Creative Business Model Brings Interface Technology to O&P Patients Nationwide

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Developing a new product is only half the battle. Getting people to use it is the other half.

Randy Alley, CP, LP, CEO and chief prosthetist of biodesigns, Thousand Oaks, California, is the inventor of the High-Fidelity (HiFi) Interface™, a patent-pending interface design for upper- and lower-limb prosthetic applications.

The HiFi Interface employs a series of longitudinal tissue compression regions with corresponding areas of soft tissue release around the limb, extending along the length of the target bone. By displacing a significant amount of the limb's residual soft tissue through the windows, or relief pockets, and out of the field of compression created by the struts, there is less tissue lying between the struts and the bone, Alley says. With less soft tissue acting as a buffer between the underlying bone and socket wall, there is less unwanted motion of the bone within the interface.

"This resistance to motion results in a more responsive prosthesis that feels lighter, offers greater stability, wastes less energy, and feels more like a part of their own body than a traditional socket," Alley says. (Author's note: For more information about the HiFi Interface, read, "High-Fi Flies in New Prosthetic Interface," The O&P EDGE, August 2010.)

"A person can have the most [technologically] advanced prosthetic foot, knee, hand, or arm, but if it doesn't connect to the body properly it won't deliver the proper results, and the individual is less likely to wear it and enjoy the benefits it is intended to deliver," Alley says.

However, Alley explains that he did not intend to fit every patient who could benefit from the HiFi Interface through his company. Rather, he wanted to open his design to select practices nationwide with similar cultures, mindsets, and clinical abilities so that they could better serve current patients and, as a result, attract new ones. Alley decided the best way to get the technology out to the marketplace was to license the HiFi Interface technology to facilities with which Alley is familiar or facilities he has worked with on a consulting basis. "We have had many potential HiFi patients contact us who didn't have the resources to travel to California and wanted to know where they could be fitted locally," Alley says. "And I didn't want to just offer a certification course."

Optimus Prosthetics, Dayton, Ohio, which Scott Schall, CP, LP, and John Brandt, CPO, LPO, opened in 2007, was the first O&P facility to officially license the interface design. Since licensing the design in May, Optimus has fitted more than 50 patients with the HiFi Interface. Alley had been working with Optimus on a consulting basis since October 2010. After watching Alley demonstrate the HiFi Interface, Schall says, "It just made sense" to partner with biodesigns and license the product.

"Most prosthetists find fitting transfemoral prosthetics more difficult than transtibial prosthetics, and patients who wear a transfemoral prosthesis have a more difficult time than those with a transtibial prosthesis," he says. "To hear about the HiFi socket interface design and that it would improve a transfemoral patient's gait efficiency, comfort, and proprioceptive feedback—I was intrigued."

It wasn't until Alley did his first fitting with the HiFi Interface on an Optimus patient who had presented the business with constant fitting challenges, that Schall was able to experience the product firsthand.

He was not only impressed, but sold. "She [the patient] commented that she felt like she could skip," Schall recalls. "That convinced me."

Schall says the HiFi Interface technology has already "proven itself" at Optimus. "Patient outcomes have improved, and our two most experienced prosthetists have commented that it has taken them to the next level as practitioners," he says.

The biodesigns business model was appealing to Optimus for two reasons: it allowed Optimus to be the first practice to market the patent-pending interface, and it provided the company with a 100-mile-radius market exclusivity agreement, Schall says. As with any business venture, Optimus was diligent about justifying the cost and its return on investment.

"A cost-justification worksheet, which addressed the number of new HiFi transfemoral fittings and HiFi transfemoral socket replacements, easily justified the investment," says Schall, who was introduced to the O&P profession in 1992 while working toward his master of science degree in rehabilitation engineering. "I had toured a local O&P practice and was intrigued with their CAD/CAM system that allowed them to manufacture prototype interfaces quickly and cost-effectively."

This is the first time Optimus has had the opportunity to be an exclusive, licensed provider of a prosthetic component, be it a socket design, knee, or foot component, Schall says. The agreement included an up-front license fee and an up-front lease payment for the limb modeling system, as well as an ongoing monthly license fee, which includes national marketing and PR support. The license is currently for the "know how," as the HiFi Interface is patent-pending; however, once a patent is issued, which biodesigns expects will happen by the end of 2011, the intellectual property license seamlessly transitions to a license to use the patented interface design, Schall says.

The biodesigns HiFi Interface made sense to Schall because it complemented his company's philosophy.

"From day one of our practice, our focus has been to combine traditional values with innovative technology. This technology has allowed us to attract a staff of ten, build lifelong relationships with patients, and build relationships with physicians, therapists, and case managers," he says.

By becoming a licensed provider of the HiFi Interface, Optimus has four goals, two of which have already been met, according to Schall.

"First, we hope to improve our patients' lives, which we have," he says. "Second, we hope to improve our practitioners' transfemoral fitting skills, which we have." Goals three and four are forthcoming. "We hope to gain market share, and we hope that HiFi will assist us in expanding the market area we serve."

Alley says his goal for the HiFi business model includes having solid representation nationwide. In addition to Optimus, biodesigns has an agreement with Sampson's Prosthetic & Orthotic Laboratory, Schenectady, New York; and Next Step Orthotics & Prosthetics, Manchester, New Hampshire; and is negotiating license agreements with several other companies. Between the four facilities, a significant number of patients have received the HiFi Interface, Alley says, adding that his company is expanding the clinical model for the interface design in response to increased domestic and global interest.

Betta Ferrendelli can be reached at

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