The key objective of this study is to present a comprehensive description of the medical device development process of medical devices. Future policy-making could benefit significantly from a detailed understanding of the way medical devices are invented, developed, tested, used, and
gradually improved. A current need, for instance, is to accelerate the approval process, especially for complex devices. This includes, for example, exploring alternatives to the use of classical statistics, and the possibility of using Bayesian probability, to improve device review and surveillance.
M. Elisabeth Paté-Cornell
Dr. M.-Elisabeth Paté-Cornell’s specialty is engineering risk analysis with application to complex systems (space, medical etc.). Her research has focused on explicit inclusion of human and organizational factors in the analysis of systems’ failure risks. Her recent work is on the use of game theory in risk analysis with applications that have included counter-terrorism and nuclear counter-proliferation problems.
She is a member of the National Academy of Engineering, the French Academie des Technologies and of several boards including Aerospace, Draper Laboratory and InQtel. Dr. Paté-Cornell was a member of the President’s Foreign Intelligence Advisory Board from December 2001 to 2008. She holds and Engineering degree (Applied Math/CS) from the Institut Polytechnique de Grenoble (France), an MS in Operations Research and a PhD in Engineering-Economic Systems, both from Stanford University.
Professor Paté-Cornell's CV can be downloaded here.
Classes taught
- MS&E 250, Risk Analysis
- MS&E 250B, Project Course in Engineering Risk Analysis
Last modified Fri, 1 Mar, 2013 at 11:28
| Title | Author(s) | Journal | Date |
|---|---|---|---|
| On black swans and perfect storms: risk analysis and management when statistics are not enough | Paté-Cornell, M.E. | Risk Analysis | 01-2012 |
| Failure Risks in the Insurance Industry: a Quantitative Systems Analysis | Paté-Cornell, M.E. and L.A. Deleris | The Risk Management and Insurance Review | 08-2009 |
| Accident Precursors | Paté-Cornell, M.E. | 01-2009 | |
| Probabilistic Risk Assessment | Paté-Cornell, M.E. | 01-2009 | |
| Games and Risk Analysis: Three examples of single and alternate moves | Paté-Cornell, M.E., Garber, R., Guikema, S., and Kucik, P. | 01-2008 | |
| Organizational Warnings and System Safety: A Probabilistic Analysis | Lakats L.M. and M.E. Paté-Cornell. | IEEE Transactions on Engineering Management | 05-2004 |
| Probabilistic Modeling of Terrorist Threats: a Systems Analysis Approach to Setting Priorities Among Countermeasures | Paté-Cornell, M.E. and S.D. Guikema | Military Operations Research | 12-2002 |
| Finding and Fixing Systems Weaknesses: Probabilistic Methods and Applications of Engineering Risk Analysis | Paté-Cornell, M. E. | Risk Analysis | 04-2002 |
| Risk and Uncertainty Analysis in Government Safety Decisions | Paté-Cornell, M.E. | Risk Analysis | 01-2002 |
| APRAM: An Advanced Programmatic Risk Analysis Method | Dillon R. L. and M.E. Paté-Cornell | International Journal of Technology, Policy and Management (IJTPM) | 04-2001 |
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- Military Operations Research Journal: Best-paper Award for the year 2002 for the paper entitled: Probabilistic Modeling of Terrorist Threats: a Systems Analysis Approach to Setting Priorities Among Countermeasures co-authored with Seth Guikema, published in December 2002; award in April 2003
- Society for Risk Analysis: Distinguished Achievement Award, December 2002 Institute for Operations Research and the Management Sciences (INFORMS): Fellows Award, November 2002
- U.S. Air Force Award for Meritorious Civilian Service, October, 2002
- Stanford Department of Management Science and Engineering: Teaching Award for graduate teaching at the doctoral level, June 2002
- IEEE Engineering Management Society (EMS): Best paper of the year for "Success Factors and Future Challenges in the Management of Faster-Better-Cheaper Space Missions," with Robin Dillon, published In February 2001. Prize in February 2002
- National Academy of Engineering: Member, elected 1995 (see "Public Service" for NAE committee membership). Council member elected 2001, re-elected April 2004. 2001-present
- Society for Risk Analysis, President 1995-1996. Fellow since 1995
- Académie des technologies (French Academy of Engineering): Conseiller, (Advisor), January 2001. Member elected November 2003
- Decision Analysis Society of the Institute for Operations Research and the Management Sciences: Chair, 2002-03
- Decision Analysis Publication Award for 1994, Decision Analysis Society of the Institute for Operations Research and the Management Sciences (with Paul Fischbeck)
- NASA-ASEE-Stanford Fellow, Summer 1994
- Edelman Management Award (The Institute for Management Science): Finalist, May 1993 (with Paul Fischbeck)
- Best Paper Award, American Nuclear Society, Reactor Safety Division, PSA '89. Organizational Extension of PRA Models and NASA Application, June 1990
- Ecole Normale Supérieure, Cachan, France: Visiting Professor, March 1996
- Electric Power Research Institute, Palo Alto, CA, Visiting Scholar, January-March, 1995
- International Institute for Applied Systems Analysis (IIASA), Laxenburg, Austria: Visiting Scholar, July-August 1979
National Academy of Engineering
Study and models of medical device development process
Designing early warning systems for crisis situations
The objective of this study is to improve existing models of adversarial, strategic decision making in crises in two ways. Our first goal is to advance the theory of adversarial decision making by incorporating a moving time-horizon into dynamic signaling games with incomplete information. Our second goal is to create a model which removes the barriers currently standing in the way of the intelligence community’s adoption of Bayesian methods.
Risk analysis and game theory: policy and management applications
This project is based on the combination of probabilistic risk analysis in a complex system (e.g., an engineered system) and game analysis between two parties. One application is based on a principal-agent model with application to the management of a complex system development where constraints can lead to shortcuts and decreased system capacity. The other application is an alternate game between insurgents and a government trying to allocate its resources between short-term protection and long-term solution to fundamental problems.
Strategic risk analysis with application to nuclear nonproliferation problems
This project centers on the application of risk and decision analysis to strategic issues. The illustration is nuclear non proliferation, and the quantitative analysis of US strategic options based on systems analyis and probability.
