Bentley Students Test Innovative Medical Device for FDA Clearance
Key Points:
- Bentley’s User Experience Center, among a few independent U.S. consultants offering FDA validation testing, conducted an innovative medical device study for FDA clearance.
- Graduate students worked alongside surgeons and technicians to assess device safety and user experiences during 80 simulated surgeries.
- Students assisted with protocols and data collection, complying with FDA requirements.
In a science lab on the first floor of Jennison Hall, Andrew Hahn, MSHFID ’25 places sterilized medical instruments on a surgical table. Ying Lung Kwan, MSHFID ’25 prepares animal tissue for a camera-assisted surgery.
But the students are not doctors, and the surgery is actually a controlled simulation.
Kwan and Hahn are part of a larger team of consultants from Bentley’s User Experience Center (UXC). Along with Danielle Gibalerio MSHFID ’26 and Raj Tanishq MSHFID ’25, they are helping to validate a medical device for use in the United States. The results of the study will go to the Food and Drug Administration (FDA) as the maker of the device seeks federal approval. On this day, they are preparing test protocols for professional surgeons, scrub nurses and technicians who will perform simulated surgeries to evaluate the performance of the device.
“Our team is conducting one of the most physically and logistically challenging FDA validation medical device studies the User Experience Center has ever tackled,” says UXC Director Chris Hass, who notes that the consultants include students in Bentley’s Master of Science in Human Factors in Information Design (MSHFID) graduate program. “Medical device development is often years in the making. The FDA medical device testing we do here in the center is one of the final steps before a product can receive clearance and be brought to market in the U.S.”
Operating at the Intersection of Business and Health Care
Bentley’s User Experience Center is among only a few commercially available independent consultants for FDA validation testing in the U.S. The company testing its medical device is one of several clients that the center works with each year.
As a full-service user experience (UX) research agency, the User Experience Center improves products and services by researching user needs, behaviors and experiences and contributing to their design. Part of Bentley’s world-class master’s and PhD Human Factors in Information Design program, the center provides end-to-end UX solutions including customized qualitative and quantitative UX and accessibility research (lab, field and remote), and strategic consulting, training and executive education.
Services, provided for commercial companies and government agencies in the U.S. and abroad, include:
- Usability testing
- Research
- Prototyping
- Benchmarking
- Design thinking
The center operates several state-of-the-art labs onsite at Bentley for conducting medical device testing. Among the tools: eye-tracking software and biometric analysis to measure user engagement and emotional response.
“On a given day, we could be conducting research, doing screen design, evaluating websites and software, and doing building walkthroughs to see how people use a certain space,” Hass says. “Particularly when it comes to medical or health care clients, we’re doing complex work in highly regulated spaces where ultimately lives are on the line.”
Developing a Precise Procedure
For this client, which has requested anonymity since testing isn’t finalized, the team performed a series of critical tasks with the device to evaluate the design performance in simulated surgical settings. The center also conducts research and evaluations that identify specific sets of design recommendations to improve safety and overall user experiences prior to final development or production.
“Our work has to be done with a high level of rigor to comply with FDA requirements,” Hass explains. “The process needs to be completely transparent so we can detail exactly what we’ve done, what we’ve learned and the import of the outcomes to ensure an objective source of truth for the FDA.”
The project consisted of approximately 80 simulated surgeries performed over the span of a month. Science labs on campus were adapted for testing given the complexity of the project and the use of biological material.
Senior UX Consultant Lena Dmitrieva, MSHFID ’02 managed the graduate student team with Hass.
“We trained students on everything from writing protocols for collecting and recording data to preparing medical instruments and organs used for the simulated surgeries,” Dmitrieva says. “After developing a streamlined process, students took center stage, moderating sessions with the outside medical team, operating technical equipment such as synchronized multi-camera setups, and observing and taking notes in accordance with strict FDA guidelines. Students interacted with the client throughout the project.”
Evaluating the surgical device being tested went beyond understanding how the product is supposed to work. Students needed to know about each micro-step within the surgery.
“If you think about the field of human factors in information design, it’s about how well a product is performing,” Dmitrieva says. “How intuitive it is, how usable it is. Students had to record exactly how the medical tool was held by the surgeon, for example, and how it was used in unison with the other instruments throughout the simulated surgeries.”
Hahn was among those who evaluated the surgical team’s use of the tool and analyzed data for the final FDA report.
“I’ve worked on a lot of digital products and interfaces, but it was interesting to be able to work on something physical,” says Hahn, who was at a digital experience agency before joining Bentley’s User Experience Center. “Having to know exactly how the tool functions and is intended to be used was much more hands-on and unlike any experience I’ve had.”
Kwan, who previously worked at the center and returned as a consultant for this project, agrees. “The medical device testing process was eye-opening. There’s more to user experience research than sitting on a computer and creating screens or an application. I cannot put a value on the physical experience of setting up surgical tools, understanding how each one works and being present during the simulated surgeries.”
Experiential Learning: Sharpening Skills, Shaping Futures
Hahn says the hands-on technical experience at the User Experience Center is strengthened by a strategic business lens.
“For me, the big draw to the Bentley graduate program is that I can focus more on business outcomes,” Hahn says. “In addition to understanding how I can be beneficial to the end user, I understand how I can help sell or market a product. That’s something I didn’t find at any other university I was looking at. I wouldn’t have gotten the physical products or even the research end of it if I didn’t come to Bentley.”
Hass adds that this kind of experiential learning is unique for many students: “As commercial consultants, Bentley students working at the User Experience Center can try out the techniques they’re learning in the classroom and perfect their craft alongside a truly important and complicated project. It takes a lot of expertise — and there’s a lot of pressure — but when they go out into the field and the job market, they’re that much more experienced and hirable.”