Healthy Design: Small Business Manufacturer of the Year, Vermont and New England
by Small Business Administration Sometimes the best ideas arrive when you least expect them. For Dr. Marie Pavini, inspiration struck one morning while conducting rounds in the intensive care unit at Rutland Regional Medical Center, observing how her patients were being immobilized and sedated to prevent tubes and lines getting dislodged.
“The problem with this is that it causes delirium, profound weakness and hospital-acquired complications like pneumonia, blood clots and wounds,“ Pavini explained. “It increases re-admissions, the need for nursing homes and home caregivers, and so many other quality-of-life-reducing things. I figured if I could solve the problem of restraint, this cascade of complications wouldn’t have to happen.“
In 2015, Pavini began researching design concepts for a functional alternative to traditional patient restraints, gathering feedback from nurses, physical therapists, and occupational therapists. The following year, she founded Healthy Design — this year’s SBA Small Business Manufacturer of the Year for Vermont and New England — and started manufacturing the first prototype of the Exersides Refraint system. (Pavini chose the word “refraint“ because it evokes a more humane approach than “restraining“ a patient.) This innovative invention uses an adjustable rod that allows patients to move their arms while preventing them from reaching their mouths or necks, thus protecting breathing tubes and intravenous lines.
Photo: Simulation patient using Exersides Refraint system. Courtesy photo.
After conducting a yearlong pilot study and then manufacturing and testing a revised prototype for another year, Healthy Design in 2019 received U.S. Food and Drug Administration approval of the product. The company has also been granted U.S. and international patents for the device.
Since the release of the Exersides Refraint, Health Design has developed several complementary products, including a virtual reality platform to educate and support hospital staff who use the system.
Photo: Dr. Pavini demonstrates the company’s virtual realty app with COO Stephen Flint. Courtesy photo.
Health Design’s success has not only brought acclaim to Pavini, who has established a thriving consulting practice, but has also helped position Vermont as a hub for global change in the health care technology industry.
Pavini is quick to praise the many individuals and organizations who have helped her throughout her business journey. Among these are the Vermont district office of the Small Business Administration and its partner organization, the Vermont Small Business Development Center, both of which provide resources for starting and managing a business.
Pavini’s said the SBA’s Small Business Technology Transfer grant program, which provides funding to small-business entrepreneurs for early-stage research and development, was crucial to getting her invention off the ground and into the marketplace.
“STTR allowed me as a physician to get funding for clinical trials for a device that is considered high risk,“ she said. “These awards have sustained us and have been our lifeblood through research, development, COVID, and business development.“
High-risk devises are defined as those that present a potential for serious risk to the health, safety or welfare of a subject or pose significant adoption issues for hospitals, clinics, surgical centers and other health care facilities.
No less crucial to Pavini was the nonfinancial support attached to the grant: the mentorship of John Reinhart, entrepreneur-in-residence at the National Institutes of Health.
“He has been amazing,“ Pavini said. “We wouldn’t be where we are if it weren’t for the STTR program through the SBA.“
In light of her success, Pavini was asked what advice she would offer to aspiring entrepreneurs.
“First, I think you have to reflect personally and decide if you are the type of person who can persevere through adversity and whether you have the time for it. It is a long difficult road, and you have to make sure that you’re ready for it.
“The next thing I would say is to contact the SBA and just tell them your intention and ask them for guidance as to what programs are offered to help them get started. From there, you do your homework to give yourself your best chance at success and keep in touch with the SBA for continued support.
“The SBA,“ she added, “is successful when you’re successful. So it’s a perfect partnership.“
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