M3/M4 Course Offerings

2026-2027 M3/M4 Course Syllabi

Physical Medicine & Rehabilitation

COURSE NUMBER:

18 01 12

TITLE:

Medical Device Design, Inquiry, and Development
This course introduces medical students to the fundamentals of medical device design, regulatory pathways, and effective design communication. Students will explore the clinician’s role in the innovation process rom identifying unmet clinical needs to collaborating with engineers and designers in the development of safe, effective, and user-centered medical technologies. Through case studies, hands-on activities, and interdisciplinary team projects, students will gain insight into: • The medical device development lifecycle • FDA regulations and standards governing medical devices • Human-centered design principles and usability testing • Communication strategies for working with technical teams • Ethical and clinical considerations in device innovation By the end of the course, students will be equipped to contribute meaningfully to medical device design efforts, whether as inventors, collaborators, or evaluators.

PREREQUISITES:

26920371 (FAMILY MEDICINE CORE CLKSP), 26931373 (INTERNAL MEDICINE CORE CLKSP), 26940373 (NEUROSCIENCE CORE CLKSP), 26946374 (OBSTETRICS/GYN CORE CLKSP), 26961373 (PEDIATRICS CORE CLKSP), 26963371 (PSYCHIATRY CORE CLKSP), 26980373 (SURGERY CORE CLKSP)

N/A

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GENERAL INFORMATION

COURSE YEAR:

CREDIT HOURS:

CREDIT WEEKS:

DOMESTIC VISITING:

INTERNATIONAL VISITING:

GRADED:

Honors/High Pass/Pass/Fail

COURSE QUALIFICATIONS:

STATUS:

Full-Time
OFFERED AS FULL-TIME AND PART-TIME: NO
ALLOWS OVERLAP: YES

COURSE LENGTH:

This 4-week intensive elective (totaling 160 hours) introduces medical students to the fundamentals of medical device design, regulatory pathways, and interdisciplinary design communication. This will be during their M4 year.

DIRECTOR:

Victoria Heasley
heasleva@ucmail.uc.edu

Aaron Burdette
burdetaj@uc.edu

ADMINISTRATIVE SUPPORT PERSON:

Michele Halley
halleymr@ucmail.uc.edu

SITE(S):

Medical Sciences Building (MSB)

MAX ENROLL:

ROTATIONS:

Rotation	Dates	Max
1	04/06/2026 - 05/01/2026	0
2	05/04/2026 - 05/29/2026	0
3	06/01/2026 - 06/26/2026	0
4	06/29/2026 - 07/24/2026	0
5	07/27/2026 - 08/21/2026	0
6	08/24/2026 - 09/18/2026	0
7	09/21/2026 - 10/16/2026	20
8	10/19/2026 - 11/13/2026	20
9	11/16/2026 - 12/11/2026	20
10	12/14/2026 - 01/08/2027	0
11	01/11/2027 - 02/05/2027	0
12	02/08/2027 - 03/05/2027	0
13	03/08/2027 - 04/02/2027	0
14	04/05/2027 - 04/30/2027	0

NOTE: If a rotation is offered in both 2 and 4 week slots, the max capacity is limited to the actual spots offered for the 4 weeks. (ie: the 2 week rotations listed share the max of the 4 week rotation)
PT Extended Electives will span the entire year, not just 4 weeks

WORKING HOURS:

40 Weekly

REPORT 1^ST DAY:

Students will report to Victory Parkway Campus, Classroom 150 on the first day of the course. Additional logistical details, including daily schedule and preparatory materials, will be emailed to enrolled students approximately two weeks prior to the course start date.

COMMENTS:

N/A

INSTRUCTION

LEARNING ACTIVITIES:

Case-Based Instruction/Learning
Concept Mapping (allows learners to organize and represent knowledge in an explicit interconnected network)
Discussion-Small Group (Small Group (=12)
Independent Learning (Instructor-guided learning activities to be performed by the learner outside of formal educational settings.)
Lecture
Mentorship
Problem-Based Learning (PBL)
Reflection
Self-Directed Learning (Learners take initiative for their own learning; diagnosing needs; formulating goals; identifying resources; implementing appropriate activities; and evaluating outcomes.)
Simulation
Team-Based Learning (TBL) (Workshops, sessions, or activities contributing to the development of teamwork skills)

In this course, we may cover complex health issues that often intersect with personal beliefs, societal debate, and evolving science. You will likely encounter information or perspectives that differ from your own. As physicians-in-training, your responsibility is to listen with curiosity, engage with evidence, and communicate respectfully—just as we do in patient care. Syllabi and course materials will be grounded in evidence-based medicine, scientific principles and reflect areas of ongoing scientific inquiry. In courses addressing policy, ethics, or societal issues, materials will be structured to promote evidence-based learning while transparently acknowledging where evidence is evolving or there are multiple viewpoints that may impact patient care.

LEARNING ENVIRONMENT POLICIES:

UCCOM strives to provide medical students with a learning environment that is conducive to their professional growth. All UCCOM and visiting medical students are encouraged to review the Student Handbook.

The Office of Student Affairs and Admissions is available to all UCCOM and visiting medical students to discuss any concerns/questions related to the learning environment. Please call 558-6796 to access faculty/staff that can assist you.

TEACHING:

50%	Attending Physician
50%	Other Faculty

FEEDBACK:

ASSESSMENT:

ASSESSMENT METHODS:
Exam, Institutionally Developed, Written/Computer-based
Portfolio-Based Assessment
Self-Assessment

FINAL GRADE:

GRADE ASSIGNED BY:

OBJECTIVES

Curricular Resources :

1.Privitera, M.B., "Contextual Inquiry for Medical Device Design," (2015) 1st edition, Elsevier Academic Press ISBN 9780128018521

2.Mechanical Engineering Design, by Joseph Shigley, & Charles Mischke, et al., 7thed, McGraw Hill

3.Product Design and Development;3rd. McGraw-Hill

4.Kucklick, T., (2006) The Medical Device R & D Handbook, Taylor & Francis

5.Fries, R., (2006) Reliable Design of Medical Devices 2nd, Taylor & Francis

6.Ashby M and Johnson K. (2002) Materials and Design: The Art and Science of Material Selection in Product Design. Butterworth-Heinemann; paperback edition

7.Getting Started with ABAQUS version 6.5 or 6.6, ABAQUS Inc (will be provided)

8.Dewhurst P, Knight and Boothroyd G. (2001) Product Design for Manufacture & Assembly Revised & Expanded. Marcel Dekker

9.Davis AR(2004) Handbook of Materials for Medical Devices. ASM International

10.Fries RC (1998) Medical Device Quality Assurance and Regulatory Compliance.Marcel Dekker

11.Justiniano JM, Gopalaswamy V, (2003)Practical Design Control Implementation for Medical DevicesInterpharm/CRC

12.Privitera, M.B., "Applied Human Factors In Medical Device Design "(2019) 1st edition, Elsevier Academic Press ISBN 978-0-12-81613-0

13.Yock, Zenios, Makower. "Biodesign"(2015) 2nd edition, Cambridge University Press.

Knowledge/Skills:

Learning Outcome Mapped AAMC Core EPA(s) Mapped LCME Standard(s)

1. Describe the medical device development lifecycle EPA 7: Form clinical questions and retrieve evidence LCME 7.6: Self-directed and lifelong learning

2. Explain key regulatory frameworks for medical devices EPA 3: Recommend and interpret common diagnostic and screening tests LCME 6.1: Program objectives

3. Apply human-centered design principles to evaluate usability and safety EPA 4: Enter and discuss orders/prescriptions LCME 7.9: Interprofessional collaborative skills

4. Identify and articulate clinical needs for innovation EPA 1: Gather a history and perform a physical exam LCME 6.3: Self-assessment and feedback

5. Collaborate effectively with engineers and designers EPA 9: Collaborate as a member of an interprofessional team LCME 7.9: Interprofessional collaborative skills

6. Critically assess ethical, legal, and clinical implications of device design EPA 5: Document a clinical encounter LCME 6.5: Medical ethics

7. Demonstrate basic design thinking skills in a team-based project EPA 13: Identify system failures and contribute to a culture of safety LCME 7.8: Communication skills

8. Reflect on the clinician’s role in innovation and device development EPA 6: Provide an oral presentation of a clinical encounter LCME 6.1, 6.3: Program objectives, self-assessment

Main Course Topics :

Medical device design

Clinical innovation

Human-centered design

FDA regulations

Biomedical engineering

Design thinking

Interdisciplinary collaboration

Usability testing

Regulatory science

Prototyping

Needs identification

Translational medicine

Health technology

Device lifecycle

Clinician-designer partnership

Medical technology development

Safety and efficacy

Design communication

Clinical entrepreneurship

Innovation in healthcare

Procedures:

We will do simulations of the following procedures:

Speculum Exam

Lumbar Puncture

Paracentesis

Placing IV with Ultrasound Guidance

Remediation Plan:

3-week self-guided discovery and design of a medical device, working outside hours with Dr. Heasley and Prof. Burdette. This would take place immediately following the end of the block.

SAMPLE WEEK

SCHEDULE NOTE:

Monday: In-person Lecture and Working in the Design Lab, 8 hours

Tuesday: Individual Assignments, hybrid and able to work in the Design Lab or at home, 8 hours

Wednesday: Team work day, in-person lecture/simulation procedure work, working in the Design Lab, 8 hours

Thursday: Individual Assignments, hybrid and able to work in the Design Lab or at home, 8 hours

Friday: In-person Lecture and Working in the Design Lab, 8 hours

ATTENDANCE AND ABSENCE POLICY

Session Attendance for M4 Students

Students may miss no more than two days of planned excused absences on a four week rotation without being required to make-up the work, at the discretion of the clerkship/elective/course director or his/her designee.
Non-AI Rotations - Per the Student Duty Hours Policy, an average of one day (24 hours) in every seven must be free of clinical responsibilities (including seminars, clinic, rounds, lectures) averaged over a four week period. These days off are assigned by the clerkship director to best align with the site schedule. Students may request to schedule 1 or more of these 4 days for planned absences that fall under 1 of the categories listed below for excused absences during non-AI rotations, in consultation with the course/elective director, who may or may not approve such planned absences.
AI Rotations - Per the Student Duty Hours Policy, an average of one day (24 hours) in every seven must be free of clinical responsibilities (including seminars, clinic, rounds, lectures) averaged over a four week period. These days off are assigned by the course director to best align with the site schedule. Students may request to schedule 1 or 2 of these days for planned absences that fall under 1 of the categories listed below for excused absences during AI rotations, in consultation with the course director, who may or may not approve such planned absences. Students must avoid scheduling Step 2 examinations during an Acting Internship.
Excused Absences - The following will be considered excused absences:
- Diagnostic, preventative, and therapeutic health services (e.g. doctor appointments, physical therapy, counselling, etc).
- Personal illness, accident or a major catastrophic event
- Death or serious illness of immediate family members. Immediate family members, as defined by UC, are Grandparents, Brother, Sister, Brother-in law, Sister-in-law, Daughter-in-law, Son-in-law, Father, Mother, Mother-in-law, Father-in-law, Step-sister, Step-brother, Step-mother, Step-father, Spouse or domestic partner, Child, Grandchild, legal Guardian or other person who stands in place of parent (in Loco Parentis)
Whenever possible, planned absences should be requested a minimum of six weeks in advance of the start of the clerkship/elective/course in which the absence will occur; this enables the clerkship/course/elective to help plan for educational event scheduling (e.g. a known appointment could be scheduled around with enough notice and the student might not have any required coursework to make up). Absences requested less than 1 week prior to the planned absence may not be considered for a possible excused absence unless extenuating circumstances prevented the student from providing timely notification per the policy. Students should first submit their request for a planned absence to the clerkship/elective/course director using the online MSSF. All planned/excused absences for any reason should be documented on the MSSF.
The COM abides by the UC Religious Observance Policy that respects the religious diversity of its students by providing opportunities, where possible, for accommodation in cases where conflicts exist between students’ religious beliefs/practices and educational activities. In clinical settings, such accommodations must honor the primacy of a commitment to patient care and avoid unduly burdening faculty, staff and the general student population involved in the affected educational and/or patient care activity.
The following items are explained in detail in the Medical Student Handbook:
- Excused/unexcused/unplanned absence, religious holidays, jury duty, and make-up work

See Attendance and Absences Policy, Religious Observance Policy, Medical Student Handbook.