New Product Development processes in medical device startups: a case study

Document Type

Conference Proceeding

Conference Track

Marketing Research/ Demographics/ Consumer Behavior

Publication Date



This study explores the new product development (NP) process in startup ventures in medical devices with no predicate devices on the market in order to determine what NPD processes were used, how aware the principals were of NPD processes and explores the impact of the FDA process on the NPD process in new ventures, and specifically the “De Novo” process for product with no prior examples on the market.

This study used a case method, and interviews were conducted with three companies that are in various stages of development of De Novo medical devices.

The results aid in an understanding of the NPD process in startup medical device ventures, and support findings from previous research into best practices in medical device design. They also shed new light on the actual implementation of NPD practices in startups, and the eclectic nature of adapting those practices to the realities of a startup.

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