A layup of the AFO materials just prior to pulling the plastic. Photographs courtesy of Click Medical.
Innovation is not uncommon in the O&P industry. Revolutionary technologies are being developed every day to help patients reach their full potential. Where the rubber meets the road, so to speak, is in making those innovations widely accessible in the medical and rehabilitation settings for patients.
An Idea Leads to Collaboration
When a six-year-old girl with cerebral palsy told Donald McGovern, CPO, FAAOP, which AFOs she had tried and liked best while enrolled in a Rehabilitation Institute of Chicago (RIC) study on AFOs, the wheels quickly began turning.
“She told me that she liked the device that held her really solidly for some things and then the device that was more flexible for other activities,” McGovern says. “She said she wanted a device that would allow her to control flexibility herself.”
Wanting to fulfill her wish, McGovern began thinking about what mix of technologies could make it possible. “I woke up at 3:30 a.m. one day and immediately thought of a company that had a technology that could make this happen, although it wasn’t being used in O&P all that much,” he says. In fact, the technology—described at the most basic level as a reel and a cable for adjusting tension—had its widest application in the ski boot industry at that time. “I began thinking how this technology could be used for controlling dorsiflexion in AFOs,” McGovern recalls.
Wesley Quigley, O&P technical coordinator at RIC, had already been using the device in other O&P applications for patients, but it had not yet been incorporated into an AFO. “We took the only kit we could get, which was for shoes, and then took the components and started putting them on AFOs,” Quigley says. “As time went on, I was able to figure out different ways to put it into the AFOs.”
Quigley pulls the plastic over the AFO model.
David Zembower, PhD, MBA, who oversees technology transfer and industry collaborations at RIC, soon made a call to the company that developed the device, Boa Technology, Denver, and says it was serendipitous that it was Jimmy Capra who answered that call.
Capra, with Boa for more than 13 years, had been tasked with creating markets by identifying the products and players necessary to grow new segments of the business. When Zembower shared what RIC had been doing, Capra was interested. In fact, Capra was already focused on advancing the medical application of the technology and had started his own company to do just that.
Thus, Click Medical, Steamboat Springs, Colorado, was founded. The company’s mission, Capra says, is to create closure and adjustment solutions for a range of O&P devices and give practitioners access to and easy use of the technology. “When Jimmy started Click Medical about a year ago, we talked more about the device and applying it to AFOs,” Zembower says. “We talked a lot about optimizing and identifying the components that would go in a kit and the process for fabricating it.”
Quigley then worked to identify what those components should be.
The goal was to manage the patient’s forward lean by enabling the practitioner or the patient to dial in, via the reel-and-cable device, the angle of the forward lean without fabricating a new AFO. This adjustability would benefit many people who wear plastic, hinged AFOs by allowing for ease of flexion of the device post-fabrication.
“It was a nice collaboration of brainstorming and we negotiated a licensing deal with Click where they would get these into the commercial marketplace so orthotists could get them out to their patients,” Zembower says.
He says the product—officially named the OrthoFit Active Dorsiflexion Adjust by Click—is the first innovation to be borne out of RIC’s clinical practice rather than out of its research labs that he’s had the opportunity to commercialize. The OrthoFit allows practitioners and patients to actively adjust the dorsiflexion of a patient within a single plastic, hinged AFO.
“Everyone in our department knows that as people come up with these really great ideas, they need to be shared as part of RIC’s mission is to improve the ability of all people,” McGovern says.
Partnership Benefits Patients
This project is a great example of how partnerships between a nonprofit research hospital and for-profit business can drive innovation and help bring that innovation to a wider number of patients.
“We could have made these inhouse, but we felt strongly that this is a product that could help people all over the world, and we needed a partner to distribute it,” Zembower says. “It’s vital that there be a commercial entity involved if you’re going to get these solutions out to people.”
The integrated dial and lace allow users or clinicians to dial in the dorsiflexion of the ankle.
Capra echoes that sentiment. “As a research institution, RIC was looking to solve a problem they had encountered. To do this they used one of Click Medical’s kits that was normally intended for prosthetic applications to solve their specific problem in orthotics,” he says. “This innovation was a beautiful example of how practitioners can use their own expertise and real-world requirements to tailor our kits to create solutions that address the specific needs of their patients.”
Pamela Hale, CPO, Click Medical’s director of clinical sales and support, says the partnership with RIC brings validity to the product in a way a medical supply company can’t on its own. And Click Medical can offer other options for further development. “Additionally, our background at Click Medical and our ability to manufacture products allows us to take this a step further and explore other ways to fabricate this device that makes it easier to use—like looking at other materials choices,” she says. “We can then put together our kits so that they are more user-friendly on the open market.”
By applying this expertise to a product line that allows for significant flexibility, Capra says his company can help O&P practitioners like those at RIC innovate on a larger scale.
“These products all hinge on the imagination level of the person working on them, and in this case, there was a solution to this problem with a really nice product,” Zembower says.
And what about that six-year-old girl? McGovern reports that she was the first to try out the new device, with great results. “She liked having the ankle locked when she was walking, but when she wanted to do things like go out on the playground, she wanted to be able to climb and do all the stuff that kids like to do,” he says.
McGovern likens the OrthoFit Active Dorsiflexion Adjust device to giving patients multiple pairs of shoes. “People don’t wear just a single pair of shoes, and typically when we give someone an AFO we’re giving them just one pair of shoes,” he says. “For example, today in Chicago it’s icy out, and I wouldn’t want to wear a gym shoe on the ice. So, it would be nice if people could load up their brace according to whatever situation they’re in.
Both RIC and Click Medical representatives are happy with the outcome of the partnership and look forward to making the device widely available to patients early this year.
“There is such an incredible process here—that concept of leveraging so much expertise that often gets sequestered in proprietary places,” Capra says. “The better we share, the better we innovate, and the more we can benefit patients.”
Tara McMeekin is a writer and editor based in Parker, Colorado.
