Any medical device should be compliant with healthcare regulatory mandates as well as offer exceptional performance that meets its intended purpose. But this is largely dependent on the quality of the surface mount assemblies used in the device.
Therefore, it is important to have a Design for Manufacturability analysis completed on the design of any medical device electronics. But this test is only effective if you know what to look for. With that being said, here are the top considerations for evaluating your medical device electronics design.
Placement of the Components
If the components of a PCB are designed at odd angles or have been placed too close to the edge of the board, then it often results in the electronics needing to go through a costly retooling process before they can proceed with any production. Therefore, the placement of the components is incredibly important, especially before production begins.
Ability to Withstand Harsh Environments
Not all SMT assemblies are going to be used in the exact same type of environments. Some will need to be able to withstand extreme heat or cold, while others might be around a lot of moisture. Knowing this information will allow you to determine whether or not the surface mount circuit board assemblies incorporate the right type of materials to survive these conditions or will need some of the materials swapped out.
Component Sourcing
While the source of the materials used by other products may not be of grave concern for many people, it is incredibly important when it comes to surface mount assemblies. This is because the components used within these PCBs will be subjected to federal regulations, which means that you must feel confident that your medical device uses only reliably-sourced materials. So you should be looking for whether or not the supplier has been vetted and there is no possibility that any of the components are counterfeit or imperfect in one way or another.
In-House Testing
Having a manufacturer that performs in-house testing for their SMT assemblies is crucial. This is what allows them to be able to do some troubleshooting on an as-needed basis, even throughout the production phase. Therefore, you will be able to save both time and money.
By taking all of these qualities into consideration, it will help you more accurately evaluate the quality of the design of your medical device electronics. To get high-quality surface mount assemblies that only use the best designs, make sure to check out Star Engineering today.
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