What are the challenges faced by medical PCB manufacturer during Healthcare Equipment Development?
With the ever-increasing population and rapid outbreak of the new diseases that have been shaking the world, there has been a steady increase in the need for state-of-art medical devices and equipment. In the past few decades, there have been tremendous technological developments that have helped to build incredible medical devices. But even with the ease due to changes in the technological landscape, it isn’t devoid of challenges.
Let us understand some of the challenges faced by medical PCB manufacturers to get life-saving medical equipment to the market.
- Rapid Deployment – In the current times when the pandemic has been engulfing the whole world, we are in a sense of urgency to build medical equipment and fasten the process of equipment development and deployment. Time has become the differentiating factor. But that doesn’t mean one should complete everything in haste. Rapid development isn’t the only end-goal. It should also be followed by rigorous testing, thorough documentation, and getting regulatory requirements on time.
- Equipment Failure – When compared to regular consumer electronics, manufacturing electronics for medical equipment has always had stringent requirements. And there is no place for failure or malfunctioning when the equipment is in use like during a critical procedure as open-heart surgery. This would have serious ramifications and would destroy much more than the reputation of your company. You must also be able to trace back the origin of components used in medical equipment in case you encounter any problems when the equipment is in use.
- Lead-free Manufacturing – Restriction of Hazardous Substances (RoHS) directs that medical equipment should adhere to RoHS standards and the company’s manufacturing medical equipment should have the capability to assemble lead-free applications. Usually, hazardous materials like lead and other substances are toxic and can no longer be used in the manufacturing of medical PCBs. So, PCB manufacturers have to have the expertise in lead-free manufacturing and differentiate that from other leaded operations.
- High-quality Production – The level of precision you maintain in the PCB assembly services should also be emulated in the production of medical equipment. In fact, production is even more critical as these components should make a robust device that is capable of working flawlessly in different conditions and environments. To meet the high-quality standards, one needs more than good soldering skills. You need to maintain precision in every aspect of manufacturing such as component procurement, assembly, engineering, inspection, test, and rework.
- Certification – The alphabet soup of the standard organizations that provide certifications to medical PCBs may seem daunting but still essential for ensuring high performance and reliability of PCBs. It is important that Medical PCBs carry the required certifications some being very general like ISO 9001 for high quality and reliability in manufacturing, IPC-A-610 for PCB assembly acceptability. Another industry standard ISO 13485 is about traceability which helps to quickly find out which parts have caused trouble when a problem is reported. There is also some other ISO certification for the quality specification. Complying with these standards at the design level helps one to pick the right components.
- Experience and Quality – Building high-quality Medical PCBs that can withstand the rigors of the environment needs high-quality skills and expertise in all areas of manufacturing. Right from the component procurement, engineering, and manufacturing, you need to find proficient people who have adequate experience in box builds. They need to develop the crucial medical equipment with high-quality wiring harnesses, cable assemblies, and full system enclosures with the circuit board assembly.
- Documentation – Another aspect of manufacturing medical equipment is the rigorous documentation work that needs to be done. Error-free documentation is a prerequisite for future designs and enhancements when required. With the manufacturing of PCBs, it is important to have documentation it works as a sample for reference. It is through this documentation work; one can have full traceability of the components and materials.
- Synergy among all stakeholders – The medical electronics manufacturing landscape is evolving at a rapid pace and it is not easy to keep up with the trends and latest technologies. One needs to know about what’s cooking in the medical electronics symposiums that are focused on advancements in electronics manufacturing. Synergy among the service providers, technologists, manufacturers, dealers, and suppliers is required to move forward in building safe and robust medical equipment.
- Increasing Power Density – There is a scarcity of power and companies have been struggling to find new means to augment power density. For instance, lead-free pacemakers that are in the market today have batteries that take up 75% of the device’s total volume. With so much occupied by the battery alone, there is a dearth of space for other components. This seriously is a hindrance and may negatively impact the prognosis of the patient. The biggest challenge right now is to figure out how to reduce the medical equipment size while improving the longevity of the medical device.
- Keeping up With Latest Trends – The electronic components in the medical field are getting increasingly smarter, smaller, and higher connectivity. This is also associated with newfound medical challenges, for instance, manufacturing and deployment of IoT medical devices need a more focused approach. The security and management of the medical devices coming to and from the cloud, the transmission units, power resources for proper data encryption in implantables, are all important and necessary to understand the implications of them. Only the best practices must be implemented to maximize the safety of the patients.
How do PCB Manufacturers help solve the problems?
An experienced PCB manufacturing company has the capabilities to respond to any challenges and needs of the medical equipment.
- Network – Even in these tougher times of pandemic where all the supply chains of PCB components are disrupted, these companies would have an extensive network of suppliers and distributors to handle the disruptions and quickly respond to the emergency requests.
- Better Response Time – These PCB manufacturing companies have dedicated personnel who work round the clock to make sure you get the equipment right on time while making every effort to preserve the safety of it.
- Engineering Services – Besides building PCB assemblies, they will also be able to help you with the engineering aspects like reviewing before production, or any other design services.
- End-to-end Capabilities – PCB manufacturing companies will have end-to-end expertise in box builds, cable & wire harness assemblies. They would also respond quickly to any requests regarding building specialized fixtures for custom assemblies.
With so many PCB Fabrication and PCB Assembly companies around, the challenge before you are to find such a company that can help you traverse through these challenges successfully. At Mermar Electronics, we specialize in offering world-class PCB manufacturing and assembly services for the medical industry. We help you to handle the challenges by providing end-to-end solutions and understanding various intricacies involved in the process. Besides, we have a team of IPC trained personnel who strictly adheres to IPC class 3 standards and also carry numerous industry certification to get the desired expertise to build medical equipment from inception to final manufacturing.
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