Medical Equipment Manufacturing: 5 Challenges in PCB Assembly
PCBs (printed circuit boards) are a central component in all kinds of technological gadgets, and medical devices are no exception.
PCBs are an integral part of many medical devices, such as pacemakers, implantable defibrillators, heart monitor systems, CT scanners, and MRI machines, controlling and monitoring all of their functions.
It is incredibly important that the PCBs used in these types of medical devices are of the highest quality, as their reliability or lack thereof could mean the difference between life and death for patients.
For this reason, PCBs that are used in medical equipment are often highly customized so that they can meet the needs of the devices they are integrated with. They must be able to continue functioning optimally even under rigorous conditions or duress.
For instance, depending on the medical device that a PCB is in, it may be subject to radiation, high temperatures, moisture, and so on. Therefore, durability is one of the most important features when it comes to medical-grade PCBs.
What are the biggest challenges in medical-grade PCB assembly?
Standard PCBs already have a wide array of stringent requirements that they need to meet, but when it comes to medical devices, the requirements are far more extensive. This poses some significant challenges for those who design, develop, and manufacture medical-grade PCBs.
The following are some of the biggest challenges that come up during the manufacturing of PCBs to be used in medical equipment:
1. Medical device manufacturing regulations
It is crucial to consider regulatory compliance issues when developing any kind of medical equipment, including those that use PCBs. It is better to look into this matter early on in the design and development process, as waiting to do so until after the device evaluation process could result in you requiring extra time to redesign your product if it is noncompliant, delaying its launch.
After you determine your product’s target market, you can begin researching the sets of standards that you must ensure it adheres to (such as those set out by REACH, RoHS, the FDA, etc.).
2. Sorting through standards and requirements
Although there are certain aspects of your PCB development that will need to meet strict regulations, there are also some standards that function merely as recommendations. With regard to medical devices and their PCBs, there are a few sets of ISO standards that would be wise to keep in mind.
ISO 13485 and 9001 certification pertains to documentation and safety; IEC/EN 60601 and ISO 14971 pertain to risk management procedures; and IPC-A 600, 6012, and 610 pertain to board quality and performance, acceptability of wire harness, soldering, enclosure, and cable assemblies.
Things tend to run smoother when you do business with a vendor that abides by ISO and IPC guidelines. When products are made that are not up to certain standards, you, your contractor, or both of you could be held responsible.
3. Component, method, and facility approval
All medical devices have crucial components that require precertification and approval before they can be used. That way, it can be ensured that these components do not contain potentially hazardous materials. If unapproved components are used in a device, the entire device may fail to meet ISO standards.
4. Part and design limitations
When a PCB is included in a medical device that is an implant, it becomes much harder to maintain as it essentially becomes a part of the patient’s body. Thus, during the construction of such a PCB, it is essential that you pay extra close attention to its size, shape, and material so that it remains functional while avoiding the addition of anything that can be harmful to the user.
5. High production costs
Due to the costly nature of regulatory compliance testing and approval, the overall production costs of medical equipment tend to be quite high. Although many parts of the world adhere to EU standards, if you want to expand your market to places where this is not the case, it may even be necessary to build multiple variations of the product, which will be twice as costly.
How Circuits Central Can Help You Overcome Any PCB Assembly Challenge
When you are designing, developing, and manufacturing medical-grade PCBs, it is crucial to work with a partner that can handle the challenges that come along with such a task. Although dealing with this kind of PCB is certainly more complicated, it is nothing that Circuits Central cannot handle.
Our team of knowledgeable and experienced PCB designers and manufacturers helps some of the largest medical equipment manufacturers in Toronto, and we can help you, too, if you are looking to put together a PCB that will be used in a medical device of some sort.
We understand that there are several crucial factors that need to be considered while working on medical-grade PCBs, and challenges can arise when it comes to developing and assembling a product that is compliant, reliable, accurate, and cost-effective all at the same time.
We will gladly take on these challenges for you so that you do not have to worry about doing so yourself. After overcoming any and all technical obstacles that are in the way, we will deliver first-rate products that meet and exceed your expectations.
Our PCB design and production experts will help ensure that your medical device is manufactured with patient safety as one of the utmost priorities. We would be happy to work closely with you to ensure that the product adheres to the required certifications and tests in your industry.
We have helped customers to develop and manufacture medical imaging equipment, chemical analysis equipment, healthcare equipment, monitoring devices, and laboratory research equipment.
We have the expertise needed to navigate the multifaceted and dynamic approval process that is necessary to meet compliance standards regarding the development of medical equipment. Since we are a turnkey manufacturer, we can ensure that you meet compliance standards at every stage of your product’s development. We can also help you with PCB testing and prototyping to make sure that your final product is nothing short of top quality.
For more information about how we can help you design and assemble medical-grade PCBs, or to learn more about our PCB assembly line and production facility, call Circuits Central at 1 (888) 602-7264 or email us at info@circuits-central.com.