Medical Device Development Process Report.pdfVIP

DELIVERABLE 5 Report on Medical Device Product Development Processes: Some Illustrative Examples P2 D5 V2 051031 Julie Eatock Brunel University Dorian Dixon University of Ulster Brian Meenan University of Ulster Terry Young Brunel University John Anderson University of Ulster April 2005 Multidisciplinary Assessment of Technology Centre for Healthcare EXECUTIVE SUMMARY New product development (NPD) is a critical aspect of commercial success. Whether a company is developing its first product, extending an existing range of devices, or diversifying its portfolio, the efficiency of the processes used to bring a product to market is extremely important. Thus there has been much detailed research into the procedural aspects that might be employed by a company in order to facilitate effective new product development within the appropriate business management structures. Indeed, a number of industries have well established and proven mechanisms, for example the automotive industry has used specific sector-wide tools for the introduction of new products over many years to great effect Purpose The product development processes used within the medical device industry are generally more complex than those encountered within most commodity markets, due to the extent and depth of the regulatory environment. Notwithstanding this additional burden, the medical device sector must still bring products to market that meet commercial and customer needs. This report provides a preliminary assessment of industrial processes within relevant parts of the medical device sector. It illustrates the breadth of the subject and looks at general aspects of