Methods
Educational Model for Medical Innovation
The Augustine program was established in 2012 through a private grant
made to the Institute for Engineering in Medicine (IEM). The purpose was
to enable Doctor of Medicine (MD) students to build bridges between
engineering, innovation, and medicine to serve the dynamic healthcare
setting. Participants are expected to be thought-leaders that understand
the entire medical device development process including regulation,
reimbursement, and funding.
The Augustine program seeks to educate medical students how to
effectively define, approach, and implement solutions to clinical
problems. The program allows up to three medical students, residents, or
fellows each year to complete a dedicated Master of Science (MS) in
Biomedical Engineering (BME) degree program with a required research
thesis over the course of ten to twelve months. Research is conducted
under the mentorship of established faculty in areas such as healthcare
informatics, medical device development, neural engineering, and other
emerging fields. In addition to engineering and elective coursework,
Augustine program participants collaborate with a multidisciplinary team
to navigate and solve a clinical problem while learning about market
research techniques, prototyping, and business development. Students
take part in the New Product Design and Business Development (NPDBD)
course with a collaborative multidisciplinary team to complete an
industry-sponsored medical technology project. The experience teaches
conceptual design, business development, intellectual property
assessment, and regulatory aspects.
One participant was tasked with designing a trans-catheter pulmonary
valve. The team mastered the required cardiac anatomy and reviewed the
unique challenges in replacing a pulmonary valve. After formulating
potential ideas, multiple prototypes were designed with common
materials. The best-performing design went through an extensive business
development evaluation including patentability, budgeting, regulation,
and manufacturing. The experience concluded with a detailed presentation
to the industry-sponsor who ultimately assumed responsibility for the
remainder of the project. The NPDBD experience becomes the core process
for methodologically approaching and solving clinical problems as
physicians. Graduates are taught to think critically about the usage and
design of technology utilized in medical practice. The program becomes a
nidus for future physicians to explore dual-careers as a
physician-scientist or engineer, providing a clinical context for the
development of medical devices. These individuals ultimately bridge the
gap between technology and medicine for the benefit of their patients.
For medical students, the joint MD/MS with the Augustine program takes
five years to complete compared to four years for the sole MD pathway.
Because a standalone MS in BME can take 1.5 to 2 years, the MS component
of the Augustine program takes advantage of the basic science medical
school courses from years one and two to satisfy biology and elective
requirements of the MS-BME degree program. Students are then responsible
for taking primarily engineering and technical courses to complete the
MS portion of the dual degree (Table 1). The program does not require
students to have an engineering degree although prerequisite coursework
in physics and mathematics must be completed. With provided funding, all
students in the program receive full tuition coverage and a one-year
stipend comparable with doctoral program candidates in engineering.
The Augustine program typically takes place between the second and third
year of medical school, often after the student has passed their first
medical licensure exam. While the timeline takes advantage of the
natural demarcation between pre-clinical and clinical education,
students can participate in the Augustine program at any point of their
medical education from medical school to residency and fellowship.
Recently, a Pediatric Cardiology fellow participated in the program.