Decision Quality for Medical Device
Companies and Their Regulators
Adam Seiver, MD, PhD,
MBA, Chief, Medical Affairs, Therapeutic Care - Philips Healthcare
February 24, 2016 (SDP Webinar Invited Talk)
Recent headlines about "superbug” transmission by
endoscopes highlight the importance of high-quality decision making when
information about adverse consequences surfaces after medical devices are
marketed. Existing practice (ISO 14971) emphasizes the use of the Risk Matrix,
which lacks foundation in decision science and may lead to arbitrary decision
making. This webinar will review a recent case where decision analysis provided
clarity for a post-market medical device decision. The webinar will also
discuss work from the AAMI/FDA Risk Principles Work Group, which proposes
Decision Quality as a framework for achieving alignment between the FDA and
Industry about post-market decision making.
Click on the file below to hear a sample of the presentation.