Hollis, NH (June 9, 2010) – Farm Design, Inc., a product development company for medical, life sciences and consumer health companies, announced today that the company has received a 2010 Gold Medical Design Excellence Award for its work on MAKO Surgical’s RIO® Robotic Arm Interactive Orthopedic System. The FDA-cleared RIO® Robotic Arm Interactive Orthopedic System is a revolutionary surgical device used to treat people living with early to mid-stage osteoarthritis.
The goal in developing this surgical device was to simplify a very complex system that uses advanced robotic technology and unique real-time 3D visualization software and transform it into an easy-to-use and intuitive device that allows surgeons to safely perform knee resurfacing procedures with speed, precision and confidence. Patients who undergo MAKOplasty®, a minimally invasive surgical procedure, experience the following benefits: reduced pain, a smaller scar and rapid recovery.
Farm worked closely with MAKO Surgical Corp. on the industrial design and ergonomics of the system. The biggest challenge was the integration of the surgeon with the robotic arm, due to the fact that early trials revealed that surgeons want to be in control of the cutting instrument, similar to traditional procedure methods. Farm’s human factors expertise helped create an ergonomic design solution that allows the surgeon to have complete freedom of movement and manipulation of the robotic system, while accommodating the size variations of users as well as patients. Farm also created the intuitive graphical user interface that guides the surgeon through each step of the procedure.
A CT scan of the patient’s knee is taken to pre-operatively determine the damaged area of the bone to be removed. The surgeon uses the 3D imaging software to create a plan for the precise removal of bone material and placement of the implant. Reflective arrays are placed on the patient’s legs so that an advanced camera and computer can track the patient’s skeletal structure to determine its exact position in space at any given time during the procedure. This allows the patient’s leg to be moved freely so the surgeon can place the knee joint in any position, allowing improved access. The system’s robotic arm floats freely while supporting the cutting instrument, and is guided directly by the surgeon throughout the procedure.
Real-time 3D geometry of the bone and the robot cutting tip is displayed on an overhead monitor— directly in the surgeon’s field of view—and guides the surgeon to remove only the diseased portion of the knee, sparing healthy bone and tissue. The surgeon simply follows the steps represented on the screen through a series of bone registration, tool calibration and bone cutting tasks. Images of the patient’s bones in the main window can be displayed as 2D or 3D views, just as in CAD software. As the surgeon shapes the bone, the real-time display shows the cutting tool and remaining material left to be removed at each stage in the process. The implant is then secured in the joint to allow the knee to move smoothly again.
The procedure, now referred to as MAKOplasty®, enables rapid patient recovery and improved anatomical functionality. Patients experience a shorter hospital stay (as little as one or two days, versus three to five days for a total knee), minimal blood loss, quicker rehabilitation and a smaller scar. MAKOplasty® is typically covered by most Medicare-approved and private health insurers.
Farm is a full-service, ISO 13485 certified and FDA compliant product development company with over thirty-five years of success in providing complete development and regulatory services for medical, life sciences and consumer health companies.
MAKO Surgical Corp. is an innovative orthopedic device company that markets both its RIO® Robotic Arm Interactive Orthopedic system and its proprietary RESTORIS® implants for minimally invasive orthopedic knee procedures.
Farm Design, Inc. and MAKO Surgical Corp. (Ft. Lauderdale, FL) attended the Medical Design Excellence Awards ceremony on June 9, 2010 in New York City at the Jacob K. Javits Center, in conjunction with the Medical Design & Manufacturing (MD&M) East Conference and Exposition. The Medical Design Excellence Awards competition is organized and presented by Canon Communications LLC (Los Angeles), and is the only awards program that recognizes contributions and advances exclusively in the design of medical products. Entries are evaluated on the basis of design and engineering features, including the innovative use of materials and user-related functions that improve healthcare delivery. Video – MAKOplasty® Animation – Patient Education.