Gail D. Baura, PhDProfessor, Medical Devices
Medical Devices, Machine Learning, Engineering Ethics
Dr. Gail Baura received a BSEE from Loyola Marymount University in 1984, and an MSEE and MSBME from Drexel University in 1987. She received a PhD in bioengineering from the University of Washington in 1993. Between these graduate degrees, Dr. Baura worked as a loop transmission systems engineer at AT&T Bell Laboratories. Since graduate school, she has served in a variety of research and development positions at IVAC Corporation, Cardiotronics Systems, Alaris Medical Systems, and VitalWave Corporation (now Tensys Medical). Her most recent industrial position was Vice President of Research and Chief Scientist at CardioDynamics. In 2006, she returned to academia.
Dr. Baura is a senior member of IEEE, an associate editor of IEEE Engineering in Medicine and Biology Magazine, an ABET Engineering Accreditation Commissioner (EAC) representing the Biomedical Engineering Society, and an ABET program evaluator for bioengineering and biomedical engineering. She holds 20 issued U.S. patents. Dr. Baura has written four engineering textbooks on medical devices and engineering ethics. As the author of the first textbook in her specialty (system theory applied to patient monitoring), she serves as an intellectual property expert witness for medical device companies in her field. As the sole expert witness for Masimo Corporation, she provided technical expertise in three separate patent interferences that resulted in the cancellation of four Nellcor Puritan Bennett (Tyco) U.S. Patents.
This course presents an overview of medical devices through the years, from historic breakthroughs to more recently developed devices associated with areas of high job growth.
This course presents an overview of the Design Control process for product development, which is mandated by the Good Manufacturing Practices of the Food and Drug Administration (FDA). To complement Design Control, market release and post-market surveillance topics are also highlighted.
This course examines the operational, strategic and commercial aspects of the regulatory approval process for new medical devices, biologics, and combination products in the United States.
Neuman MR, Baura GD, Meldrum S, Soykan O, Leder RS, Micera S, Zhang Y.-T. “Advances in Medical Devices and Medical Electronics (Invited Paper in Special IEEE Centennial Issue detailing predictions for next 100 years in 19 technical areas)”. Proceedings of the IEEE 2012;100(May 13, 2012):1537-1550
Baura GD. Medical Device Technologies: A Systems Based Overview Using Engineering Standards. Burlington, MA: Elsevier Academic Press; 2011, 512 p.
Baura GD. A Biosystems Approach to Industrial Patient Monitoring & Diagnostic Devices. San Rafael, CA: Morgan & Claypool Publishers; 2008
Baura GD. Engineering Ethics: an Industrial Perspective. Burlington, MA: Elsevier Academic Press; 2006, 220 p.
Baura GD. System Theory and Practical Applications of Biomedical Signals. Hoboken, NJ: Wiley-IEEE Press; 2002, 440 p.
Baura GD, Foster DM, Kaiyala K, Porte D, Kahn SE, Schwartz MW. “Insulin transport from plasma into the central nervous system is inhibited by dexamethasone in dogs”. Diabetes 1996;45(1):86-90
Baura GD, Foster DM, Porte D, Kahn SE, Bergman RN, Cobelli C, Schwartz MW. "Saturable Transport of Insulin from Plasma Into the Central-Nervous-System of Dogs In-Vivo - A Mechanism for Regulated Insulin Delivery to the Brain". Journal of Clinical Investigation 1993;92(4):1824-1830
Physiologic signals provide a wealth of information that can be used to develop new medical devices. These signals can be harnessed to enable diagnosis and monitor various conditions. Because the clinical usage requirements for patient monitoring and diagnostic devices are so high, Dr. Baura utilizes system theory, the transdisciplinary study of the synthesis and design of systems and the analysis of their performance , as the preferred substitute for heuristic, empirical processing. Dr. Baura has successfully applied a basic "toolkit" of system theory algorithms to a variety of signals related to large volume infusion and syringe pumps, electrocardiographs, noninvasive continuous blood pressure monitors, noninvasive continuous cardiac output monitors, electronic thermometers, electroencephalographs, external defibrillators, and pacemakers.
Dr. Baura divides system theory algorithms into three categories: filtering, modeling, and control. Since the hospital environment is an infinite source of signal distortion, filtering is a necessary requirement before digital signal processing and/or control can be applied to a signal of interest and may include the pseudorandom binary sequence, adaptive filtering, time-frequency analysis, and time-scale analysis. Once a signal of interest has been sufficiently filtered, it may be modeled to enable signal classification, prediction, control, and investigation of underlying physiologic mechanisms. Typical approaches include the ARMA (autoregressive with moving average and exogenous input) model, artificial neural networks, and fuzzy models.
Current Research Projects
Research in the Baura lab is focused on a new sensor and detection algorithm for drowsiness monitoring and on efficient methodologies for identifying candidate biomarkers for obesity.
Future Research InterestsThe Baura Lab is looking for collaborators at public universities who are interested in the retention rates of women in engineering.
5,609,576 Fluid flowimpedance monitoring system
6,016,445 Method and apparatus for electrode and transthoracic impedance estimation
6,058,325 Method and apparatus for high current electrode, transthoracic and transmyocardial impedance estimation
6,186,955 Noninvasive continuous cardiac output monitor
6,253,103 Method and apparatus for high current electrode, transthoracic and transmyocardial impedance estimation
6,471,655 Method and apparatus for the noninvasive determination of arterial blood pressure
6,514,211 Method and apparatus for the noninvasive determination of arterial blood pressure
D468,433 Electrode for use on a living subject
D471,281 Electrode for use on a living subject
6,561,986 Method and apparatus for hemodynamic assessment including fiducial point detection
D475138 Electrode for use on a living subject
6,602,201 Apparatus & method for cardiac output in a living subject
6,636,754 Apparatus & method for cardiac output in a living subject
7,043,293 Method and apparatus for waveform assessment
7,149,576 Apparatus & method for defibrillation of a human subject
7,251,524 Apparatus and method for determining cardiac output in a living subject
7,270,580 Method & apparatus for conducting electrical current
7,503,896 Method and apparatus for the noninvasive assessment of hemodynamic parameters including blood vessel location
7,570,989 Method and apparatus for signal assessment including event rejection
7,639,146 Blink monitor for detecting blink occurrence in a living subject
|Gail D. Baura, PhD|
|Location:||Building 517, Room B223|