Roadmap to Early-Stage Medical Device Design through Experiential Learning and Role-Play

Oct 15, 2026

Uploaded by OmBimo

Purpose: Biomedical engineers need the ability to understand and retain basic anatomy and physiology, apply fundamental engineering principles, think critically, and communicate across disciplines to enable successful medical device development and clinical translation. Methods: An undergraduate medical device design course uses a holistic inventors, investors, and surgeons (IIS) perspective with interactive presentations, guest lectures, labs, field trips, and role-playing in a 15-week curriculum aligned to ABET objectives. Results: Reported A&P learning improved 204%, role-playing was rated highly, and course evaluations were favorable.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages26

Reading Time1 h 6 min

AccessFree to download

Abstract

Purpose

Methods

Results

Conclusions

Introduction

Role of the Biomedical Engineer

Medical Device Design Course Considerations

Roadmap to Early-Stage Medical Device Design through Experiential Learning and Role-Play Steven C . Koenig, University of Louisville, United States Gretel Monreal, University of Louisville, United States Abstract Purpose: Biomedical engineers that have the ability and skill sets to comprehend and retain basic anatomy and physiology (A&P) knowledge, apply fundamental engineering principles, use critical thinking, and communicate effectively across multiple disciplines to facilitate successful development and clinical translation of medical devices. The authors created an undergraduate medical device design course that follows a roadmap for developing novel devices and/or innovative technology from concept to clinical product with the course focusing on the earlystage of the development process. Methods: A holistic approach is taught from the unique perspective of inventors, investors, and surgeons (IIS) by integrating interactive presentations, guest lectures, labs, field trips, and roleplaying activities into a 15-week curriculum and meets ABET student learning objectives. Individual assignments require oral presentations and written reports that mimic project leaders on design teams, and group assignments are completed through IIS role-playing. These activities culminate with individual student design projects that help build self-confidence in their ability to successfully jump into and navigate the medical device development process. This is accomplished by identifying a clinical need, formulating an innovative concept, defining design criteria, fabricating a prototype to demonstrate proof-of-concept, bench testing to demonstrate feasibility, completing an invention disclosure, making an elevator pitch with constructive classroom critique, and writing an executive summary and detailed report emulating a NIH SBIR Phase I grant. Results: Course effectiveness was demonstrated by: (1) 204% improvement in A&P knowledge,(2) positive role-playing evaluations (98 .7% of students reporting that it was a useful educational experience, written feedback), and (3) favorable course evaluations. Conclusions: A roadmap for early-stage development of medical devices using a holistic, experiential learning approach is presented to prepare undergraduate bioengineering students for future healthcare careers as engineers, scientists, clinicians, and/or entrepreneurs. Keywords biomedical engineering, experiential learning, undergraduate, device, design Introduction Role of the Biomedical Engineer The history of engineering education in the United States dates back to the separation from England during the American Revolution, when Congressman John Adams recognized the need for a school of engineering to support military efforts, manufacturing, and civil infrastructure (Grayson, 1980, Hazarika et al., 2019), the latter of which was being accomplished either by Americans with no formal training or foreign-educated engineers (Mann, 19; Reynolds, 1992; Lee, 1963) . Adams wrote a letter to General William Heath in 1776 that read in part: Engineers are very scarce, rare and dear. We want many, and Seem to have none. I think it high Time We should have an Academy for their Education. (Klosky & Klosky, 2013; Smith 1976). General George Washington himself was a talented surveyor but similarly with no formal engineering training and recognized this need, thus leading Congress to establishing the Military Academy at West Point in 1802, where the cadets would provide military support while also assisting with public works (Grayson, 1980) . The Academy’s educational structure was modelled after the French Ecole Polytechnique’s curriculum which emphasized civil engineering and design through didactic instruction (Grayson, 1980, Reynolds, 1992) . Advances in transportation, communication, agriculture, and civil infrastructure facilitated westward expansion and, as machinery increased in complexity, led to engineers specializing in a

FAQs

What problem the course is designed to address?

It targets biomedical engineers’ need to retain A&P knowledge, apply engineering fundamentals, think critically, and communicate effectively across disciplines to support medical device development and clinical translation.

What teaching methods are used in the 15-week curriculum?

The course integrates interactive presentations, guest lectures, labs, field trips, and role-playing activities, taught from an inventors, investors, and surgeons (IIS) perspective and aligned to ABET learning objectives.

How is student learning assessed in the reported results?

Effectiveness is demonstrated through a 204% improvement in A&P knowledge, positive role-playing evaluations (98.7% of students reporting it was useful), and favorable course evaluations.

Oct 15, 2026

Uploaded by OmBimo