As technology provides greater convenience to consumers, it is also transforming how we access health and medical services. Advances in capabilities will continue to grow the market for medical devices, with analysts expecting it to reach $432.6 billion globally by 2025.
One key component that supports this growth is printed circuit boards (PCBs). Modern medicine depends on these electronics to automatically perform any number of functions. A PCB can use wireless networking to monitor, store, and transmit crucial information about a patient to a healthcare practitioner. In some instances, these devices will automatically update a person’s electronic health record (EHR), making critical personal health information available to anyone during an emergency.
While telemedical solutions have been around for ages, access to sophisticated and precise analysis tools that are wearable and programmable is reshaping human healthcare. Data-driven medical solutions present a unique opportunity for organizations to provide quality healthcare to a larger number of patients.
In some instances, these devices can deliver medicine automatically using the information they gather directly from the patient. The FDA and USDA regulate the manufacturing and use of these products. Though they have already proven to be essential for some conditions, including:
As the intent is to improve the health and wellbeing of individuals, the regulations that apply to these products are necessarily stringent. Manufacturing a medical device requires approval from the FDA or USDA, depending on the type of device and its application.
Producing a PCB is part of an assembly process. Each layer of the PCB needs to be securely bonded while maintaining the continuity and integrity of the circuit. Usually, this requires a soldering process for each level while not degrading any of the previous layers. Finally, you’ll need to connect other components to the PCB to produce the device.
Once you have a product, you must go through the certification and classification process. Your device is subjected to rigorous testing and safety inspections. Any quality defect will need either a design change or additional safety systems included in the final product specification.
The device classification will depend on the application of your product. Invasive devices require the highest level of production quality and functional safety testing, while others used in diagnostics and treatment systems will also need precise manufacturing processes.
To ensure a safe, reliable, and consistent manufacturing process, surface mount technologies have become common in medical device production processes. It eliminates through-holes by mounting the individual parts directly onto the PCB.
This technology also improves the manufacturing process using automation as part of the production technique. Components take up less space making medical devices lightweight and reduces the use of lead that was common in older soldering processes. Any device manufactured using a surface mount process is better suited to deal with vibrations and constant movement, making them more reliable in medical applications.
Sonic Manufacturing can assist your product team to design, prototype, and manufacture sophisticated medical devices. With our state-of-the-art surface mount production lines and years of technical expertise in PCB assembly procedures, we can help ensure your product quality and performance according to the most stringent standards.
For more information about Sonic Manufacturing’s PCB assembly capabilities when designing your next innovative medical device, get in touch with one of our experts today.