8:35 am – 10:45 am Setting the Stage: Introductory Session

Introductions (Danica Marinac-Dabic.FDA),

Goals for the Day (Peter McCulloch, Oxford, Art Sedrakyan, Cornell)

8:55 am  The challenges of medical device & surgical procedure regulation, William Maisel         (A summary of the major issues from science and policy perspectives)

9:15 am  Methodological paradigms for evaluating innovation in medical devices  (Mary Beth) 9:35 am     Conceptual framework for evidence evaluation for devices & procedures ( Art)

9:45 am     IDEAL: What it is and why it is relevant? – (Peter)