Mar 28, 2024  
2021-2022 Undergraduate Academic Catalog 
    
2021-2022 Undergraduate Academic Catalog [ARCHIVED CATALOG]

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BE 3005 - Professional Topics in BME

2 lecture hours 0 lab hours 2 credits
Course Description
This course introduces students to a range of important professional biomedical engineering topics. These include, but are not limited to: finding and using technical literature; identifying codes and standards for medical devices and systems; the regulation of medical devices (including the FDA device approval process and QSR design control requirements); career options in BME; finding internships, jobs and graduate programs; intellectual property considerations; ethics considerations in the medical device industry (including regulations on human subject research); quality control in the manufacturing of medical devices; user experience of medical devices; and entrepreneurship and business aspects of health care and medical devices. (prereq: none)
Course Learning Outcomes
Upon successful completion of this course, the student will be able to:
  • Identify what constitutes human subject research and describe the IRB approval process
  • Identify ethical considerations for scenarios involving the medical device industry
  • Identify relevant sources of standards and codes related to specific medical devices
  • Identify ways to mitigate patient risk associated with medical devices
  • Identify whether a device is an FDA medical device and its likely FDA classification
  • Describe FDA Quality System Regulation design controls and identify when they apply to the medical device design and manufacturing processes
  • Identify methods to ensure quality in the manufacture of medical devices
  • Identify salient considerations of the various career options in BME
  • Use formal methodology to identify design requirements
  • Describe the general options for protecting the intellectual property of medical device designs
  • Articulate different viewpoints of a current controversial issue, including how each impacts marketing and accessibility of medical devices.

Prerequisites by Topic
  • None

Course Topics
  • Introduction to FDA regulation of the medical device industry and device classification
  • Codes and standards (including JCAHO, NFPA, NEC, AAMI, ANSI, IEC 60601)
  • Introduction to intellectual property protection
  • Using library resources to research literature, standards and patents and navigate the FDA website
  • FDA QSR design control requirements overview
  • Identification of user requirements and design requirements for medical devices
  • Hazard analysis and risk mitigation in device design
  • Quality control processes for medical device manufacture
  • Medical device and health care economics and market analysis
  • Human subject research and the IRB process
  • Human factors and medical error involving devices
  • Career options in BME
  • Fundamentals in clinical engineering/health care technology management
  • Using career placement resources to find jobs and internships and apply for graduate school
  • Ethics in the medical device industry
  • Contemporary BME issues

Coordinator
Dr. Jeffrey LaMack



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