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.