation catheters Portable X-ray generators• High-frequency/high-voltage PCBs • Thermal management criticalIEC 60601 EMC Compliance UL 94V-0
Rigid-Flex PCBs• Dynamic flex rating: 100k cycles • 40% weight savings • 500 mil bend radiusSurgical robots Portable ventilators Digital stethoscopes• Rigid flex PCB medical • Vibration-prone environmentsIPC-6013D Class 3 MIL-P-50884
Biocompatible PEEK™• 0.02% moisture absorption • V-0 flammability • Radiation resistance: 1000 MradChronic implants • Spinal stimulators • Cardiac rhythm leads Dental imaging sensors• PCB assembly for implantable medical devicesISO 10993-5 Cytotoxicity USP Class VI
PTFE RF Substrates• Dk: 2.0-10.2 at 10GHz • DF: 0.001-0.002 • Phase stability: ±2.5 ppm/°C•Microwave ablation systems •5G-connected implantables •Telemedicine devices• Signal integrity medical electronics • High-frequency designsIEC 60601-1-2 EMC IPC-6012 Class 3
Flexible PCBs

Flex PCB is the first choice for medical equipment. Flex PCBs are a good choice for medical devices. They are flexible and can fit in tight spaces.

Flexible aluminum PCBs

Some high-power medical devices require harder PCBs, which are unsuitable for flex PBCs. Because of 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 like prosthetics and implants can benefit from these materials. They are exceptionally durable, stable in heat, and resistant to chemicals.

Ceramic PCBs

Ceramic PCBs have a low thermal expansion coefficient and high thermal conductivity. This makes them a great choice for medical device makers. These PCBs can work in extremely high temperatures. They also perform well at high frequencies. They are easy to use for high-density tracing and are resistant to chemicals.

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. Rigid boards are more durable and offer better design options. They are lighter and smaller than flex boards.

Material Performance Rankings
CharacteristicBest MaterialWorst MaterialPerformance Gap
Flex Cycle LifePolyimide Flex PCB (>500k cycles)FR4 (<10k)50X
Thermal ConductivityAluminum Nitride (180 W/mK)Standard FR4 (0.3 W/mK)600X
Chemical ResistancePEEK™ (pH 0-14 stability)Paper-PhenolicInfinite
High-Frequency LossRogers RO3003™ (tan δ 0.001)G-10 FR4 (0.02)20X

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 in 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. A PCB fabricator can help you design high-reliability PCBs. They can work with you to reduce safety risks and solve specific problems. Learn NextPCB's PCB Assembly Services

  • 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 has strict rules for tracking components. A good PCB manufacturer can give detailed records of testing and inspection.

  • 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 can be highly prone to corrosion. This happens when manufacturers and solderers leave behind residues, like inorganic salts and acids, during the process. As a result, your electrical device may end its useful life without warning because of 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.

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 skillfully create smaller PCBs that deliver excellent 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.

Technologies for Medical PCB Assembly

  • Flex and Rigid-Flex
  • Multi-layer/High-Density Interconnect PCBs
  • SMT and SMD
  • 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.Compact-siz