Events
Decision Quality for Medical Device Companies and Their Regulators
SDP Free Webinar - February 24, 2016 - 8:00 - 9:00 a.m. PT
Speaker: Adam Seiver, MD, PhD, MBA, Chief, Medical Affairs Therapeutic Care- Philips Healthcare
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.
Speaker: Adam Seiver, MD, PhD, MBA, Chief, Medical Affairs Therapeutic Care- Philips Healthcare
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.
Add this event to your calendar
|
Location
GoToWebinar
|
|
Dates
Feb 24, 2016
08:00 AM - 09:00 AM |
|
Contact
Hilda Cherekdjian
|
|
Respondent Email
|
Speaker
Adam Seiver serves as Chief, Medical Affairs for the Therapeutic Care business unit of Philips Healthcare. Prior to joining Respironics in 2003—and Philips via acquisition in 2008—he practiced trauma surgery and surgical intensive care for 20 years on the faculty of the Department of Surgery at Stanford Medical School. Dr. Seiver holds an MD and PhD (Decision Analysis) from Stanford, with an MBA from Duke. He completed his surgery residency at Stanford leading to Board certification in Surgery with Added Qualifications in Critical Care. Additionally, he holds Board certification in Clinical Informatics.
Moderator
Dr. Bruce Judd, Partner - Strategic Decisions Group, has 45 years of experience as a consultant and educator in strategic decision-making. As an educator he founded and directs SDG's Executive Education program, which provides courses and coaching to help clients transform the way they make strategic decisions. He has taught in MBA programs for 20 years at Stanford’s Graduate School of Business and at Kellogg School of Management. As a consultant, his specialty is making complex corporate decisions in many industries including energy and high-tech. He has also completed several successful public-sector risk-benefit projects in arms control, reactor safety, and nuclear safeguards.
