Course Syllabus Course Information Course Number: Course Title: Section: Time: Location: Credit Hours: ITDE 610 Introduction to Engineering Innovation in Medicine 100, 101 Section 100: T 1-2PM, MW 9AM-12PM Section 101: T 1-2PM, MW 1PM-4PM EnMed Innovation Center (EIC) - EnMed Tower, Room 106, 140 3 Instructor Details Section 100 Instructor: Office: Phone: E-Mail: Office Hours: Nicholas Sears EnMed Tower, Room 108 832-289-5518 nicksears@tamu.edu By Appointment Section 101 Co-Instructor: Office: Phone: E-Mail: Office Hours: Shannon Wilson EnMed Tower, Room 108 713-487-5236 sni94@tamu.edu By Appointment Course Description An overview of concepts and topics at the intersection of engineering, medicine, and design for innovation including the design of medical technologies, rapid prototyping tools and techniques; discussion of intellectual property protection, and commercialization strategies, engineering design processes, design in a regulated environment (FDA), ideation and concept development methods, prototype development technologies, pre-clinical testing, path-to-market strategies, and entrepreneurship; includes weekly expert panel sessions, skills development workshops, and field trips. Course Prerequisites Admission to the EnMed program; Approval of Instructor Page 1 of 9 Course Syllabus Course Learning Outcomes At the end of this course, students will be able to address the following learning objectives that mainly address Program Learning Outcome 7 (Medical Technologies): (a) Engineering Principles: 1. Outline the physical principles that underpin medical technologies and explain how different components of medical devices interact with the human body, including bio-compatibility, signal processing, and physiological impact. (b) Design and Prototyping: 2. Demonstrate how design specifications affect the form and function, create detailed 3D models of medical technologies with specific design features, and fabricate physical prototypes of medical devices based on detailed design specifications (c) Medical Device Electronics: 3. Understand basic principles of electrical circuits, design and create functional circuits to achieve specific tasks, and implement circuits and corresponding software to control environmental variables. (d) Digital Health: 4. Identify and apply AI and ML techniques in digital health platforms for predictive analytics, remote patient monitoring, and diagnostics. (e) Bioengineering: 5. Analyze biofabrication and biomechanical analysis systems to create and understand biological tissues and analogues, as well as engineered materials. Program Learning Outcomes This course will also address, to a lesser extent, EnMed’s Program Learning Outcomes: 1. *Application of Knowledge: Students will demonstrate an ability to identify, formulate, and solve complex engineering problems by applying principles of engineering, science, and mathematics. 2. *Ethics: Students will choose ethical courses of action in practice. 3. *Communication Skills: Students will effectively communicate ideas, constraints, problems, and potential solutions associated with current issues in engineering. 4. Biodesign-Identify: Students will identify and screen needs from clinical observation, biomedical literature, and peer interactions. 5. Biodesign-Invent: Students will generate and evaluate concepts that address a clinical need. 6. Biodesign-Implement: Students will develop an implementation plan for new medical technologies, including navigating regulatory, reimbursement, and commercial hurdles. 7. Medical Technologies: Students will be able to select and utilize existing medical technologies and outline the physical and engineering principles underlying their design and function. 8. Teamwork: Students will be able to form and work effectively in multidisciplinary teams on real-world problems in healthcare. *Based on ABET 1, 4, and 3 respectively. Page 2 of 9 Course Syllabus Textbook and/or Resource Materials None. Grading Policy Standard Letter Grading Scale A >= 90 % B = 80-89 % C = 70-79 % D = 60-69 % F = <60 % *Final grades will be rounded to the nearest 1%. For example, a final grade of 89.5% will be rounded to 90 for a grade of “A,” but a grade of 89.4 will be rounded to 89 for a grade of “B.” Grade weighting: In-Class and Homework Assignments 70% Readiness Assessment Tests (RATs) 20% Design Showcase 10% Total 100% In-Class and Homework Assignments – Workshops will have deliverables in the form of assignments, which may include team-based and individual components. Canvas assignments will be in the form of a “quiz” on canvas which currently cannot be set as team ‘assignments’, so a team designee will be asked to submit on behalf of the team and indicate (assigned) teammates. Readiness Assessment Tests (RATs) – Each class will begin with a brief (individual) assessment to evaluate each student’s understanding of preparatory materials assigned for review prior to class. Design Showcase – Groups will be assigned a course-long design project to demonstrate understanding of lecture content and workshop skills. Students will use skills learned from the workshops to develop a prototype and short presentation/demonstration to be delivered at the end-of-term Design Showcase. Note on Teamwork – All members are expected to contribute to the planning and execution of team assignments. Students may be asked to complete peer review evaluations for all team members. These evaluations may be considered when determining assignment and final course grades. Grades for team/group assignments will reflect individual effort and contributions. Late Work Policy Late work will not be accepted except in the case of a university excused absence (see TAMU Student Rule 7). Corrections Policy A select number of assignments may be eligible for corrections and subsequent re-grading (at the instructor's discretion). The purpose for allowing corrections to completed work is to provide an opportunity for students to learn by correcting their mistakes. The highest grades that can be achieved for corrected assignments is 90%. Corrections will not be accepted for late work nor will corrections be Page 3 of 9 Course Syllabus accepted after the corrections deadline set by the instructor. The corrections process is not a loophole to get extra time on an assignment; Original submissions must clearly demonstrate a genuine effort to complete the assignment on time to the best of the student's ability. Original submissions not completed in good-faith (i.e. that demonstrate a lack of serious effort to complete the assignment on time and with a level of quality commensurate with professions of engineering and of medicine) will result in the submission being ineligible for resubmission. Attendance Policy Although engineering courses are not delivered by the School of Medicine or EnMed medical faculty, this course will follow attendance policies that match those promulgated by the School of Medicine for medical courses. The intent is to maintain a consistent policy so that students only need to know and follow a single policy. The university views class attendance and participation as an individual student responsibility. Students are expected to attend class and to complete all assignments. Please refer to Student Rule 7 in its entirety for information about excused absences, including definitions, and related documentation and timelines. The Office of Academic Affairs administers the attendance and absence policy. Requests for excused absences, including requests for healthcare, must be submitted through the Pre-Clerkship Absence Request Form. Students need not disclose the specific type of healthcare that is being sought. Course directors, teaching faculty, and educational support staff do not handle determination of excused and unexcused absences, nor can they adjust decisions made by the Office. Students with recurring absences (excused or unexcused) or late arrivals to events will be required to meet with Academic Affairs. It is the student’s responsibility to provide documentation to substantiate an excused absence within 3 business days of returning to school. Confidential information may be redacted from this documentation. Documentation may be required for repetitive absences even if excused. Excused absences and tardies may be requested in the case of: 1. Physician-documented illness serious enough to prevent attendance 2. Participation in legal proceedings 3. Death or illness of a loved one 4. Observance of a major religious holy day 5. Presentation of research or scholarship at a professional conference related to the student’s academic program, provided that the student is a presenter. 6. Other situations may qualify as excused absences and will be evaluated by the Assistant Dean of Pre-Clerkship or designee on a case-by-case basis. Please refer to the Student Policies and Guidelines website for full details of the Attendance and Absence Policy. Consequences for late arrivals or unexcused absences to mandatory events are administered by the Office of Academic Affairs within established guidelines. Excessive absences may incur additional requirements Page 4 of 9 Course Syllabus of a student, up to and including repetition of a course. Students with a chronic or recurring medical condition are encouraged to contact Academic Affairs to discuss their condition to decrease the need for recurring documentation. The School retains the right to require additional documentation of any absence, as deemed necessary. Makeup Work Policy Students will be excused from attending class on the day of a graded activity or when attendance contributes to a student’s grade, for the reasons stated in Student Rule 7, or other reason deemed appropriate by the instructor. Please refer to Student Rule 7 in its entirety for information about makeup work, including definitions, and related documentation and timelines. Absences related to Title IX of the Education Amendments of 1972 may necessitate a period of more than 30 days for make-up work, and the timeframe for make-up work should be agreed upon by the student and instructor” (Student Rule 7, Section 7.4.1). “The instructor is under no obligation to provide an opportunity for the student to make up work missed because of an unexcused absence” (Student Rule 7, Section 7.4.2). Students who request an excused absence are expected to uphold the Aggie Honor Code and Student Conduct Code. (See Student Rule 24.) Makeup work following an excused absence must be coordinated with the course instructor within 2 business days of returning to school after an absence. Comments on the ENMED program This course is part of an advanced professional degree, and each student in the ENMED program has chosen to take on additional responsibilities above those of the already demanding medical curriculum. The instructors intend to hold you to the utmost standards of professionalism. This extends to issues of academic honesty, attendance, effort in coursework, and interpersonal professionalism. Your involvement in this program indicates that you want to be a leader in your field, and we will hold you to that standard. Page 5 of 9 Course Syllabus Course Schedule Week# Week Start Session Topic 1 Mondays 9AM/1PM* Session Topic 2 Wednesdays 9AM/1PM* Lecture Topic (Tuesdays 1PM) (Sears/Wilson) Orientation (Black) ENGR Design process, FDA 22 5/26 Reverse engineering, CAD DICOM reconstruction 23 6/2 Mold assembly design Molding and Traditional Machining Part 1 (Sears) Design inputs/outputs 24 6/9 Traditional Machining Part 2 and MRI Basic circuits and soldering (Carothers) Intellectual Property & NDAs (Black) Commercialization, Paths to Market, Entrepreneurship (Powell) Intro to AI & ML 25 6/16 Basic Arduino circuits Functional Arduino circuits Part 1 26 6/23 Functional Arduino circuits Part 2 Coding Introduction (Python) 27 6/30 Machine Learning Artificial Intelligence, Large (Hiles) Ideation & Concept Language Models Development *See detailed student google calendar for exact times. Open lab/office hours on Tues/Thurs (typical). Final “Design Showcase” on Thursday, July 3rd, 1-3PM. University Policies This section outlines the university level policies that must be included in each course syllabus. The TAMU Faculty Senate established the wording of these policies. NOTE: Faculty members should not change the written statements. A faculty member may add separate paragraphs if additional information is needed. Attendance Policy The university views class attendance and participation as an individual student responsibility. Students are expected to attend class and to complete all assignments. Please refer to Student Rule 7 in its entirety for information about excused absences, including definitions, and related documentation and timelines. Page 6 of 9 Course Syllabus Makeup Work Policy Students will be excused from attending class on the day of a graded activity or when attendance contributes to a student’s grade, for the reasons stated in Student Rule 7, or other reason deemed appropriate by the instructor. Please refer to Student Rule 7 in its entirety for information about makeup work, including definitions, and related documentation and timelines. Absences related to Title IX of the Education Amendments of 1972 may necessitate a period of more than 30 days for make-up work, and the timeframe for make-up work should be agreed upon by the student and instructor” (Student Rule 7, Section 7.4.1). “The instructor is under no obligation to provide an opportunity for the student to make up work missed because of an unexcused absence” (Student Rule 7, Section 7.4.2). Students who request an excused absence are expected to uphold the Aggie Honor Code and Student Conduct Code. (See Student Rule 24.) Academic Integrity Statement and Policy “An Aggie does not lie, cheat or steal, or tolerate those who do.” “Texas A&M University students are responsible for authenticating all work submitted to an instructor. If asked, students must be able to produce proof that the item submitted is indeed the work of that student. Students must keep appropriate records at all times. The inability to authenticate one’s work, should the instructor request it, may be sufficient grounds to initiate an academic misconduct case” (Section 20.1.2.3, Student Rule 20). Texas A&M at College Station You can learn more about the Aggie Honor System Office Rules and Procedures, academic integrity, and your rights and responsibilities at aggiehonor.tamu.edu. Americans with Disabilities Act (ADA) Policy Texas A&M University is committed to providing equitable access to learning opportunities for all students. If you experience barriers to your education due to a disability or think you may have a disability, please contact the Disability Resources office on your campus (resources listed below) Disabilities may include, but are not limited to attentional, learning, mental health, sensory, physical, or chronic health conditions. All students are encouraged to discuss their disability related needs with Disability Resources and their instructors as soon as possible. Texas A&M at College Station Disability Resources is located in the Student Services Building or at (979) 845-1637 or visit disability.tamu.edu. Page 7 of 9 Course Syllabus Title IX and Statement on Limits to Confidentiality Texas A&M University is committed to fostering a learning environment that is safe and productive for all. University policies and federal and state laws prohibit gender-based discrimination and sexual harassment, including sexual assault, sexual exploitation, domestic violence, dating violence, and stalking. With the exception of some medical and mental health providers, all university employees (including full and part-time faculty, staff, paid graduate assistants, student workers, etc.) are Mandatory Reporters and must report to the Title IX Office if the employee experiences, observes, or becomes aware of an incident that meets the following conditions (see University Rule 08.01.01.M1): ● The incident is reasonably believed to be discrimination or harassment. ● The incident is alleged to have been committed by or against a person who, at the time of the incident, was (1) a student enrolled at the University or (2) an employee of the University. Mandatory Reporters must file a report regardless of how the information comes to their attention – including but not limited to face-to-face conversations, a written class assignment or paper, class discussion, email, text, or social media post. Although Mandatory Reporters must file a report, in most instances, a person who is subjected to the alleged conduct will be able to control how the report is handled, including whether or not to pursue a formal investigation. The University’s goal is to make sure you are aware of the range of options available to you and to ensure access to the resources you need. Texas A&M at College Station Students wishing to discuss concerns in a confidential setting are encouraged to make an appointment with Counseling and Psychological Services (CAPS). Students can learn more about filing a report, accessing supportive resources, and navigating the Title IX investigation and resolution process on the University’s Title IX webpage. Statement on Mental Health and Wellness Texas A&M University recognizes that mental health and wellness are critical factors that influence a student’s academic success and overall wellbeing. Students are encouraged to engage in healthy self-care by utilizing available resources and services on your campus Texas A&M College Station Students who need someone to talk to can contact Counseling & Psychological Services (CAPS) or call the TAMU Helpline (979-845-2700) from 4:00 p.m. to 8:00 a.m. weekdays and 24 hours on weekends. 24-hour emergency help is also available through the 988 Suicide & Crisis Lifeline (988) or at 988lifeline.org Links to an external site.. Page 8 of 9 Course Syllabus Statement on the Family Educational Rights and Privacy Act (FERPA) FERPA is a federal law designed to protect the privacy of educational records by limiting access to these records, to establish the right of students to inspect and review their educational records and to provide guidelines for the correction of inaccurate and misleading data through informal and formal hearings. Currently enrolled students wishing to withhold any or all directory information items may do so by going to howdy.tamu.edu and clicking on the "Directory Hold Information" link in the Student Records channel on the MyRecord tab. The complete FERPA Notice to Students and the student records policy is available on the Office of the Registrar webpage. Items that can never be identified as public information are a student’s social security number, citizenship, gender, grades, GPR or class schedule. All efforts will be made in this class to protect your privacy and to ensure confidential treatment of information associated with or generated by your participation in the class. Directory items include name, UIN, local address, permanent address, email address, local telephone number, permanent telephone number, dates of attendance, program of study (college, major, campus), classification, previous institutions attended, degrees honors and awards received, participation in officially recognized activities and sports, medical residence location and medical residence specialization. Page 9 of 9
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