Medical Device PCB Assembly and Electronic Contract Manufacturing
Medical device industry manufacturers — including those that manufacture high performance electronic medical devices and other electronic devices — are required to meet strict sanitary and quality control benchmarks. If your device includes printed circuit boards or other electronics, this presents an additional challenge. The best way to minimize risk is to work with a medical device circuit board manufacturer that has experience in your industry.
EMSG has been providing the medical equipment industry with PCB electronic assembly services and contract manufacturing since 1995. We are FDA-registered and follow all relevant best practices during the circuit board assembly process. As a result, we are an electronic medical device manufacturer that is uniquely equipped to help you bring to market reliable pumps, robotics, power supplies and other medical devices.
Keep reading to learn more about our services or contact our office for assistance.
Our PCB Assembly and Design Process
The medical device field is just one of many industries that has come to rely on printed circuit boards for highly specialized equipment. As a leader in the PCB Manufacturing industry, EMSG is fully capable of meeting the stringent requirements of the health and medical field when it comes to PCB assembly.
Prototyping and Custom Design Preparation for PCBs
The process our engineers use to set components can be automated for high-volume orders. However, specialized medical equipment often calls for more customization. Our team is fully equipped to meet any unique requirements you have as we assemble your circuit boards in small batches with superior attention to detail.
At EMSG, we use exclusive PCB design software to ensure that each PCB component is positioned for maximum efficiency and quality assurance. After prototyping, PCB assembly is our next step.
Placing and Setting Components
EMSG has a cost-effective, efficient system for placing and setting electronic components on the surfaces of printed circuit boards. We use surface mount technology, which is commonly referred to as SMT. This powerful assembly process allows us to meet the unique requirements of the medical field during circuit board assembly.
Through SMT, the engineers at EMSG are able to create higher connection densities and increasingly complex circuit systems in smaller assemblies for precise medical equipment.
Completing the Final Inspection
We always manufacture PCB units in small batches, which allows our staff to perform quality assurance checks at several critical moments throughout the design and manufacturing process. Our PCB assembly process ends with a final inspection using Automated Optical Inspection (AOI) or X-ray inspection. Our 1 Mirtec MV-3L and 1 Mirtec MV 3 OMNI 3D machines accurately detect soldering and component-level errors. Our X-ray inspection station features digital control, an X-Y table and an image intensifier. This technology enables our engineers to ensure the high level of quality necessary for medical applications.
Our Specialty PCB Manufacturing Capabilities
The unparalleled experience of our highly trained staff sets us apart from our competitors, but our state-of-the-art facility is also a major factor in our industry-leading manufacturing capabilities. We operate in a 20,000-square-foot facility with approximately 4,000 square feet of office and engineering space. Our sizable facility and top-notch equipment allows our engineering staff to manufacture components and units in small to medium batches to ensure superior quality.
EMSG is one of only a few companies registered with the FDA for the express purpose of printing circuit boards and assemblies for applications within the health and medical field. In fact, we're the only company that can produce a 4-foot continuous LED circuit board. The medical industry has strict requirements when it comes to safety, reliability and cleanliness — and EMSG is prepared to meet all of them.
PCBs in Medical Devices
As PCB designs advance, so too do their applications in a growing range of advanced technology and medical equipment. In addition, due to smart devices connected to the Internet of Things (IoT), devices are now expected to give healthcare professionals more real-time data on their patients than ever before — as well as operate with greater precision based upon more precise sensors. Add to this the breakthroughs wearable technology is making in health care, and it’s clear why the proliferation of advanced PCBs for medical devices is showing no signs of slowing down.
Medical Device Applications for PCBs
Some of the most integral uses of medical PCB devices include:
- Infusion Pumps: From insulin to patient-controlled analgesia (PCA) pumps, the ability for patients to have precisely delivered fluids in both stationary and portable models is significantly improving the benefits of various therapies. In almost all cases where infusion pumps provide specific amounts of medicines, nutrients and other fluids in an automated fashion, PCBs are making sure the pumps perform to FDA regulations.
- CT and CAT Scanners: Computerized tomography (CT) and computerized axial tomography (CAT) scanners produce highly detailed X-ray images. These are so sensitive to changes in density that they can even represent tissues found inside organs in the body with high accuracy. While these scanners take 2-D images of the “slice” of the body being scanned by combining the data from multiple images, computers equipped with multilayer PCBs can create 3-D pictures of that data.
- Robotics: The use of robotics in the medical field is growing rapidly. In fact, experts predict that by 2023, the global medical robotics market will reach $20 billion. Some of the most critical uses of robots include telemedicine, sanitation and disinfection, surgical assistance, medical transportation, rehabilitation and automated prescription dispensing systems. Of course, highly advanced PCBs drive all these robots and systems.
- Power Supplies for Medical Devices: The safety of patients and the professionals treating them is a key consideration for healthcare organizations and medical devices manufacturers. For this reason, medical power supplies in the U.S. are required to comply with safety standards as outlined in IEC60601-1. To ensure they do so, they must be outfitted with top-quality PCBs.
Today’s medical devices are lighter and more compact than ever before thanks to their use of surface-mount technology (SMT) circuit boards. Surface mounting allows for products up to one-third the size of those employing conventional circuit boards. It's also extremely fast and cost-effective.
EMSG is a leading expert in surface mount technology (SMT) circuit board design and assembly capabilities for critical medical devices. We assemble all types of PCBs in various medical devices to the IPC-A-610 standard, in both leaded and ROHS technologies. Our investment in high-quality equipment allows us to turn around orders faster without affecting quality control.
In addition to SMT assembly, we can also provide conventional thru-hole assembly. Thru-hole mounting is a more time-consuming process that has some benefits when manufacturing robust devices and during the prototyping stages of a project. For assistance determining which method is best for your project, contact EMSG directly.
EMSG is your partner for more than just medical PCB manufacturing services. We are fully qualified to provide consignment PCB assembly for healthcare companies. We can help you source parts including wiring harnesses and sub-assemblies and perform the box build and final assembly according to your specifications. We can also perform inspection and testing as well as drop-shipping to your end-user.
Contract manufacturing is an excellent option for smaller companies that want to take the hassle and expense out of bringing their product to market. As a complete turnkey solutions provider, EMSG will work to make the process smooth and trouble-free, keeping your costs down and respecting your broader business goals.
Our Commitment to Quality Control and Assurance
The risks of bringing a nonconforming product to market are obvious for critical medical device manufacturers. Aside from reputational damage, there's also the potential for fines and liability costs that can jeopardize the future of your business. To manage risk, you need to work with partners you can trust.
That's where EMSG comes in. As a leading electronic medical device manufacturer, we perform all PCB assembly, manufacturing and functional testing services in our York, PA, facility. Our business is ISO 9001 registered, which means transparency and quality management are integral parts of our organizational culture.
Request a PCB Quote From EMSG
To ensure a high level of customer service for all clients, we serve manufacturers within a 500-mile radius of our York, PA, headquarters. That puts us within range of many Northeastern biotech and medical device manufacturing companies and a short drive from all major population centers. To learn how we can help you, call our offices at 717-764-0002 or email our office to request a consultation with one of our experts. Also, please feel free to fill out our request a quote form. If you don't have design or Gerber files we can help with our expert engineering team. If you need a quick turnaround or quote please let us know and we'll accommodate the best we can.