A thorough knowledge of the Food and Drug Administration (FDA) regulations of medical devices, and the understanding of a clinical device evaluation process are among the top expertise areas sought after by industry employers in their biomedical engineering (BME) hires. In the past, we have been only marginally successful teaching these topics to our students. Due to various curriculum constraints (e.g. long capstone design sequence), the coverage of regulatory compliance topics was limited to high-level information, with lectures distributed throughout different courses. Student feedback indicated that the presentation of these topics had little continuity and lacked the details and specific examples necessary to appreciate the significance of device regulation in the medical device industry. Furthermore, our Industrial Advisory Committee continuously stressed the importance of expanded coverage of the clinical device evaluation process in the BME curriculum, including device-study-appropriate statistical methods, as such knowledge would be the differentiating factor for our graduates when seeking employment.
To address the abovementioned issues, during a recent institution-wide curriculum revision, we developed a new three-credit course Biomedical Device Evaluation with emphasis on FDA regulation and clinical devices evaluation processes. The course topics include history of FDA regulation, the differences between regulation processes for devices and pharmaceuticals, regulatory compliance fundamentals (e.g. intended use and indications for use, device classification, regulatory controls, and Quality System Regulation), regulatory pathways to market, postmarket surveillance, design of preclinical and clinical device trials and appropriate statistical methods, risk management, and other related topics. The course also includes presentations of medical device case studies that influenced regulation processes in the United States and worldwide such as clinical studies of heart valves using historical controls, multi-center clinical trials in orthopedic devices, challenges in conducting implantable device trials using an example of Left Ventricular Assist Devices, design of clinical studies to validate the effectiveness of in vitro diagnostic devices, and lessons learned from pacemaker leads studies of postmarket surveillance. The course also includes presentations from regulatory industry experts and FDA representatives. It is important to note that additional, related topics (e.g. medical device standards, international regulations) are covered in our other courses (e.g. Professional Topics in Biomedical Engineering) and together with this course, constitute a comprehensive view of the medical device regulation field.
In the current academic year, the Biomedical Device Evaluation course is being taught for the first time. Upon its completion, a survey will be administered to the students to assess their perceived knowledge of the regulatory compliance and clinical device evaluation topics as well as their level of confidence in that knowledge, relative to other professional BME topics, which do not have a designated course in our curriculum.
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