Master of Science in Medical Device Engineering

The journey begins with students learning how engineering principles are applied to create devices that improve patient care. 

The graduate-level course provides a comprehensive introduction to active and passive devices for healthcare applications. Topics include medical implantable and wearable devices, and standards in the design and development of medical technology. 

Innovation must also meet regulatory requirements: this course prepares students to navigate FDA regulations, quality systems, and the approval process, ensuring that new technologies can safely reach patients. 

The United States Food and Drug Administration is responsible for the safety and efficacy of medical devices sold in the United States. This course will focus on Title 21 Subchapter H (Medical Devices) of the Code of Federal Regulations, in particular Part 820 (Quality System Regulation) which governs the design, development, manufacture and post-sale facets. Other parts relevant to Medical Device Design and Development such as Part 801 (Labeling) and Part 822 (Post Market Surveillance) will also be discussed. 

Successful products are designed not only for performance but also for the people who use them. Safety, usability, and patient-centered design are key considerations from the very beginning. 

This course will help understand human factors engineering processes for designing medical devices. Topics include design theory, risk and safety and testing/standards/regulations used in the medical industry.

Good medical device design depends on the scientific knowledge needed to select appropriate materials and understand how fluids such as blood and air move through the body and affect medical device performance. 

The interaction between the human body environment and synthetic materials, including materials for medical implants and for dental restoration and appliances is explored. Tissue engineering, biosensing, imaging and drug delivery interact directly with biomaterials. Consideration of new technologies that depend on overcoming present material limits, and improving material/biological environment interactions.

Once a design is completed, prototypes must become manufacturable products that meet industry standards. 

This course provides a comprehensive overview of medical device manufacturing processes and technologies. It will cover the essential manufacturing principles and regulations governing the medical product manufacturing process including quality assurance and control.

Engineering decisions must be supported by data; our students learn how to setup testing, analyze results, evaluate device performance, and make evidence-based design improvements. 

A comprehensive introduction to statistical techniques and their implementation in design and quality control of medical devices. Topics include design of experiments and response surface approximations and their implementation via statistical software. 

Modern medical devices often include intelligent control systems that enable devices to monitor conditions, respond in real time, and improve patient outcomes.

This course explores the principles and applications of control systems in designing and developing medical devices. Students will learn about integrating control theory, mechanical engineering and biomedical engineering to create devices that improve healthcare delivery and patient outcomes.

As designs become more sophisticated, virtual testing helps engineers improve designs efficiently while reducing development time and cost. 

This course provides an introduction to the numerical analysis of fluid flows. Special techniques required for solution of the governing equations for viscous, inviscid and boundary layer flows. Applications to convective heat and mass transfer. Turbulence modeling and other submodels for complex engineering applications. 

The program culminates in a graduate project, where students integrate everything they have learned in a case study. They identify a real-world problem, design and/or evaluate a medical device solution, analyze its performance, consider manufacturing and regulatory requirements, and demonstrate their readiness to contribute to the medical device industry.   

This course is the culminating experience for the Master of Science in Medical Device Engineering program.