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.