June 24, 2007
June 24, 2007
June 27, 2007
Continuing Professional Development
12.1515.1 - 12.1515.7
Understanding the Medical Product Development Process: Continuing Professional Development for Life Science Professionals
Navigating the medical product development maze from concept to market can result in a challenging experience. The life science industry is a highly regulated industry and depending on the medical product and classification (device, pharmaceutical, or biologic) the approval process can be complex and lengthy. Unlike high-tech products such as consumer electronics which may have a relatively short time-to-market cycle, medical products can take anywhere from 3 to 7 years before they make it to the market.
Modern technology has made many inroads in the advancement of medical technology and engineers and scientists are playing a key role. As students make the transition to becoming professionals and professionals seek to enhance their careers, continued education and skills enhancement is taking center stage. This paper describes the development of a continuing education certificate program in medical product development for both professional development and workforce development. Various disciplines may be involved throughout the development cycle from marketing to engineering to regulatory affairs. Possessing a thorough understanding of medical product design and manufacturing increases the level of expertise needed to enhance the safety and quality of medical products. A common development cycle for medical products is presented with explanations of the various phases within the product development cycle.
The Medical Product Development Certificate program has been designed to provide core knowledge of the medical product development process. Through evaluated learning and competency-based courses, students increase their knowledge of clinical and regulatory compliance, good manufacturing practices, and quality assurance.
Rodriguez, R. (2007, June), Understanding The Medical Product Development Process: Continuing Professional Development For Life Science Professionals Paper presented at 2007 Annual Conference & Exposition, Honolulu, Hawaii. 10.18260/1-2--1848
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