BMA 520 - Evaluation of Biomedical Materials (4 credit hours) Spring semester

Course Directors: 

Schedule: Mondays and Fridays, 4:00 - 5:45pm

Prerequisite: Graduate or Upper Level Undergraduate Standing

General Objectives: This course serves a multidisciplinary group of students, assuming a starting level of Bachelor's degree knowledge.  From that point, we will address (1) characteristics of specific materials used for various types of devices; (2) selection criteria based on function and longevity; (3) performance testing in vitro and in vivo; (4) evaluation of material breakdown in biological media, and potential toxicologic consequences; (5) design of clinical trials; (6) surgical considerations; and (7) ethical, regulatory, and legal issues.  The course utilizes your primary field of expertise as a guide to specific topics of biomaterials evaluation.  A "case study" midway through the course allows you to work together to actually design and promote a new implant device for an unmet medical need, with particular attention to regulatory requirements and market realities.  You are encouraged to share your own expertise with the faculty and your colleagues in the class.  The anticipated schedule of topics is given on the attached page.

Requirements and Evaluation Criteria

è Adherence to  the University's Academic Integrity requirements

è Case Study (Group Project) Preparation and Presentation (30% of final grade)

• extent of contribution to group productivity
• apparent extent of preparation for assigned role
• ability to anticipate and respond to materials-related problems
• correctness of information presented

è Written Paper (15% of final grade)

• clarity of written presentation (background discussion, concepts, pros/cons of technique or device, recommendations)
• correctness of information presented
• synthesis of recommendations/conclusions based on scientific, economic, ethical, regulatory, and sociological factors
• spelling, punctuation

è Take-Home Test (15% of final grade)

• clarity and correctness of answers to short answer/essay questions, emphasize fundamental concepts

è Final Examination (Oral) (40% of final grade)

• demonstration of understanding of concepts of biomaterials evaluation (pre- and post-implant)
• demonstration of ability to suggest/outline a reasonable series of investigations for any material/end-use scenario and to discuss rationale for selection
• demonstration of understanding of key issues in the development of biomedical devices (e.g. in vitro model design; in vivo models; clinical trials; regulation of laboratory studies, animal studies, and clinical trials; FDA device review and approval processes)
• percentage and number of questions answered correctly within 1-hour period

è Class Attendance, Constructive Participation in Class, Completion of Recommended Reading

  (These items are positive factors for numerical scores that are close to next-higher letter grade.)

è Course Evaluation

• You will be asked to evaluate the course content, lectures, and faculty in a written format at two points in the course.

Outline and Schedule of Topics

Text - to be announced.  Other reading assignments will be provided as "hand-outs", or as material available in UB's Health Sciences Library (e.g. journal articles), or as "web" assignments.

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