PCE News
aMDI: Crossing the Development Valley of Death
April 11, 2022
MedHealth interviewed Dr. Brent Nowak, executive director of the GVSU applied Medical Device Institute regarding it's unique offerings for the medical technology industry. Text from the original MedHealth article is below.
Having the resources, space, and technical expertise available to bring innovative products to market is no easy feat. Early-stage business owners often find themselves in a complex web of what they know and don’t know about the business and production world, and when it comes time to put everything together, there’s an endless stream of vendors, regulations, and other barriers that can complicate the process, sometimes stopping would-be lifesaving devices from reaching their full potential.
The applied Medical Device Institute (aMDI), part of the Padnos College of Engineering and Computing at Grand Valley State University (GVSU), is dedicated to enhancing student learning experiences, engaging faculty and the community to bring novel medical devices and innovative technology to market. We interviewed Dr. Brent Nowak, aMDI’s executive director, to see just what this unique “unicorn” business has to offer the medtech industry and early-stage entrepreneurs.
Questions & Answers
So really—what’s with the lowercase “applied?”
Whenever you talk to anybody in the industry and there’s a university, they think “you want us to hire your students” or “you want to co-op”—but we’re very applied. [GVSU is] not a tier-one research academic university engaged in basic research, such as trying to find out what dark matter is—we’re more applied, developmental, with a focus on commercializing. This is the bottom line.
Tell us about aMDI—what was the motivation to create this resource?
aMDI—applied Medical Device Institute—is part of Grand Valley State University in the Padnos College of Engineering and Computing. We provide engineering services for students and faculty, but also the industry and community as a whole. We’re supporting the educational mission [of GVSU] as a liberal arts academic institution and provide students an opportunity to work in real-world experiences. As an engineering intern, they could be working on their master’s thesis or other academic pursuits, but they’re a regular employee. For faculty, the benefit is that they also get to pursue real-world problems, but they can bring those results back into the classroom, making their curriculum more relevant. So, from the academic side, everybody benefits—our community, partners, and industry get some very high-powered intellectual talent. Clients don’t have to have their own R&D (research and development) department and they don’t have to hire three or four different engineering firms trying to bring it all together. We can create these very unique multidisciplinary teams. That’s our niche—solving difficult multidisciplinary, early-stage kinds of problems—because we can offer the state-of-the-art equipment and resources and talent at a very strong capital efficiency.
How did you hear about MedHealth? Can you tell us about the partnerships that you’ve formed as a result of matchmaking?
I was on a MedHealth Summit panel, and aMDI has participated in two [matchmaking events]—one before COVID and one during—and from each one I must have a list of 20+ people that I’ve met, ranging anywhere from faculty members to investors to other organization service providers like aMDI. These conversations have led to dozens of opportunities for aMDI to serve healthcare innovators, and we have substantially grown our footprint in the Midwest due to our relationship with MedHealth.
But one of the things that aMDI does very well is redirect these individuals or companies to other people across the state, and then we’ll make the introductions. Afterwards, you follow up and say, “Hey, did you make contact? Have you made any progress? If you need anything else, I’m always available.” I think that this is what the mission is—we don’t let go of people that we make contact with, whether they’re from Canada or the U.S. We handhold down through the whole process.
What types of companies do you typically work with?
Companies come to us in all different stages of development. We’ve had over 50 projects so far in our six years of existence and they vary everywhere from individual entrepreneurs that may have been faculty or students to somebody out in the community. That’s very important—we’ve had clients like a hairdresser that had encountered a medical procedure or condition that caused excessive saliva and she discovered this is a huge problem in intensive care units or in nursing homes and then started developing a medical device. We get some very interesting problems from faculty, students, stay-at-home persons that are not seasoned entrepreneurs or medical device people. But then again, we have very experienced companies that come to us that want to introduce a new product or transition into the medical device industry, or companies that have bought other companies that need assistance meeting some FDA requirements. It’s a wide range of companies and a wide range of problems.
Do you have any other examples of how you’ve supported medical device innovators?
We also work with people from the medical health professions. We completed this project with Spectrum’s Meijer Heart Center and Corindus Cardiovascular, Inc. (recently acquired by Siemens). We worked with Dr. Ryan Madder, who has a mission in life to get his surgical teams out of the radiation fields created by machines during cardiovascular procedures. Using Corindus’ robot, Dr. Madder asked, “Could you do this remotely? I want to do this surgery while the patient is in Ludington in a snowstorm and I’m in Grand Rapids.” We needed to find a way to use commodity internet—the same internet we use to binge watch Netflix and stream the Olympics—to perform the robotic procedure remotely. Ultimately, aMDI’s small role was to break the Internet in a controlled fashion to make sure the process would work. Dr. Madder was able to complete 20+ procedures from Ludington in preclinical trials here in Grand Rapids. The idea is that you can get world-class experts like Dr. Madder to save anybody around the world now.
What is aMDI going to be doing in the next few months?
Our organization is all about helping everyone grow. As aMDI grows, we’re going to be posting three to four positions, advertising broadly and letting people know we’re here. Grand Rapids provides a huge opportunity for a lot of people who live on the East or West Coast who are tired of paying large rents. Young families that want to have a different lifestyle. I think there’s really an opportunity for us to grow and bring in some very high-powered talent into West Michigan and the whole state.
We’re also working on what we’re going to be doing in the next six to nine months. We’re pursuing some large federal grants to grow our capacity—right now we have a state-of-the-art 3D additive manufacturing system in polymers, and our system is the only one that’s dedicated to medical device development. We’re now going into 3D with metals, so that lends itself to the dental field as well as aerospace and other industries. While aMDI is focused on medical devices, we’re supporting other industries just based on our capacity and capability.
There’s been a lot of construction here in Grand Rapids and GVSU, and we finished the new P. Douglas Kindschi Hall of Science building on Allendale campus and are just finishing a third new building in downtown Grand Rapids as part of the health campus. It’s opened up a lot of wet lab space. In addition, we have a new innovation design center that the engineering school has acquired, so we can do a lot of the industrial commercial space that we’re using for commercializing and helping startups to grow their companies as well. We’re creating office spaces and basically incubation spaces even though we’re not a formal incubator. People should reach out to Linda Chamberlain, director of the Technology Commercialization Office, if they’re interested in these spaces.
What else do you want people to know that we haven’t covered about aMDI?
We’re not your traditional siloed university office—even though aMDI is part of an academic institution, we move at the pace of industry. What differentiates us from other university kinds of programs is our intellectual property policy—anything that innovators pay for, they own. Inventors are named on patents, and our intellectual property policies are very liberal. It makes us very attractive to companies that are very sensitive about trade secrets. We treat every client in complete confidentiality and students and faculty like any other industrial commercial partner. We’re not trying to compete with them—we’re trying to help them solve a problem and connect them with contract manufacturing, packaging, sterilization services, regulatory people, etc. We’re a one-stop service—we don’t provide them all, but we are your partner to help steward you along that whole commercialization pathway.
What’s one piece of advice that you’d give an early-stage medical device company?
Go into it with the expectation that there is a great deal to learn. Everything will shock you, from cost trade-offs between 3D Additive and other traditional manufacturing processes. Get several quotes on anything, get two experts in each field and not all from the same town or neighborhood.
Visit the applied Medical Device Institute website.