Medical Device PCBs
As medical technology has become more computerized, many diagnostic and treatment practices have come to depend on printed circuit boards (PCBs) that require small, higher-density circuits to pack a larger number of connections into a tiny area along with other high-technology features that help make the products reliable and accurate.
The medical industry demands the highest standards of quality, precision, and reliability when it comes to their circuit board needs. Our engineering and production teams have expertise in all aspects of medical-grade PCBs, including an intimate knowledge of the IPC Class II and IPC Class III specification and HALT/HASS testing. We provide robust PCB solutions that exceed all the specific requirements of a medical device to ensure that our customers can get UL, FDA, IEC, and other necessary approvals. Backed by decades of experience of engineering and manufacturing high-technology rigid, flex, and rigid-flex PCBs, we have the expertise needed to manufacture high-volume production runs for medical printed circuit boards that include complex designs for implantable devices, patient monitoring, CT scans, and many others.
Medical Prototype PCBs
To ensure successful product launch, we offer design and engineering assistance to our medical device customers. This is particularly important because not only must we deliver the prototypes quickly, but they must be manufacturable in volume using the same processes that were used to manufacture the prototype. Those who are experienced with rigid PCBs, flex circuits and rigid-flex designs for medical devices understand that a change in processes or materials can cause a product launch delay due to having to resubmit paperwork or potentially even new samples.
Our job is to work with our customers at the design levels to ensure that when we encounter design challenges like working with very thin dielectric materials, materials with dissimilar X/Y dimensional stability, or very fine line requirements that the PCB can meet the quality requirements such as IPC Class II or III along with the customers testing protocols. Our team of mechanical, electrical, process, CAD, and layout engineers invest the time with our customers so that we can provide optimized manufacturing yields and cost reduction.
Medical PCB Technologies
As the technology of medical devices continues to advance, we see the PCBs containing one or more of the following PCB technologies:
IPC Class III:
The biggest issue here is reliability as the 3 biggest factors of the specification.
- The PCB can have no annular ring breakout.
- It must have a minimum of 1 mil of plating in the though holes.
- Tighter tolerances on conductor spacing and widths.
HDI / Via-in-Pad:
This technology allows us to reduce the footprint of the PCB.
This requires that the PCB fabricator has invested in equipment such as laser direct imaging so that the fabricator can get the production yield that is required as IPC Class III requires that there is very little reduction in the line width during processing.
While FR-4 is the most common PCB laminate many medical devices require expertise in polyimide, Teflon, ceramic, and other materials in order to meet their unique requirements.
This is critical to do even before any prototypes are made; if any major design for manufacturing changes need to be made, it can send you back to the drawing board. Remember, many unique features can be done in small quantities but are almost impossible to produce reliably in production.
Choosing the Right PCB Manufacturer
Working with your PCB fabricator, who is experienced in PCBs used in medical devices, is your best defense against project delays. Little things like circuitry directions, added copper thieving to ensure flatness, and internal layer recommendations are the types of things that PCB manufacturers like Epec know and that many electrical engineers haven’t yet experienced. Our job is to ensure the health of the public, and we take this responsibility very seriously.