Personalized Medicine & Applied Engineering M.S. Program

An 8-week summer clinical immersion session provides students with early hands-on learning and shadowing of the current 3D innovation landscape. Students will be assigned to a clinical mentor. They will shadow their mentor in the clinics and operating rooms, observing how they incorporate personalized medicine into the treatment of patients.

This 8-week clinical immersion program starts in the summer before the academic year. This part of the program provides experience in a clinical environment and gives the student a chance to find a clinical mentor for their thesis research. Students will work with their physician mentors to identify causes of preventable medical/surgical errors, device user-related hazards and device failure hazards, with the goal of addressing these preventable complications with medical device design projects. In addition, students will participate in didactics with a structured summer curriculum focusing on needs identification, assessment and risk management. Participating faculty come from all disciplines.

This course is broken up into three models:

• Module 1: Rules and regulations. Basics of medical devices, FDA Regulation, QMS, Design controls, Clinical trials, stats, ethics, IRB, HIPPA
• Module 2: Introduction to image analysis and image processing, Medical imaging, image acquisition, Image management, PACS, DICOM, Image processing algorithm development
• Module 3: VR/AR/XR, Medical education, Simulation, Diagnostics, Procedures, CCAM, YSM simulation center

This course is designed to give students an understanding of the use of 3D technologies in medicine. This course is broken down into 3 modules:

• Module 4: 3D Printing, 3D Models, Surgical instruments, Point of care printing, Bioprinting, Quality management, printing validation
• Module 5: Surgical planning, 3D anatomic model creation, Use of CAD with 3D models, Surgical planning tools, Model validation
• Module 6: Image guided intervention, Computer navigation, Robotics, Interventional Medicine

The course is designed to provide an introduction to basic research methodology and design, which includes statistical analysis techniques. Students will demonstrate their knowledge of the course materials by analyzing, interpreting, and summarizing research writing in professional journals and by planning a research study.

Upon completion of this course, students will be able to:

1. Discuss issues related to research ethics, responsible conduct of human and animal research, and data collection, as well as recognize how to avoid plagiarism.

2. Utilize effective techniques for conducting a literature search using online databases and managing references.

3. Critique research articles and determine the quality of publications, identifying issues related to methodology and guidelines to improve scientific rigor and reproducibility.

4. Identify and apply the steps involved in the scientific method by formulating a research question, building effective scientific aims, generating a research hypothesis, and designing an experimental plan (study) to address the question.

5. Generate and store data in an effective format and then select and perform appropriate statistical calculations to analyze data.

6. Interpret visual representations of data (i.e. tables, graphs).

7. Utilize scientific principles and inductive reasoning to translate and interpret results.

8. Present aspects of the scientific method, including experimental design and results, in an accurate and professional manner.

9. Outline the processes related to manuscript reviews, writing, authorship, and journal impact factors.

10. Demonstrate a clearer understanding of possible careers and how acquired skills and interests match up to a given career path.

This course is an opportunity to work with a physician/surgeon or research scientist on the development of a personalized 3D treatment, either a medical device, 3D solution or point of care manufacturing modality. It's a yearlong 3D healthcare capstone research project within a YSM or SEAS lab focusing on developing point of care 3D printing technologies. A dedicated instructor will oversee the thesis research projects by facilitating a structured process with milestones, reports and presentations. The students will be required to present biweekly updates in a group presentation format. The instructor will facilitate these interactions with the clinician mentors.

Each student will have a clinical advisor that will provide the student with a broad clinical challenge. The advisor will most likely be established during the summer clinical session. The student will have to develop a prospectus that includes a description and background of the research problem, a research question with a well-defined purpose, and detailed summary explaining the clinical relevance, significance and impact of the research. This prospectus will be due within the first 4 weeks of the course, and will be reviewed by a panel consisting of the faculty steering committee. The student will have a choice of several clinical advisors, and will be assisted by the ENAS990 course director, through a meet and greet as well as discussions, to find the best fit.

We foresee that many students may have a combined MD / MS thesis, similar to medical students in the Masters in Health Science program. For the MS, the research would have to be within the personalized medicine discipline and be conducted during their Master's program. To receive combined credit for their MD thesis, the thesis would need to meet all of the MD thesis requirements, including that it would be overseen by a primary YSM mentor, or a YSM faculty member who is willing to sponsor the thesis in their Dept if the primary mentor is not a YSM faculty. The proposal would also need to be reviewed by the YSM OSR educational group to obtain formal approval.

(Spring semester for Masters Thesis)

A semester-long course exploring the biodesign innovation process, FDA regulation, ISO requirements, use of finite element analysis, medical device failure analysis, industry field trips, industry discussions. While learning about the regulatory framework and design principals required to develop a medical device, students will work with clinical mentors in solving a clinical problem with a novel medical device.