Press Release / Media

biodesigns Receives 6th US Patent for Prosthetic Interface Technology

By | Biodesigns, Press Release / Media, Prosthetics, Socket Technology

Southern California-based biodesigns, inc., a biomechanically-focused, outcomes-driven, prosthetic clinic and human interface development company, is pleased to announce their sixth US patent for their innovative High-Fidelity™ (HiFiTM) prosthetic interface technology. This latest patent awarded July 7, 2020, Methods for Bone Stabilization (US10,702,404), complements their interface technology patent portfolio including Methods of Bone Stabilization (US10,123,888), Methods for Use of Compression Stabilized Prosthetic Socket Interface (US8,323,353), Method, System, and Tools for Affixing Compression Stabilized Prosthetic Socket Interface (US8,656,91), and Adaptable Socket System, Method and Kit (US9,283,093 and US10,326,027).

The core of biodesigns’ patented and patents-pending HiFi™ Osseostabilizing™ Human Device Interface (HDI) technology is its focus on capturing the underlying bone, to better control and sync the interface with skeletal movement. When motion and force are captured closer to the bone the prosthesis will react more instinctively, providing the user with improved function, performance, and proprioception.

“When I traveled the US for nearly 10 years fitting complex prosthetic systems, I continually saw the problems, poor outcomes, and rejection rates caused by the Standard of Care (SOC) sockets, especially for upper limb prosthetic wearers. It was then I decided to dedicate my career to improving the human device interface with more biomechanically-focused, outcomes-driven designs,” stated Randall Alley, CEO biodesigns and HiFiTM Inventor.

To help make their interface designs accessible to more patients in the US and around the world, biodesigns offers HiFiTM training events, including the upcoming HiFiTM Femoral and Tibial Interface training and licensing virtual event on Wed., Sept. 23th for Certified Prosthetists (CP’s) and Certified Prosthetists Orthotists (CPO’s). In this course CP’s/CPO’s will learn the principles of the HiFiTM design, how to utilize the HiFiTM Imager for diagnostic assessment as well as efficient casting or scanning, the HiFiTM modification technique, the clinical experience, research and data supporting the design, as well as reimbursement strategies.

In order to assist with enforcement and licensing of its intellectual property portfolio, biodesigns utilizes Fish IP Law LLP, a premier intellectual property law firm. To note, Hanger’s Comfort Flex, Sabolich’s Socket, Lim’s Infinite Socket, Martin Bionic’s Socketless Socket, the MAS Socket and REVO Limb do not have a license to the HiFi™ Interface technology. Prosthetists are encouraged to contact biodesigns if they believe they may have unknowingly utilized the HiFiTM technology in these or other socket designs.  


biodesigns Awarded Phase I SBIR Contract for Exoskeleton Interface From Army

By | Biodesigns, Exoskeletons, HiFi, Military, Press Release / Media, Prosthetics, Socket Technology
WESTLAKE VILLAGE, Calif. – biodesigns, inc., Southern California, was awarded a Phase I Small Business Innovation Research (SBIR) contract from the Department of the Army, U.S. Army Research and Engineering Command, for their proposal, “Bio-Inspired Interfaces for Osseostabilized Human-Exoskeleton Connectivity.”
Randall Alley, biodesigns’ Founder/CEO and Head of User-Interface Technologies, will serve as the Principal Investigator (PI) on the Army contract, and will utilize his team’s experience in human connection technology to design a paradigm altering, innovative, exoskeleton interface attachment design.

biodesigns Rejects Standard Of Care Sockets – So Should You

By | Biodesigns, HiFi, Press Release / Media, Prosthetics, Socket Technology

biodesigns declares they are a “bucket free” zone.

You see, we know something. And we think you know it too. Simply stated, there’s something just not right with the prosthetic industry. There’s something wrong when an entire field-from prosthetists to manufacturers, to therapists to doctors to the media and to just about everyone else who is in some way, shape or form involved in prosthetics-is focused on everything but the problem that affects you, the one who has to live with it, the most: your socket, or as we prefer to call it, your interface.
Sure you hear people say “oh, the socket is the most important part of a prosthesis.” Or, “the socket fit is everything.” Then how is it they continue to use interface designs that are decades old? Designs that pay little attention to biomechanical principles, that completely ignore the health of the wearer? You see, they can talk a good game all day long, but in the end, they’re focused on the components, the “sexy” stuff like microprocessor knees, powered ankles, or the latest electric hand. We get it, that’s all great gear, and it has its place. But guess what? With an entire industry enamored more with the attached accessories than the interface itself, what do you think suffers? Bingo!
At biodesigns, the interface is everything to us. Sure we provide the latest in cutting edge technology, and yes we’re probably more familiar with how to optimize manufacturer components than just about anyone else in the field. But tuning complex prosthetic systems is child’s play to us. Where we really dig deep is in the science of the interface. You see, we don’t describe our designs as merely “a good fit.” Making a tube or bucket “fit” your limb is no challenge. Having it stay on and be comfortable should be a given, not some great achievement. That’s like the prosthetist hitting the power button on your freshly delivered bionic leg and saying “yep, the light came on, I think we’re all goood.”
The serious challenges lay beyond simple comfort and suspension. Our focus is in extracting every ounce of effort you put in to the system and transferring it to the rest of the prosthesis. Our goal is to make you one with your entire system, so much so, you forget you are wearing it. This is embodiment. And to do this we have to rise above the incredibly low threshold of “yep, looks like a good fit!” or “gosh, it looks like it’s gonna stay on” and work on truly replacing what you lost. This means we have to mimic your actual skeletal motion, not absorb it in some loose fitting bucket. This means we have to encourage your neural network to start regrowing by fooling the brain into thinking your arm or leg is back. This means giving you a High-Fidelity Interface system. Do you think we arrived at that name by accident? Fidelity: the degree to which a copy of something shows the true character of the original. Cambridge dictionary. Isn’t that what you are looking for? To get as close as possible to what you lost? A bucket or a tube can’t do it. That’s why this is-and will always be a “NO BUCKET ZONE.”
Randall Alley, ceo, biodesigns, inc.

Back on the Ice: Innovative Socket Gets Arm Amputee Playing Hockey

By | Biodesigns, HiFi, Press Release / Media, Prosthetics, Socket Technology, Upper Extremity
WESTLAKE VILLAGE, CA – After nearly 30 years away from his passion, Andrew Carter has returned to ice hockey. The long-absence from the game wasn’t self-imposed for the 48-year-old. “I grew up playing on the street and organized leagues on ice until I was 14 when I lost my hand and wrist in an electrical accident,” he said. Fast forward from 1984 to 2013 and Carter found a way to get back on the ice through a prosthetic attachment that enables him to control the hockey stick, coupled with an innovative socket system that keeps his prosthesis not only snug and secure, but radically alters the way he plays his game — the HiFi™ Interface System created by Randall Alley, CEO and chief prosthetist of biodesigns inc., a prosthetic clinic and R&D facility.
“I was physically active all my life but I didn’t realize there were prosthetics that would stay on and perform in the way that the HiFi system does and also the hockey specific attachment made by Bob Rodocy from TRS Inc.,” Carter said. It was Radocy, who is also an arm amputee, who referred Carter to Alley, who is known for his extensive experience in upper-limb prosthetics and his commitment to superior biomechanics. Alley previously fit Radocy in a HiFi socket he uses for swimming and scuba.  With the HiFi, Carter was able to return to the ice for the first time since he was a teenager. “The HiFi makes me a much better player. It enables me to go out there and be competitive because of the way it perfectly captures every motion of my arm,” Carter said. Unlike most upper-extremity prostheses for heavy physical activity, this one does not have a series of straps and shoulder harnesses to hold it on. The four internal compression areas of the socket control the shaft of the underlying bone by gently displacing some soft tissue out of the way, causing the remaining soft tissue surrounding the bone to become denser.
“At a glance, it might look uncomfortable,” Carter said, “but it actually isn’t. There is virtually no movement inside the actual prosthesis. The usual give and take of soft tissue movements inside a normal prosthetic shell is completely gone, and that translates into a substantial increase in both power and accuracy. This is great for me and probably not so good for opposing goaltenders.” Carter’s return to the ice came after months of relearning how to stick handle, pass and shoot, practicing on dry land. “What the HiFi and TRS’s terminal device enabled me to do is to be able to get back out there and play. I don’t really think of it as a prosthesis; it’s an extension of me,” he said. Carter joined the Ice Angeles 8-Bits adult hockey team in 2014 and was instrumental as the 8-Bits swept the finals to become league champions in 2017. “Hockey has been my favorite sport for a long time so it’s been a really big deal for me to come back and play on the team and be in the locker room with my teammates,” he said.
Besides hockey playing, Carter is a regular at the gym, but found difficulty in holding weights and doing upper body exercises. “It’s very difficult with one hand to load your body evenly and do a great deal of upper body exercises, so I invented a device called the Carter Cuff to help me and other amputees or persons whose hand function is temporarily or permanently impaired. The Carter Cuff is an armband, which includes a number of reinforced D-Rings providing connection to exercise machines and free weights. An optional shoulder harness can be attached to the armband for additional stability. It allows the user with a disability to perform numerous exercises that would otherwise by impossible. The user can row, press, pull down, press down, curl, chop and perform suspension, barbell, dumbbell and kettle bell work, all while loading the body evenly.
“It’s become this really special second life that I couldn’t envision. I’m lucky to be in a position where I can do this. I’m lucky that I got referred to Randy by Bob. I got VIP treatment from the day I walked in there. Randy has been nothing but amazing!”

Learn more about the Carter Cuff. Click here.

biodesigns Delivers World’s Most Advanced Arm During CA Fires

By | Press Release / Media, Upper Extremity

WESTLAKE VILLAGE, Calif., Nov. 15, 2018 — biodesigns, inc., Southern California, delivers the “Luke Arm” to amputee during the recent fires that hit Westlake Village.

Amidst the fires and evacuations that recently hit Westlake Village and surrounding areas, amputee Brian Roberson is one of a few individuals to receive the world’s most advanced upper limb prosthetic system – the modular, bionic Luke Arm and X-Frame Interface.

The Luke Arm, manufactured and distributed by Mobius Bionics LLC of New Hampshire, provides advanced features and capabilities including state-of-the-art flexibility, strength and dexterity. The Luke Arm is the result of 10 years of development by a team led by Dean Kamen’s company DEKA Research & Development, as part of DARPA’s (Defense Advanced Research Projects Agency) Revolutionizing Prosthetics Program (RP2007).

Randall Alley, CEO and Chief Prosthetist for biodesigns, Westlake Village, was a primary interface (socket) consultant previously engaged by DEKA on the Luke Arm RP2007 project to assist with the user attachment strategy. Alley, knowing traditional socket approaches would yield inferior results and arm rejections, brought his innovative High-Fidelity and X-Frame interface designs to the program. His success with the Luke Arm system eventually led biodesigns to their own DARPA SBIR contract and now biodesigns is one of a few companies in the world authorized to fit this advanced bionic arm.

“At biodesigns we have an intense focus on socket/interface biomechanics and how it relates to user acceptance and user performance with their prosthetic system(s). While the prosthetic industry has seen incredible advancements in components, it has not only lacked progress in socket technology, it has all but ignored the critical role of the interface in ensuring wearer success. The sockets being used by most prosthetists today are decades old and have been plagued with numerous issues. As the components become more advanced, the interface or connection platform becomes vitally important. Our goal is to continue to develop innovative, non-surgical attachment approaches focused on achieving superior user comfort, stability, connectivity, and the ultimate goal – device embodiment,” stated Alley.

Brian, who is currently living out-of-state, traveled to biodesigns in CA due to their unique interface expertise, experience and success fitting this advanced arm system.

“I have experienced a lot these last few days but am very happy to be back at biodesigns office practicing with this new arm,” stated Brian Roberson.  As a machinist, this new arm will allow me to go back to work and help me regain my life back.”

About biodesigns inc.

Southern California-based biodesigns, inc. is a technology-driven prosthetics company specializing in the most advanced patient care, research and product development for individuals who have experienced upper and lower limb loss. The company’s approach utilizes innovative clinical techniques and the most biomechanically advanced prosthetic interface systems available, including the High-Fidelity Interface and Imager System. biodesigns works with upper and lower limb wearers of all ages and activity levels, but also provides interface/socket trainings and licensing to other prosthetists as well as consulting services in and outside the field of prosthetics.

DARPA’s Revolutionizing Prosthetics Program

By | Biodesigns, DARPA, HiFi, Military, Myoelectric, Press Release / Media, Prosthetics, Socket Technology, Upper Extremity

Randall Alley served as DEKA’s  interface consultant on the LUKE Arm project. With Alley’s socket technology, patients went from rejection of the bionic arm due to its weight to enthusiastic acceptance. Chuck, a bilateral upper limb study participant, stated the “HiFi is the best invention in 100 years.” Featured here is Ryan testing the Gen3 LUKE Arm with Alley’s XFrame.