Getting to market with rapid FDA 510K approval and enhancing the Vertebral Motion Analysis system with computer vision expands Ortho Kinematics’ ability to treat more patients and improve outcomes.
Healthcare – Medical Devices
Artificial Intelligence – Computer Vision
- System limitations constrained the ability to support growth
- Recognized the need to rewrite the system and move to modern architecture
- Strong market demand created pressure to deliver quickly and obtain FDA 510K approval
- Needed to increase efficiency and improve measurement accuracy to improve diagnosis
- Budgeted 90 days for 510K submission process; obtained FDA approval in just 27 days
- Reduced image processing time by 25%
- Moved to a WPF front-end and .NET back-end for a modern, scalable, and efficient system
- Enriched system with computer vision for improved diagnosis
- Expanded capabilities to treat more patients
Headspring is a partner we can trust. Working with their team is very much a collaboration, and through that collaboration we were able to hold an aggressive timeline and successfully launch a new platform that is responsive, efficient and scalable.
Ortho Kinematics is an imaging informatics company focused on spinal diagnostics. The company delivers a new standard for patients and physicians by leveraging spine biomechanical data to improve the diagnosis and treatment of pain related to spinal instability. The core system, Vertebral Motion Analysis (VMA), uses fluoroscopy imaging and proprietary analytical software to generate accurate and precise measurements used in the detection of spinal instability.
Support growth initiatives
The VMA system gained traction with physicians, and Ortho Kinematics expected new orders to double within a 4-month timeframe. The current system capacity was at its limit, and technical limitations constrained the ability to support the rapid product adoption. Expecting rapid growth, the platform needed to be scalable and more responsive for end users.
Become more efficient
Ortho Kinematics needed to reduce the time to produce test results. Images uploaded to the VMA online servers spent 150 minutes in the processing queue. The challenge was to reduce the time required to markup events while improving the level of accuracy. Faster markups meant more capacity to treat more patients.
Move to modern architecture
The VMA system was written with MATLAB, which worked well as a proof of concept and for the initial release. To strengthen their portfolio, Ortho Kinematics required a modern architecture and system rewrite. In conjunction, MATLAB required significant hosting and server costs that negatively impacted profit margins.
Get to market fast
The revolutionary VMA system had proven beneficial with patients achieving better treatment outcome, and providers realizing reduced cost of care. A strong market demand for the improved imaging technology challenged Ortho Kinematics to move to market with speed. This included obtaining FDA 510K regulatory approval for medical devices as quickly as possible.
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Industry experience in healthcare
Obtaining FDA 510K clearance is a complex process, and Ortho Kinematics needed a partner with experience in the highly regulated healthcare market with a thorough understanding of FDA standards and the rigid 510K submission process. Headspring has proven success with 510K submissions and approvals, including all the detailed software documentation, testing verification, and design validation.
Ortho Kinematics was in a time crunch and needed a partner who could work fast enough to meet their tight deadlines. Headspring’s agile delivery, development speed, and accurate scoping and estimation enabled them to exceed business deadlines, accelerate the product timeline, and satisfy FDA requirements.
The right team
Headspring’s collaborative style fit the business needs, and the depth of the team coupled with unique experience in the healthcare space allowed for the flexibility to ramp up and dial down team members as needed to support project initiatives. Solid technical qualifications and .NET expertise solidified the partnership.
- The system rewrite in .NET equipped Ortho Kinematics with a solid foundation to achieve a modern, scalable, and efficient replacement for MATLAB. They would no longer be constrained by the limitations and slowness of MATLAB and eliminated the high cost associated with server and hosting expenses.
- The rewrite utilized a WPF front end, which offered a very polished, responsive, and customizable user experience. The Ortho Kinematics team was set on harnessing the power of the local PC’s capabilities to do the computer vision for the vertebra tracking, so a thick desktop client was the optimal solution.
- OpenCV replaced and improved upon MATLAB functionality. This would enrich the system with real time image processing capabilities, circle detection algorithms, and the ability to generate more accurate motion measurements and precise calculations.
Transparent delivery process
Ortho Kinematics wanted to be hands-on and involved throughout the project. The agile delivery process included requirements definition, demos, and flexible backlog discussions in bi-weekly sprints. Headspring did thorough analysis of the business to fully understand the historical implementation of the software and how previous code was handled. This due diligence and business alignment ensured every change was deliberate and rooted in business value. Headspring kept a constant pulse on the system performance and cross referenced the existing MATLAB code to ensure a smooth rewrite and no disruptions to the business.
Documentation for FDA 510K
Headspring generated solid testing plans, supporting evidence, and thorough safety and efficacy documentation to prepare for a successful FDA submission. The rewrite was prioritized based on which features were imperative to the business and would demonstrate the device is equivalent to the predicate device. As the final submission deadline approached, last minute requirements were rapidly turned around in a matter of days to keep the submission on track.
Successful 510k submission
Ortho Kinematics successfully got the product to market with 510K approval. They budgeted 90 days for the process, and the FDA approved the VMA System in just 27 days – surpassing all expectations.
The average time imaging events spent in the processing queue decreased 25% – most notably, the reduced time spent waiting for background measurement processing. The new system enabled a more efficient workflow for minor markup correction, and users were able to quickly pivot to adjust markups, whereas before an incorrect label required users to restart the entire process. The efficiency of the system enabled Ortho Kinematics to significantly expand capacity, run more tests, and ultimately treat more patients.
Modern system for a competitive advantage
The new system eliminated the high server and hosting expenses, resulting in cost savings that provided Ortho Kinematics the flexibility to negotiate contracts with new providers and invest further in R&D. The new platform in .NET significantly reduced the time DevOps spent resolving production errors from inconsistent or unreliable processing logic in the old software. This allocated more time for implementing new features and conducting exploratory research.
Enhanced system with new capabilities
Beyond the system rewrite, new feature enhancements made the system more robust. The grid calibration corrects non-linear radial distortion which yields precise calculations for the angulation between bones and provides physicians with the levels of accuracy needed to detect instability. Standard x-rays rely on a single image, whereas the VMA system takes hundreds of images and performs calculations across every image to precisely identify movement and tracking. New reporting features allow for full spinal imaging, instead of only lumbar and cervical vertebrae, which equips physicians with more data points for a thorough diagnosis.
Expanded to treat more patients
The previous system only worked for patients with typical anatomy (i.e. five vertebrae in the lumbar region) and would not work on patients who had an extra lumbar vertebra. The new system was designed to function for patients with the presence of a sixth lumbar vertebra, ultimately allowing Ortho Kinematics to serve a greater number of patients.
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