The Medical Devices innovation track focuses on the imperative need to improve healthcare systems with more accurate and less invasive alternatives to treat, diagnose and prevent injuries and diseases. Both, the World Health Organization (WHO) and the United States Food and Drug Administration (FDA), define medical devices as pieces of equipment or apparatus that include a wide range of application and levels of complexity. With a history of 5% annual growth, the medical device industry is in continuous research and development with indefinite opportunity to innovate. Accordingly, the innovation track provides the skills and knowledge needed to pursue in this field.

This track prepares the next generation of scientists and engineers to revolutionize in this field. It will enhance the development of an entrepreneurial and business mindset customized to consider the challenges of this field (e.g. risks on human life, strict government regulations). Medical device development is costly and complex; therefore, objectives of this track include learning by implementing the design process into real problems.

To summarize, the track offers experiential learning related to:
(1) Entrepreneurial & business mindset
(2) Major challenges in medical device development (e.g. Governmental regulations)
(3) Data collection and experimentation with human subjects
(4) Design controls and protocols
(5) Assessment of clinical needs
(6) Design methodology

The program requires ININ 5105 as a core technical course that provides comprehensive knowledge and experiential learning of medical device development with project-based learning implemented to start creating a solution for a particular clinical need. Upon completion of this course, participants could continue developing the innovations they started in the program or replicate the process for other innovation. UPRM E-ship Network provides the support for the continuation of these projects and a series of core courses in entrepreneurship are offered every semester to complete the track. A second course must be taken from a list of elective courses for participants to reinforce their knowledge depending on their particular interests. 

Suggested Technical Courses:

Course Codification Course Name Course Description Pre-Requirements Co-Requirements
ININ 5105 (Core Requisite) Introduction to Medical Device Design Methods This course presents the fundamental methods for medical device development. It is designed for students interested in a comprehensive study of the medical device development process, from concept ideation to marketing. It discusses methods that aid completing the procedures of product definition, design, risk management, production planning and market introduction, in an environment of multiple stakeholders, FDA (Food and Drug Administration) regulations and intellectual property protections. The course includes case studies illustrating important considerations to manage the complexities of the development process. ININ 4020 or INME 4055 or INEL 4205 or INQU 4008 None
ININ 4996 (Elective) Principles of Medical Device Packaging This course presents an overview of medical device packaging from raw material and converting processes to end use. It includes an introduction to medical device packaging, the packaging matrix as a design tool, the development of packaging specifications, the most commonly used packaging equipment, process control tools, sterilization requirements, supply chain requirements (Unique Device Identification - UDIs), FDA requirements and regulations, and package testing standards [International Safe Transit Association (ISTA)/American Standards for Testing and Materials(ASTM)], among others. It is designed for students interested in the HealthCare Packaging Industry, specifically in medical device packaging. ININ 4020 None
INEL 5208 (Elective) Principles of Biomedical Instrumentation Theoretical and practical aspects of the methods used to measure physiological events with emphasis in the cardiovascular, pulmonary and nervous systems. INEL 4201 or consent of the department head None
INEL 6097 (Elective) Biomedical Acoustics Application of acoustics principles toward the design of diagnostic and therapeutic medical devices. Use of computer tools to simulate the acoustic response of systems composed of biological tissues. Graduate standing or consent of the instructor. None
INME 6065 (Elective) Principlies of Biomedical Engineering Application of engineering principles and quantitative methods in biology to analyze and describe complex biological systems. Survey of human anatomy and physiology, modern molecular biology, professional ethics, and regulatory issues. Authorization of the Director. None