It is a fact that some days are just better than others. On some days, it seems as if all the stars are aligned perfectly, while on others it seems that well… most of the stars are on vacation. Even on my worst day, the sight of a child smiling despite fight for their life due to a medical malady reminds me of how lucky I really am. And how lucky we all are for the developers of advanced medical electronics devices that enable healthcare professionals to conquer diseases and illnesses we may fall prey to and provide hope of a better future for such children.
Advanced medical device laboratory
Making these advanced products available is not a simple process. In fact, regulations and standards for developing medical devices are more stringent than for any other electronics and PCB development. This oversight is warranted as patient safety is the primary objective. Balancing this objective with patient needs, as well as competing products, provides an impetus to create the best medical electronics device as quickly as possible. Meeting this mandate requires the optimization of your medical electronics manufacturing process, which can be accomplished by following the steps presented in this article.
Optimizing Your Medical Electronics Manufacturing Process
Regulations and standards for medical electronics and PCBs exceed those required for any other industry. This includes extensive testing for direct contact and laboratory devices. Although there is a long list of things to do before your product can be utilized by medical professionals and patients, there are also some things that should not be done. For example, it is required that your electronic medical devices be classified in the FDA database. However, you should not apply for 510(k) or premarket approval (PMA) if your device type is already exempt. This may be the case if your medical device is a class 1 or class 2 or the device is already listed. Your CM is required to build your board according to its IPC 6011 classification, which is based on performance and expected operational lifetime. For medical electronics devices, this is typically class 2 or class 3. You should not opt for the higher and more stringent manufacturing requirements if class 2 meets your device’s objectives.
In addition to the dos and don’ts above, you should also follow the steps listed below for the optimization of your medical electronics manufacturing process.
Medical Electronics Manufacturing Optimization Steps
Step #1: Choose the best qualified CM
The most important decision you will make is to ensure that your contract manufacturing requirements are satisfied by your contract manufacturer (CM). One of the best metrics to ensure this is to make sure your CM is medical device certified.
Step #2: Ensure supply chain is traceable
The medical industry places a high premium on supply chain integrity. This means that you must select traceable components and from registered suppliers.
Step #3: Incorporate design considerations to aid manufacturing
When selecting materials, laying out your board, and all other design activities, you should incorporate manufacturing considerations, including DFM guidelines tailored to your CM’s equipment capabilities and processes.
Step #4: Ensure design transfer is accurate and secure
Another important consideration is the PCB design transfer with your CM. Not only does your design package have to be complete and accurate, but there are documentary controls that must be followed.
Step #5: Make sure manufacturing institutes quality control
Probably the most important regulation that guides your device development is the quality management system (QMS) framework, which includes specific directives for manufacturing under ISO 13485 section 7.
Step #6: Implement a responsive risk management plan
As part of the QMS requirements, you must also institute a risk management plan according to the specifications and suggestions given in ISO 14971. These are to ensure that any issues or risks with your device are identified and addressed quickly.
Step #7: Ensure your CM can respond to changes quickly
In order to implement needed changes, whether from identified risks, due to design updates or other sources, your CM must have an agile manufacturing process to minimize or eliminate any gaps or shortfalls in product delivery.
By following these steps your medical electronics manufacturing should be optimized and contribute to a highly efficient development process.
|Tempo's Advanced Custom PCB Manufacturing Service for Complex Medical Systems Development
Tempo Automation, the industry leader in fast, high-quality PCB prototype and low-volume manufacturing, is committed to working with you beginning on day 1 of design to ensure that your medical electronics manufacturing process is optimized.
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 how you can assist in the optimization of the medical electronics manufacturing process for your design, contact us.