aMDI guides med devices to commercialization

(As seen on WZZM TV 13)A unique resource in Grand Rapids can help medical device entrepreneurs along the path from idea to commercialization.

The applied Medical Device Institute (aMDI) offers services for people with viable ideas to navigate the complicated pathway, helping with technical services, intellectual property, business review and mentoring from experienced researchers, engineers and medical professionals.

The program is a nonacademic unit of the Grand Valley State University Padnos College of Engineering and Computing, housed on the fifth floor of the Cook-DeVos Center for Health Sciences.

The only like it in Michigan, the program can help entrepreneurs from anywhere along the path, said Brent Nowak, aMDI founding executive director, and he can formulate a team for whatever the project needs.

“Our niche is we'd like to take the more challenging problems, multidisciplinary problems,” he said.

“Coming to us with these problems in the applied domain, we're well fit for answering those kinds of questions.”

As part of the university, the program can receive matching funds and grants, which lowers user fees for the expert advice, making aMDI particularly valuable, he said. The charges for services are about half to two-thirds of what others in the industry charge, he said.

The program also allows entrepreneurs who fund their projects to maintain ownership of the intellectual property, which he said is not always the case in university settings.

Nowak said aMDI answers two questions when first working with a new company: whether the idea is technically feasible, and if it could be a viable business.

These questions are answered looking at several factors, including whether the idea addresses a real unsolved problem; if there is a market for the commercialized device, including payments through insurance; regulatory issues; experience levels of the management team; and development funding.

After solving the technical issues, they address prototyping, testing and other necessities for commercialization.

Nowak said many people have ideas that are not viable, not needed or not thought out well enough. Initial research for device development can take five to seven years.

Even if there is a promising device with a strong business plan, he said regulatory challenges and costs need to be considered. Fees for a regulatory consultant can be $1,000 per hour, he said.

These are all questions that he said need to be answered before spending a dime.

If there’s not strong technical viability or risk management, he said aMDI will refer people to other startup organizations, where they can work on identifying risks and determining costs and then come back.

Nowak said aMDI has worked on about two dozen projects and redirected close to as many.

Nowak said companies he has redirected have called later to thank him for the insight of needing a strong business plan, which he said is important to keep from getting into financial trouble.

He said there is a saying in the industry: “You're an overnight success in 10 years.”

“Yes, it’s challenging,” Nowak said. “That doesn't mean don't try.”

Developers can work with aMDI throughout the whole process or just for pieces of the project, whenever help is needed along the path. Sometimes companies come in with products they want to enhance.

He said the program is meant to act as a conduit between the different arms of the health industry, often working with companies in different cycles as they bounce back and forth between other innovation organizations.

“We kind of fit in the center so we can help people develop programs in the community.”

One of its first design projects was a female catheter prototype for Spectrum Innovations that now is in clinical trials, which was one of a couple cycles the product spent with aMDI.

Nowak said aMDI has worked on projects that have had involvement from every health care provider organization in Michigan.

Another company aMDI has worked with is Encoris, helping develop the S2T Surgical Smart Trainer, a spinal surgical training device that has the potential to solve many issues, such as high exposure to radiation, and logistical and costly challenges of using cadavers.

The team also created a robotic surgery arm that can be used remotely.

Funded through a grant, aMDI is helping incubate MediSurge, a medical device company that handles design, development and manufacturing processes.

After a few years of research, Nowak launched aMDI in 2016 and started getting projects right away.

The program has a dedicated staff and provides working opportunities for faculty and students studying several fields.

One student is Noah Keefer, who is pursuing his bachelor's degree in product design and manufacturing engineering. He has learned several machining skills he hopes to one day use in the biomedical engineering field, specializing in prosthetics.

“It gives us some real-world experience,” he said. "We work with industries on actual products.”

As the medical device industry continues elevating in the area, Nowak said he has been asked by venture capital organizations to join meetings and give feedback on projects.

As the program becomes more widely known, and through its collaborative efforts with The Right Place, Nowak said he thinks more companies will continue showing interest.

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