Innovative design keeps medical market healthy
01 October 2008
Industry analysts predict that the European medical market will be growing fast during the next five years. Over 65 per cent of connectors used in medical applications are standard Molex products and the company considers this rapidly evolving market and the role of the distribution channel
The rapid market growth in the medical device industry is driven by a number of socio-demographic factors, such as escalating population growth rate and longer life expectancy. However, it is the huge increases in government inward investment towards healthcare, for both developed and emerging economies, that is attracting the attention of big industry players.
These OEMs are no longer just developing diagnostic or therapeutic devices but are focusing on the entire patient care cycle, that is diagnosis, treatment, management and rehabilitation, to improve the overall level
of care to the patient. As with most fastmoving industry sectors, it is design innovation that is key to growing market share and reducing costs.
Within the medical industry, the required demands for connectors tend to be application-specific rather than industryspecific. Such demands can include high mating cycles (up to 100k in some cases), the ability to withstand sterilisation (like autoclave), meeting IP67 sealing conditions or withstanding magnetic or X-ray equipment environments. There is also the need to ensure compatibility with medical standards. For example, bio-compatible materials must meet the FDA (the US government’s Food and Drug Adminstration) requirement for the class of device. When connectors are used on or within the device, it is the OEM who will drive these application and compatibility issues and ensure the connector industry meets them, not the governing medical device regulatory body.
Medical device classes
Medical devices are organised into one of three classes. Class I is aimed generally at external devices, such as surgical scissors, elastic bandages, manual stethoscopes and in-vitro tests kits, which present minimal potential for harm to the user and are often simple in design. This low-risk classification is subject to general controls, which include company registration, medical device listing, device manufacturing controls, labelling regulation and pre-market notification.
More invasive is Class II, which encompasses devices such as x-ray machines, ultrasound equipment, powered wheelchairs and infusion pumps. This classification is for those areas in which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such
assurances. They are therefore subject additionally to special controls, which may include special labelling requirements, mandatory performance standards and post-market surveillance (tracking), and additional pre-clinical and clinical performance data as the governing medical device regulatory body, such as the FDA, deems necessary.
Class III devices, the highest risk classification, are usually those that support or sustain human life and are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury. These devices require premarket approval and include; replacement heart valves, silicon gelfilled breast implants and implanted cerebella stimulators. Also, premarket notification is currently required for implantable pacemaker pulse generators and endosseous implants.
There are four major market segments in the medical industry that come under the spotlight in relation to the electronics industry, including; patient monitoring, therapeutic equipment, diagnostic and imaging equipment, and hospital and patient care. New medical technologies are already enabling doctors to diagnose and treat patient illnesses earlier with home and point-of-care devices that allow providers to monitor the patient’s condition outside the hospital environment. Reliability of the electronics used is critical to the successful care and safety of the patient, and interconnects play a crucial role in the overall reliability of the system.
A major driving force in patient monitoring is that equipment manufacturers are producing more compact handheld monitors to enable testing in hospital clinics, doctors’ offices or even at home. PCB real estate is critical within these devices. Increasingly, manufacturers are selecting smaller products, such as SlimStack
0.40mm, 0.50mm FFC, and 1.00mm Pico-Clasp , to save space on PCBs.
Smaller interfaces like Micro-USB, CradleCon and HandyLink are also gaining in popularity as manufacturers are adopting higher density data interfaces in their equipment to ensure secure routing of data signals for both their internal and external interfaces. Manufacturers are also working with Molex to develop custom I/O connectors for devices that use customer-specific test strip solutions.
Therapeutic device manufacturers are increasingly improving the portability of their devices and simplifying their user interfaces to ensure that they are both practical and safe. These relatively simple equipment modifications enable the devices to be used for extramural treatment. Molex’s range of fine-pitch wire-to-board, board-toboard and power connectors, and its ability to replace PCBs with Copper Flex assemblies, helps manufacturers reduce the size and cost of equipment to make it more suitable for home or office use.
To optimise the user interface of therapeutic devices, Molex also has the ability to work with the manufacturer to develop custom keypad solutions, such as capacitive membrane switches, switches with embedded LEDs or PCB-substrate front panel keypads (both passive and active designs), dome arrays (polyester and metal dome) or silicon rubber keypad assemblies.
Within MRI, CT or ultrasound equipment, there is a strong need to create, manipulate and store images in real-time. This involves processing large amounts of data rapidly, which results in backplane, storage and I/O connector speeds in excess of 5Gbit/sec.
New backplane products like VHDM-HSD, GbX and high density MicroTCA backplanes and storage products such as Serial ATA products, Serial Attached SCSI products and the iPass interconnect system are specifically designed with integrated internal shielding to offer excellent performance at these higher system and storage speeds.
Similarly, newer digital display interfaces such as DVI, HDMI and DisplayPort* are increasingly being adopted as standard interfaces for patient displays of imaging equipment as they offer improved resolution over existing analogue displays.
Hospital networks to laboratory equipment applications require a broad range industry standard cables and custom-designed harness assemblies. Molex offers high-end design services and fully integrated cable harness solutions that address manufacturers’ needs for higher signal density, higher speeds and increased power.
The fast growing medical industry needs a broader range of connector solutions than ever before. Distributors like Molex, with connectors readily available through its global distribution channel will have an advantage. Furthermore, the distribution channel’s ability to support technical innovation needs of R&D, as well as the volume and lead-time needs of production, will distinguish distributors as partners for OEMs in the medical industry.
DERMOT BYRNE is Industry Marketing Manager – Medical, Molex
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