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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.  

Click here for access to the full video and pdf.

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Keywords: evaluation anamod, framing framestruc, uncertainty analysis uncanal, risk matrix, influence diagram infldiag, decision quality decqual

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