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Reusable devices face significant design challenges that single-use devices do not. A design engineer must think about how the device will perform not only during the first use, but for every subsequent use. Many medical devices need to be able to function safely after hundreds of cleaning and disinfection or sterilization cycles; these devices must therefore be designed to comfortably withstand the stresses of the reuse procedure. Additionally, reusable devices need to be designed so that they may effectively be rendered safe for reuse by either health-care staff or patients at home. If the process is too difficult or complex, there is a possibility that the device will not be fully rendered safe for reuse.
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Today, surgeons face many limitations when it comes to helping a patient who suffers from a severe craniofacial injury, or an injury pertaining to the skull and the face. Most often a result of cancer or warrelated circumstances, the injury is both psychologically and physically damaging.
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Right now, signals from your brain are instructing the muscles around each eye to contract, panning your view left to right and adjusting focus along the way. The photoreceptors in your eyes react to the photons reflecting off each letter, ultimately transmitting information through the optic nerve, back to the primary visual cortex, where they are translated into meaning. Although it goes mostly unnoticed, your nervous system is constantly hard at work.
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When a medical product fails in the field, everyone suffers — not just the patient, but also the manufacturer and its employees, investors, suppliers, and even competitors. No one wants a product failure, least of all the company liable for its safety. Faced with a crisis, the manufacturer has three priorities: (1) protect patients; (2) resolve the problem as quickly as possible; and (3) prevent the problem from recurring.
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As medical devices increase in functionality, they need more robust and complex embedded software. Handling that complexity usually requires the software to utilize an operating system (OS). Choosing a commercial OS, however, typically involves making compromises among attributes such as development cost, user interface, and realtime operation. An OS that offers separate software partitions to run different applications in both eliminates compromise and simplifies development.
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Negative pressure wound therapy (NPWT) is a widely used modality to improve healing of acute and chronic wounds though the application of topical reduced pressure. This therapy helps to literally suck wounds closed. Non-healing wounds from diabetes or bed sores are pervasive healthcare problems, and although patients can benefit greatly from devices that deliver NPWT as demonstrated in hundreds of studies including randomized controlled trials, the costs associated with devices that provide this therapy continue to rise. In 2009, the costs associated with NPWT rose to the eighth most expensive in Medicare’s entire durable medical equipment category. With government emphasis on reducing healthcare spending, there is a need for an alternative to traditional NPWT devices.
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Currently, mammography is the only FDA-approved independent breast cancer screening method — but it has its limitations, and may be ineffective for women with dense breasts — about 25% of women. In addition to being uncomfortable for women, it misses from 15 to 20 percent of breast cancer cases despite conversion to digital mammograms, according to the U.S. National Cancer Institute.
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