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By United States. Coast Guard. District, 17th.; Alaska. Office of Statewide Cultural Programs

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Medical devices and technologies will be increasingly available to the growing worldwide population through the use of lower cost materials and manufacturing techniques, as well as by increased competition from manufacturers in countries with lower labor costs. Additional cost savings and improved worldwide access can be achieved by developing simpler devices or techniques that can be used by a broader range of clinicians with lower skill sets or less training. Medical simulation and telementoring technologies may further broaden access to clinicians in rural or underserved areas, by providing these clinicians with high quality training tools and remote guidance from expert surgeons and physicians.

5 Each device component (electrical, mechanical, and others) must be tested, both individually and as part of the functioning unit. In some cases, of course, a series of prototypes may be necessary. The first iteration is the α-prototype, which is generally created using rapid prototyping methods such as stereolithography or CNC modeling. Such methods are capable of producing functioning prototypes quickly and at a relatively low cost. While the α-prototype is created as a functioning unit that meets all design specifications, it may not perform as predicted.

This system assigns products with a six-digit code, based on the industry and/or business sector that the product falls within. According to the International Trade Association (ITA) of the US Department of Commerce, all medical devices fall within one of eight NAICS categories (ITA, 2009). These categories are as follows: • In Vitro Diagnostic Substances: Includes chemical, biological, or radioactive substances used for diagnostic tests performed in test tubes, petri dishes, machines, and other diagnostic test-type devices (NAIC 325413).

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