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Syllabus


BIOEN 3801, Biomedical Engineering Design I (3 credits)

Department: Bioengineering
Designation: Required for BME Majors in their Junior Year
Catalog Description: First semester of a two semester capstone biomedical engineering design class covered from the perspective of FDA design mandates. Students will design and prototype a medical device using FDA requirements for Design Control. All projects will be planned, managed and executed using FDA Design Control Requirements. To accomplish this, projects will utilize customer driven inputs to motivate the development of product specifications. Prototypes will be fabricated based on these specifications. The prototypes will be tested and
evaluated to ensure the specifications are met. All projects will be implemented using a planned, multidisciplinary, ethics-based team approach. Students will also choose whether they will use their design project or an outside project for their senior project class and will provide a written and oral project proposal for their senior project. Lecture: 2 hours and Lab: 3 hours.

Prerequisite: BME Major Status or Instructor Permission
Instructors: Kelly W. Broadhead, Ph.D. (KWB) and Robert Hitchcock, Ph.D. (RH)
Office hours: During lab time on Tuesday and Wednesday in MEB 2405 or by appointment.
KW Broadhead email: kelly.broadhead@utah.edu phone: 585-7605
B Hitchcock email: R.Hitchcock@utah.edu phone: 585-7741

Lecture & Lab Times: Please refer to the University of Utah class schedule website.

References (required): FDA 21CFR820: Title 21--Food and Drugs, Subchapter H - Medical Devices, Part 820 Quality System Regulation (available on the web at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?
CFRPart=820& showFR=1
)
Text (suggested ): (recommended) Design Controls for the Medical Device Industry, Marie B. Teixeira and Richard Bradley, Marcel Decker, Inc. 2002. ISBN:0-8247-0830-X • Available at http://www.engnetbase.com/ejournals/
books/book_km.asp?id=1651
or
(alternative) Design of Biomedical Devices and Systems, 1st Edition, P.H. King and R.C. Fries, Marcel Decker, Inc., 2003. ISBN:0-8247-0889-X

Learning Objectives:
1) Students will design and prototype a medical device using FDA requirements for Design Control.
a) Students will be to explain and describe Design Control within the overall structure of FDA-QSR (Quality System Requirements) and other international regulatory requirements.
b) Students will apply FDA-QSR Design Control in their projects.

2) All projects will be planned, managed, documented and executed using FDA Design Control Requirements.
a) Students will create a project plan and implement their design project based on this plan.
b) Students will develop and implement a hazard management plan within the scope of the overall project plan.
c) Students will be able to explain tools and concepts of design management including how to deal with people of different backgrounds (engineers, physicians, and patients).
d) Students will assemble a Design History File that will include appropriate version controlled documentation.
e) Students will apply the QSR design process including appropriate written documentation and oral presentations.
f) Students will be able to explain the design control process beyond prototype verification testing including design validation and experimental design including human studies.
3) The medical device design projects will require customer driven inputs, product specifications, prototype fabrication, testing & evaluation.
a) Students will formulate project ideas by interacting with potential customers (clinicians and patients).
b) Design requirements will be determined and documented based on customer interactions.
c) Design specifications will be derived based on design requirements.
d) Students will determine unambiguous acceptance criteria to verify prototype designs.
e) Various design tools including CAD and modeling software will be applied to determine potential design solutions.
f) Students will evaluate various aspects of their designs by modeling electronics, hardware and software.
g) Students will develop a prototype device based on specifications, models and other input criteria.
h) The prototype designs will be tested and verified to determine if they meet the design specifications.

4) All projects will be implemented using a planned, multidisciplinary, ethics-based team approach.
a) Students will be able to identify the elements of QSR project planning and implementation that are important to all design projects (medical and non-medical).
b) Students will assemble into "multidisciplinary" teams and report on team management and dynamics.
c) Students will present their design work in written form by means of team reports and the Design History File.
d) Students will present their design work in oral form by means of Design Reviews.
e) Students will be able to identify engineering constraints and considerations including economic, environmental, sustainability, manufacturability, health, safety, social, and political.
f) Students will explore and analyze projects for ethical issues and potential solutions will be proposed.

5) Students will choose whether they will use their design project or an outside project for their senior project class.
a) The design projects will be developed and implemented in such a way that the students may desire to use them for their senior project.
b) Students will determine (formally indicate) by (insert date here) if they will use their Biomedical Device Design project as their senior project.
c) Students will provide a written and oral project proposal for their senior project.

BIOEN 4801, Biomedical Engineering Design II (3 credits)

Department: Bioengineering
Designation: Required for BME Majors in their Senior Year
Catalog Description: Continuation of BIOEN 3801. Initial designs will be prototyped before going through a design review. Design verification issues and improvements will then be solved in a redesign phase following a design process based on FDA-QSR. Projects will be team oriented and lead to increased project management skills. In addition, discussions on design considerations will continue. A final written design document and an oral presentation of the< working prototype will culminate the class. Lecture: 1 hour and Lab: 3 hours + 3 hours arranged.

Prerequisite: BME Major Status or Instructor Permission

Instructors: Kelly W. Broadhead, Ph.D. (KWB) and Jeff Wolchok, Ph.D. (JW)
Office hours: During lab time on Wednesday in MEB 2560 or by appointment.
KW Broadhead email: kelly.broadhead@utah.edu phone: 801-585-7605
J Wolchok email: J.Wolchok@utah.edu phone: 801-503-4034

Lecture & Lab Times: Please refer to the University of Utah class schedule website.

References (required): FDA 21CFR820: Title 21--Food and Drugs, Subchapter H - Medical Devices, Part 820 Quality System Regulation (available on the web at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.
cfm?CFRPart=820& showFR=1)


Text (suggested): (recommended) Design Controls for the Medical Device Industry, Marie B. Teixeira and Richard Bradley, Marcel Decker, Inc. 2002. ISBN:0-8247-0830-X or
(alternative) Design of Biomedical Devices and Systems, 1st Edition, P.H. King and R.C. Fries, Marcel Decker, Inc., 2003. ISBN:0-8247-0889-X

Learning Objectives:
1) Students will design and prototype a medical device using FDA requirements for Design Control.
a) Students will be to explain and describe Design Control within the overall structure of FDA-QSR (Quality System Requirements) and other international regulatory requirements.
b) Students will apply FDA-QSR Design Control in their projects.

2) All projects will be planned, managed, documented and executed using FDA Design Control Requirements.
a) Students will create a project plan and implement their design project based on this plan.
b) Students will develop and implement a hazard management plan within the scope of the overall project plan.
c) Students will be able to explain tools and concepts of design management including how to deal with people of different backgrounds (engineers, physicians, and patients).
d) Students will assemble a Design History File that will include appropriate version controlled documentation.
e) Students will apply the QSR design process including appropriate written documentation and oral presentations.
f) Students will be able to explain the design control process beyond prototype verification testing including design validation and experimental design including human studies.

3) The medical device design projects will require customer driven inputs, product specifications, prototype fabrication, testing & evaluation.
a) Students will formulate project ideas by interacting with potential customers (clinicians and patients).
b) Design requirements will be determined and documented based on customer interactions.
c) Design specifications will be derived based on design requirements.
d) Students will determine unambiguous acceptance criteria to verify prototype designs.
e) Various design tools including CAD and modeling software will be applied to determine potential design solutions.
f) Students will evaluate various aspects of their designs by modeling electronics, hardware and software.
g) Students will develop a prototype device based on specifications, models and other input criteria.
h) The prototype designs will be tested and verified to determine if they meet the design specifications.

4) All projects will be implemented using a planned, multidisciplinary, ethics-based team approach.
a) Students will be able to identify the elements of QSR project planning and implementation that are important to all design projects (medical and non-medical).
b) Students will assemble into "multidisciplinary" teams and report on team management and dynamics.
c) Students will present their design work in written form by means of team reports and the Design History File.
d) Students will present their design work in oral form by means of Design Reviews.
e) Students will be able to identify engineering constraints and considerations including economic, environmental, sustainability, manufacturability, health, safety, social, and political.
f) Students will explore and analyze projects for ethical issues and potential solutions will be proposed.

5) Students will choose whether they will use their design project or an outside project for their senior project class.
a) The design projects will be developed and implemented in such a way that the students may desire to use them for their senior project.
b) Students will determine (formally indicate) by (insert date here) if they will use their Biomedical Device Design project as their senior project.
c) Students will provide a written and oral project proposal for their senior project.

Other Items:
U of Utah Content Disclaimer: http://www.utah.edu/disclaimer/index.html
ADA Policy: http://www.hr.utah.edu/oeo/ada/guide/faculty
Faculty Responsibilities: http://www.admin.utah.edu/ppmanual/8/8-12-4.html
Accommodations Policy: http://www.admin.utah.edu/facdev/accommodations-policy.pdf
College of Engineering Guidelines including the ADA Policy: http://www.coe.utah.edu/SemesterGuidelines.pdf