In the March 2021 issue of the O&P Edge, Randall Alley, CEO and Head of User-Interface Technology, notes the issues with existing prosthetic socket designs and introduces a new model to consider for attachment, the Biotensegrity Bridge™, and describes how the patented and patents-pending HiFi Interface™ System creates a stable and functional “bridge” for attaching prosthetic devices.
“Since soft tissue (fascia) has a nonlinear stress/strain arrangement, traditionalists have incorrectly applied linear laws using levers and pulleys (mechanical physics) to explain the effects that the forces of gravity and tension elicit on our bodies. Biotensegrity has emerged as a new model of structural biology that is in diametric opposition to the Newtonian model of linear mechanical forces we all learned in school. Understanding the dynamic and continuous relationships between the soft tissue (fascia) and fluids within the body opens up new and exciting opportunities for better understanding the nature and role of the human-device interface,” stated Alley. “I give you what I am terming the Biotensegrity Bridge™ as a better way to approach interface integration.”
It’s not difficult to get a patent if you have a novel idea and know how to explain it well. With my HiFi Interface technology, I was pressed by examiners many times with prior art, and often, though it was easy for me to know the differences, it was challenging to find attorneys that could convey those differences in a way that made it easy for the examiners to understand and appreciate. Once I found a legal team I felt was the right fit, the objections became less and less of an obstacle and more of a fun exercise. When I look back at my experiences, I could have never guessed that interface innovation would take so long or be such an uphill battle in terms of acceptance into the O&P field.
Along my journey, I have noticed there are several types of clinicians: 1) those committed to providing their patients with the best outcomes/results, regardless of where the technology comes from; 2) those that want to put down innovation or discredit it due to “not invented here” biases or misconceptions about what is truly novel; 3) those stuck in the past with no desire to change or try new ideas; 4) those that focus on bells and whistles, components doing all the work, or aesthetics instead of focusing on the core interface connection; 5) those that are more interested in speed and convenience for them or their staff over what is best outcomes for their patients, and finally; 6) those that blame the patient for poor interface performance.
I have a question to pose to our readers, which one fits you best? While we stand on the shoulders of giants from the past, there are new giants among us, awaiting their next big idea. At biodesigns, we are betting on osseostabilization™ and have received multiple patents for our technologies. When patients’ lives are on the line, I see a significant shift in mindset is necessary. In Gottschalk’s famous article on femur bone control, my point is perfectly illustrated. Gottschalk was convinced the femur couldn’t be controlled with any then current or previous socket designs and that surgery was required. He was absolutely right when the article was published in 1989. Thankfully, things have changed and I believe the key is omnidirectional stabilization of the underlying bone and mimicking intended skeletal motion to maximize prosthetic embodiment.
We need to continually strive for improvement and push our industry to do better. It is with the utmost conviction I believe clinicians should focus more on science and interface biomechanics, and less on art. Sure the two can and should coexist. But our threshold for success has been too low for too long. Our primary goal must be far more than achieving patient tolerance of our devices, or making the interface look cool using additive manufacturing or colorful materials as a panacea for poor socket design. We first should be asking ourselves, did the wearer get their life back, and did we, to the best of our ability, come even remotely close to returning what they lost. As new materials and processes are introduced into the field, including scanning and 3D printing, it’s easy to be more excited about the way the socket looks, but if the same issues are occurring (high levels of falls, instability, rotational issues, pistoning, uneven gait, discomfort, lack of proprioception, etc.), although I can appreciate the benefits of new materials, perhaps we shouldn’t be patting ourselves on the back quite yet.
-Randall Alley, CEO, biodesigns