Medical PCB devices are categorized under IPC 610 class 3/3A as they are expected to operate in extreme conditions with consistent performance. Patient safely is the highest concern in this application. So, PCB design and manufacturing have several challenges and as a medical device producer, you have to identify and evaluate the capabilities of manufacturers.
Medical PCB assembly challenges:
-The accuracy of signal communication is crucial in medical devices. This depends on many parameters like PCB material, stack up, layout strategy, component selection, etc.
-Medical PCBs have a high mix of analog and digital circuits and hence the design should strictly follow signal integrity guidelines.
-Electro-magnetic interference is a common concern for medical devices. Providing shielding circuits for critical signals is mandatory in medical PCBs.
-Healthcare devices are expected to consume minimal power to run for a longer duration. An optimized power management circuit design is an obvious challenge for PCB assemblers.
Medical PCB manufacturing challenges:
Validating the production process for the safety and precision of medical devices is a top priority. The process verification ensures adherence to temperature, pressure, and other environmental requirements while manufacturing medical PCBs.
Maintaining the production cost is difficult as medical PCBs require high-grade substrates and superior components to achieve the expected performance and reliability. Also, additional inspection and testing requirements to meet quality measures increase the overall production cost of medical PCBs.
Traceability of every part is important in medical PCB manufacturing. Identifying potential manufacturing defects and the ability to backtrack components is essential but difficult.
Medical PCB manufacturing and PCB assembly process requirements:
The medical PCB production capabilities and process requirements are quite stringent. The materials used are carefully selected to meet the unique requirements of medical devices. The PCB fabrication and assembly processes need advanced machines to build durable and reliable medical PCBs. Surface mount technology, automated inspection/testing, and trackable documentation are all important requirements for medical PCB manufacturing.
Based on applications like implants, monitors, and diagnostic equipment, the thickness of medical PCB varies. The assembly line should support these varying parameters. Most medical PCBs require RoHS manufacturing setups. A thorough post-assembly cleaning process is compulsory to get rid of any impurities or harmful particles in medical devices.
Medical PCBs are used in critical applications like pacemakers and surgery equipment where data transfer should be highly accurate. Any error in the circuit can have improper consequences on the device operator or user. Thus, medical-grade PCBs should endure rigorous testing before deployment.