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Project Summary 2010 - 2011 Title: Critical Factors in Medical Device Development Participants: Scholars Advisors Collaborators Lourdes A. Medina Richard A. Wysk, PhD Gül E. Okudan Kremer, PhD Abstract: Medical device development is an important part of healthcare with products that can improve the quality of life. The identification of important factors for medical device development, mostly completed by survey based studies, has gained attention. These studies, however, are the subject of criticism due to their subjectivity. At the same time, they fail to address important factors from the regulatory perspective. Success measures used in the literature include: (1) rating the perceived success in general, (2) rating the perceived success with a basis on specific factors such as meeting the expected profit, sales, and deadlines, and (3) measuring and estimating the development time. The literature focuses on the analysis of internal factors, which are those that can be controlled by the company to improve the chances of success in the development of medical devices. The internal factors that have been demonstrated to impact success are summarized as: (1) experience, (2) performing preliminary market and financial analysis, (3) communicating NPD priorities to staff, (4) customer involvement, (5) new product development (NPD) process completeness and proficiency, and (6) complexity and technical challenge. External factors have not been studied comprehensively although a survey performed by the Advanced Medical Technology Association in 2003 demonstrated the importance of external factors as reported by the industry. In the survey, they identified: (1) the top ten factors affecting companies' ability to develop new medical technologies over the past five years, and (2) the top ten factors influencing companies' product development priorities over the past five years. The Food and Drug Administration (FDA) was identified by the industry as the most important factor for both questionnaires. Other factors of relevance included: (1) customer’s demand for cost-saving/cost-effective technology and pricesensitivity, (2) costs such as R&D, clinical research, litigation, availability of capital funds, (3) coverage and reimbursement requirements (Medicare and private payers), and (4) intellectual property (IP) protection issues. As a result of the lack of studies on external factors and the apparent importance of the FDA, the objective of this project was to perform a quantitative analysis that shows an objective approach to identify important factors in the regulations for medical device development in the United States. The FDA regulates medical devices in the US, with the assessment of risks and benefits. The FDA must

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