Electronics and its related technology are a vital part of the continued evolution of modern medicine and medical equipment. Innovation is ever-expanding, forcing all categories within this industry to change with it. This is especially true in modern medicine and health care. New technology’s increasing role is not going unnoticed. The electronic age is extending its reach into all sectors of medicine and healthcare. Almost every process that is a part of modern medicine is touched by electronic evolution. Improving, updating and bringing medicine and health care into the future is happening now.
Tablets, iPads and smartphones are now taking the place of traditional systems that monitor and record. Patients now have the choice of conducting a complete dialogue with their medical professional at home.
Here are some electronic advancements in medicine and healthcare that have made their debut in the past decade:
- Electronic health records (EHRs): For too long, there were poorly integrated systems. In fact, most healthcare systems weren’t even connected at all. There were separate systems that were isolated — each handled documentation, orders, and other tasks. When systems were merged into one structured platform, there finally was more efficiency and speed to facilitate patient care. EHRs have taken giant steps in consolidating patient information. Next, it has the potential to be used as a tool in the modernization of data-driven medicine. Collecting data about the population is integral to constantly improving results and success rates of medicine and treatment.
- Mobile Health: Saying goodbye to cords and wires while unplugging from traditional electrical outlets, Mobile Health is allowing doctors and their patients to take their health care to-go. By 2019, reports say that the worldwide mobile health market will surpass $20 billion. IPads and smartphones afford healthcare specialists to freely transmit and receive information. Mobile health can also be used for ordering, documentation tasks and the simple act of researching something while talking to a patient.
- Wireless Communications: Hospitals have only recently started using walkie-talkies and instant message apps. These have taken the place of pagers/beepers and overhead PA systems. Medical equipment’s slow move into modern day technology has been blamed on HIPAA concerns and security questions. There are systems available for medical pros to convey secure alerts, messages and information such as lab tests that use smartphones, web applications or other clinically-based systems.
- Worn Medical Devices: The market for medical devices that people can wear is expanding at a rate of 16.4 percent a year. Collection of data is achieved by utilizing sensors and medical gadgets that can be easily worn by people. One goal of the healthcare industry is to gather as much information as possible. Wearables can do very useful things like let someone know if their elderly relative or patient has tripped and fallen, or if someone’s about to get an infection from a cut.
Advancements in electronics and technology continuously help to advance the wave of services that no longer need to take place in doctors’ offices and hospitals. All they seem to need are intuitive, people-friendly electronic devices and an internet connection.
What is PCB Assembly and Where Does It Show up in Modern Medicine Today?
PCBA stands for Printed Circuit Board Assembly. PCBA is created by soldering electronic components to a printed circuit board. A PCBA is nothing but a PCB before said components are soldered onto it.
A PCB assembly has nothing to do with the fabrication of a PCB. It is a completely different process. Creating PCBs takes a multi-phase undertaking that includes the design of a PCB, then subsequently the evolution of a preliminary model of a PCB.
To use the PCB in a device, electronic components have to be soldered onto it, or assembled. The assembly process relies on various factors:
- Circuit board classification — what kind is it?
- Characteristics of the electric components that are being soldered on the board.
- For what reason is the circuit board being utilized?
The next step involves the gathering all the components required to assemble the PCBs. The majority of the parts include those that help in the soldering of electronic components:
- The PCB (Printed Circuit Board)
- Electronic components to be soldered
- Soldering parts like the solder wire, paste, bar and its preformed material
- Soldering equipment — soldering station, wave soldering machine, inspection and testing equipment and SMT equipment
Once all necessary components are gathered and laid out accordingly, the assembly process can begin.
Assembling the PCBs
Some of the components have protruding leads, which are like little “legs” that fit in the tiny holes on the PCB (called through-holes). These protruding elements of the components can then be soldered to the PCB. These elements are attached by Wave Soldering or Traditionally Soldering. When the soldering is complete, there is required cleaning and testing for the PCBA. If anything is wrong with the PCBA, it needs to be reworked — which is completed by hand, involving more soldering.
Surface Mount Technology (SMT)
There are no through-holes or tiny protruding leads required for SMT. Surface Mount Technology is exactly what it sounds like: Components are mounted right onto the surface of the PCBs. That said, the components used in SMT are called SMDs (Surface Mount Devices), to differentiate them from their tiny-footed counterparts. Different equipment, components and soldering items are unlike those used in the through-hole assembly process. We will discuss SMTs in much greater detail later in this piece.
Printed Circuit Boards and Its Role in Modern Medical Technology
PCBs are fundamentally critical in the fields of medicine and healthcare. As innovation has moved forward into the future, diagnostic, treatment and research strategies have progressed toward becoming automated. This means there is more work for PCBs to do in the field of medical devices and equipment.
The roles that PCBs play in medicine and healthcare is huge, and it’s only getting bigger. Medical PCBs are used in the cardiovascular field, for heart-related applications, like pacemakers. They are also used in medical imaging applications, like in MRIs. Third, they can be found in monitoring devices and gadgets such as body temperature monitors. There are countless PCB assembly solutions for the medical industry.
What Types of Medical Devices Use PCB Assembly?
There are many medical devices that use PCB assembly. The medical implementation of PCBs continues to grow as electronics advance to become more efficient and concentrated.
Implantable Medical Devices
The PCB is a complicated component of an implantable medical device. It does not have a static standard to which all PCBs adhere, due to the delicate nature of the implant, and what it is supposed to accomplish for the patient. Implantable medical devices include:
- Cochlear implants allow the hearing-impaired to process sounds and actually hear. Some, for the first time in their lives.
- Implanted defibrillators help to protect people who are at an elevated risk for cardiac problems from sudden trauma.
- Responsive Neurostimulator (RNS) is an implanted device (on the brain) that is used in people with epilepsy. Epileptics who do not respond well to medication to control seizures often turn to RNS as a last resort. This device monitors brain activity around the clock. It will deliver an electric shock whenever it senses abnormal brain activity.
Typically, specifications are given to the PCB maker by the client depending on the needs of the patient, as well as the unique implementation of the implant.
Medical Imaging/Diagnostic Devices
Medical imaging and diagnostic devices play a vital part in the delivery of modern healthcare. PCBs are used in a variety of medical imaging and diagnostic devices — some of which include:
- MRIs (Magnetic Resonance Imaging)
- CT (Computerized Axial Tomography) Scans
- Ultrasound equipment
Physicians and healthcare professionals depend on the information these advanced imaging techniques provide to guide their treatments moving forward.
Monitoring devices also employ PCB technology in the healthcare field. Some device examples that utilize medical PCB include:
- Bodily temperature monitors
- Blood glucose monitors
- Blood pressure monitors
Along with implantable devices, medical imaging devices and monitoring devices, there are several additional devices that use PCBs. The following are some more examples:
- Heart monitors
- Heart pacemakers
- Nerve Stimulator Unit
- Infusion fluid controls
- EMG activity systems
- X-ray computed tomography
- Peristaltic infusion technology
- Flow rate and dispensing systems
- Electrical muscle stimulation equipment
PCBs used in medical devices are created specifically for the medical instrumentation, as well as carefully designed to meet a broad range of lab and care settings, as well as testing scenarios.
Is Surface Mount Technology the best PCB assembly process for medical devices?
Surface Mount Technology, or SMT, is a technique that manufactures electric circuits where the parts are placed directly on the flat surface of a PCB. The resulting product is called an SMD, or Surface Mount Device. The component is simply mounted. There are no through-holes involved. SMT differs from the more customary process, which involves leaded (footed) components going through holes in a PCB, and then going through the soldering process.
SMT’s greatest plus is that it allows for ease of automation. It is much easier to automate surface mount than to solder tiny leads through tiny holes that sometimes aren’t prepared correctly. Say goodbye to expensive processes! Some other advantages include:
- There are not as many holes required for the PCBs, so there’s less drilling.
- Less costly than the through-hole PCBA method.
- Either side of a circuit board can have components placed on it.
- Surface Mount Technology’s components take up less space — they’re much smaller than the traditional leaded parts.
- SMT density is better than that of the traditional component.
- SMTs perform much better than the traditional PCBA when dealing with vibrating and constant motion.
Currently, SMT is the way most PCB makers are going regarding production. Since they are a lot smaller, they perform better. Ease of manufacturing makes this process popular as well. Automated assembly is rendered simple, eliminating the need for hands-on involvement throughout the manufacturing process.
What Are the Requirements for Medical Device Manufacturers?
There are design requirements, and then there are FDA requirements. It is important to know about both aspects. Medical devices, wearable and implantable, have become so popular that the market for them will most likely continue to expand over the next few years. With proliferation comes difficulties regarding design and manufacturing, specifically regarding design requirements. Three comprehensive questions regarding design specifications include:
- What is Its Purpose? The first issue to be established regards its purpose. The device has to have a clear, beneficial purpose. Instead of beginning by creating a solution that is seeking a problem, medical device designers have to begin by identifying a current medical difficulty or problem that their device resolves or ameliorates.
- Does the Device Make Sense? Similarly, medical devices and wearables need to be practical. These medical devices have to be specialized and extremely accurate. They also need to be small. Can the design be as minute as possible without losing any performance or functional capabilities?
- Is it Flexible? Flexibility is a difficult design hurdle because it is a new consideration for today’s health care market. Let’s face it, in the past, medical devices were mostly large, unyielding, and definitely not as “wearable” as they are today. Today, there are flexible and rigid-flex printed circuit boards that are adjustable, pliable and more heat resistant.
The FDA’s Center for Devices and Radiological Health (CDRH) regulates companies who produce, sell and import all of the medical devices in the United States. These companies must go through several steps to be in compliance with the FDA.
- Establishment registration — Companies must register their company with the FDA.
- Medical Device Listing — Manufacturers have to list their device(s) with the FDA.
- Premarket Notification 510(k) — A company may not distribute their device before receiving permission to do so from the FDA.
- Investigational Device Exemption (IDE) for clinical studies — The device can participate in a clinical study to collect information regarding its safety and usability to support Premarket Notification approval.
- Quality System (QS) regulations are related to the inspection of the manufacturing, design, purchasing, packaging, labeling, storing, installing and servicing of medical devices.
- Labeling requirements regard labels, brochures and other readable items linked to the medical device in question.
- Medical Device Reporting (MDR) touch upon malfunctions that lead up to serious injuries or death that require reporting to the FDA. MDR program facilitates reporting.
As experimentation and continued development with medical PCB assembly continues, PCB manufacturing and modern medical diagnosis equipment will continue to work towards providing the highest quality of life for patients — as well as save lives.
Why Should You Choose EMSG For Your Medical Device PCB Manufacturing needs?
When it comes to outsourcing your electronic assembly needs, it is a crucial decision for any company. Electronic Manufacturing Services Group, Inc. will deliver not only the highest quality of customer service — designed solutions to meet your needs — but the industry experience you deserve. Located in York, Pennsylvania, EMSG carries more than 30 years of manufacturing expertise. We specialize in electronic component and PCB assembly services and manufacturing. The expansion of our production and technical capabilities over the years has made us an industry leader in the PCB assembly service field. We are ISO 9001 certified and FDA registered, which means we always strictly adhere to expandable quality control practices. We also specialize in the following technologies:
- Surface-Mount Technology (SMT) Manufacturing
- Through-Hole Manufacturing
- Electronic Assembly
- Box Building and Final Assembly
- Testing and Inspection
We are fully staffed and equipped to help you meet your PCB and electronic manufacturing needs. Our headquarters in York, PA offers a 20,000 square foot production space in which all printed circuit board manufacturing is completed. We work on fast turnaround times in addition to utilizing our in-house inspection program and testing services. To directly request a quote, or if you’d like more information about our services, please call us at 717-764-0002. We can also be reached through our website on our contact form.