Kambiz Behzadi Presents BMD at LSI Europe '23

The company is developing a novel medical devices to enhance the reliability and safety of orthopedics procedures.
Kambiz Behzadi
Kambiz Behzadi
President, BMD



Kambiz Behzadi  0:05  
Hello, my name is Kambiz Behzadi orthopedic surgeon in California back to talk to you about the alternative to robotics. In total hip arthroplasty. Total hip replacement is a $7 billion a year industry in the medical device companies have developed robotics to assist surgeons with these procedures. And yet despite this massive infusion of technology, this procedure is still plagued by problems namely aseptic loosening and mal positioning of implants. Together these problems account for nearly 75% of total hip replacement failures. Today I will explain why robotics have not been able to solve these problems and why robotics have failed to address the unmet needs of the orthopedic surgeon. Robotics as an assistive technology has been adopted and less than 1% of total hip replacements. My alternative has the potential to capture the entire market. Let's talk about why adaption of robotics and total replacement is so poor. robotic platforms provide the surgeon with a fixed arm that holds the position of the impaction growth as they impact the implant into bone. Although this was designed to benefit the surgeon by constraining the length of the implant, it actually produces a detrimental effect. The fixed arm disrupts the tactile feedback that the surgeon feels when they interact with the patient. So just rely on this tactile sense to determine whether the implant is stable within bone. Without this tactile feedback, the surgeon are more likely to install an implant either too loose or too tight, which results in aseptic loosening or fracture. Robotic performed also required that surgeons establish a global 3d coordinate system in the OR space. This requires application of trackers to bone landmarking registration of tools and calibration of all components, this process can take between 20 to 30 additional minutes. Establishing the system requires the surgeon commit extra time to the operation, which increases the risk of infection and blood loss for the patient. The extra workflow also creates increased risk of error for the surgery. This extra workflow is not capable of being delegated to others. Thus, robotic platforms create more for the surgeon to plan keep track of and do during this operation. This poses a major problem because the surgeon has a finite amount of time and attention during the operation. And this additional cognitive load causes the surgeon to split his focus away from the patient and the strategy itself. And beyond these problems, robotic platforms have never directly addressed the unmet needs of the orthopedic surgeons. This platform still cannot prevent aseptic loosening aseptic loosening occurs because surgeons do not have the proper tools to press fit implants reliably. Surgeons still have to use a mallet and their own tactile sensors to press fit implants. And the mallet gives a no control of either the magnitude or the direction of force. And with respect to my positioning, the robotic arm offers only minimal benefit to the surgeon because although it lacks the alignment of the implant, it does not allow easy adjustment of the implants position we which is sometimes necessary for obtaining better stability. Thus, robotic systems remain unsophisticated because they require the use of a primitive knowledge in any systems always as weak as its weakest link. Develop an alternative that directly addresses these problems or new approach involves two fundamental changes in how we install implants. First, we use vibration energy instead of discrete impacts to install implants and second, we use local positioning systems for visibility of the implant instead of the global positioning system of the robot. vibration energy decreases the frictional forces at the implant bone interface this allows surgeons to have complete control over both the magnitude and direction of applied force. This allows implant installation to be done with less force as well as surgeons cannot modulate the amount of force which helps them reach the sweet spot of optimal infant stability. Vibration also allows surgeons to control the direction of force and therefore the positioning of the implant. Addition of IMU sensors to vibratory insertion tools in combination with screws sensors in bone create local positioning systems, which allows surgeons to visualize and continuously adjust the alignment of the implant. I'd like to show you a short video that encapsulates this concept the setup for vibratory insertion and local positioning systems is very simple and involves a screw sensor, a computer a vibratory insertion tool and receiver. This method does not involve establishing a global 3d coordinate system in the OR space is based on a local positioning system which can be set up in one minute and which can wirelessly communicate with your phone or your computer. By pairing vibration with the local positioning system and IMU technology the surgeon can now visualize and continuously adjust the alignment of the implant. This tool is lightweight and handheld and because it's not affixed to anything the surgeons tact feedback is maintained. Thus the surgeon will have greater ability to assess the stability of the implant. Managing leg length and offset is a critical part of any total hip replacement, both for stability of the implant and also to prevent leg length discrepancies, which is the most common cause of lawsuits in orthopedics. The school sensors allow surgeons to obtain perfect leg length by allowing them to monitor leg length and offset effortlessly during the operation. These tools add no extra work for for the surgeon, they require no additional personnel to operate. And the surgeon is not burdened with additional tasks and concerns when using this tool. The focus can remain where it belongs on the patient and the procedure. And perfect ligaments. Over the last decade, total hip replacement complications have increased at the same time. Meta analysis have shown no significant difference in outcomes complications and revision rates between traditional and robotic assisted hip replacements. 1 billion total hip replacement procedures are performed annually. This is a large market with persistent problems and no adequate solutions. Whoever develops technologies that decrease the risk of failures and revisions stands to gain market share and control the total hip implant and dispose of the market. My technology provides this opportunity. Current robotic systems cost up to $1 million require additional personnel to operate. And such personnel are not readily available and required training. where technology is low cost at $30,000 requires no additional personnel is intuitive for the surgeon and requires minimal training for use. And finally, this technology frees the surgeon to perform the operation with whatever approach they desire, given them the confidence that they can achieve both optimal primary inputs, the stability and the exact desired alignment. I'm already working with several universities and private engineers to develop these tools. I'm seeking additional funding to help commercialize these projects. If you have interest in this project, please let me know and I would love to tell you more about it. Thank you

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