The impact one printed circuit board can have on a person, especially on a medical patient, always amazes me. Whether it’s a heart monitor, laser eye correction equipment, or X-ray imaging system, the electronics that make it work can be found on one or more PCBAs. Without PCBAs, these pieces of equipment would be a mish-mash of wires and electronic components, and they would not serve their life-saving purposes.
When you produce cutting-edge technology used in the medical field, you must ensure you provide the most reliable product with the highest quality. Once you’re ready to move from design to manufacturing, you’ll need to consider how your contract medical PCB manufacturer meets or exceeds critical quality and reliability standards. Your CM should also be able to deliver quality products on time without breaking the bank. So how will you know if your CM can find the right balance between cost, delivery, and quality?
Quality and Manufacturing Standards for Medical Equipment
When you look at the standards and regulatory agencies that govern medical equipment manufacturing, it’s like eating alphabet soup. Between government agencies, industry standards organizations, and safety organizations, you’re working in a sea of acronyms:
If you’ve marketed and sold a piece of medical equipment in the United States, you know the U.S. Food and Drug Administration (FDA) can be your best friend or your worst enemy. The FDA’s 21CFR820 Quality System Regulation requires that medical device manufacturers validate their manufacturing and quality control processes when they are not fully verified by subsequent inspections or tests. If your CM already has the relevant certifications and accreditations, regulatory bodies will know that certain requirements will be met. This streamlines the overall qualification process, ideally helping you get your product to market sooner.
International Organization for Standardization (ISO) certifications are critical for any electronics manufacturer, especially for manufacturers of medical equipment. The ISO 9000 series of quality standards specify quality and reliability requirements on many aspects of design, manufacturing, and testing processes in a range of industries. Competent electronics manufacturers take efforts to obtain and maintain at least one ISO 9000 certification, usually ISO 9001.
For medical technology, the ISO 13485 and 13488 standards are actually aligned with some of the ISO 9000 series standards, although they go further in specifying quality and reliability standards for medical products. The newest version of this standard (ISO 13485:2016) is more closely aligned to regulatory requirements in the United States, Australia, Canada, and Japan, making this particular certification a critical requirement for any CM you’d want to partner with.
One important aspect of quality control that CMs must consider is traceability. A CM must have the ability to document and trace every use of every component in every PCB they manufacture so that an affected product can immediately be pulled in the case of a recall. A firm that is already ISO 13485 certified should have full knowledge of the recall procedures for medical practices and have systems in place to comply with relevant regulations.
When it comes to PCB manufacturing for medical devices, some of the most important standards are upheld by IPC (now the Association Connecting Electronics Industries, formerly the Institute of Interconnecting and Packaging Electronic Circuits). The IPC-6012D and the IPC-A-600 series standards, both of which are critical for PCBs, separate different manufacturing standards into classes.
- Class 1 defines standards for everyday consumer electronics, like a remote control for a television or a household microwave.
- Class 2 defines a higher standard for devices like personal computers or cell phones.
- Class 3 is the most stringent standard and is often required for automotive or military applications. Class 3A was also defined in 2015 as an addendum to the IPC-6012DS standard and specifies requirements for aerospace and related applications.
A CM that is IPC-6012 Class 2 certified will be able to meet quality and reliability standards for a significant portion of the medical device market. Your CM should be at least Class 2 certified.
Quality, Cost, and Delivery
When selecting a CM for your next medical project, you’ll need to consider cost, quality, and delivery. Most manufacturers are pretty good in one or two of these areas. However, finding a CM that can excel at what matters most to you is critical to finding the right partner. And when you’re working with medical devices, quality is paramount. Consider these aspects when selecting a medical PCB manufacturer:
- Inspection and testing. Ensuring quality throughout the manufacturing and assembly process requires testing at each step, which increases costs and could delay delivery. In contrast, some CMs may deliver finished products quickly and at a competitive cost, but quality suffers because they lack sufficient inspection and testing processes. This might decrease your manufacturing costs on the front end, but you put yourself at risk of an expensive redesign, or an even more expensive recall on the backend.
- Supply chain management. A CM will generally manage the supply chain for your medical PCBA. They should also have quality management systems, ERP systems, and a vetting process for each vendor in their supply chain. The vetting process is particularly important to ensure that vendors only provide compliant components. The last thing you need is to find out that a batch of components was manufactured with substandard parts. Lead times can be reduced when your CM has a great relationship with component suppliers and actively manages your supply chain.
- Design validation. Your CM should also have the expertise to identify manufacturability problems, evaluate your bill of materials, and optimize the overall manufacturing and assembly process. A CM with deep engineering experience can even recommend simple redesigns that can dramatically reduce manufacturing costs, help you plan for EOL components or parts shortages, or enhance the manufacturability of your design while maintaining strict quality standards.
Overall, long-term risk can be suppressed when your CM streamlines the inspection and testing process and is willing to meet regularly to discuss yield and testing data. In the end, cost should take a back seat to quality control.
Streamline Qualification with Your Medical PCB Manufacturer
Once you find a certified CM that fits within the quality-cost-delivery triad, and once your product has passed qualification, it’s best to stick with that CM. The slightest change in the manufacturing process may require requalification by regulatory bodies or third-party certification organizations. If you switch to a completely new manufacturer, there is no guarantee that your product will meet important ISO or IPC standards.
If you do need to make a process or design change, working with a manufacturer that is certified to these important standards, familiar with the qualification process, and recognized by major regulatory bodies may help ease requalification.
Understanding and achieving regulatory approval in the medical device industry can seem daunting, especially if you try to navigate the maze of acronyms and legal codes on your own. A knowledgeable, experienced medical PCB manufacturer can clarify the process and maintain consistency throughout the lifetime of your relationship.
Not all CMs are the same, and choosing the right one can greatly enhance the production process. If you are looking for a CM that prides itself on building every PCB assembly to the highest standards, look no further than VSE. At VSE, we’re more than an electronics assembler; we have deep experience and the necessary certifications required to bring your next medical project to market. Contact us today to learn more.