Farm

DJO Aircast AirSelect Walking Boot

Farm helped DJO become a leader in the category of orthopedic therapy products by developing the innovative Aircast walking cast. In 2013, Farm helped DJO build on that success with the creation of AirSelect, a breakthrough addition to the DJO product family that brings significant improvements in both product performance and user comfort.

Farm’s technical team, industrial designers, and human factors engineers developed the new sole design using wearable prototypes, advanced real-time testing, and computerized motion path analysis. The result is a product that helps the patient walk with a more natural gait.

Our engineers collaborated with DJO to design a unique compression pump and manifold system. The system provides easy-to-reach and operate controls and precisely distributes air pressure exactly where it’s needed to improve comfort and stability.

The previous Aircast had a sole made of rubber. For the new product, Farm engineers switched to Ethylene-vinyl Acetate (EVA), which makes the part significantly lighter and allowed us to incorporate DJO’s proprietary SoftStrike heel cushioning technology. At the same time, Farm strategically designed all of the plastic parts in AirSelect to minimize material use.

Farm created a shell design that supports DJO's long history of combining patient comfort with clinical performance. Part of that success depends on offering a wide range of sizes, creating a challenge in designing multiple shell, sole, and panel components for the various configurations. By creating a flexible and scalable CAD architecture, Farm was able to minimize engineering time for the 15 different size options required by the client.

To maximize the new walker's performance, Farm combined finite element analysis (FEA) with sophisticated rapid prototyping methods. This approach allowed the team to correlate FEA results with actual test data to accurately predict performance in the final molded and assembled product. The success of this approach was verified in testing of the first injection-molded parts.

The new AirSelect weighs 20% less than the previous DJO product, is easier to use, and offers a more comfortable experience for the patient.

Corindus Vascular Robotics CorPath Guidewire Delivery System

Corindus, a startup company working in the field of catheter lab robotics, challenged Farm to develop and refine their existing percutaneous coronary intervention (PCI) system; used by physicians to robotically control and deliver guidewires and other angioplasty devices to a target lesion deep inside a patient’s vascular system with enhanced precision and safety. The system is comprised of a robotically-driven, single-use cassette, robotic drive base, articulating positioning arm, and operator control console. Farm was tasked with completely redesigning the Corindus system to improve its performance, reliability and manufacturability.

Farm led the systems engineering effort for development of Corpath, including technology and requirements development; human factors, mechanical engineering, software and electronics design. In order to ensure wide clinical acceptance, an open architecture system was developed to support the dozens of guidewire, balloon and stent products currently manufactured by industry leaders. Developing intellectual property to secure competitive advantage in the market was essential for Corindus. To help our client achieve this goal, Farm developed proprietary and patentable technologies for driving and rotating coronary guidewires and devices, converted the durable cassette to single use, and engineered the interface of the cassette to the robotic drive base. To optimize access to the patient and ensure articulation and maneuverability of the catheter inside the body, our Human Factors team determined the impact of varying patient sizes to inform the articulating arm’s architecture and required range of motion. The guidewire and device loading process was simplified for users by minimizing steps and allowing easy identification of interaction points including levers and controls. One of the key benefits of the new system is that the physician no longer needs to wear a cumbersome lead apron to protect them from the X-rays that are used during a procedure to “see” inside the patient. When using the Corpath 200, the physician is able to perform PCI procedures while sitting within a lead-shielded control cockpit. The control console was designed to optimize the footprint inside an already crowded catheter lab, and includes an angled touch-screen, joystick and easy to navigate graphical user interface to minimizes head, neck, and back strain.

Concurrent to the specification and technology development, our team undertook the effort to commercialize the system. We delivered a reliable system architecture; mechanical, software and electronic sub-systems (including a custom, Windows-based single-board computer); single-use cassette design optimized for manufacturability; and fully functioning, pre-clinical prototype devices.

The Corindus CorPath 200 is the only robotic catheterization system to have received FDA 510(k) clearance for use in PCI procedures. In late 2015, they received a clearance for radial access procedures, and more recently, won FDA 510(k) clearance for the CorPath system to be used in peripheral interventions.

TransMedics Organ Care System

Farm collaborated with TransMedics to develop the world's first and only mobile live organ support system that allows a human donor heart or lung to travel for up to 4 hours while supporting the organ’s living functions.

The Organ Care System (OCS) is designed to maintain organs in a healthy, functioning state outside the human body while allowing real-time, clinical evaluation prior to transplant surgery. The portable, modular cart houses all elements of the system, including an oxygen supply and a perfusion pump that maintains the flow of warm, nutrient-rich blood to the organ.

Hot-swappable batteries provide full system power during transport, and are designed to be easily exchanged by an accompanying technician. Since it’s critical for the technician to be able to operate the system and assess the health of the organ during transport, Farm incorporated a detachable, wireless LCD monitor to display and control system functions. Finally, we designed the upper, detachable organ containment module to be easily carried by two people, using lightweight carbon fiber to manufacture most of the outer housing.

Farm has helped TransMedics achieve a true breakthrough in organ transplantation technology.

ConMed DetachaTip Multi-Use Reposable Instruments

ConMed, a leading manufacturer of surgical devices, asked Farm to help develop an improved version of its popular DetachaTip laparoscopy tool handle. ConMed challenged our team to design and engineer a new reposable (extended-use disposable) handle that would be more comfortable, offer greater control and precision, and address the wide range of hand ergonomics of surgeons’ personal working preferences. We had to design the handle ergonomics for female surgeons without compromising the fit for a large male hand, and the controls on the handle had to be accessible for right- or left-handed use. Finally, despite being a limited-use instrument, the device needed to convey high quality and durability with the precise feel of a long-term, reusable device.

Our team carefully observed several laparoscopic procedures and learned that we could create a truly differentiated product if we designed it for the varied approaches that surgeons use for gripping the tool. Surgeons usually hold these devices like scissors, but in order to rest their hands during a long surgery, they often shift to a technique called “palming,” where they cradle the tool in the palm of the hand. Yet another common grip approach is used when the surgeon holds the tool almost vertically.

Building on our extensive research, Farm began the process of designing the form of the handle and the tactile interaction points to accommodate surgeon work habits and ergonomic needs. As the overall design evolved, Farm’s engineers crafted the part design and internal mechanisms to achieve a highly precise feel in the operation of the product.

The new DetachaTip offers significant improvements designed to help surgeons work more effectively. When holding the new DetachaTip, the user’s fingers naturally fall into a comfortable position, no matter which grip approach is used, and it’s easy to access all controls. Ed Connell from ConMed’s marketing team said this: “When we put the new DetachaTip handle into a surgeon’s hand for the first time, they initially think it feels weird. But then they operate it, they realize that every handle they’ve ever used has been far less comfortable. Every surgeon who tries this tool loves it.”

Hologic Affirm Prone Breast Biopsy System

Based on the success of its award-winning Selenia Dimensions mammography system, Hologic returned to Farm for help developing the Affirm™ prone biopsy system, the first breast biopsy table to offer integrated 3D tomosynthesis scanning for superior imaging detail. In response, Farm and Hologic designed a breakthrough biopsy system whose next-generation technology is underscored by a more comfortable experience for the patient, a streamlined workflow for technical staff, and an iconic design evolution of Hologic’s visual brand.

Farm’s design of the Affirm™ prone biopsy system was driven by a comprehensive understanding of the interaction between the patient, the technologist, and the biopsy table. The Farm team observed multiple procedures, followed by one-on-one interviews with both patients and clinical staff, capturing the details of both the patient experience and the operational challenges faced by the technologists. Farm then conducted an ergonomic study of women, mapping how their bodies came into contact with the biopsy table. Guided by this gathered data, dozens of concepts were developed, refined, and fabricated for padding shapes, foam combinations, foot and arm supports, and access inserts. The result was a highly customizable and integrated support system that comfortably cushioned the patient in any position. Fully configurable, the system was designed to address various patient body types and allow complete access to biopsy targets.

The Affirm™ prone biopsy system delivers a new level of design innovation to the Hologic product family, offering better access to challenging lesion locations, a streamlined workflow that makes operation fast and easy, and an integrated support system that greatly increases the patient’s comfort.

In April 2016, Hologic announced the U.S. Food and Drug Administration (FDA) clearance and commercial launch of the Affirm™ prone biopsy system, the first dedicated prone biopsy system to offer both 2D and 3D imaging-guided breast biopsies.

Stryker Mako Robotic System

Farm’s collaboration with MAKO Surgical Corp. helped bring true product innovation to the hands of orthopedic surgeons by introducing a proprietary, interactive robotic surgical system for treating patients living with early to mid-stage osteoarthritis of the knee. The Rio® allows the physician to precisely resurface damaged areas of the knee without compromising the surrounding healthy bone and tissue. Our team focused Farm’s strategic, research-driven process on task analysis by observing live knee replacements and interviewing surgeons in an effort to simplify and refine the procedure. Early-stage mockups and subsequent prototypes then helped the team uncover greater efficiencies in the operating room, including a reduction in the number of procedure steps, while increasing operational accuracy and precision. Farm’s human factors experts helped create an ergonomic design solution that gives the surgeon complete freedom of movement and precise control of the robotic arm. At the same time, the system accommodates the size variations of users as well as patients.

The result? An extraordinary minimally-invasive surgical experience with reproducible precision for every patient. An added benefit—patients can return to an active lifestyle with far less recovery time and a smaller scar compared to total knee arthroplasty procedures.

Since its launch, the RIO® device initially gained FDA approval for partial knee resurfacing, followed by approval for total hip replacement, prompting Stryker Corporation to acquire MAKO Surgical Corp. for approximately $1.65 billion in 2013. In 2015, the FDA granted approval for RIO® to be used in total knee replacement procedures, further expanding its capabilities. According to Stryker officials, the company sold more than 40 of the RIO® devices in 2015, helping to power orthopedic net sales of $1 billion and further supporting claims by industry analysts that robotic surgery will account for 23 percent of total knee procedures in the next decade.