Medical Systems Engineering

Whether designing investigational drugs and medical devices or conducting clinical trials, it is important to have a basic understanding of the form and function of the human body. Learn about human anatomy and physiology as related to pharmaceuticals and medical device design for clinical studies. Clinical examples and modeling techniques are used to demonstrate the applications of anatomy and physiology in the development of investigational drugs and medical devices. Course focus is on human safety in clinical studies.

Explore the opportunities and need for medical devices through the examination of mortality and morbidity with special attention to medical problems that affect patients' productivity. A market and need-driven systems engineering approach is applied to the examination of medical device design. The designs of medical devices are then studied through a layered approach of examining the underlying physiological mechanisms, the applicable biomedical sensors and actuators as well as the control processing power requirements. Exemplary medical device solutions are studied.

Gain an in-depth understanding of the structure and function of the cardiovascular and pulmonary systems. Expand your knowledge of the biomedical engineering principles involved in the design and development of cardiovascular and pulmonary devices, drugs, and diagnostics. In addition, participants are introduced to pathophysiology, diagnostic techniques, and therapeutic interventions for cardiovascular and pulmonary systems. Topics to be covered include: cardiovascular rheology and hemodynamics, and pulmonary biomechanics; thrombosis, hypertension, ischemic heart disease, Chronic Obstructive Pulmonary Disease (COPD) and lung pathologies; Angiography, Ultrasound, Spirometry, and Pulmonary Function Tests; and therapeutic interventions in the form of drugs, cardiac pacemakers, defibrillators and ventricular assist devices.

Learn to use Design of Experiments (DOE) to dramatically improve product and process innovation, effectiveness, and efficiency. DOE is the scientific approach used by researchers to build empirical mathematical models of product and process performance. These models are formulas that can be used to optimize product and process performance while significantly reducing costs. This software-based course provides practical hands-on training covering basic and advanced DOE methodology. Learn how to: create 1st and 2nd order empirical product and process models; use these models and Response Surface Methodology (RSM) to optimize product and process performance; reduce variation and increase robustness of product and process performance by using Residual Analysis, RSM, and Dual Response Analysis; and much more.

Further your understanding of FDA regulatory requirements and how they relate to appropriate software engineering practices for medical device software development. Gain an understanding of FDA software compliance and learn how to evaluate their key software engineering activities against FDA Quality Systems Regulation (QSR) and FDA software specific guidance documents. This course is of interest to software project managers, software developers, software test engineers, quality assurance professionals, regulatory affairs professionals, and individuals interested in working in the medical device software development industry.

Increase your understanding of medical electronics and the application of electronic circuits and systems for medical devices. This course provides an overview of the applications of electrical engineering in medicine and biology with an emphasis on the theory and practice of detection, measurement, and monitoring of physiological signals. In particular, participants learn about signal-processing of bioelectronic data and diagnostic interpretation.

Computer simulations have become a useful part of biomedical modeling in the process of engineering innovative medical products, to gain insight into the operation of those biomedical systems. A focus is placed on biomedical data analysis and visualization, imaging, and simulation for application development of biomedical devices. Participants learn how to utilize computational biomedical modeling for the development of medical products requiring mechanical and electrical engineering design, prototype fabrication, in vitro and in vivo testing, finite element analysis (FEA), and computational fluid dynamics (CFD) analysis and design for manufacturability.

The use of human subjects in clinical trials for drug and device development requires sound ethical practices. Explore topics that include FDA regulations and guidance, informed consent process, the make-up and function of Institutional Review Boards (IRB), the IRB review process, and basic biomedical ethics. Course topics are enhanced by case studies, small group discussions, and research document reviews.