26 March 2012

Farm’s Director and Program Manager, Darrin Manke, is featured in Medical Design Technology magazine’s March 2012 issue in a section titled Perspectives on Design Challenges. Darrin provides insights on one of the most challenging design obstacles he’s faced in the development of a medical device.

From the MDT feature: “One key obstacle is successfully entering the healthcare market with a disruptive technology. A disruptive technology is a new technology that has the ability to create a new market and may eventually displace earlier technologies and/or methods of performing a task or procedure. This new method or technology must provide real improvements in performance, cost, time, features, clinical outcomes, and be easily adopted by existing users. User adoption is critical, which usually means the technology has to be designed in a way that it can be integrated into current workflow and methods, and not require extensive training. Easy integration means increased adoption and ultimately leads to market penetration.”

6 March 2012

ZOLL Medical’s Propaq MD was recognized at EMS Today 2012 as a top product at this year’s conference, held in Baltimore Maryland. Farm worked on the development of the Propaq MD, which was designed for military and air medical operations and combines the proven features of Propaq monitors with the capabilities of ZOLL defibrillation and non-invasive pacing technologies. The device is amazingly small and lightweight, weighing only 10 pounds. Capabilities include a large, high-contrast color LCD display, a full 12-lead ECG for on-screen review, and night vision goggle (NVG) mode for military and air medical nighttime operation. Monitoring capabilities include heart rate, SpO2, ETCO2, respiration, non-invasive blood pressure, two temperatures, and three invasive pressures. The device is capable of monitoring all patients, whether adult, pediatric, or neonatal.

The Propaq MD is the only FDA-cleared airworthy defibrillator to provide monitoring of three invasive pressures necessary for treating critical patients during long transports.

2 November 2011

In the episode titled “Heart-Shaped Box,” “the residents are inspired by a medical miracle when they witness a harvested heart that continues to beat outside the body.” – Official episode description. The plot focuses on the challenges that surgeons face when dealing with transplantation and illustrates how warm blood perfusion may benefit patients awaiting a donor heart. Farm helped develop TransMedics’ Organ Care System, the world's first and only system that allows a living organ transplant. The OCS™ HEART is not commercially available in the U.S. It is undergoing clinical investigation in the PROCEED II trial at leading heart transplantation centers.

The system is commercially available in Europe and Australia and is in clinical use in many leading heart transplantation centers.

26 October 2011

Farm is thrilled to announce that our former client, Viaflo, now part of Integra Biosciences, is one of five finalists in this year’s 2011 NH Product of the Year Award, sponsored by the New Hampshire High Tech Council.

Integra’s VIAFLO 96, introduced in January, is as easy and effortless to use as any single-channel pipette and can draw or dispense material from 96 pipettes at a time in a variety of configurations. Pipettes, which are employed for life science research, are tiny tubes used by lab workers to draw and release very small, but very precisely measured, amounts of liquid. Four different pipetting heads are available for the VIAFLO 96, which can be interchanged in a matter of seconds, allowing lab workers to perform a wide set of applications with volumes ranging between 0.5µl and 1250µl.

In a recent article featured in the Nashua Telegraph, titled “High-Tech Lab Pipettes Drive Hudson Firm’s Sales,” Farm was credited with much of the design work for the device. The winner of the 2011 NH Product of the Year honors will be decided November 14, 2011. Farm wishes Integra’s VIAFLO 96 the best of luck!

20 September 2011

Ergonomics in Design (EID) magazine, a publication affiliated with the Human Factors and Ergonomics Society (HFES), recently honored Farm’s director of research and usability, Beth Loring, and senior industrial designer, Erin Lemieux, with a Best Ergonomics in Design Article Award.

Erin and Beth were honored at the HFES annual meeting in Las Vegas on September 20, 2011, for their collaboration on the article, titled "User Research Improves Laparoscopic Instruments.” A panel of four EID editorial board members and four HFES Fellows remarked how well Loring and Lemieux wrote their article, with a style that was “clear, informative…that noted a good practice of user-centered design.”

The case study discusses the redesign of a laparoscopic instrument handle and takes the reader through the steps of observation, interviews, ranking exercises, data analysis, design requirements, concept development, iterative user testing, and the final design, all in a succinct, practical way that the judges said was “very complete… a textbook-like article”. In the judges’ words, the case study shows “the practical value” of good user-centered practice and design.

Download the award-winning case study “User Research Improves Laparoscopic Instrument.”

24 August 2011

It all started back in the summer of 1971, when Farm’s founder, Dave Roche, began working as an independent contractor. In 1982, Jack Harkins, Farm’s president, joined Dave Roche and together created Roche Harkins Design. In 1992, Mark Baerenrodt joined the firm as an industrial designer, and in 2000 became Jack’s partner after Dave retired. For close to 20 years, Roche Harkins Design developed consumer, medical, and laboratory products, focusing on industrial design services with an emphasis on mechanical engineering and manufacturability. In 2000, Roche Harkins made the strategic decision to focus primarily on the development of medical devices and instruments. In 2002, the firm chose to leverage the medical focus by changing the name of the company from Roche Harkins Design to Farm. This decision was made to create a recognizable and memorable brand, and to reflect the evolution of what the company had become.

The name Farm is not only a statement of what we do by bringing new technologies and products to market, it is also a reflection of where we are located, our culture, and our values as a company. Farm is proud to be celebrating 40 years of experience providing complete development services for medical, life sciences, and consumer health companies.

15 August 2011

Medtronic has been recognized as a 2011 R&D 100 award winner for the development of the Arctic Front^® Cardiac CryoAblation Catheter System. The minimally invasive balloon-based system is used to treat patients with abnormal heart rhythms, also referred to as atrial fibrillation. The device creates circumferential lesions around the pulmonary vein—the source of the erratic electrical signals—and freezes the surrounding tissue. Farm assisted in the development of the Arctic Front^® Cardiac CryoAblation Catheter System, contributing to the industrial design and human factors of the device.

1 August 2011

Securus Medical Group, a biomedical technology startup, has chosen Farm to partner with to develop and commercialize its flagship product, the L-View Probe. Securus is developing a technology that provides real-time temperature mapping within a hollow body cavity which is expected to have several clinical applications where the risk of thermal organ damage is high. The technology hopes to provide clinicians with a simple to use, real-time, noncontact, thermal map of body cavity tissue temperature. This information will guide the physician to achieve the desired clinical outcome without risk of injury to surrounding tissue.

Securus, which relocated from Boston to the Global Cardiovascular Center in July, selected Farm to aid in the software, electronics, mechanical packaging, human factors, and industrial design of the new device. Farm’s experience in cardiovascular applications and onsite office at the GCIC will give Securus the full support and guidance necessary to develop the L-View Probe technology, the world’s first temperature mapping system.

Securus has already received a $350,000 grant from Cleveland Clinic’s Global Cardiovascular Innovation Center (GCIC). And on August 1, JumpStart Inc. and RiverVest Partners announced a co-investment of $750,000 to fund the product development effort.

29 July 2011

Farm’s director and program manager, Darrin Manke, was interviewed recently for Medical Product Outsourcing (MPO) magazine’s July/August 2011 issue. In the article, titled “Finding the Right Balance,” Darrin describes how Farm’s user-centered design approach increases creativity in uncovering unarticulated user needs while developing medical technologies and devices for clients. Darrin points out the relevance of the FDA’s “Medical Devices – Application of Usability Engineering to Medical Devices” (IEC 62366:2007) and the long-awaited standard ANSI/AAMI HE75:2009, a huge compendium of human factors design guidelines and best practices. The article goes on to highlight how medical device designers must merge aesthetics, performance, and efficacy in today’s medical device industry to remain competitive.

8 June 2011

Farm has been honored with a 2011 Gold Medical Design Excellence Award (MDEA) for work on the Selenia Dimensions tomosynthesis (3D) breast mammography system. Farm worked with Hologic on the industrial design, human factors engineering, and user interface for the Selenia Dimensions system. The first commercially available tool to deliver on the extraordinary promise of breast tomosynthesis, the mammography system provides digital 2D and 3D images of the breast, giving radiologists the ability to identify subtle tissue changes in an effort to revolutionize how breast cancer is detected today. To view the official press release - click here.

Farm and Hologic were honored at the Medical Design Excellence Award presentation ceremony on Wednesday, June 8, 2011, at New York City's Jacob K. Javits Convention Center, held in conjunction with the MD&M East Conference and Exposition.

Photo (courtesy of Hologic): Nikos Gkanatsios, Georgia Hitzke, and Ian Shaw from Hologic (left to right) and Darrin Manke, Director and Program Manager at Farm Design, Inc.(far right) accepting the award from Paul Miller, CEO of UBM Canon and UBM Electronics.

1 June 2011

Farm’s business development manager, Brian McLaughlin, is featured in Orthopedic Design & Technology magazine’s May/June 2011 issue. In the article, titled “Turnkey=Survival,” McLaughlin weighs in on the different implant materials and coatings that manufacturers and suppliers are utilizing to remain competitive in an industry where design for manufacturability is key to survival.

6 April 2011

Farm is pleased to announce that it is a named supplier for a 2011 Medical Design Excellence Award (MDEA) winning product. Farm collaborated with Hologic on the Selenia Dimensions tomosynthesis (3D) system. The Selenia Dimensions system constructs 3D images of the breast, giving radiologists the ability to identify subtle tissue changes that may not be seen with typical 2D mammography. As a result, recalls may be reduced, unnecessary biopsies may be eliminated, and breast cancers may be identified earlier.

Farm is responsible for aiding in the development of the workstation, enhancing the graphical touchscreen interface, and improving ergonomics that include proprietary X-ray exposure controls which greatly eliminate repetitive joint motion and user fatigue.

The MDEA winners will be honored on Wednesday, June 8, in a presentation ceremony at New York City's Jacob K. Javits Convention Center. The ceremony is being held in conjunction with the June 7-9, 2011, Medical Design & Manufacturing (MD&M) East Conference and Exposition. Farm will be exhibiting at booth 942.

4 April 2011

TransMedics, a client of Farm’s, recently announced that its portable lung perfusion system has been CE marked in Europe. The OCS^TM LUNG was developed by TransMedics to address the limitations of current cold static lung preservation methods. The OCS^TM LUNG is a portable, warm perfusion and ventilation system with built-in monitoring capabilities for lung transplantation.

Farm worked with TransMedics on the Organ Care System (OCS), which received a 2007 Medical Design Excellence Award. TransMedics will be presenting “Long Term Clinical Value of OCS^TM HEART and Initial Clinical Experience with OCS^TM LUNG” on April 13 at the Hilton San Diego Bayfront Hotel in San Diego, CA.

4 March 2011

Medtronic announced on March 4, 2011, that it received European regulatory approval for the Achieve electrophysiology mapping catheter. The Achieve is used for the assessment of pulmonary vein isolation when treating paroxysmal atrial fibrillation. Farm worked with CryoCath on the Arctic Front cryoballoon ablation system, now marketed under Medtronic's CryoCath business unit and used in conjunction with the Achieve Mapping Catheter. Medtronic received FDA approval for the Arctic Front System on Dec 17, 2010. The Achieve Mapping Catheter is deployed through the Arctic Front guidewire lumen, and features eight evenly spaced electrodes on a loop, enabling physicians to map electrical conduction among the left atrium and pulmonary veins. The catheter helps physicians assess pulmonary vein potentials both before and after cryoablation as well as time-to-effect during cryoablation.

1 March 2011

On March 1, 2011, Echo Therapeutics announced it had received the 2011 North American Frost & Sullivan Technology Innovation Award in Pharmaceuticals and Biotechnology in recognition of its Prelude^TM SkinPrep System breakthrough technology. Farm was responsible for the complete design, systems engineering, and prototyping of the Prelude^TM SkinPrep System, including two critical device-to-patient disposables, which are an important part of the overall delivery therapy. Echo Therapeutics is now accelerating the device manufacturing validation and getting ready for commercial launch. Marketing efforts are expected to kick off in the third quarter 2011 pending FDA approval.

3 February 2011

Farm’s Director of Business Development, Marc Dubreuil, was interviewed for Orthopedic Design & Technology magazine’s January/February 2011 issue. In the article, titled “More Tools in the Toolbox,” Marc Dubreuil discusses the importance that medical device manufacturers are placing on human factors and usability in an effort to improve device performance and safety and to reduce errors. Marc candidly talks about Farm’s usability process, Farm’s focus on user interaction, and the importance of user research when working with clients.

26 January 2011

Corindus Vascular Robotics announced on January 26, 2011, that it has been granted FDA Investigational Device Exemption (IDE) conditional approval to evaluate the safety and effectiveness of its CorPath® 200 System. Farm was involved in the development effort of the CorPath® 200 System, which allows interventional cardiologists to perform robotic-assisted placements of coronary guidewires and stent/balloon catheters from a cockpit during percutaneous coronary intervention (PCI) procedures. PCI is performed by interventional cardiologists in a catheterization laboratory (cath lab) utilizing X-ray angiography imaging.

Essentially, the CorPath® 200 System is an ergonomically optimized cockpit designed to protect interventional cardiologists from radiation exposure while enhancing visualization and minimizing fatigue. The IDE approval will allow Corindus to evaluate the safety and effectiveness of its CorPath® 200 System and begin its pivotal trial, CorPath PRECISE (Percutaneous Robotic-Enhanced Coronary Intervention Study), which will closely monitor the radiation exposure of interventional cardiologists while using the CorPath technology and compare the findings to the radiation exposure experienced while performing the procedure at the table. The trial is a prospective, single-arm, multi-center study, which will initially enroll 154 patients.

The CorPath PRECISE trial will be conducted at leading medical centers across the United States, including Columbia University, St. Elizabeth’s Medical Center, Virginia Commonwealth University Medical Center, and St. Joseph’s Hospital Health Center.

3 November 2010

On November 3, 2010, IDEV Technologies, a leader in the development of medical technologies for endovascular and interventional applications and a client of Farm’s, announced U.S. Food and Drug Administration (FDA) 510(k) clearance to market the SUPERA VERITAS Transhepatic Biliary System. The SUPERA VERITAS delivery system is currently cleared in the U.S. for palliative treatment of biliary strictures produced by malignant neoplasms and is used to deploy the SUPERA^® wire interwoven nitinol stent. The SUPERA VERITAS delivery system provides easier deployment of the SUPERA^® stent compared to earlier systems, eliminating multiple steps previously required for preparation and delivery, giving operators more precision. Commercial availability of the SUPERA VERITAS Transhepatic Biliary System is planned for the first quarter of 2011.

28 October 2010

In a recent interview by Fresh Water magazine, Farm’s Director of Business Development, Marc Dubreuil, and Tom Sudow, Director of Business Development at the Global Cardiovascular Innovation Center (GCIC), talked about Farm’s new office at Cleveland Clinic’s GCIC facility. Fresh Water, a weekly e-magazine and website, reports on Northeast Ohio organizations and neighborhood developments with a focus on technology, innovation, and entrepreneurship.

Read the full article—Clinic's Cardiovascular Incubator Adds Top Product Developer to its Growing Crop of High-tech Firms

25 August 2010

Echo Therapeutics, a client of Farm’s, recently announced the completion of a clinical trial of its Prelude SkinPrep System, which Farm helped develop. The device allows clinicians to permeate the outermost protective layer of the skin, offering patients a safe, painless, and needle-free alternative to traditional drug delivery therapies and non-invasive glucose monitoring.

The clinical study evaluated the ability of Prelude to ablate the skin prior to the application of OTC 4% lidocaine cream for faster-acting, local dermal anesthesia. As a result of the successful clinical trial, a 510(k) premarket notification to the FDA is expected and additional applications for painless, needle-free delivery of medications and blood glucose monitoring are planned for the future.

Check out the MedGadget article and Echo press release.

2 August 2010

Farm is pleased to announce that it has been invited by the Global Cardiovascular Innovation Center (GCIC), led by Cleveland Clinic, to open an office in the new GCIC Incubator Facility, located in the Cleveland Health-Tech Corridor, one of the leading biomedical, healthcare, and technology regions in the nation.

The GCIS Incubator Facility is a $250M, 65,000-square-foot building strategically located on the southern edge of Cleveland Clinic’s main campus and near the main campuses of Case Western Reserve University and University Hospitals. Companies with offices in GCIC have access to researchers, physicians, laboratories, business services, and the full breadth and success of the Cleveland Clinic to support startup technologies and ventures in cardiovascular applications.

Farm’s onsite office will give GCIC’s startup companies the ability to access Farm’s full development support and guidance in the areas of user research, human factors engineering, user interface design, industrial design, systems engineering (mechanical, electrical, software), usability testing, pilot production, and regulatory compliance. Farm’s expertise will help these new companies develop solutions to commercialize innovative medical products and technologies. Read the featured article on MedCity News.

8 July 2010

Farm and MAKO Surgical have been chosen by an independent judging panel and the editors of R&D Magazine to receive a 2010 R&D 100 Award for the Rio® Robotic Arm Interactive Orthopedic System. The award recognizes the hundred most technologically significant products introduced in the past year. Since 1963, the R&D 100 Awards have identified revolutionary technologies newly introduced to market, many of which have become household names, helping to shape everyday life for many Americans. The 2010 R&D 100 Award winners will be recognized at the R&D 100 Awards Banquet, which will be held at the Renaissance Orlando Hotel at SeaWorld in Florida on Thursday, November 11, 2010.

8 June 2010

Medical Design Technology magazine stopped by Farm’s booth at MD&M East and interviewed Marc Dubreuil, Director of Business Development at Farm, to learn about the collaboration between Farm and MAKO Surgical Corp. on the design of the RIO® Robotic Arm Interactive Orthopedic System. The video also features Paul Abrams, MAKOplasty Specialist, explaining how the surgeon uses the device and Brian Schmitz, Director of Platform Development at MAKO Surgical Corp., discussing the reasons Farm was selected and highlighting the end result.

9 June 2010

Farm has been honored with a 2010 Gold Medical Design Excellence Award (MDEA) for work on the Rio^® Robotic Arm Interactive Orthopedic System. This revolutionary device, marketed by MAKO Surgical Corp., assists surgeons during minimally invasive knee resurfacing operations.

Farm’s collaboration with MAKO Surgical Corp. brings true product innovation to the hands of surgeons by introducing a proprietary, interactive robotic surgical system that helps treat people living with early to mid-stage osteoarthritis of the knee.

Farm’s human factors expertise helped create an ergonomic design solution that enables the surgeons to have complete freedom of movement of the robotic arm, providing seamless interaction and manipulation during replacement procedures while also accommodating the size variations of users and patients.

On Wednesday, June 9, 2010 the 2010 MDEA winners were honored in a presentation ceremony at New York City's Jacob K. Javits Convention Center. The ceremony is being held in conjunction with the June 8-10, 2010 Medical Design & Manufacturing (MD&M) East Conference and Exposition. Please check out Farm's photos from MD&M-East.

12 May 2010

A case study was recently published in Ergonomics in Design magazine - a publication affiliated with the Human Factors and Ergonomics Society - titled, "User Research Improves Laparoscopic Instruments," co-written by Farm's Director of Research & Usability, Beth Loring, and Industrial Designer, Erin Lemieux.

The case study features a development project that Farm worked on for Cardinal Health's Diamond Line of laparoscopic instruments. The case study discusses how Farm's multi-disciplinary team conducted human factors and user research to design a new handle with improved ergonomics, resulting in improved comfort and usability by utilizing a user-centered development process. Read the case study...

11 May 2010

Farm is pleased to offer our Quality Management System (QMS) as an added value to our clients. May 11, 2010 Farm received ISO 13485:2003 certification by the certifying body, TUV, specific to activities for the development of medical products. Farm also maintains compliance to FDA Quality System Regulation of Section 21 of the Code of Federal Regulations Part 820. Farm's goal is a development process that can meet the unique requirements of our diverse clients. Learn more about Farm's Regulatory Compliance services.

19 March 2010

Cook Medical launched the NavAlign Inferior Vena Cava (IVC) Filter Placement System with a femoral access option this week at the annual scientific meeting of the Society of Interventional Radiology in Tampa Bay, Florida. The femoral access option complements the already available jugular access version. Check out the press release…

5 March 2010

Farm, in conjunction with HollisHelpsHaiti.org, would like to thank everyone who stopped in to donate items and supplies for the victims of the earthquakes that devastated Haiti. HollisHelpsHaiti.org and friends worked together to support the ongoing efforts of the Haitian Community Center of New Hampshire to help the victims in Haiti who are in dire need. All donated items were packed on Tuesday, March 2 at Anheuser-Busch in Merrimack, NH. The relief effort was a complete success!

A 53-foot truck (5,000 cubic feet of space) was packed full and driven to Florida, where it will be shipped to Haiti to assist in the relief effort.

Farm employees donated money, as well as goods, which was used to purchase the following items:

• 10 packages of toilet paper
• 10 boxes of Cheerios
• 10 boxes of oatmeal
• 14 bags of rice (50lbs each)
• 5 cooker/steamer pots
• 2 boxes of diapers
• 4 boxes of baby wipes
• 9 canisters of baby formula
• Various packages/boxes of feminine hygiene products
• 2 rolls of black parachute cord (1,000 feet each)

St. Mary's Bank is still accepting cash donations. Thanks again for making this effort a complete success!

15 January 2010

MAKO Surgical Corp., a client of Farm, has announced the commercial availability of the Lateral Unicompartmental Knee Resurfacing Application for its RIO^® Robotic Arm Interactive Orthopedic System. The new application complements MAKO's existing unicompartmental and bicompartmental knee applications. The MAKO robotic arm system is the first FDA-cleared device of its kind. It is a less invasive partial knee resurfacing procedure that spares healthy bone and tissue, preserves ligaments, and allows for a more rapid recovery and a more natural-feeling knee. Click  Click here to read the press release.

20 November 2009

Farm had the opportunity to partner with Cook Medical on the NavAlign IVC filter delivery system and is excited to learn it's being unveiled at TCT2009. To learn about the NavAlign IVC filter delivery system visit the "Our Work" section. Read the article as seen on medGadget.

17 November 2009

The annual New Hampshire High Technology Council (NHHTC) NH Product of the Year Awards was held Tuesday night, November 17, at the Radisson Hotel in Manchester, NH.

Farm & Viaflo jointly submitted the VOYAGER® Electronic Adjustable Spacing Pipettor for consideration and were chosen as one of four finalists to compete for the title of NH's 2009 Product of the Year.

Farm and Viaflo attended the awards event where the finalists were given the opportunity to showcase their product & explain its significance in a seven-minute presentation to a large audience including Governor John Lynch.

On behalf of Viaflo & Farm, Viaflo's Larry Keene (vice president of sales), accepted the Judge's Award and a Gubernatorial Citation from Governor John Lynch for the VOYAGER ® Electronic Adjustable Spacing Pipettor.

The NHHTC's Product of the Year competition celebrates innovation at its peak in great achievements in product design and development in the Granite State.

12 November 2009

What is World Usability Day (WUD)? Founded in 2005, World Usability Day is an initiative of the Usability Professionals' Association (UPA) to ensure that products and services important to human life are easier to access and simpler to use. It's about making our world work better, and making life easy and user friendly. Each year, over 200 events are organized in more than 43 countries around the globe to increase awareness and train professionals in the tools and issues central to quality usability research, development and practice.

On Thursday, November 12, 2009 Farm participated in WUD's 5-year anniversary event titled, "Designing for a Sustainable World". The event took place in Boston beginning at South Station and ending at MIT's Stata Center.

Farm's exhibit focused on medical product development. Farm designers and engineers created an exhibit that demonstrated how design research informs not only usability, but sustainability as well. Farm used case study examples from Aircast and Cooper Surgical and applied product life-cycle thinking to show opportunities where the goals of usability, manufacturing, and reduced environmental impact align. This has not only helped visitors understand the environmental impacts of medical products over the course of their life-cycle, but has also emphasized that "green" products are more than just a trend; they create real benefits for both users and manufacturers.

The event was a thought-provoking success! Many of the visitors had never thought about the sustainability of medical products before. As part of the day's activities, Farm gathered responses from visitors and gained insights about what elements of sustainability are meaningful to consumers of medical and home healthcare products.

Check out Flickr to see photos from the event!