ENGG 325: Introduction to Surgical Innovation


19F: Arrange
Paulsen, Mirza

No Textbook Required

20W: Arrange
Paulsen, Mirza

20S: Arrange
Paulsen, Mirza

20F: Arrange

21W: Arrange

21S: Arrange

  • Permission of Instructor Required
  • 3-term course
  • This course replaces ENGG 296.

Introduction to Surgical Innovation will engage students in an immersive experience, a cornerstone technique for innovative thinking and creative design. It comprises of three 10-week terms over one academic year (fall/general surgery, winter/surgical elective, and spring/surgical research). Student effort is approximately 20 hours per week (15 hours of activity and 5 hours to prepare assignments, read, think, and write). This unique course provides experiential learning on the life cycle of surgical devices, including:

  1. defining a clinical need;
  2. consideration of surgical risks and benefits from a patients point of view;
  3. steps in the surgical procedure that could benefit from innovation to improve patient outcomes or make the procedure easier to perform;
  4. managing surgical implants and instruments from a surgical scrub technologist's point of view;
  5. steps in surgical device procurement, processing, packaging, sterilization, and inventory management;
  6. post-surgical patient care and device performance surveillance. 

The course begins in the fall term with a general surgery rotation. Engineering doctoral TPSI (Training Program in Surgical Innovation) students work alongside 3rd year medical students and surgical residents.  Each morning they attend the daily conference (e.g., indications, morbidity & mortality, journal club, tumor board, or grand rounds, 3-5h/wk). TPSI students participate in the weekly medical student case discussion (2h) and also the weekly surgical resident simulation bioskills workshop (2h). Each student is assigned a surgeon proctor to help them navigate the clinical environment and understand context. Each week the student observes at least one outpatient clinic patient encounter (1-2h) and one surgical procedure (3-5h) with the proctor or another surgeon colleague arranged through the proctor. The outpatient clinic encounters focus on pre-operative patients to observe surgical consent discussions and post-operative patients to highlight surgical outcomes ascertainment and adverse event surveillance. On the day of surgery, the student arrives early to meet the surgical scrub technologist and help prepare for the surgery. The student then meets the patient preoperatively with the proctor and observes the surgical procedure from start to finish. The student follows the surgical scrub tech post-operatively to see instrument processing through central supply processing, sterilization and inventory management.  Each week the student produces a 1-page write-up identifying opportunities for innovation to improve patient outcomes or easy of performance for the observed surgical procedure. The write-ups are evaluated and scored by Drs. Paulsen and Mirza. The winter term has a similar schedule with a different proctor (and set of surgeon colleagues) from a surgical subspecialty of the student's choice, such as minimally invasive general surgery, oncologic surgery, otolaryngology, anesthesiology, neurosurgery or orthopedic surgery. The spring term is a research rotation in which students select a clinical mentor and an engineering mentor to guide development of a research proposal.  The rotation focuses on medical research methods, including design of clinical trials, evaluation of benefits and harms, and standards for surgical materials/device performance and implant bioeffects. The rotation emphasizes clinical trial design and data analysis from a regulatory perspective. Activities include engaging clinicians, engineers, other scientists, and the medical device industry to understand relevant FDA regulations and legislation, roles and responsibilities of federal advisory committees, types of applications (PMA/IDE/510k), review and consult processes, and role of device companies. Participants learn about the steps required to develop, protect, and finance an idea as a “laboratory” exercise and work to implement a specific idea (project), culminating in the development of a draft IP position and business plan. The focus of the training experience is on innovation and creation of new technology-driven start-up companies (not on business management). The final written assignment for the Surgical Innovation Course is a 6-page research proposal for development and validation of a novel surgical technology, similar in format to an NIH Small Business Innovation Research (SBIR) grant. The student also attends at least one hospital surgical implant purchasing committee meeting during the term and writes a one-page report on the device procurement decision-making process. Both the purchasing process write-up and research proposal are evaluated and scored by the student's mentors and also by Drs. Paulsen and Mirza.