Medical devices is a fast growth segment in the health care industry. The demand for devices is accelerating from two particular areas, emerging foreign markets where the devices are relatively new, and in the U.S. with its aging population.
Medical devices manufacturers face unique challenges when compared to other equipment manufacturers. Not only do they face the product complexity, the demand for more variety by customers, the competitive pressures, and the downward price pressures; they also face the following unique complexities.
New technologies, new standards, and new regulations are continuously being introduced into the medical device market. Staying on top of these changes can make the difference between success and failure. Collaborating with doctors, medical experts, engineers, regulators and suppliers of technology must be quick and pervasive. Medical device manufacturers can also suffer when these changes cause time-to-market issues for new or modified products.
The medical device industry is subject to a long list of regulations, standards and compliance items. These include FDA, ISO, Federal hazardous substance and other local or international mandates. These regulations can differ slightly within geographies and sometimes have particular nuances. A manufacturer must comply with these regulations or risk penalties or malpractice lawsuits. These same regulatory items can also contribute to expensive redesigns in some of the products.
With medical malpractice, competitive challenges, and customer demands for more features and functions, maintaining quality standards has become even harder. Medical device manufacturers must be more exacting and persistent with their quality and documentation efforts. Recalls can be expensive for the cost of product replacement, but can be even more damaging to company image, and future product reputation.
Another challenge for medical equipment manufacturers is access to low-cost, on-call 24/7 technical support. Medical devices are used around the clock across the globe, and require timely support to avoid costly problems.
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