Better Business Series: OrthoCare Innovations Is Changing the Game

If you follow O&P news, you've probably heard of Orthocare Innovations, Oklahoma City, Oklahoma. Through a complex progression of acquisitions, ambitious hiring, and cooperative agreements-plus some native expertise in politics and fund-wrangling-Orthocare is on course to become a game-changing force in the profession, one with ambitions to help usher in a next-generation vision of O&P patient care and devices.

Just two years after its founding, the company claims to have the largest non-university-affiliated prosthetics research group in the United States. It has pulled in tens of millions of dollars in federal research grants, and at the time of this article's writing, Congress is considering granting it $8 million more to found a major rehabilitation-technology-transfer center.

Throughout the past two years, it has announced hires of top-level researchers in biomechanics, bionics, and prosthetics. Its scientific and corporate advisory boards read like a Who's Who in American business and science, and include the heads of groups such as the Orthotic and Prosthetic Group of America (OPGA), Waterloo, Iowa, and Hanger Orthopedic Group, Bethesda, Maryland.

During this time, Orthocare Innovations and its staff have made scientific and technical contributions to technologies central to the Defense Advanced Research Projects Agency

(DARPA)-sponsored Revolutionizing Prosthetics 2009 (RP2009) program, whose objective, according to the RP2009 website, is to "create, within this decade, a fully functional (motor and sensory) upper limb that responds to direct neural control." Beyond its laboratory contributions, Orthocare may also play a significant role in seeing these technologies transition from the lab bench into clinical use.

Through in-depth interviews with principal players at the company, The O&P EDGE found out how they've come so far, what they're offering the profession, and what lessons they have for and have learned from other O&P businesses.

Company Genesis

Doug McCormack David Boone

Orthocare is the product of the long industry experience of three people: David Boone, CP, MPH, PhD; Kim Coleman, MS; and Doug McCormack, JD. McCormack, who approached the other two co-founders about the venture, was already a serious power in O&P in 2007. An amputee himself who has studied not only law, but also biomedical engineering and political science, he has spent more than 15 years working as a lawyer and lobbyist handling policy, law, and funding issues for national organizations and early-stage companies alike. As the former vice president and legal counsel for the Amputee Coalition of America (ACA), he was pivotal in securing millions in funding for the ACA. He also served on major projects for the American Orthotic & Prosthetic Association (AOPA); Otto Bock HealthCare, Minneapolis, Minnesota; and Hanger.

McCormack says he decided to found the company because he "wanted to set a strategic course and execute it based on my own experience and desires, as opposed to helping others advance their own businesses."

Stuart Harshbarger and Matt Kozlowski work on hand componentry.

As an initial move, he purchased an interest in Cyma Corporation, Seattle, Washington. A private spinoff of the Prosthetics Research Study (PRS), Cyma held licenses for a number of novel rehabilitative technologies, including the StepWatch clinical activity-monitoring system. Coleman had served as principal investigator on a number of Cyma projects, including those that led to the development of StepWatch, and Boone was Cyma's head of research.

At Cyma, McCormack says, he recognized the possibilities of combining Boone's and Coleman's scientific and engineering expertise with his own passion for building organizations. "That combination of assets and abilities could be tremendously effective in setting a new course of action in the field," he says. In October 2007, McCormack, Boone, and Coleman purchased Cyma and formed Orthocare Innovations, LLC.

Carol Sorrels

"We decided to launch our company around the notion that there is significant opportunity to bridge the gap that exists between technology development, productization of those technologies, and successful transfer of those technologies into the commercial marketplace, " McCormack recalls.

According to Carol Sorrels, Orthocare's director of marketing and communications, one of Orthocare's first acts was to arrange a meeting between its principals and their longtime industry colleague, Stuart Harshbarger, who was then the program manager and systems integrator for RP2009, as well as a member of the principal professional staff at Johns Hopkins University Applied Physics Laboratory (JHUAPL), Laurel, Maryland, which leads the DARPA arm program. Considering the team's scientific capacity and McCormack's business and legislative record, Harshbarger strongly encouraged Orthocare to join RP2009, and by December 2007, the company was a program contractor.

Building the DARPA Connection

Stuart Harshbarger

In April 2008, Orthocare purchased Martin Bionics, which was also an RP2009 research partner. This purchase bought Orthocare a larger role in the program. Then, in January 2009, Orthocare announced one of its most significant news items of the year: a technology licensing agreement with Oak Ridge National Laboratories (ORNL) that enables the application of mesofluidics (small-scale hydraulics technology) developed under the DARPA program for use in new O&P devices.

With its strong ties to JHUAPL and demonstrated technology-transition initiatives, Orthocare then made another major score in June 2009: Harshbarger and another key member of the RP2009 leadership team, Matt Kozlowski, PhD, left behind most of their JHUAPL duties to join Orthocare. Harshbarger, now Orthocare's chief scientific officer, led more than $100 million in federally supported research from 2005-2009 at JHUAPL. Kozlowski, now Orthocare's director of robotic systems, also serves as program manager for the U.S. Navy's Advanced Explosive Ordnance Disposal Robot System (AEODRS) system integration effort. According to Harshbarger, they joined the company because of their "desire to see the [DARPA] research efforts through the transition process and into clinical use." The company is now assessing prototype devices stemming from the mesofluidics agreement, and plans to begin commercializing the technology within the next several months.

Boone asserts, "The whole [RP2009] project is really a once-in-a-lifetime opportunity for a researcher in a field like prosthetics. I certainly have never seen anything like that level of effort and expertise put together to bear on prosthetics, and I don't think I ever will again.... Our unique position was that we were one of the few participants in that whole project who was technically capable of participating in Revolutionizing Prosthetics and were also set up...to commercialize and to disseminate that kind of technology to clinical use."

Strength through Diversity However, the company's product-development reach extends far beyond the DARPA arm. Orthocare has developed or is aggressively researching toward market other forward-thinking technologies both related and unrelated to O&P, including highly dexterous robotic manipulation systems for military and homeland security applications and an incontinence-management system that prevents pressure ulcers by alerting nurses when nursing-home patients need to be changed.

Harshbarger explains, "What Orthocare has is a more holistic view of how some of these technologies interrelate. For example, if someone develops a pressure ulcer, that could lead to limb loss and further affect their mobility and quality of life.... Looking at technologies so that they are used to the maximum benefit to improve the users' outcome-to prevent injury, help mitigate injury, and then foster the recovery process-is very consistent with Orthocare's mission."

Cooperation and Support The business savvy required to bring these technologies to market has made Orthocare into what Thomas Kirk, PhD, calls an "innovative, fast-moving company" that has made "remarkable progress in identifying the relevant projects, applying talented personnel to develop forward-thinking solutions, and working with the appropriate government entities to secure funding and support." Kirk, who is Hanger's president and CEO, is just one of the high-powered members of Orthocare's business advisory board. The company's business and science advisory boards include thinkers at the top of their fields who have helped Orthocare through not only the myriad challenges that early-stage businesses generally face, but also the minefields of federal funding and regulation.

The company has also cultivated cooperative agreements with more than a dozen private, federal, and university groups, including Lockheed Martin, Bethesda; and the National Institutes of Health's (NIH) National Institute of Nursing Research and National Center for Medical Rehabilitation Research. These relationships have made Orthocare a more appealing recipient for contracts and grants.

McCormack says, "By marrying up public policy and the ability to tap federal sources of funding both through the political process and through the competitive grant process, we have an opportunity to be the company that can bridge the gap between early-stage research and commercialization of technology in this field."

Developing the Future OPGA President Dennis Clark says, "I believe that in the next 15 years, we'll have more innovation in orthotics and prosthetics than since the Civil War, and Orthocare Innovations will be right at the tip of the spear, leading those innovative changes."

Orthocare's particular vision for the future of prosthetics is at the center of the company's mission and has driven its research into technologies such as a dynamically adjusting prosthetic socket, a computerized prosthetic-alignment system (Compas), and a haptic-feedback system for prostheses. ( Editor's note: For more information on Compas, see " Alignment Systems Step Forward ." )

"Most of what we're doing here is predicated on a major concept-that prostheses are going to become more adaptable to the needs of the user and their environment," Boone says. "Until recently, a person using a prosthesis adapted to the device rather than the other way around, and we see that as fundamentally changing.... When we look at prosthetic function, we're thinking about not just standing or sitting in our rooms-the world is hilly and hot, and having prosthetic devices that adapt in real time to the changing needs and environments of their users is where we're going."

To achieve this next-generation thinking, Orthocare is focusing on two major fronts: data-driven technology and a common directive within the community of prosthetists and researchers.

"The basis of any science is being able to measure something and reproduce it," Boone explains, "and that is one of the main things that has kept prosthetics from being more of a science and less of an art." He also believes that technology that facilitates evidence-based practice "solidifies reimbursement." He asserts that it will "put the measure of function onto solid ground, so people can understand what they're paying for."

However, though reimbursement fuels the profession, innovation guides it, and Orthocare maintains that if the profession shares a vision of the future, innovations will be easier.

To serve that purpose, the company has formed the Orthocare Innovations Foundation, a 501(c)3 nonprofit that includes the Limb Restoration Institute. The institute's first project will be a conference titled Prosthetics 2020: The Future of Physical Restoration. Expected participants at the invitation-only event, October 28-29, include representatives from the Department of Defense (DoD), the U.S. Department of Veterans Affairs (VA), National Institutes of Health (NIH), Rehabilitation Institute of Chicago (RIC), JHU, and Hanger. The purpose of the conference is to bring experts together to share ideas and, ideally, to develop consensus about directions to pursue in both O&P technology and the clinical models needed to deliver it.

The Take-away For all this ambition, the company remains cautiously optimistic. McCormack allows that from the perspective of an early-stage company, Orthocare's success "is an indication that if you build the right kind of teams, are aggressive and really persistent, a lot can be achieved. Some may have the notion that, for a host of reasons, this field is locked up and controlled by a very small handful of companies. But from our perspective, there is opportunity to effect change in the field and to do that in a very meaningful way-and we're really staking our claim to that. Our approach to affecting the field is to have a sound scientific underpinning, which makes it difficult for anyone to discount what you're doing."

However, when asked what lessons Orthocare's successes might offer the O&P industry, McCormack demurred. "I would say that it's more about what we can learn from other companies. We're very respectful of the history and the origin of companies that have true global reach and a history of excellence, like Otto Bock, with its 90 years of history. We're hoping to learn for many years from the companies that have come before us and achieved so much."

Morgan Stanfield can be reached at linkEmail('morgan','opedge.com');

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