(F-239) Development of a Student-Led Biodesign Training Program for Medical Students and Engineering Undergraduates

Introduction: Health technology and medical device innovation is a dynamic, rapidly growing field that requires collaborative participation by individuals from multidisciplinary educational backgrounds, including bioengineering, medicine, and healthcare. However, owing to the already rigorous demands of clinical training, medical students have limited formal opportunities to develop skills in design thinking and innovation methodologies. Conversely, while engineering undergraduates build technical competencies through hands-on laboratory coursework and capstone design projects, they may benefit from greater access to clinical immersion opportunities and exposure to translational applications. To address these unmet educational needs, we developed an extracurricular biodesign training program that integrates MD candidates at Baylor College of Medicine (BCM) and engineering undergraduates at Rice University into interdisciplinary project teams that seek to identify real-world clinical problems and propose practical solutions substantiated by a viable business case. The teams’ efforts are guided by lectures from volunteer domain experts in opportunity definition, solution landscaping, concept development, prototyping, market analysis and intellectual property strategy, among other areas of expertise. Notably, our program – which is currently in its first year of implementation with a pilot cohort of 19 students – has been entirely student led, from its conception to lecture curriculum planning and project management. Our objective is that this initiative will prepare medical and engineering students to enter the biomedical innovation space and serve as a launching pad for the future careers of aspiring physician-entrepreneurs and health technologists.

Materials and Methods: Our program is structured into three phases (“blocks”) that model the Stanford Biodesign Process [1], which we have adapted to fit into a 9-month extracurricular commitment aligned with a typical academic year. This approach builds on the successes of Bluegrass Biodesign, a similar initiative recently developed at the University of Louisville [2]. Block 1 focuses on needs finding and screening via clinical immersion and stakeholder analysis. Block 2 is centered on concept generation, evaluating prior art, and market analysis. Block 3 involves low- to high-fidelity prototyping, testing, and intellectual property & regulatory strategy. Each block culminates in a deliverable presentation to a panel of advisors affiliated with the Interdisciplinary Surgical Technology and Innovation Center (INSTINCT) at Baylor College of Medicine.

Teams are composed of four to five medical students and two engineering undergraduates. Participants are expected to contribute between one to three hours to their projects each week. Each team is paired with a clinical faculty mentor who can serve as a key opinion leader during project discussions and facilitate access to immersion and interview opportunities. Throughout each block, teams also receive didactic instruction via a series of monthly lectures delivered by healthcare innovators working in academia and industry. In this way, our program leverages the full scope of opportunities available to trainees within the network of Texas Medical Center institutions and partners beyond.

Results, Conclusions, and Discussions: Our program is currently in its first year of implementation with a pilot cohort of 19 students. This group is subdivided into 13 MD candidates at BCM and six Rice University undergraduates. Participants bring a diverse set of educational backgrounds spanning multiple engineering fields, biology, chemistry, business administration, global health, and visual arts. Additionally, multiple participants have professional experience in academic research, applied product development in industry, and healthcare consulting. This fosters an environment that lends well to peer mentorship between individuals with synergistic, complementary skill sets.

For this pilot, participants were assigned to three teams based on their academic year, clinical interests, and educational background. Each team was aligned with a physician mentor in the field of cardiothoracic surgery, orthopedic surgery, or ophthalmology. Together, the teams identified a total of 156 unmet clinical needs through observations and interviews during Block 1. These needs were systematically clustered, filtered, and refined into 12 unique needs statements representing potential project opportunities. Each team ultimately selected a single need to pursue during Blocks 2 and 3 based on personal interest, estimated total addressable market, and perceived project feasibility given programmatic constraints and participants’ expertise.

The effectiveness of our approach towards biodesign training was assessed halfway through Block 2 by qualitatively surveying participants about their expectations and program outcomes thus far. Three key themes emerged from the responses. Particularly for the medical trainees, our program seems to have influenced participants’ career aspirations, with one student stating that “biodesign has helped me see how doctors have the skills to become innovators beyond clinicians”. Others emphasized community development, saying that the “most valuable part of the program is having a diverse, interdisciplinary group of motivated individuals to bounce ideas off of.” Finally, nearly all students commented on the value of the didactic curriculum being delivered by industry experts and that “this framework for innovation is not something we usually learn in school.”

Taken together, these promising results highlight the need and desire for earlier exposure to biodesign methodologies and the efficacy of our student-led, extracurricular approach towards this training at the undergraduate and medical school levels.

References:
[1] Yock P, Zenios S, Makower J, Brinton T, Kumar U, Watkins J, Denend L, Krummel T, and Kurihara C. Biodesign: The Process of Innovating Medical Technologies. 2nd ed. Cambridge: Cambridge University Press; 2015.

[2] Bluegrass Biodesign – Center for Health Process Innovation. University of Louisville. https://louisville.edu/medicine/healthprocessinnovation/opportunities/bluegrass-biodesign. Accessed 24 Jul 2023.