Going to the doctor can be an anxiety-inducing experience for many because it unlocks fears of the unknown. In extreme cases, this anxiety manifests as iatrophobia or fear of seeking medical care. Allaying fears is a complex issue, but the best solution is reminding people that better health outcomes are born from early and regular check-ups. Medical devices help support physicians and other healthcare workers accurately diagnose, monitor, and support patients through countless maladies.
For the high responsibility placed on this equipment, producing cutting-edge technology in the medical field requires reliable devices with some of the highest quality requirements in PCB manufacturing. Transitioning from design to the medical device manufacturing industry can be mediated with a medical PCB contract manufacturer (CM) that meets or exceeds critical quality and reliability standards. A CM should also be able to deliver quality products within accepted timeframes while maintaining the key high-reliability characteristics as assessed throughout manufacturing.
A Sample of Medical Industry Regulations
|FDA||Devising and maintaining quality system management framework||21CFR820|
|ISO||Establishes criteria for a quality management system, up to and including certification||ISO 9001|
|IPC||Provides threshold guidelines for quality in PCB production, typically through visual inspection modes||IPC-6012D, IPC-A-600|
Quality Standards in the Medical Device Manufacturing Industry
It can be challenging to discern which standards and regulations are in play for medical device manufacturing. Between government agencies, industry standards organizations, and safety organizations, there’s an ocean of acronyms to sift through:
Marketing or selling a piece of medical equipment in the United States must meet the approval of the U.S. Food and Drug Administration (FDA). The FDA’s 21 CFR 820 Quality System Regulation requires that medical device manufacturers validate their manufacturing and quality control processes when subsequent inspections or tests do not fully verify them. A CM with the relevant certifications and accreditations informs regulatory bodies that certain requirements will be met. This streamlines the qualification process, reducing turnaround time and getting products to market sooner.
International Organization for Standardization (ISO) certifications are critical for any electronics manufacturer, especially for medical equipment manufacturers. The ISO 9000 series of quality standards specify quality and reliability requirements on many aspects of design, manufacturing, and testing processes in various industries. Competent electronics manufacturers should obtain and maintain at least one ISO 9000 certification, usually ISO 9001.
The ISO 13485 and 13488 standards for medical technology align with some of the ISO 9000 series standards, although they further specify quality and reliability standards for medical products. The newest version of this standard (ISO 13485:2016) is more closely aligned with regulatory requirements in the United States, Australia, Canada, and Japan, making this certification a critical requirement for any reputable CM.
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 from shelves during 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.
In PCB manufacturing for medical devices, some of the most important standards are upheld by the Association Connecting Electronics Industries, or IPC (formerly known as the Institute of Interconnecting and Packaging Electronic Circuits, the organization chose to keep its recognizable acronym after renaming). The IPC-6012D and the IPC-A-600 series standards, both 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 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 aerospace and related application requirements.
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. Unless production is focused solely on disposable high-volume electronics, a CM should be at least Class 2 certified to meet the quality standards of dedicated service devices.
Balancing Quality, Cost, and Delivery Times
When selecting a CM, cost, quality, and delivery are all necessary considerations. This check should not be binary: different productions will have different goals, and trying to optimize for every variable is likely to result in a muddled job. Instead, find a CM that can excel at the factor(s) most relevant to the production. Suffice it to say that quality is paramount when working with medical devices.
Weigh these attributes 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. Although increased turnaround times are unfortunate, sacrificing quality due to insufficient inspection and testing processes can undercut the service life of a device. This option 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 back end.
- Supply chain management. A CM will generally manage the supply chain for your medical PCB. 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: increased lead times and shortages of components have caused a flood of counterfeits. However, lead times can be reduced when your CM has a great relationship with component suppliers and actively manages part buys.
- Design validation. A CM should also have the expertise to identify manufacturability problems, evaluate your bill of materials, and optimize the overall manufacturing and assembly process. Manufacturers with extensive engineering experience can even recommend simple redesigns that can dramatically reduce manufacturing costs, help plan for end-of-life (EOL) component revisions and parts shortages, or enhance the manufacturability of your design while maintaining strict quality standards.
Overall, long-term risk can be suppressed when a CM streamlines the inspection and testing process and is willing to meet regularly to discuss yield and testing data. Cost concerns are always inescapable, but they should take a back seat to quality control in most industries, especially medical devices.
A Healthy Service Life Depends on a Quality CM
After finding a certified CM that fits within the quality-cost-delivery triad and post-qualification of design, the CM is likely to be well acquainted with the design and manufacture of the device. Slight changes in the manufacturing process may invite requalification by regulatory bodies or third-party certification organizations. Therefore, switching to a completely new manufacturer carries no guarantees that your product will meet important ISO or IPC standards. When a process or design element does change, working with a certified manufacturer will maintain standards and likely ease qualification efforts.
Understanding and achieving regulatory approval in the medical device manufacturing industry can seem daunting, but a knowledgeable medical PCB manufacturer can clarify the process and maintain consistency during production. At VSE, we’re a team of engineers dedicated to building electronics for our customers. Paired with our valued manufacturing partners, we deliver exceptional quality PCBAs that save and change lives in healthcare.