Seven million data points sounds like a lot of information to gather. But Orthocare Innovations (Oklahoma City, OK), which manufactured the Computerized Prosthesis Alignment System (Compas), knew it would take work to remove the guesswork from lower-extremity prosthesis fittings. The company obtained those millions of data points by working with dozens of amputees, who helped perfect the technology simply by walking with different alignment settings.
Prosthesis misalignment has been linked to skin breakdown from uneven socket pressure distribution, joint pain from unbalanced loading of the knee or hip, and lower back pain. To ensure proper alignment, some prosthetists turn to gait laboratories. Gait labs offer computerized gait analysis, but that process can be both costly and time-consuming, not to mention that the data are usually best left to be interpreted by specialized technicians. As a result, this method is less helpful during therapy and rehabilitation.
“The Compas takes the trial and error out of the alignment process to deliver a perfectly fitted prosthesis,” says juror Pascal Malassigne, an industrial design professor at the Milwaukee Institute of Art and Design.
The Compas includes a titanium sensor that measures torques and determines the weight, balance, and gait timing of the prosthesis. A master unit is mated to the sensor, which is a permanent part of the prosthesis (Orthocare’s circuitry and sensor technologies are built into the prosthetic limb). The master unit provides the power and Bluetooth connection. The device communicates via Bluetooth with a graphical software system on the prosthetist’s computer, which automatically interprets the gait data with proprietary algorithms, then displays the data on screen. The software provides the prosthetist with direct, simple feedback for improving alignment.
“The Compas provides healthcare providers with a relatively simple, fast, and easy-to-use tool that can significantly improve the quality, comfort, and usefulness of lower limb prosthetics,” observes Richard Meyst, juror and founder of consulting firm Fallbrook Engineering Inc. (Escondido, CA). “Using actual data collected from patients, the prosthetist can precisely and accurately make alignment adjustments to the prosthesis which provide the patient with an efficient, comfortable normal walking gait.”
A target population for this device is veterans from the war in Iraq. As the combat enters its eighth year, the number of amputees has steadily increased. Orthocare introduced the technology to the U.S. Department of Veterans Affairs during the production phase specifically to reach this population.
“[The jurors] liked the fact that this product will help many of our returning armed service people who have been permanently impacted by distant wars. It is an excellent product with superior design,” Meyst says.
“One trend we’re seeing is more incremental software-based features,” says Yadin David, a juror and founder of Biomedical Engineering Consultants LLC (Houston). Indeed, that trend served many of the MDEA entrants well. They were able to take ordinary devices that the medical world has seen millions of times—pill bottles, glucose monitors, prostheses, and stethoscopes—and present them in a different light. Software and data features were key to the innovations.
Lawrence Lloyd

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