9361357 Barnes The research objective will be to conduct a feasibility study. This study will be conducted with the following specific objectives in mind. 1) Identify the components contained in the state of the art (LCD) Life Cycle Design technology that have applications in medical device design. Decide what classes of medical devices would benefit from such technology. 2) Study the possibility of enhancing and adapting these practices to medical device. 3) Investigate the implications of the current device law and identify the issues that will effect the design and development of such devices. Begin to form guidelines for documentation and design that integrate these findings. 4) Become aware of the trends and possible direction of future legislation in order to keep modularity and adaptability of the end product a reality. 5) Gather input from current medical device manufactures in order to get a feel for their current design practices and what they could really use and need as an end product. 6) Study the possibility of implementing state of the art telecommunications such that the end product could act as the link between the designers/manufacturers and the regulating body. Investigate any related database and artificial intelligence systems that have analogous applications. 7) Begin to narrow the structure of the above objectives and focus on the relevant issues. Prepare a model design "walk through" of an example medical device. Accomplishing these objectives would provide the necessary background information required to start specifying the actual design tool. These goals are rather academic in nature but relate directly to the innova tive aspects of the identified opportunity. This feasibility study will shape the follow on research needed as well as providing substantiated results that will be useful in soliciting commercial funds.
