As technology within the medical device industry evolves, more diagnostic, research and treatment methods rely on Printed Circuit Boards.
PCBs are essential components of a vast range of high-grade medical equipment, used throughout the world. You’ll find medical printed circuit boards in everything from pacemakers, defibrillators and heart monitors to medical imaging systems, MRIs, CT scans, ultrasonic equipment and much more. Because you’ll find them in a such critical equipment it’s crucial that these PCBs are outsourced to a reputable manufacture capable of achieving the high standards that they require.
Here are 5 considerations when outsourcing Medical Device PCBs:
Choose a manufacturer that understands their importance
With medical device PCBs there is no margin for error and the difference between right or wrong could mean life of death. It is important to outsource to a manufacturer that understands this and demonstrates this understanding throughout the design, prototyping and assembly process.
As with most industries and specialisms, working towards and achieving accreditations that demonstrate commitment to quality Is always a good indication of capability and trust. In March 2019 UK Electronics received an accreditation for ISO 13485:2016 – Medical Devices. This ISO 13485 manufacturing certification means the manufacturer covers the regulatory requirements and adheres to a broad set of rules and guidelines, regarding documenting, taking certain steps for medical device product development, manufacture, and PCB assembly, as well as incorporating basic medical device safety standards.
Clean work environment
The workspace environment where the PCB assembly takes places is incredibly important. Temperature, pressure, moisture, air quality are all parameters that can change the output of medical equipment. A committed approach to a clean working environment eliminates failures caused by board contamination making products less susceptible to corrosion-induced failures, thus reducing the need for maintenance or repair.
Supply chain relationships
When it comes to meeting medical device PCB timescales it’s incredibly important that the manufacturer has resilient supply chain relationships. Medical devices require extremely reliable and long-lasting components so it’s important to know if they have links with reputable component suppliers. Furthermore, can you utilise their procurement and forecasting experience? The current coronavirus pandemic has placed many strains on manufacturers without these relationships, which can lead to shortages and the risk of counterfeit components entering the market.
When researching a potential contract manufacturer, use all the resources available to you to establish their experience, expertise and reputation. Ask questions, request a review of your boards and find out if they’ve manufactured similar designs and to what production volumes. If you probe using the appropriate questions, you’re more likely to find the answers you’re looking for.
Do you require the assistance of a Medical Device PCB manufacturer? With over 35 years’ experience in the industry, UK Electronics provides a high quality, cost-effective service to customers who choose to outsource their PCB’s electronic design, manufacture, assembly and test requirements. The Covid-19 pandemic has proved a troubling time for everyone in the industry however our production lines are still open and fully functional, and we continue to navigate the situation with success.