Published in Health Care
Brent Nowak, top, serves as executive director of the Applied Medical Device Institute at Grand Valley State University in Grand Rapids. AMDI partners with medical device companies such as Bloomfield Hills-based Sterilogy LLC, which is developing a product that reminds caregivers to sanitize their hands before making contact with patients. Brent Nowak, top, serves as executive director of the Applied Medical Device Institute at Grand Valley State University in Grand Rapids. AMDI partners with medical device companies such as Bloomfield Hills-based Sterilogy LLC, which is developing a product that reminds caregivers to sanitize their hands before making contact with patients. PHOTO: MARK SANCHEZ

Accelerating Development: Medical device firms turn to GVSU institute for R&D help

BY Sunday, November 25, 2018 08:39pm

 

GRAND RAPIDS — Hal Zaima’s innovation seeks to address a lingering and serious problem in health care: infections acquired in hospitals that lead to the deaths of thousands of patients annually.

His company invented a device that reminds caregivers to sanitize their hands before making contact with patients, and keeps a record of their compliance.

The Bloomfield Hills-based Sterilogy LLC had the design down for much of the device, except the electronic components. One company Sterilogy hired to design the electronics was “doing a decent job” but was “fitting us in” to its schedule, Zaima said. Another company Zaima went to “really couldn’t get it done.”

On a referral from the Michigan Economic Development Corp., Sterilogy looked west in the spring of 2017 and connected with Grand Valley State University’s Applied Medical Device Institute (AMDI). Staff and engineering students there solved the problem and developed a prototype for Sterilogy.

As Sterilogy now works to tweak the design to make it more “manufacturing-friendly” and prepares for beta-testing the hand-sanitizer system in 2019, Zaima credits the company’s progress to AMDI.

“We couldn’t have gotten to where we are today without AMDI,” said Zaima, Sterilogy’s co-founder and president. “AMDI was able to take our statement of work and make it into a working prototype, make it into reality.”

The Sterilogy system is one of many projects AMDI has worked on in just a few years. The institute is a non-academic unit of GVSU’s Padnos College of Engineering and Computing.

Housed on the fifth floor of GVSU’s Cook-DeVos Center for Health Sciences on Michigan Street in Grand Rapids, AMDI works to assess and develop innovations for clients who have ideas for new medical devices. 

AMDI Executive Director Brent Nowak describes the institute as a “one-stop source for health care development” and innovation services.

“The overall theme is accelerating medical device development to market,” Nowak said. “Time is money.”

Finding solutions

The institute provides contract engineering, analysis, design, fabrication and testing services to clients developing new medical devices. The work typically involves bringing in faculty and undergraduate and graduate students to work on projects, as well as outside expertise.

AMDI also can connect with private-sector partners such as local manufacturers, hospitals or physicians who can help create a solution for a client. Those outside partnerships are valuable because “there’s really more problems to solve than the AMDI can do,” Nowak said.

“We put the right people on the problem,” he said. “We find the right solution.”

Since launching three years ago, ADMI has worked on more than 30 projects. The institute, which is supported by revenue from fees charged to clients, has about $2 million in projects in the pipeline for 2019, Nowak said.

Past projects have included a female urinary collection device that reduces urinary tract infections, testing the ability to perform remote robotic surgery for a local surgeon, and development work on a surgical training model developed by Holland-based Encoris Group Corp.

The Encoris S2T Surgical Smart Trainer uses high-definition cameras, LEDs, and a software package that creates intricate, X-ray-like images displayed on a tablet or computer screen. Real-time imaging and web connectivity will allow users to conduct training sessions through webinars.

The model would alleviate the need for surgeons, device companies, academics and researchers to use cadavers in training people how to use a new surgical instrument or device, as well as reduces their exposure to X-rays.

AMDI provided “tremendous help” to design the first prototype for the model and later developed the imaging components that provide users real-time X-ray images during training procedures, said Jim TenBrink, Encoris’ co-founder and vice president of client development. The institute also has helped to improve the accuracy level of images, TenBrink said.

“To be able to produce X-ray images is the gist of the trainer. Without that, it’s nothing, really,” he said.

Addressing needs

At Sterilogy, the hand-sanitizing system uses three components: A unit with sanitizer that caregivers wear, an electronic unit attached to patient beds, and a base station placed in a central location such as a nursing station. When a doctor or nurse approaches a patient, the device will vibrate to remind them to sanitize their hands, if they have not already, and then beep a few seconds later if a sensor does not detect use of the sanitizer.

The system uploads data into a database so hospitals can track each caregiver’s compliance with policies to sanitize their hands before contact with a patient.

“If there are multiple patients in a room, it’s more convenient to have a portable sanitizing unit at the ‘point of care,’ rather than having to run back and forth to one mounted on a wall or to a sink,” Zaima said.

The U.S. Centers for Disease Control and Prevention estimate that about 1.7 million hospital-acquired infections occur annually nationwide, caused by a number of factors. Hospital-acquired infections result in the death of nearly 100,000 people a year and add an estimated $20 billion in health care costs, according to the CDC.

The CDC does not break down the role of hand hygiene in the incidence rate of hospital-acquired infections, although an agency website on the issue notes that “on average, health care providers clean their hands less than half of the times they should.”

Several hospitals in the Detroit area are interested in beta testing the new system, Zaima said. 

Finding niches

Back at AMDI, one new element to the operation coming soon is a lab equipped to test packaging for medical device companies.

Quite often, the testing process for medical device packaging can take up to 18 months to earn U.S. Food and Drug Administration certification, and at a high cost, Nowak said. The process includes testing the packaging’s strength, endurance, ability to withstand temperature extremes, and its protection of the device from drops and vibrations during shipping.

“The amount of testing that goes into the packaging is phenomenal, and that costs time and money,” Nowak said.

The new lab fits with AMDI’s mission to support and lure device companies to the region and to build the sector into a larger part of West Michigan’s economy.

“We’re trying to bring businesses here and grow them,” said Nowak, noting that about 20 percent of the institute’s outstanding proposals are for companies from outside of West Michigan.

They include firms based in Ohio and Indiana.

Nowak joined GVSU’s faculty five years ago and later became head of AMDI. He previously worked for 11 years at the Southwest Research Institute in San Antonio, Texas.

A nonprofit contract research and development organization, the Southwest Research Institute began in 1947. Working across several economic sectors, the institute in 2017 had a staff of nearly 2,600 — more than 10 percent of whom were doctorates and another 20 percent held graduate degrees — and a budget approaching $600 million, according to an annual report.

“Talk about an entrepreneurial ecosystem,” said Nowak, who holds an ambitious vision for AMDI to become an entrepreneurial force in West Michigan, like what the Southwest Research Institute is in south Texas.

“There is the right culture in West Michigan, especially Grand Rapids, to grow an organization like this,” Nowak said. 

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