Description
Analysis of transmission structures and circuit elements at microwave frequencies.
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; (4) steps in the surgical procedure that could
benefit from innovation to improve patient outcomes or make the procedure easier to
perform; (5) managing surgical implants and instruments from a surgical scrub technologist’s
point of view; (6) steps in surgical device procurement, processing, packaging,
sterilization, and inventory management; (7) post-surgical patient care
and device performance surveillance.
The course begins in the fall term with a general surgery rotation. Engineering
doctoral TSI (Training 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). TSI 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
graduate courses 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.
Prerequisites
Permission of Instructor Required
Notes
Three-term course. This course replaces ENGG 296.
