Research is an important part of the O&P industry, unveiling innovative devices and treatments to help amputees live to their greatest potential. Although academic researchers usually are the ones with their hands in the research field, it is essential for orthotists and prosthetists to also participate in research because they know their patients’ needs well. For an orthotist or prosthetist interested in research, or a researcher just starting out, applying for grants supported by federal agencies, such as the National Institutes for Health or the Department of Veterans Affairs, is a good place to start.

“Federal agencies with over $100 million in extramural research and development (R&D) budgets are required to reserve 2.5% of their budget for small business awards and when you put all that money together it is over a billion dollars,” Kenton Kaufman, PhD, PE, W. Hall Wendel, Jr., Musculoskeletal Research Professor at the Mayo Clinic in Rochester, Minn., told O&P Business News. “So there is a good amount of money available and there is a long list of federal agencies that participate, but I think the most important thing to know is that they are mandated by law to designate a certain amount of money for this activity.”

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Grant application

Before applying for a grant, a practitioner should have a clear idea of what is to be researched and assemble a team to support the research. No matter what institution one applies to for funding, the most important part of the proposal is that one has an idea that will help educate and advance the O&P industry through the beginning of data gathering.

“Whenever you go in for a grant proposal you have to demonstrate the merit of an idea and you have to have already done some preliminary work,” Steven Gard, PhD, associate professor at Northwestern University and executive director of the Northwestern University Prosthetics-Orthotics Center, told O&P Business News. “If you are proposing to do an experiment, you need to have collected some pilot data, or if you are proposing to do some sort of development project, it is always good if you are able to come up with some sort of a prototype.”

Not only is it important to have a unique research topic, but having a great team to work with is important as well. Team members who are each experts in a certain area of research, such as the literature review, or a clinician with many years of practical experience, will help procure a grant. Part of the grant application includes a biography section for the team to fill out, such as honors, awards and other grants and previous research to show how the proposed research will fit with the rest of the portfolio.

“From the funder’s standpoint, all the funders want to get the best possible people to do the work. From the researcher’s standpoint you want to go to the best possible funder to get the funds for what you want to do,” Michael Orendurff, PhD, senior scientist and director of the Biomechanics Laboratory at Orthocare Innovations, told O&P Business News. “You want a large enough budget to accomplish the proposed research, but even more important than a large budget is a long enough budget. A lot of grants only last 1 [year] to 3 years and you have to hire all of these incredibly great people who are usually pretty expensive.”

The biography section is only one part of the application. Your team must put together a proposal that includes a literature review, which explains the purpose of your research, why the research is important and how you plan on performing the research. You must also include an experimental framework with a budget justification explaining who will do the work and how you will spend the money if you receive the grant.

“I always set up an experimental framework without any thought of how much money is available because I want to design the best experiment possible. Usually the whole study costs a lot more than whatever funding is available. So looking at the money available and what the agency is, we find a piece of the full experiment that is a logical, standalone piece that fits the budget,” Silvia Raschke, PhD, principal investigator for the Center for Rehabilitation, Engineering and Technology (CREATE) with the British Columbia Institute of Technology, said. “I tend to think of a lot of these experiments as part of a larger puzzle piece. It would be lovely if we got the funding to build the whole puzzle at once, but that is usually not possible. So I try to look at if we can build one or two or three of the puzzle pieces within the money that is available and move on to the next puzzle piece once the first piece is finished.”

Each institution has its own review period during which a panel reads and reviews all grant proposals and suggests which proposals should be funded. After their review of the proposal, they may make recommendations on how to improve the research plan.

“The review panel will provide suggestions and recommendations and many times you have to submit a revised application based on reviewer comments,” Gard said. “While you are required to address those comments, you are not always required to implement all of their suggestions. But if you don’t, you have to explain clearly why you don’t want to make those changes to your application.”

Many companies and institutions take 1 month to put together a proposal for a grant. However, depending on the size of the grant proposal, the process could take longer. It is important to thoroughly supply all information requested to avoid being denied the grant because of missing information.

“What you are trying to do is build a compelling story as to why you should be funded and not one of the other people who has submitted a proposal,” said Raschke, who is also project leader with the Technology and Product Evaluation Group, British Columbia Institute of Technology.

“Remember these organizations are not monoliths,” Ananth Natarajan, MD, co-founder of Infinite Biomedical Technologies, said. “They are essentially filled with well-meaning people who are trying to make the world a better place. So, if you approach them at the human level and explain what you are trying to accomplish, a lot of times you can develop them as internal champions to help you.”

National Institutes of Health

The National Institutes of Health (NIH) provides many opportunities for grant funding through their Request for Proposals, which lists open calls for proposals from different NIH institutes and centers. Generally, the NIH funds grant proposals relevant to public health needs and are within NIH institute and center priorities. However, NIH will support unsolicited research and training applications that do not fall within the scope of NIH-requested targeted announcements, but they request that all projects are unique as they “cannot support a project already funded or pay for research that has already been done.”

After you submit the grant proposal, it goes through a rigorous two-step peer review process to assess its scientific merit. According to the NIH, “the first level of review is carried out by a Scientific Review Group (SRG) composed primarily of non-federal scientists who have expertise in relevant scientific disciplines and current research areas. The second level of review is performed by Institute Center National Advisory Councils or Boards. These advisory councils are composed of both scientific and public representatives chosen for their expertise, interest or activity in matters related to health and disease. Only applications that are favorably recommended by both the SRG and the Advisory Council may be recommended for funding.”

Although each NIH grant program has its own set of eligibility requirements, the NIH supports scientists at various stages in their careers and is committed to supporting new and early stage investigators. All domestic or foreign, public or private, non-profit or for-profit organizations are eligible to receive NIH grants, but the NIH may limit eligibility for certain types of programs. Finally, foreign institutions and international organizations are eligible to apply for research grants, except for Kirschstein-NRSA institutional research training grants, program project grants, center grants, resource grants, Small Business Innovative Research/Small Business Technology Transfer grants or construction grants. However, some grants may be awarded to domestic projects with a foreign component.

Small Business Innovative Research

For small businesses interested in pursuing research, going through the Small Business Innovative Research (SBIR) program may be ideal. A highly competitive program, SBIR “encourages domestic small businesses to engage in Federal Research/Research and Development (R/R&D) that has the potential for commercialization.” The goals of SBIR are to stimulate technological innovation, meet federal research and development needs, encourage innovation and entrepreneurship by socially and economically disadvantaged individuals and to increase private sector commercialization of innovations derived from federal research and development funding.

Phases I and II of the three-phase program are the only phases that are funded; the third phase supports small business efforts to pursue commercialization objectives based on the results from the previous phases.

“Phase I awards normally do not exceed $150,000 and have a period performance of 6 months. So this is basically establishing the technical merit, the feasibility and the commercial potential,” Kaufman said. “The phase II award is a continuation of the work done in phase I, and, again, is reviewed for scientific and technical merit. These awards generally do not exceed $1 million and have a 2-year period of performance.”

To be eligible for phase I or phase II awards, a small business must be organized for profit and have a place of business located in the United States. It must be 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or at least 51% owned and controlled by another for-profit business with the same citizen and residency requirements, and must have no more than 500 employees, including affiliates.

For companies pursuing research in the O&P industry, it is especially important to focus on the end goal.

“For a company pursuing research grant funding, I think it is in the best interest of everyone if the company thinks of a commercialization strategy and a pathway to get the research to the patients in the end, because without that it becomes an endless cycle of just pursuing grant after grant,” Rahul Kaliki, PhD, chief executive officer of Infinite Biomedical Technologies, told O&P Business News.

Although not every application can be accepted, according to Mark Pitkin, PhD, research professor of physical medicine and rehabilitation at Tufts University School of Medicine, you may resubmit your application after it is reworked.

“If the application is not funded but has a certain level of positive parameters an applicant is provided with comments by reviewers,” Pitkin, who has been both an applicant and review panelist for SBIR, said. “In most cases, they are constructive and there is a high probability that when the comments are addressed the applicant could be successfully funded. So one should not be discouraged if they are rejected. Just read the comments by the reviewers carefully and address them in the best possible way. You may decide to include some new members to your team, probably from academia. That could help in conducting objective evaluation of your innovative technology in the university laboratory with the adequate equipment and statistics.”

NIDRR

According to its website, the mission of the National Institute on Disability and Rehabilitation Research (NIDRR) “is to generate new knowledge and promote its effective use to improve the abilities of people with disabilities to perform activities of their choice in the community, and also to expand society’s capacity to provide full opportunities and accommodations for its citizens with disabilities.”

“[NIDRR] is tuned in to the wants and the needs of the end user of the product or as the primary beneficiaries of the research and development projects,” Gard said. “So they have a slightly different emphasis area than the NIH or VA.”

Grants are awarded through nine programs: disability and rehabilitation research projects; rehabilitation research and training centers; rehabilitation engineering research centers; Switzer research fellowship program; field-initiated projects; spinal cord injury model systems centers; and small business innovation research. Although NIDRR accomplishes its mission largely through grants with institutions of higher education, for-profit and non-profit organizations and other agencies and organizations, individuals are also eligible to apply through the Switzer research fellowship program.

Because not all grant areas are funded every year, NIDRR provides a listing of planned and open competitions so researchers can determine which areas are likely to be in competition in a given year. Grant competitions for NIDRR are also listed in the Federal Register.

Non-traditional grants

Although there are not many non-traditional ways of obtaining grants and funding in the O&P field, two sources for researchers in the O&P industry to apply for funding are through the American Orthotic & Prosthetic Association (AOPA) and the Orthotics & Prosthetics Education Research Foundation (OPERF).

On an annual basis, AOPA sends out a Request for Pilot (RFP) to fund four small grant pilot projects, which are reviewed and scored by the Center for O&P Learning (COPL). After reviewing COPL’s recommendations, the AOPA board decides on specific funding of $15,000 for each project.

AOPA occasionally will also issue specific RFPs related to needed research. These specific research projects have ranged in size from $50,000 to $250,000, and four to six grants of this size have been awarded during the last 5 years.

“Typically, AOPA’s grants are well defined. They will put our requests for applications, but in specific areas and investigators are welcome to submit proposals to achieve desired objectives set forth by AOPA,” Gard told O&P Business News.

Another non-traditional path is through OPERF, which was established in 2008 to specifically serve the O&P profession. A 501(c)3 not-for-profit organization, funds contributed to OPERF are used to award grants to researchers in the profession, as well as to students attending O&P education programs and for educators pursuing advanced degrees through a competitive grant program.

“OPERF has funded a few projects in our laboratory at the Northwestern University Prosthetics-Orthotics Center over the last several years,” Gard said. “In particular, some of our graduate students have received fellowships from them that provide a small amount of funding to assist with their projects. Additionally, OPERF does provide larger grants that go to principal investigators to assist with research projects being undertaken by faculty and other full-time researchers.”

According to Gard, manufacturers will also fund grant proposals, but the research may not be as transparent as when they are funded by other industries.

“In a lot of cases manufacturers will want final approval of testing protocols of their products. In that case they do have considerable influence over the study topic,” he said. “However, that is not to say those projects don’t turn out research, because in most cases they do, but the manufacturers want to partner with the investigator to produce the final research product.”

Collaboration

Whether one is a researcher with several years of experience or a researcher just starting out, the best way to be approved for a grant is to collaborate with the researchers and practitioners who are the best in their field and who have the most experience.

“If somebody is interested in doing research they would benefit from getting involved with experienced investigators, somebody who has had several grant proposals funded,” Gard said. “There are tips and tricks to putting together a good research proposal so it helps to have an experienced mentor if you want to break into the field of research.”

Practitioners who are looking to take a step into research may attend a conference, find a topic of interest and inform the researchers of their interest in the project.

“I do think that going to a conference, listening to someone talk and saying I would like to collaborate is an important first step,” Orendurff said. “I think also having that dialogue between the researcher and practicing prosthetist or orthotist is incredibly important because the researcher is not in the field. They don’t know what the problems are. They have this other set of skills, but to help them define a really important question they desperately need that dialogue with the actual clinical practice person in the trenches doing the work.” — by Casey Murphy

Disclosure: Kaliki is an employee and shareholder of Infinite Biomedical Technologies. Gard, Kaufman, Natarajan, Orendurff and Raschke have no relevant financial disclosures.