Marie Pavini loves her job as a critical care physician at Rutland Regional Medical Center. But she’s never liked the restraints and sedation techniques used to keep ICU patients from pulling out their tubes.
“Those wrist restraints are, I think, archaic and barbaric,” said Pavini. The restraints tend to upset patients, she said, requiring more sedation. “It just never made any sense to me that anyone who was tied down and sedated was ever going to get better. We were doing the opposite.”
So Pavini started working on an alternative that would enable patients to move around more. Her invention, which she calls a “refraint,” uses an adjustable rod that enables patients to move their arms but prevents them from reaching their mouths or necks so they can’t remove breathing tubes or intravenous lines.
“’Refraint’ is gentler, where you’re ‘refraining’ rather than being restrained from doing it,” Pavini said. “It’s softer.”
With help from University of Vermont Medical Center physician Renee Stapleton, Pavini has developed a prototype, bootstrapping most of the cost and using some small grants. Last year, the company, Exersides, won a $1.8 million grant from the federal government’s STTR program, receiving $371,000 for the first phase of research, a feasibility study on the device. Next month, she expects to receive the remaining $1.48 million for Phase II, which will pay for testing the device at the University of Vermont, Johns Hopkins, and the University of California, San Diego.
Pavini, who teaches at UVM Medical Center, has worked at the Rutland hospital for 16 years. She recently spent some time talking to VTDigger about her medical device business, which is based at the Mint makerspace in Rutland and has two remote employees. The interview has been edited for length and clarity.
VTDigger: How did you start the transition from doctor to entrepreneur?
Marie Pavini: This was about 2015. I went to Home Depot, got some crude things, and started putting it together. Then I went to a couple of classes at the (Small Business Administration) about how to start a business. Not that I really wanted a business at that time; I just wanted to figure out how to get this developed. The SBA sent me to the Small Business Development Center, and that’s where I got an advisor.
VTD: Do you think being in Rutland — away from Chittenden County, where there is more support for entrepreneurs — made the process easier or harder?
MP: If I had been working at a big academic institution like UVM in Burlington, it would have been a lot harder to do what I wanted with the product. It would have been out of my hands. The institution would have put it through its bureaucracies, and so the patents would have been done differently, and different people would have gotten involved. In Rutland, my contract is basically written that any intellectual property I have is mine.
It’s a lot more expensive for me, but I feel like I’m in control.
VTD: What kind of help have you received?
MP: The first grant I got was $25,000 with a company in Lebanon, New Hampshire called SIMBEX through a program called TREAT (Center for Translation of Rehabilitation Engineering Advances and Technology). If you’re chosen, they give you a portion of National Institutes of Health grant money, and some guidance from a design engineer, a commercialization expert, and a clinical trial expert.
During that time, I did a pilot study and it worked out very well, and started talking to Dr. Renee Stapleton at UVM, and she got people she knows and put together a 10-investigator team and we applied for the STTR grant.
VTD: What is the problem you were trying to solve?
MP: If you get in a car accident, or have a heart attack or some surgery, and you end up intubated in an ICU, you are going to be tied to the bed so you won’t pull out that breathing tube or feeding tube.
Because you’re tied to the bed, if you wake up, you’re going to be really agitated and fearful, and you’re going to be so upset and struggling that the nurse is going to sedate you. When you’re immobile and sedated, you’re having hallucinations. Lots of people have told their stories after this. They think they are in a war, or their family is being tortured and they can’t get to them, they think there are spiders all over the place, really awful stuff.
They are finding this delirium stays with you after you leave the ICU. You’re not the same anymore. People talk about PTSD.
Oftentimes, you caught something else from the hospital, a ventilator-associated pneumonia, you can get pressure ulcers — all stuff that makes you sicker. So much of it is because of restraint and sedation.
VTD: What prompted you to create a solution?
The night nurses and I would try to come up with interesting ways to put something in the patients’ hands so they couldn’t pull the tube out – we’d roll up face cloths and tape them together. But nothing really worked, and for the longest time I kept wishing “they” would come up with something.
Then my brother had a hemorrhagic stroke. He was in intensive care in the ICU in Massachusetts. I went back there, and he couldn’t move half of his body, and they kept tying down his good hand and sedating him. You can’t tell if someone is getting worse if they’re sedated. If they weren’t sedated, they might show you some sign of something, that they could follow commands.
I had to stay there day and night, refusing restraint and refusing sedation and staying with him. He was so happy to have me there and awake and listening to stories and me telling him what was going on at home, bringing his brain back around.
He died in 2009; he was in his late 40’s. That kind of gave me the impetus to say, “OK, nobody is doing this, I’ve got to do it.”
VTD: How did you refine your prototype?
MP: The device itself has changed based on feedback from doctors, nurses, patients, families. I have listened very intently, and I’ve talked to some of the big companies and they tell me I’m much more nimble than they are; I can get a lot more done.
In the pilot study, patients made comments: They wished they could do this or that, so we changed that handle dramatically. Nurses starting saying, ‘I wish there was a place to put the IVs, I wish I could reach the hand,’ so we kept changing and changing and adding and making it more comfortable with easier access, easier to put together, easier to clean, and more.
But it’s basically still an arm rod with a handle.
VTD: What do you know about the market for this type of device?
MP: There are 27,000 adult intubated ICU patients every day. A patient will usually wear restraints for five to 10 days. And that’s just adults, and only ICU patients — they still restrain other patients who are not intubated, like the confused, the elderly.
You can get wrist restraints on Amazon for pretty cheap, but when you buy them from a hospital, the price goes way up, five times or higher, because it has to go through all the regulations. I won’t be able to go on Amazon. It’s not just a little bracelet; it’s a real device you would have to know how to use correctly. I have to go through the whole thing with the FDA and ISO certification. I don’t have a price; we don’t know how much it’s going to cost us to make.
VTD: What work have you done toward commercialization?
MP: For about three years, I’ve been going to critical care conferences, ICU doc conferences, and ICU therapist conferences. I have a simulation patient that I put the restraints on, and people come around and look at it, and I take feedback.
I have a following. When we do get to the market I have a list of 1,000 names that I will let know.
VTD: Did you get help learning about starting a business?
MP: I kept reading. I read blogs, and if there was a link that led me to something else, I read that. I learned about the STTR grant at an American Thoracic Society meeting in Baltimore a few years ago. You just keep putting yourself out there, going to conferences.
The problem is Vermont is so small there aren’t medical device meetings, just general business meetings. With medical devices, the market is different; the regulatory landscape and compliance is such a narrow path with twists and turns regular companies don’t have. I have to do a lot of stuff in Massachusetts.
The Mint has been very helpful for me. It’s a real maker space with a 3D printer.
I did Road Pitch last year at the Champlain Makers Fair, and won $500. That was useful because it makes you gather your thoughts in order to tell someone else about what you have. You have to really figure everything out, and you have to have a slide deck with financials and a market strategy. You find everywhere you might be weak.
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