Medical Device PCB

Traditional Chinese medicine emphasizes observation, listening, questioning, and pulse diagnosis. Doctors use methods such as pulse-taking, auscultation, and tongue inspection to diagnose patients. Despite its 5,000-year history, this approach poses significant challenges for novice doctors. We will find that most reliable traditional Chinese medicine practitioners are already elderly. Therefore, there is a need to utilize advanced electronic devices to fill in the gaps and expedite the learning process.

Modern medical systems revolve around electronics, leveraging various advanced devices to make medical processes more scientific and efficient. This not only enhances diagnostic accuracy but also accelerates the training process from novice to expert. The development of medical electronics is inseparable from PCB technology, which contributes to the compactness and sophistication of medical devices. In this article, TechSparks will provide insights and recommendations for your medical PCB projects through an industry overview, technical challenges, ISO 13485, and more.

Medical electronic equipment

Table of Contents

Prospects of the Medical PCB Market

Aging Population

The trend of population aging is intensifying, with the incidence and prevalence of various chronic diseases on the rise. According to the latest data from the Alzheimer’s Association, there are currently over 1.5 million people in Germany suffering from Alzheimer’s disease, and this number is expected to double by 2050. This indicates a continuous increase in the demand for early detection and diagnosis of related brain abnormalities. With a deeper understanding of mild cognitive impairment symptoms and ongoing research into the neuro-pathological mechanisms, there is an urgent need for MRI and PET scanning devices to provide more accurate diagnostics and monitoring.

Additionally, typical elderly health issues include neck pain, osteoarthritis, chronic obstructive pulmonary disease, heart disease, and various cancers. These health challenges among the elderly population impose higher requirements on the medical electronic device market, implying the need for more advanced medical circuit boards to meet these demands.

Aging Population

Telemedicine

The outbreak of the COVID-19 pandemic has sparked a renewed global focus on the health and medical field. As the virus spread globally through respiratory transmission, people began to realize the importance of telemedicine. Through zero-contact monitoring and treatment, telemedicine has effectively reduced the risk of cross-infection between medical professionals and patients, playing a crucial role in controlling the pandemic.

With the rapid development of 5G technology, telemedicine is encountering new opportunities. 5G technology offers high-speed data transmission and extremely low latency, providing robust support for telemedicine. However, to harness the applications of 5G technology, telemedicine device PCB need to meet the requirements of high-speed signal transmission while also accommodating 5G modules compatible with 5G signals.

Telemedicine equipment PCB

Wearable Medical Devices

With the increasing focus on health, wearable medical devices such as heart rate monitors, activity trackers, and sleep monitors are rapidly gaining popularity. Worn on the body, these devices can monitor various physiological signs in real-time, with key considerations being size, battery life, and safety.

Additionally, the issue of data security generated by wearable medical devices also requires robust support to ensure the privacy and security of user data. This involves implementing encryption and authentication measures to protect sensitive medical information from unauthorized access or leaks. To meet these diverse needs, significant technological breakthroughs are required in medical PCB, including integration, miniaturization, and energy efficiency.

Wearable Medical Devices PCB

Challenges in Medical PCB Design

Signal Issues in Medical PCB

In traditional electronic devices, when signals experience delays or loss, users might express a few complaints, but these issues typically do not lead to serious consequences. However, in medical devices, signal stability problems could directly jeopardize patient safety. Doctors require real-time monitoring of vital signs such as heart rate and blood oxygen saturation, and the entire surgical process and medication usage rely on this data. To avoid signal integrity issues in medical PCB, the following practices are recommended during the design phase:

  • Layered Layout: Reduce the mutual capacitance and inductance between signals and ground planes by placing circuits with different functions in layered proximity. Consider using separate layers for signal and ground planes on the PCB.
  • Differential Signal Design: This is highly effective for high-speed signal transmission. Transmit equal but opposite signals simultaneously to reduce electromagnetic interference, improve immunity to interference, and decrease common-mode noise in signal transmission, thereby enhancing signal integrity.
  • Specialized Materials: For medical devices highly sensitive to signals, it is advisable to use advanced materials such as ceramic substrates or Rogers laminates developed specifically for high-speed and high-frequency circuits, even though it may entail additional costs.
  • Wiring Optimization: For high-speed signal wiring, avoid 90-degree corners, minimize the length of wiring, use wider signal traces and spacing to reduce signal transmission delay and distortion.

Miniaturization of Medical PCB

Medical devices like hearing aids, thermometers, and arrhythmia monitors place extremely high demands on the size and performance of PCB. This is because these devices typically require compact designs to achieve lightweight construction and reduce power consumption.

To achieve the miniaturization of medical device PCB, using flexible circuits is often the wisest choice. Flexible PCB can easily adapt to three-dimensional spatial layouts, thereby improving space utilization to meet the demands for miniaturization and flexibility. However, many medical devices require more complex circuits, often necessitating more layers and higher integration density. However, manufacturers often struggle to achieve flexible PCB with more than 12 layers.

Furthermore, to fulfill the required functions in limited space, a large number of small components need to be arranged in a smaller space. This poses a challenge for designers as they need to balance various factors such as space and heat dissipation. These considerations require a high level of technical and engineering expertise to meet the stringent requirements of medical PCB.

Reliability of Medical PCB

In addition to external diagnostic devices, some critically ill patients may require implantable medical devices to assist in managing their health. The most common example is a pacemaker, which is implanted around the heart to adjust its beating using electrical impulses, ensuring the heart beats at a normal rate. Implantation requires an in-body surgical procedure, and any surgery comes with certain risks. This means implantable devices need to operate continuously in the complex internal environment of the human body and maintain a high level of reliability over an extended period to avoid the risk and harm associated with secondary surgeries.

The assistive nature within the human body is unparalleled to other environments, and implantable medical PCB must withstand all imaginable threats such as temperature changes, humidity, salinity, and mechanical stress. To achieve this, high-performance materials and processes are necessary to ensure that the circuit board can function properly and is less susceptible to damage in the in-body environment.

Medical PCB and ISO 13485

Medical PCB and ISO 13485

Throughout the previous sections, we have emphasized the quality and reliability issues of medical PCBs. This significance is reflected in the international standard ISO 13485, which clearly outlines the quality requirements for medical PCB. Therefore, for users seeking medical PCB solutions, it is crucial to check whether the manufacturer is ISO 13485 certified.

ISO 13485, with the full name “Medical devices — Quality management systems — Requirements for regulatory purposes,” is a standard specifically designed for quality management systems in the context of medical device regulations. It covers various aspects, including the design, production, storage, distribution, installation, service, and final decommissioning of medical devices.

Built upon the ISO 9001, ISO 13485 applies the Plan-Do-Check-Act (PDCA) concept, with a distinct emphasis on the generation of documents and records. It underscores a risk-based process management approach.

ISO 13485 is applicable to a variety of medical products, including non-active medical devices, active (non-implant) medical devices, active (implant) medical devices, in vitro diagnostic medical devices, sterilization methods for medical devices, medical devices using specific substances or technologies, and services related to medical devices. In other words, almost all production permits for medical PCB rely on ISO 13485 certification.

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