Of the structures and mechanisms Vishal Patel studied while pursuing his mechanical engineering degree, K-wires weren’t familiar.
The wires are relatively common to pediatric orthopaedic surgeons and are frequently used to help young patients heal from proximal humerus fractures, more commonly known as a broken shoulder.
For Patel, those wires would become the critical component for the challenge posed in his Medical Device Design course at the Yale School of Engineering and Applied Sciences taught by Yale Orthopaedics & Rehabilitation professors. Patel and his classmates were part of a team investigating how to improve a medical device using the wires for pediatric patients who had suffered a fracture. By default, Patel wanted to come up with something novel.
“You start these projects thinking that you want to find a new high-tech solution,” Patel said. “When you’re through, you see that sometimes simplicity is the best approach for everyone involved.”
The Medical Device Design class, taught by Assistant Professor Daniel Wiznia, MD, and Steven Tomassini, a research scientist in the Department of Orthopaedics & Rehabilitation, has grown in popularity at the Yale School of Engineering and Applied Sciences since it launched in 2012. Students attend lectures and participate in field trips to meet various stakeholders: surgeons, medical device manufacturers, and potential patients. The class isn't limited to engineering students, either. Undergraduates and graduates participate in the course, with backgrounds as diverse as art, astrophysics, and psychology.
Wiznia, a Yale SEAS alum, and Tomassini, a biomedical engineer, teach the course to expose students to what they found to be one of the most exciting parts of medicine: surgical innovation. This year’s projects included designs for integrating voice recognition with artificial intelligence in hospitals (think along the lines of an Amazon Alexa for doctors) and tools for helping patients facing urinary tract troubles. The students are provided a base of knowledge, and their creativity and training are put to the test.
They shadow doctors in clinics. They attend and observe surgeries. They use their lab’s supercomputer to simulate different prototypes and try others in the Center for Engineering, Innovation and Design. It culminates in a sales-pitch style final presentation to Wiznia, Tommasini, and everyone else who has been involved in their work.
“We teach the students how to develop medical devices by bringing together industry, physicians, and engineering expertise to solve medical and surgical problems,” Wiznia said. “We give them the tools and guidance along the way, but ultimately it’s up to them to determine the best solutions.”
The course also provides opportunities beyond the classroom. Some students are in the process of seeking patents for their designs, and the connections they make with industry professionals could lead to their actual use in operating rooms and hospitals. In recent years, students have had patents developed alongside medical device companies and some have continued their projects once the course has formally ended for the semester, Tommasini said.
“This is a hands-on experience for the students,” Tommasini said. “The devices are designed to improve surgical procedures, increase the accuracy of diagnosis, and better monitor patient health. Devices designed during the course have led to collaborations with industry and, with the assistance of the Office of Cooperative Research, have led to start-up businesses based on their patented, innovative designs.”
When we have projects like this at Yale, students have the latitude to engage in these cross-discipline confrontations that can leverage the breadth of expertise and create something to benefit a patient, but potentially benefit mankind."You're providing value at a distance. The work they complete here might not only benefit the person we have sitting in front of us, but also the patient in Paris, in Istanbul, and other places across the world.
Professor Daniel Cooperman, MD
The work spanning different industries and sectors is what intrigued Patel to the class. He didn't expect to build a bond with the physicians and find a deeper connection to his project that could have life-altering implications for some of the youngest patients, he said.
“You’re working in a situation where more is on the line than in another situation with entrepreneurship,” Patel said. “The takeaway for us was that the surgeons felt like the devices they’ve been using are a bit archaic. They believed that updating the design could improve outcomes and also help the patients.”
Patel’s team met with Pediatric Section faculty members Professor Daniel Cooperman, MD, and Assistant Professor Adrienne Socci, MD, the interim section chief, who served as mentors for the project. The team found that the faculty members appreciated the simplicity of the existing device using K-wires, small metallic pins that pass through the skin of the patient but connect to the fractured bones. The wires act as a form of suspension for the device but can be tricky to place as bones mature at varying rates in children.
The trick, in some cases, are the children themselves. The bones that are held together by the wires need to remain stable, and if the children fidget too much, they could become loose and displace, which could have implications beyond the original injury. What became of Patel's team's work, though, was innovation, Cooperman said.
Through the students' work, the project yielded a potentially new design that could be more flexible for young children and more straightforward for surgeons to use, Cooperman said. The class not only gives students an edge when they graduate but also allows surgeons to continue to innovate even with packed clinical schedules.
"When we have projects like this at Yale, students have the latitude to engage in these cross-discipline confrontations that can leverage the breadth of expertise and create something to benefit a patient, but potentially benefit mankind," Cooperman said. "You're providing value at a distance. The work they complete here might not only benefit the person we have sitting in front of us, but also the patient in Paris, in Istanbul, and other places across the world."
The problems presented to students evolve and change each semester, but the attraction to students is applying classroom skills to real-world medical problems. Another student in the class, Trevor Chan, who is majoring in architecture and mechanical engineering, said the class melded concepts learned in both degree programs.
His team worked alongside orthopaedic surgeons Assistant Professor Brad Yoo, MD, and Assistant Professor Matthew Riedel, MD, on a design for a new surgical retractor for trauma patients. He said the process included conflict – but in a positive light. The team was required to consider the needs of surgeons and companies, patients, and others involved in the process. That "conflict," Chan said, allows students to learn how to manage.
“My biggest takeaway throughout this process is how crucial it is to consider the design of a product from every possible angle,” Chan said. “We received input from a variety of people, including Yale New Haven Hospital surgical technicians, nurses, medical device manufacturers, and people familiar with the process of FDA regulatory approval. Ultimately, the device we make needs to serve its purpose in the hands of a surgeon, but for it to get there, it needs to be easily manufactured, easily sterilized, and it needs to be approved for use.”