ABSTRACT
A medical device is broadly defined as a device designed through mechanical and electrical engineering intended to affect the structure or any function of the human body and which achieve its primary purpose through use of a pharmacological substance. In the medical device industry, Bayesian methods are generally being used in two areas. This chapter discusses new opportunities and activities around augmenting clinical trials with stochastic engineering models as a prior data source. Discussion and examples in this chapter are structured primarily around the model of a class III cardiac lead medical device and will include a summary of a mock submission, conducted in a collaboration by the Food and Drug Administration and industry, detailing the use of both stochastic engineering models and adaptive Bayesian trials. Consequently, the medical device industry has invested much time and resources to safely and efficiently bring a lead to market. The medical device industry is unlikely to tolerate such long delays and may choose less complex non-Bayesian designs.
