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Oct 26
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biodesigns Announces New HiFi Digital Program

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

Prosthetic Interfaces for Improved Outcomes and Efficiency

Southern California-based biodesigns, inc., the leader in non-surgical human interface development and attachment technology, is pleased to announce the patented and patents-pending HiFi Rapid Technology Deployment (RTD) Digital Program for the creation of biomechanically-superior prosthetic interfaces. The RTD Digital Program utilizes the highly successful patented and patents-pending HiFi Interface™ technology while leveraging innovations in scanning and 3D printing, for improved patient outcomes and operational efficiencies. The RTD Program is being introduced initially to a limited number of existing HiFi Trained and Licensed Orthotic and Prosthetic (O&P) Facilities throughout the country, with plans for a full global roll-out in 2022.

“There are several scanning/3D fabrication programs currently available to prosthetists, but their entire focus lies in simplifying the process and achieving faster turnaround,” stated Randall Alley, CEO and Head of User Interface Technology at biodesigns, inc. “And while much improvement has been made in the speed and ease of the fitting process with advanced fabrication technology, this does not compensate for poor interface biomechanics. So you end up receiving primitive socket designs, but they’re delivered quickly and efficiently, not an ideal scenario. The primary focus should always be superlative interface performance and superior patient outcomes, bolstered by a simple and efficient process of shape capture, rapid revision and turnaround.”

The RTD Program is the latest product offering from biodesigns and allows for a more simplified HiFi program with consistent results, regardless of the skill or experience of the prosthetist, and at a much lower entry price.

“We wanted to introduce the RTD program into the field for the last several years, but the 3D printing technology was not where we needed it to be. Now with the introduction of our patented handheld HiFi Freestyle™ dynamic compression equipment, advanced CAD/CAM software for modifications, and our Filament Innovations Icarus printer for transparent and extremely strong HiFi diagnostic interfaces in record time, we have a unique fabrication program that exceeds all others. It’s as easy as compress, scan and send, and we will do the rest.”

Trained prosthetists will have the option of using a HiFi Authorized C-Fab Center or using their own in-house fabrication for definitive interfaces. The RTD Program has several options based on the size, capabilities, and license purchased by the O&P facility.

Critical to the new RTD Program is HiFi’s patent protection. biodesigns’ robust patent portfolio includes Method of Manufacturing Prosthetic Socket Interfaces (US10,878,137), Methods for Bone Stabilization, (US10,702,404, 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, (US8,656,918), Adaptable Socket System, Method and Kit (US9,283,093, US10,369,027, EP2914221B1, and CA2,889,918), System and Method for Engaging Target with Artificial Limb Equipment (CN106913407B), and Adjustable Pod System, Method and External Member (CN104884005B).

For more information visit www.biodesigns.com

About biodesigns:

Southern California-based biodesigns, inc. is a technology-driven facility specializing in the most advanced patient care, research and product development in non-surgical Human Device Interfaces. In prosthetics, it is reestablishing a connection that has been lost; with the military, it is enhancing mission-critical performance and reducing injury; and in consumer wearables it is improving the way individuals interact with tech, tools, and gear. biodesigns’ mission is to create the universal interface standard for Orthotics & Prosthetics (O&P), Exoskeletons, Orthopedics, and consumer wearables and deploy it worldwide. biodesigns’ intellectual property portfolio is managed by Fish IP Law LLP, a premier intellectual property law firm.

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Dec 19
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biodesigns Announces 11th Patent for Interface Technology, Expands Licensing Program

By Biodesigns, Press Release / Media, Socket Technology, Uncategorized

WESTLAKE VILLAGE, Calif., Dec. 19th, 2020 – Southern California-based biodesigns, inc., the leader in non-surgical human interface development and technology, is pleased to announce another patent for their innovative High-Fidelity™ (HiFiTM) Interface technology. This latest patent, Method of Manufacturing Prosthetic Socket Interface (US10,878,137), complements their interface technology patent portfolio including Methods for Bone Stabilization, (US10,123,888, US10,702,404), Methods for Use of Compression Stabilized Prosthetic Socket Interface, (US8,323,353), Method, System, and Tools for Affixing Compression Stabilized Prosthetic Socket Interface, (US8,656,918), Adaptable Socket System, Method and Kit (US9,283,093, US10,369,027, EP2914221B1, CA2,889,918), System and Method for Engaging Target with Artificial Limb Equipment (CN106913407B), and Adjustable Pod System, Method and External Member (CN104884005B).

Randall Alley, biodesigns’ CEO, Chief Prosthetist, and Head of User-Interface Technology, has discovered a revolutionary approach for attaching items, equipment, tools and technology non-surgically to the body. The core of the patented and patents-pending HiFi™ Osseostabilizing™ Human Device Interface (HDI) technology is its ability to improve worn device performance and control by syncing the interface more effectively and efficiently to skeletal motion. By surrounding the underlying bone with an alternating array of compression, users experience improved connectivity, a heightened sense of proprioception, and a higher level of device embodiment, whether wearing a prosthesis, exoskeleton, or other wearable technologies.

“When I traveled the world for nearly 15 years fitting complex prosthetic systems, I continually witnessed poor outcomes  and high rejection rates caused by the Standard of Care (SOC) sockets being provided. Patients’ biggest complaints were discomfort and feeling disconnected from their prosthesis. It was then I decided to dedicate my career to improving the human device interface by focusing more on interface biomechanics to achieve improved comfort, increased user feedback, enhanced performance, and ultimately greater device acceptance,” stated Alley. “Today, I am pleased to see the HiFi™ interface technology expand into other industries. Our goal is simple – device embodiment so we can be one step closer to seamless human-device integration.”

To make the technology more accessible to patients globally, biodesigns licenses the HiFi™ Prosthetic Interface technology to other Orthotic and Prosthetic (O&P) facilities in the U.S. and abroad, including several NHS (National Health Services) facilities who are interested in improving their outcomes for upper and lower limb prosthetic wearers. Additional programs include a license to their exoskeleton interface technology as well as a license to their recreational consumer interface products, including exolimb™ which is scheduled to launch in 2021.

About biodesigns:

Southern California-based biodesigns, inc. is a technology-driven facility specializing in the most advanced patient care, research and product development in non-surgical Human Device Interfaces. In prosthetics, it is reestablishing a connection that has been lost; with the military, it is enhancing mission-critical performance and reducing injury; and in consumer wearables it is improving the way individuals interact with tech, tools, and gear. biodesigns’ mission is to create the universal interface standard in Orthotics & Prosthetics (O&P), Exoskeletons, Orthopedics, and consumer wearables. biodesigns’ intellectual property portfolio is managed by Fish IP Law LLP, a premier intellectual property law firm.

For more information visit www.biodesigns.com

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Dec 01
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biodesigns First Facility in US to Test BrainRobotics’ Myoelectric Hand, Captain Carey DuVal First US Amputee

By Biodesigns, HiFi, Myoelectric, Press Release / Media, Uncategorized, Upper Extremity

https://www.foxla.com/news/westlake-village-prosthetics-company-tests-state-of-the-art-bionic-arm

WESTLAKE VILLAGE, Calif., Dec. 1, 2020 – Southern California-based biodesigns, inc., a biomechanically-focused, outcomes-driven, prosthetic clinic and human interface development company, has been engaged to test BrainRobotics’ new myoelectric prosthetic hand with select prosthesis wearers, including transradial (below elbow) amputee, US Army Captain Carey DuVal.

When determining who should test their new hand terminal device in the US, BrainRobotics searched online and connected with individuals in the O&P (orthotic and prosthetic) and adaptive community, including Adaptive CrossFit coaches. BrainRobotics noted that transradial amputee Captain Carey Duval, and other high-functioning amputees, stressed the critical importance of their interface or socket to their overall success and improved prosthesis performance. Captain Carey DuVal, under the care of Randall Alley, CEO and Chief Prosthetist at biodesigns, originally sought out Alley for his patented and patents-pending High-Fidelity™ Interface technology out of frustration with existing sockets that were holding him back from performing at an elite level.

“The High-Fidelity Interface with Osseostabilizing™ technology is a complete departure from Standard of Care Sockets. The HiFi Interface focuses on manipulating soft tissue via an alternating, circumferential array of targeted compression to capture the wearers’ underlying bone to better control and sync the interface and hence the prosthesis with skeletal motion. This provides the user with improved function, improved range of motion, enhanced stability, added proprioception, and overall improved component and prosthesis satisfaction,” stated Alley. “Carey needed a system that could keep up with him. A veritable “super-user”, he is the perfect person to test our HiFi Interface with the BrainRobotics’ hand.”

The fitting process and socket design utilized will often determine whether a component or prosthesis is ultimately accepted or rejected by the wearer. A main goal for BrainRobotics’ US marketing strategy, as they await FDA approval, is to engage users and prosthetists that have demonstrated high levels of success, to test all parts of their system, including hand function and ease of fabrication. Currently BrainRobotics is targeting an official US launch in Q1 2021.

“With the BrainRobotics’ hand I quickly noticed the grip system seemed to be more intuitive and very responsive, allowing me to switch easily and quickly between different grips,” stated Captain DuVal.

“Our initial feedback is very positive, and this with only the 2-site option being tested,” stated Alley. “I expect even more encouraging results when the 8-channel system with embedded pattern recognition becomes available for us to evaluate.”

About BrainRobotics:

The BrainRobotics’ hand design is based on research that began in 2015 in the Harvard Innovations Lab and leverages advanced BMI (brain/machine interface) technology to deliver more capability, usability, and affordability to the prosthetic industry. The initial US product launch will consist of the 2-site myoelectric version available for transradial amputees or those with congenital amelia, with a more advanced, 8-channel version to include pattern recognition and AI integrated into the arm system. While there are several prosthetic hands currently available for upper limb wearers, the goal of the BrainRobotics’ hand is to complement function with greater intuition, while making the system more affordable and accessible. BrainRobotics’ goal is to have a terminal device package, including the hand, wrist, electrodes, batteries, and charger, at a cost 30% below existing prosthetic hand solutions.

About Captain Carey DuVal:

Carey DuVal, a transradial amputee as a result of a VBIED attack during combat deployment to Afghanistan in 2014, made history as the first amputee to be selected during US Army Special Forces Assessment and Selection to attend the prestigious Special Forces Qualification Course (Q-Course). Captain DuVal credits his HiFi Interface as the game changer and reason he was able to perform at such an elite level. “I notice my body is much more symmetrical now as I don’t favor my sound side,” he said. “I’ve recently gotten back to all of my previous max lifts. The HiFi allows me to do things that no other socket in the world can do.” Capt. DuVal also participates in CrossFit and competed in the WheelWod open and qualified for the WheelWod Games. WheelWod is the adaptive version of the CrossFit Games and, like CrossFit, includes aerobics, weightlifting and gymnastic movements. Currently stationed at Fort Bragg, Capt. DuVal will be retiring within a year and he intends to put his experiences with prosthetics to help others by training as a physical rehabilitation specialist for amputees.

About Randall Alley, biodesigns:

Randall Alley is CEO, Chief Prosthetist and Head of User-Interface Technologies for biodesigns. Alley is a board-certified prosthetist and received both his prosthetic certificate and Bachelor of Science in Kinesiology from UCLA. Alley has 30 years experience fitting challenging prosthetic patients and was co-founder and former director of the world’s largest upper limb prosthetic program. It was his dissatisfaction with the numerous issues cause by the Standard of Care Prosthetic Sockets that led him to dedicate his career to improving the interface. Alley was also the Principal Investigator on two SBIR/DOD contracts, has contributed to five upper limb prosthetic and orthotic textbooks, received a Certificate of Appreciation from the US Army, the Clinical Creativity Award from the American Academy of Orthotists and Prosthetists, was the Interface Consultant on DARPA’s/DEKA’s Bionic LUKE Arm Revolutionizing Prosthetic Program, and has over 10 patents for his human attachment technologies.

For more information, visit www.brainrobotics.com

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Oct 06
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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.
Sep 18
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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 the main focus is on everything else but the core problem that affects you the most: your socket, or as we prefer to call it, your interface.

It’s common to hear prosthetists say 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 what’s attached rather than how it’s attached, who do you think suffers?

At biodesigns, the interface is everything to us. Sure we provide the latest in cutting edge technology, and are experts in optimizing components, but 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 isn’t the challenge. Having it stay on and be comfortable should be a given, not some “great achievement.”

The truly serious challenges lay beyond simple comfort and suspension. Our focus is in extracting every ounce of effort you put in to the interface and transferring it to the rest of the system. Our goal is to make you one with your prosthesis, 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. Do you think we arrived at that name by accident? Fidelity: the degree to which a copy of something mimics the true character of the original. 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 biodesigns is – and will always be – a “NO BUCKET ZONE.”

–Randall Alley, CEO, biodesigns, inc.

May 22
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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.
Oct 09
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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.

Sep 09
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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.

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