Research and Technology

Our Goal

biodesigns is best known as a pioneer of the interface revolution in prosthetics. Our insight, expertise and breakthrough product designs are born out of our understanding of human biomechanics and its relationship to device comfort, usability, and user acceptance. Innovation is our core driving force for our R&D as we create performance-enhancing interface products and systems for users of all ages, capabilities, and performance levels. But we go beyond simple improvements as we create revolutionary design platforms that can change a mindset, preconceived notions or even spawn a new category or industry.
Our ultimate goal is complete device embodiment, i.e. being one with the device attached. We have documented this in our prosthetic clinic as our HiFi Interface wearers regularly report their prostheses feel like a part of them, feel connected to them. Many report phantom sensations returning to their limb, allowing them to feel the ground and prevent falls. This degree of acceptance of a non-surgical attachment breaks the boundaries of what many thought was possible.
Our main product development areas include rehabilitation (helping someone quickly get back to where they were and then some), military/elite athletes (helping someone push beyond what they thought was possible) and lifestyle/recreational enthusiasts (helping someone at any level perform better).

High-Fidelity (HiFi) Interface and Imager System for Upper and Lower Limb Prosthetic Wearers

In our prosthetic clinic, we refuse to make the Standard of Care (SOC) “bucket” socket, as we feel it is 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 platform. Instead of having your bone flopping around inside your socket, our design captures and controls your underlying bone without surgery, resulting in a removable prosthesis that not only feels and performs better, but one that feels connected to you. Many of our HiFi wearers even report 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.

HiFi Modular Interface Technology for Upper and Lower Limb Prosthetic Wearers

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, prosthetic socket kits, sockets purely by measurements (i.e. no patient casting or scanning), and other modular sockets that promote modularity at the expense of performance. biodesigns’ Modular Interface Systems utilize our proven, patented and patents-pending compression and tissue release technology, allowing our modular platform to be lightweight, streamlined, comfortable, adjustable, stable, strong, and biomechanically superior to all other designs. Currently biodesigns has two patents  for our modular interfaces with more in the works.

X-Frame Custom and Modular Socket Technology for Upper Limb (Shoulder) Prosthetic Wearers

Traditional socket designs for the shoulder disarticulation level historically have encompassed large areas of the body and shoulder. In the early 90’s Randall Alley introduced the custom X-Frame Shoulder Socket which marked a turning point for interfaces at this level. Now biodesigns continues our evolution of this highly successful and stable design with the Modular and Sensorized X-Frame as part of our DARPA contract. The Mod-X features Instafit™, biodesigns’ completely new approach to delivering a sensorized and stable platform, especially ideal for the more advanced components including Mobius’ LUKE Arm.

Measurement Metrics for Prosthetic Interfaces

Elevating the creation of the prosthetic interface from a skill-derived solely from trial-and-error experience-to a measurable science 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. And we’ll drop a hint: it goes way beyond comfort and staying on! Users have put up with a lot of issues due to poor performing sockets based on art instead of science. We know you’re not putting your prosthesis on your wall and admiring it from afar, you’re using it to walk, run, lift and live so it must keep up with your needs and demands. Key interface measurement metrics analyzed as part of our IRB study included pressure, rate of rise of pressure (pressure profile), 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.

HiFi Training and Licensing for Certified Prosthetists

We know that access and geography is a big factor when choosing a prosthetist and not everyone can come to biodesigns in Southern California for their HiFi Prosthetic Interface System. We also know our interface technology is such a game changer for wearers that access to it is critical for short and long term rehabilitation, the prevention of sound side breakdown and osteoarthritis (OA). Therefore, we developed an innovative HiFi training and licensing model for certified prosthetists. Our prosthetist training elevates the skill of the clinician by teaching them the proven principles of the HiFi Interface and Imager System which is backed by clinical evidence, 1000’s of users worldwide, and pages of wearer testimonials. Prosthetists can learn the HiFi for radial, humeral, tibial and femoral levels of amputation or limb amelia/meromelia. The HiFi Interface and Imager Technology is patented and patent-pending. Unauthorized use of this technology or its trademarks is prohibited.

Adaptive Diagnostic Tooling for Customized Upper Limb Prosthetic Socket Fitment

(DARPA SBIR, Topic # SB151-001, Contract #D15PC00174)
For our Direct to Phase II plus Option, biodesigns was tasked with developing for DARPA a suite of innovative diagnostic and operational fitment tools allowing prosthetists of varying skill/experience to create improved, stable, and highly functional custom upper limb sockets. The tools biodesigns created for this contract 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 Interface’s biomechanical principles of bone control through compression and tissue release technology. The tools were tested, validated and proven successful (by both clinician and wearer) at three different prosthetic facilities through an IRB approved study. A Phase II Option demonstrated feasibility of real-time interface adjustments, using dynamic platforms matched to modular designs based on HiFi principles.

Motion-Capturing Fast-Access Osseostabilizing (MOFO) Limb Exoskeleton for Military, Law Enforcement, Early Responders

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 patent-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 on the wearer, saving time, energy and injury, without sacrificing range of motion or strength. MOFO designs developed at biodesigns 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/compression-release-stabilized (CRS) approach over standard methods. The MOFO can be configured for the mission or task at hand, intended for warfighters including Spec Ops soldiers, Astronauts, Police, Paramedics and other early/first responders.
Current attachment strategies are flawed, with users fighting against and exerting too much energy to control the connected device.
The core of our human connectivity approach is our patented and patent-pending compression and tissue release technology, also referred to as the High-Fidelity (HiFi) or Compression-Release-Stabilized (CRS). By controlling the bone within the limb with Osseostabilization™, we are able to create a syncing of the interface (and hence the external device connected to it) to skeletal motion, an effect dubbed Osseosynchronization™.
Interested in learning more about our technology, partnerships and commercialization efforts?