Portable and wearable medical devices represent a huge market for rapid growth in the medical technology industry. Patient monitors are evolving from fixed-bed devices at hospital beds to small, lightweight, integrated devices that provide patients with full mobility so they can stay at home and in the community while being cared for by physicians. A variety of advanced technologies are driving innovation in mobile healthcare services, and exciting telemedicine and electronic medical devices for diagnostics and monitoring enable physicians to communicate with more and more people in a more efficient manner, even Patients can also be located in remote locations around the world. The patient's optimal comfort and mobility depend on whether more functions can be packaged in o devices that are thinner and thinner in size. Emerging and highly reliable devices can perform seamlessly in non-traditional medical environments, surpassing the limitations of the clinical environment, presenting unique challenges for medical device designers.
Compliance to ensure a high degree of reliability and safety
Medical technology represents a highly regulated industry that provides extremely rigorous medical-grade guidelines for high-density medical devices used in home medical telemetry and portable applications. The relevant regulations relate to the procurement, manufacturing and packaging processes of materials. There are currently a number of industry regulatory ratings and environmental rating standards for electronic components, including US Food and Drug Administration (FDA) certification, ISO 13485, ISO 10993, RoHS, and REACH. Suppliers may also need to comply with the ISO 9001 Quality Management System and the ISO 14001 Environmental Management System.
FDA and other industry specifications, including AAMI-53 and IEC60601 global safety standards, UL/CSA, etc., are critical to the design criteria for medical technology. The FDA's classification and general control criteria are based on the intended use of the device and will consider the potential risks to the patient. Class 2 and Class 3 devices require a more rigorous definition of performance and risk management than a lower-risk class of equipment. Registered and certified manufacturers need to meet a variety of demanding quality system requirements, including a wide range of inspection, tracking and traceability standards. The supplier's FDA registration certification further ensures the quality and safety of the electronic components used in disposable, portable and wearable medical devices.
Point the way for interconnected products
Among the instruments used in various medical fields, connectors are ubiquitous - medical imaging, treatment, minimally invasive surgical instruments, implanted electronic devices, patient monitors, and various sensors. Choosing interconnect technology for a specific application is a critical first step. In past designs, versatile devices may require an infinite number of connectors. Today, connector options typically combine copper power cables with signal lines, fiber, fluid or gas connections, or even RF antenna interfaces, all packaged in o a single integrated interface. Proper selction of connectors can reduce total cost, enable more compact packaging, and improve the delivery of medical services. Therefore, it is very important to successfully indicate the direction in the maze of connector technology.
Before identifying the connector type, the designer first needs to identify each type of connection, that is, board-to-board, wire-to-board, wire-to-wire, panel-mount, or in-line termination, in addition to identifying the socket through-hole termination. It is also a surface mount termination. The relevant standard should specify the number and type of interface contacts and the configuration of the associated cable. A cable is used for electrocardiography, defibrillators, power supplies, analog signals, digital signals, bandwidth, fiber optics, or a combination of the above, which will determine the diameter, length, shape, and material of the cable. In each design, there are limitations on package size, and manufacturers also have preferences for the ideal physical size and brand requirements of the final product, such as logo marking and serialization for product tracking.
The specifications of the connector are primarily dependent on the intended use in a real world environment. The various application functions, as well as any potential misuse, together determine the physical properties required for the connector. In portable devices, the design requirements are much higher, allowing the patient to move freely. Portable medical devices meet design specifications that are closer to smartphones than traditional medical devices used in clinical settings. The number of medical technology devices connected may range from single-use sensors in disposable sensors to tens of thousands of insrtions and withdrawals of nuclear magnetic resonance coils, or mobile blood glucose meters that are worn 24 hours a day, seven days a week. The construction of the device worn or carried by the patient must be capable of functioning under a variety of conditions. In the field environment, for example, there are various levels of temperature and humidity in the patient's home, and the number of occurrences of shocks, vibrations, and accidental drops far exceeds the situation in which the various devices in the clinical environment are operated by professionals. (See Figure 1)
The characteristics and challenges of connector technology in the era of mobile medical
Figure 1 - Circular connectors with medical grade plastic housings have proven to be extremely economical in a variety of portable diagnostic and patient monitoring devices
Mechanical characteristics of the connector
A variety of high durability materials are suitable for the manufacture of lightweight portable and wearable medical technology equipment. The contact pads and coatings of the connectors are typically made of metal, while the housing and strain relief are medical grade plastic or metal. Gold-plated contacts typically have the best performance in harsh environments. Despite the economics of tin materials, gold plating is the most reliable contact and has the highest number of insrtions and removals. In addition, the effectiveness of nickel-palladium-gold coatings has been proven and widely adopted in the industry.
The connector interface can be properly pulled out and designed to be visually inspected to reduce debris build-up. If contaminants are found, they can be excluded before they affect performance. The sterilization process of medical devices, especially contact with disinfecting wipes, gamma ray radiation, ethylene gas contact, autoclaving, and the Sterrad process, also have an impact on material selction and design. Each disinfection method produces different levels of exposure, exposure to various chemicals, various reactions, and risks to the integrity of the connector. Medical technology applications often require connectors to withstand fluid intrusion, and in most cases require IP6 or IP7 protection levels. (See Figure 2)
The characteristics and challenges of connector technology in the era of mobile medical
Figure 2 - High-performance, cost-effective user-selctable spot round connector with lightweight medical grade plastic housing that withstands autoclaving and other sterilization processes
According to the connection with the device, the medical connector is divided in o two types: locked type and non-locked type. In components that connect a patient to a portable device, it is often desirable to implement a secure locking connection to avoid accidental disconnection. In addition, the connector may be required to be safely disconnected in the event that an axial force is applied to avoid accidental injury to the patient, connector or cable assembly. Even in non-locking connectors, medical cables require a rigid connection between the plug and the socket. Loose connections can result in intermittent contact, creating unwanted noise or signal degradation that can interfere with device performance.
The choice of pins and slots, as well as the physical design of the plugs and sockets, allows for control of insrtion and retention. Retention defines what the connector is held by the socket. If the connector is desired to have a high number of insrtions and removals, it is generally necessary to achieve retention by metal pins and slots. In some cases, for example, if the hand-held defibrillator requires a securely latched connector, a flexible outer cover may be wrapped over the connector to protect the latching mechanism. If the holding force is achieved by the pin slot and the friction of the connector housing is insufficient, the holding force can be increased by design so that the axial force applied to the cable is not directly applied to the connector to remove the external force. On the shaft. In contrast, the design of the non-locking connector can break the connector by the axial force applied to the cable. Using a right-angle connector gives you another way to increase retention and prevent accidental pull-out.
During the insrtion and removal process, measuring the retention force at pre-established time intervals ensures that the required retention force is maintained during the design life of the connector. Validation testing of medical connectors is critical to ensuring that the specifications are met or exceeded in the final design.
Three-layer connector design solution
Finished connector solutions provide medical technology manufacturers with a way to leverage the proven economics of other industries. For example, high-performance medical circular connectors are a cost-effective option with a well-recognized contact design, highly durable insrtion force, and a body style of plastic or metal that withstands the effects of the sterilization process. The round connector with lightweight medical grade plastic housing delivers high quality electrical performance at competitive prices for a wide range of applications including medical catheters and other portable devices.
In some applications, standard off-the-shelf connectors are not sufficient. Custom or hybrid connectors may be more suitable for design requirements. Designing new connectors allows for maximum design flexibility and offers the most comprehensive options, but at a much higher cost. Manufacturing custom connectors typically requires injection molded hard plastic insulators to insrt pins and/or slots therein. The assembly is covered with a rigid material to ensure structural robustness and physical strength. The secondary overmolded material provides the connector with color, surface finish, and the look and feel required by the OEM.
Custom connectors typically require higher engineering and manufacturing costs in advance, and this investment can be extremely worthwhile. Design elements can be better addressed with less compromise. The unique pin socket pattern or connector shape prevents the insrtion of incompatible connectors, ensuring the patient's personal safety. Alternatively, the shape of the connector may need to be closely matched to the shape of the device to optimize portability. When a separate connector cable assembly chapter must carry multiple types of voltages and signals, it may be more desirable to use a custom connector because the standard connector does not meet the standard requirements in this case.
A hybrid connector solution allows for a price and function balance. Hybrid products use proven technology to optimize functions with the basic components of standard connectors without the additional cost of manufacturing new connectors. Hybrid connectors may be combined with a rugged, overmolded housing to improve grip and a pre-molded pedestal or die ring to relieve stress or increase IP protection. Hybrid connectors are less expensive, and the finished look, feel, and functionality of the finished product have most of the performance benefits required to customize the connector. In addition, designing hybrid connectors can also reduce development time.
Take advantage of the industry's best connector technology
Medical technology manufacturers need to use the best technology in the industry to provide high-quality, compatible products for medical product lines to meet complex medical needs. MID (Molded Interconnect Device) / LDS (Laser Direct Molding) provides 3D selction tracking and is extremely flexible to use injection molded plastic for soldering, plastic welding, insrt molding, overmolding and wire bonding processes . The MID-LDS 3D custom component solution places special emphasis on functionality, space, weight and cost issues to simplify the manufacturing process of miniature connectors, antennas and sensors.
These components combine the expertise of MID technology with LDS antennas to enable fine-pitch 3D circuits in stand-alone compact molding equipment for high-density implantable and wearable patient monitors. LDS uses fewer components and can improve performance in applications such as medical catheters compared to larger, less-designed processing equipment or components. This technology is unique, especially for wireless remote and sensor-based patient monitoring applications (for example, a device connected to a blood glucose meter via a remote base station sends readings to the physician's office).
Make informed decisions on connectors, simplify design and manufacturing processes, and provide experienced medical component suppliers with guidance for designers to ensure complete compliance in terms of specification, risk assessment, cost estimation and test verification for portable and Wearable medical devices offer fully compatible electrical, signal and mechanical interconnect products.