Recently, there was a deadly explosion that killed seven people and injured nine others at a nuclear weapons testing site in Russia. The spike in radiation level led to a brief evacuation of the nearby village of Nyonoksa. Although not nearly as catastrophic, this incident does remind us of the Chernobyl accident of 1986, where 30 people lost their lives, 28 from radiation poisoning, as a result of the nuclear power plant explosion. These disasters do not indicate that nuclear energy is too dangerous to utilize, as there are well over 400 nuclear energy facilities safely operating today. However, it demonstrably illustrates the need for adequate control of processes that may pose safety risks.
Radiation equipment and other medical devices used in medical diagnoses also pose some degree of risk to the patients. This risk is not always immediately fatal. In fact, more often, especially for laboratory equipment, the risk is that inaccurate or incomplete data may be captured that could lead to the wrong prognosis and therefore the wrong treatment. Nevertheless, the utmost concern for patient safety should and is the prevailing principle for all medical device development. Adhering to this high standard necessitates that effective PCB design controls for the medical device industry be developed and followed. Let’s see how best to create and institute controls that will ensure all requirements for safe and reliable board development are realized.
Creating PCB Design Controls for the Medical Device Industry
The medical device industry scrutinizes its suppliers more than any other industry. The number of regulations and standards that govern the development of medical devices, electronics, and the boards that comprise them can be extensive. However, these controls are necessary to establish the minimum threshold that your PCB design and all associated activities should meet. The most important of these are: ISO 13485, which defines a quality management system (QMS) framework to which your PCB development QMS must adhere; and ISO 14971, which provides you with a step-by-step process to create and institute a risk management plan. These standards, along with other regulatory requirements, are mostly dependent upon the classification of your medical device and should be a major part of your PCB design control plan; however, to maximize effectiveness, customization is key.
PCB Design Control Customization
Undoubtedly, your PCB design control plan has to incorporate means to meet the medical device industry’s regulations. However, there are other challenges to consider for your development process. These include the development and operational lifecycles, where and by whom your device will be used, and how to best handle contingencies like supply chain shortages and board failures in the field. In fact, the PCB Design Control plan should be customized to your client, device and operational environment.
Putting Your Custom PCB Design Control Plan into Action
In today’s competitive medical device market, creating a good, or even great medical device may not be sufficient to guarantee market acceptance. At least, not initially. For example, it is common for equipment such as laboratory test machines to be acquired and utilized throughout the institution, company, organization, or larger network of entities under the same administrative umbrella. This is advantageous and allows for flexibility in staffing, as employees that are reassigned do not have to learn an entirely new set of tools. It also reduces training or learning curves, as experienced personnel are in-house to train new employees. And when upgrades are needed, the client will typically use the same supplier. Therefore, it is essential that your customer’s short-term and future needs be fundamental considerations for your plan.
Competition also drives another essential part of your plan, the development cycle. The approval process for medical devices can be quite long, especially for class 2 and class 3 devices that require 510(k) approval. Typically, much of the control over the time for the approval process rests with regulatory agencies; however, you do have a great deal of control over your development schedule. As medical device development demands the highest quality, your development schedule depends almost exclusively on the speed of your prototype iteration cycle to ensure that the number of cycles needed is available. And your choice of CM and fabrication and assembly services will dictate how fast you can cycle through prototyping.
Understanding your device's operational life cycle is also important. For example, if your device is intended for use in academia or a research institution the lifecycle expectation is typically less than if your device is for clinical use. This expectation, coupled with your board’s production level efficiency have implications for your supply chain. Therefore, optimizing component selection is also an important aspect of effective control.
In order to implement a PCB design control plan that fully incorporates your client needs, it must contain an efficient, structured and responsive way to deal with board failures. Obviously, the best way to minimize this issue is by maximizing the yield rate of your PCBAs. However, it is unlikely that board failures can be completely eliminated as a concern. Therefore, it is important to establish a dynamic management strategy that is able to leverage any failures to improve the development process. A good mechanism for tracking and managing failures is a risk matrix for medical device development. It is equally important that you are able to respond to the contingency quickly by instituting any process changes required. This capability depends upon the agility of your CM’s manufacturing for medical device PCBs.
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The execution of your plan defines the effectiveness of your PCB design controls for the medical industry. However, by instituting the actions above, optimizing your medical device contract manufacturing, and establishing open collaboration with your client and contract manufacturer (CM) your plan will be successful at meeting your medical device development objectives.
At Tempo Automation, we will partner with you and support your PCB design control plan by delivering high-quality boards that meet all medical industry requirements, fast. And to help you get started on the best path, we furnish information for your DFM checks and enable you to easily view and download DRC files. If you’re an Altium Designer or Cadence Allegro user, you can simply add these files to your PCB design software. For Mentor Pads or other design packages, we furnish DRC information in other CAD formats and Excel.
If you are ready to have your design manufactured, try our quote tool to upload your CAD and BOM files. If you want more information on PCB design controls for the medical device industry, contact us.