When the undergraduate program in bioengineering was established in 2007, the Senior Design Program was a mere twinkle in the eye of Dr. John DesJardins, now Hambright Professor in the College of Engineering, Computing and Applied Science. By fall semester 2011, the program was established in its current form; to date, approximately 500 BIOE seniors have participated. Editor
As engineers, we like to make things. Cars, planes, bridges, medical devices; you name it, we can make it. To design something however, requires that we have a plan in place, and that we have identified a clear need worth solving. The goal of a needs-based design cycle is to identify unmet problems within an active system and then design innovative solutions to solve that need or problem. In bioengineering, the clinical environment is the perfect place to have students engage physicians and patients as stakeholders, work with them to identify problems and needs, and then design solutions to those needs.
For undergraduate students, engaging in clinically based needs finding can be challenging. Healthcare facilities are usually not accustomed to interacting with dozens of undergraduate students, and it is often difficult to engage sufficient numbers of clinical mentors to give students access to clinical staff and opportunities for shadowing or environment-immersion experiences. In 2011, our bioengineering program partnered with the Greenville Health System to develop a collaborative design program that allows students to directly engage with clinicians, problems, and environments and through hands-on collaboration, to solve real problems in the healthcare community.
Over the last seven years, we have developed a robust, outcomes-based, multi-semester design program that incorporates an innovative combination of clinical, educational and entrepreneurial processes to accelerate a student-led, service learning model of biomedical device design and enhance the students’ understanding of civic responsibility through biomedical design.
The Senior Design program engages a surprising diversity of stakeholders in the university and community. Each year, an estimated 300 people from the university, community, healthcare facilities, industry and government actively participate in diverse roles. The multisemester program incorporates an innovative combination of clinical, educational, and industrial processes to accelerate student-led translation of needs-based surgical devices.
The specific components of this department-wide program now include: 1) A six-week summer clinical/entrepreneurship immersion program with the Greenville Health System and university technology transfer office for 10-20 design-track focused rising juniors and seniors; 2) A two-semester senior design experience that uses clinical needs-based problem identification to match up to 25 teams of students with regional clinicians to develop biomedical-device solutions through prototyping, testing and validation; 3) A two-semester graduate curriculum to accelerate exceptional designs towards commercialization, 4) a diversity of K-12 outreach activities and events that include products from these design programs; and 5) significant community participation as mentors, advisors and participants in our end-of-year senior design symposium. In addition, between 2011 and 2015 the Clemson Department of Bioengineering had a two-semester freshmen design experience program.
During a typical two semesters of senior design, we have over 25 teams of four to five students partner with over 30 clinicians in the community. The students shadow and collaborate with clinicians during the semester (some have the opportunity to shadow for up to 6 weeks during our NIH-supported DeFINE [Design Fundamentals in Needs Finding Experience program]) to identify hundreds of opportunities for innovation. From these clinical needs, students perform needs assessments and select opportunities that have the highest potential clinical and economic impact.
The teams then follow an industry-modeled design gate process, and over the next eight months, novel products are designed, manufactured, tested and presented to peers and the community. A typical design-year might include over 20 pre-patent disclosures, ten national design competition entries, 1 patent disclosure, and hundreds of mentions on our graduating students’ resumes. Some specific examples of novel surgical devices that have been designed include A Post-arthroscopic Arterial Wound Closure Device, A Breast Nipple Reconstruction Patch, A Laparoscopic Extraction of Tumor Masses, A Sternal Chest Cutting Guide, A Chest Tube Port Stabilization Device, and An Abdominal Fascia Closure Device.
In addition to the students, faculty and graduate student mentors have been recruited and engaged for each design team and project. In recent years, one to two bioengineering faculty and two to three graduate students have been recruited for each team. For 2016-2017, we had 15 faculty and 24 graduate students; each is assigned to mentor two teams.
We have had over 150 teams and technologies developed over the last seven years. Each of these design projects is not something that students or faculty thought might be fun to make; rather, each represents the potential solution to a critical clinical problem or need for which our students spend thousands of dollars and two semesters to develop a novel device. Products by MUSC startups have been approved by the FDA and acquired by publicly traded corporations and have attracted substantial investment dollars to South Carolina.
