We refuse to make Standard of Care (SOC) sockets because we believe they are detrimental to the health and well-being of our patients. Our HiFi Interface System is the “anti-bucket” as it utilizes our Osseostabilizing™ technology to create the most comfortable, energy-efficient, functional and stable interface. Instead of a bone shifting around inside a “bucket” socket, our design captures and controls the underlying bone without surgery, resulting in a removable prosthesis that feels and performs better. Many of our HiFi wearers say they forget they are wearing their prosthesis. The HiFi technology is a game changer in prosthetics and is supported with clinical evidence and multiple patents.

We know geography is a big factor when choosing a prosthetist and not everyone can come to biodesigns for their HiFi Prosthetic Interface. We also know our technology is such a game changer that access to it is critical for short and long term rehabilitation. Therefore, we introduced the HiFi training and licensing model. Our training elevates the skill of the clinician by teaching them the proven principles of the HiFi System, which is backed by clinical evidence, 1000’s of users worldwide, and numerous testimonials. Prosthetists can learn the HiFi for radial, humeral, tibial and femoral levels of amputation or limb amelia/meromelia. The HiFi Technology is patented and patent-pending. Unauthorized use of  it or its trademarks is prohibited.

biodesigns’ research on lower limb HiFi sensorized interfaces measured real-time force profiles during ambulation, allowing us to better understand the effects of compression on tissue perfusion throughout the gait cycle. This data was valuable when creating our prosthetist training as improper compression could result in poor results and problems for wearers.

Elevating the creation of the prosthetic interface from a skill-derived solely from trial-and-error experience-to a measurable science with improved outcomes was part of the goal of our DARPA contract. During this project we designated key metrics to help determine what constitutes a successful socket fitting. Key interface measurement metrics analyzed during our IRB study included comfort levels, pressure, rate of rise of pressure, shear and slippage during movement under light and heavy load conditions. Our goal is to change the Standard of Care not with artful or decorative sockets, but scientifically proven designs.

(DARPA SBIR, Topic # SB151-001, Contract #D15PC00174)

For our DARPA Direct to Phase II+Option contract, biodesigns was tasked with developing a suite of innovative diagnostic and operational fitment tools allowing prosthetists of varying skill and experience to create improved, stable, and highly functional upper limb sockets. The tools created included a Sensorized Imaging Tool (SIT), an Adjustable Tether Fitting Tool (ATFT), Sensorized Socket Tool, (SST) and an Advanced Sensorized Socket Tool (SST+), all derived from the HiFi’s biomechanical principles of bone control through our patented and patents pending technology. The tools were tested, validated and proven successful by both clinician and wearer at different prosthetic facilities through an IRB study. A Phase II Option demonstrated feasibility of real-time interface adjustments using dynamic platforms matched to modular designs based on HiFi principles.

Traditional sockets for the shoulder disarticulation level historically have encompassed large areas of the body and shoulder. In the early 90’s Randall Alley introduced the biomechanically-focused custom X-Frame Shoulder Interface. biodesigns continues our evolution of this highly successful design with the ModX, a modular, sensorized version of the X-Frame, as part of our DARPA contract. The ModX features Instafit™, biodesigns’ new approach to delivering a sensorized and stable interface platform, especially ideal for the more advanced components.

Modular Prosthetic Interfaces are exciting to consider, but only if modularity does not sacrifice user performance, outcomes, reimbursement, and the role of the prosthetist. We are not supportive of off-the-shelf prosthetics, socket kits, sockets made purely by limb measurements, and other designs that promote modularity at the expense of performance. biodesigns’ Modular Interface Systems utilize our proven, patented and patents-pending compression technology, allowing our modular platform to be lightweight, streamlined, comfortable, adjustable, stable, strong, and biomechanically superior. Currently biodesigns has several patents for our modular interfaces with several pending.

The MOtion-Capturing Fast-Access Osseostabilizing (MOFO) Limb Exoskeleton improves field performance by providing a biomechanically-based, rapidly accessible, load-carrying and redistribution platform. The patents-pending MOFO is specifically designed as a dual-use, joint operations platform, to both stabilize and carry mission critical objects of a specific size, weight and shape more effectively and efficiently, saving the wearer time, energy and injury, without sacrificing range of motion or strength. MOFO designs point the way to improved device / equipment / communications attachment platforms, showing it is possible to be “one with your gear” and further demonstrates the many advantages of our HiFi/CRS approach over standard attachment methods. The MOFO can be configured for the mission or task at hand, intended for warfighters including Spec Ops soldiers, Astronauts, Police, Paramedics and first responders.