Baxter International, a Fortune 500 American health care company, recently signed a licensing agreement with the University of Michigan to acquire rights for a new surgical device that was developed by a small five-person classroom of Engineering 490/Design and Manufacturing 450 students.
In a statement, Michael Campbell, vice president of Baxter's microsurgery business, said Baxter International is looking forward to utilizing the new device.
"We are excited to work with the experts at the University of Michigan and license this promising new technology that could lead to a meaningful impact for microsurgeons," he said.
This surgical device, mirroring that of a small silicone pen with an easily adjustable steel spine, would make the complicated and tedious process of connecting arteries more efficient by reducing a 25-minute procedure to only six minutes. Called the arterial everter, it could be applied to a multitude of procedures including breast mastectomies or severely injured limbs suffered from car wrecks.
This medical success greatly impacts the field of reconstructive surgery and health care.
The arterial everter works in addition to existing equipment known as the GEM microvascular anastomotic coupler system, made by Synovis Micro Companies Alliance Inc., a supplementary company owned by Baxter.
The GEM coupler is an appliance that works adeptly with veins; however, when attempting to sew small millimeter-sized arteries with extremely dense walls, it can make tissue transfers incredibly difficult. The arterial everter disperses the compact walls over the coupler, effectively connecting the wide arteries.
Paul Cederna, a professor and chief of plastic surgery at the University Medical School, and Albert Shih, a professor of biomedical and mechanical engineering, were co-teaching a senior-level engineering design course when they realized the coupler deficit challenged their students to devise a solution.
“The students struggled but then they excelled at end and created a great design," Shih said. "Is this significant? Yes. You dream about your innovation being used by someone so it can enact change. Eventually it will happen, it hasn’t happened yet, but it is in the right pathway to reach an impact on health care.”
Jeff Plott, a mechanical engineering research fellow and doctoral student in Shih’s lab, serves as the product development mentor on the project. Plott revealed the trials of the developmental process.
“We started our design process with a ton of brainstorming by conjuring up many different ideas, and then started narrowing that down with a combination of what we think works versus what is feasible to make versus how is it going to get through the regulatory landscape? We then starting thinking more of it; it can be something that is commercially viable,” Plott said. “You’re kind of balancing all of those things. By the end of the semester, the students had prototyped a device that was a first proof of concept. It showed that it was possible to flip an artery over the pin and that is where we left off.”
Plott then paired with other surgeons at the University to further evolve the concept and transform it into a product that could be monetized.
“That device made by the students was far away from being something that was usable by surgeons in the future and also something that was manufacturable and economically viable,” he said. “So, after that semester, I led the development of transforming the device into something that could meet all of these requirements."
In order to make the transition from idea to marketed technology, the Coulter Translational Research Partnership Program, a sector of the Department of Biomedical Engineering, provided funding for product design and testing. It also gave expert advice to fully develop the technology and place it into the hands of the health care business.
Baxter then signed the licensing agreement with the University for the arterial everter to be accessible worldwide. However, Baxter will first need to file for Food and Drug Administration approval and other licenses.
After working tirelessly with students, surgeons and engineers, Plott rejoices over the success of the technology.
“This licensing agreement is a great validation of our idea. Our end goal, of course, is always to make a difference. This partnership will greatly accelerate that path and will enable us to get us there as quickly as possible,” he said.