Students Translate Healthcare Challenges into Market-Ready Tools in Nine-Month Graduate Program

Medical device innovation takes more than bringing a good idea to life as a prototype. Students in the nine-month Master of Engineering in Medical Device Design, or MDD, program at the University of California, Davis, know this. 

Through a capstone design project, students work alongside clinicians, engineers and business mentors to translate healthcare challenges into market-ready technologies, gaining experience in the clinical, regulatory and business aspects that underpin successful medical device development.

“Working through the medical device lifecycle on a micro scale exposes students to the phases of development they will encounter in their careers, whether they decide to pursue employment with a startup, at an established device company or as medtech entrepreneurs,” said Kathleen Gallo, the lecturer who leads the capstone series.

Learning from Clinical Mentors

At the beginning of the master’s degree, each student selects a clinical mentor to work alongside and shadow. UC Davis Health is blocks away from the students’ classrooms at Aggie Square in Sacramento, allowing for special access to hands-on learning experiences, a hallmark of the program’s interdisciplinary, translational approach to medical device development.

Students observe their mentors as they care for their patients, both in the operating room and in the clinic, making notes on where processes or procedures can be improved. For Mateo Madrigal, he learned from mentor Dr. Rodney Diaz about otolaryngology, a medical field in which he had no prior knowledge.

“I was just sitting there in the clinic watching, and I thought to myself, ‘I don’t know what he’s doing,’” Madrigal said.

This curiosity led him to a conversation with Dr. Diaz, who described that he was applying gentian violet, an antibiotic used to treat stubborn infections, to the patient’s ear. This led to a deeper discussion between them about the challenges of resolving persistent ear infections, especially when patients struggle to keep up with treatment at home.  

From this conversation, Madrigal developed a needs statement for a small wearable device that can automatically deliver medication for ear infections, which Dr. Diaz and his care team helped refine into a clinically viable concept. Madrigal brought this concept to his design team, who decided to pursue the idea for their capstone project.

For teammate Adam Shishani, who also knew nothing of otolaryngology prior to their project, this was an eye-opening experience and one of his key takeaways from the program. 

“You think, ‘We know nothing about [what they do, so] how can we possibly identify problems that they haven't already identified?’ It turns out, you don't have to be a specialist to contribute [meaningful innovations].”

Technical Guidance from Engineering Experts

Following their work with clinical mentors, another capstone design team of MDD students realized there was a need for a tool that helps doctors plan aneurysm treatments with greater precision and speed.

An aneurysm is when a blood vessel in the brain becomes stretched and balloons with blood. To prevent the vessel from rupturing, doctors implant a mesh diverter to redirect blood flow and allow the blood vessel to heal and return to its normal shape. This requires the doctors to take several medical images of a patient’s brain before surgery to identify the best location to place the diverter.

The team, comprised of Zhongyu “Max” Gao, Owen Bosley and Dominic Apuan, realized a tool that could create a 3D model of a patient’s brain to simulate blood flow before surgery could shorten procedure times and decrease the amount of medical imaging required, lowering radiation risk to the patient. 

However, none of the team members had much experience with building software capable of simulating blood flow. They turned to their engineering mentor, Assistant Professor of Teaching in Biomedical Engineering Xianglong Wang, an expert in flow dynamics simulation.

Gao said Wang helped the team understand how medical simulation is developed and used in real clinical settings. Wang also encouraged them to look at established and medically validated platforms rather than developing an entirely new system from scratch.

Crafting a Sound Business Plan with Regulations in Mind

In addition to clinical insight and engineering support, students receive guidance on how to market and pitch their device to investors, as well as how to design their device to ensure it meets federal regulations.

To navigate the complexities of business plans and federal regulations, the capstone design teams are assigned a business mentor.

“[Our business mentor] was really helpful in teaching us about FDA regulations, as well as reimbursement, intellectual property laws, and all that other stuff,” Apuan said. “There was always a guiding hand for us. It never felt like we were lost.”

The business mentorship helped Arthur McKenzie, one of the student engineers behind the wearable device for ear infections, realize that effective medical device design integrates an entrepreneurial mindset from the very beginning.

“You need to almost know everything before you make the device choices,” McKenzie said. “Input from stakeholders, how to market the device and who our customer base is.”

For Madrigal, this lesson boils down to thinking about more than the working prototype.

“This program really helps you maximize your efficiency, and to really think about the product development [as an interdisciplinary effort], rather than just trying to get a working prototype,” he explained

Designing Insights for a Successful Career

At the end of the MDD program, teams presented their capstone designs and business plans during an event open to the public. The event was both a celebration of what they’ve accomplished and a chance to put what they’ve learned over the nine-month program to the test, with medtech investors in attendance.

Dominic Apuan is confident that he will be able to succeed in any position following the MDD program. 

“I feel like everything was well-crafted to allow us, if we wanted to, to explore product management and business development, which are important parts of the medical device process,” Apuan said. “If you join a company right out of school, you're inserted into just one step of the way. But for us, being able to see the design, from start to finish, is really valuable.”

Apuan’s classmate, Martin Croshaw, agreed, saying the program’s approach to biomedical engineering was exactly what he wanted after his undergraduate degree.

“In undergrad, engineering design was very much directed at, ‘Let’s just see what we can create,’” he said. “For this program, it’s asking how your innovation could benefit healthcare systems across the country or even around the world.”

While some students have secured industry jobs before graduation, others are considering turning their capstone designs into a business startup. 

“If we do commit to starting a startup, it will be a continuation of this program,” said Shishani, whose team developed the wearable device for ear infections. “If it fails or if it succeeds, it doesn't matter; we will learn a lot, and that knowledge can be taken anywhere.”