Designing Medical Device Studies to Address Multiple Purposes – From Regulatory Submissions to Market Education

The medical device industry faces many challenges in the global medical technology market. Regulatory scrutiny, growing competition, pricing pressures, more sophisticated customers, pressure for shortening time to market, and technology obstacles are just a few of many challenges for manufacturers of medical devices. This is particularly true for manufacturers of innovative devices that challenge the standard medical practice where new regulatory, reimbursement and market acceptance questions need to be successfully addressed. 

A common mistake of medical device manufacturers is to treat clinical trials as an obstacle to overcome for obtaining regulatory clearance or approval rather than a valuable tool to collect the knowledge and evidence needed to successfully bring their new medical device to the market.  

Developing a robust and sustained clinical trial strategy that continuously builds the clinical profile of a new medical device throughout its lifecycle is critical to bring a new device to the challenging medical device market. Starting from fully understanding the device performance through demonstrating “reasonable assurance of safety and effectiveness”, convincing payors to reimburse the device and up to gathering compelling data to support market penetration, a clinical trial strategy is an essential tool to achieve commercial success.

This session will discuss the development of a robust clinical strategy early in a device’s lifecycle to generate the knowledge and evidence to successfully support its clinical value pre- and post-launch.