The external catheter for female hospital patients is just one of the projects underway at applied Medical Device Institute. Courtesy aMDI
An external catheter for female hospital patients may be available in the next year, and it will have been created and developed in Grand Rapids.
Brent Nowak said the uCol is one of a handful of medical devices the new applied Medical Device Institute, where he serves as executive director, is working on with its partners.
The aMDI has been operating for just over a year but became an official unit of Grand Valley State University earlier this year. It is housed on the fifth floor of the Cook-DeVos Center for Health Sciences.
Nowak emphasized aMDI is a nonacademic unit of GVSU that operates "within and for" GVSU students, faculty and staff and provides services for industry, "thereby supporting our ecosystem and community."
He said the relationship gives GVSU faculty the opportunity to do scholarly work and GVSU students a chance to work on real-world projects for the health care industry.
“We do research and development, prototyping and development of medical devices, and we involve the students and faculty,” Nowak said.
A native of Jackson, Nowak returned to the state after spending most of his career in Texas.
He said 11 of those years were spent at the Southwest Research Institute as the assistant director of the Manufacturing Systems Department.
The Southwest Research Institute does fee-for-service research and development and has approximately 3,000 employees on a 22-acre campus. It does $500 million to $600 million worth of business per year.
“I led programs in building manufacturing systems for GM, Frito Lay and others, and we did autonomous underwater vehicles for the Navy and for NASA,” Nowak said.
Nowak has come to Grand Rapids to develop a similar fee-for-service institute and fill what he said is a missing piece in medical device development in Grand Rapids.
“We are trying to fill a niche in Grand Rapids,” he said, “the space where we can help solve problems around medical device development on early ideas.”
In its initial year, aMDI has worked with five clients and has seven projects.
“Right now, we are looking to double those amounts, and we want to hire more to support that kind of work,” Nowak said.
aMDI has three full-time staff, four graduate students and three undergraduate students working on projects.
Recruiting talent is one of Nowak’s key goals for aMDI in its first few years.
“We have a need in our community for people who cross the barrier between the medical and engineering fields,” he said.
He also expects the institute to be financially sustainable within its first five years of operation.
Using the fee-for-service model, Nowak said aMDI is able to work with partners in multiple ways. He gave two examples of current projects that each operate a little differently.
The first is the previously mentioned external catheter for female hospital patients, uCol.
The project originated through an existing partnership between GVSU and Spectrum Health Innovations.
“Urinary tract infections, or UTIs, are a major concern in hospitals across the nation, not just at Spectrum,” Nowak said.
In fact, UTIs are the most commonly acquired infection in a hospital setting and are often the result of indwelling catheters.
An external catheter had previously been developed for male patients, but nothing similar had been created for female patients who are stuck with only indwelling catheters.
“That problem leads to between $500 million and $600 million of additional health care costs across the nation, including 13,000 deaths per year,” Nowak said.
He said Spectrum Health Innovations brought the problem to GVSU’s students, who worked on developing a solution.
“Our students came up with an idea and a rough prototype,” Nowak said.
After that initial stage, Spectrum Health Innovations turned to aMDI for additional work on the device.
“We looked at technical feasibility and the business viability of that device, and we made some prototypes and did some initial testing,” Nowak said.
“This has led to interest from three different local manufacturers interested in licensing the device and bringing the product to market, plus interest from two major medical device sales and distribution agencies around the nation.
“This is a medical device we may see on the market within the next year.”
Nowak said this example illustrates how industry, academia and aMDI can collaborate on new health care devices using the fee-for-service model.
Another example is the work aMDI is doing with Surge Cardiovascular, in Grand Rapids, on an aortic arch cannula device.
“Surge Cardiovascular is an existing business. They already had their own products on the market,” Nowak said.
The company came directly to aMDI for work on the device.
“The university is not part of this, so aMDI is acting as a nonacademic unit,” Nowak said.
He explained a cannula is a tube that goes into the human body to drain fluid or as a blood bypass system.
“In this case, the cannula is a tube that goes into the aortic arch, which is an artery that goes above the heart where all the different blood vessels come out, and it delivers blood to different parts of the body. They use it for heart bypass surgery, so the body continues to get healthy blood during surgery.”
Nowak said Surge Cardiovascular wants to develop a better version that will reduced sidewall pressure and reduce turbulence.
“They want it to better mimic natural blood flow rather than it just being a garden hose,” Nowak said.
He said a couple of the reasons are so it doesn’t damage the sidewall or stir up plaque.
Surge Cardiovascular came to aMDI for computational fluid dynamics modeling, provided by GVSU professor Wael Mokhtar, who is an expert in fluid dynamics and blood flow modeling.
“He did the analysis with two grad students helping,” Nowak said.
Nowak said Surge Cardiovascular took the results back to its plant for more testing and prototyping and will bring the product back to aMDI in the spring for more work and testing.
“We are their remote R&D department, and we are helping them pursue state funding to help commercialize this product and working with injection molding companies and sterilization and packaging companies to help them turn it into a product,” Nowak said. “We are helping them through the whole development path to where they bring a product to market.
“And, when it’s done, we go away, and they don’t have the burden of overhead and staff.”
Nowak said the benefit to the wider community is Surge Cardiovascular does all of its manufacturing in Walker.
The fee-for-service model means in the end, all of the intellectual property belongs to Surge Cardiovascular.
“That is where this is different from the other example, which involves shared intellectual property,” Nowak said.
“At aMDI, if anyone comes to us, we are fee for service, so the person funding the work owns all the intellectual property, but in the GVSU/Spectrum Health Innovations case, since it came through the university and the students and faculty were involved in it, the intellectual property is shared, because of its origins.”
Dr. Brent Mulder, senior director for Spectrum Health Innovations, said aMDI fills an important niche in the medical device development process.
“A lot of these projects we work on with the university are early stage, and aMDI bridges a gap,” Mulder said. “You get the full professional skills of Brent Nowak and his team but also their willingness to work on those early stage projects.”
Mulder said he expects Spectrum Health Innovations will work on a number of early stage projects with aMDI and not only ones it’s collaborating on with GVSU.
“I don’t see a reason why we wouldn’t take any of our projects to aMDI, whether a project (is) with GVSU or an internal project,” he said. “We look at how we can get these device ideas to the next stage. Really taking it from the early stage idea to can we develop a prototype and then can we turn this into a product that can be used at Spectrum Health? So, I see us working with them closely on a number of projects.”
The institute and Spectrum Health Innovations also share a goal: to get more medical devices on the market.
“We’d like to see Grand Rapids have a lot more devices and startups that we can launch from some of these great ideas that come from our staff members,” Mulder said.
Nowak said in 10-15 years, he hopes Grand Rapids will be benefitting from a substantial increase in medical device manufacturing.