Feasibility of Human Factors Research in Medical Device Development
Patient safety is strictly at the forefront during the inception and development stages of medical devices production. Protecting medical device users is a key concern when global medical device companies are seeking to bring a new product to the U.S. market. The Food & Drug Administration (FDA) has set forth clear expectations regarding necessary documentation that must be submitted along with the premarket submission for medical devices. One of such essential documentations includes a valid Human Factors Summary Report. Identifying important elements that define and govern human factors consulting firms that create such reports is the main focus of this project. Examining the reliability, integrity, functionality, and influence that such reports carry is not only looked into closer, but its findings are also conceptualized in the form of a booklet, which advertises human factors consulting services to potential clients. The objective is to clearly define what constitutes a successful report, how are such services beneficial to their client and ultimately patients, and the processes that encompass human factors research. The booklet serves as a visualization tool that serves not only as an informational source, but also as a summary of all key elements.