Manufacturing PCBs for Medical Equipment

Printed circuit board (PCB) contract manufacturers aim to help with component and materials selection, DFM, standards, and more.

Ken Ghadia, Sales Engineer

June 3, 2022

5 Min Read
Image courtesy of Technotronix

Technological innovations have massively advanced healthcare. Medical equipment has been upgraded by the introduction of flexible substrate materials and evolved printed circuit board (PCB) manufacturing processes. Medical PCB manufacturers follow strict guidelines to achieve the precision and high-efficiency requirements of this segment.

While developing medical equipment, the PCB manufacturer has to focus on a robust design that can work in all circumstances for an extended duration. Also, the device should be safe for operators, without any fear of shock or damage. Very few manufacturers can build medical PCBs, and the design has to conform with regulatory standards like ISO 13485.

Some important considerations for PCB manufacturing for medical equipment include:

  • User safety is the primary concern in the design, manufacturing, and assembly of the medical device.

  • Consistent output is the key in designing PCBs for monitoring or diagnostic medical devices for accurate diagnosis.

  • Meeting all the industry-set standards specific to the medical sector is an arduous but essential task during PCB production.

  • A quicker timeline has to be planned for product launches, as the market is highly competitive.

  • If the design is for a wearable or implantable medical device, then the usability of such products is even more important to ensure a simple, easy-to-use design.

  • The lifespan of the medical device should be assessed and planned while designing the PCB.

  • Understanding the effect of remaining debris left behind by medical devices is essential. The suitable maintenance steps are to be ritually followed. 

  • A detailed evaluation of all corner cases has to be performed during the operation of the medical equipment.

Choosing a certified contract manufacturer (CM) is highly recommended for medical PCBs. There are several challenges to building successful medical equipment, and an experienced CM will be able to help you make the right decisions while choosing components and materials, provide design for manufacturing (DFM) reviews, and suggest effective production practices to meet the regulatory standards for medical PCBs.

An industry-certified CM will be capable of addressing such concerns with planned and controlled manufacturing and assembly processes. Moreover, choosing a turnkey PCB assembly provider will help you to a great extent, as your whole PCB will be developed at one place.

PCB Production

Following a well-planned schedule is the primary rule for any CM specializing in medical PCB production. There is an increased demand for new medical devices in the industry today, and the competition is quite huge. To stay ahead in the business, tracking and controlling the entire production line is vital for the CM. They should be capable of running rapid prototyping with swift ramp-up abilities.

Emphasis on precision is important throughout the PCB production process. The working environment can be extreme and calls for a robust medical PCB. The CM should be able to help you with an accurate selection of board material, components, and assembly procedures. Their inspection, test, and rework process should also be exceptional.

In the high-tech healthcare industry, a CM has to specialize in multiple PCB manufacturing services like rapid response prototyping, effective component sourcing, box-building, etc. to achieve a high production yield. Today, CMs are well experienced in providing a complete solution rather than just the basic PCB fabrication and assembly services.

To assemble the final healthcare product, all the parts must fit and operate together flawlessly. The recent miniaturization of medical wearables and implantable devices has made the task even more challenging. To handle this issue successfully, CMs offer box-build manufacturing services. Along with PCB assembly, CMs can assist with cable assemblies, wire harnesses, subassemblies, etc. This will reduce any dimensional or connectivity faults and provide complete medical equipment with the right form, fit, and function.

Standards for PCB Manufacturing

Adhering to ISO 9001 standards for quality and IPC-A-610 standards for the acceptability of the PCB assemblies is mandatory. PCBs should be manufactured by ISO 13485 certified manufacturers. This ensures the traceability of parts and materials used in the medical device and encompasses a detailed documentation process for additional reference. An ISO 13485 certified CM will also ensure that its production team is completely aware of the customer’s requirements and avoid many common mistakes in the assembly process. The certification confirms the quality process followed, as the audit reports will be available for medical OEMs to verify.

To meet the requirements of predictability, reliability, and user safety, medical PCBs are subjected to rigorous inspection and testing procedures. There are regulatory test standard certifications for medical PCBs such as:

  • IEC 60601-1: To ensure that no signal failure shall cause any unacceptable risk to the operator or the patient.

  • IEC 61010-1: To specify the safety requirements for a variety of laboratory equipment.

PCB Component Traceability

In a medical device production process, the traceability of each component, material, or cable used in the medical equipment is very crucial. The CM should implement an efficient documentation process to identify parts and products. For instance, a bar code tracking system could be used for assembled PCBs. If any device fails in the field of operation, then the CM can easily identify and trace the product back to the source of the attached work order.

Based on the geographical locations in which the equipment is sold, it may be necessary to comply with the Restriction of Hazardous Substances (RoHS) directive to ensure a safe healthcare product. Lead and other hazardous materials should not be present in the components and materials used in the PCB. Also, the solder paste applied on the circuit board should be lead-free. Many CMs offer RoHS-compliant assembly services, such as sourcing RoHS-compliant parts and materials for the fabrication with lead-free soldering. They can also hire staff skilled in RoHS standards for PCB assembly.

To build high-performance medical equipment, CMs can help you with multiple component sources and offer DFM review and other design assistance. They can work on shifts to meet strict deadlines and can provide complete manufacturing support. They are quick in responding to new requests and modifications. CMs can efficiently help you in tackling the challenges involved in developing robust, reliable, and user-safe medical equipment.

About the Author(s)

Ken Ghadia

Sales Engineer, Technotronix

Ken Ghadia works as sales engineer at Technotronix. He brings 15 years of experience in print circuit board sales and technical client service. Feel free to get in touch with him on Twitter.



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