All Posts By

julie alley

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, more 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

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

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.  

 

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.

Captain DuVal – First Amputee to Attend Special Forces Qualification Course

By | Biodesigns, HiFi, Military, Myoelectric, Prosthetics, Socket Technology, Upper Extremity

Captain Carey DuVal is an amazing example of someone who doesn’t let his amputation prevent him from achieving his goals. Captain DuVal is a transradial  (below elbow) amputee as result of a VBIED attack during combat deployment to Afghanistan in 2014. Captain DuVal has utilized biodesigns’ HiFi upper limb prosthetic socket since 2015 as Active Duty Combat Arms Officer.

Captain DuVal is the first amputee of any kind to be selected at the U.S. Army Special Forces Assessment and Selection while utilizing a prosthesis. He is also the first amputee to attend the Special Forces Qualification Course. At the Q-Course, DuVal had to complete all the physical challenges of his fellow soldiers proving with the proper “equipment” (interface system), he could pass all the physical requirements.  Captain DuVal credits the HiFi for allowing him to compete at his highest level. Congrats to Captain DuVal. You are a true hero.

 

 

biodesigns Delivers Advanced Arm During Corona Virus Outbreak

By | Biodesigns, biomechanics, HiFi, Socket Technology, Upper Extremity

biodesigns, in California, best known for their prosthetic interface/socket technology, recently delivered an advanced arm system during this unusual time as a result of the Corona Virus. “We consider our business vital to our patients and want them to know we are here for them,” stated Randall Alley, CEO, Chief Prosthetist for biodesigns. The system delivered included advanced technology including Alley’s patented and patents-pending HiFi interface design, Coapt Engineering’s Gen2 Pattern Recognition, College Park’s Espire Powered Elbow, and Motion Control’s Wrist Rotator and External Terminal Device (ETD2). The system will also be used with the user’s existing ilimb Quantum hand. biodesigns takes great pride in designing prosthetic systems that are appropriate for their users. “This user is long time wearer that has proven time and time again the many functional benefits he receives from his prostheses,” stated Alley.

 

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.

Jason’s Bionic Arm – HiFi Interface, Coapt, LTI Elbow, I-Limb Hand

By | Biodesigns, biomechanics, HiFi, ilimb, Myoelectric, Prosthetics, Socket Technology, Upper Extremity
“There is definitely a preconceived notion that a body-powered system is lighter, but with this HiFi socket it makes the arm feel just as light as body-powered. There is more stability across the entire length of the arm. There are no pinch points, way more degrees of freedom, more responsive, better connection to all the sensors.”

 

Amputee Has Shocking Reaction to her Socket

By | Biodesigns, biomechanics, BK, HiFi, Prosthetics, Socket Technology

Arlene, a below-knee amputee for almost 20 years, couldn’t believe the difference between her traditional socket and her new HiFi. With the HiFi, “it feels so much more natural. I don’t have to think about walking. That’s Amazing!”  In my old socket, it “feels like I’m going to go down. The knee is going to buckle. It’s a little scary.” Arlene shows the HiFi can help users of all ages. Everyone can benefit from HiFi’s ability to provide added stability and control.

Biomechanical Design Considerations for Transradial Prosthetic Interface: A Review

By | Biodesigns, biomechanics, HiFi, Prosthetics, Socket Technology, Upper Extremity

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.

First Threadless Valves for Suction Sockets Sold to Otto Bock Healthcare

By | Biodesigns, Lower Extremity, ottobock, Prosthetics, Upper Extremity
Randall Alley, BSc, CP, owner of biodesigns inc., Westlake Village, California, announced that the PushValve and MagValve, two threadless auto-expulsion valves for upper- and lower-extremity prosthetic suction sockets, have been sold to Otto Bock Healthcare, headquartered in Duderstadt, Germany.

Alley conceived the threadless valve concept, and with the help of tranfemoral amputee Adam Soss and engineer Dustin Bouch, created the world’s first threadless valve family for preparatory and definitive suction socket applications.

“Many of today’s valve designs haven’t changed significantly in their approach to providing suction suspension since they were conceived decades ago,” said Alley. “I wanted to create a valve that was an improvement over existing valves and ultimately one that is easier for patients to use–hence the idea for a threadless design.”

The PushValve is a latching, threadless auto-expulsion valve designed primarily for above-knee suction socket applications, Alley explained. The lower-profile MagValve is a magnetic threadless auto-expulsion valve suitable for both upper- and lower-extremity suction sockets.

“The main advantage of the threadless valve design is that it does not require any twisting, but instead can quickly and effortlessly push in and pull out,” according to a company statement. “In addition, audible feedback lets a patient know they are properly seated and secure: they just click into place. No special tools are required for tightening/loosening, and there is no threat of pulling hairs. The valves are also ideal for bilateral amputees and individuals with hand involvement who wouldn’t be able to easily manage existing screw-in valves. Both valves are also perfect for active individuals who have a need for speed.”

To purchase the valves for your patients’ prosthetic sockets visit ottobocks website.  https://shop.ottobock.us/Prosthetics/Lower-Limb-Prosthetics/Socket-Technologies-Liners/Valves/c/1606