Over the past decade, numerous scientific and technological breakthroughs in the medical device industry have resulted in an accelerated pace of research and innovation within this domain. Further, the demand for high quality and efficient medical devices, driven by a growing geriatric population and increasing incidence of various chronic clinical conditions, is on the rise. However, one of the primary challenges faced by this industry is the complex and time-consuming product development lifecycle of a new medical device. Specifically, the clinical stage is exceedingly resource intensive, involving high costs and greater risks.Furthermore, new advancements have facilitated the development and enforcement of more informed regulatory guidelines and instructions to ensure the safety of medical devices. Subtle differences in regulatory guidelines across various geographical regions need to be considered by medical device developers in order to receive approval in different markets. This has further resulted in longer trials, higher costs (due to rise in patient enrollments), and increased time-to-market. In order to overcome the abovementioned challenges, medical device developers are actively outsourcing their clinical research and associated operations to specialized medical device CROs, which are known to have the required capabilities and expertise.
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