The National Institutes of Health is not prone to hyperbole, so when one of its small business innovation reviewers calls a technology a “marvel of engineering,” one tends to sit up and take notice. The technology in question is a mobile therapeutic compression device developed by medtech startup Recovery Force (RF; Fishers, IN). It relies on woven nickel-titanium (aka nitinol) fibers embedded in textiles to improve circulation. The key breakthrough here is mobility—conventional devices tether patients to beds or wall-mounted units and restrict their movement. A primary challenge in bringing this technology to market was finding a manufacturing partner that had the skillset to combine electronics with textiles, knew how to navigate the FDA regulatory process and had the scope to accelerate the path from prototype to production. Manufacturing giant Jabil (St. Petersburg, FL) checked all the boxes.
The technology centers on woven nitinol fibers that are embedded in textiles, explained RF in a case study that was released today. “These woven fibers have the unique ability to change shape in real time to deliver sequencing compressions that increase circulation to the body’s cardio-vascular and lymphatic systems,” said the company. In addition to the clinical benefits—reduced post-operative pain and prevention of blood clots, to name two—which are currently being assessed in a collaboration with the Mayo Clinic, the device can also be used by athletes to jump-start warm-up and recovery activities.
When RF set out to find a manufacturing partner, it struggled to find one with the right mix of capabilities, said Matt Wainscott, RF co-founder and Executive Vice President. “The first company had a textile background; the second had an electronics background. What we really needed was a total turnkey solution,” explained Wainscott. Jabil and its Nypro Healthcare operation, along with its Radius Innovation and Development consultancy and the expertise Jabil gained from its acquisition of e-textiles company Clothing+, fit the bill.
In helping RF to refine the prototype, Radius researched a number of markets, including automotive, pharma, medical and sports, to inform the user interface and look and feel of the device. Human factors design was crucial, added RF, since the product was going to be used by different types of people and had to be intuitive and comfortable.
Fifteen different designs resulted from this initial research, and elements from a handful of those were incorporated into the final design. “Nypro took what we learned integrating our technology into some of those prototypes," said Matt Wyatt, RF co-founder and CEO. “They made the product more elegant, more functional, more user-friendly and, of course, ultimately scalable, which is a critical piece to this whole technology play.”
RF is starting sensibly with low-volume production, confident that Jabil’s capabilities will allow it to scale up on a dime as the need arises. The first product is a compression device to improve blood circulation in the back. RF is now in the process of selecting sales channel partners for two business segments: Class II medical devices, including a blood clot prevention product; and consumer wearables.
The startup is continuing to work with Jabil to develop technologies for devices that treat upper-body extremities and plan for FDA submissions. Footwear products to assist diabetics and treat plantar fasciitis are seen as another business opportunity, and an additional 15 devices are in the development pipeline.