BMES 488_588 - Medical Device Development - Spring %2711

BMES 488_588 - Medical Device Development - Spring %2711 -...

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Drexel University Department of Biomedical Engineering BMES 488/588 Medical Device Development, Credits = 3, Wednesday: 6:00 pm - 8:50 pm Bossone 709 2011 Syllabus – Product Development 101 Instructor: Kambiz Pourrezaei, PhD Contact Information: x2260, pourrezk@drexel.edu Office Hours: 3508 Market St, Room 104, 9am-4pm, or by appointment Co-Instructor: Sandy Weininger, PhD Contact Information: s andy.weininger@fda.hhs.gov Teaching Assistant: Emily Mathews, MS Contact Information: eam55@drexel.edu (via WebCT) Medical device product development needs to take into account a diverse set of disciplines to achieve a safe and successful product. This course will expose the student to several of these disciplines with the objective of raising the awareness of safety throughout the product development life cycle. Lectures will be given on the objectives of the regulatory process and some of its mechanisms, on (safety) risk management and design controls, on the use of human factors and standards, and on the design of clinical studies and forensic engineering. Students taking this class will have an understanding of some of the complex engineering decisions that support a safe medical device and will have a guide as to where they need to concentrate further. SPRING TERM DATE 2011 Monday March 28 Classes Begin Monday May 30 Memorial Day (University Holiday) Monday June 6 Last Day of Classes Tuesday June 7 Term Examinations Begin Friday June 10 Term Examinations End Course Schedule Week 1. March 30, 2011 Page 1 03:00:36
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Overview – (Weininger/FDA) Week 2. April 6, 2011 Week 3. April 13, 2011 Overview Of Authorities Of Jurisdiction – (Fitzgerald/FDA) Week 4. April 20, 2011 Week 5. April 27, 2011 Risk Management – (Taylor/FDA) Week 6. May 4, 2011 Week 7. May 11, 2011 Clinical studies/trials design/Labeling – (Barraj/Exponent & Datlof/ Hogan & Hartson, LLP) Week 8. May 18, 2011 Week 9. May 25, 2011 Internal Product Development processes (lifecycles), assurance cases – (Chapman/FDA) Week 10. June 1, 2011 Week 11. END June 8, 2011 Final (classes end June 5 th )
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Week 1: March 30 th , Overview – (Weininger/FDA) Raise awareness of issues – provide sources to delve deeper. 1. 1. What is a medical device 2. 2. Regulatory process 2.1. Safety 2.2. Effectiveness 3. 3. Issues that need to be addressed in design and development 3.1. Engineering 3.2. Scientific 3.3. Regulatory 3.4. Legal 3.5. Clinical 3.6. Consider adding reimbursement/payment? 3.7.
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This note was uploaded on 07/08/2011 for the course BM 501 taught by Professor Kop during the Spring '11 term at Bloomsburg.

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BMES 488_588 - Medical Device Development - Spring %2711 -...

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