North Carolina-based software research and development company Kitware and its three Arkansas university partners received a $1.725 million Small Business Innovation Research grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This Fast-Track award will support design, development, and validation of a Virtual Rotator Cuff Arthroscopic Skill Trainer (ViRCAST) to virtually simulate arthroscopic rotator cuff repair surgery and demonstrate its effectiveness as a training platform for surgical residents.
Surgical repair of the rotator cuff is one of the most common orthopedic procedures performed and accounts for approximately 75,000 procedures each year in the U.S. alone.
ViRCAST is being developed in response to the needs of teaching hospitals across the country for an arthroscopy training program that provides standardized, quantified feedback for evaluation and self-assessment. This simulator can readily be incorporated into surgery-training curriculum.
For the three-year project, Kitware is collaborating with the University of Central Arkansas, University of Arkansas for Medical Sciences, and Arkansas Children’s Hospital. The project will be led by principal investigators Dr. Venkata S. Arikatla of Kitware and Dr. Tansel Halic of UCA.
Co-principal investigators include Dr. Sinan Kockara of UCA, Dr. Shahryar Ahmadi, director of the UAMS Shoulder and Elbow Surgery Center, and Dr. Andinet Enquobahrie, the director of medical computing at Kitware.
Prior to this SBIR award, Halic and Kockara worked extensively with Kitware and UAMS on related projects.
The Problem
“Surgical treatment of the rotator cuff with arthroscopy has increased by 141% in the last decade alone,” said Arikatla.
Arthroscopy is a minimally invasive surgical procedure on a joint in which an examination and sometimes treatment of damage is performed using an arthroscopel, an endoscope that is inserted into the joint through a small incision.
Simulation-based training has been shown to decrease operative time which reduces operating room and anesthesia costs and increase clinical productivity. Patients benefit from reduced charges associated with decreased operative time as well as reduced error rate.
“Our interest of the project stemmed from the long discussions with Dr. Shahryar Ahmadi of UAMS. After several discussions with Dr. Ahmadi and observations of shoulder arthroscopy in the actual operating room, we realized that surgery residents need a risk-free, low-cost, realistic training environment where they can practice and improve their skills while getting quantitative feedback for their performances,” said Drs. Halic and Kockara.
“Over the years, arthroscopy has evolved as a prevailing technique for the visualization, diagnosis and treatment of joint ailments as opposed to the open surgery. Our discussions with Dr. Ahmadi revealed the lack of standardized curriculum or training program for arthroscopy. Our research also revealed that there are no standard guidelines and regulations regarding the objective performance measurement for the proficiency and training level of the surgeons,” said Dr. Ariklatla.
Arkansas Collaboration
The project will be led by Drs. Arikatla and Halic, both of whom have more than a decade of experience working with simulation-related technologies and have worked on numerous NIH-funded projects.
“The project PIs will work with the business development team at Kitware to move towards commercialization,” said Dr.Arikatla.
Ahmadi (UAMS) is an expert in arthroscopy who has been instrumental in guiding the PIs on the clinical problem. Kockara (UCA) and Dr. Adinet Enquobahrie (Kitware) bring decades of experience in image processing and executing small business grants.
In 2017, Drs. Halic, Kockara and Ahmadi won a grant through the Arkansas IDeA Network of Biomedical Research Excellence (INBRE) program to optimize difficulty scenarios for virtual simulation of Arthroscopic Rotator Cuff repair surgery. “Kitware became very interested in our INBRE project. Kitware’s Drs. Arikatla and Andinet Enquobahrie were also engaged in orthopedic surgery and minimally invasive surgery fields in other ongoing projects. After many meetings with Dr. Arikatla, we decided to work closely on this project. Thanks to our INBRE award, we had protected time for research and as a result, we developed preliminary studies for this SBIR project,” said Dr. Halic.
“UCA will work on all the specific aims of the project including the design and development of the simulator and hardware interfaces. This work will be followed by rigorous human subject studies that aim to understand the effectiveness of the simulator,” said Dr. Kockara.
This project requires distinct disciplines and expertise. “Our skills and abilities complement each other, and we have long record of collaboration. We all like to work together that creates synergy in research. At the end of the day, we all like what we do and feel and share the strong desire to contribute to our field and eventually help directly or indirectly to patients’ well-being,” said Dr. Halic.
The ViRCAST Solution
“The ViRCAST platform will provide residents with a safe environment to reduce training time for acquisition of necessary skills and provide an objective skill learning process with quantitative measures. ViRCAST will incorporate structured and customized learning that is expected to improve trainee’s psychomotor skills while providing cognitive feedback. It will also assist training by providing increasing difficulty scenarios,” said Dr. Ariklatla.
Unlike the competition, ViRCAST will offer:
- Fully physics-based simulation
- Advanced arthroscopy tasks, such as anchor placement and knot-tying tasks and their hardware interfaces together
- Cognitive tasks (e.g. prevention of excessive bleeding) and various difficulty cases
- Support for individual and deliberate learning
Once fully developed, ViRCAST will become part of an open-source toolkit-Interactive Medical Simulation Toolkit (iMSTK) designed for rapid prototyping of medical trainers and planners that Kitware has been developing in collaboration with Rensselaer Polytechnic Institute and UCA.
“iMSTK serves as the foundational software platform that Kitware will use to commercialize ViRCAST,” said Dr. Ariklatla.
Customers
Kitware anticipates marketing ViRCAST directly to surgical instrument manufacturers and major university teaching hospitals. There are 94 teaching hospitals with arthroscopy programs in the US. Around 640 residents complete orthopedic residency training every year, and approximately 90% pursue fellowship training.
ASBTDC Assistance
“Our team’s unique virtual reality approach to surgical simulation will enable ViRCAST to deliver effective solutions for teaching hospitals and surgical residents in North America, Canada, and beyond, as well as providing a customized tool for corporate R&D and surgical training facilities. In addition to the self-paced learning that will be provided by our trainer, we will work in conjunction with teaching hospitals such as UAMS and Children’s National Medical Center to build a certification simulator,” said Dr. Ariklatla.
“We very much appreciate ASBTDC and its staff for their contributions. Especially, we would like to note that Rebecca Todd was excellent, and she had been urging us to develop SBIR proposals since the very beginning. She has been very active and was bringing all the help that we require during the business and commercialization plan development. ASBTDC staff were great and extremely helpful during the proposal development, specifically in market research,” said Drs. Halic and Kockara.
“ASBTDC’s services were crucial for us to compile a strong commercialization plan. Their market research staff produced a timely, 100-page report with extensive research on the competitive landscape for ViRCAST (obtained quotes in some cases), quantitative target market research with citations and ten-year projections for the market nature and size. This detailed research material allowed us to draft a an extremely detailed commercialization plan that was supported by quantitative data,” said Dr. Ariklatla.
Lessons Learned
“SBIR proposal development was a quite an experience. We learned a lot. The commercial side of it was interesting, difficult, and at the same time fun. NIH SBIR proposals require many details and documentation. We learned that the proposal needs to be perfect, with no gaps in any parts. The significance, innovation, and approach should be all nicely laid out and strongly supported with a carefully thought-out business plan,” said Dr. Kockara.
Advice for Arkansas University Researchers Interested in SBIR Project Collaboration
“SBIR grant proposals should be well thought-out proposals that involve careful time management and strong involvement of a company with preferably a record of producing similar products. The project deliverables and details should be considered and planned well in advance of the submission deadline. Coordination and harmony of all parties involved are critically important for success,” said Dr. Halic.
“Research reported in this publication was supported by the National Institute of Arthritis And Musculoskeletal And Skin Diseases of the National Institutes of Health under Award Number R44AR075481. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.”