Manufacturing electronics for medical equipment has always had more stringent requirements put on it than regular consumer electronics. Obviously, you want to make sure that there isn’t a chance of failure during a critical procedure such as open-heart surgery. You also need to make sure that the components used in medical equipment can be easily traced back to their origin in case problems are discovered with those components that could affect the operation of the equipment.
But now there is a new factor that needs to be considered in the manufacturing of electronics, and that is time. As we have seen with the need to rapidly design and deploy new medical equipment to fight the COVID-19 pandemic, there is more pressure now to hasten medical equipment development. At the same time, there is still the need to satisfy the testing, documentation, and regulatory requirements of manufacturing medical electronics. Let’s look at some of the challenges that PCB manufacturers are having to work through in order to get these lifesaving products to market sooner.
The Importance of Precision in Medical Equipment Development
Medical equipment manufacturing is a tightly controlled process to ensure that the products built are of the highest quality. To accomplish this, manufacturers must keep the following goals in mind:
- The product has to work in all circumstances, and therefore must have a more robust design than standard consumer products.
- The product has to be safe to operate in its expected conditions. Medical equipment can be used in a variety of environments, and users need to be able to operate the equipment without fear of shock or failure.
- The product has to be designed according to applicable industry standards, such as ISO 13485. Among other things, this standard defines traceability requirements so that you can quickly find out which parts are used in which devices in case there is ever a reported problem with a specific component.
- The product has to be built by a manufacturer that carries the applicable licenses to build medical devices, such as the medical device manufacturing license of the State of California.
Now with the threat of the world-wide COVID-19 pandemic, there is a new sense of urgency in building medical equipment. Specific medical devices are needed for testing and treating the virus, as well as other types of equipment to provide other support services. Here though is where some of the challenges in manufacturing have begun to manifest.
Specific Problems for Manufacturers Due to the Pandemic
When the virus appeared it first affected offshore manufactures. Many of these manufacturers were already observing the Lunar New Year and had shut down their production according to their annual practice. The pandemic, however, extended this shutdown, which affected the lead times for devices and components. Manufacturing of circuit boards began to shift to other locations around the world until they too had to limit production because of shelter in place orders.
Another area that was impacted was in overseas shipping. Air Freight carriers like FedEx and UPS will often utilize space on commercial flights. With these flights being canceled, however, this has also added to the lead time of getting timely shipments of devices and components. Additionally, postal operators are having difficulty with international mail services due to the pandemic resulting in stalled shipments or temporary surcharges on shipments.
Fortunately, though, there are still some options open for people who still need to get their urgent medical equipment built quickly.
How Your PCB Contract Manufacturer is Providing Solutions
Local PCB CMs due to their business model and flexibility are often able to respond quickly to your medical equipment needs. Here are some of the advantages that you can realize by using the services of a local PCB CM:
- Response time: Although the shelter in place orders have had an impact, building medical equipment is considered an essential business and PCB CMs are able to do this work. Many CMs have implemented dedicated shifts to make sure that this work gets done while at the same time ensuring the safety of their staff.
- Components: While the global PCB supply chain has been impacted due to the pandemic, local CMs typically have an extensive network of suppliers and distributors to satisfy their immediate needs. This enables them to respond quickly to your urgent medical equipment assembly requests.
- Engineering services: In addition to building your printed circuit board assemblies, your PCB CM will also be able to help you on the engineering side. Whether this help is in the form of a DFM review before production, or full out design services, these CMs are ready to get your job done.
- Complete manufacturing capabilities: Another big advantage with local PCB CMs is their ability to do more than just PCB assembly. These CMs often will do box builds as well as cable and wire harness assembly. Their business model also enables them to respond quickly to new requests such as building specialized fixtures for unique assemblies as you can see in the picture below.
A special production fixture to help increase the manufacturing output of a new medical device
At VSE, we understand the importance of getting your medical devices built as quickly as possible in order to get them into the fight against the Coronavirus. This work still has to be fully within the parameters of all applicable medical equipment standards and regulations, however, while at the same time ensuring the safety of you, our staff, and all of our customers. Fortunately, we are already prepared for this process and are currently building medical equipment specifically for virus detection.
VSE has the engineering staff, supply chain network, and manufacturing teams that you need to get your medical equipment built quickly and ready to be used in response to the current crises.
