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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 21
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My Personal Experience Pursuing Innovation in the O& P Field

By Biodesigns, Food for thought, HiFi, Prosthetics

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

Oct 12
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Biodesigns presents at 2020 SoCalBio Conference in Los Angeles California for Innovative Prosthetic Socket HiFi Interface

biodesigns To Present at SoCalBio’s Annual Conference, Oct. 21-23, 2020

By Biodesigns, Exoskeletons, HiFi, Prosthetics, Socket Technology
Biodesigns selected to present at 2020 SoCalBio Conference for innovative prosthetic socket HiFi Socket

biodesigns has been selected to present their High-Fidelity Interface Technology at the upcoming SoCalBio’s annual meeting. This year the event will be virtual, allowing more people to attend. biodesigns’ presentation will be during the emerging company presentations on Friday, Oct. 23rd, 2020. biodesigns will be highlighting their HiFi osseostabilization and osseosynchronization technology and it’s application in the areas of prosthetics, exoskeletons, and wearables.

The companies were selected from a large pool of applicants by members of SoCalBio’s Innovation Catalyst Program, a unique network of senior bioscience and healthcare professionals who provide presentation and business coaching for SoCalBio Conference presenters.

“The Annual SoCalBio Conference is a unique opportunity for emerging Southern California healthcare companies to present their vision to investors,” said Peter Blaisdell, PhD, Chairperson of the SoCalBio Innovation Catalyst Program. “Beyond funding, the conference allows participating companies to build relationships with industry peers and allied service providers vital to their growth.”

To learn more about the event or to get tickets, visit: www.socalbio.org

May 31
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Randall Alley Hosts HiFi Overview Webinar 6/3

By Lower Extremity, Prosthetics, Upper Extremity

Randall Alley, HiFi Interface Inventor, is asking prosthetists to look to science not art when creating interface designs. It is well documented that current socket designs are plagued by inherent issues causing instability, rotational issues, pistoning, falls, skin issues, excessive energy expenditure, and the inability for wearers to sit up straight. Randall will be highlighting the research and benefits of his HiFi Interface System technology, including improved comfort, function, stability, faster walking speeds, improved gait symmetry and more. No more “buckets.” Time to step up to a better design. Time to step up for better science. Time to step up for our patients.

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