Farm, a Flex company, is a full-service, ISO 13485-certified product development company with over 45 years of experience providing award-winning development services for medical, life sciences, and consumer healthcare companies. We offer expertise in User Research, Human Factors Engineering, Industrial Design, User Interface Design; Mechanical, Electrical, and Software Engineering; Usability Testing, Pilot Production Support and Regulatory Compliance.
Farm is located one hour north of Boston, our unique facilities consist of a development center featuring design, development, assembly, and test facilities and a business center located in a restored circa-1740 colonial. In August 2010 Farm opened a third office in the Global Cardiovascular Innovation Center (GCIC), a business incubator led by Cleveland Clinic located on the southern edge of Cleveland Clinic’s main campus and near the main campuses of Case Western Reserve University and University Hospitals.
DJO Global, Aircast AirSelect
Ten years ago Farm helped DJO become a leader in the category of orthopedic therapy products by developing the innovative Aircast walking cast. In 2013, Farm is helping 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.
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.
CareFusion, Snowden-Pencer® Take-Apart Laparoscopic Instrument
Because Farm played a key role in developing Cardinal Health’s Diamond-Line® Instruments, CareFusion, a Cardinal Health spin-off, chose to collaborate with Farm on a new line of reusable, take-apart laparoscopic tools that support safe cleaning and sterilization protocols for reusable medical devices.
Farm worked closely with Cardinal Health to establish and validate user requirements for the new tools, beginning the project with an international, ethnographic user research program. The resulting data helped Farm design innovative mechanisms for intuitive articulation and verifiable reassembly, and helped the team conduct usability validation testing to ANSI/AAMI ST79:2006 and AORN 2007, standards which ensure that device manufacturers make thoroughly cleanable devices and include instructions for sterilization and handling.
Working from the brand identity and ergonomics of the Diamond-Line®, Farm generated several concepts with varying component configurations (hyper-extending thumb bow, breech load, side load, inner pawl, rear lifter) that address the requirements for easy cleaning and sterilization. To prevent accidental part disconnection, Farm developed intuitive tactile and audible snap-in-place parts and markings to help ensure proper assembly. Farm maintained the original multi-dexterous handle and integrated ratchet to give physicians comfortable and intuitive control during surgical procedures. The patented ring-handle design accommodates both precision and palm-style grips while minimizing hand fatigue.
The final design is based on user testing of working prototypes, and its features include three take-apart components that are easy to clean, sterilize, and inspect, creating a more cost-effective alternative to traditional disposable instruments.
Cook Medical, NavAlign IVC Filter Delivery System
Pulmonary embolisms (PE) affect thousands of Americans each year, and if left untreated, can kill one out of three individuals. PEs occur when a blood clot becomes dislodged from the vein wall and migrates to the lung, blocking blood flow in the pulmonary artery. To combat this life-threatening condition, surgeons implant IVC filters to trap embolisms before they can cause damage. Cook Medical partnered with Farm to redesign their existing IVC filter delivery system to make it easier to install these life-saving vascular devices.
Farm conducted human factors and usability research, including surgeon interviews and extensive task analysis, to better understand the physical and cognitive steps required to position and deploy a filter. We discovered unnecessary steps in the workflow as well as critical elements of the existing design that contributed to user error and possible misalignment of the filter. The team then created concepts that addressed these issues and tested them with users to compare single or two-handed approaches, as well as to define many ergonomic and cognitive improvements.
Farm's filter delivery system eliminates the effects of pull/push and rotation on the filter, reducing the potential for misalignment. We designed a unique tactile feedback feature into the delivery tool that lets the user feel when the filter is in the correct location. This allows the surgeon to watch the display monitor and eliminates premature deployment. We also reduced the number of steps needed to complete the deployment of the filter, and engineered the product to be more cost-effective to manufacture. The result is a simplified device that features precise control, increased accuracy, and improved device efficacy.
The NavAlignTM system has exceeded user expectations. It is a totally unique and highly intuitive device that includes features unavailable on any other IVC filter delivery system on the market today.
Cooper Surgical, Sensiport Laparoscopic Trocar
When Cooper Surgical came to Farm, it was with the goal of improving the function and reducing the cost of manufacturing of its Sensiport Laparoscopic Entry System. By employing advanced materials and manufacturing processes, including one of the industry’s first Titanium Nitride-on-Aluminum combinations, Farm showed Cooper Surgical how the Sensiport System could be manufactured with fewer parts and greater efficiency.
Farm’s innovative enhancements allowed Cooper to reduce the production costs of the Sensiport by 50% and reduce its overall weight. This critical weight reduction lets the surgeon more reliably position the trocar within the surgical site and control its operation during surgery.
Farm also improved the existing shield-lock safety mechanism by altering its mechanics. This refined safety mechanism prevents a dramatic increase in the pressure required for surgeons to perforate the patient’s tissues, allowing more precise incisions and safer procedures. The result? A better trocar that enhances our client’s bottom line.
Covidien, Kendall SCD 700 Series Controller
Covidien, a recognized global innovator in intermittent pneumatic compression (lPC) technology, chose Farm for the engineering, human factors, graphical user interface, and design of its compression controller. The Kendall SCD™ 700 Series Controller, used in conjunction with the Kendall SCD™ Sequential Compression Comfort Sleeve, helps reduce the incidence of potentially fatal venous thromboembolisms by delivering sequential, gradient, and circumferential compression to the leg.
Farm's team conducted generative research to gain a better understanding of the use environment and the device's elements of interaction with patients and clinicians. Field research uncovered unmet user needs, including the ability to operate the device with one hand, a flexible yet secure method for attaching the device securely to hospital bedrails of varying widths, and a simplified GUI.
Instead of using a typical off-the-shelf medical monitor mount, Farm’s development team focused on creating concepts that could integrate the bed rail mount and actuation mechanism into the overall form of the device. Prototypes were fabricated for mechanical feasibility and models were created for preference testing, resulting in the selection of a single clip / angled arm design. Multiple refinements were completed to optimize the design based on performance, ergonomics, development risk, cost, reliability, and manufacturability.
Emphasis on early detailed engineering and Finite Element Analysis greatly influenced the component design and reduced development time. Farm also improved the controller by working with sound experts to mitigate pneumatic pump noise by designing and implementing a muffler and foam enclosure to aid in pump vibration isolation.
The collaboration between Farm and Covidien brought the new controller from concept to commercialization in just 14 months. The result was a single-handed use device that mounts securely to the various hospital bed rails found on the market today. A large display with strategically placed buttons and animated icons provides users with real-time status feedback, improving controller functionality, ease of use, and overall operation. The Kendall SCD™ Sequential Compression Comfort Sleeve and the Kendall SCD™ 700 Series Controller received 510(k) clearance from the U.S. Food and Drug Administration on November 4, 2010.
Echo Therapeutics, Prelude SkinPrep System
Echo Therapeutics, a startup company with a prototype skin permeation technology, collaborated with Farm in the development of a safe, painless, and needle-free alternative to traditional drug delivery therapies and non-invasive glucose monitoring. Echo’s device allows clinicians to permeate the outermost protective layer of the skin and is intended for use in hospital critical care units.
Farm was responsible for the complete design, systems engineering, and prototyping of the device, including two critical device-to-patient disposables that play an important part in the overall delivery therapy. Operating under Farm’s design controls, the systems engineering team conducted a feasibility study of Echo’s existing proof-of-concept prototype. Engineers then identified, recorded, and analyzed functional and performance data to help them understand any deficiencies in the existing design and the necessary changes required in order to meet product requirements.
Farm was responsible for all component selection and for developing and testing a refined system architecture, including software and hardware. Throughout the development process, we built several fully-functional units for engineering evaluation, for verification testing, and for clinical trial use in proving device efficacy.
To date, Echo Therapeutics has successfully used the Prelude™ SkinPrep System to increase the permeability of the skin, allowing for analyte extraction and drug delivery in both internal and external clinical trials. A 510(k) submission for market clearance is expected, and additional applications for painless, needle-free delivery of medications and blood glucose monitoring are planned for the future.
Hologic, Selenia Dimensions breast tomosynthesis system
Farm collaborated with Hologic to develop Selenia Dimensions, their next generation mammography system featuring Tomosynthesis 3D imaging technology. Selenia Dimensions offers more accurate imaging and a better user experience for both the patient and the operating technician.
Farm conducted observational research and one-on-one interviews to better understand the habits and practices of technicians, and the ways in which patients interact with the device. These findings led to the creation of an innovative “flush” form that greatly improves patient comfort by integrating patient interaction areas into the surface of the enclosure. The team then redesigned the device controls to optimize their accessibility and ease of use while strategically locating them to avoid inadvertent contact with the patient and accomodate the rotational movement of the system.
In addition, Farm developed an entirely new workstation with an array of new features, including an enhanced graphical touch screen interface and proprietary x-ray exposure controls that greatly eliminate repetitive joint motion and user fatigue. These ergonomic improvements, integrated with the new design language, leverage Hologic’s brand equity and highlight the new “Tomo” technology as representing a significant leap forward in women’s healthcare.
MAKO Surgical Corp., Rio® Robotic Arm Interactive Orthopedic 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.
IDEV Technologies, SUPERA® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System
IDEV Technologies, an emerging medical device company and developer of endovascular and interventional applications, developed the first transhepatic biliary wire interwoven nitinol self-expanding stent that offers unsurpassed strength, flexibility, durability, and conformability even with joint flexion.
Farm partnered with IDEV Technologies in the development of the SUPERA® delivery system. To gain a deeper understanding of technology and usability issues, Farm conducted a competitive audit of existing devices on the market. We then observed multiple procedures and conducted interviews with physicians and technicians. Each step of the process was evaluated (storage, preparation, positioning, deployment, and removal/disposal) for ergonomics and usability optimization. Our analysis of the resulting data led to key recommendations for design development as well as initial architectures focused on simplifying steps, minimizing hand repositioning, and single-hand use. Farm built three interactive device prototypes for the 2008 Vascular Interventional Advances (VIVA) Conference and conducted preference testing with ten physicians to narrow down the control scenarios and ergonomic form. Rapid iterations of 3D models through the subsequent development process helped us verify the ergonomics as well as the industrial design identity of the device. Farm was also responsible for the engineering development, including all control mechanisms and part design. Key improvements included:
- Packaging that allows flushing of the device prior to removal
- Integrated rear flush ports to reduce snagging of bed sheets and improve access
- Reduction of prep, delivery, and removal steps
- Low-profile handle features that won’t snag
- Handle form and slider design that mitigates hand and thumb repositioning
- Full single-hand use throughout the procedure
The new device not only allows for more precise stent placement, but gives physicians increased accuracy with fewer steps required for preparation and delivery.
Medtronic/CryoCath, Technologies Arctic Front® Cryoballoon
With 400,000 new cases every year, atrial fibrillation is the most prevalent cardiac arrhythmia affecting over four million patients worldwide.
The Arctic Front® cryoablation device delivers a refrigerant through an inflatable balloon to freeze tissue and disable unwanted electrical circuits that contribute to paroxysmal atrial fibrillation (FAB). The cryoballoon catheter is introduced into the heart’s left atrium and positioned in the opening of the pulmonary vein. Once positioned, the surgeon expands the balloon, causing occlusion, and freezes the tissue by releasing refrigerant into the balloon.
Farm developed the industrial design and human factors of the device’s delivery handle and conducted user testing to verify optimal shape and control scenarios. Comfort, size, flexibility, and the ability for the physician to steer and retract the catheter’s balloon tip easily and safely were key factors that needed to be addressed in the updated device. Farm developed a new handle shape and refined the rotational/pivoting lever, allowing the physician to steer the tip using only his/her thumb. The exact shape and pivoting force of the lever was optimized to improve positioning accuracy. For ease of retraction, Farm implemented a sliding control that stretched the balloon, thus reducing its diameter and allowing it to be retrieved into the catheter safely and without damage.
The end result was significant improvement in ease of use and safety of the device. The Arctic Front® cryoablation device became Cryocath’s flagship product, prompting global medical technology leader, Medtronic, to acquire the company in 2008.
Perkin Elmer, Liquid Chromatography System
Farm’s Industrial Design work for PerkinElmer harnessed a comprehensive range of new liquid chromatography products into a cohesive and integrated offering with a single brand voice. The new Flexar™ system is a model for efficiency and flexibility in liquid chromatography analysis. It offers an array of interchangeable products designed to meet the needs of a variety of users and applications. Each component is designed with a fixed outer dimension and consistent materials – that in any configuration – maintain a solid, integrated appearance. Other unique design innovations include a system of sub-bezels and tubing management features that accommo¬date all possible configurations, and provide improved usability and enormous consistency across any combination of products.
12 Silver lake Road
Hollis, NH 03049
Farm, Cleveland Clinic
Global Cardiovascular Innovation Center
10000 Cedar Avenue
Cleveland, OH 44106
Email: email@example.com (link sends e-mail)
Contact Name: Dan O'Sullivan, Director of Industrial Design
User Research, Human Factors Engineering, User Interface Design, Industrial Design, Systems Engineering (Mechanical, Electrical, Software), Usability Testing, Pilot Production Support and Regulatory Compliance.