Business

IowaMADE aims to bring medical devices from concept to market

University of Iowa's company is mostly run by engineering students

Dr. Ron Abrons, Associate Professor of Anesthesia and director of Airway Management Training and Research, holds an Abrons Articulating Oral Airway in the Cullen conference room at the University of Iowa Hospitals and Clinics in Iowa City on Wednesday, May. 30, 2018. (Stephen Mally/The Gazette)
Dr. Ron Abrons, Associate Professor of Anesthesia and director of Airway Management Training and Research, holds an Abrons Articulating Oral Airway in the Cullen conference room at the University of Iowa Hospitals and Clinics in Iowa City on Wednesday, May. 30, 2018. (Stephen Mally/The Gazette)
/

Patients come in all shapes and sizes. But anesthesiologists have had only a single device to enable those patients to breathe during surgery.

“They work well for a good amount of people, but for some folks they don’t,” said Dr. Ron Abrons, associate professor of anesthesiology at the University of Iowa. “When you put folks to sleep, obviously you’ve got to breathe for them.

“That can be difficult, especially for people who have sleep apnea or other anatomic abnormalities that don’t let you pass air through.”

Abrons’s solution, the Abrons Oral Airway, opens to displace the patient’s tongue, clearing a larger airway for assisted breathing.

It’s the first product of IowaMADE, a “virtual medical device company” organizers hope will speed improved products to market while providing its student staff experience in the devices’ development and marketing.

“It’s going to be fascinating,” said Dr. Matthew Howard. “I don’t know of any other university that’s done anything like this.”

Howard, chairman of the Department of Neurosurgery at the University of Iowa Hospitals and Clinics, oversees IowaMADE, launched last September. The program has no full-time staff.

ARTICLE CONTINUES BELOW ADVERTISEMENT

“It doesn’t cost much of anything, but people are learning a lot and it’s a lot of fun,” he said.

“It’s the first of its kind as far as we’re aware,” said Jordan Kaufmann, director of start-ups for UI Ventures. “The concept of taking devices the faculty has developed, wrapping a quality (assurance) system around them and selling them directly out of the university — we don’t have any precedent for that that I’ve found.”

Perfecting the process

Abrons’s device, a refinement of a widely used oral airway that’s essentially a simple one-piece tube, was a good candidate for IowaMADE.

“They’re all very simple devices,” Kaufmann said. “Something simple that fits the FDA requirements and that also can be manufactured relatively easy.”

The program’s second product, an improved spatula device for ophthalmic use, was scheduled for introduction this week.

It’s produced at Master Tool and Manufacturing Inc. of Hiawatha, which developed the prototype for the stainless steel tool.

“We’ve basically perfected the process,” company President Bob Bitterman said. “We buy sheet stock (steel), and then we laser-cut them and polish the edges, put them in some plastic and form the tools.”

Howard said IowaMADE can develop such improved, low-cost devices cheaper and more quickly than large for-profit companies.

ARTICLE CONTINUES BELOW ADVERTISEMENT

Thank you for signing up for our e-newsletter!

You should start receiving the e-newsletters within a couple days.

“A standard medical device company, they will have a brick-and-mortar facility and they will have full-time employees,” he said. “It’s very, very expensive, and a very large portion of the budget goes to the sales force.

“Our thing is more of an Amazon model. We know the physician wants this device, we’re going to create it, we don’t need a sales force. The university has an unusually strong capacity to reach practicing physicians.”

It’s run by students, mostly, Kaufmann said, backed by consultants to guide development and assure FDA compliance.

IowaMADE’s current four-member student staff was recruited from the College of Engineering, largely through word-of-mouth, Kaufmann said.

“I hope to have it much larger,” she said. “Kind of the student-newspaper model.”

‘this is a product we can work on’

Approved for “investigational” use and available at iowamade.org for $18.62, the Abrons Oral Airway is approved for use and is about halfway through clinical trials.

“It is on the market currently,” Abrons said. “It’s kind of obvious that it works, and we’ll have that statistically significant data showing that.”

Abrons said he had the idea for the improved airway about a decade ago, after noting the difficulties he and other anesthesiologists had intubating larger, heavier patients.

ARTICLE CONTINUES BELOW ADVERTISEMENT

The two-piece Abrons airway pivots on a simple hinge to provide its wider opening, which also allows a fiber-optic tube and miniature camera to be passed into the trachea.

“I came up with this idea of a simple device that articulates and can function to actually displace the tongue, and that’s where it all started,” he said.

Abrons took some time off after graduating from medical school to obtain a provisional patent on his improved device. He joined the UI in 2011.

“I decided I would like to get the expertise of the university, so I brought it to them and they said, ‘Yeah, this is a product we can work on,’” he said.

“They helped me get it from a provisional to a full patent, which obviously costs money.”

“You’ve got this perfectly good oral airway sitting here, you’ve got it all the way through to injection-molded with a medical grade manufacturer, why not sell it?” Kaufmann reasoned.

Grants through UI’s Gap program funded development of a prototype and a production-quality injection mold. That program, to fund basic research and commercial development of faculty inventions, since has been discontinued due to budget cuts.

IowaMADE development funding will come through the appropriate academic department, to be reimbursed with revenue from sales.

ARTICLE CONTINUES BELOW ADVERTISEMENT

“It’s a level of vetting,” Kaufmann said. “They know the field since they are in the field.”

“The cost structure is very low,” Howard said. “If a product is modestly successful and there are revenues ahead of expenses, it would go back to the department.”

Kaufmann said IowaMADE hasn’t done much marketing beyond placing the Abrons airway on its website. She said a team of business students is developing a plan to boost its visibility this summer through medical conferences, online training websites and other venues.

“We’re getting a pipeline together,” she said.

“It’s nice,” Abrons said of the experience. “I really hope this can get to a point where people know enough about it so they use it.”

“That’s the thing that makes this so rewarding,” said Master Tool’s Bitterman, who received a corneal transplant at UIHC. “The age group (of potential patients) is basically children, newborns even, all the way through. We’ve developed this different process to come up with different tools and procedures.”

Give us feedback

We value your trust and work hard to provide fair, accurate coverage. If you have found an error or omission in our reporting, tell us here.

Or if you have a story idea we should look into? Tell us here.

CONTINUE READING

Give us feedback

We value your trust and work hard to provide fair, accurate coverage. If you have found an error or omission in our reporting, tell us here.

Or if you have a story idea we should look into? Tell us here.